From: Neurological and psychiatric safety of tafenoquine in Plasmodium vivax relapse prevention: a review
Event—n (%) patients | Gradea | Integrated safety summary | |
---|---|---|---|
Tafenoquine (N = 483) | Primaquine (N = 264) | ||
Nervous system disorders | Any | 105 (22) | 60 (23) |
Grade 1 | 78 (16) | 38 (14) | |
Grade 2 | 26 (5) | 19 (7) | |
Grade 3 | 0 | 2 (< 1) | |
NA | 1 (< 1) | 1 (< 1) | |
Headache | Any | 64 (13) | 40 (15) |
Grade 1 | 45 (9) | 22 (8) | |
Grade 2 | 18 (4) | 16 (6) | |
Grade 3 | 0 | 2 (< 1) | |
NA | 1 (< 1) | 0 | |
Dizziness | Any | 59 (12) | 30 (11) |
Grade 1 | 52 (11) | 25 (9) | |
Grade 2 | 7 (1) | 4 (2) | |
NA | 0 | 1 (< 1) | |
Migraine | Any | 3 (< 1) | 1 (< 1) |
Grade 1 | 2 (< 1) | 0 | |
Grade 2 | 1 (< 1) | 1 (< 1) | |
Syncope | Any | 2 (< 1) | 1 (< 1) |
Grade 1 | 1 (< 1) | 1 (< 1) | |
Grade 2 | 1 (< 1) | 0 | |
Balance disorder | Any | 1 (< 1) | 0 |
Grade 2 | 1 (< 1) | 0 | |
Somnolence | Any | 1 (< 1) | 0 |
Grade 2 | 1 (< 1) | 0 | |
Tremor | Any | 1 (< 1) | 1 (< 1) |
Grade 1 | 1 (< 1) | 1 (< 1) | |
Burning sensation | Any | 0 | 1 (< 1) |
Grade 1 | 0 | 1 (< 1) | |
Dysaesthesia | Any | 0 | 1 (< 1) |
Grade 1 | 0 | 1 (< 1) | |
Hypoaesthesia | Any | 0 | 1 (< 1) |
Grade 2 | 0 | 1 (< 1) | |
Psychiatric disorders | Any | 15 (3) | 12 (5) |
Grade 1 | 9 (2) | 7 (3) | |
Grade 2 | 6 (1) | 5 (2) | |
Insomnia | Any | 15 (3) | 8 (3) |
Grade 1 | 9 (2) | 4 (2) | |
Grade 2 | 6 (1) | 4 (2) | |
Anxiety | Any | 2 (< 1) | 3 (1) |
Grade 1 | 0 | 2 (< 1) | |
Grade 2 | 2 (< 1) | 1 (< 1) | |
Depression | Any | 0 | 1 (< 1) |
Grade 1 | 0 | 1 (< 1) | |
Expanded definition of NPAEs | |||
Asthenia | Any | 8 (2) | 5 (2) |
Grade 1 | 7 (1) | 2 (< 1) | |
Grade 2 | 1 (< 1) | 3 (1) | |
Fatigue | Any | 3 (< 1) | 0 |
Grade 1 | 3 (< 1) | 0 | |
Labyrinthitis | Any | 2 (< 1) | 0 |
Grade 1 | 2 (< 1) | 0 | |
Alcohol intolerance | Any | 1 (< 1) | 0 |
Grade 1 | 1 (< 1) | 0 | |
Vertigo | Any | 3 (< 1) | 1 (< 1) |
Grade 1 | 2 (< 1) | 1 (< 1) | |
Grade 2 | 1 (< 1) | 0 | |
Vestibular disorder | Any | 1 (< 1) | 0 |
Grade 1 | 1 (< 1) | 0 |