This readme.txt file was generated on 2023-05-12 by Nicole Fetcho ------------------- GENERAL INFORMATION ------------------- 1. Title of Dataset: A randomized, open-label study of the tolerability and efficacy of one or three daily doses of ivermectin plus diethylcarbamazine and albendazole (IDA) versus one dose of ivermectin plus albendazole (IA) for treatment of onchocerciasis 2. Author Information: Principal Investigator Contact Information Name: Nicholas O. Opoku Institution: University of Health and Allied Sciences Institutions ROR: https://ror.org/054tfvs49 Address: PMB 31, Ho, Volta Region, Ghana Email: noopoku@uhas.edu.gh ORCiD:0000-0001-9495-8874 Contact person for questions Name: Gary J. Weil Institution: Washington University School of Medicine Institutions ROR: https://ror.org/01yc7t268 Address: 660 S. Euclid Ave, St. Louis MO, 63110 Email: gary.j.weil@wustl.edu ORCiD: 0000-0002-6336-3824 Contact person for questions Name: Peter U. Fischer Institution: Washington University School of Medicine Institutions ROR: https://ror.org/01yc7t268 Address: 660 S. Euclid Ave, St. Louis MO, 63110 Email: pufischer@wustl.edu ORCiD: 0000-0003-4558-3417 Associate or Co-investigator Contact Information Name: Nicole L. Fetcho Institution: Washington University School of Medicine Institutions ROR: https://ror.org/01yc7t268 Address: 660 S. Euclid Ave, St. Louis MO, 63110 Email: fetcho80@wustl.edu ORCiD: Associate or Co-investigator Contact Information Name: Augustine R. Hong Institution: Washington University School of Medicine Institutions ROR: https://ror.org/01yc7t268 Address: 660 S. Euclid Ave, St. Louis MO, 63110 Email: ahong22@wustl.edu ORCiD: 0000-0003-0811-9084 Associate or Co-investigator Contact Information Name: Kerstin Fischer Institution: Washington University School of Medicine Institutions ROR: https://ror.org/01yc7t268 Address: 660 S. Euclid Ave, St. Louis MO, 63110 Email: kfischer@wustl.edu ORCiD: Associate or Co-investigator Contact Information Name: Daphne Lew Institution: Washington University School of Medicine Institutions ROR: https://ror.org/01yc7t268 Address: 660 S. Euclid Ave, St. Louis MO, 63110 Email: daphne.lew@wustl.edu ORCiD: 0000-0001-5433-2367 Associate or Co-investigator Contact Information Name: Charles W. Goss Institution: Washington University School of Medicine Institutions ROR: https://ror.org/01yc7t268 Address: 660 S. Euclid Ave, St. Louis MO, 63110 Email: cwgoss@wustl.edu ORCiD: 0000-0003-2682-7316 Associate or Co-investigator Contact Information Name: Felix Doe Institution: Hohoe Municipal Hospital Institutions ROR: https://ror.org/054tfvs49 Address: PMB 31, Ho, Volta Region, Ghana Email: felixdoedr@yahoo.com ORCiD: Associate or Co-investigator Contact Information Name: Bettina Duben Institution: University Hospital Bonn Institutions ROR: https://ror.org/01xnwqx93 Address: Venusberg-Campus 1, 53127 Bonn, Germany Email: bettina.dubben@ukbonn.de ORCiD: Associate or Co-investigator Contact Information Name: Shelter Gordor Institution: University of Health and Allied Sciences Institutions ROR: https://ror.org/054tfvs49 Address: PMB 31, Ho, Volta Region, Ghana Email: gshelter@uhas.edu.gh ORCiD: Associate or Co-investigator Contact Information Name: Rukaya Laryea Institution: University of Health and Allied Sciences Institutions ROR: https://ror.org/054tfvs49 Address: PMB 31, Ho, Volta Region, Ghana Email: rlaryes@uhas.edu.gh ORCiD: 0000-0001-9147-118X Associate or Co-investigator Contact Information Name: Michael Ekuoba-Gyasi Institution: St. Thomas Eye Hospital Institutions ROR: Address: Kpanla St, Accra, Ghana Email: mikegyasi67@gmail.com ORCiD: 0000-0002-6929-2588 Associate or Co-investigator Contact Information Name: Achim Hoerauf Institution: University Hospital Bonn Institutions ROR: https://ror.org/01xnwqx93 Address: Venusberg-Campus 1, 53127 Bonn, Germany Email: hoerauf@uni-bonn.de ORCiD: 0000-0002-8671-3831 Associate or Co-investigator Contact Information Name: Eric Kanza Institution: University of Health and Allied Sciences Institutions ROR: https://ror.org/054tfvs49 Address: PMB 31, Ho, Volta Region, Ghana Email: hoerauf@uni-bonn.de ORCiD: Associate or Co-investigator Contact Information Name: Mahama Alhassan Seidu Institution: School of Biomedical and Allied Sciences Institutions ROR: https://ror.org/054tfvs49 Address: Harley St, Accra, Ghana Email: maseidu@ug.edu.gh ORCiD: 0000-0003-2105-5169 Associate or Co-investigator Contact Information Name: Christopher King Institution: Case-Western Reserve University Institutions ROR: https://ror.org/051fd9666 Address: 10900 Euclid Ave, Cleveland, OH 44106 Email: cxk21@case.edu ORCiD: 0000-0003-3873-7860 3. Date of data collection (single date, range, approximate date) 2019/12 - 2022/03 4. Geographic location of data collection (where was data collected?): Hohoe, Ghana 5. Information about funding sources that supported the collection of the data: Funder name: Bill and Melinda Gates Foundation Award number: OPP1190749 Award # URL: http://dx.doi.org/10.13039/100000865 6. Contextual description of the data: Data collected from participants at during a clinical trial in Hohoe, Ghana where participants are identified by a unique participant ID. There are two datasets. The Safety dataset includes demographics, skin snip results, adverse event results, and ophthalmological data from baseline, day of treatment, Day 1-7, Month 3, Month 12, and Month 18. The Nodulectomy data set contains data pertaining to sectioned nodules read by scientists at 18 months which indicate embryogenesis in female worms, number of male and female worms, and worm calcification. 7. DOI for the dataset: https://doi.org/10.48765/xq0p-e188. -------------------------- SHARING/ACCESS INFORMATION -------------------------- 1. Licenses/restrictions placed on the data: CC-BY 4.0 2. Links to publications that cite or use the data: PLOS Neglected Tropical Disease in review --------------------- DATA & FILE OVERVIEW --------------------- 1. File List A. Filename: Baselineto18MonthSS.csv Short description: The dataset includes demographics, vital signs, skin snip results, adverse event results, and opthalmological data collected from the participants at baseline, day of treatment, Days 1-7, Month 3, Month 12, and Month 18. B. Filename: Baselineto18MonthSS_datadictionary.csv Short description: Data dictionary describing variables, values, and form names for the Baselineto18MonthSS.csv dataset. C. Filename: Nodulectomy_treatment.csv Short description: The data set contains data pertaining to sectioned nodules read by scientists at 18 months which indicate embryogenesis in female worms, number of male and female worms, living and dead worms, microfilarae in uterus, and worm calcification. D. Filename: Nodulectomy_treatment_data_dictionary.csv Short description: Data dictionary describing variables, values, and form names for the Nodulectomy_treatment.csv dataset. 2. Relationship between files: All datasets were collected from the same clinical trial conducted in Hohoe Ghana. The Baselineto18MonthSS dataset contains data collected directly from participants throughout the clinical trial. The nodulectomy_treatment dataset was collected at the 18 month time-point and contained scientific readings of nodule specimens collected from participants. 3. Are there multiple versions of the dataset? No -------------------------- METHODOLOGICAL INFORMATION -------------------------- 1. Description of methods used for collection/generation of data: Screening and participant enrollment Screening and recruitment were performed in Nkwanta North District in the Volta region of Ghana (approximately 4 hours by car from the clinical trial center in Hohoe, Ghana). Screening was conducted in communities that are hypoendemic for onchocerciasis (nodule prevalence < 20%) where MDA of IVM had only recently been implemented. The study team met with community leaders and local health personnel in Nkwanta North and held open community meetings to explain the purposes and plans for the study prior to screening and recruitment of participants. The meetings and consent forms were in English and a local language (either Twi or Konkomba) used in the study area. Participation required written consent for adults and written consent from a parent or guardian plus assent for minors younger than 18 years of age. Medical history and physical examinations A brief medical history reviewed prior illnesses and current medications. This included an oral review of systems to identify baseline symptoms with special attention to any history of prior onchocercal eye or skin disease or treatment. Serum tests for aspartate aminotransferase, alanine transaminase, and creatinine were performed to rule out serious liver or kidney disease. The physical examination included height, weight, and vital signs with special attention to skin lesions and lymph nodes. Onchocercal nodules were detected by manual palpation. Skin snip examinations to detect Mf Four skin snips were collected (one from each posterior iliac crest and posterior calf) with a Holth corneoscleral punch (Everhards, Meckenheim, Germany). Snips were weighed and incubated in 100 µl of isotonic saline in individual wells of a flat-bottomed microtiter plate at ambient temperature for at least 8 hours. Snips in the microtiter wells were then examined with an inverted microscope, and Mf were counted by experienced microscopists. Mean values for Mf/mg for four snips were calculated. Persons who performed skin snips or counted Mf by microscopy were masked with respect to participant treatments. Ophthalmological examinations A panel of tests was performed as described in detail in the study protocol. Briefly, the panel included tests of visual acuity, color vision, visual field testing by frequency doubling technology (FDT) perimetry, pupillary reflex, applanation tonometry, indirect ophthalmoscopy, fundus photography and optical coherence tomography (OCT), which provides detailed images of the posterior segment including the retina. Slit lamp examinations were performed to assess ocular abnormalities in the cornea and anterior segment. Participants sat with their heads bent as far forward and down for 10 minutes as tolerated prior to the slit lamp examination to optimize visualization of Mf in the anterior chamber. The total ocular Mf count was calculated by summing the numbers of Mf identified in the anterior chamber of each eye. Drug treatment, adverse event (AE) assessments, and follow-up Participants were pretreated with IVM 150 µg/kg by mouth at least 6 months before the planned Part 2 study treatment to clear or reduce Mf counts in skin and eyes. A second IVM pretreatment was provided to all participants because of delayed regulatory approval for the Part 2 study and delays related to SARS-2-COVID lockdowns. The second IVM pretreatments were provided more than 1 year after the first pretreatment. The median interval between the second IVM pretreatment and the Part 2 study treatment was 7.3 weeks (range 1-28 weeks). Participants were transported from their home villages to the UHAS School of Public Health Research Centre (which is located within the grounds of the Hohoe Municipal Hospital) for Part 2 treatments and clinical evaluations. A study statistician prepared a random treatment allocation schedule and participants were randomized sequentially into one of the three treatment arms by the study pharmacist. The arms included a single dose of IVM 150 µg/kg plus ALB 400 mg fixed dose (IA), a single dose of IA plus DEC 6 mg/kg (IDA1), or three consecutive daily doses of IDA (IDA3). All treatments were oral and directly observed. Participants were evaluated daily for 7 days after treatment and asked whether they had symptoms suggestive of systemic (e.g., fever, headache), cutaneous, or