TrialPanorama/TrialPanorama-database huggingface dataset:
Study: NCT00498927

Adverse event: AST, SGOT
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 47 at risk

Adverse event: CNS cerebrovascular ischemia
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 47 at risk

Adverse event: Cognitive disorder
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 47 at risk

Adverse event: Confusional state
Serious: yes
Organ System: General disorders
Frequency: 3 affected / 47 at risk

Adverse event: Extremity-lower (gait/walking)
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 47 at risk

Adverse event: Fatigue (asthenia, lethargy, malaise)
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 47 at risk

Adverse event: Infection, other
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 47 at risk

Adverse event: Mood alteration - Agitation
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 47 at risk

Adverse event: Pain - Back
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 47 at risk

Adverse event: Pain - Head/headache
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 47 at risk

Adverse event: Pyramidal tract dysfunction
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 47 at risk

Adverse event: Seizure
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 47 at risk

Adverse event: Speech impairment
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 47 at risk

Adverse event: Thrombosis/thrombus/embolism
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 47 at risk

Adverse event: Dehydration
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 47 at risk

Adverse event: Neurology - Other (specify)
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 47 at risk

Adverse event: Fatigue (asthenia, lethargy, malaise)
Serious: no
Organ System: General disorders
Frequency: 3 affected / 47 at risk

Adverse event: Glucose, high (hyperglycemia)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 7 affected / 47 at risk

Adverse event: Leukocytes (total WBC)
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 6 affected / 47 at risk

Adverse event: Lymphopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 7 affected / 47 at risk

Adverse event: Neuropathy: sensory
Serious: no
Organ System: Nervous system disorders
Frequency: 3 affected / 47 at risk

Adverse event: Platelets
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 3 affected / 47 at risk
Study: NCT00498940

Adverse event: Bleeding at lead site
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 30 at risk

Adverse event: Arrhythmia
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 31 at risk
Study: NCT00499083

Adverse event: Febrile neutropenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 3 at risk

Adverse event: Embolism
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 3 at risk

Adverse event: Hypokalaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 3 at risk

Adverse event: Stomatitis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 3 at risk

Adverse event: palmar-plantar erythrodysesthesia
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 3 at risk

Adverse event: Bone pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 3 at risk

Adverse event: White blood cell count decreased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 3 at risk

Adverse event: Neutrophil count decreased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 3 at risk
Study: NCT00499122

Adverse event: Febrile neutropenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 4 affected / 41 at risk

Adverse event: Peripheral sensory neuropathy
Serious: yes
Organ System: Nervous system disorders
Frequency: 4 affected / 41 at risk

Adverse event: Abdominal pain
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 41 at risk

Adverse event: Fatigue
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 41 at risk

Adverse event: Headache
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 41 at risk

Adverse event: Cellulitis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 41 at risk

Adverse event: Neutropenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 41 at risk

Adverse event: Muscular weakness
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 41 at risk

Adverse event: Deep vein thrombosis
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 41 at risk

Adverse event: Peripheral artery occlusion
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 41 at risk

Adverse event: Constipation
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 41 at risk

Adverse event: Palmar-plantar erythroysaesthesia
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 6 affected / 41 at risk

Adverse event: Pulmonary embolism
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 41 at risk

Adverse event: Nausea
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 41 at risk

Adverse event: Nausea
Serious: no
Organ System: General disorders
Frequency: 31 affected / 41 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 29 affected / 41 at risk

Adverse event: Consitpation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 16 affected / 41 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 15 affected / 41 at risk

Adverse event: Peripheral sensory neuropathy
Serious: no
Organ System: Nervous system disorders
Frequency: 11 affected / 41 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 11 affected / 41 at risk
Study: NCT00499174

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 15 affected / 78 at risk

Adverse event: Pain Testicle
Serious: no
Organ System: General disorders
Frequency: 1 affected / 78 at risk

Adverse event: Incontinence, urinary
Serious: no
Organ System: Renal and urinary disorders
Frequency: 3 affected / 78 at risk

