Table 3.
Adverse events
| Cabotegravir group (n=1614) | TDF-FTC group (n=1610) | ||
|---|---|---|---|
| Grade 2 or higher adverse event | 1487 (92·1%) | 1486 (92·3%) | |
| Most common adverse events (grade ≥2)* | |||
| Decreased creatinine clearance | 1166 (72·2%) | 1197 (74·3%) | |
| Gastrointestinal disorders† | 334 (20·7%) | 370 (23·0%) | |
| Increased creatinine | 340 (21·1%) | 330 (20·5%) | |
| Abnormal uterine bleeding† | 311 (19·3%) | 306 (19·0%) | |
| Headache† | 276 (17·1%) | 280 (17·4%) | |
| Upper respiratory tract infection† | 276 (17·1%) | 312 (19·4%) | |
| Chlamydia infection† | 261 (16·2%) | 287 (17·8%) | |
| Urinary tract infection† | 229 (14·2%) | 209 (13·0%) | |
| Increased amylase | 169 (10·5%) | 149 (9·3%) | |
| Decreased blood glucose | 146 (9·0%) | 146 (9·1%) | |
| Vulvovaginal candidiasis | 127 (7·8%) | 150 (9·3%) | |
| Gonococcal infection† | 126 (7·8%) | 125 (7·8%) | |
| Vulvovaginal trichomoniasis | 124 (7·7%) | 109 (6·8%) | |
| Back pain | 106 (6·6%) | 112 (7·0%) | |
| Blood creatinine phosphokinase | 86 (5·3%) | 69 (4·3%) | |
| Abnormal weight loss | 85 (5·3%) | 107 (6·6%) | |
| Vaginal discharge | 83 (5·1%) | 58 (3·6%) | |
| Nasopharyngitis | 75 (4·6%) | 86 (5·3%) | |
| Decreased blood phosphorous | 58 (3·6%) | 83 (5·2%) | |
| Grade 3 or higher adverse event | 276 (17·1%) | 280 (17·4%) | |
| Most common adverse events (grade ≥3)‡ | |||
| Decreased creatinine clearance | 110 (6·8%) | 125 (7·8%) | |
| Increased creatinine | 73 (4·5%) | 67 (4·2%) | |
| Increased creatine phosphokinase | 41 (2·5%) | 32 (2·0%) | |
| Abnormal weight loss | 21 (1·3%) | 36 (2·2%) | |
| Increased alanine aminotransferase | 11 (0·7%) | 15 (0·9%) | |
| Increased aspartate aminotransferase | 14 (0·9%) | 13 (0·8%) | |
| Adverse events of special interest | |||
| Seizure | 0 | 1 (0·1%) | |
| Hepatic-related discontinuation | 15 (0·9%) | 18 (1·1%) | |
| Serious adverse events | 33 (2·0%) | 33 (2·0%) | |
| Deaths | 3 (0·2%) | 0 | |
| Injection site reactions§ | |||
| Any | 577/1519 (38·0%) | 163/1516 (10·8%) | |
| Grade ≥2 | 192/1519 (12·6%) | 25/1516 (1·6%) | |
Table cut based on imputed date of onset date when date is missing without missing month and year. Includes adverse events assigned MedRA codes by clinic staff. For participants reporting multiple events of the same MedRA term, the highest grade is counted. TDF-FTC=tenofovir disoproxil fumarate plus emtricitabine.
*
Includes only adverse events reported by at least 5% of participants in either study group.
†
Contains grouping of similar MedRA terms that fall within this preferred term.
‡
Includes only adverse events reported by at least 1% of participants in either study group.
§
Includes only participants who received one or more injections (ie, 1519 in the cabotegravir group and 1516 in the TDF-FTC group).