ocular AEs. A study physician performed a directed physical examination for all participants. All participants had full ophthalmological examinations as described above on the day before treatment, on days 3 and 7 after treatment, and 3 months after treatment. A skin snip test was performed shortly before treatment, and this was repeated at 12 and 18 months after treatment. Treatment masking While this was an open-label study, medical/technical staff who assessed skin Mf, AEs, performed eye examinations, and assessed nodule histology were masked with regard to treatment arm. The study pharmacist and his assistant were responsible for treating study participants. Data acquisition, transfer, and management The study used an electronic data capture (EDC) system developed by CliniOps (Fremont, CA, USA) to capture and transfer clinical data. De-identified clinical data were entered directly into tablet computers loaded with a mobile data management application called CliniTrial. The data were entered by designated, trained members of the UHAS research team on the day of enrollment or AE assessment. A parallel participant key (separate from CliniTrial and maintained at UHAS) linked study ID numbers with personal identifying information such as name and date of birth. The participant key was not shared with investigators or staff at Washington University. The EDC system employed is 21 CFR Part 11 compliant, and electronic case report forms (CRFs) were developed to comply with International Council for Harmonization on Good Clinical Practice (ICH GCP) and CDASH/CDISC standards [20]. Validation checks and automated alert checks wer quality at the point of entry. Data were entered into tablet computers, and encrypted data were uploaded daily to a secured cloud server via the internet. The cloud server uses multi-available zone and geo-redundant backups to protect against data loss. A data manager at Washington University performed additional data cleaning and validation and communicated with the UHAS data manager and study investigators to clear queries prior to data lock. AEs were coded using MedDRA dictionaries (version 20.0)[21]. Paper case report forms were used for backup in case of EDC or equipment malfunction and for documentation of serious adverse events. All written forms (i.e., consent and backup data collection forms) were stored at the study site per Ghana FDA requirements for storing source documents. Laboratory test results (skin snip Mf counts, blood analysis data etc.) were recorded on paper forms and transferred into REDCap software (https://projectredcap.org) for analysis. AE assessment Adverse events were scored using a modified version of the National Cancer Institute Common Terminology Criteria for Adverse Events tables, version 4.0. Study ophthalmologists added additional details regarding ocular AEs to the CTCAE tables for this study. The tables were used to classify and score the severity of adverse events. Briefly, grade 1 AEs are mild events that would not prevent participants from working or performing household chores. Grade 2 AEs are moderate events that would prevent work or performance of household chores. Records of participants with AEs with severity of grade 3 or higher that interfered with activities of daily living were to be evaluated by an independent medical monitor who was not part of the research team. The medical monitor’s role was to review the report with the lead study physician to determine whether it met criteria for a serious adverse event (SAE) and whether the AE was related to the study treatment [22]. Nodulectomy and processing of nodules Surgical removal of onchocercomas was performed at the Hohoe Municipal Hospital 17.5 to 18.5 months after treatment using standard procedures [23]. Small nodules (<1 cm in diameter) were placed in 80% ethanol. Larger nodules (>1 cm in diameter) were cut in half prior to fixation. Nodule samples were transported to the Pathology Department at the University of Ghana, School of Medicine in Accra and embedded in paraffin as described previously [24]. Each paraffin block received a unique barcode that was linked in a separate database with other participant information. Technicians, working on the nodules did not know treatment histories or whether different nodules belonged to the same participant. Paraffin blocks were shipped to Washington University in St. Louis for further processing. Ten consecutive 5 µm sections were cut from each block with a rotary microtome HM340E (MICROM, Laborgeräte GmbH, Jena, Germany). Blocks that could not be cut because of calcification were examined with a dissecting microscope to detect calcified worm structures. Histology, digitalization and evaluation of nodules Two consecutive sections were stained with Meyer’s hematoxylin & eosin (H&E, Merck, Darmstadt, Germany), and a polyclonal rabbit antibody directed against an O. volvulus aspartic protease (APR, GenBank U81605) for assessment of worm viability [25]. Stained slides were scanned using an Olympus scanner (Olympus VS120 Brightfield Slide Scanning System, Tokyo, Japan) at 20X magnification [26]. The digital images were checked for quality and uploaded to a secure cloud server for assessment. The digital images of nodule sections (mean file size ~9.5 GB) were assessed independently by two readers using the open source viewing software OlyVia 2.19 (Olympus). Each reader recorded results using a digital case report form in REDCap. One reader (BD) was based in Bonn, Germany and the other reader (KF) was based in St. Louis, USA. Images were read in the same orientation relative to barcode labels on the scanned slides to facilitate communication and comparisons. The readers reviewed nodule sections, counted worms, and judged the viability and fertility of adult O. volvulus worms according to previously published criteria [27, 28]. Females with collapsed uterus branches were not included in the fertility analysis. Females with morulae or later stage embryos in the uterus were considered to be fertile (Fig. 1G). Dead worms were recorded as females unless they were clearly identifiable as males. Heavily calcified nodules (Fig. A) that could not be sectioned were arbitrarily (and conservatively) considered to contain one dead female worm. The nodule assessments of both readers were compared using SAS software (SAS Institute Inc., Cary, NC, USA, https://www.sas.com). After initial readings were completed, readers met virtually to resolve discrepancies and finalize results before the code was broken. Data management for skin snip and biochemistry laboratory results Data were recorded on paper case report forms and later entered into REDCap at the UHAS School of Public Health; that data center also validated and cleaned the data. REDCap files included participants’ study identification numbers without personal identifiers. Encrypted REDCap data were transferred to a dedicated server housed at Washington University in St. Louis. A data manager at Washington University performed additional data cleaning and validation and communicated with the UHAS data manager and study investigators to clear queries before data lock. 2. Methods for processing the data: Data was collected through the electronic data collection software program CliniOps and REDCap. Data was cleaned using data query tools via CliniOps and REDCap. Data was downloaded from the CliniOps and REDCap into a csv file for sharing. 3. Instrument- or software-specific information needed to interpret the data: Microsoft Excel, Google Sheets or software spreadsheet program to open csv files. 4. Standards and calibration information, if appropriate: N/A 5. Environmental/experimental conditions: Data was collected in direct patient care setting in a hospital by nurses and in sterile laboratory environment by laboratory personnel. Data was entered two ways: directly into a CliniOps application Apple iPad minis and entered through a laptop computer into REDCap. 6. Describe any quality-assurance procedures performed on the data: Data was analyzed and checked for discrepancies using query tools in CliniOps and REDCap. 7. People involved with sample collection, processing, analysis and/or submission: Two Ghana Data managers, Ghana Optometrist, Two Ghana Ophthalmologists,Four Ghana nurses, Two Ghana Laboratory technicians, US based scientist, Germany based scientist, and US based Data Manager. Nicholas O. Opoku (Study PI), Gary J. Weil (Study PI), Peter U. Fischer (Study PI), Nicole L. Fetcho (Data Manager), Augustine R. Hong (Optholmologist), Kerstin Fischer (Study scientist), Daphne Lew (Statistician), Charles W. Goss (Statistician), Felix Doe (Co-Investigator), Bettina Duben (Scientist), Shelter Gordor (Laboratory Manager), Edwin Anyomitse (Laboratory Technician), Edem Agbogah (In Country Data Manager), Dickson Kugali (Data Entry Clerk), Catherine Srem Sei (Ophthalmic Technician), Manasseh Amo-Nkrumah (Ophthalmic Technician), Rukaya Laryea (Scientist), Michael Ekuoba-Gyasi (Opthalmologist), Achim Hoerauf (Scientist), Eric Kanza (Opthalmologsit), Mahama Alhassan Seidu (Scientist), Christopher King (Co-Investigator), Nicolien Dorgbefu (Study coordinator), Robert Ewuis-Wilson (Optometrist), Philip Djeagbo Tetteh (Optometrist), Kasu Emmanuel (Medical Monitory), Margaret Williams (Site Monitor), J Gavu Lipe (Pharmacist), Mary Tsedzah (Lead Nurse), Patricia Azumatse (Study Nurse), Bright Dzamesi (Study Nurse), Felicia Tormenyi (Study Nurse), Dinah Searyoh (Study Nurse), Vivian Gantuah (Study Nurse), Kakibi Bukala (Study Nurse), Slyvanus Hadzitsey (Study Nurse), Gifty Doe (Study Nurse), Rita Botsoe (Study Nurse), David Kabogya (Field Coordinator), George Brebur (Village coordinator), Silas Meba (Village coordinator), Simeon Binsil (Village coordinator), James Kpobanyi (Village Coordinator), J Ukpok (Village Coordinator) ----------------------------------------- DATA-SPECIFIC INFORMATION FOR: Nodulectomy_treatment.csv ----------------------------------------- 1. Number of variables:82 2. Number of cases/rows: 450 3. Missing data codes: Code/symbol: -- Definition: Data not entered/No data 4. Variable List 1. Name: rec_id a. Description: Last digits of barcode of nodule. Unique ID for nodule b. Value labels if appropriate 2. Name: barcode_id a. Description: Full barcode of nodule. Unique ID for nodule b. Value labels if appropriate 3. Name: subject_id a. Description: Participant ID of participant with the removed nodule (identified through the barcode_id) b. Value labels if appropriate 4. Name: treatment_arm a. Description: Randomized drug regimen treatment group, participant is randomized to one treatment group b. Value labels if appropriate: 1 Dose IVM + ALB , 1 Dose IVM + DEC + ALB , 3 Dose IVM + DEC + ALB 5. Name: evaluation a. Description: Evaluation of nodule possible, yes/no? b. Value labels if appropriate: 0= No , 1= Yes 6. Name: evaluation_collapse a. Description: Yes/no worm(s) collapsed? b. Value labels if appropriate: 0= No , 1= Yes 7. Name: evaluation_no a. Description: If answer no to evaluation possible, provide reason b. Value labels if appropriate 8. Name: worm_no_fem a. Description: Total number of female worms b. Value labels if appropriate: 0= 0 , 1= 1 , 2= 2 , 3= 3 , 4= 4 , 5= 5 , 6= 6 9. Name: wom_no_live_fem a. Description: Number of female live worms b. Value labels if appropriate: 0= 0 , 1= 1 , 2= 2 , 3= 3 , 4= 4 , 5= 5 , 6= 6 10. Name: wom_no_dead_fem a. Description: Number of female dead worms b. Value labels if appropriate: 0= 0 , 1= 1 , 2= 2 , 3= 3 , 4= 4 , 5= 5 , 6= 6 11. Name: worm_no_male a. Description: Total number of male worms b. Value labels if appropriate: 0= 0 , 1= 1 , 2= 2 , 3= 3 , 4= 4 , 5= 5 , 6= 6 12. Name: worm_no_live_male a. Description: Number of male live worms b. Value labels if appropriate: 