Artesunate-mefloquine combination therapy in acute Plasmodium falciparum malaria in young children: a field study regarding neurological and neuropsychiatric safety

Table 1 Occurrence of drug-related neuropsychiatric and neurological adverse events

Neuropsychological or neurological symptom	Number of patients suffering from at least one event/number of analyzed patients*	95-% confidence interval
Dizziness	1/213	0.0 - 2.59%
Headache	1/209	0.0 - 2.64%
Vertigo	1/211	0.0 - 2.61%
Convulsions	0/212	0.0 - 1.72%
Paraesthesia	0/76	0.0 - 4.74%
Dysaethesia	0/76	0.0 - 4.74%
Sleeplessness (insomnia)	4/213	0.5 - 4.74%
Nightmares	1/30	0.1 - 17.2%
Hyperactivity	1/213	0.0 - 2.59%
Anxiety	0/213	0.0 - 1.72%
Panic Attack	0/213	0.0 - 1.72%
Unexplained sadness	0/213	0.0 - 1.72%
Mood changes	0/213	0.0 - 1.72%
Confusion	0/212	0.0 - 1.72%
Aggressive behavior	1/213	0.0 - 2.59%
Tension	0/213	0.0 - 1.72%
Visual hallucinations	0/80	0.0 - 4.51%
Acoustic hallucinations	0/76	0.0 - 4.74%
Hearing loss	0/211	0.0 - 1.73%
Dysarthria	0/209	0.0 - 1.75%
Word finding disturbance (1)	0/204	0.0 - 1.79%
Eating behavior	1/213	0.0 - 2.59%
Swallowing disturbance	0/213	0.0 - 1.72%
Tremor	0/211	0.0 - 1.73%
Dystonia, ataxia	0/212	0.0 - 1.72%
Hypereflexia	0/213	0.0 - 1.72%
Hyporeflexia	0/213	0.0 - 1.72%
Clonus	0/213	0.0 - 1.72%
Dysdiadochokinesis	0/164	0.0 - 2.22%
Disturbed vision	0/151	0.0 - 2.41%
Nystagmus	0/199	0.0 - 1.84%
Double vision	0/71	0.0 - 5.06%
Acoustic acuity	0/122	0.0 - 2.98%
Forgetfullness	0/93	0.0 - 3.89%
Word finding disturbance (2)	0/72	0.0 - 4.99%

Nightmares were only assessed in children 5 years in age or older
Paraesthesia, dysaethesia, visual and acoustic hallucinations, double vision and word finding disturbance (2) were only assessed in children 3.5 years in age or older
Acoustic acuity was only assessed in children 1.5 years in age and or older
* N = Number of patients who had the examination at Day 7 or for whom the related NNAE was reported at any time

ISSN: 1475-2875