Number of adverse events by category and safety group
| Placebo | Co-trimoxazole | |||
|---|---|---|---|---|
| Group | Subgroup | Number of individuals with ≥1 (%) | Number of individuals with ≥1 (%) | p Value |
| Blood disorder | 3 (3.5) | 6 (6.5) | 0.356 | |
| Cardiac disorder | 9 (10.5) | 3 (3.3) | 0.055 | |
| Dental condition | 1 (1.2) | 2 (2.2) | 1 | |
| Ear disorder | 1 (1.2) | 0 (0.0) | 0.483 | |
| Eye disorder | 3 (3.5) | 5 (5.4) | 0.722 | |
| General disorders | 14 (16.3) | 17 (18.5) | 0.699 | |
| Gastrointestinal | 21 (24.4) | 41 (44.6) | 0.005 | |
| Nausea | 6 (7.0) | 17 (18.5) | 0.022 | |
| Immune system disorder | 1 (1.2) | 0 (0.0) | 0.483 | |
| Infection | 59 (68.6) | 38 (41.3) | <0.001 | |
| Pneumonia | 8 (9.3) | 0 (0.0) | 0.002 | |
| LRTI | 38 (44.2) | 27 (29.4) | 0.04 | |
| URTI | 14 (16.3) | 6 (6.5) | 0.039 | |
| Injury | 0 (0.0) | 3 (3.3) | 0.247 | |
| Investigations | 7 (8.1) | 11 (12.0) | 0.399 | |
| Metabolic disorder | 8 (9.3) | 13 (14.1) | 0.318 | |
| Muscle and tissue disease | 11 (12.8) | 12 (13.0) | 0.96 | |
| Neoplasia | 4 (4.7) | 1 (1.1) | 0.199 | |
| Nervous system | 11 (12.8) | 11 (12.0) | 0.866 | |
| Medical and surgical procedures | 5 (5.8) | 1 (1.1) | 0.108 | |
| Psychiatric | 4 (4.7) | 5 (5.4) | 1 | |
| Renal and urinary disease | 3 (3.5) | 3 (3.3) | 1 | |
| Reproductive and breast | 2 (2.3) | 0 (0.0) | 0.232 | |
| Respiratory | 39 (45.4) | 35 (38.0) | 0.323 | |
| Skin disorder | 4 (4.7) | 14 (15.2) | 0.019 | |
| Vascular disorders | 7 (8.1) | 9 (9.8) | 0.702 | |
| None | 21 (24.4) | 16 (17.4) | 0.248 |
LRTI, lower respiratory tract infection; URTI, upper respiratory tract infection.