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Table 4 Frequency of all NPAEs occurring with tafenoquine/chloroquine versus primaquine/chloroquine (day 1 to day 180) [9,10,11]

From: Neurological and psychiatric safety of tafenoquine in Plasmodium vivax relapse prevention: a review

Event—n (%) patientsGradeaIntegrated safety summary
Tafenoquine (N = 483)Primaquine (N = 264)
Nervous system disordersAny105 (22)60 (23)
Grade 178 (16)38 (14)
Grade 226 (5)19 (7)
Grade 302 (< 1)
NA1 (< 1)1 (< 1)
 HeadacheAny64 (13)40 (15)
Grade 145 (9)22 (8)
Grade 218 (4)16 (6)
Grade 302 (< 1)
NA1 (< 1)0
 DizzinessAny59 (12)30 (11)
Grade 152 (11)25 (9)
Grade 27 (1)4 (2)
NA01 (< 1)
 MigraineAny3 (< 1)1 (< 1)
Grade 12 (< 1)0
Grade 21 (< 1)1 (< 1)
 SyncopeAny2 (< 1)1 (< 1)
Grade 11 (< 1)1 (< 1)
Grade 21 (< 1)0
 Balance disorderAny1 (< 1)0
Grade 21 (< 1)0
 SomnolenceAny1 (< 1)0
Grade 21 (< 1)0
 TremorAny1 (< 1)1 (< 1)
Grade 11 (< 1)1 (< 1)
 Burning sensationAny01 (< 1)
Grade 101 (< 1)
 DysaesthesiaAny01 (< 1)
Grade 101 (< 1)
 HypoaesthesiaAny01 (< 1)
Grade 201 (< 1)
Psychiatric disordersAny15 (3)12 (5)
Grade 19 (2)7 (3)
Grade 26 (1)5 (2)
 InsomniaAny15 (3)8 (3)
Grade 19 (2)4 (2)
Grade 26 (1)4 (2)
 AnxietyAny2 (< 1)3 (1)
Grade 102 (< 1)
Grade 22 (< 1)1 (< 1)
 DepressionAny01 (< 1)
Grade 101 (< 1)
Expanded definition of NPAEs
 AstheniaAny8 (2)5 (2)
Grade 17 (1)2 (< 1)
Grade 21 (< 1)3 (1)
 FatigueAny3 (< 1)0
Grade 13 (< 1)0
 LabyrinthitisAny2 (< 1)0
Grade 12 (< 1)0
 Alcohol intoleranceAny1 (< 1)0
Grade 11 (< 1)0
 VertigoAny3 (< 1)1 (< 1)
Grade 12 (< 1)1 (< 1)
Grade 21 (< 1)0
 Vestibular disorderAny1 (< 1)0
Grade 11 (< 1)0
  1. Data are from the DETECTIVE phase 2b, DETECTIVE phase 3, and GATHER trials (safety population). Vivax malaria patients were treated with chloroquine plus either single-dose tafenoquine 300 mg or primaquine 15 mg for 14 days. Adverse events of Grade 3 and above in any treatment group are italicized
  2. Note that this includes adverse events that were associated with recurrences after day 29. Subjects that experienced recurrence received further treatment with primaquine. Thus, the comparison of adverse events before day 29 provides a more reliable indicator of potential differences caused by drug treatment (see Fig. 4)
  3. aCommon Terminology Criteria for Adverse Events v4.0