TrialPanorama/TrialPanorama-database huggingface dataset:
Study: NCT02967393

Adverse event: Wheezing
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 20 at risk

Adverse event: Hand foot and mouth disease
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 20 at risk

Adverse event: Asthma Exacerbations
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 6 affected / 20 at risk

Adverse event: Local Reaction to Vaccine
Serious: no
Organ System: Immune system disorders
Notes: includes mild, moderate and severe local reactions
Frequency: 19 affected / 20 at risk

Adverse event: Pyrexia
Serious: no
Organ System: Immune system disorders
Frequency: 4 affected / 20 at risk

Adverse event: Headache
Serious: no
Organ System: General disorders
Frequency: 7 affected / 20 at risk

Adverse event: Muscles Aches
Serious: no
Organ System: General disorders
Frequency: 2 affected / 20 at risk

Adverse event: Bone pain
Serious: no
Organ System: General disorders
Frequency: 2 affected / 20 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 6 affected / 20 at risk

Adverse event: Decrease Appetite
Serious: no
Organ System: General disorders
Frequency: 4 affected / 20 at risk

Adverse event: Stomache Ache
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 6 affected / 20 at risk

Adverse event: Irritability
Serious: no
Organ System: General disorders
Frequency: 7 affected / 20 at risk

Adverse event: Asthma Exacerbations
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 4 affected / 20 at risk

Adverse event: Local Reaction to Vaccine
Serious: no
Organ System: Immune system disorders
Notes: includes mild, moderate and severe local reactions
Frequency: 19 affected / 20 at risk

Adverse event: Pyrexia
Serious: no
Organ System: Immune system disorders
Frequency: 5 affected / 20 at risk

Adverse event: Headache
Serious: no
Organ System: General disorders
Frequency: 7 affected / 20 at risk

Adverse event: Muscles Aches
Serious: no
Organ System: General disorders
Frequency: 5 affected / 20 at risk

Adverse event: Bone pain
Serious: no
Organ System: General disorders
Frequency: 4 affected / 20 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 12 affected / 20 at risk

Adverse event: Decrease Appetite
Serious: no
Organ System: General disorders
Frequency: 8 affected / 20 at risk

Adverse event: Stomache Ache
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 7 affected / 20 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 20 at risk

Adverse event: Irritability
Serious: no
Organ System: General disorders
Frequency: 11 affected / 20 at risk
Study: NCT02967458

Adverse event: Urticaria
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 55 at risk

Adverse event: Throat tightness
Serious: no
Organ System: General disorders
Frequency: 1 affected / 55 at risk
Study: NCT02968134

Adverse event: Death
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 8 at risk
Study: NCT02968173

Adverse event: Tachycardia paroxysmal
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 50 at risk

Adverse event: Bronchitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 50 at risk

Adverse event: Bronchitis viral
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 50 at risk

Adverse event: Nasopharyngitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 50 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 50 at risk

Adverse event: Respiratory tract infection viral
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 50 at risk

Adverse event: Haemangioma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 50 at risk

Adverse event: Tachycardia paroxysmal
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 50 at risk

Adverse event: Bronchitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 50 at risk

Adverse event: Bronchitis viral
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 50 at risk

Adverse event: Nasopharyngitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 50 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 50 at risk

Adverse event: Respiratory tract infection viral
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 50 at risk

Adverse event: Haemangioma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 50 at risk
Study: NCT02968433

Adverse event: Contusion
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 16 at risk

Adverse event: Skin and subcutaneous tissue disorder
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 8 affected / 16 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 16 at risk

Adverse event: Hypotension
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 16 at risk

Adverse event: Nervous system disturbance
Serious: no
Organ System: Nervous system disorders
Frequency: 3 affected / 16 at risk

Adverse event: Abdominal distension
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 16 at risk

Adverse event: Urinary frequency distrubance
Serious: no
Organ System: Renal and urinary disorders
Frequency: 2 affected / 16 at risk

Adverse event: Abdominal pain upper
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 16 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 16 at risk

Adverse event: Musculoskeletal and connective tissue disorder
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 3 affected / 16 at risk

Adverse event: Chest discomfort
Serious: no
Organ System: General disorders
Frequency: 1 affected / 16 at risk

Adverse event: Oropharyngeal pain
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 16 at risk