0= 0 , 1= 1 , 2= 2 , 3= 3 , 4= 4 , 5= 5 , 6= 6 13. Name: worm_no_dead_male a. Description: Number of male dead worms b. Value labels if appropriate: 0= 0 , 1= 1 , 2= 2 , 3= 3 , 4= 4 , 5= 5 , 6= 6 14. Name: live_f1 a. Description: Yes/no if female worm #1 is alive b. Value labels if appropriate: 0= No , 1= Yes 15. Name: live_f2 a. Description: Yes/no if female worm #2 is alive b. Value labels if appropriate: 0= No , 1= Yes 16. Name: live_f3 a. Description: Yes/no if female worm #3 is alive b. Value labels if appropriate: 0= No , 1= Yes 17. Name: live_f4 a. Description: Yes/no if female worm #4 is alive b. Value labels if appropriate: 0= No , 1= Yes 18. Name: live_f5 a. Description: Yes/no if female worm #5 is alive b. Value labels if appropriate: 0= No , 1= Yes 19. Name: live_f6 a. Description: Yes/no if female worm #6 is alive b. Value labels if appropriate: 0= No , 1= Yes 20. Name: mf_in_nodule a. Description: If microfilarae is present in the nodule or not (yes/no) b. Value labels if appropriate: 0= No , 1= Yes 21. Name: amount_nodular_mf a. Description: Range of mf present in the nodule if mf are present b. Value labels if appropriate: 1= 1-10 , 2= 11-50 , 3= >50 22. Name: embryogen_judgepos_f1 a. Description: Female worm #1: Yes/no if the uterus of the female worm is able to be examined b. Value labels if appropriate: 0= No , 1= Yes 23. Name: uterus_empty_f1 a. Description: Female worm #1: Yes/no if the uterus of the female worm is empty b. Value labels if appropriate: 0= No , 1= Yes 24. Name: only_embryo_oocytes_f1 a. Description: Female worm #1: Yes/no if only oocytes are examined in the female uterus b. Value labels if appropriate: 0= No , 1= Yes 25. Name: norm_embryo_morulae_f1 a. Description: Female worm #1: Yes/no if normal morulae are examined in the female uterus b. Value labels if appropriate: 0= No , 1= Yes 26. Name: degen_embryo_morulae_f1 a. Description: Female worm #1: Yes/no if degenerated morulae are examined in the female uterus b. Value labels if appropriate: 0= No , 1= Yes 27. Name: norm_embryo_coiled_f1 a. Description: Female worm #1: Yes/no if normal coiled microfilarae are examined in the female uterus b. Value labels if appropriate: 0= No , 1= Yes 28. Name: degen_embryo_coiled_f1 a. Description: Female worm #1: Yes/no if degenerated coiled microfilarae are examined in the female uterus b. Value labels if appropriate: 0= No , 1= Yes 29. Name: norm_embryo_stretched_f1 a. Description: Female worm #1: Yes/no if normal stretched microfilarae are examined in the female uterus b. Value labels if appropriate 30. Name: degen_embryo_stretched_f1 a. Description: Female worm #1: Yes/no if degenerated stretched microfilarae are examined in the female uterus b. Value labels if appropriate: 0= No , 1= Yes 31. Name: embryogen_judgepos_f2 a. Description: Female worm #2: Yes/no if the uterus of the female worm is able to be examined b. Value labels if appropriate: 0= No , 1= Yes 32. Name: uterus_empty_f2 a. Description: Female worm #2: Yes/no if the uterus of the female worm is empty b. Value labels if appropriate: 0= No , 1= Yes 33. Name: only_embryo_oocytes_f2 a. Description: Female worm #2: Yes/no if only oocytes are examined in the female uterus b. Value labels if appropriate: 0= No , 1= Yes 34. Name: norm_embryo_morulae_f2 a. Description: Female worm #2: Yes/no if normal morulae are examined in the female uterus b. Value labels if appropriate: 0= No , 1= Yes 35. Name: degen_embryo_morulae_f2 a. Description: Female worm #: 2Yes/no if degenerated morulae are examined in the female uterus b. Value labels if appropriate: 0= No , 1= Yes 36. Name: norm_embryo_coiled_f2 a. Description: Female worm #2: Yes/no if normal coiled microfilarae are examined in the female uterus b. Value labels if appropriate: 0= No , 1= Yes 37. Name: degen_embryo_coiled_f2 a. Description: Female worm #2: Yes/no if degenerated coiled microfilarae are examined in the female uterus b. Value labels if appropriate: 0= No , 1= Yes 38. Name: norm_embryo_stretched_f2 a. Description: Female worm #2: Yes/no if normal stretched microfilarae are examined in the female uterus b. Value labels if appropriate 39. Name: degen_embryo_stretched_f2 a. Description: Female worm #2: Yes/no if degenerated stretched microfilarae are examined in the female uterus b. Value labels if appropriate: 0= No , 1= Yes 40. Name: embryogen_judgepos_f3 a. Description: Female worm #3: Yes/no if the uterus of the female worm is able to be examined b. Value labels if appropriate: 0= No , 1= Yes 41. Name: uterus_empty_f3 a. Description: Female worm #3: Yes/no if the uterus of the female worm is empty b. Value labels if appropriate: 0= No , 1= Yes 42. Name: only_embryo_oocytes_f3 a. Description: Female worm #3: Yes/no if only oocytes are examined in the female uterus b. Value labels if appropriate: 0= No , 1= Yes 43. Name: norm_embryo_morulae_f3 a. Description: Female worm #3: Yes/no if normal morulae are examined in the female uterus b. Value labels if appropriate: 0= No , 1= Yes 44. Name: degen_embryo_morulae_f3 a. Description: Female worm #3: Yes/no if degenerated morulae are examined in the female uterus b. Value labels if appropriate: 0= No , 1= Yes 45. Name: norm_embryo_coiled_f3 a. Description: Female worm #3: Yes/no if normal coiled microfilarae are examined in the female uterus b. Value labels if appropriate: 0= No , 1= Yes 46. Name: degen_embryo_coiled_f3 a. Description: Female worm #3: Yes/no if degenerated coiled microfilarae are examined in the female uterus b. Value labels if appropriate: 0= No , 1= Yes 47. Name: norm_embryo_stretched_f3 a. Description: Female worm #3: Yes/no if normal stretched microfilarae are examined in the female uterus b. Value labels if appropriate 48. Name: degen_embryo_stretched_f3 a. Description: Female worm #3: Yes/no if degenerated stretched microfilarae are examined in the female uterus b. Value labels if appropriate: 0= No , 1= Yes 49. Name: embryogen_judgepos_f4 a. Description: Female worm #4: Yes/no if the uterus of the female worm is able to be examined b. Value labels if appropriate: 0= No , 1= Yes 50. Name: uterus_empty_f4 a. Description: Female worm #4: Yes/no if the uterus of the female worm is empty b. Value labels if appropriate: 0= No , 1= Yes 51. Name: only_embryo_oocytes_f4 a. Description: Female worm #4: Yes/no if only oocytes are examined in the female uterus b. Value labels if appropriate: 0= No , 1= Yes 52. Name: norm_embryo_morulae_f4 a. Description: Female worm #4: Yes/no if normal morulae are examined in the female uterus b. Value labels if appropriate: 0= No , 1= Yes 53. Name: degen_embryo_morulae_f4 a. Description: Female worm #4: Yes/no if degenerated morulae are examined in the female uterus b. Value labels if appropriate: 0= No , 1= Yes 54. Name: norm_embryo_coiled_f4 a. Description: Female worm #4: Yes/no if normal coiled microfilarae are examined in the female uterus b. Value labels if appropriate: 0= No , 1= Yes 55. Name: degen_embryo_coiled_f4 a. Description: Female worm #4: Yes/no if degenerated coiled microfilarae are examined in the female uterus b. Value labels if appropriate: 0= No , 1= Yes 56. Name: norm_embryo_stretched_f4 a. Description: Female worm #4: Yes/no if normal stretched microfilarae are examined in the female uterus b. Value labels if appropriate 57. Name: degen_embryo_stretched_f4 a. Description: Female worm #4: Yes/no if degenerated stretched microfilarae are examined in the female uterus b. Value labels if appropriate: 0= No , 1= Yes 58. Name: embryogen_judgepos_f5 a. Description: Female worm #5: Yes/no if the uterus of the female worm is able to be examined b. Value labels if appropriate: 0= No , 1= Yes 59. Name: uterus_empty_f5 a. Description: Female worm #5: Yes/no if the uterus of the female worm is empty b. Value labels if appropriate: 0= No , 1= Yes 60. Name: only_embryo_oocytes_f5 a. Description: Female worm #5: Yes/no if only oocytes are examined in the female uterus b. Value labels if appropriate: 0= No , 1= Yes 61. Name: norm_embryo_morulae_f5 a. Description: Female worm #5: Yes/no if normal morulae are examined in the female uterus b. Value labels if appropriate: 0= No , 1= Yes 62. Name: degen_embryo_morulae_f5 a. Description: Female worm #5: Yes/no if degenerated morulae are examined in the female uterus b. Value labels if appropriate: 0= No , 1= Yes 63. Name: norm_embryo_coiled_f5 a. Description: Female worm #5: Yes/no if normal coiled microfilarae are examined in the female uterus b. Value labels if appropriate: 0= No , 1= Yes 64. Name: degen_embryo_coiled_f5 a. Description: Female worm #5: Yes/no if degenerated coiled microfilarae are examined in the female uterus b. Value labels if appropriate: 0= No , 1= Yes 65. Name: norm_embryo_stretched_f5 a. Description: Female worm #5: Yes/no if normal stretched microfilarae are examined in the female uterus b. Value labels if appropriate 66. Name: degen_embryo_stretched_f5 a. Description: Female worm #5: Yes/no if degenerated stretched microfilarae are examined in the female uterus b. Value labels if appropriate: 0= No , 1= Yes 67. Name: embryogen_judgepos_f6 a. Description: Female worm #6: Yes/no if the uterus of the female worm is able to be examined b. Value labels if appropriate: 0= No , 1= Yes 68. Name: uterus_empty_f6 a. Description: Female worm #6: Yes/no if the uterus of the female worm is empty b. Value labels if appropriate: 0= No , 1= Yes 69. Name: only_embryo_oocytes_f6 a. Description: Female worm #6: Yes/no if only oocytes are examined in the female uterus b. Value labels if appropriate: 0= No , 1= Yes 70. Name: norm_embryo_morulae_f6 a. Description: Female worm #6: Yes/no if normal morulae are examined in the female uterus b. Value labels if appropriate: 0= No , 1= Yes 71. Name: degen_embryo_morulae_f6 a. Description: Female worm #6: Yes/no if degenerated morulae are examined in the female uterus b. Value labels if appropriate: 0= No , 1= Yes 72. Name: norm_embryo_coiled_f6 a. Description: Female worm #6: Yes/no if normal coiled microfilarae are examined in the female uterus b. Value labels if appropriate: 0= No , 1= Yes 73. Name: degen_embryo_coiled_f6 a. Description: Female worm #6: Yes/no if degenerated coiled microfilarae are examined in the female uterus b. Value labels if appropriate: 0= No , 1= Yes 74. Name: norm_embryo_stretched_f6 a. Description: Female worm #6: Yes/no if normal stretched microfilarae are examined in the female uterus b. Value labels if appropriate 75. Name: degen_embryo_stretched_f6 a. Description: Female worm #6: Yes/no if degenerated stretched microfilarae are examined in the female uterus b. Value labels if appropriate: 0= No , 1= Yes 76. Name: comments_f a. Description: comments on embryogenesis/female worms b. Value labels if appropriate 77. Name: live_m1 a. Description: Male worm #1: Yes/no if male worm is alive b. Value labels if appropriate: 0= No , 1= Yes 78. Name: live_m2 a. Description: Male worm #2: Yes/no if male worm is alive b. Value labels if appropriate: 0= No , 1= Yes 79. Name: live_m3 a. Description: Male worm #3: Yes/no if male worm is alive b. Value labels if appropriate: 0= No , 1= Yes 80. Name: live_m4 a. Description: Male worm #4: Yes/no if male worm is alive b. Value labels if appropriate: 0= No , 1= Yes 81. Name: live_m5 a. Description: Male worm #5: Yes/no if male worm is alive b. Value labels if appropriate: 0= No , 1= Yes 82. Name: live_m6 a. Description: Male worm #6: Yes/no if male worm is alive b. Value labels if appropriate: 0= No , 1= Yes ----------------------------------------- DATA-SPECIFIC INFORMATION FOR: Baselineto18MonthSS.csv ----------------------------------------- 1. Number of variables: 468 2. Number of cases/rows: 2986 rows 3. Missing data codes: Code/symbol: -- Definition: Data not entered/No data 4. Variable List 1. Name: SubjectID a. Description: