Table 3.

Summary of treatment‐emergent adverse events (EMR 200585‐001 and EMR 200661‐001; safety populations)

EMR 200585‐001	Treatment A (N = 31)	Treatment B (N = 32)	Treatment C1 (N = 15)	Treatment C2 (N = 15)	Treatment D1 (N = 14)	Treatment D2 (N = 15)
No. of TEAEs	E	E	E	E	E	E
Any TEAEs	7	4	2	8	0	3
Serious TEAEs	0	0	0	0	0	0
TEAEs resulting in discontinuation	0	0	0	0	0	0
TEAEs of severe intensity	0	0	0	0	0	0
IMP‐related TEAEs	5	3	0	8	0	1
No. of subjects experiencing TEAEs	n (%)	n (%)	n (%)	n (%)	n (%)	n (%)
Any TEAEs	5 (16.1)	4 (12.5)	1 (6.7)	6 (40.0)	0 (0.0)	3 (20.0)
Serious TEAEs	0	0	0	0	0	0
TEAEs resulting in discontinuation	0	0	0	0	0	0
TEAEs of severe intensity	0	0	0	0	0	0
IMP‐related TEAEs	4 (12.9)	3 (9.4)	0 (0.0)	6 (40.0)	0 (0.0)	1 (6.7)
Notes (EMR 200585‐001) EMR, electronic medical record; IMP, Investigational Medicinal Product; N, number of subjects; n, number of AEs; ODT, orally dispersible tablet; PZQ, praziquantel; TEAEs, treatment‐emergent adverse events. A = New ODT‐PZQ formulation at 40 mg/kg dispersed in water after a meal. B = Current PZQ formulation at 40 mg/kg given with water after a meal. C = New ODT‐PZQ formulation at 20 mg/kg dispersed in water after a meal (C1) or new ODT‐PZQ formulation at 60 mg/kg dispersed in water after a meal (C2). D = New ODT‐PZQ formulation at 40 mg/kg dispersed in water without a meal (D1) or current PZQ formulation at 40 mg/kg given as crushed tablets with water after a meal (D2).
EMR200661001	Treatment A (N = 36)	Treatment B (N = 36)	Treatment C1 (N = 18)	Treatment C2 (N = 17)	Treatment D (N = 35)	Treatment E (N = 36)
No. of TEAEs	E	E	E	E	E	E
Any TEAEs	12	23	5	7	7	1
Serious TEAEs	0	0	0	0	0	0
TEAEs resulting in discontinuation	0	0	0	0	0	0
TEAEs of severe intensity	0	0	0	0	0	0
IMP‐related TEAEs	9	23	2	4	4	1
No. of subjects experiencing TEAEs	n (%)	n (%)	n (%)	n (%)	n (%)	n (%)
Any TEAEs	8 (22.2%)	17 (47.2%)	4 (22.2%)	4 (23.5%)	5 (14.3%)	1 (2.8%)
Serious TEAEs	0	0	0	0	0	0
TEAEs resulting in discontinuation	0	0	0	0	0	0
TEAEs of severe intensity	0	0	0	0	0	0
IMP‐related TEAEs	7 (19.4%)	17 (47.2%)	1 (5.6%)	3 (17.6%)	4 (11.4%)	1 (2.8%)
Notes (EMR200661‐001)EMR, electronic medical record; IMP, Investigational Medicinal Product; N, number of subjects; n, number of AEs; ODT, orally dispersible tablet; PZQ, praziquantel; TEAEs, treatment‐emergent adverse events. A = MSC2499550A formulation at 20 mg/kg dispersed in water, after a meal. B = Current PZQ formulation (Cysticide) at 40 mg/kg given with water after a meal. C = MSC2499550A formulation at 10 (C1) or 30 (C2) mg/kg (randomized 1 to 1) given dispersed in water, after a meal. D = MSC2499550A formulation at 20 mg/kg given dispersed in water without a meal. E = MSC2499550A formulation at 20 mg/kg directly disintegrated in the mouth without water after a meal.