Table 4.
Clinical and laboratory grade 3 or 4 adverse events, serious adverse events, and deaths that occurred until week 48
| Supplemental dolutegravir arm (n=53) | Placebo arm (n=55) | ||
|---|---|---|---|
| Participants with clinical grade 3–4 adverse events | 11 (21%) | 10 (18%) | |
| Total number of clinical grade 3–4 adverse events* | 13 | 18 | |
| Clinical grade 3–4 adverse events | |||
| Weight loss | 2 (4%) | 2 (4%) | |
| Insomnia | 3 (6%) | 0 | |
| Pneumonia | 2 (4%) | 1 (2%) | |
| Nausea or vomiting (or both) | 0 | 2 (4%) | |
| Gastritis | 0 | 2 (4%) | |
| Rash | 0 | 2 (4%) | |
| Trauma-related injury | 2 (4%) | 0 | |
| Reactivation of or unsuccessfully treated tuberculosis | 0 | 2 (4%) | |
| Acute renal impairment | 0 | 2 (4%) | |
| Balanitis with paraphimosis | 1 (2%) | 0 | |
| Bowel obstruction | 0 | 1 (2%) | |
| Oesophageal candidiasis | 0 | 1 (2%) | |
| Hyperkalaemia | 1 (2%) | 0 | |
| Immune reconstitution inflammatory syndrome | 1 (2%) | 0 | |
| Peripheral neuropathy | 1 (2%) | 0 | |
| Prostatitis | 0 | 1 (2%) | |
| Drug-related clinical grade 3–4 adverse events† | 5 (9%) | 3 (5%) | |
| Participants with serious adverse events | 0 | 5 (9%)‡ | |
| Drug-related serious adverse events | 0 | 1 (2%) | |
| Deaths | 0 | 3 (5%) | |
| Participants with laboratory grade 3–4 adverse events | 12 (23%) | 13 (24%) | |
| Low CD4 count | 9 (17%) | 7 (13%) | |
| Low estimated glomerular filtration rate | 2 (4%) | 6 (11%) | |
| High potassium | 1 (2%) | 2 (4%) | |
| High alanine aminotransferase | 0 | 1 (2%) | |
Data are n (%) or n. Data capture adverse events that took place at any point from the first dose of study drug until the end of week 48.
Total number of adverse events.
Drug-related clinical adverse events defined as at least possibly related to treatment.
One participant was admitted to hospital with treatment-resistant oesophageal candidiasis, atrophic gastritis, and acute renal impairment and died secondary to presumed cardiac arrest; one participant died secondary to a trauma-related event; one participant was admitted to hospital with severe community-acquired pneumonia and had a subsequent readmission for nosocomial pneumonia, one participant was admitted to hospital with a lichenoid rash possibly related to antituberculosis therapy, and one participant was admitted to hospital with bowel obstruction and died shortly after corrective surgery.