Adverse event: Pollakiuria
Serious: no
Organ System: Renal and urinary disorders
Frequency: 34 affected / 78 at risk

Adverse event: Urinary retention
Serious: no
Organ System: Renal and urinary disorders
Frequency: 12 affected / 78 at risk

Adverse event: Ejaculatory dysfunction
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 37 affected / 78 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 7 affected / 99 at risk

Adverse event: Pain Testicle
Serious: no
Organ System: General disorders
Frequency: 9 affected / 99 at risk

Adverse event: Incontinence, urinary
Serious: no
Organ System: Renal and urinary disorders
Frequency: 11 affected / 99 at risk

Adverse event: Pollakiuria
Serious: no
Organ System: Renal and urinary disorders
Frequency: 29 affected / 99 at risk

Adverse event: Urinary retention
Serious: no
Organ System: Renal and urinary disorders
Frequency: 12 affected / 99 at risk

Adverse event: Ejaculatory dysfunction
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 41 affected / 99 at risk
Study: NCT00499343

Adverse event: Cytokine release syndrome
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 41 at risk

Adverse event: Febrile neutropenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 7 affected / 41 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 41 at risk

Adverse event: Febrile neutropenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 6 affected / 43 at risk

Adverse event: NAUSEA/VOMITING
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 43 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 43 at risk
Study: NCT00499863

Adverse event: Syncope
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 145 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 14 affected / 145 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 15 affected / 145 at risk

Adverse event: Weight decreased
Serious: no
Organ System: Investigations
Frequency: 8 affected / 145 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 37 affected / 145 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 8 affected / 145 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 18 affected / 145 at risk

Adverse event: Insomnia
Serious: no
Organ System: Psychiatric disorders
Frequency: 9 affected / 145 at risk

Adverse event: Irritability
Serious: no
Organ System: Psychiatric disorders
Frequency: 16 affected / 145 at risk

Adverse event: Negativism
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 72 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 72 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 7 affected / 72 at risk

Adverse event: Weight decreased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 72 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 72 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 72 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 9 affected / 72 at risk

Adverse event: Insomnia
Serious: no
Organ System: Psychiatric disorders
Frequency: 2 affected / 72 at risk

Adverse event: Irritability
Serious: no
Organ System: Psychiatric disorders
Frequency: 5 affected / 72 at risk
Study: NCT00499915

Adverse event: Death
Serious: yes
Organ System: General disorders
Notes: All infants in this study are born premature and at risk for other complications. These children passed away while enrolled in this study.
Frequency: 1 affected / 83 at risk

Adverse event: Death
Serious: yes
Organ System: General disorders
Notes: All infants in this study are born premature and at risk for other complications. These children passed away while enrolled in this study.
Frequency: 1 affected / 82 at risk
Study: NCT00500071

Adverse event: Syncope
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 317 at risk

Adverse event: Sinus arrest
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 317 at risk

Adverse event: Abdominal pain upper
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 42 affected / 317 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 17 affected / 317 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 17 affected / 317 at risk

Adverse event: Irritability
Serious: no
Organ System: General disorders
Frequency: 51 affected / 317 at risk

Adverse event: Weight decreased
Serious: no
Organ System: Investigations
Frequency: 54 affected / 317 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 137 affected / 317 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 44 affected / 317 at risk

Adverse event: Affect liability
Serious: no
Organ System: Psychiatric disorders
Frequency: 23 affected / 317 at risk

Adverse event: Initial insomnia
Serious: no
Organ System: Nervous system disorders
Frequency: 36 affected / 317 at risk

Adverse event: Insomnia
Serious: no
Organ System: Nervous system disorders
Frequency: 51 affected / 317 at risk
Study: NCT00500110

Adverse event: Alanine aminotransferase
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 36 at risk

Adverse event: Fatigue
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 36 at risk

Adverse event: Febrile neutropenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 36 at risk

Adverse event: Acute coronary syndrome
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 36 at risk

