TrialPanorama/TrialPanorama-database huggingface dataset:
Study: NCT02366637

Adverse event: Palpitations
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 8 at risk

Adverse event: Bronchitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 8 at risk

Adverse event: Contusion
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 8 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 8 at risk

Adverse event: Haematoma
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 8 at risk

Adverse event: Dyspepsia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 7 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 7 at risk

Adverse event: Arthropod bite
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 7 at risk

Adverse event: Contusion
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 7 at risk

Adverse event: Haemarthrosis
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 7 at risk

Adverse event: Vulvovaginal pruritus
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 3 at risk

Adverse event: Chronic obstructive pulmonary disease
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 7 at risk
Study: NCT02366767

Adverse event: hypoglcyemic seizure
Serious: yes
Organ System: Endocrine disorders
Notes: Had seizure after taking dinner insulin and food was delayed
Frequency: 1 affected / 10 at risk
Study: NCT02366936

Adverse event: non-blanchable pressure ulcer
Serious: no
Organ System: Investigations
Frequency: 1 affected / 32 at risk
Study: NCT02367066

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

Adverse event: Vessel puncture site haemorrhage
Serious: no
Organ System: General disorders
Frequency: 2 affected / 20 at risk

Adverse event: Insomnia
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 20 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 20 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 20 at risk

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

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

Adverse event: Frequent bowel movements
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 20 at risk

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

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

Adverse event: Vessel puncture site haemorrhage
Serious: no
Organ System: General disorders
Frequency: 2 affected / 20 at risk

Adverse event: Swelling
Serious: no
Organ System: General disorders
Frequency: 1 affected / 20 at risk

Adverse event: Vessel puncture site reaction
Serious: no
Organ System: General disorders
Frequency: 1 affected / 20 at risk

Adverse event: Insomnia
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 20 at risk

Adverse event: Dermatitis contact
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 20 at risk
Study: NCT02367105

Adverse event: Cardiac failure congestive
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 41 at risk

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

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

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

Adverse event: Acute kidney injury
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 41 at risk

Adverse event: hypoglycemia, asymptomatic and symptomatic
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 4 affected / 41 at risk

Adverse event: Elevated PSA
Serious: no
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 4 affected / 41 at risk

Adverse event: Dizziness/orthostasis
Serious: no
Organ System: Vascular disorders
Frequency: 4 affected / 41 at risk

Adverse event: Cardiac failure congestive
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 42 at risk

Adverse event: Pulmonary embolism
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 42 at risk

Adverse event: Duodenitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 42 at risk

Adverse event: Cellulitis
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 42 at risk

Adverse event: Ankle fracture
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 42 at risk

Adverse event: Immune thrombocytopenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 42 at risk

Adverse event: Hyperglycaemic hyperosmolar nonketotic syndrome
Serious: yes
Organ System: Endocrine disorders
Frequency: 1 affected / 42 at risk

Adverse event: Intestinal obstruction
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 42 at risk

Adverse event: hypoglycemia, asymptomatic and symptomatic
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 4 affected / 42 at risk

Adverse event: Elevated PSA
Serious: no
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 42 at risk

Adverse event: Dizziness/orthostasis
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 42 at risk
Study: NCT02367131

Adverse event: Atrial flutter
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 414 at risk

Adverse event: Stress cardiomyopathy
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 414 at risk

Adverse event: Age-related macular degeneration
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 414 at risk

Adverse event: Hepatic cirrhosis
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 414 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 414 at risk

Adverse event: Blood glucose increased
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 414 at risk
Study: NCT02367170

Adverse event: Transitory hypotension
Serious: no
Organ System: Cardiac disorders
Notes: Procedure interrupted to correct hypotension. Subject stabilized and procedure restarted and completed successfully
Frequency: 1 affected / 1 at risk
Study: NCT02367521

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 5 affected / 17 at risk

Adverse event: Depression
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 17 at risk

Adverse event: Anxiety
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 17 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 17 at risk

Adverse event: Vision blurred
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 17 at risk

Adverse event: Fatigue
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 17 at risk

Adverse event: Discomfort
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 17 at risk

Adverse event: Puff Face
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 17 at risk

Adverse event: Eye Twitching
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 17 at risk

Adverse event: Sleep disorder
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 17 at risk

Adverse event: Other
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 17 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 5 affected / 17 at risk

Adverse event: Depression
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 17 at risk

Adverse event: Anxiety
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 17 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 17 at risk

Adverse event: Discomfort
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 17 at risk

Adverse event: Face Twitching
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 17 at risk

Adverse event: Sleep disorder
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 17 at risk

Adverse event: Other
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 17 at risk
Study: NCT02367716

