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Table 1 Patient disposition by region (randomized patients)

From: A randomized, double-blind, phase 2b study to investigate the efficacy, safety, tolerability and pharmacokinetics of a single-dose regimen of ferroquine with artefenomel in adults and children with uncomplicated Plasmodium falciparum malaria

  Artefenomel mg: Ferroquine mg
  800:400 800:600 800:900 800:1200 Total
African patients > 6 months and ≤ 5 years (Primary population of interest)
 Randomized 73 (100) 74 (100) 73 (100) 72 (100) 292 (100)
 Treated 72 (98.6) 74 (100) 72 (98.6) 71 (98.6) 289 (99.0)
 Discontinued prior to treatment 1 (1.4) 0   1 (1.4) 3 (1.0)
 Completed 25 (34.2) 32 (43.2) 38 (52.1) 36 (50.0) 131 (44.9)
 Discontinued prematurely: 48 (65.8) 42 (56.8) 35 (47.9) 36 (50.0) 161 (55.1)
 Criteria met for established anti-malarial treatmenta 44 (60.3) 38 (51.4) 29 (39.7) 32 (44.4) 143 (49.0)
 Patient's request 0 1 (1.4) 1 (1.4) 0 2 (0.7)
 Investigator's judgement 0 0 0 1 (1.4) 1 (0.3)
 AE 3 (4.1) 1 (1.4) 3 (4.1) 1 (1.4) 8 (2.7)
 Lost to follow-up 0 1 (1.4) 0 1 (1.4) 2 (0.7)
 Not eligibleb 1 (1.4) 0 0 1 (1.4) 2 (0.7)
 Other 0 1 (1.4) 2 (2.7) 0 3 (1.0)
African patients > 5 years
 Randomized 16 (100) 15 (100) 18 (100) 15 (100) 64 (100)
 Treated 16 (100) 15 (100) 18 (100) 15 (100) 64 (100)
 Discontinued prior to treatment 0 0 0 0 0
 Completed 2 (12.5) 4 (26.7) 8 (44.4) 9 (60.0) 23 (35.9)
 Discontinued prematurely: 14 (87.5) 11 (73.3) 10 (55.6) 6 (40.0) 41 (64.1)
 Criteria met for established anti-malarial treatmenta 10 (62.5) 9 (60.0) 7 (38.9) 5 (33.3) 31 (48.4)
 Patient's request 1 (6.3) 2 (13.3) 2 (11.1) 1 (6.7) 6 (9.4)
 Investigator's judgement 1 (6.3) 0 0 0 1 (1.6)
 AE 0 0 1 (5.6) 0 1 (1.6)
 Lost to follow-up 1 (6.3) 0 0 0 1 (1.6)
 Other 1 (6.3) 0 0 0 1 (1.6)
Asian patients
 Randomized 4 (100) 5 (100) 6 (100) 6 (100) 21 (100)
 Treated 4 (100) 5 (100) 6 (100) 5 (83.3) 20 (95.2)
 Discontinued prior to treatment 0 0 0 1 (16.7) 1 (4.8)
 Completed 0 1 (20.0) 2 (33.3) 1 (16.7) 4 (19.0)
 Discontinued prematurely: 4 (100) 4 (80.0) 4 (66.7) 5 (83.3) 17 (81.0)
 Criteria met for established anti-malarial treatment a 3 (75.0) 4 (80.0) 3 (50.0) 4 (66.7) 14 (66.7)
 Patient's request 1 (25.0) 0 1 (16.7) 0 2 (9.5)
 Investigator's judgement 0 0 0 1 (16.7)  
  1. Treatment failure was defined as patients who met any of the criteria for early treatment failure, late clinical failure or late parasitological failure. Early treatment failure (Day 1 to 3) was any of the following: (i) danger signs or severe malaria at Day 1, 2 or 3 in the presence of parasitaemia; (ii) parasite count at Day 2 higher than at Day 0, irrespective of axillary temperature; (iii) parasitaemia at Day 3 with axillary temperature ≥ 37.5 °C; (iv) parasite count at Day 3 ≥ 25% at Day 0. Late clinical failure (Day 4 to 63) was any of the following: (i) danger signs or severe malaria in the presence of parasitaemia on any day between Day 4 and Day 63 in patients who did not previously meet any of the criteria of early treatment failure; (ii) presence of parasitaemia on any day between Day 4 and Day 63 with axillary temperature ≥ 37.5 °C (or history of fever) in patients who did not previously meet any of the criteria of early treatment failure. Late parasitological failure was defined as the presence of parasitaemia on any day between Day 7 and Day 63 and axillary temperature < 37.5 °C in patients who did not previously meet any of the criteria of early treatment failure or late clinical failure
  2. Data presented are the number (%) of randomized patients. Items in italic represent the reasons for premature study discontinuation. All doses of artefenomel and ferroquine are expressed as adult-equivalent doses
  3. bTwo patients were randomized in error and not treated. The status at last study contact was missing
  4. aEstablished anti-malarial treatment was recommended as rescue treatment in case of (i) vomiting during or after ferroquine dosing or vomiting within 35 min after artefenomel re-dosing, and (ii) treatment failure