TrialPanorama/TrialPanorama-database huggingface dataset:
Study: NCT03086018

Adverse event: Hospitalization due to accident
Serious: yes
Organ System: Social circumstances
Notes: Was hospitalized after an accident at home, in which the back was injured requiring surgery. Participant could not continue in trial.

No causality to IMD
Frequency: 1 affected / 30 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: General disorders
Notes: Two participants reported colds during the study. One of the two participants reported it twice (on two separate Occasions).

No causality to IMD
Frequency: 2 affected / 30 at risk

Adverse event: Tore Meniscus
Serious: no
Organ System: General disorders
Notes: Participant tore left meniscus when the foot was twisted while walking. No causality to IMD
Frequency: 1 affected / 30 at risk

Adverse event: Scratch on ear canal
Serious: no
Organ System: General disorders
Notes: Participant reported discomfort in ear. Upon inspection, a small scratch was found on the ear canal.
Frequency: 1 affected / 30 at risk

Adverse event: Dome in Ear
Serious: no
Organ System: Product Issues
Notes: Dome fell off in the ear canal.
Frequency: 1 affected / 30 at risk

Adverse event: Headache
Serious: no
Organ System: General disorders
Notes: Participant reported getting a headache after being in too much noise
Frequency: 1 affected / 30 at risk

Adverse event: Irritation in ear
Serious: no
Organ System: General disorders
Notes: Participant reported irritation and pain in ear after wearing the domes for a few days. Removed device till problem resolved.
Frequency: 1 affected / 30 at risk

Adverse event: Sore Concha
Serious: no
Organ System: Product Issues
Notes: Sore spot in concha, which resolved overnight after removing the device for the evening.
Frequency: 1 affected / 30 at risk

Adverse event: Back pain
Serious: no
Organ System: General disorders
Notes: Trouble with lower back pain. No causality to IMD
Frequency: 1 affected / 30 at risk

Adverse event: Pressure point
Serious: no
Organ System: General disorders
Notes: Pressure point in ear when device not in ear correctly. Problem resolved after removal of device.
Frequency: 1 affected / 30 at risk

Adverse event: Tore Groin muscle
Serious: no
Organ System: General disorders
Notes: Tore groin muscle on the right side after picking up grandchild. No causality to IMD
Frequency: 1 affected / 30 at risk

Adverse event: Leg problem
Serious: no
Organ System: General disorders
Notes: Leg problems caused by spinal cord compression. No causality to IMD
Frequency: 1 affected / 30 at risk

Adverse event: Face Swelling
Serious: no
Organ System: General disorders
Notes: Face swelling caused by allergic reaction to eye drops. No causality to IMD
Frequency: 1 affected / 30 at risk
Study: NCT03086057

Adverse event: Potential Disclosure
Serious: no
Organ System: Social circumstances
Frequency: 1 affected / 17 at risk

Adverse event: Homicidal ideation
Serious: no
Organ System: Social circumstances
Frequency: 1 affected / 17 at risk

Adverse event: Police involvement
Serious: no
Organ System: Social circumstances
Notes: Using study phone to call police (but then hang up)
Frequency: 1 affected / 17 at risk
Study: NCT03086135

Adverse event: Wound infection
Serious: yes
Organ System: Infections and infestations
Notes: Infection at implant site starting shortly after surgery, lead to explantation.
Frequency: 1 affected / 51 at risk

Adverse event: Infection and infestations
Serious: yes
Organ System: Infections and infestations
Notes: One subject was hospitalized three days due to an influenza infection.
Frequency: 1 affected / 51 at risk

Adverse event: Atrial fibrilation
Serious: yes
Organ System: Cardiac disorders
Notes: 0ne subject was treated for persistent atrial fibrillation.
Frequency: 1 affected / 51 at risk

Adverse event: Hypoacusis
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 18 affected / 51 at risk

Adverse event: General disorders and administration site conditions other
Serious: no
Organ System: General disorders
Frequency: 14 affected / 51 at risk

Adverse event: Otitis externa
Serious: no
Organ System: Infections and infestations
Frequency: 4 affected / 51 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 3 affected / 51 at risk