Adverse event: Lead dislodgement
Serious: yes
Organ System: Product Issues
Notes: Two events were lead dislodgments and are adjudicated as related to the Quartet™ 1458Q LV lead, other event are adjudicated as related to Right Ventricular (RV) Lead
Frequency: 3 affected / 120 at risk

Adverse event: Hematoma/Seroma
Serious: yes
Organ System: Product Issues
Notes: subject was diagnosed with pocket hematoma/seroma. This was treated by draining approximately 20ml of clear fluid from the pocket and the administration of prophylactic antibiotics.This event was related to PG
Frequency: 1 affected / 120 at risk

Adverse event: Inappropriate Shocks
Serious: yes
Organ System: Product Issues
Notes: inappropriate shock is the most frequently reported SADE, occurring in 3.3% (4/120) of enrolled subjects and none were due to the Quartet™ 1458Q LV lead. 4 events were related to Pulse Generator (PG). 1event was related to RV lead.
Frequency: 4 affected / 120 at risk

Adverse event: Infection
Serious: yes
Organ System: Infections and infestations
Notes: three events were assessed as a pocket infection,2 events were related to PG ,1event was related to system
Frequency: 3 affected / 120 at risk

Adverse event: Pneumothorax/Hemothorax
Serious: yes
Organ System: Injury, poisoning and procedural complications
Notes: chest x-ray showed that a pneumothorax had developed on the left side. The subject was successfully treated with closed thoracic drainage then discharged. This event was related to procedure
Frequency: 1 affected / 120 at risk

Adverse event: Rise in Threshold and Exit Block
Serious: yes
Organ System: Product Issues
Notes: This event was related to RV Lead
Frequency: 1 affected / 120 at risk

Adverse event: Infection
Serious: no
Organ System: Infections and infestations
Notes: One subject developed a pocket infection three days post-implant and was successfully treated with antibiotics. This event was related to PG
Frequency: 1 affected / 120 at risk

Adverse event: Pneumothorax/Hemothorax
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: subject complained of breathing-related chest pain in the post-operative setting. A chest x-ray revealed left-sided pleural effusion, which was successfully treated by non-invasive means. This event was related to procedure
Frequency: 1 affected / 120 at risk
Study: NCT02367729

Adverse event: Ear discomfort
Serious: no
Organ System: General disorders
Frequency: 3 affected / 57 at risk

Adverse event: Adhesive allergy
Serious: no
Organ System: Immune system disorders
Notes: localized skin irritation
Frequency: 1 affected / 57 at risk

Adverse event: Ear discomfort
Serious: no
Organ System: General disorders
Frequency: 3 affected / 47 at risk

Adverse event: Adhesive allergy
Serious: no
Organ System: Immune system disorders
Notes: localized skin irritation
Frequency: 2 affected / 47 at risk

Adverse event: Syncope
Serious: no
Organ System: Nervous system disorders
Notes: triggered by needle phobia
Frequency: 1 affected / 47 at risk
Study: NCT02367859

Adverse event: Influenza like illness
Serious: no
Organ System: General disorders
Frequency: 1 affected / 1 at risk

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

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

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

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

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

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

Adverse event: Dermatologic syndrome
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 1 at risk
Study: NCT02367872

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 6 at risk

Adverse event: Alanine aminotransferase increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 6 at risk

Adverse event: Pharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 6 at risk

Adverse event: Blood loss anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 6 at risk

Adverse event: Gastroduodenal ulcer
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 6 at risk

Adverse event: Contusion
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 6 at risk

Adverse event: Fall
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 6 at risk

Adverse event: Blood pressure decreased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 6 at risk

Adverse event: Blood pressure decreased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 6 at risk

Adverse event: Orthostatic hypotension
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 6 at risk

Adverse event: Orthostatic hypotension
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 6 at risk

Adverse event: Alanine aminotransferase increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 6 at risk

Adverse event: Dumping syndrome
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 6 at risk

Adverse event: Toothache
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 6 at risk

Adverse event: Blood pressure decreased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 6 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 6 at risk
Study: NCT02367911

Adverse event: Sinusitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 71 at risk

Adverse event: Trichorrhexis
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 71 at risk

Adverse event: Application site dryness
Serious: no
Organ System: General disorders
Frequency: 1 affected / 73 at risk

Adverse event: Application site pain
Serious: no
Organ System: General disorders
Frequency: 1 affected / 73 at risk

Adverse event: Gastroenteritis viral
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 73 at risk
Study: NCT02368002

Adverse event: Depressive disorders
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 235 at risk

Adverse event: Hypertension
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 235 at risk

Adverse event: Dehydration & Hypertension
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 235 at risk

