TrialPanorama/TrialPanorama-database huggingface dataset:
Study: NCT03252431

Adverse event: Febrile neutropenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 197 at risk

Adverse event: Fatigue
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 197 at risk

Adverse event: Diabetic ketoacidosis
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 197 at risk

Adverse event: Syncope
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 197 at risk

Adverse event: Acute kidney injury
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 197 at risk

Adverse event: Pulmonary embolism
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 197 at risk

Adverse event: Hypertension
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 197 at risk

Adverse event: Angioedema
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 197 at risk

Adverse event: Urticaria
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 197 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 197 at risk

Adverse event: Bone pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 31 affected / 197 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 12 affected / 197 at risk

Adverse event: Leukocytosis
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 14 affected / 197 at risk

Adverse event: Asthenia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 13 affected / 197 at risk

Adverse event: Anaemia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 196 at risk

Adverse event: Neutropenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 196 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 196 at risk

Adverse event: Myocardial infarction
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 196 at risk

Adverse event: Hepatitis toxic
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 196 at risk

Adverse event: Bone pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 23 affected / 196 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 6 affected / 196 at risk

Adverse event: Leukocytosis
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 10 affected / 196 at risk

Adverse event: Asthenia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 12 affected / 196 at risk
Study: NCT03252925

Adverse event: Abdominal pain or diarrhea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 36 affected / 66 at risk

Adverse event: Cystitis haemorrhagic
Serious: no
Organ System: Renal and urinary disorders
Frequency: 27 affected / 66 at risk

Adverse event: Pyrexia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 20 affected / 66 at risk

Adverse event: Upper gastrointestinal complications
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 66 at risk

Adverse event: Erythra
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 11 affected / 66 at risk

Adverse event: Cough or expectoration
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 9 affected / 66 at risk

Adverse event: Dizziness or headache
Serious: no
Organ System: Vascular disorders
Frequency: 5 affected / 66 at risk

Adverse event: Gastrointestinal haemorrhage
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 6 affected / 66 at risk

Adverse event: Chest discomfort
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 66 at risk

Adverse event: Epilepsy
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 66 at risk

Adverse event: Abdominal pain or diarrhea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 49 affected / 74 at risk

Adverse event: Cystitis haemorrhagic
Serious: no
Organ System: Renal and urinary disorders
Frequency: 43 affected / 74 at risk

Adverse event: Pyrexia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 37 affected / 74 at risk

Adverse event: Upper gastrointestinal complications
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 18 affected / 74 at risk

Adverse event: Erythra
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 15 affected / 74 at risk

Adverse event: Cough or expectoration
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 15 affected / 74 at risk

Adverse event: Dizziness or headache
Serious: no
Organ System: Vascular disorders
Frequency: 12 affected / 74 at risk

Adverse event: Gastrointestinal haemorrhage
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 6 affected / 74 at risk

Adverse event: Chest discomfort
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 5 affected / 74 at risk

Adverse event: Epilepsy
Serious: no
Organ System: Nervous system disorders
Frequency: 4 affected / 74 at risk
Study: NCT03252964

Adverse event: Haemorrhage
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Bleeding at CGM sensor insertion site.
Frequency: 1 affected / 52 at risk

Adverse event: Pain
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Pain at CGM sensor insertion site
Frequency: 1 affected / 52 at risk
Study: NCT03253328

Adverse event: Non-healing amputation site
Serious: no
Organ System: Vascular disorders
Notes: Non-healing amputation site
Frequency: 1 affected / 16 at risk

Adverse event: Erosive oesophagitis
Serious: no
Organ System: General disorders
Notes: Erosive esophagitis
Frequency: 1 affected / 16 at risk

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

Adverse event: Diabetic ketoacidosis (DKA)
Serious: no
Organ System: Endocrine disorders
Notes: Diabetic ketoacidosis (DKA)
Frequency: 1 affected / 16 at risk

Adverse event: Amputation stump revision due to a fall
Serious: no
Organ System: General disorders
Notes: Amputation stump revision due to a fall
Frequency: 1 affected / 16 at risk

Adverse event: Death
Serious: no
Organ System: Infections and infestations
Notes: Complications associated with diabetic ketoacidosis (DKA)
Frequency: 1 affected / 16 at risk

Adverse event: Conversion from BKA to AKA
Serious: no
Organ System: Surgical and medical procedures
Notes: Conversion from below knee amputation (BKA) to above knee amputation (AKA)
Frequency: 1 affected / 17 at risk

Adverse event: Stump pain
Serious: no
Organ System: Vascular disorders
Notes: Stump pain
Frequency: 1 affected / 17 at risk

