Background
Methods
Study population
Protocol
Anti-malarial drug treatment
The neurological and neuropsychiatric examination
Concomitant medication
Statistical methods for evaluating neurological and neuropsychiatric safety
Results
Study participants
Neurological and neuropsychiatric outcome (safety)
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% |
Symptom | Yes | No | ND | |||
---|---|---|---|---|---|---|
N | % | N | % | N | % | |
Dizziness
| 93 | 43.7 | 120 | 56.3 | . | . |
Headache
| 85 | 39.9 | 114 | 53.5 | 14 | 6.6 |
Vertigo
| 14 | 6.6 | 191 | 89.7 | 8 | 3.8 |
Convulsions
| . | . | 213 | 100.0 | . | . |
Paraesthesia
| 1 | 1.2 | 77 | 93.9 | 4 | 4.9 |
Dysaethesia
| . | . | 78 | 95.1 | 4 | 4.9 |
Sleeplessness (insomnia)
| 85 | 39.9 | 128 | 60.1 | . | . |
Nightmares
| 2 | 6.5 | 28 | 90.3 | 1 | 3.2 |
Hyperactivity
| 18 | 8.5 | 195 | 91.5 | . | . |
Anxiety
| 26 | 12.2 | 187 | 87.8 | . | . |
Panic Attack
| 30 | 14.1 | 183 | 85.9 | . | . |
Unexplained sadness
| 23 | 10.8 | 190 | 89.2 | . | . |
Mood changes
| 25 | 11.7 | 188 | 88.3 | . | . |
Confusion
| 4 | 1.9 | 208 | 97.7 | 1 | 0.5 |
Aggressive behavior
| 19 | 8.9 | 194 | 91.1 | . | . |
Tension
| 12 | 5.6 | 201 | 94.4 | . | . |
Visual hallucinations
| 3 | 3.7 | 77 | 93.9 | 2 | 2.4 |
Acoustic hallucinations
| . | . | 78 | 95.1 | 4 | 4.9 |
Hearing loss
| . | . | 211 | 99.1 | 2 | 0.9 |
Dysarthria
| 3 | 1.4 | 205 | 96.2 | 5 | 2.3 |
Word finding disturbance (1)
| . | . | 200 | 93.9 | 13 | 6.1 |
Eating behavior
| 154 | 72.3 | 59 | 27.7 | . | . |
Swallowing disturbance
| . | . | 213 | 100.0 | . | . |
Tremor
| . | . | 205 | 96.2 | 8 | 3.8 |
Dystonia, ataxia
| 3 | 1.4 | 209 | 98.1 | 1 | 0.5 |
Hypereflexia
| . | . | 213 | 100.0 | . | . |
Hyporeflexia
| 8 | 3.8 | 205 | 96.2 | . | . |
Clonus
| . | . | 213 | 100.0 | . | . |
Dysdiadochokinesis
| 1 | 0.5 | 137 | 64.3 | 75 | 35.2 |
Disturbed vision
| . | . | 128 | 60.1 | 85 | 39.9 |
Nystagmus
| . | . | 192 | 90.1 | 21 | 9.9 |
Double vision
| 1 | 1.2 | 62 | 75.6 | 19 | 23.2 |
Acoustic acuity
| 1 | 0.5 | 100 | 53.8 | 85 | 45.7 |
Forgetfullness
| 1 | 0.5 | 70 | 32.9 | 142 | 66.7 |
Word finding disturbance (2)
| 1 | 1.2 | 68 | 82.9 | 13 | 15.9 |