Table 3.
Side Effects and Serious Adverse Event Summary Through Week 48
| Total (n = 13) | Pioglitazone (n = 6) | Placebo (n = 7) | |
|---|---|---|---|
| Description | |||
| Fatigue | 3 | 1 | 2 |
| Weight gain | 3 | 2 | 1 |
| Dizziness | 1 | 0 | 1 |
| Headache | 1 | 0 | 1 |
| Insomnia | 1 | 0 | 1 |
| Abdominal pain | 1 | 1 | 0 |
| Diarrhea | 1 | 0 | 1 |
| Sore throat | 1 | 0 | 1 |
| Weight loss | 1 | 0 | 1 |
| Conjunctivitis | 1 | 1 | 0 |
| Polydypsia | 1 | 0 | 1 |
| Laboratory abnormalities | |||
| Decreased serum albumin | 5 | 2 | 3 |
| Increased cholesterol | 3 | 1 | 2 |
| Hematuriaa | 1 | 0 | 1 |
| Elevated bilirubin | 1 | 0 | 1 |
| Proteinuria | 1 | 1 | 0 |
| Glycosuria | 1 | 1 | 0 |
| Serious adverse events | |||
| Dental abscess | 1 | 0 | 1 |
| Renal insufficiency | 1 | 0 | 1 |
| Adenocarcinoma, lung | 1 | 0 | 1 |
a
Subject diagnosed with renal calculi after presentation with hematuria.
Table includes all symptoms and laboratory abnormalities of grade 1 or higher identified as probably not, possibly, probably, and/or definitely related to study participation.