Table 3.
Adverse events
| System classification | Pioglitazone events, n (%) | Pioglitazone Patients affected, n (%) | Pioglitazone Events per patient, minimum–maximum | Placebo, n (%) | Placebo Patients affected, n (%) | Placebo Events per patient, (minimum–maximum) |
|---|---|---|---|---|---|---|
| Headache of any type | 36 (26.5) | 8 (50) | 1–12 | 35 (23.6) | 9 (52.9) | 1–11 |
| Musculoskeletal pain/injury | 17 (12.5) | 7 (43.8) | 1–6 | 23 (15.5) | 9 (52.9) | 1–7 |
| Urinary tract infection, cyst rupture and kidney pain | 12 (8.8) | 7 (43.8) | 1–3 | 18 (12.2) | 9 (52.9) | 1–4 |
| PKD/kidney abdominal pain | 0 (0) | 4 (2.7) | 2 (11.8) | 2 | ||
| Gastrointestinal disorder (e.g. diarrhea, gastroesophageal reflux disease) | 9 (6.6) | 6 (37.5) | 1–2 | 10 (6.8) | 5 (29.4) | 1–5 |
| Infection or virus non genitourinary system | 38 (27.9) | 13 (81.3) | 1–7 | 30 (20.3) | 15 (93.8) | 1–6 |
| Dizziness, lightheadedness and vertigo | 6 (4.4) | 4 (25) | 1–3 | 6 (4.1) | 3 (17.6) | 1–4 |
| Skin problems | 5 (3.7) | 4 (25) | 1–2 | 2 (1.4) | 2 (11.8) | 1 |
| Allergies | 3 (2.2) | 3 (18.8) | 1 | 0 (0) | ||
| Edema not meeting safety endpoint criteria | 4 (2.9) | 3 (18.8) | 1–2 | 0 (0) | ||
| Othera | 6 (4.4) | 5 (3.1) | 1–2 | 20 (13.5) | 11 (64.7) | 1–6 |
a
Generalized linear mixed modeling (GLMM) Analysis of the ‘other’ category indicated a significant difference between pioglitazone and placebo in terms of the number of patients with at least one ‘other’ AE (P = 0.0135) and rate of ‘other’ AEs (P = 0.0370). Post hoc analysis was performed to assess the ‘other’ AE category. For subjects who received at least one dose of pioglitazone or placebo, GLLM with binomial distribution and a random patient effect was used to analyze if a patient was more likely to have an ‘other’ AE (yes or no) while on pioglitazone versus placebo. GLLM with Poisson distribution was used to determine if the drug had an effect on the number of ‘other’ AEs a patient experienced.