1 Non‐serious adverse events |
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Other data |
No numeric data |
2 Central nervous system |
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Other data |
No numeric data |
2.1 Affect lability |
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Other data |
No numeric data |
2.2 Aggression |
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Other data |
No numeric data |
2.3 Anorexia |
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Other data |
No numeric data |
2.4 Anxiety |
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Other data |
No numeric data |
2.5 Fingernail biting |
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Other data |
No numeric data |
2.6 Daydreams |
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Other data |
No numeric data |
2.7 Difficulty falling asleep |
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Other data |
No numeric data |
2.8 Depression |
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Other data |
No numeric data |
2.9 Disturbed sleep |
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Other data |
No numeric data |
2.10 Dizziness |
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Other data |
No numeric data |
2.11 Drowsiness |
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Other data |
No numeric data |
2.12 Dysthymia |
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Other data |
No numeric data |
2.13 Emotional lability |
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Other data |
No numeric data |
2.14 Euphoria/hypomania |
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Other data |
No numeric data |
2.15 Asthenia and fatigue |
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Other data |
No numeric data |
2.16 Headache |
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Other data |
No numeric data |
2.17 Increased need to sleep |
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Other data |
No numeric data |
2.18 Involuntary movements |
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Other data |
No numeric data |
2.19 Irritability |
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Other data |
No numeric data |
2.20 Nervousness |
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Other data |
No numeric data |
2.21 Nightmares |
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Other data |
No numeric data |
2.22 Restlessness and agitation |
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Other data |
No numeric data |
2.23 Sadness |
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Other data |
No numeric data |
2.24 Stares |
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Other data |
No numeric data |
2.25 Excessive talking |
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Other data |
No numeric data |
2.26 Taciturnity ('talking too little') |
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Other data |
No numeric data |
2.27 Tics |
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Other data |
No numeric data |
2.28 Isolation and lack of interest in others |
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Other data |
No numeric data |
2.29 'Zombie like' demeanour |
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Other data |
No numeric data |
2.30 Somnolence |
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Other data |
No numeric data |
2.31 Obsession |
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Other data |
No numeric data |
2.32 Mood disorder |
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Other data |
No numeric data |
2.33 Confusional state |
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Other data |
No numeric data |
2.34 Sleep disorder |
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Other data |
No numeric data |
2.35 Propensity to cry |
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Other data |
No numeric data |
2.36 Sedation |
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Other data |
No numeric data |
2.37 Daytime sleepiness |
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Other data |
No numeric data |
2.38 Dysphoria |
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Other data |
No numeric data |
2.39 Logorrhoea |
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Other data |
No numeric data |
2.40 Impaired concentration |
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Other data |
No numeric data |
2.41 Difficulty waking up |
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Other data |
No numeric data |
2.42 Urinary incontinence |
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Other data |
No numeric data |
2.43 Paralysis |
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Other data |
No numeric data |
2.44 Affective disorder |
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Other data |
No numeric data |
2.45 Jumbled thoughts |
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Other data |
No numeric data |
2.46 Bulimia |
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Other data |
No numeric data |
2.47 Sleep late |
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Other data |
No numeric data |
2.48 Tooth grinding |
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Other data |
No numeric data |
2.49 Tremor |
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Other data |
No numeric data |
2.50 Stuttering |
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Other data |
No numeric data |
2.51 Flushing |
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Other data |
No numeric data |
2.52 Apathy |
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Other data |
No numeric data |
2.53 Abnormal behaviour |
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Other data |
No numeric data |
2.54 Stereotypies |
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Other data |
No numeric data |
2.55 Quietness |
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Other data |
No numeric data |
2.56 EEG changes |
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Other data |
No numeric data |
2.57 Did not like themselves |
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Other data |
No numeric data |
2.58 Sleep walking |
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Other data |
No numeric data |
2.59 Personality and behaviour disorders |
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Other data |
No numeric data |
2.60 Vertigo |
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Other data |
No numeric data |
3 Cardiovascular and respiratory system |
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Other data |
