Table 2.
Participants with adverse events during the first 6 months after treatment by adverse event category and severity (grade)
|
All participants |
Adolescents (12–17 years) |
||||||
|---|---|---|---|---|---|---|---|
| Moxidectin | Ivermectin | Moxidectin | Ivermectin | ||||
| Number of participants | 978 | 494 | 55 | 24 | |||
| Serious adverse events | |||||||
| Any grade | 39 (4%) | 17 (3%) | 0 | 0 | |||
| 1 | 1 (<1%) | 0 | 0 | 0 | |||
| 2 | 12 (1%) | 9 (2%) | 0 | 0 | |||
| 3 | 21 (2%) | 4 (1%) | 0 | 0 | |||
| 4 | 12 (1%) | 5 (1%) | 0 | 0 | |||
| Unrelated adverse events | |||||||
| Any grade | 950 (97%) | 483 (98%) | 50 (91%) | 23 (96%) | |||
| 1 | 897 (92%) | 458 (93%) | 48 (87%) | 23 (96%) | |||
| 2 | 611 (63%) | 305 (62%) | 13 (24%) | 1 (4%) | |||
| 3 | 202 (21%) | 115 (23%) | 6 (11%) | 1 (4%) | |||
| 4 | 63 (6%) | 36 (7%) | 1 (2%) | 1 (4%) | |||
| Non-Mazzotti adverse drug reactions | |||||||
| Any grade | 0 | 0 | 0 | 0 | |||
| Mazzotti reactions | |||||||
| Any grade | 967 (99%) | 478 (97%) | 55 (100%) | 22 (92%) | |||
| 1 | 918 (94%) | 430 (87%) | 55 (100%) | 20 (83%) | |||
| 2 | 711 (73%) | 339 (69%) | 35 (64%) | 8 (33%) | |||
| 3 | 303 (31%) | 145 (29%) | 12 (22%) | 3 (13%) | |||
| 4 | 321 (33%) | 178 (36%) | 20 (36%) | 11 (46%) | |||
| Ocular Mazzotti reactions | |||||||
| Any grade | 113 (12%) | 47 (10%) | 8 (15%) | 3 (13%) | |||
| 1 | 101 (10%) | 39 (8%) | 8 (15%) | 3 (13%) | |||
| 2 | 15 (2%) | 7 (1%) | 0 | 0 | |||
| 3 | 3 (<1%) | 2 (<1%) | 0 | 0 | |||
| 4 | 0 | 0 | 0 | 0 | |||
| Laboratory Mazzotti reactions* | |||||||
| Any grade | 788 (81%) | 415 (84%) | 43 (78%) | 16 (67%) | |||
| 1 | 373 (38%) | 193 (39%) | 14 (26%) | 4 (17%) | |||
| 2 | 346 (35%) | 178 (36%) | 16 (29%) | 5 (21%) | |||
| 3 | 196 (20%) | 91 (18%) | 11 (20%) | 2 (8%) | |||
| 4 | 266 (27%) | 163 (33%) | 15 (27%) | 9 (38%) | |||
| Clinical Mazzotti reactions | |||||||
| Any grade | 944 (97%) | 446 (90%) | 54 (98%) | 18 (75%) | |||
| 1 | 859 (88%) | 398 (81%) | 51 (93%) | 17 (71%) | |||
| 2 | 567 (58%) | 253 (51%) | 29 (53%) | 4 (17%) | |||
| 3 | 136 (14%) | 61 (12%) | 1 (2%) | 1 (4%) | |||
| 4 | 90 (9%)† | 25 (5%)† | 7 (13%) | 2 (8%) | |||
Data are n (%). The numbers of participants at a given grade within each category or subcategory of events do not sum up to the total number for that category or subcategory because some participants had different types of events with different grades within the same category or subcategory. For participants with more than one episode of the same type of event at different levels of severity, we recorded the most severe grade. Adverse events were classified as serious or non-serious and as non-Mazzotti adverse drug reactions (ie, treatment-related), Mazzotti reactions (ie, adverse events related to accelerated microfilarial death after treatment with microfilarial drugs), or unrelated adverse events as explained in the Methods.
Changes in laboratory values considered Mazzotti reactions are most frequently haematological (eosinopenia followed by eosinophilia, lymphocyte decrease followed by lymphocytosis) but might also affect serum biochemistry (most frequently aspartate and alanine aminotransferase; appendix).
p=0·010.