Table 2.
Adverse events* by treatment group, Kisumu, Kenya, 2019.
| TFV/LNG IVR n (%) |
TFV-only IVR n (%) |
Placebo IVR n (%) |
Overall n (%) |
|
|---|---|---|---|---|
| Adverse events (AEs)a | ||||
| Total AEs (any grade) | 47 (42.7%) | 47 (42.7%) | 16 (14.5%) | 110 (100.0%) |
| Serious AEs | 0 (0%) | 1 (100.0%) | 0 (0%) | 1 (100.0%) |
| Participants reporting at least one AE | ||||
| AE (any grade) | 11 (100.0%) | 10 (90.9%) | 5 (100.0%) | 26 (96.3%) |
| Severity of AEb | ||||
| Grade 1: Mild | 0 (0%) | 1 (10%) | 1 (20%) | 2 (8%) |
| Grade 2: Moderate | 11 (100%) | 8 (80%) | 4 (80%) | 23 (88%) |
| Grade 3: Severe | 0 (0%) | 0 (0%) | 0 (0%) | 0 (0%) |
| Grade 4: Potentially life-threatening | 0 (0%) | 1 (10%) | 0 (0%) | 1 (4%) |
| Grade 5: Death | 0 (0%) | 0 (0%) | 0 (0%) | 0 (0%) |
| Relationship of AE to IVR usec | ||||
| Any related AE | 6 (55%) | 1 (10%) | 0 (0%) | 7 (27%) |
| No related AE | 5 (45%) | 9 (90%) | 5 (100%) | 19 (73%) |
TFV, tenofovir; LNG, levonorgestrel; IVR, intravaginal ring; AE, adverse event(s).
*
July 2017 update of the Division of AIDS (DAIDS) table (https://rsc.niaid.nih.gov/sites/default/files/daidsgradingcorrectedv21.pdf).
a
Events reported. More than one event may have been reported per participant. Percentages given are among total events reported and represent a row percent.
b
Participants reporting more than one AE were counted only once using the highest severity of AE reported.
c
Participants reporting more than one AE were counted only once using the closest relationship to IVR use reported (i.e., “related” or “not related”).