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Additional file 1 of Onchocerca volvulus microfilariae in the anterior chambers of the eye and ocular adverse events after a single dose of 8 mg moxidectin or 150 µg/kg ivermectin: results of a randomized double-blind Phase 3 trial in the Democratic Republic of the Congo, Ghana and Liberia

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posted on 2024-03-16, 04:41 authored by Eric M. Kanza, Amos Nyathirombo, Jemmah P. Larbelee, Nicholas O. Opoku, Didier K. Bakajika, Hayford M. Howard, Germain L. Mambandu, Maurice M. Nigo, Deogratias Ucima Wonyarossi, Françoise Ngave, Kambale Kasonia Kennedy, Kambale Kataliko, Kpehe M. Bolay, Simon K. Attah, George Olipoh, Sampson Asare, Mupenzi Mumbere, Michel Vaillant, Christine M. Halleux, Annette C. Kuesel
Additional file 1: Fig S1. mfAC pre-treatment, 4 days, 1, 6, 12 and 18 months post-treatment among participants with < 10 mfAC pre-treatment by pre-treatment SmfD. Fig S2. mfAC pre-treatment, 4 days, 1, 6, 12 and 18 months post-treatment among participants with ≥ 10 mfAC pre-treatment by pre-treatment SmfD. Fig S3. mfAC 1, 6, 12 and 18 months post-treatment among participants with < 10 mfAC pre-treatment by post-treatment SmfD. Fig S4. mfAC 1, 6, 12 and 18 months post-treatment among participants with ≥ 10 mfAC pre-treatment by post-treatment SmfD. Table S1. Participants with both eyes evaluated at each timepoint by pre-treatment SmfD and mfAC category and sex. Table S2. Mean (SD), minimum and maximum mfAC levels among participants with increases from pre-treatment to Day 4 or Month 1 and from Day 4 to Month 1 resulting in mfAC levels in a higher mfAC category. Table S3. Number (%) of participants by mfAC category on Day 4 or Month 1 after treatment by pre-treatment and Day 4 mfAC category and treatment arm. Table S4. Output linear model for mfAC. Table S5. Ocular medical history of study participants by study area. Table S6. Output of final logistic model of the factors impacting the risk to have at least one ocular Mazzotti reaction. Table S7. Number (%) of participants with ocular adverse events starting within 1 and between month 1 and end of 6 months after treatment by ocular AE based on MedDRA coding. Table S8. Number of ocular adverse events starting within 1 and between month 1 and end of 6 months after treatment by ocular AE based on MedDRA coding. Table S9. Output of final logistic model of the factors and covariates impacting the risk to have at least one ocular adverse event. Table S10. Literature data on mfAC number change early after treatment with diethylcarbamazine, ivermectin and suramin. Table S11. Microfilariae in the blood and urine before and after treatment (data from the moxidectin Phase 2 study, across all participants and for participants with > 20mf/mg skin).

Funding

UNICEF/UNDP/World Bank/WHO Special Programme for Research and Training in Tropical Diseases (WHO/TDR), World Health Organization, Geneva, Switzerland

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