Table 2. Clinical outcomes by randomised arm.
| Control (N = 271) | RAL (N = 270) | ||||||
|---|---|---|---|---|---|---|---|
| n | Rate/100 py | n | Rate/100 py | Hazard Ratio | 95%CI | p-value | |
| Deaths | 11 | 2.4 | 8 | 1.6 | 0.7 | (0.3, 1.8) | 0.456 |
| AIDS or death | 29 | 6.6 | 34 | 7.6 | 1.2 | (0.7, 1.9) | 0.538 |
| Serious adverse events | 33 | 7.4 | 40 | 8.8 | 1.2 | (0.8, 1.9) | 0.456 |
| Adverse events | 1391 | 297.2 | 1387 | 285.0 | 0.9 | (0.8, 1.1) | 0.238 |
| Number of participants reporting Grade 3/4 adverse events* | n | % | n | % | |||
| Number of Grade 3/4 adverse events | |||||||
| Total | 45 | 16.6 | 36 | 13.3 | |||
| 55 | 46 | ||||||
| Infections and infestations | 11 | 4.1 | 7 | 2.6 | |||
| 12 | 13 | ||||||
| General disorders and administration site conditions | 4 | 1.5 | 5 | 1.9 | |||
| 4 | 5 | ||||||
| Gastrointestinal disorders | 7 | 2.6 | 1 | 0.4 | |||
| 9 | 1 | ||||||
| Blood and lymphatic system disorders | 4 | 1.5 | 3 | 1.1 | |||
| 10 | 3 | ||||||
| Metabolism and nutrition disorders | 2 | 0.7 | 3 | 1.1 | |||
| 2 | 5 | ||||||
| Pregnancy, puerperium and perinatal conditions | 2 | 0.7 | 3 | 1.1 | |||
| 2 | 4 | ||||||
| Ceased antiretroviral therapy due to any grade adverse event | 12/46 | 26.1 | 9/45 | 20.0 | |||
*Grade 3/4 adverse events summarised by MedDRA System Organ Class which were reported by 5 or more people
py: person years