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Table 3 Time-matched analysis: placebo and baseline corrected QTcI data for NEPA and moxifloxacin dose groups

From: Effects of combined netupitant and palonosetron (NEPA), a cancer supportive care antiemetic, on the ECG of healthy subjects: an ICH E14 thorough QT trial

Time, h NEPA200/0.5 NEPA600/1.5 Moxifloxacin
Estimate1 Upper bound2 Estimate1 Upper bound2 Estimate1 Upper bound2
1 3.2 5.2 3.5 5.3 12.2 15.1
2 3.8 5.9 1.0 2.8 12.7 15.6
4 5.5 7.6 1.7 3.5 13.7 16.6
5 4.8 6.9 2.5 4.3 12.2 15.1
6 3.5 5.6 4.3 6.1 9.7 12.6
7 4.5 6.5 4.1 5.9 10.5 13.4
8 5.3 7.4 4.3 6.1 9.6 12.6
10 6.1 8.1 5.2 7.0 10.8 13.7
12 5.7 7.8 3.6 5.4 9.2 12.1
14 6.7 8.7 4.9 6.7 7.5 10.4
16 5.5 7.6 7.0 8.8 8.0 10.9
18 6.0 8.1 5.3 7.1 7.1 10.0
23.5 1.7 3.7 3.3 5.1 4.7 7.6
30 4.9 7.0 4.4 6.2 5.2 8.1
36 3.9 6.0 3.2 5.0 3.8 6.7
42 4.3 6.4 0.8 2.6 3.0 5.9
47.5 1.8 3.8 0.6 2.4 2.3 5.3
Time average 4.6 5.7 3.4 4.5 8.4 9.5
  1. ANOVA, analysis of variance; QTcI, individually heart rate-corrected QT interval.
  2. NEPA200/0.5: 200 mg netupitant (50 mg + 150 mg) + 0.50 mg palonosetron (1 × 0.50 mg).
  3. NEPA600/1.5: 600 mg netupitant (4 × 150 mg) + 1.50 mg palonosetron (3 × 0.50 mg).
  4. 1Mixed-model ANOVA is fit for placebo-corrected change from baseline and includes terms for treatment, gender, time, and a time-by-treatment interaction.
  5. 2Upper bound, upper 1-sided 95% ANOVA model-based confidence limit.