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Table 6 Interim results

From: The adaptive designs CONSORT extension (ACE) statement: a checklist with explanation and elaboration guideline for reporting randomised trials that use an adaptive design

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
  1. N, total number of patients per group (denominator); n, patients with recorded parasitic clearance per groups (events); CI, confidence interval
  2. ap-value from Fisher’s exact test, adaptation rule met to escalate dose so dosage increased to 10 mg/kg and continue recruitment
  3. badaptation rule to escalate dose not met so recruitment was continued with the same dosage (10 mg/kg in single-dose arm
  4. c, ep-values from a Chi-square test
  5. d includes patients in interim analysis 2; patients in interim analysis 1 did not contribute to any subsequent interim analysis
  6. e adaptation rule to escalate dose not met but concerns arose regarding low cure in each arm and recruitment was terminated