Table 5 Adverse events classified as nervous system disorders or psychiatric disorders reported across the entire tafenoquine development programme classified by total tafenoquine dose [74]
From: Neurological and psychiatric safety of tafenoquine in Plasmodium vivax relapse prevention: a review
Adverse event, n (%) | All placeboa (N = 794) | Total TQ 300 mg ≤ 3 days (N = 807) | Total TQ > 300 mg ≤ 3 days (N = 1482) | Total TQ > 300 mg > 3 days (N = 1445) | All TQb (N = 4129) |
|---|---|---|---|---|---|
Any nervous system disorder | 170 (21) | 142 (18) | 240 (16) | 269 (19) | 734 (18) |
 Headache | 149 (19) | 98 (12) | 164 (11) | 211 (15) | 544 (13) |
 Migraine | 4 (< 1) | 3 (< 1) | 0 | 3 (< 1) | 8 (< 1) |
 Sinus headache | 1 (< 1) | 0 | 0 | 4 (< 1) | 4 (< 1) |
 Tension headache | 0 | 0 | 0 | 2 (< 1) | 2 (< 1) |
 Head discomfort | 0 | 0 | 1 (< 1) | 0 | 1 (< 1) |
 Visual field defect | 0 | 0 | 0 | 1 (< 1) | 1 (< 1) |
 Lethargy | 0 | 0 | 28 (2) | 28 (2) | 56 (1) |
 Somnolence | 1 (< 1) | 3 (< 1) | 21 (1) | 1 (< 1) | 25 (< 1) |
 Amnesia | 0 | 0 | 0 | 1 (< 1) | 1 (< 1) |
 Depressed level of consciousness | 0 | 1 (< 1) | 0 | 0 | 1 (< 1) |
 Disturbance in attention | 0 | 0 | 1 (< 1) | 0 | 1 (< 1) |
 Dysgeusia | 1 (< 1) | 0 | 17 (1) | 1 (< 1) | 18 (< 1) |
 Paraesthesia | 0 | 0 | 3 (< 1) | 4 (< 1) | 8 (< 1) |
 Hypoaesthesia | 1 (< 1) | 0 | 3 (< 1) | 1 (< 1) | 4 (< 1) |
 Hyperaesthesia | 0 | 0 | 0 | 1 (< 1) | 2 (< 1) |
 Burning sensation | 0 | 0 | 0 | 0 | 1 (< 1) |
 Coordination abnormal | 0 | 0 | 0 | 2 (< 1) | 2 (< 1) |
 Balance disorder | 0 | 1 (< 1) | 0 | 0 | 1 (< 1) |
 Dizziness | 24 (3) | 62 (8) | 56 (4) | 33 (2) | 171 (4) |
 Syncope | 0 | 2 (< 1) | 1 (< 1) | 2 (< 1) | 5 (< 1) |
 Presyncope | 0 | 0 | 0 | 1 (< 1) | 1 (< 1) |
 Dizziness postural | 1 (< 1) | 0 | 0 | 0 | 0 |
 Loss of consciousness | 1 (< 1) | 0 | 0 | 0 | 0 |
 Tremor | 0 | 1 (< 1) | 1 (< 1) | 2 (< 1) | 4 (< 1) |
 Muscle contractions involuntary | 0 | 0 | 1 (< 1) | 0 | 1 (< 1) |
 Sciatica | 0 | 0 | 0 | 2 (< 1) | 3 (< 1) |
 Post herpetic neuralgia | 0 | 0 | 1 (< 1) | 1 (< 1) | 2 (< 1) |
 Trigeminal neuralgia | 0 | 0 | 0 | 1 (< 1) | 1 (< 1) |
Any psychiatric disorder | 8 (1) | 16 (2) | 19 (1) | 37 (3) | 79 (2) |
 Insomnia | 8 (1) | 15 (2) | 12 (< 1) | 15 (1) | 48 (1) |
 Abnormal dreams | 0 | 1 (< 1) | 0 | 6 (< 1) | 7 (< 1) |
 Sleep disorder | 0 | 0 | 0 | 3 (< 1) | 3 (< 1) |
 Nightmare | 0 | 0 | 0 | 2 (< 1) | 2 (< 1) |
 Agitation | 0 | 0 | 0 | 2 (< 1) | 2 (< 1) |
 Anxiety | 0 | 2 (< 1) | 0 | 0 | 2 (< 1) |
 Anxiety disorder | 0 | 0 | 0 | 2 (< 1) | 2 (< 1) |
 Irritability | 0 | 0 | 1 (< 1) | 0 | 2 (< 1) |
 Neurosis | 0 | 0 | 0 | 1 (< 1) | 1 (< 1) |
 Panic attack | 0 | 0 | 0 | 1 (< 1) | 1 (< 1) |
 Psychotic disorder | 0 | 0 | 1 (< 1) | 0 | 1 (< 1) |
 Stress | 0 | 0 | 0 | 1 (< 1) | 1 (< 1) |
 Euphoric mood | 0 | 0 | 1 (< 1) | 2 (< 1) | 3 (< 1) |
 Depressed mood | 0 | 0 | 1 (< 1) | 1 (< 1) | 2 (< 1) |
 Depression | 0 | 0 | 0 | 2 (< 1) | 2 (< 1) |
 Bipolar disorder | 0 | 0 | 0 | 1 (< 1) | 1 (< 1) |
 Disinhibition | 0 | 0 | 1 (< 1) | 0 | 1 (< 1) |
 Mood altered | 0 | 0 | 1 (< 1) | 0 | 1 (< 1) |
 Alcoholic hangover | 0 | 0 | 0 | 1 (< 1) | 1 (< 1) |
 Tic | 0 | 0 | 1 (< 1) | 0 | 1 (< 1) |