Adverse event: Ovarian cancer
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 132 at risk

Adverse event: Kidney infection
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 127 at risk

Adverse event: Ovarian cancer
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 127 at risk
Study: NCT02368132

Adverse event: Hospitalization due to surgery
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 112 at risk

Adverse event: Hospitalization - Illness
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 112 at risk

Adverse event: Hospitalization due to surgery
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 122 at risk

Adverse event: Hospitalization - Illness
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 122 at risk

Adverse event: Hospitalization/ER
Serious: yes
Organ System: General disorders
Frequency: 3 affected / 122 at risk

Adverse event: Surgery
Serious: yes
Organ System: General disorders
Notes: outpatient
Frequency: 1 affected / 122 at risk

Adverse event: Hospitalization due to surgery
Serious: yes
Organ System: General disorders
Frequency: 3 affected / 85 at risk

Adverse event: Hospitalization - Illness
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 85 at risk

Adverse event: Surgery
Serious: yes
Organ System: General disorders
Notes: outpatient
Frequency: 2 affected / 85 at risk
Study: NCT02368210

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 75 at risk

Adverse event: Application site pain
Serious: no
Organ System: General disorders
Frequency: 1 affected / 75 at risk

Adverse event: Hordeolum
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 75 at risk

Adverse event: Influenza
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 75 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 75 at risk

Adverse event: Skin laceration
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 75 at risk

Adverse event: Muscle strain
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 75 at risk

Adverse event: Application site pruritus
Serious: no
Organ System: General disorders
Frequency: 1 affected / 76 at risk

Adverse event: Cellulitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 76 at risk

Adverse event: Psoriasis
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 76 at risk
Study: NCT02368314

Adverse event: Sepsis
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 64 at risk

Adverse event: Infection of surgery wound surface
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 64 at risk

Adverse event: Hypertension
Serious: no
Organ System: Vascular disorders
Frequency: 11 affected / 64 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 40 affected / 64 at risk

Adverse event: Elevated gamma glutamyl tranferase
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 7 affected / 64 at risk

Adverse event: Hyperglycaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 6 affected / 64 at risk

Adverse event: Elevated D-dimer
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 23 affected / 64 at risk

Adverse event: Increase of activated partial thromboplastin time
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 5 affected / 64 at risk

Adverse event: Infection of surgery wound surface
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 59 at risk

Adverse event: Surgery wound dehiscence
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 59 at risk

Adverse event: Large trochanter fracture
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 59 at risk

Adverse event: Hemorrhagic discharge from surgical wound
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 59 at risk

Adverse event: Oedema of lower limbs
Serious: no
Organ System: Vascular disorders
Frequency: 3 affected / 59 at risk

Adverse event: Hypertension
Serious: no
Organ System: Vascular disorders
Frequency: 17 affected / 59 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 35 affected / 59 at risk

Adverse event: Elevated gamma glutamyl tranferase
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 59 at risk

Adverse event: Hyperglycaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 3 affected / 59 at risk

Adverse event: Elevated D-dimer
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 39 affected / 59 at risk

Adverse event: Increase of activated partial thromboplastin time
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 59 at risk
Study: NCT02368431

Adverse event: Suicidal ideation
Serious: yes
Organ System: Psychiatric disorders
Notes: Hospitalized for detox and suicidal ideation
Frequency: 3 affected / 46 at risk

Adverse event: Homicidal ideation
Serious: yes
Organ System: Psychiatric disorders
Notes: hospitalized
Frequency: 1 affected / 46 at risk

Adverse event: Alcohol detoxification
Serious: no
Organ System: Psychiatric disorders
Frequency: 2 affected / 46 at risk

Adverse event: Alcohol detoxification
Serious: no
Organ System: Psychiatric disorders
Frequency: 6 affected / 46 at risk
Study: NCT02368691

Adverse event: Cardiac failure congestive
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 32 at risk

Adverse event: Pleural effusion
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 32 at risk

Adverse event: Pulmonary embolism
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 32 at risk

Adverse event: Tumour flare
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 32 at risk

Adverse event: Urinary tract infection
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 32 at risk

Adverse event: Dehydration
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 32 at risk

Adverse event: Constipation
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 32 at risk

Adverse event: Rib fracture
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 32 at risk

Adverse event: investigations
Serious: no
Organ System: Investigations
Frequency: 13 affected / 32 at risk

Adverse event: GI
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 8 affected / 32 at risk

Adverse event: metabolism
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 8 affected / 32 at risk

Adverse event: Blood disorder
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 4 affected / 32 at risk

Adverse event: nervous system
Serious: no
Organ System: Nervous system disorders
Frequency: 3 affected / 32 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 3 affected / 32 at risk