Adverse event: Pyrexia
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 36 at risk

Adverse event: Neutrophil count decreased
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 36 at risk

Adverse event: thrombosis/embolism
Serious: yes
Organ System: Vascular disorders
Frequency: 2 affected / 36 at risk

Adverse event: Vomiting
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 36 at risk

Adverse event: alanine transaminase
Serious: no
Organ System: Investigations
Frequency: 6 affected / 36 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 36 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 5 affected / 36 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 16 affected / 36 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 9 affected / 36 at risk
Study: NCT00500149

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 7 affected / 115 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 6 affected / 115 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 115 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 115 at risk
Study: NCT00500240

Adverse event: Pancreatitis acute
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 25 at risk

Adverse event: Death
Serious: yes
Organ System: General disorders
Notes: Deaths were due to progressive disease and were not related to the study treatment.
Frequency: 8 affected / 25 at risk

Adverse event: Pain
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 26 at risk

Adverse event: Febrile neutropenia
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 26 at risk

Adverse event: Hypoglycaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 26 at risk

Adverse event: Death
Serious: yes
Organ System: General disorders
Notes: Deaths were due to progressive disease and were not related to the study treatment.
Frequency: 10 affected / 26 at risk
Study: NCT00500318

Adverse event: Enteritis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 86 at risk

Adverse event: Diverticulum
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 86 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 5 affected / 86 at risk

Adverse event: Chronic Obstructive Pulmonary Disorder
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 86 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 5 affected / 86 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 5 affected / 86 at risk

Adverse event: Bronchitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 95 at risk

Adverse event: Bladder transitional cell carcinoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 95 at risk

Adverse event: Chronic obstructive pulmonary disease
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 95 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 7 affected / 95 at risk

Adverse event: Chronic Obstructive Pulmonary Disorder
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 7 affected / 95 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 95 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 95 at risk
Study: NCT00500331

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 48 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 47 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 47 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 47 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 47 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 48 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 48 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 48 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 48 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 48 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 48 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 48 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 48 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 48 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 47 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 47 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 5 affected / 48 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 48 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 4 affected / 48 at risk
Study: NCT00500578

Adverse event: Diarrhoea
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Severe diarrhea occured in 1 patient
Frequency: 1 affected / 18 at risk

Adverse event: Acute graft versus host disease
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Notes: Affected 1 patient
Frequency: 1 affected / 18 at risk

Adverse event: Chronic graft versus host disease
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Notes: Affected 1 patient
Frequency: 1 affected / 18 at risk

Adverse event: Anaemia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 18 at risk

Adverse event: Elevated Transaminase Level
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 18 at risk

Adverse event: Elevated Bilirubin level
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 18 at risk

Adverse event: Diarrhoea
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Severe diarrhea occured in 1 patient
Frequency: 4 affected / 32 at risk

Adverse event: Bladder spasm
Serious: yes
Organ System: Renal and urinary disorders
Notes: Occured in 1 patient
Frequency: 1 affected / 32 at risk

Adverse event: Neutropenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Notes: Occured in 1 patient
Frequency: 1 affected / 32 at risk

Adverse event: Anaemia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 32 at risk

Adverse event: Elevated creatinine
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 32 at risk

Adverse event: Hyperglycaemia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 32 at risk
Study: NCT00500890

Adverse event: Febrile neutropenia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1 at risk
Study: NCT00501293

Adverse event: Seizure
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 109 at risk

Adverse event: Hallucination
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 109 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 10 affected / 109 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 11 affected / 109 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 12 affected / 109 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 11 affected / 109 at risk

Adverse event: Irritability
Serious: no
Organ System: Psychiatric disorders
Frequency: 6 affected / 109 at risk

Adverse event: Syncope
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 53 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 53 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 6 affected / 53 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 13 affected / 53 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 8 affected / 53 at risk

Adverse event: Irritability
Serious: no
Organ System: Psychiatric disorders
Frequency: 4 affected / 53 at risk