Adverse event: Constipation resulting in hospitalization
Serious: no
Organ System: Gastrointestinal disorders
Notes: Constipation resulting in hospitalization
Frequency: 1 affected / 17 at risk

Adverse event: Faecaloma
Serious: no
Organ System: Gastrointestinal disorders
Notes: Fecal impaction
Frequency: 1 affected / 17 at risk

Adverse event: Wound necrosis
Serious: no
Organ System: Infections and infestations
Notes: Wound necrosis
Frequency: 1 affected / 17 at risk
Study: NCT03253913

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

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 25 at risk

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

Adverse event: Infection
Serious: no
Organ System: Infections and infestations
Frequency: 6 affected / 25 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 25 at risk

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

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

Adverse event: Infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 25 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 25 at risk

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

Adverse event: Infection
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 25 at risk
Study: NCT03253926

Adverse event: Headache
Serious: no
Organ System: Product Issues
Frequency: 3 affected / 15 at risk

Adverse event: Abdominal discomfort
Serious: no
Organ System: Product Issues
Frequency: 6 affected / 15 at risk

Adverse event: Body pain
Serious: no
Organ System: Product Issues
Frequency: 1 affected / 15 at risk

Adverse event: Anxiety/Jittery
Serious: no
Organ System: Product Issues
Frequency: 1 affected / 15 at risk

Adverse event: Eye dryness/discomfort
Serious: no
Organ System: Product Issues
Frequency: 2 affected / 15 at risk

Adverse event: Trouble sleeping
Serious: no
Organ System: Product Issues
Frequency: 2 affected / 15 at risk

Adverse event: Headache
Serious: no
Organ System: Product Issues
Frequency: 1 affected / 15 at risk

Adverse event: Abdominal discomfort
Serious: no
Organ System: Product Issues
Frequency: 4 affected / 15 at risk

Adverse event: Body pain
Serious: no
Organ System: Product Issues
Frequency: 1 affected / 15 at risk

Adverse event: Anxiety/Jittery
Serious: no
Organ System: Product Issues
Frequency: 1 affected / 15 at risk

Adverse event: Eye dryness/discomfort
Serious: no
Organ System: Product Issues
Frequency: 1 affected / 15 at risk
Study: NCT03254394

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 4 affected / 12 at risk

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

Adverse event: Arrhythmia
Serious: no
Organ System: Cardiac disorders
Frequency: 2 affected / 12 at risk

Adverse event: Vision blurred
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 12 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 12 at risk

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

Adverse event: Pruritus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 12 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 4 affected / 14 at risk

Adverse event: Somnolence
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 14 at risk

Adverse event: Paraesthesia
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 14 at risk

Adverse event: Arrhythmia
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 14 at risk

Adverse event: Vision blurred
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 14 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 6 affected / 14 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 14 at risk

Adverse event: Pruritus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 14 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 3 affected / 14 at risk
Study: NCT03254459

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 17 affected / 50 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 6 affected / 50 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 50 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 5 affected / 50 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 8 affected / 50 at risk

Adverse event: Somnolence
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 50 at risk

Adverse event: Hypoxia
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 50 at risk

Adverse event: Pruritus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 4 affected / 50 at risk

Adverse event: Haematoma
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 50 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 39 affected / 50 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 26 affected / 50 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 50 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 11 affected / 50 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 9 affected / 50 at risk

Adverse event: Somnolence
Serious: no
Organ System: Nervous system disorders
Frequency: 3 affected / 50 at risk

Adverse event: Hypoxia
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 14 affected / 50 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 4 affected / 50 at risk

Adverse event: Pruritus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 8 affected / 50 at risk
Study: NCT03254719

Adverse event: Myalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 5 affected / 40 at risk
Study: NCT03255031

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 33 at risk

Adverse event: Foreign body
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 33 at risk

Adverse event: Liver function test increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 33 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 33 at risk

Adverse event: Panic attack
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 33 at risk

Adverse event: Nephrolithiasis
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 33 at risk

Adverse event: Abdominal discomfort
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 20 at risk

Adverse event: Liver function test increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 20 at risk
Study: NCT03255200

Adverse event: Urticaria
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 87 at risk

Adverse event: Abdominal pain upper
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 87 at risk

Adverse event: Back pain
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 87 at risk

Adverse event: Myocardial infarction
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 87 at risk

Adverse event: Urinary tract infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 87 at risk

Adverse event: Lung neoplasm malignant
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 87 at risk

Adverse event: Intervertebral disc protrusion
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 87 at risk

Adverse event: Dyspnoea
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 87 at risk

Adverse event: Radiculopathy
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 87 at risk

Adverse event: Vocal cord paresis
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 87 at risk

