Table 3

Number of adverse events by category and safety group

PlaceboCo-trimoxazole
GroupSubgroupNumber of individuals with ≥1 (%)Number of individuals with ≥1 (%)p Value
Blood disorder3 (3.5)6 (6.5)0.356
Cardiac disorder9 (10.5)3 (3.3)0.055
Dental condition1 (1.2)2 (2.2)1
Ear disorder1 (1.2)0 (0.0)0.483
Eye disorder3 (3.5)5 (5.4)0.722
General disorders14 (16.3)17 (18.5)0.699
Gastrointestinal21 (24.4)41 (44.6)0.005
Nausea6 (7.0)17 (18.5)0.022
Immune system disorder1 (1.2)0 (0.0)0.483
Infection59 (68.6)38 (41.3)<0.001
Pneumonia8 (9.3)0 (0.0)0.002
LRTI38 (44.2)27 (29.4)0.04
URTI14 (16.3)6 (6.5)0.039
Injury0 (0.0)3 (3.3)0.247
Investigations7 (8.1)11 (12.0)0.399
Metabolic disorder8 (9.3)13 (14.1)0.318
Muscle and tissue disease11 (12.8)12 (13.0)0.96
Neoplasia4 (4.7)1 (1.1)0.199
Nervous system11 (12.8)11 (12.0)0.866
Medical and surgical procedures5 (5.8)1 (1.1)0.108
Psychiatric4 (4.7)5 (5.4)1
Renal and urinary disease3 (3.5)3 (3.3)1
Reproductive and breast2 (2.3)0 (0.0)0.232
Respiratory39 (45.4)35 (38.0)0.323
Skin disorder4 (4.7)14 (15.2)0.019
Vascular disorders7 (8.1)9 (9.8)0.702
None21 (24.4)16 (17.4)0.248
  • LRTI, lower respiratory tract infection; URTI, upper respiratory tract infection.