|
Parasite clearance at day 30 (initial cure)
|
Treatment group
|
Parasite clearance rate, n/N (%)
|
Differences in parasite clearance rates (95% CI)
|
P-value
|
|---|
|
Interim analysis 1
|
Single dose, 7.5 mg/kg
|
10/20 (50.0%)
|
Reference
| |
|
Multiple dose, 7x3mg/kg
|
16/18 (88.9%)
|
38.9% (12.6 to 65.2)
|
0.015a
|
|
Interim analysis 2b
|
Single dose, 10 mg/kg
|
16/20 (80.0%)
|
Reference
| |
|
Multiple dose, 7x3mg/kg
|
19/25 (76.0%)
|
−4.0% (−28.2 to 20.2)
|
0.748c
|
|
Interim analysis 3d
|
Single dose, 10 mg/kg
|
29/40 (72.5%)
|
Reference
| |
|
Multiple dose, 7x3mg/kg
|
37/44 (84.1%)
|
11.6% (−6.0 to 29.1)
|
0.196e
|
- N, total number of patients per group (denominator); n, patients with recorded parasitic clearance per groups (events); CI, confidence interval
- ap-value from Fisher’s exact test, adaptation rule met to escalate dose so dosage increased to 10 mg/kg and continue recruitment
- badaptation rule to escalate dose not met so recruitment was continued with the same dosage (10 mg/kg in single-dose arm
- c, ep-values from a Chi-square test
- d includes patients in interim analysis 2; patients in interim analysis 1 did not contribute to any subsequent interim analysis
- e adaptation rule to escalate dose not met but concerns arose regarding low cure in each arm and recruitment was terminated