Unique Participant Identifier b. Value labels if appropriate 2. Name: Timepoint a. Description: Time point where data is collected b. Value labels if appropriate: Screening= Treatment= Day 1= Day 2= Day 3= Day 4= Day 5= Day 6= Day 7= Month 3= 3. Name: dem_date_icf a. Description: Date at which informed consent is provided b. Value labels if appropriate: open text 4. Name: dem_gender a. Description: Gender of participant b. Value labels if appropriate: 1= Female , 2= Male 5. Name: dem_birth_mm_yyyy a. Description: Date of birth b. Value labels if appropriate: date format mm_yyyy 6. Name: dem_ageyrs a. Description: Age of participant b. Value labels if appropriate: open text 7. Name: dem_job a. Description: Job of participant b. Value labels if appropriate: open text 8. Name: dem_village a. Description: Village of residence b. Value labels if appropriate: open text 9. Name: dem_duration a. Description: Duration of years in village b. Value labels if appropriate: open text 10. Name: dem_vil_ot1 a. Description: Second village of residence b. Value labels if appropriate: open text 11. Name: dem_dur_ot1 a. Description: Duration of years in village b. Value labels if appropriate: open text 12. Name: dem_vil_ot2 a. Description: Third village of residence b. Value labels if appropriate: open text 13. Name: dem_dur_ot2 a. Description: Duration of years in village b. Value labels if appropriate: open text 14. Name: dem_vil_ot3 a. Description: Fourth village of residence b. Value labels if appropriate: open text 15. Name: dem_dur_ot3 a. Description: Duration of years in village b. Value labels if appropriate: open text 16. Name: dem_vil_ot4 a. Description: Fifth village of residence b. Value labels if appropriate: open text 17. Name: dem_dur_ot4 a. Description: Duration of years in village b. Value labels if appropriate: open text 18. Name: dem_residence_text a. Description: Other areas of residence text box b. Value labels if appropriate: open text 19. Name: cm_date a. Description: Date of form completion b. Value labels if appropriate: DD-MM-YYYY 20. Name: cm_medname a. Description: Name of medication b. Value labels if appropriate: open text 21. Name: cm_dose a. Description: Dose of medication b. Value labels if appropriate: open text 22. Name: cm_unit_dose a. Description: Unit dose of medication b. Value labels if appropriate: open text 23. Name: cm_frequency a. Description: frequency of medication b. Value labels if appropriate: open text 24. Name: cm_route a. Description: Route of medication b. Value labels if appropriate: open text 25. Name: cm_indication a. Description: Reason for treatment of medication b. Value labels if appropriate: open text 26. Name: cm_indication_text a. Description: Description of reason for treatment b. Value labels if appropriate: open text 27. Name: cm_date_start a. Description: Start date of medication b. Value labels if appropriate: DD/MM/YYYY 28. Name: cm_date_end a. Description: End date of medication b. Value labels if appropriate: DD/MM/YYYY 29. Name: cm_ongoing a. Description: Medication use is ongoing? b. Value labels if appropriate: 0 = No, 1 = Yes 30. Name: mh_date a. Description: Patient's medical history= yes/no b. Value labels if appropriate: 0 = No, 1 = Yes 31. Name: mh_gen_term1 a. Description: Event term for general medical history adverse event b. Value labels if appropriate: 1= Abdominal pain 2= Acute swelling (beyond baseline lymphedema) 3= Cough 4= Diarrhea 5= Difficulty breathing (wheezing or dyspnea) 6= Dizziness= giddiness= or fainting 7= Fatigue 8= Fever (non-axillary temperatures only) 9= Headache 10= Joint or muscle pain 11= Muscle Weakness 12= Nausea 13= Swollen or painful nodes (armpit or groin)* 14= Vomiting 15= Other illness or symptoms 32. Name: mh_other1 a. Description: Description of general medical history b. Value labels if appropriate: open text 33. Name: mh_present_yn1 a. Description: Yes/no if another general medical history adverse event occurred b. Value labels if appropriate: 0 = No, 1 = Yes 34. Name: mh_grade1 a. Description: Grade of adverse event b. Value labels if appropriate 1= 1 - Mild 2= 2 – Moderate 3= 3 - Severe 4= 4 - Life-threatening 35. Name: mh_ocular_trauma a. Description: Previous ocular trauma yes/no b. Value labels if appropriate: 0 = No, 1 = Yes 36. Name: mh_ocular_trauma_text a. Description: Text for ocular trauma description b. Value labels if appropriate: open text 37. Name: mh_ocular_history a. Description: Previous other significant ocular injury yes/no b. Value labels if appropriate: 0 = No, 1 = Yes 38. Name: mh_ocular_history_text a. Description: Description of previous other ocular injury b. Value labels if appropriate: open text 39. Name: mh_notes a. Description: Notes for past medical history b. Value labels if appropriate: open text 40. Name: vs_date a. Description: Date of form completion b. Value labels if appropriate 41. Name: vs_yn a. Description: Vital signs taken? b. Value labels if appropriate: 0= No , 1= Yes 42. Name: vs_weight_yn a. Description: Weight taken? b. Value labels if appropriate: 0= No , 1= Yes 43. Name: vs_weight a. Description: Weight (kg) b. Value labels if appropriate: Weight (kg) 44. Name: vs_height_yn a. Description: Height taken? b. Value labels if appropriate: 0= No , 1= Yes 45. Name: vs_height a. Description: Height (cm) b. Value labels if appropriate: Height (cm) 46. Name: dem_bmi a. Description: BMI b. Value labels if appropriate: [vs_weight]/([vs_height]*0.01)^(2) 47. Name: vs_systolic_yn a. Description: Systolic blood pressure taken? b. Value labels if appropriate: 0= No , 1= Yes 48. Name: vs_systolic a. Description: Systolic blood pressure= sitting (mm HG) b. Value labels if appropriate 49. Name: vs_diastolic_yn a. Description: Diastolic blood pressure taken? b. Value labels if appropriate: 0= No , 1= Yes 50. Name: vs_diastolic a. Description: Diastolic blood pressure= sitting (mm HG) b. Value labels if appropriate 51. Name: vs_respiratory_yn a. Description: Respiratory rate taken? b. Value labels if appropriate: 0= No , 1= Yes 52. Name: vs_respiratory a. Description: Respiratory rate (breaths/min) b. Value labels if appropriate 53. Name: vs_pulse_yn a. Description: Pulse rate taken? b. Value labels if appropriate: 0= No , 1= Yes 54. Name: vs_pulse a. Description: Pulse rate (Beats/Min) b. Value labels if appropriate 55. Name: vs_temp_yn a. Description: Temperature taken? b. Value labels if appropriate: 0= No , 1= Yes 56. Name: vs_temp a. Description: Temperature (Oral) (Celsius) b. Value labels if appropriate 57. Name: pe_date a. Description: Date of form completion b. Value labels if appropriate 58. Name: pe_yn a. Description: Physical examination performed at this visit? b. Value labels if appropriate: 0= No , 1= Yes, 2= Refused 59. Name: pe_gen_result a. Description: General appearance Exam Results: b. Value labels if appropriate: 1= Normal , 2= Abnormal , 3= Not Examined 60. Name: pe_gen_desc a. Description: Description of abnormalties b. Value labels if appropriate 61. Name: pe_skin_result a. Description: Skin Exam Results: b. Value labels if appropriate: 1= Normal , 2= Abnormal , 3= Not Examined 62. Name: pe_skin_desc a. Description: Description of abnormalties b. Value labels if appropriate 63. Name: pe_lymph_result a. Description: Lymph nodes Exam Results: b. Value labels if appropriate: 1= Normal , 2= Abnormal , 3= Not Examined 64. Name: pe_lymph_desc a. Description: Description of abnormalties b. Value labels if appropriate 65. Name: pe_heent_result a. Description: HEENT Exam Results: b. Value labels if appropriate: 1= Normal , 2= Abnormal , 3= Not Examined 66. Name: pe_heent_desc a. Description: Description of abnormalties b. Value labels if appropriate 67. Name: pe_heart_result a. Description: Heart Exam Results b. Value labels if appropriate: 1= Normal , 2= Abnormal , 3= Not Examined 68. Name: pe_heart_desc a. Description: Description of abnormalties b. Value labels if appropriate 69. Name: pe_lungs_result a. Description: Lung Exam Results: b. Value labels if appropriate: 1= Normal , 2= Abnormal , 3= Not Examined 70. Name: pe_lungs_desc a. Description: Description of abnormalties b. Value labels if appropriate 71. Name: pe_breast_result a. Description: Breast Exam Result: b. Value labels if appropriate: 1= Normal , 2= Abnormal , 3= Not Examined 72. Name: pe_breast_desc a. Description: Description of abnormalties b. Value labels if appropriate 73. Name: pe_abdomen_result a. Description: Abdomen Exam Result: b. Value labels if appropriate: 1= Normal , 2= Abnormal , 3= Not Examined 74. Name: pe_abdomen_desc a. Description: Description of abnormalties b. Value labels if appropriate 75. Name: pe_genitalia_result a. Description: External Genitalia Exam Result: b. Value labels if appropriate: 1= Normal , 2= Abnormal , 3= Not Examined 76. Name: pe_genitalia_desc a. Description: Description of abnormalties b. Value labels if appropriate 77. Name: pe_extre_result a. Description: Extremities Exam Result: b. Value labels if appropriate: 1= Normal , 2= Abnormal , 3= Not Examined 78. Name: pe_extre_desc a. Description: Description of abnormalties b. Value labels if appropriate 79. Name: pe_neuro_result a. Description: Neurological Exam Results b. Value labels if appropriate: 1= Normal , 2= Abnormal , 3= Not Examined 80. Name: pe_neuro_desc a. Description: Description of abnormalties b. Value labels if appropriate 81. Name: pe_back_result a. Description: Back Exam Result: b. Value labels if appropriate: 1= Normal , 2= Abnormal , 3= Not Examined 82. Name: pe_back_desc a. Description: Description of abnormalties b. Value labels if appropriate 83. Name: pe_notes a. Description: Additional Notes b. Value labels if appropriate 84. Name: sn_date a. Description: Date of form completion b. Value labels if appropriate 85. Name: sn_yn a. Description: Are Skin nodules present? b. Value labels if appropriate: 0= No , 1= Yes 86. Name: sn_body_map a. Description: Body map image of nodule site placements on human body b. Value labels if appropriate 87. Name: sn_site_1 a. Description: Head b. Value labels if appropriate: 0= No , 1= Yes 88. Name: sn_nodule_1 a. Description: Number of nodules located on head b. Value labels if appropriate 89. Name: sn_site_2 a. Description: Chest Wall b. Value labels if appropriate: 0= No , 1= Yes 90. Name: sn_nodule_2 a. Description: Number of nodules located on chest wall b. Value labels if appropriate 91. Name: sn_site_3 a. Description: Right Iliac Crest b. Value labels if appropriate: 0= No , 1= Yes 92. Name: sn_nodule_3 a. Description: Number of nodules located on right iliac crest b. Value labels if appropriate 93. Name: sn_site_4 a. Description: Left Iliac Crest b. Value labels if appropriate: 0= No , 1= Yes 94. Name: sn_nodule_4 a. Description: Number of nodules located on left iliac crest b. Value labels if appropriate 95. Name: sn_site_5 a. Description: Right Knee b. Value labels if appropriate: 0= No , 1= Yes 96. Name: sn_nodule_5 a. Description: Number of nodules located on right knee b. Value labels if appropriate 97. Name: sn_site_6 a. Description: Left Knee b. Value labels if appropriate: 0= No , 1= Yes 98. Name: sn_nodule_6 a. Description: Number of nodules located on left knee b. Value labels if appropriate 99. Name: sn_site_7 a. Description: Sacrum b. Value labels if appropriate: 0= No , 1= Yes 100. Name: sn_nodule_7 a. Description: Number of nodules located on sacrum b. Value labels if appropriate 101. Name: sn_site_8 a. Description: Left Trochanter b. Value labels if appropriate: 0= No , 1= Yes 102. Name: sn_nodule_8 a. Description: Number of nodules located on left trochanter b. Value labels if appropriate 103. Name: sn_site_9 a. Description: Right Trochanter b. Value labels if appropriate: 0= No , 1= Yes 104. Name: sn_nodule_9 a. Description: Number of nodules