Adverse event: Fall
Serious: no
Organ System: General disorders
Frequency: 1 affected / 16 at risk

Adverse event: Influenza like illness
Serious: no
Organ System: General disorders
Frequency: 2 affected / 16 at risk

Adverse event: Tremor
Serious: no
Organ System: General disorders
Frequency: 1 affected / 16 at risk

Adverse event: Involuntary movement
Serious: no
Organ System: General disorders
Frequency: 5 affected / 16 at risk

Adverse event: Muscular weakness
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 16 at risk

Adverse event: Sleep disorder
Serious: no
Organ System: General disorders
Frequency: 2 affected / 16 at risk

Adverse event: Headache
Serious: no
Organ System: General disorders
Frequency: 2 affected / 16 at risk

Adverse event: Gastrointestinal disorders
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 16 at risk

Adverse event: Pain in extremity
Serious: no
Organ System: General disorders
Frequency: 1 affected / 16 at risk
Study: NCT02968576

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 25 at risk

Adverse event: Vomitting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 25 at risk

Adverse event: Headache
Serious: no
Organ System: General disorders
Frequency: 1 affected / 25 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: General disorders
Frequency: 7 affected / 25 at risk

Adverse event: Respiratory tract infection
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 25 at risk

Adverse event: Swelling face
Serious: no
Organ System: General disorders
Frequency: 1 affected / 25 at risk
Study: NCT02968602

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 16 at risk

Adverse event: Arthritus
Serious: no
Organ System: General disorders
Frequency: 1 affected / 16 at risk

Adverse event: Sedation
Serious: no
Organ System: General disorders
Frequency: 2 affected / 16 at risk

Adverse event: Restlessness
Serious: no
Organ System: General disorders
Frequency: 2 affected / 16 at risk

Adverse event: Loss of Appetite
Serious: no
Organ System: General disorders
Frequency: 2 affected / 16 at risk

Adverse event: Insomnia
Serious: no
Organ System: General disorders
Frequency: 2 affected / 16 at risk

Adverse event: Malaise
Serious: no
Organ System: General disorders
Frequency: 2 affected / 16 at risk

Adverse event: Dizziness
Serious: no
Organ System: General disorders
Frequency: 2 affected / 16 at risk

Adverse event: Musculoskeletal stiffness
Serious: no
Organ System: General disorders
Frequency: 1 affected / 16 at risk

Adverse event: Uticaria
Serious: no
Organ System: General disorders
Frequency: 1 affected / 16 at risk

Adverse event: Headache
Serious: no
Organ System: General disorders
Frequency: 1 affected / 16 at risk

Adverse event: Hostility
Serious: no
Organ System: General disorders
Frequency: 1 affected / 16 at risk

Adverse event: Tremor
Serious: no
Organ System: General disorders
Frequency: 1 affected / 16 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 16 at risk

Adverse event: Hypersalavation
Serious: no
Organ System: General disorders
Frequency: 2 affected / 16 at risk

Adverse event: Sedation
Serious: no
Organ System: General disorders
Frequency: 3 affected / 16 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 16 at risk

Adverse event: Somatic Concern
Serious: no
Organ System: General disorders
Frequency: 1 affected / 16 at risk

Adverse event: Back pain
Serious: no
Organ System: General disorders
Frequency: 1 affected / 16 at risk

Adverse event: "Zoning out"
Serious: no
Organ System: General disorders
Frequency: 1 affected / 16 at risk
Study: NCT02968992

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 18 at risk

Adverse event: Loss of Appetite
Serious: no
Organ System: General disorders
Frequency: 2 affected / 18 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 5 affected / 18 at risk

Adverse event: Fever/chills
Serious: no
Organ System: General disorders
Notes: Fever or chills were associated with respiratory infections
Frequency: 4 affected / 18 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 18 at risk

Adverse event: Other conditions
Serious: no
Organ System: General disorders
Notes: Other conditions consist of any other medical issues that were not included in the standard side effects.
Frequency: 12 affected / 18 at risk

Adverse event: Hospitalisation
Serious: yes
Organ System: Infections and infestations
Notes: Participant suffered an infection from cat bite, which required hospitalization, and he was withdrawn from study
Frequency: 1 affected / 18 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 18 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 18 at risk

