Table 3.
Grades 2+ and 3+ adverse events, serious adverse events and injection site reaction summary by Cohort and Study arm
| Total TGW Participants Enrolled | TGW | MSM | ||
|---|---|---|---|---|
| TDF/FTC (n=304) | CAB-LA (n=266) | TDF/FTC (n=1978) | CAB-LA (n= 2014) | |
| n (%) | n (%) | n (%) | n (%) | |
| Number of Participants with Grade 2+ AEs 1 | 270 (88.8) | 246 (92.5) | 1846 (93.3) | 1860 (92.4) |
| Number of Participants with Grade 3+ AEs 1 | 76 (25.0) | 66 (24.8) | 691 (34.9) | 661 (32.8) |
| Serious adverse events 1 | 12 (4.0) | 17 (6.4) | 109 (5.5) | 103 (5.1) |
| Participants who received at least one injection | 266 (87.5) | 250 (94.0) | 1815 (91.8) | 1867 (92.7) |
| Number of participants who have reported any injection site reaction (ISR) | 77 (28.9) | 217 (86.8) | 575 (31.7) | 1507 (80.7) |
CAB-LA: Cabotegravir; MSM: men who have sex with men; TDF/FTC: Tenofovir disoproxil fumarate/emtricitabine; TGW: transgender women.
Included are only adverse events that were assigned Medical Dictionary for Regulatory Activities (MedDRA), version 23.1 terms by clinical staff. Injection-site reactions and sexually transmitted infections are not included. Inappropriately enrolled participants, including enrolled participants who were later found to have failed to meet a key inclusion/exclusion criteria, and participants who did not receive any oral trial drug are excluded. In cases in which a participant had multiple events with the same MedDRA term, only one event is counted.