Skip to main content

Table 2 Time-averaged analysis: mean changes from baseline

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

Endpoint

Parameter

Placebo (N = 50)

NEPA200/0.5(N = 48)

NEPA600/1.5(N = 49)

Moxifloxacin (N = 49)

Change from baseline

Change from baseline

Placebo-corrected change from baseline

Change from baseline

Placebo-corrected change from baseline

Change from baseline

Placebo-corrected change from baseline

Primary

QTcI, ms

–2.1

2.6

4.7

1.5

3.6

6.3

8.4

 

(Min;max)

(−8.3; 4.8)

(−5.8; 30.6)

 

(−7.3; 14.3)

 

(−2.6; 15.3)

 

Secondary

HR, bpm

–0.7

–4.0

–3.3

–3.7

–3.0

–0.4

0.3

 

PR, ms

1.1

0.7

–0.4

1.3

0.2

–0.2

–1.3

 

QRS, ms

–0.3

0.7

1.0

0.2

0.5

0.0

0.3

 

QT, ms

–0.4

9.3

9.7

8.6

9.0

6.9

7.3

 

QTcF, ms

–2.1

0.5

2.6

0.5

2.6

6.0

8.1

 

QTcB, ms

–3.0

–3.9

–0.9

–3.5

–0.5

5.5

8.5

  1. bpm, beats per minute; min, minimum; max, maximum; HR, heart rate; ms, milliseconds; QTcB, Bazett correction; QTcF, Fridericia correction; 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. NEPA 600/1.5: 600 mg netupitant (4 × 150 mg) + 1.50 mg palonosetron (3 × 0.50 mg).