Adverse event: Loss of Appetite
Serious: no
Organ System: General disorders
Frequency: 1 affected / 18 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 4 affected / 18 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 18 at risk

Adverse event: Other conditions
Serious: no
Organ System: General disorders
Notes: Other conditions consist of any other medical issues that were not included in the standard side effects.
Frequency: 9 affected / 18 at risk
Study: NCT02969187

Adverse event: Minor adverse event
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Two patients in the study arm developed urticarial rash over the abdominal wall at the site on injection. The rash was itchy but limited only to the abdominal area at the injection site. At subsequent follow up, the rash has resolved.
Frequency: 2 affected / 51 at risk
Study: NCT02969317

Adverse event: Abdominal pain upper
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 12 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 12 at risk

Adverse event: Anxiety
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 12 at risk
Study: NCT02969382

Adverse event: Schizophrenia
Serious: yes
Organ System: Psychiatric disorders
Frequency: 3 affected / 125 at risk

Adverse event: Suicide attempt
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 125 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 15 affected / 125 at risk

Adverse event: Somnolence
Serious: no
Organ System: Nervous system disorders
Frequency: 6 affected / 125 at risk

Adverse event: Anxiety
Serious: no
Organ System: Psychiatric disorders
Frequency: 9 affected / 125 at risk

Adverse event: Insomnia
Serious: no
Organ System: Psychiatric disorders
Frequency: 13 affected / 125 at risk

Adverse event: Schizophrenia
Serious: no
Organ System: Psychiatric disorders
Frequency: 7 affected / 125 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 125 at risk

Adverse event: Agitation
Serious: no
Organ System: Psychiatric disorders
Frequency: 6 affected / 125 at risk

Adverse event: Cardiovascular insufficiency
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 120 at risk

Adverse event: Schizophrenia
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 120 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 11 affected / 120 at risk

Adverse event: Somnolence
Serious: no
Organ System: Nervous system disorders
Frequency: 8 affected / 120 at risk

Adverse event: Anxiety
Serious: no
Organ System: Psychiatric disorders
Frequency: 2 affected / 120 at risk

Adverse event: Insomnia
Serious: no
Organ System: Psychiatric disorders
Frequency: 4 affected / 120 at risk

Adverse event: Schizophrenia
Serious: no
Organ System: Psychiatric disorders
Frequency: 7 affected / 120 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 6 affected / 120 at risk

Adverse event: Agitation
Serious: no
Organ System: Psychiatric disorders
Frequency: 6 affected / 120 at risk
Study: NCT02969408

Adverse event: Acute myocardial infarction
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 397 at risk

Adverse event: Myocardial infarction
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 397 at risk

Adverse event: Gastrooesophageal reflux disease
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 397 at risk

Adverse event: Gastroenteritis salmonella
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 397 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 397 at risk

Adverse event: Craniofacial fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 397 at risk

Adverse event: Fractured sacrum
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 397 at risk

Adverse event: Humerus fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 397 at risk

Adverse event: Ilium fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 397 at risk

Adverse event: Pelvic fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 397 at risk

Adverse event: Rib fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 397 at risk

Adverse event: Road traffic accident
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 397 at risk

Adverse event: Dehydration
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 397 at risk

Adverse event: Hypokalaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 397 at risk

Adverse event: Migraine
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 397 at risk

Adverse event: Acute respiratory failure
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 397 at risk

Adverse event: Asthma
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 397 at risk

Adverse event: Pulmonary embolism
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 397 at risk

Adverse event: Deep vein thrombosis
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 397 at risk

Adverse event: Asthma
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 68 affected / 397 at risk
Study: NCT02969499

Adverse event: Death
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Patient passed away 2 days after their last ECT due to pneumonia but it was felt that was unlikely to be directly related to ECT treatment as the patient was frail
Frequency: 1 affected / 33 at risk

Adverse event: Delirium
Serious: no
Organ System: Renal and urinary disorders
Notes: Two participants had ECT held temporarily due to increased confusion when they developed a urinary tract infection. The delirium in each was not deemed to be related to ECT.
Frequency: 2 affected / 33 at risk

Adverse event: Agitation
Serious: no
Organ System: Nervous system disorders
Notes: Two participants manifested agitation/restlessness after ECT, and it was not clear if this represented an exacerbation of their (Neuro-Psychiatric Symptoms) NPS or if there was concurrent transient post-ECT delirium.
Frequency: 2 affected / 33 at risk

