Table 3.
Adverse Events.
| Adverse Event | Early Antiretroviral Therapy (N = 252) |
Deferred Antiretroviral Therapy (N = 125) |
Total (N = 377) |
|---|---|---|---|
| All adverse events — no. of events | 1356 | 1063 | 2419 |
| Clinical adverse event | |||
| Stage C event — no. of events | |||
| HIV wasting | 3 | 3 | 6 |
| Pneumocystis jiroveci pneumonia | 0 | 4 | 4 |
| Recurrent bacterial infections | 0 | 2 | 2 |
| HIV encephalopathy | 1 | 8 | 9 |
| CMV pneumonitis | 0 | 2 | 2 |
| Disseminated CMV infection | 0 | 1 | 1 |
| Esophageal candidiasis | 0 | 1 | 1 |
| Extrapulmonary tuberculosis | 1 | 1 | 2 |
| Severe stage B event — no. | |||
| Failure to thrive* | 12 | 12 | 24 |
| Lymphoid interstitial pneumonitis | 0 | 1 | 1 |
| Chronic lung disease | 1 | 0 | 1 |
| Stage C or severe stage B event | |||
| No. of events | 18 | 35 | 53 |
| No. of participants with event† | 16 | 32 | |
| Most frequently reported infections — no. of infections (no./100 person-years) | |||
| Grade 3 or 4 gastroenteritis | 29 (14.1) | 36 (38.2) | 65 (21.7) |
| Grade 1 or 2 gastroenteritis | 180 (87.5) | 123 (130.5) | 303 (101.0) |
| Grade 3 or 4 pneumonia | 25 (12.2) | 25 (26.5) | 50 (16.7) |
| Grade 1 or 2 pneumonia | 66 (32.1) | 56 (59.4) | 122 (40.7) |
| Meningitis | 1 (0.5) | 6 (6.4) | 7 (2.3) |
| Tuberculosis | 17 (8.3) | 19 (20.2) | 36 (12.0) |
| Laboratory grade 3 or 4 adverse event — total no. of events (no. of drug-related events)‡ | |||
| Alanine or aspartate aminotransferase elevation | 6 (2) | 1 (0) | 7 (2) |
| Anemia | 5 (3) | 2 (1) | 7 (4) |
| Neutropenia | 19 (10) | 3 (3) | 22 (13) |
| Thrombocytopenia | 3 (1) | 1 (0) | 4 (1) |
| Elevated γ-glutamyltransferase§ | 0 (0) | 2 (0) | 2 (0) |
| Hypernatremia | 6 (0) | 5 (0) | 11 (0) |
| Hyponatremia | 1 (0) | 1 (0) | 2 (0) |
| Hyperkalemia | 1 (0) | 0 (0) | 1 (0) |
| Hypokalemia | 1 (0) | 1 (0) | 2 (0) |
| Total events | 42 (16) | 16 (4) | 58 (20) |
| Serious adverse event — no. (%) | |||
| Participants with ≥1 event¶ | 55 (21.8) | 55 (44.0) | 110 (29.2) |
| Death | 10 (4.0) | 20 (16.0) | 30 (8.0) |
| Life-threatening event | 9 (3.6) | 4 (3.2) | 13 (3.4) |
| New or prolonged hospitalization | 41 (16.3) | 46 (36.8) | 87 (23.1) |
| Persistent or significant disability or incapacity | 0 | 1 (0.8) | 1 (0.3) |
Failure to thrive was defined as the documented loss of body weight or body weight crossing two major percentile lines (50th, 25th, 10th, or 5th) and failure to gain weight within 4 weeks with standard management, with no other cause identified during investigation, or for patients already below the 5th percentile, failure of weight gain to parallel the 5th percentile (in the absence of chronic diarrhea and fever for >30 days).13 CMV denotes cytomegalovirus.
Some of these participants may have had more than one event.
This category includes all adverse events deemed to be possibly, probably, or definitely drug-related.
An elevation was considered to be present if the assayed value was 10 or more times the upper limit of the normal age-adjusted range.
A participant may have had an event that was included in more than one category of serious adverse events.