Table 5.
Group (number of pairs) | QTc (msec) Pre-infusion | QTc (msec) Post-infusion | ΔQTc (msec) | HR (bpm) Pre-Infusion | HR (bpm) Post-Infusion | ΔHR (bpm) |
---|---|---|---|---|---|---|
All (n = 136) * | 426.77 (38.78) | 429.28 (40.25) | 2.51 (32.99) | 79.07 (15.33) | 82.46 (13.17) | 3.39 (9.92) |
No cardiac event (n = 116) | 424.88 (40.06) | 426.98 (41.18) | 2.10 (33.33) | 79.92 (15.53) | 82.86 (13.53) | 2.94 (9.91) |
Cardiac event (n = 20) | 437.75 (28.65) | 442.60 (32.09) | 4.85 (31.66) | 74.05 (13.39) | 80.10 (10.87) | 6.05 (9.76) |
Rhythm abnormalities (n = 18) | 439.44 (29.79) | 442.67 (33.79) | 3.22 (32.89) | 75.44 (13.39) | 80.44 (11.30) | 5.00 (9.70) |
Myocardial injury (n = 4) | 429.00 (29.15) | 437.50 (15.20) | 8.50 (21.79) | 68.75 (10.34) | 77.75 (12.55) | 9.00 (9.90) |
Data shown are mean (SD);
Only ECGs performed within 4 h after the end of the infusion are included because ECGs performed later were onsidered to not reflect the real QTc increase potentially caused by plitidepsin. A total of 136 pairs of measurements were available, corresponding to the same number of plitidepsin infusions; Bpm: beats per minute; ECG: electrocardiogram; HR: heart rate; SD: standard deviation.