Table 4.
Adverse Events Following Treatment of Lymphatic Filariasis
| IDA (n = 43) | IA (n = 48) | |
|---|---|---|
| At least 1 AE n (%) | 20 (47) | 19 (40) |
| Individuals with ≥2 AEs | 14 (33) | 6 (13) |
| Severe or serious AEs | 0 | 0 |
| Fever ≥37.5°Ca | 7 (17) | 6 (12) |
| Hemodynamic changesb | 4 (10) | 2 (4) |
| Overall grade 1 AEs (subjective)c | 20 (47) | 19 (40) |
| Overall grade 2 AEs (subjective)c | 5 (12) | 1 (2) |
| Grade 2 AEs by symptoms | ||
| Fatigue | 2 (5) | 0 |
| Nausea/vomiting | 1 (2) | 1 (2) |
| Muscle ache | 0 | 1 (2) |
| Joint pain | 1 (2) | 0 |
| Eye swelling | 1 (2) | 0 |
| Rash | 1 (2) | 0 |
| Lightheadedness | 0 | 1 (2) |
| Dyspnea | 1 (2) |
Abbreviations: AE, adverse event; IA, ivermectin plus albendazole; IDA, ivermectin plus diethylcarbamazine plus albendazole.
aThe number of individuals with temperatures ≥37.5°C based on axillary temperature. The highest temperature recorded posttreatment was 38.4°C.
bDefined as a change in blood pressure of 30 mm Hg systolic or 20 mm Hg diastolic compared with the pretreatment recording. One subject in the IA arm developed transient hypertension (170/110) and another had a decrease in systolic blood pressure not considered to be hypotensive (100/60). One subject treated with IDA also developed transient hypertension (160/110) and 3 subjects had decreases in systolic blood pressure, but without meeting criteria for hypotension. None of these changes required medical intervention (all were grade 1).
cOnly grade 2 AEs are listed by symptoms. With respect to specific grade 2 AEs, 1 participant in the IA treatment arm had 3 different grade 2 AEs and 2 participants in the IDA treatment arm had 2 different grade 2 AEs.