| 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) |  |