Table 2.
Adverse Events.*
| Event | Overall (N = 4562) | Cabotegravir Group (N = 2280) | TDF-FTC Group (N = 2282) |
|---|---|---|---|
| number of participants (percent) | |||
| Any adverse event of grade 2 or higher | 4222 (92.5) | 2106 (92.4) | 2116 (92.7) |
| Most common adverse events of grade 2 or higher† | |||
| Decreased creatinine clearance | 3257 (71.4) | 1588 (69.6) | 1669 (73.1) |
| Increased creatine kinase | 953 (20.9) | 484 (21.2) | 469 (20.6) |
| Nasopharyngitis‡ | 844 (18.5) | 447 (19.6) | 397 (17.4) |
| Increased serum creatinine | 810 (17.8) | 382 (16.8) | 428 (18.8) |
| Upper respiratory infection‡ | 516 (11.3) | 257 (11.3) | 259 (11.3) |
| Musculoskeletal discomfort‡ | 513 (11.2) | 254 (11.1) | 259 (11.3) |
| Increased lipase | 509 (11.2) | 249 (10.9) | 260 (11.4) |
| Headache‡ | 458 (10.0) | 237 (10.4) | 221 (9.7) |
| Increased aspartate aminotransferase | 384 (8.4) | 188 (8.2) | 196 (8.6) |
| Increased alanine aminotransferase | 351 (7.7) | 159 (7.0) | 192 (8.4) |
| Increased blood glucose | 322 (7.1) | 199 (8.7) | 123 (5.4) |
| Increased amylase | 317 (6.9) | 148 (6.5) | 169 (7.4) |
| Diarrhea‡ | 313 (6.9) | 152 (6.7) | 161 (7.1) |
| Rash‡ | 260 (5.7) | 116 (5.1) | 144 (6.3) |
| Hypoglycemia‡ | 246 (5.4) | 120 (5.3) | 126 (5.5) |
| Pyrexia | 185 (4.1) | 122 (5.4) | 63 (2.8) |
| Any adverse event of grade 3 or higher | 1494 (32.7) | 727 (31.9) | 767 (33.6) |
| Most common adverse events of grade 3 or higher§ | |||
| Increased creatine kinase | 633 (13.9) | 324 (14.2) | 309 (13.5) |
| Decreased creatinine clearance | 349 (7.7) | 159 (7.0) | 190 (8.3) |
| Increased serum creatinine | 156 (3.4) | 80 (3.5) | 76 (3.3) |
| Increased lipase | 152 (3.3) | 76 (3.3) | 76 (3.3) |
| Increased aspartate aminotransferase | 122 (2.7) | 53 (2.3) | 69 (3.0) |
| Increased alanine aminotransferase | 55 (1.2) | 23 (1.0) | 32 (1.4) |
| Serious adverse event | 241 (5.3) | 120 (5.3) | 121 (5.3) |
| Adverse events of special interest | |||
| Seizure | 7 (0.2) | 2 (0.1) | 5 (0.2) |
| Liver-related adverse event resulting in discontinuation of oral tablets or both oral tablets and injections | 95 (2.1) | 47 (2.1) | 48 (2.1) |
Included are only adverse events that were assigned Medical Dictionary for Regulatory Activities, version 23.1 (MedDRA) terms by clinical staff. Injection-site reactions and sexually transmitted infections are not included. Inappropriately enrolled participants 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.
Only adverse events that were reported in at least 5% of the participants in either trial group are shown.
This adverse event category combines multiple MedDRA terms that were too similar to report individually.
Only adverse events that were reported in at least 1% of the participants in either trial group are shown.