Adverse event: Hypotension/Bradycardia
Serious: no
Organ System: Cardiac disorders
Notes: One participant had a transient bout of hypotension and bradycardia after an ECT treatment
Frequency: 1 affected / 33 at risk
Study: NCT02969707

Adverse event: Headache / Scalp Irritation
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: One Participant experienced a headache and scalp irritation under the site of the TMS coil (a common side effect) during active treatment.
Frequency: 1 affected / 49 at risk

Adverse event: Medication Withdrawal During Washout
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: One patient experienced medication withdrawal during the washout period for the study.
Frequency: 1 affected / 52 at risk

Adverse event: Dizziness
Serious: no
Organ System: Ear and labyrinth disorders
Notes: Dizziness from MRI machine during scanning session
Frequency: 1 affected / 52 at risk
Study: NCT02969863

Adverse event: Hypoglycaemia
Serious: yes
Organ System: Endocrine disorders
Notes: The subject reported a hypoglycemic event that he was not called for. Remote monitoring did not see this or notify study staff. The subject reported that he treated using oral carbohydrates, and it resolved without incident.
Frequency: 1 affected / 24 at risk
Study: NCT02969876

Adverse event: Tripped, hit knee, went to ER
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 2 at risk

Adverse event: Migraines
Serious: no
Organ System: General disorders
Frequency: 1 affected / 2 at risk

Adverse event: Headaches
Serious: no
Organ System: General disorders
Frequency: 1 affected / 2 at risk
Study: NCT02969915

Adverse event: Death
Serious: yes
Organ System: General disorders
Frequency: 104 affected / 1114 at risk

Adverse event: Death
Serious: yes
Organ System: General disorders
Frequency: 125 affected / 1200 at risk
Study: NCT02969928

Adverse event: Headache
Serious: no
Organ System: General disorders
Frequency: 1 affected / 23 at risk

Adverse event: Abdominal pain upper
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 23 at risk

Adverse event: Nausea/vomiting
Serious: no
Organ System: General disorders
Frequency: 3 affected / 23 at risk

Adverse event: Metallic taste
Serious: no
Organ System: General disorders
Frequency: 7 affected / 23 at risk

Adverse event: Diarrhea/ abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 23 at risk

Adverse event: Somnolence
Serious: no
Organ System: General disorders
Frequency: 2 affected / 23 at risk

Adverse event: Pruritus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 23 at risk

Adverse event: Headache
Serious: no
Organ System: General disorders
Frequency: 2 affected / 23 at risk

Adverse event: Abdominal pain upper
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 23 at risk

Adverse event: Nausea/vomiting
Serious: no
Organ System: General disorders
Frequency: 6 affected / 23 at risk

Adverse event: Metallic taste
Serious: no
Organ System: General disorders
Frequency: 13 affected / 23 at risk

Adverse event: Diarrhea/ abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 23 at risk

Adverse event: Somnolence
Serious: no
Organ System: General disorders
Frequency: 3 affected / 23 at risk
Study: NCT02970032

Adverse event: Pulmonary embolism
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 20 at risk

Adverse event: Pulmonary embolism
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 20 at risk

Adverse event: Pulmonary embolism
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 20 at risk

Adverse event: Pulmonary embolism
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 20 at risk
Study: NCT02970292

Adverse event: Schizophrenia
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 198 at risk

Adverse event: Hallucination, auditory
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 198 at risk

Adverse event: Suicidal ideation
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 198 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 13 affected / 198 at risk

Adverse event: Somnolence
Serious: no
Organ System: Nervous system disorders
Frequency: 13 affected / 198 at risk

Adverse event: Insomnia
Serious: no
Organ System: Psychiatric disorders
Frequency: 10 affected / 198 at risk

Adverse event: Schizophrenia
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 198 at risk

Adverse event: Psychotic symptom
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 198 at risk

Adverse event: Self-injurious ideation
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 198 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 18 affected / 198 at risk

Adverse event: Somnolence
Serious: no
Organ System: Nervous system disorders
Frequency: 7 affected / 198 at risk

Adverse event: Insomnia
Serious: no
Organ System: Psychiatric disorders
Frequency: 7 affected / 198 at risk