located on right trochanter b. Value labels if appropriate 105. Name: sn_site_10 a. Description: Other nodule site b. Value labels if appropriate: 0= No , 1= Yes 106. Name: sn_site_10_text a. Description: Description of other nodule site b. Value labels if appropriate 107. Name: sn_nodule_10 a. Description: Number of nodules located on the other nodule site b. Value labels if appropriate 108. Name: sl_date a. Description: Date of form completion b. Value labels if appropriate 109. Name: sl_yn a. Description: Are there Skin Lesions yes/no? b. Value labels if appropriate: 0= No , 1= Yes 110. Name: sl_puritusd a. Description: Pruritus - Diffuse yes/no? b. Value labels if appropriate: 0= No , 1= Yes 111. Name: sl_puritusl a. Description: Pruritus - Localized yes/no? b. Value labels if appropriate: 0= No , 1= Yes 112. Name: sl_scratch a. Description: Evidence of Scratching yes/no? b. Value labels if appropriate: 0= No , 1= Yes 113. Name: sl_apo a. Description: Acute papular onchodermatitis yes/no? b. Value labels if appropriate: 0= No , 1= Yes 114. Name: sl_cpo a. Description: Chronic papular onchodermatitis yes/no? b. Value labels if appropriate: 0= No , 1= Yes 115. Name: sl_lo a. Description: Lichenified onchodermatitis yes/no? b. Value labels if appropriate: 0= No , 1= Yes 116. Name: sl_oa a. Description: Onchocercal atrophy yes/no? b. Value labels if appropriate: 0= No , 1= Yes 117. Name: sl_od a. Description: Onchocercal depigmentation yes/no? b. Value labels if appropriate: 0= No , 1= Yes 118. Name: sl_sowda a. Description: Sowda skin lesion yes/no? b. Value labels if appropriate: 0= No , 1= Yes 119. Name: sl_pon a. Description: Palpable onchocercal nodules yes/no? b. Value labels if appropriate: 0= No , 1= Yes 120. Name: sl_other a. Description: Other skin lesion yes/no? b. Value labels if appropriate: 0= No , 1= Yes 121. Name: sl_othertext a. Description: Text description of sl_othertext b. Value labels if appropriate 122. Name: oe_date a. Description: Date of form completion b. Value labels if appropriate 123. Name: oe_yn a. Description: General Ocular Exam Performed yes/no? b. Value labels if appropriate: 0= No , 1= Yes 124. Name: oe_itch_r a. Description: Right Eye: Ocular itching yes/no? b. Value labels if appropriate: 0= No , 1= Yes 125. Name: oe_tear_r a. Description: Right Eye: Watering eyes yes/no? b. Value labels if appropriate: 0= No , 1= Yes 126. Name: oe_blur_r a. Description: Right Eye: Blurred vision yes/no? b. Value labels if appropriate: 0= No , 1= Yes 127. Name: oe_night_r a. Description: Right Eye: Night Blindness yes/no? b. Value labels if appropriate: 0= No , 1= Yes 128. Name: oe_pain_yn_r a. Description: Right Eye: Ocular pain yes/no? b. Value labels if appropriate: 0= No , 1= Yes 129. Name: oe_pain_grade_r a. Description: Right Eye: Ocular pain Grade yes/no? b. Value labels if appropriate: 0= No , 1= Yes 130. Name: oe_photo_yn_r a. Description: Right Eye: Photophobia yes/no? b. Value labels if appropriate: 0= No , 1= Yes 131. Name: oe_photo_grade_r a. Description: Right Eye: Grade of photophobia b. Value labels if appropriate: 0= None 1= Grade 1 2= Grade 2 3= Grade 3 4= Grade 4 132. Name: oe_other_yn_r a. Description: Right Eye: Other ocular symptom yes/no? b. Value labels if appropriate: 0= No , 1= Yes 133. Name: oe_other_text_r a. Description: Right Eye: Text description of oe_other_text_r b. Value labels if appropriate 134. Name: oe_other_grade_r a. Description: Right Eye: Grade of other symptom yes/no? b. Value labels if appropriate 0= None 1= Grade 1 2= Grade 2 3= Grade 3 4= Grade 4 135. Name: oe_itch_l a. Description: Left Eye: Ocular itching yes/no? b. Value labels if appropriate: 0= No , 1= Yes 136. Name: oe_tear_l a. Description: Left Eye: Watering eyes yes/no? b. Value labels if appropriate: 0= No , 1= Yes 137. Name: oe_blur_l a. Description: Left Eye: Blurred vision yes/no? b. Value labels if appropriate: 0= No , 1= Yes 138. Name: oe_night_l a. Description: Left Eye: Night Blindness yes/no? b. Value labels if appropriate: 0= No , 1= Yes 139. Name: oe_pain_yn_l a. Description: Left Eye: Ocular pain yes/no? b. Value labels if appropriate: 0= No , 1= Yes 140. Name: oe_pain_grade_l a. Description: Left Eye: Ocular pain Grade yes/no? b. Value labels if appropriate: 0= No , 1= Yes 141. Name: oe_photo_yn_l a. Description: Left Eye: Photophobia yes/no? b. Value labels if appropriate: 0= No , 1= Yes 142. Name: oe_photo_grade_l a. Description: Left Eye: Grade of photophobia Value labels if appropriate: 0= None 1= Grade 1 2= Grade 2 3= Grade 3 4= Grade 4 143. Name: oe_other_yn_l a. Description: Left Eye: Other ocular symptom yes/no? b. Value labels if appropriate: 0= No , 1= Yes 144. Name: oe_other_text_l a. Description: Left Eye: Text description of oe_other_text_l b. Value labels if appropriate 145. Name: oe_other_grade_l a. Description: Left Eye: Other Grade Value labels if appropriate: 0= None 1= Grade 1 2= Grade 2 3= Grade 3 4= Grade 4 146. Name: oeyn1 a. Description: Visual Acuity for Distance Exam Performed yes/no? b. Value labels if appropriate: 0= No , 1= Yes 147. Name: oe_va_uncorrected_r a. Description: Right Eye: Uncorrected b. Value labels if appropriate 148. Name: oe_va_corrected_r a. Description: Right Eye: Corrected b. Value labels if appropriate 149. Name: oe_va_color_r a. Description: Right Eye: Color Vision b. Value labels if appropriate 150. Name: oe_va_text_r a. Description: Right Eye: Comments on right eye visual acuity b. Value labels if appropriate 151. Name: oe_va_uncorrected_l a. Description: Left Eye: Uncorrected b. Value labels if appropriate 152. Name: oe_va_corrected_l a. Description: Left Eye: Corrected b. Value labels if appropriate 153. Name: oe_va_color_l a. Description: Left Eye: Color Vision b. Value labels if appropriate 154. Name: oe_va_text_l a. Description: Comments on left eye visual acuity b. Value labels if appropriate 155. Name: oeyn2 a. Description: Confrontation Visual Field Performed yes/no? b. Value labels if appropriate: 0= No , 1= Yes 156. Name: oe_vfd_r a. Description: Right Eye: Visual Field Defect - Right abnormal/normal? b. Value labels if appropriate: 1= Normal, 2= Abnormal 157. Name: oe_vfd_l a. Description: Left Eye: Visual Field Defect - Left abnormal/normal a. Value labels if appropriate: 1= Normal, 2= Abnormal 158. Name: oeyn5 a. Description: Extraocular Movement and Eyelids Exams Performed yes/no? b. Value labels if appropriate 159. Name: oe_as_pupil_r a. Description: Right Eye: Status of pupil b. Value labels if appropriate: 1= Normal 2= Abnormal 3= RAPD? 160. Name: oe_as_em_r a. Description: Right Eye: Extraocular Movement b. Value labels if appropriate: 1= Normal, 2= Abnormal 161. Name: oe_as_em_text_r a. Description: Right Eye: Comments on extraocular movement b. Value labels if appropriate 162. Name: oe_as_eyelid_r a. Description: Right Eye: Eyelid b. Value labels if appropriate: 1= Normal, 2= Abnormal 163. Name: oe_as_eyelid_text_r a. Description: Right Eye: Comments on eyelid b. Value labels if appropriate 164. Name: oe_as_tear_r a. Description: Right Eye: Tearing b. Value labels if appropriate: 1= Normal, 2= Abnormal 165. Name: oe_as_tear_text_r a. Description: Right Eye: Comments on tearing b. Value labels if appropriate 166. Name: oe_as_pupil_l a. Description: Left Eye: Status of pupil b. Value labels if appropriate: 1= Normal 2= Abnormal 3= RAPD? 167. Name: oe_as_em_l a. Description: Left Eye: Extraocular Movement b. Value labels if appropriate: 1= Normal, 2= Abnormal 168. Name: oe_as_em_text_l a. Description: Left Eye: Comments on extraocular movement b. Value labels if appropriate 169. Name: oe_as_eyelid_l a. Description: Left Eye: Eyelid b. Value labels if appropriate: 1= Normal, 2= Abnormal 170. Name: oe_as_eyelid_text_l a. Description: Left Eye: Comments on eyelid b. Value labels if appropriate 171. Name: oe_as_tear_l a. Description: Left Eye: Tearing b. Value labels if appropriate: 1= Normal, 2= Abnormal 172. Name: oe_as_tear_text_l a. Description: Left Eye: Comments on tearing b. Value labels if appropriate 173. Name: oeyn3 a. Description: FDT Exam Performed yes/no? b. Value labels if appropriate: 0= No , 1= Yes 174. Name: oe_fdtp_reliable_r a. Description: Right Eye: Reliable? b. Value labels if appropriate: 0= No , 1= Yes 175. Name: oe_fdtp_reliable_text_r a. Description: Right Eye: Text description of oe_fdtp_reliable_text_r b. Value labels if appropriate 176. Name: oe_fdtp_desc_r a. Description: Right Eye: Text description of visual field defects b. Value labels if appropriate 177. Name: oe_fdtp_mean_r a. Description: Right Eye: Mean Deviation b. Value labels if appropriate 178. Name: oe_fdtp_std_r a. Description: Right Eye: Pattern Standard Dev b. Value labels if appropriate 179. Name: oe_fdtp_grade_r a. Description: Right Eye: Grade b. Value labels if appropriate: 0= Grade 0 1= Grade 1 2= Grade 2 3= Grade 3 4= Grade 4 180. Name: oe_fdtp_reliable_l a. Description: Left Eye: Reliable? b. Value labels if appropriate 181. Name: oe_fdtp_reliable_text_l a. Description: Left Eye: Text description of oe_fdtp_reliable_text_l b. Value labels if appropriate 182. Name: oe_fdtp_desc_l a. Description: Left Eye: Text description of visual field defects b. Value labels if appropriate 183. Name: oe_fdtp_mean_l a. Description: Left Eye: Mean Deviation b. Value labels if appropriate 184. Name: oe_fdtp_std_l a. Description: Left Eye: Pattern Standard Dev b. Value labels if appropriate 185. Name: oe_fdtp_grade_l a. Description: Left Eye: Grade b. Value labels if appropriate: 0= Grade 0 1= Grade 1 2= Grade 2 3= Grade 3 4= Grade 4 186. Name: oeyn4 a. Description: Ocular Microfilariae Exams Performed yes/no? b. Value labels if appropriate: 0= No , 1= Yes 187. Name: oe_omf_head a. Description: Time start head down b. Value labels if appropriate: [HH:MM] 188. Name: oe_omf_time a. Description: Time Mf count started b. Value labels if appropriate: [HH:MM] 189. Name: oe_omf_ac_r a. Description: Right Eye: Number of mf in anterior chamber b. Value labels if appropriate 190. Name: oe_omf_ac_l a. Description: Left Eye: Number of mf in anterior chamber b. Value labels if appropriate 191. Name: oe_omf_ac_motile a. Description: Motile: Number of mf in anterior chamber motile b. Value labels if appropriate 192. Name: oe_omf_cornea_r a. Description: Right Eye: Number of mf in cornea b. Value labels if appropriate 193. Name: oe_omf_cornea_l a. Description: Left Eye: Number of mf in cornea b. Value labels if appropriate 194. Name: oe_omf_cornea_motile a. Description: Motile: Number of mf in cornea b. Value labels if appropriate 195. Name: oe_omf_po_r a. Description: Right Eye: Number of mf in punctate opacities b. Value labels if appropriate 196. Name: oe_omf_po_l a. Description: Left Eye: Number of mf in punctate opacities b. Value labels if appropriate 197. Name: oeyn7 a. Description: Anterior Segment - Conj and Sclera Exam Performed yes/no? b. Value labels if appropriate: 0= No , 1= Yes 198. Name: oe_as_conjun_yn_r a. Description: Right Eye: Conjunctivitis ocular anteri yes/no? b. Value labels if appropriate: 0= No , 1= Yes 199. Name: oe_as_conjun_r a. Description: Right Eye: Conjunctivitis Grade b. Value labels if appropriate 0= None 1= Grade 1 2= Grade 2 3= Grade 3 4= Grade 4 200. Name: oe_as_follicles_r a. Description: Right Eye: Follicles ocular anteri yes/no? b. Value labels if appropriate: 0= No , 1= Yes 201. Name: oe_as_papillae_r a. Description: Right Eye: Papillae ocular anteri yes/no? b. Value labels if appropriate: 0= No , 1= Yes 202. Name: oe_as_scleritis_yn_r a. Description: Right Eye: Scleritis ocular anteri yes/no? b. Value labels if appropriate: 0= No , 1= Yes 203. Name: oe_as_scleritis_r a. Description: Right Eye: Scleritis Grade b. Value labels if appropriate: 0= None 1= Grade 1 2= Grade 2 3= Grade 3 4= Grade 4 204. Name: oe_as_chemosis_r