Table 2.
Patient | Treatment | QTc baseline (ms) | QTc maximum (ms) | ECG findings |
---|---|---|---|---|
ROSI-002 | Rosiglitazone | 352 | 407 | Increase of QtcF >50 ms on day 4, NCS |
ROSI-007 | Rosiglitazone | 396 | 427 | Increase of QtcF >50 ms on day 2, NCS. Finished on day 4 |
ROSI-008 | Rosiglitazone | 356 | 424 | Increase of QtcF >50 ms on day 2, NCS. Continue on day 7, NCS |
ROSI-009 | Placebo | 342 | 425 | Increase of QtcF >50 ms on day 4 with associated bradycardia, NCS Increase of QtcF >50 ms on day 7, NCS and without bradycardia |
ROSI-010 | Placebo | 336 | 409 | Increase of QtcF >50 ms on day 4, NCS. Finished on day 7 |
ROSI-012 | Rosiglitazone | 323 | 404 | Increase of QtcF >50 ms on day 2, NCS. Finished on day 4 |
ROSI-014 | Placebo | 364 | 425 | Left bundle branch block from screening, NCS Increase of QtcF >50 ms on day 4, NCS. Finished on day 14 Bradycardia on day 4, NCS |
ROSI-021 | Placebo | 361 | 414 | Increase of QtcF >50 ms on day 4, NCS. Finished on day 7 |
ROSI-022 | Placebo | 349 | 402 | Increase of QtcF >50 ms on day 4, NCS. Finished on day 7 |
These abnormalities were not clinically significant (NCS). QT corrected for heart rate using Fridericia’s method