Table 3. Superiority analysis for primary safety outcome and secondary outcomes -ITT population.

Outcome	Placebo: participants with ≥1 event (%); (no. of events)	Placebo rate per 100 pyar (95% C.I. time to 1st event)	CTX: participants with ≥1 event (%); (no. of events)	CTX rate per 100 pyar (95% C.I. time to 1st event)	Stratified log-rank statistic (P-value)	Adjusted Hazard Ratio (95% C.I.)
Primary safety outcome
Grade 3 / 4 haematological adverse event	233 (21.3%) 427 events	10.6 (9.4; 12.1)	318 (28.9%) 616 events	15.3 (13.7; 17.1)	18.08 (<0.0001)	0.7 (0.59; 0.82)
Secondary outcomes
All-cause mortality	18 (1.7%)	0.73 (0.46; 1.16)	19 (1.8%)	0.76 (0.49; 1.19)	0.01 (0.91)	0.96 (0.50; 1.83)
All WHO stage 2, 3 or 4 events or death	97 (8.9%) 125 events	4.1 (3.4; 5.0)	77 (7.1%) 99 events	3.2 (2.6; 4.0)	2.53 (0.11)	1.28 (0.95; 1.72)
Confirmed clinical malaria	276 (25.3%) 350 events	13 (11.6; 14.7)	86 (7.9%) 103 events	3.6 (2.9; 4.4)	122.6 (<0.0001)	3.62 (2.84; 4.61)
Hospital admissions	93 (8.5%) 110 events	4 (3.3; 4.9)	53 (4.9%) 65 events	2.2 (1.7; 2.9)	12.36 (0.004)	1.82 (1.30; 2.50)
SAEs	102 (9.4%) 124 events	4.4 (3.6; 5.3)	67 (6.2%) 90 events	2.8 (2.2; 3.5)	8.44 (0.0037)	1.58 (1.16; 2.15)