a. Description: Right Eye: Chemosis ocular anteri yes/no? b. Value labels if appropriate: 0= No , 1= Yes 205. Name: oe_as_conjun_nodules_r a. Description: Right Eye: Conjunctival Nodules b. Value labels if appropriate: 0= No , 1= Yes 206. Name: oe_as_conjnodules_text_r a. Description: Right Eye: number of conjuctival nodules and size b. Value labels if appropriate 207. Name: oe_as_conj_other_r a. Description: Right eye: comments on conj and schelera exam b. Value labels if appropriate 208. Name: oe_as_conjun_yn_l a. Description: Left Eye: Conjunctivitis ocular anteri yes/no? b. Value labels if appropriate: 0= No , 1= Yes 209. Name: oe_as_conjun_l a. Description: Left Eye: Conjunctivitis Grade Value labels if appropriate 0= None 1= Grade 1 2= Grade 2 3= Grade 3 4= Grade 4 210. Name: oe_as_follicles_l a. Description: Left Eye: Follicles ocular anteri yes/no? b. Value labels if appropriate: 0= No , 1= Yes 211. Name: oe_as_papillae_l a. Description: Left Eye: Papillae ocular anteri yes/no? b. Value labels if appropriate: 0= No , 1= Yes 212. Name: oe_as_scleritis_yn_l a. Description: Left Eye: Scleritis ocular anteri yes/no? b. Value labels if appropriate: 0= No , 1= Yes 213. Name: oe_as_scleritis_l a. Description: Left Eye: Scleritis Grade Value labels if appropriate: 0= None 1= Grade 1 2= Grade 2 3= Grade 3 4= Grade 4 214. Name: oe_as_chemosis_l a. Description: Left Eye: Chemosis ocular anteri yes/no? b. Value labels if appropriate: 0= No , 1= Yes 215. Name: oe_as_conjun_nodules_l a. Description: Left Eye: Conjunctival Nodules b. Value labels if appropriate 216. Name: oe_as_conjnodules_text_l a. Description: Left Eye: number of conjuctival nodules and size b. Value labels if appropriate 217. Name: oe_as_conj_other_l a. Description: Left eye: comments on conj and schelera exam b. Value labels if appropriate 218. Name: oeyn8 a. Description: Anterior Segment - Cornea Exam Performed yes/no? b. Value labels if appropriate: 0= No , 1= Yes 219. Name: oe_as_glob_yn_r a. Description: Right eye: Globular Infiltrates b. Value labels if appropriate: 0= No , 1= Yes 220. Name: oe_as_glob_r a. Description: Right eye: Globular Infiltrates Total Number b. Value labels if appropriate 221. Name: oe_as_po_yn_r a. Description: Right eye: Punctate Opacities b. Value labels if appropriate: 0= No , 1= Yes 222. Name: oe_as_po_r a. Description: Right Eye: Punctate Opacities Total Number b. Value labels if appropriate 223. Name: oe_as_sk_yn_r a. Description: Right Eye: Sclerosing Keratitis b. Value labels if appropriate: 0= No , 1= Yes 224. Name: oe_as_sk_r a. Description: Right Eye: Sclerosing Keratitis Zone b. Value labels if appropriate 1= 1 2= 2 3= 3 4= 4 225. Name: oe_as_cornea_other_r a. Description: Right Eye: Comments on cornea exam b. Value labels if appropriate 226. Name: oe_as_glob_yn_l a. Description: Left Eye: Globular Infiltrates b. Value labels if appropriate: 0= No , 1= Yes 227. Name: oe_as_glob_l a. Description: Left Eye: Globular Infiltrates Total Number b. Value labels if appropriate 228. Name: oe_as_po_yn_l a. Description: Left Eye: Punctate Opacities b. Value labels if appropriate: 0= No , 1= Yes 229. Name: oe_as_po_l a. Description: Left Eye: Punctate Opacities Total Number Value labels if appropriate 230. Name: oe_as_sk_yn_l a. Description: Left Eye: Sclerosing Keratitis b. Value labels if appropriate: 0= No , 1= Yes 231. Name: oe_as_sk_l a. Description: Left Eye: Sclerosing Keratitis Zone b. Value labels if appropriate 1= 1 2= 2 3= 3 4= 4 232. Name: oe_as_cornea_other_l a. Description: Left Eye: Comments on cornea exam b. Value labels if appropriate 233. Name: oeyn9 a. Description: Iris Anterior Chamber Exam Performed yes/no? b. Value labels if appropriate: 0= No , 1= Yes 234. Name: oe_as_au_yn a. Description: Right Eye: Anterior Uveitis b. Value labels if appropriate: 0= No , 1= Yes 235. Name: oe_as_au_r a. Description: Right Eye: Anterior Uveitis Grade b. Value labels if appropriate 0= None 1= Grade 1 2= Grade 2 3= Grade 3 4= Grade 4 236. Name: oe_as_au_cell_r a. Description: Right Eye: Anterior Uveitis b. Value labels if appropriate: 0= No , 1= Yes 237. Name: oe_as_au_flare_r a. Description: Right Eye: Anterior Uveitis b. Value labels if appropriate: 0= No , 1= Yes 238. Name: oe_as_au_comment_r a. Description: Right Eye: Comments on anterior uveitis b. Value labels if appropriate 239. Name: oe_as_au_yn_l a. Description: Left Eye: Anterior Uveitis b. Value labels if appropriate: 0= No , 1= Yes 240. Name: oe_as_au_l a. Description: Left Eye: Anterior Uveitis Grade b. Value labels if appropriate 0= None 1= Grade 1 2= Grade 2 3= Grade 3 4= Grade 4 241. Name: oe_as_au_cell_l a. Description: Left Eye: Anterior Uveitis b. Value labels if appropriate: 0= No , 1= Yes 242. Name: oe_as_au_flare_l a. Description: Left Eye: Anterior Uveitis b. Value labels if appropriate: 0= No , 1= Yes 243. Name: oe_as_au_comment_l a. Description: Left Eye: Comments on anterior uveitis b. Value labels if appropriate 244. Name: oeyn10 a. Description: Anterior Segment -Lens/Cataract Exam Performed yes/no? b. Value labels if appropriate: 0= No , 1= Yes 245. Name: oe_as_lens_r a. Description: Right Eye: Lens/Cataract b. Value labels if appropriate: 0= No , 1= Yes 246. Name: oe_as_nuclear_r a. Description: Right Eye: Nuclear Grade b. Value labels if appropriate 0= None 1= Grade 1 2= Grade 2 3= Grade 3 4= Grade 4 247. Name: oe_as_cortical_r a. Description: Right Eye: Cortical Grade b. Value labels if appropriate 0= None 1= Grade 1 2= Grade 2 3= Grade 3 4= Grade 4 248. Name: oe_as_postsub_r a. Description: Right Eye: Posterior Subcapsular Grade b. Value labels if appropriate 0= None 1= Grade 1 2= Grade 2 3= Grade 3 4= Grade 4 249. Name: oe_as_other_text_r a. Description: Right Eye: Comments on anterior segment b. Value labels if appropriate 250. Name: oe_as_lens_l a. Description: Left Eye: Lens/Cataract b. Value labels if appropriate: 0= No , 1= Yes 251. Name: oe_as_nuclear_l a. Description: Left Eye: Nuclear Grade b. Value labels if appropriate 0= None 1= Grade 1 2= Grade 2 3= Grade 3 4= Grade 4 252. Name: oe_as_cortical_l a. Description: Left Eye: Cortical Grade b. Value labels if appropriate 0= None 1= Grade 1 2= Grade 2 3= Grade 3 4= Grade 4 253. Name: oe_as_postsub_l a. Description: Left Eye: Posterior Subcapsular Grade b. Value labels if appropriate 0= None 1= Grade 1 2= Grade 2 3= Grade 3 4= Grade 4 254. Name: oe_as_other_text_l a. Description: Left Eye: Comments on anterior segment b. Value labels if appropriate 255. Name: oeyn6 a. Description: Right Eye: Intraocular pressure done yes/no? b. Value labels if appropriate: 0= No , 1= Yes 256. Name: oe_ip_time a. Description: Right Eye: Intraocular pressure Time conducted [HH:MM] b. Value labels if appropriate 257. Name: oe_ip_gt_r a. Description: Right Eye: Goldman Tonometry b. Value labels if appropriate 258. Name: oe_ip_gt_l a. Description: Left Eye: Goldman Tonometry b. Value labels if appropriate 259. Name: oe_ip_gt_text a. Description: Comments on Goldman Tonometry b. Value labels if appropriate 260. Name: oeyn11 a. Description: Posterior Segment - Vitreous/Floaters Exam Performed yes/no? b. Value labels if appropriate: 0= No , 1= Yes 261. Name: oe_ps_vd_r a. Description: Right Eye: Vitreous Degeneration b. Value labels if appropriate: 0= No , 1= Yes 262. Name: oe_ps_mflive_r a. Description: Right Eye: Number of live mf b. Value labels if appropriate 263. Name: oe_ps_mfdead_r a. Description: Right Eye: Number of dead mf b. Value labels if appropriate 264. Name: oe_ps_vd_l a. Description: Left Eye: Vitreous Degeneration b. Value labels if appropriate: 0= No , 1= Yes 265. Name: oe_ps_mflive_l a. Description: Left Eye: Number of live mf b. Value labels if appropriate 266. Name: oe_ps_mfdead_l a. Description: Left Eye: Number of dead mf b. Value labels if appropriate 267. Name: oeyn12 a. Description: Posterior Segment - Optic Disc Exam Performed yes/no? b. Value labels if appropriate: 0= No , 1= Yes 268. Name: oe_ps_ratio_r a. Description: Right Eye: Cup/dsk ratio: b. Value labels if appropriate 1= 0.1 2= 0.2 3= 0.3 4= 0.4 5= 0.5 6= 0.6 7= 0.7 8= 0.8 9= 0.9 10= 0.99 269. Name: oe_ps_glaucoma_r a. Description: Right Eye: Glaucoma ocular poster yes/no? b. Value labels if appropriate: 0= No , 1= Yes 270. Name: oe_ps_glaugrade_r a. Description: Right Eye: Glaucoma Grade b. Value labels if appropriate 0= None 1= Grade 1 2= Grade 2 3= Grade 3 4= Grade 4 271. Name: oe_ps_edema_r a. Description: Right Eye: Optic nerve Edema yes/no? b. Value labels if appropriate: 0= No , 1= Yes 272. Name: oe_ps_endemagrade_r a. Description: Right Eye: Optic nerve Edema Grade b. Value labels if appropriate 0= None 1= Grade 1 2= Grade 2 3= Grade 3 4= Grade 4 273. Name: oe_ps_atrophy_r a. Description: Right Eye: Optic N. Atrophy yes/no? b. Value labels if appropriate: 0= No , 1= Yes 274. Name: oe_ps_atrophygrade_r a. Description: Right Eye: Optic N. Atrophy Grade b. Value labels if appropriate 0= None 1= Grade 1 2= Grade 2 3= Grade 3 4= Grade 4 275. Name: oe_ps_optic_notes_r a. Description: Right Eye: Commnets on optic disc b. Value labels if appropriate 276. Name: oe_ps_ratio_l a. Description: Left Eye: Cup/dsk ratio: b. Value labels if appropriate 1= 0.1 2= 0.2 3= 0.3 4= 0.4 5= 0.5 6= 0.6 7= 0.7 8= 0.8 9= 0.9 10= 0.99 277. Name: oe_ps_glaucoma_l a. Description: Left Eye: Glaucoma ocular poster yes/no? b. Value labels if appropriate: 0= No , 1= Yes 278. Name: oe_ps_glaugrade_l a. Description: Left Eye: Glaucoma Grade b. Value labels if appropriate 0= None 1= Grade 1 2= Grade 2 3= Grade 3 4= Grade 4 279. Name: oe_ps_edema_l a. Description: Left Eye: Optic nerve Edema yes/no? b. Value labels if appropriate: 0= No , 1= Yes 280. Name: oe_ps_endemagrade_l a. Description: Left Eye: Optic nerve Edema Grade b. Value labels if appropriate 0= None 1= Grade 1 2= Grade 2 3= Grade 3 4= Grade 4 281. Name: oe_ps_atrophy_l a. Description: Left Eye: Optic N. Atrophy yes/no? b. Value labels if appropriate: 0= No , 1= Yes 282. Name: oe_ps_atrophygrade_l a. Description: Left Eye: Optic N. Atrophy Grade b. Value labels if appropriate 0= None 1= Grade 1 2= Grade 2 3= Grade 3 4= Grade 4 283. Name: oe_ps_optic_notes_l a. Description: Left Eye: Comments on optic disc b. Value labels if appropriate 284. Name: oeyn13 a. Description: Posterior Segment - Retina Exam Performed yes/no? b. Value labels if appropriate: 0= No , 1= Yes 285. Name: oe_ps_macular_r a. Description: Right Eye: Macular Edema b. Value labels if appropriate: 0= No , 1= Yes 286. Name: oe_ps_intrahem_r a. Description: Right Eye: Intraretinal Hemorrhage b. Value labels if appropriate: 0= No , 1= Yes 287. Name: oe_ps_chorioretinal_r a. Description: Right Eye: Chorioretinal Atrophy b. Value labels if appropriate: 0= No , 1= Yes 288. Name: oe_ps_chorioretinalgrade_r a. Description: Right Eye: Chorioretinal Atrophy Grade b. Value labels if appropriate 0= None 1= Grade 1 2= Grade 2 3= Grade 3 4= Grade 4 289. Name: oe_ps_retina_notes_r a. Description: Right Eye: Comments on retina b. Value labels if appropriate 290. Name: oe_ps_macular_l a. Description: Left Eye: Macular Edema b. Value labels if appropriate: 0= No , 1= Yes 291. Name: oe_ps_intrahem_l a. Description: Left Eye: Intraretinal Hemorrhage b. Value labels if appropriate: 0= No , 1= Yes 292. Name: oe_ps_chorioretinal_l a. Description: Left Eye: Chorioretinal Atrophy b. Value labels if appropriate: 0= No , 1= Yes 293. Name: oe_ps_chorioretinalgrade_l a. Description: Left Eye: Chorioretinal Atrophy Grade grade 4/none? b. Value labels if appropriate 0= None 1= Grade 1 2= Grade 2 3= Grade 3 4= Grade 4 294. Name: oe_ps_retina_notes_l a. Description: Left Eye: Commets on retina b. Value labels if appropriate 295. Name: oeyn15 a. Description: OCT Macular done yes/no? b. Value labels if appropriate: 0= No , 1= Yes 296. Name: oe_oct_signal_r