TABLE 3.

Adverse events occurring in >5% of subjects on tafenoquine or mefloquine (prophylactic phase)a

Adverse eventNo. (%) of subjects by AE severity and treatment group
MildModerateSevereTotal
TafenoquineMefloquineTafenoquineMefloquineTafenoquineMefloquineTafenoquineMefloquine
At least one AE431 (88)140 (86)194 (39)46 (28)18 (4)3 (2)454 (92)143 (88)
Gastrointestinal
    Gastroenteritis109 (22)36 (22)80 (16)17 (11)6 (1)0182 (37)51 (32)
    Diarrhea77 (16)28 (17)02 (1)1 (<1)077 (16)30 (19)
    Nausea27 (6)13 (8)1 (<1)00028 (6)13 (8)
    Abdominal pain19 (4)11 (7)5 (1)3 (2)1 (<1)024 (5)13 (8)
    Vomiting19 (4)8 (5)2 (<1)1 (<1)0021 (4)8 (5)
Musculoskeletal
    Injury149 (30)46 (28)45 (9)4 (3)3 (<1)2 (1)178 (36)49 (30)
    Back pain65 (13)24 (15)12 (2)2 (1)0074 (15)26 (16)
    Arthralgia52 (11)17 (11)9 (2)1 (<1)0055 (11)18 (11)
Respiratory
    URTI97 (20)30 (19)6 (1)2 (1)00101 (21)32 (20)
    Pharyngitis24 (5)2 (1)2 (<1)1 (<1)0025 (5)3 (2)
Dermatological
    Rash70 (14)20 (12)1 (<1)1 (<1)0070 (14)21 (13)
    Fungal dermatitis43 (9)8 (5)1 (<1)00044 (9)8 (5)
Headache (constitutional AE)59 (12)18 (11)2 (<1)2 (1)0061 (12)20 (12)
Viral infection23 (5)7 (4)16 (3)6 (4)1 (<1)039 (8)13 (8)
  • a In total, there were 492 tafenoquine subjects and 162 mefloquine subjects. AE, adverse event; URTI, upper respiratory tract infection.