Table 2.
DEC/ALB (N=91) | IVM/DEC/ALB (N=41) | |
---|---|---|
Number of participants with AEs (percent) | ||
At least one AE | 37 (41) | 24 (59) |
Individuals with two or more AEs | 24 (26) | 19 (46)* |
Fever§ | 19 (21) | 14 (34) |
Hemodynamic changes¶ | 4 (4) | 5 (12) |
Overall Grade 1 AEs (subjective)† | 36 (40) | 22 (54) |
Overall Grade 2 and 3 AEs with severity grade >1† | 5 (5) | 11 (27)*** |
Frequency of AEs with severity grade >1 | ||
Fatigue | 5 (5) | 8 (20) |
Headache | 3 (3) | 7 (17) |
Nausea/vomiting | 2 | 4 (10) |
Itch/rash | 0 | 2 (5) |
Muscle ache | 3 (3) | 5 (12) |
Eye swelling | 0 | 1 (2) |
Scrotal pain/swelling | 2 (2) | 4 (10) |
Dyspnea | 0 | 2 (5) |
p<0.05
Auricular temperature ≥37.5°C. The highest temperature recorded post-treatment was 41.1°C.
Defined as a change in blood pressure of 30 mm Hg systolic or 20 mm Hg diastolic compared to the pre-treatment recording. Three of five individuals in the IVM+DEC+ALB group had reduced blood pressure. All four individuals in the DEC+ALB group had reduced blood pressure.
Only grade 2 or 3 AEs are listed by symptoms. All but one participant with grade 2 symptoms had more than one AE.
p<0.001 by chi-square