a. Description: Right Eye: Macular OCT Signal Strength b. Value labels if appropriate 297. Name: oe_oct_subfield_r a. Description: Right Eye: Central Subfield Thickness b. Value labels if appropriate 298. Name: oe_oct_subfield_grade_r a. Description: Right Eye: CST Grade b. Value labels if appropriate: 1= Grade 1 2= Grade 2 3= Grade 3 299. Name: < oe_oct_volcube_r a. Description: Right Eye: Volume cube b. Value labels if appropriate 300. Name: oe_oct_volcube_grade_r a. Description: Right Eye: Vol Cube Grade b. Value labels if appropriate: 1= Grade 1 2= Grade 2 3= Grade 3 301. Name: oe_oct_edema_r a. Description: Right Eye: Comments on Macular edema b. Value labels if appropriate 302. Name: oe_oct_ped_r a. Description: Right Eye: Pigment Epithelial Detachment yes/no? b. Value labels if appropriate: 0= No , 1= Yes 303. Name: oe_oct_srd_r a. Description: Right Eye: Serous Retinal Detachment yes/no? b. Value labels if appropriate: 0= No , 1= Yes 304. Name: oe_oct_va_r a. Description: Right Eye: Vitreomacular adhesion b. Value labels if appropriate: 0= No , 1= Yes 305. Name: oe_oct_vt_r a. Description: Right Eye: Vitreomacular Traction b. Value labels if appropriate: 0= No , 1= Yes 306. Name: oe_oct_em_r a. Description: Right Eye: Epiretinal Membrane b. Value labels if appropriate: 0= No , 1= Yes 307. Name: oe_oct_rpe_r a. Description: Right Eye: Retinal Pigment Epithelium (RPE) thickening yes/no? b. Value labels if appropriate: 0= No , 1= Yes 308. Name: oe_oct_ira_r a. Description: Right Eye: Inner Retinal Atrophy yes/no? b. Value labels if appropriate: 0= No , 1= Yes 309. Name: oe_oct_ora_r a. Description: Right Eye: Outer Retinal Atrophy yes/no? b. Value labels if appropriate: 0= No , 1= Yes 310. Name: oe_oct_ellipsoid_r a. Description: Right Eye: Loss of Inner segment ellipsoid zone yes/no? b. Value labels if appropriate: 0= No , 1= Yes 311. Name: oe_oct_mf_r a. Description: Right Eye: Visualization of Mf yes/no? b. Value labels if appropriate: 0= No , 1= Yes 312. Name: oe_oct_abnormalchor_r a. Description: Right Eye: Choroidal abnormality b. Value labels if appropriate: 0= No , 1= Yes 313. Name: oe_oct_text_r a. Description: Right Eye: Comments on Macular OCT b. Value labels if appropriate 314. Name: oe_oct_signal_l a. Description: Left Eye: Macular OCT Signal Strength b. Value labels if appropriate 315. Name: oe_oct_subfield_l a. Description: Left Eye: Central Subfield Thickness b. Value labels if appropriate 316. Name: oe_oct_subfield_grade_l a. Description: Left Eye: CST Grade b. Value labels if appropriate: 1= Grade 1 2= Grade 2 3= Grade 3 317. Name: oe_oct_volcube_l a. Description: Left Eye: Volume Cube b. Value labels if appropriate 318. Name: oe_oct_volcube_grade_l a. Description: Left Eye: Vol Cube Grade: grade 3/grade? b. Value labels if appropriate: 1= Grade 1 2= Grade 2 3= Grade 3 319. Name: oe_oct_edema_l a. Description: Left Eye: Comments on macular edema b. Value labels if appropriate 320. Name: oe_oct_ped_ a. Description: Left Eye: Pigment Epithelial Detachment yes/no? b. Value labels if appropriate: 0= No , 1= Yes 321. Name: oe_oct_srd_l a. Description: Left Eye: Serous Retinal Detachment yes/no? b. Value labels if appropriate: 0= No , 1= Yes 322. Name: oe_oct_va_l a. Description: Left Eye: Vitreomacular adhesion b. Value labels if appropriate: 0= No , 1= Yes 323. Name: oe_oct_vt_l a. Description: Left Eye: Vitreomacular Traction b. Value labels if appropriate: 0= No , 1= Yes 324. Name: oe_oct_em_l a. Description: Left Eye: Epiretinal Membrane b. Value labels if appropriate: 0= No , 1= Yes 325. Name: oe_oct_rpe_l a. Description: Left Eye: Retinal Pigment Epithelium (RPE) thickening yes/no? b. Value labels if appropriate: 0= No , 1= Yes 326. Name: oe_oct_ira_l a. Description: Left Eye: Inner Retinal Atrophy yes/no? b. Value labels if appropriate: 0= No , 1= Yes 327. Name: oe_oct_ora_l a. Description: Left Eye: Outer Retinal Atrophy yes/no? b. Value labels if appropriate: 0= No , 1= Yes 328. Name: oe_oct_ellipsoid_l a. Description: Left Eye: Loss of Inner segment ellipsoid zone yes/no? b. Value labels if appropriate: 0= No , 1= Yes 329. Name: oe_oct_mf_l a. Description: Left Eye: Visualization of Mf yes/no? b. Value labels if appropriate: 0= No , 1= Yes 330. Name: oe_oct_abnormalchor_l a. Description: Left Eye: Choroidal abnormality b. Value labels if appropriate: 0= No , 1= Yes 331. Name: oe_oct_text_l a. Description: Left Eye: Additional macular OCT b. Value labels if appropriate 332. Name: oeyn16 a. Description: OCT Retinal Nerve Fiber Layer and Optic Nerve done yes/no? b. Value labels if appropriate: 0= No , 1= Yes 333. Name: oe_oct_ret_signal_r a. Description: Right eye: Retinal Nerve Signal Strength b. Value labels if appropriate 334. Name: oe_oct_ret_rnfl_r a. Description: Right eye: RNFL thickness in micrometer b. Value labels if appropriate 335. Name: oe_oct_ret_rnfl_grade_r a. Description: Right eye: Grade for RNFL thickness b. Value labels if appropriate: 1= Grade 1 2= Grade 2 3= Grade 3 336. Name: oe_oct_ret_ratio_r a. Description: Right eye: Average CD ratio b. Value labels if appropriate 337. Name: oe_oct_ret_rnfl_l a. Description: Left Eye: Retinal Nerve Signal Strength ( /10) high:10/range? b. Value labels if appropriate 338. Name: oe_oct_ret_rnfl_grade_l a. Description: Left Eye: Avg RNFL Thickness Grade grade 3/grade? b. Value labels if appropriate: 1= Grade 1 2= Grade 2 3= Grade 3 339. Name: oe_oct_ret_ratio_l a. Description: Left Eye: Left Eye: Text description of oe_oct_ret_ratio_l b. Value labels if appropriate 340. Name: oeyn17 a. Description: Peripheral Retinal OCT done yes/no? b. Value labels if appropriate: 0= No , 1= Yes 341. Name: oe_oct_text2_r a. Description: Right eye: Comments on Peripheral Retinal OCT b. Value labels if appropriate 342. Name: oe_oct_ret_yn_l a. Description: Left Eye: Peripheral Retinal OCT done yes/no? b. Value labels if appropriate: 0= No , 1= Yes 343. Name: oe_oct_text2_l a. Description: Left Eye: Comments on Peripheral Retinal OCT b. Value labels if appropriate 344. Name: oeyn14 a. Description: Fundus Photography Exam Performed yes/no? b. Value labels if appropriate: 0= No , 1= Yes 345. Name: oe_fp_ynot a. Description: Comments on if the form is not completed b. Value labels if appropriate 346. Name: oe_fp_redfree_r a. Description: Right Eye: Text description of oe_fp_redfree_r b. Value labels if appropriate 347. Name: oe_fp_ca_yn_r a. Description: Right Eye: Comments: b. Value labels if appropriate: 0= No , 1= Yes 348. Name: oe_fp_cagrade_r a. Description: Right Eye: Chorioretinal Atrophy b. Value labels if appropriate: 0= None 1= Grade 1 2= Grade 2 3= Grade 3 4= Grade 4 349. Name: oe_fp_comments_r a. Description: Right Eye: Comments on Chorioretinal Atrophy b. Value labels if appropriate 350. Name: oe_fp_redfree_l a. Description: Left Eye: Text description of oe_fp_redfree_l b. Value labels if appropriate: 0= No , 1= Yes 351. Name: oe_fp_ca_yn_l a. Description: Left Eye: Red-Free b. Value labels if appropriate 352. Name: oe_fp_cagrade_l a. Description: Left Eye: Comments: b. Value labels if appropriate: 0= None 1= Grade 1 2= Grade 2 3= Grade 3 4= Grade 4 353. Name: oe_fp_comments_l a. Description: Left Eye: Comments on Chorioretinal Atrophy b. Value labels if appropriate 354. Name: da_tx_date a. Description: Date of drug administration b. Value labels if appropriate 355. Name: da_tx_time a. Description: Time of Drug Administration (HH:MM) mm]/format? b. Value labels if appropriate 356. Name: da_alb_calc a. Description: Calculated dose of Albendazole b. Value labels if appropriate 357. Name: da_dec_calc a. Description: Calculated dose of DEC b. Value labels if appropriate 358. Name: da_ivm_calc a. Description: Calculated dose of Ivermectin b. Value labels if appropriate 359. Name: da_tx_arm a. Description: Randomized drug regimen treatment group, participant is randomized to one treatment group b. Value labels if appropriate: 1= 1-Dose IVM + ALB 2= 1-Dose IVM + DEC + ALB 3= 3-Dose IVM + DEC + ALB 360. Name: da_tx_arm_1 a. Description: Drug Regimen for 1 and 2 days post treatmnet b. Value labels if appropriate: 3-Dose IVM + DEC + ALB 361. Name: da_alb_dose a. Description: Albendazole (ALB) dose (400 mg) b. Value labels if appropriate: 1= 1 tablet (400 mg) 362. Name: da_dec_dose a. Description: Diethylcarbamazine citrate (DEC) dose (6mg/kg) b. Value labels if appropriate: 1= 1 tablet (100 mg) 2= 2 tablets (200 mg) 3= 3 tablets (300 mg) 4= 4 tablets (400 mg) 5= 5 tablets (500 mg) 6= 6 tablets (600 mg) 363. Name: da_ivm_dose a. Description: Ivermectin (IVM) dose (200 ug /kg) b. Value labels if appropriate 1= 1 tablet (3 mg) 2= 2 tablets (6 mg) 3= 3 tablets (9 mg) 4= 4 tablets (12 mg) 5= 5 tablets (15 mg) 6= 6 tablets(18 mg) 7= 7 tablets(21 mg) 364. Name: da_yn a. Description: Did Patient Vomit the pills yes/no? b. Value labels if appropriate: 0= No , 1= Yes 365. Name: da_alb_dose_rad a. Description: Dose given if patient vomitted: 2nd Albendazole (ALB) dose (400 mg) b. Value labels if appropriate: 1= 1 tablet (400 mg) 366. Name: da_dec_dose_rad a. Description: Dose given if patient vomitted: 2nd Diethylcarbamazine citrate (DEC) dose b. Value labels if appropriate: 1= 1 tablet (100 mg) 2= 2 tablets (200 mg) 3= 3 tablets (300 mg) 4= 4 tablets (400 mg) 5= 5 tablets (500 mg) 6= 6 tablets (600 mg) 367. Name: da_ivm_dose_rad a. Description: Dose given if patient vomitted: 2nd Ivermectin (IVM) dose (200 ug /kg) b. Value labels if appropriate 1= 1 tablet (3 mg) 2= 2 tablets (6 mg) 3= 3 tablets (9 mg) 4= 4 tablets (12 mg) 5= 5 tablets (15 mg) 6= 6 tablets(18 mg) 7= 7 tablets(21 mg) 368. Name: bio_date a. Description: Biomarker Collection Date (DD-MM-YYYY) b. Value labels if appropriate 369. Name: bio_venous_yn a. Description: Venous Blood Sample Collected: yes/no? b. Value labels if appropriate: 0= No , 1= Yes 370. Name: bio_urine_yn a. Description: Urine Sample Collected: yes/no? b. Value labels if appropriate: 0= No , 1= Yes 371. Name: pm_date_re_icf a. Description: Re-Consent Date b. Value labels if appropriate 372. Name: pm_return_yn a. Description: Participant Returned for Part II yes/no? b. Value labels if appropriate: 0= No , 1= Yes 373. Name: pm_ynot a. Description: If not returned or reconsenting, select a reason from the drop down b. Value labels if appropriate: 1= Relocated 2= Declined 3= Pregnant 4= Deceased 5= Ineligible for Part II 6= Other 374. Name: pm_ynot_other a. Description: If other was selected for pm_ynot, then describe "other" b. Value labels if appropriate 375. Name: preg_date a. Description: Pregnancy Test Date b. Value labels if appropriate 376. Name: preg_results a. Description: Pregnancy Test Results b. Value labels if appropriate: 1= Positive 2= Negative 3= Indeterminate 4= Not Done 377. Name: ie_date a. Description: Inclusion/Exclusion Form Date b. Value labels if appropriate 378. Name: ie1_yn a. Description: Participant Eligible for the study yes/no? b. Value labels if appropriate: 0= No , 1= Yes 379. Name: ie_1 a. Description: Able to provide informed consent or parental consent/assent to participate in the study yes/no? b. Value labels if appropriate: 0= No , 1= Yes 380. Name: ie_2 a. Description: Male or Female subject aged 16-70 years yes/no? b. Value labels if appropriate: 0= No , 1= Yes 381. Name: ie_3 a. Description: Subject with Onchocerca volvulus infection= at least 1.0 microfilariae/mg by skin snip yes/no? b. Value labels if appropriate: 0= No , 1= Yes 382. Name: ie_4 a. Description: Subject with at least one palpable subcutaneous onchocercal nodule yes/no? b. Value labels if appropriate: 0= No , 1= Yes 383. Name: ie_5 a. Description: Treatment with IVM after the pre-treatment clearing dose provided in the Part I study yes/no? b. Value labels if appropriate: 0= No , 1= Yes 384. Name: ie_6 a. Description: FEMALE ONLY: Childbearing