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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 disorder170 (21)142 (18)240 (16)269 (19)734 (18)
 Headache149 (19)98 (12)164 (11)211 (15)544 (13)
 Migraine4 (< 1)3 (< 1)03 (< 1)8 (< 1)
 Sinus headache1 (< 1)004 (< 1)4 (< 1)
 Tension headache0002 (< 1)2 (< 1)
 Head discomfort001 (< 1)01 (< 1)
 Visual field defect0001 (< 1)1 (< 1)
 Lethargy0028 (2)28 (2)56 (1)
 Somnolence1 (< 1)3 (< 1)21 (1)1 (< 1)25 (< 1)
 Amnesia0001 (< 1)1 (< 1)
 Depressed level of consciousness01 (< 1)001 (< 1)
 Disturbance in attention001 (< 1)01 (< 1)
 Dysgeusia1 (< 1)017 (1)1 (< 1)18 (< 1)
 Paraesthesia003 (< 1)4 (< 1)8 (< 1)
 Hypoaesthesia1 (< 1)03 (< 1)1 (< 1)4 (< 1)
 Hyperaesthesia0001 (< 1)2 (< 1)
 Burning sensation00001 (< 1)
 Coordination abnormal0002 (< 1)2 (< 1)
 Balance disorder01 (< 1)001 (< 1)
 Dizziness24 (3)62 (8)56 (4)33 (2)171 (4)
 Syncope02 (< 1)1 (< 1)2 (< 1)5 (< 1)
 Presyncope0001 (< 1)1 (< 1)
 Dizziness postural1 (< 1)0000
 Loss of consciousness1 (< 1)0000
 Tremor01 (< 1)1 (< 1)2 (< 1)4 (< 1)
 Muscle contractions involuntary001 (< 1)01 (< 1)
 Sciatica0002 (< 1)3 (< 1)
 Post herpetic neuralgia001 (< 1)1 (< 1)2 (< 1)
 Trigeminal neuralgia0001 (< 1)1 (< 1)
Any psychiatric disorder8 (1)16 (2)19 (1)37 (3)79 (2)
 Insomnia8 (1)15 (2)12 (< 1)15 (1)48 (1)
 Abnormal dreams01 (< 1)06 (< 1)7 (< 1)
 Sleep disorder0003 (< 1)3 (< 1)
 Nightmare0002 (< 1)2 (< 1)
 Agitation0002 (< 1)2 (< 1)
 Anxiety02 (< 1)002 (< 1)
 Anxiety disorder0002 (< 1)2 (< 1)
 Irritability001 (< 1)02 (< 1)
 Neurosis0001 (< 1)1 (< 1)
 Panic attack0001 (< 1)1 (< 1)
 Psychotic disorder001 (< 1)01 (< 1)
 Stress0001 (< 1)1 (< 1)
 Euphoric mood001 (< 1)2 (< 1)3 (< 1)
 Depressed mood001 (< 1)1 (< 1)2 (< 1)
 Depression0002 (< 1)2 (< 1)
 Bipolar disorder0001 (< 1)1 (< 1)
 Disinhibition001 (< 1)01 (< 1)
 Mood altered001 (< 1)01 (< 1)
 Alcoholic hangover0001 (< 1)1 (< 1)
 Tic001 (< 1)01 (< 1)
  1. aThe placebo group includes healthy volunteers treated with placebo and P. vivax subjects treated with chloroquine alone in P. vivax relapse prevention
  2. bAlso includes 392 subjects who received < 300 mg total dose and 3 subjects who received 300 mg total dose > 3 days