Table 3.
Adverse events (AE) by body system and treatment
| Body system preferred term severity | Pioglitazone (N=77) | Placebo (N=77) |
| n (%) | n (%) | |
| Blood and lymphatic system disorders | 5 (6.5) | 1 (1.3) |
| Cardiac disorders | 4 (5.2) | 1 (1.3) |
| Eye disorders | 1 (1.3) | 3 (3.9) |
| Gastrointestinal disorders | 15 (19.5) | 14 (18.2) |
| General disorders | 8 (10.4) | 5 (6.5) |
| Immune system disorders | 0 (0.0) | 1 (1.3) |
| Infections and infestations | 15 (19.5) | 27 (35.1) |
| Injury poisoning and procedural complications | 0 (0.0) | 1 (1.3) |
| Investigations* | 15 (19.5) | 7 (9.1) |
| Metabolism and nutrition disorders | 4 (5.2) | 1 (1.3) |
| Musculoskeletal and connective tissue disorders | 4 (5.2) | 4 (5.2) |
| Nervous system disorders | 16 (20.8) | 12 (15.6) |
| Psychiatric disorders | 2 (2.6) | 2 (2.6) |
| Renal and urinary disorders | 5 (6.5) | 2 (2.6) |
| Reproductive system and breast disorders | 0 (0.0) | 2 (2.6) |
| Respiratory thoracic and mediastinal disorders | 6 (7.8) | 9 (11.7) |
| Skin and subcutaneous tissue disorders | 3 (3.9) | 2 (2.6) |
| Surgical and medical procedures | 1 (1.3) | 0 (0.0) |
| Vascular disorders | 1 (1.3) | 2 (2.6) |
n=number of subjects who had specific AE at least once; % of total number of subjects.
A total of 13 SAE were observed in 10 subjects. Eight SAEs while on placebo and five while on pioglitazone. All SAEs were followed until resolved.
*Abnormal lab values.
SAE, serous adverse event.