age (between age 12 -50) with Positive Pregnancy Test yes/no? b. Value labels if appropriate: 0= No , 1= Yes 385. Name: ie_7 a. Description: FEMALE ONLY: Lactating women who had a delivery within last 1 month prior to potential enrollment can be included yes/no? b. Value labels if appropriate: 0= No , 1= Yes 386. Name: ie_8 a. Description: Low probability of remaining in the area (based on the subject’s assessment) over next 7 months yes/no? b. Value labels if appropriate: 0= No , 1= Yes 387. Name: ie_9 a. Description: Base line severe eye diseases and/or other eye diseases that interfere with visualization of the posterior segment of the eye yes/no? b. Value labels if appropriate: 0= No , 1= Yes 388. Name: ie_10 a. Description: Known or suspected allergy or hypersensitivity reactions or intolerance to Ivermectin= Diethylcarbamazine or Albendazole yes/no? b. Value labels if appropriate: 0= No , 1= Yes 389. Name: ie_11 a. Description: Significant comorbidities such as epilepsy= stroke= advanced heart disease= uncontrolled diabetes= emphysema= severe anemia= liver or renal disease yes/no? b. Value labels if appropriate: 0= No , 1= Yes 390. Name: ie_12 a. Description: Six months after pre-treatment of IVM= >5 motile Mf in the anterior chamber in either eye at the time of enrollment yes/no? b. Value labels if appropriate: 0= No , 1= Yes 391. Name: ie_13 a. Description: Six months after pre-treatment of IVM= any Mf identified in the posterior segment of the eye at the time of enrollment yes/no? b. Value labels if appropriate: 0= No , 1= Yes 392. Name: ie_14 a. Description: Are there any other condition identified by study clinicians or investigators that may preclude participation in the study yes/no? b. Value labels if appropriate: 0= No , 1= Yes 393. Name: ie_14_other a. Description: Text description of other conditions in ie_14 b. Value labels if appropriate 394. Name: ie2_date a. Description: Participant Eligibility Date (DD-MM-YYYY) b. Value labels if appropriate 395. Name: ie2_yn a. Description: Based on the screening exams and enrollment criteria is the Participant Eligible for Part II yes/no? b. Value labels if appropriate: 0= No , 1= Yes 396. Name: ss_date a. Description: Date of skin snips b. Value labels if appropriate: 397. Name: ss_reader a. Description: Skin Snip Reader Initials b. Value labels if appropriate 398. Name: ss_weight_ric a. Description: Skin Snip - Right Iliac Crest - Weight (mg): b. Value labels if appropriate 399. Name: ss_mfcount_ric a. Description: O. volvulus microfilaria count (mf) - Right Iliac Crest: b. Value labels if appropriate 400. Name: ss_mfdensity_ric a. Description: O. volvulus microfilaria density (mf/mg) b. Value labels if appropriate: [ss_mfcount_ric]/[ss_weight_ric] 401. Name: ss_weight_lic a. Description: Skin Snip - Left Iliac Crest - Weight (mg): b. Value labels if appropriate 402. Name: ss_mfcount_lic a. Description: O. volvulus microfilaria count (mf) - Left Iliac Crest: b. Value labels if appropriate 403. Name: ss_mfdensity_lic a. Description: O. volvulus microfilaria density (mf/mg) - Left Iliac Crest b. Value labels if appropriate: [ss_mfcount_ric]/[ss_weight_ric] 404. Name: ss_weight_rc a. Description: Skin Snip - Right Calf- Weight (mg): b. Value labels if appropriate 405. Name: ss_mfcount_rc a. Description: O. volvulus microfilaria count (mf) - Right Calf: b. Value labels if appropriate 406. Name: ss_mfdensity_rc a. Description: O. volvulus microfilaria density (mf/mg) - Right Calf b. Value labels if appropriate: [ss_mfcount_rc]/[ss_weight_rc] 407. Name: ss_weight_lc a. Description: Skin Snip - Left Calf- Weight (mg): b. Value labels if appropriate 408. Name: ss_mfcount_lc a. Description: O. volvulus microfilaria count (mf) - Left Calf b. Value labels if appropriate 409. Name: ss_mfdensity_lc a. Description: O. volvulus microfilaria density (mf/mg) - Left Calf b. Value labels if appropriate: [ss_mfcount_rc]/[ss_weight_rc] 410. Name: ae_date a. Description: Date of Adverse Event b. Value labels if appropriate 411. Name: ae_yn a. Description: Were any adverse events experienced yes/no? b. Value labels if appropriate: 0= No , 1= Yes 412. Name: ae_cat a. Description: What Sign/Symptom Category does the AE fall under? b. Value labels if appropriate: 1= General , 2= Ocular , 3= Skin 413. Name: ae_gen_term a. Description: Dropdown description of ae_gen_term b. Value labels if appropriate: 1= Abdominal pain , 2= Acute swelling (beyond baseline lymphedema) , 3= Cough , 4= Diarrhea , 5= Difficulty breathing (wheezing or dyspnea) , 6= Dizziness= giddiness= or fainting , 7= Fatigue , 8= Fever (non-axillary temperatures only) , 9= Headache , 10= Joint or muscle pain , 11= Muscle Weakness , 12= Nausea , 13= Swollen or painful nodes (armpit or groin)* , 14= Vomiting , 15= Other illness or symptoms 414. Name: ae_gen_term_other1 a. Description: Text description of ae_gen_term_other1 b. Value labels if appropriate 415. Name: ae_ocular_term a. Description: Dropdown description of ae_ocular_term b. Value labels if appropriate: 1= Blurred vision , 2= Cataract , 3= Chorioretinal Atrophy , 4= Color Vision Deficiency , 5= Conjunctivitis , 6= Corneal Opacity , 7= Corneal ulcer , 8= Eye pain , 9= Flashing lights , 10= Glaucoma 416. Name: ae_ocular_term_other1 a. Description: Text description of ae_ocular_term_other1 b. Value labels if appropriate 417. Name: ae_skin_term a. Description: Dropdown description of ae_skin_term b. Value labels if appropriate: 1= Bullous dermatitis , 2= Erythema multiforme , 3= Erythroderma , 4= Itching skin , 5= Pain of skin , 6= Pruritus , 7= Rash , 8= Rash maculo-papular , 9= Skin ulceration , 10= Urticaria , 11= Other Skin 418. Name: ae_skin_term_other1 a. Description: Text description of ae_skin_term_other1 b. Value labels if appropriate 419. Name: ae_grade a. Description: Grade of adverse event b. Value labels if appropriate: 1= Bullous dermatitis , 2= Erythema multiforme , 3= Erythroderma , 4= Itching skin , 5= Pain of skin , 6= Pruritus , 7= Rash , 8= Rash maculo-papular , 9= Skin ulceration , 10= Urticaria , 11= Other Skin 420. Name: ae_mazzotti a. Description: Mazzotti Reaction yes/no? b. Value labels if appropriate: 0= No , 1= Yes 421. Name: aestdat a. Description: AE Start Time b. Value labels if appropriate 422. Name: ae_stdat a. Description: AE Start Date: b. Value labels if appropriate 423. Name: aeendat a. Description: AE Stop Time b. Value labels if appropriate 424. Name: ae_endat a. Description: AE Stop Date b. Value labels if appropriate 425. Name: ae_sae a. Description: Is the adverse event serious (SAE) yes/no? b. Value labels if appropriate: 0= No , 1= Yes 426. Name: ae_relation a. Description: Relationship possible between AE and IVM? b. Value labels if appropriate: 1= Definite , 2= Probable , 3= Possible , 4= None 427. Name: ae_outcome a. Description: Outcome of adverse event b. Value labels if appropriate: 1= Resolved , 2= Resolved with Sequalae , 3= Persisting , 4= Death 428. Name: ae_sae_instr a. Description: Descriptive text b. Value labels if appropriate 429. Name: ae_action_none a. Description: Action Taken? b. Value labels if appropriate: 0= No , 1= Yes 430. Name: aeshosp a. Description: Hospitalization or prolonged hospitalization yes/no? b. Value labels if appropriate: 0= No , 1= Yes 431. Name: ae_hosp_y a. Description: Descriptive text b. Value labels if appropriate 432. Name: ae_conmed a. Description: Participant was taking other medications yes/no? b. Value labels if appropriate: 0= No , 1= Yes 433. Name: ae_conmed_y a. Description: Descriptive text b. Value labels if appropriate 434. Name: ae_drop a. Description: Withdrawn From Study yes/no? b. Value labels if appropriate: 0= No , 1= Yes 435. Name: ae_other a. Description: Other adverse events yes/no? b. Value labels if appropriate: 0= No , 1= Yes 436. Name: ae_other_text a. Description: Comments on other adverse events b. Value labels if appropriate 437. Name: initial_date a. Description: Date of Initial Report b. Value labels if appropriate 438. Name: follow_up a. Description: Number of follow ups b. Value labels if appropriate 439. Name: follow_up_date a. Description: Date of follow up b. Value labels if appropriate 440. Name: gender a. Description: Gender b. Value labels if appropriate: 1= Male , 2= Female 441. Name: dob a. Description: Date of birth b. Value labels if appropriate 442. Name: sae_term a. Description: SAE Term b. Value labels if appropriate 443. Name: start_date a. Description: Start Date b. Value labels if appropriate 444. Name: end_date a. Description: End date b. Value labels if appropriate 445. Name: serious_criteria a. Description: Checkbox description of serious criteria b. Value labels if appropriate: 1= Inpatient or Prolonged Hospitalization , 2= Life-threatening (immediate risk of death) , 3= A persistent or significant disability/incapacity , 4= Congenital Anomaly or Birth Defect , 5= Other Serious or Important Medical Event , 6= Death 446. Name: admission_date a. Description: Date of Admission b. Value labels if appropriate 447. Name: discharge_date a. Description: Date of discharge b. Value labels if appropriate 448. Name: death_date a. Description: Date of Death b. Value labels if appropriate 449. Name: death_cause a. Description: Cause of death b. Value labels if appropriate 450. Name: autopsy_yn a. Description: Was autopsy completed yes/no? b. Value labels if appropriate 451. Name: deathcert_yn a. Description: Is death certificate available yes/no? b. Value labels if appropriate 452. Name: outcome a. Description: Outcome b. Value labels if appropriate: 1= Recovered/Resolved , 2= Recovered/Resolved with sequelae , 3= Recovering/Resolving , 4= Not Recovered/Not Resolved , 5= Fatal , 6= Unknown 453. Name: grade a. Description: CTCAE Grade of SAE b. Value labels if appropriate: 1= Grade 1 / Mild , 2= Grade 2 / Moderate , 3= Grade 3 / Severe , 4= Grade 4 / Life-threatening , 5= Grade 5 / Death 454. Name: treatment_date a. Description: Treatment Date b. Value labels if appropriate 455. Name: alb_dose a. Description: Albendazole number of tablets b. Value labels if appropriate 456. Name: dec_dose a. Description: DEC number of tablets b. Value labels if appropriate 457. Name: ivm_dose a. Description: Ivermectin number of tablets b. Value labels if appropriate 458. Name: sae_relationship a. Description: Relationship of SAE to Drug b. Value labels if appropriate: 1= Not related , 2= Possibly related , 3= Probably related , 4= Related 459. Name: alternate_cause a. Description: Possible alternate cause of SAE other than study drug b. Value labels if appropriate: 1= Study disease-related , 2= Concomitant medication (specify) , 3= Pre-existing condition (specify) , 4= Other (specify) 460. Name: alt_cause_other a. Description: Specify alternate cause b. Value labels if appropriate 461. Name: lab_name a. Description: Name, description, and units used for laboratory tests conducted for SAE participant b. Value labels if appropriate 462. Name: medication a. Description: Name, description, and units used for medication for SAE participant b. Value labels if appropriate 463. Name: mh_diagnosis a. Description: Discription and diagnosis of past medical history for SAE participant b. Value labels if appropriate 464. Name: narrative_sum a. Description: Detailed description of the serious adverse event including time, date, cause, and other contributing factors b. Value labels if appropriate 465. Name: reporter_id a. Description: Name of reporter of SAE b. Value labels if appropriate 466. Name: location a. Description: Location of Reporter b. Value labels if appropriate 467. Name: investigator_id a. Description: Name of SAE investigator b. Value labels if appropriate 468. Name: investigator_date a. Description: Date of completion of SAE form b. Value labels if appropriate