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Table 2 Summary of primary and secondary endpoints by treatment group (ITT population)

From: In vivo susceptibility of Plasmodium falciparum to artesunate in Binh Phuoc Province, Vietnam

Characteristic Artesunate 2mg/kg Artesunate 4mg/kg DHA-Piperaquine Overall comparisons
  (N=55) (N=56) (N=55) (p-value )
Clearance rate constant (“slope”) K     
[ − loge parasitaemia/hour] $     
 - median (IQR) 0.20(0.12,0.27) 0.25(0.11,0.39) 0.23(0.12,0.33) 0.19
Clearance half life T1/2 [hours]     
 - median (IQR) 3.54(2.61,5.88) 2.72(1.80,6.31) 2.98(2.10,5.82) 0.19
 - geometric mean (95%CI) 3.85(3.32,4.46) 3.32(2.67,3.89) 3.38(2.89,3.95)  
 -T1/2 > 6.2hours 11/55(20%) 15/55(27%) 10/55(18%)  
Treatment outcomes – WHO     
[PCR-uncorrected]     
 - Early treatment failure (ETF) 2 (4%) 0 (0%) 0 (0%)  
 - Late clinical failure (LTF) 1(2%) * 0 (0%) 0 (0%)  
 - Late parasitological failure 0 (0%) 0 (0%) 1 (2%)£  
 - Withdrawn or lost from follow-up 6 (11%) 10 (18%) 3 (5%)  
 - Adequate clinical and parasitological response (ACPR) 46 (84%) 46 (82%) 51 (93%)  
Risk of failure [PCR-uncorrected]     
 - Kaplan-Meier analysis (ITT) # 6% 0% 2% 0.16
 - Proportion (“per protocol”) 3/49 (6%) 0/46 (0%) 1/52 (2%) 0.21
Risk of failure [PCR-corrected]     
 - Kaplan-Meier analysis (ITT) # 6% 0% 0% 0.04¥
 - Proportion (“per protocol”) 3/49 (6%) 0/46 (0%) 0/51 (0%) 0.07
Parasite clearance time (PCT100)     
 - median (IQR) [hours] # 60 (36, 78) 42 (30, 78) 48 (36, 72) 0.49
 - Proportion with PCT>72h # 0.27 0.27 0.22 -
Parasite-reduction ratio (%) £     
 - at 24 hours – median (IQR) 48 (5,282) 212 (11,2931) 113 (12,561) 0.02 €
 - at 48 hours – median (IQR) 3430 (151,Inf) Inf (217,Inf) Inf (435,Inf) -
Fever clearance time #     
 - median (IQR) [hours] 30 (18, 42) 24 (12,42) 24 (18,36) 0.86
  1. Summary measures in each group are median (IQR) or n (%).
  2. ($) Slope could not be estimated for one patient on Artesunate 4mg/kg, (*) PCR: recrudescence, (£) PCR: new infection, (#) Kaplan-Meier estimates, (£) Missing follow-up parasitaemia values at 24 and 48 hours replaced by 0 if the patient had prior documented parasite clearance; no missing data remained after this imputation. Values of infinity (Inf) correspond to patients without parasitaemia at 24 or 48 hours, respectively.
  3. ¥ Pairwise comparisons: Artesunate 2mg/kg vs. Artesunate 4mg/kg (p=0.08), Artesunate 2mg/kg vs. DHA-Piperaquine (p=0.07).
  4. € Pairwise comparisons: Artesunate 2mg/kg vs. Artesunate 4mg/kg (p=0.01), Artesunate 2mg/kg vs. DHA-Piperaquine (p=0.048), Artesunate 4mg/kg vs DHA-Piperaquine (p=0.27).