Adverse event: Benign prostatic hyperplasia
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 87 at risk

Adverse event: Arterial haemorrhage
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 87 at risk

Adverse event: Intervertebral disc protrusion
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 87 at risk

Adverse event: Gastroenteritis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 87 at risk

Adverse event: Death; Cause Unknown, Unrelated to Study Treatment
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 87 at risk

Adverse event: Shoulder fracture
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 87 at risk

Adverse event: Overdose
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 87 at risk

Adverse event: Arthralgia
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 87 at risk

Adverse event: Hip pain
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 87 at risk

Adverse event: Sacral pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 6 affected / 87 at risk
Study: NCT03255967

Adverse event: Hospitalisation
Serious: yes
Organ System: General disorders
Frequency: 15 affected / 119 at risk

Adverse event: Death related
Serious: yes
Organ System: General disorders
Frequency: 6 affected / 119 at risk

Adverse event: Delirium
Serious: yes
Organ System: Psychiatric disorders
Frequency: 5 affected / 119 at risk

Adverse event: Increase in symptoms of dementia
Serious: no
Organ System: Nervous system disorders
Frequency: 7 affected / 119 at risk

Adverse event: Change in pre-existing condition
Serious: no
Organ System: General disorders
Frequency: 1 affected / 119 at risk

Adverse event: Fall
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 9 affected / 119 at risk

Adverse event: Injury not life threatening
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 119 at risk

Adverse event: Delirium False Positive
Serious: no
Organ System: Psychiatric disorders
Frequency: 2 affected / 119 at risk

Adverse event: Caregiver severe depression (Increase Score on PHQ-9 [Day 60])
Serious: yes
Organ System: Psychiatric disorders
Frequency: 2 affected / 119 at risk

Adverse event: Caregiver suicide idealization
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 119 at risk

Adverse event: Change in pre-existing condition
Serious: no
Organ System: General disorders
Frequency: 4 affected / 119 at risk

Adverse event: Depressive Symptoms (Score on PHQ-9)
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 119 at risk

Adverse event: Hospitalisation
Serious: yes
Organ System: General disorders
Frequency: 19 affected / 96 at risk

Adverse event: Death related
Serious: yes
Organ System: General disorders
Frequency: 10 affected / 96 at risk

Adverse event: Delirium
Serious: yes
Organ System: Psychiatric disorders
Frequency: 5 affected / 96 at risk

Adverse event: Increase in symptoms of dementia
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 96 at risk

Adverse event: New Diagnosis
Serious: no
Organ System: General disorders
Frequency: 1 affected / 96 at risk

Adverse event: Fall
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 6 affected / 96 at risk

Adverse event: Injury not life threatening
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 96 at risk

Adverse event: Hospitalisation
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 96 at risk

Adverse event: Caregiver severe depression (Increase Score on PHQ-9 [Day 60])
Serious: yes
Organ System: Psychiatric disorders
Frequency: 2 affected / 96 at risk

Adverse event: Depressive Symptoms (Score on PHQ-9)
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 96 at risk
Study: NCT03255980

Adverse event: Pruritus
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Notes: Hypersensitivity
Frequency: 1 affected / 20 at risk

Adverse event: Ear infection
Serious: no
Organ System: Infections and infestations
Notes: Infections - pathogen unspecified
Frequency: 1 affected / 20 at risk
Study: NCT03256045

Adverse event: Non-ST segment elevation myocardial infarction
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 9 at risk

Adverse event: Fracture, pathologic
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 9 at risk

Adverse event: Fracture, non-pathologic
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 9 at risk

Adverse event: Fall
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 9 at risk

Adverse event: Hypertension
Serious: no
Organ System: Vascular disorders
Frequency: 2 affected / 9 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 9 at risk

Adverse event: Syncope
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 9 at risk
Study: NCT03256227

Adverse event: Severe Suicidal ideation
Serious: yes
Organ System: Psychiatric disorders
Frequency: 2 affected / 64 at risk

Adverse event: ER visit
Serious: no
Organ System: General disorders
Frequency: 11 affected / 64 at risk

Adverse event: Hospitalisation
Serious: no
Organ System: General disorders
Frequency: 8 affected / 64 at risk

Adverse event: Severe Suicidal ideation
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 64 at risk

Adverse event: Psychological decompisation
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 64 at risk

Adverse event: ER visit
Serious: no
Organ System: General disorders
Frequency: 14 affected / 64 at risk

Adverse event: Hospitalisation
Serious: no
Organ System: General disorders
Frequency: 6 affected / 64 at risk

Adverse event: Mild Suicidal ideation
Serious: no
Organ System: Psychiatric disorders
Frequency: 2 affected / 64 at risk