No numeric data |
3.1 Cough |
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Other data |
No numeric data |
3.2 Pharyngolaryngeal pain |
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Other data |
No numeric data |
3.3 Upper respiratory tract infection |
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Other data |
No numeric data |
3.4 Tachycardia |
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Other data |
No numeric data |
3.5 Abnormal ECG |
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Other data |
No numeric data |
3.6 Nasal congestion |
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Other data |
No numeric data |
3.7 Palpitation |
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Other data |
No numeric data |
3.8 Systolic blood pressure |
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Other data |
No numeric data |
3.9 Diastolic blood pressure |
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Other data |
No numeric data |
3.10 Pulse rate |
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Other data |
No numeric data |
3.11 ECG‐QT |
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Other data |
No numeric data |
3.12 Cold fingers |
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Other data |
No numeric data |
3.13 Sweating |
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Other data |
No numeric data |
3.14 Hypertension |
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Other data |
No numeric data |
3.15 Hypotension |
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Other data |
No numeric data |
3.16 Respiratory, thoracic and mediastinal disorders |
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Other data |
No numeric data |
3.17 Proportion of patients with micro‐nucleated (Mn) peripheral lymphocytes |
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Other data |
No numeric data |
4 Gastrointestinal system |
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Other data |
No numeric data |
4.1 Abdominal pain |
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Other data |
No numeric data |
4.2 Constipation |
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Other data |
No numeric data |
4.3 Decreased appetite |
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Other data |
No numeric data |
4.4 Decreased weight |
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Other data |
No numeric data |
4.5 Diarrhoea |
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Other data |
No numeric data |
4.6 Dry mouth |
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Other data |
No numeric data |
4.7 Gastrointestinal adverse events |
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Other data |
No numeric data |
4.8 Nausea |
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Other data |
No numeric data |
4.9 Upset stomach |
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Other data |
No numeric data |
4.10 Vomiting |
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Other data |
No numeric data |
4.11 Dyspepsia |
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Other data |
No numeric data |
4.12 Gastroenteritis |
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Other data |
No numeric data |
4.13 Increased appetite |
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Other data |
No numeric data |
4.14 Xerostomia |
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Other data |
No numeric data |
5 Musculoskeletal system |
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Other data |
No numeric data |
5.1 Chest pain |
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Other data |
No numeric data |
5.2 Height |
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Other data |
No numeric data |
5.3 Weight |
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Other data |
No numeric data |
5.4 BMI |
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Other data |
No numeric data |
5.5 Height z score |
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Other data |
No numeric data |
5.6 Weight z score |
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Other data |
No numeric data |
5.7 BMI z score |
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Other data |
No numeric data |
5.8 Increased mobility |
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Other data |
No numeric data |
5.9 Bone mineral density |
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Other data |
No numeric data |
6 Immune system |
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Other data |
No numeric data |
6.1 Nasopharyngitis |
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Other data |
No numeric data |
6.2 Pyrexia |
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Other data |
No numeric data |
6.3 Allergies |
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Other data |
No numeric data |
6.4 Cold symptoms |
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Other data |
No numeric data |
6.5 Pharyngitis |
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Other data |
No numeric data |
6.6 Viral infection |
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Other data |
No numeric data |
6.7 Rash |
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Other data |
No numeric data |
6.8 Rhinitis |
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Other data |
No numeric data |
6.9 Ear disorders |
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Other data |
No numeric data |
6.10 Fever |
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Other data |
No numeric data |
6.11 Infections |
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Other data |
No numeric data |
7 Urogenital system: enuresis |
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Other data |
No numeric data |
8 Other body systems |
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Other data |
No numeric data |
8.1 Hair loss |
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Other data |
No numeric data |
8.2 Skin problems |
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Other data |
No numeric data |
8.3 Accidental injury |
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Other data |
No numeric data |
8.4 Voice frequency |
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Other data |
No numeric data |
8.5 Hypersalivation |
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Other data |
No numeric data |
8.6 Nasal bleeding |
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Other data |
No numeric data |
8.7 Chromosomal aberration |
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Other data |
No numeric data |