Adverse event: Nervous system disorders other
Serious: no
Organ System: Nervous system disorders
Frequency: 3 affected / 51 at risk
Study: NCT03086213

Adverse event: bleeding related to the puncture in the pleural cavity
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 24 at risk

Adverse event: bleeding related to the puncture in the pleural cavity
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 24 at risk
Study: NCT03086356

Adverse event: Haematoma
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 12 at risk

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

Adverse event: Albumin urine present
Serious: no
Organ System: Investigations
Frequency: 12 affected / 12 at risk

Adverse event: Alpha 1 microglobulin increased
Serious: no
Organ System: Investigations
Frequency: 12 affected / 12 at risk

Adverse event: Protein urine present
Serious: no
Organ System: Investigations
Frequency: 11 affected / 12 at risk

Adverse event: Activated partial thromboplastin time prolonged
Serious: no
Organ System: Investigations
Frequency: 10 affected / 12 at risk

Adverse event: Urine electrophoresis abnormal
Serious: no
Organ System: Investigations
Frequency: 10 affected / 12 at risk

Adverse event: Prothrombin level decreased
Serious: no
Organ System: Investigations
Frequency: 4 affected / 12 at risk

Adverse event: Blood triglycerides increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 12 at risk
Study: NCT03086460

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 43 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 36 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 40 at risk

Adverse event: Hypertension
Serious: no
Organ System: Vascular disorders
Frequency: 2 affected / 40 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 44 at risk

Adverse event: Hypertension
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 41 at risk
Study: NCT03086707

Adverse event: Blood glucose decreased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 7 at risk
Study: NCT03086967

Adverse event: incorrect foley placement
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Notes: foley bulb was not placed in the cervix
Frequency: 1 affected / 99 at risk
Study: NCT03087773

Adverse event: Any hospitalisation
Serious: yes
Organ System: Cardiac disorders
Notes: Empagliflozin 35 events / Placebo 34 events
Frequency: 31 affected / 237 at risk

Adverse event: Hospitalisation due to heart failure
Serious: yes
Organ System: Cardiac disorders
Notes: Empagliflozin 6 events / Placebo 4 events
Frequency: 3 affected / 237 at risk

Adverse event: Hospitalisation due to cardiovascular event
Serious: yes
Organ System: Cardiac disorders
Notes: Empagliflozin 2 events / Placebo 5 events
Frequency: 2 affected / 237 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Infections and infestations
Notes: Empagliflozin 18 events / Plazebo 8 events
Frequency: 11 affected / 237 at risk

Adverse event: Genital fungal infection
Serious: no
Organ System: Infections and infestations
Notes: Empagliflozin 7 events / Placebo 2 events
Frequency: 7 affected / 237 at risk

Adverse event: Any hospitalisation
Serious: yes
Organ System: Cardiac disorders
Notes: Empagliflozin 35 events / Placebo 34 events
Frequency: 32 affected / 239 at risk

Adverse event: Hospitalisation due to heart failure
Serious: yes
Organ System: Cardiac disorders
Notes: Empagliflozin 6 events / Placebo 4 events
Frequency: 4 affected / 239 at risk

Adverse event: Hospitalisation due to cardiovascular event
Serious: yes
Organ System: Cardiac disorders
Notes: Empagliflozin 2 events / Placebo 5 events
Frequency: 5 affected / 239 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Infections and infestations
Notes: Empagliflozin 18 events / Plazebo 8 events
Frequency: 7 affected / 239 at risk

Adverse event: Genital fungal infection
Serious: no
Organ System: Infections and infestations
Notes: Empagliflozin 7 events / Placebo 2 events
Frequency: 2 affected / 239 at risk
Study: NCT03087786

Adverse event: Hiccups
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 8 affected / 49 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 49 at risk

Adverse event: Dispepsia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 49 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 49 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 49 at risk

Adverse event: Diarrhorea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 49 at risk

Adverse event: Pharyngitis streptococcal
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 49 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 49 at risk

Adverse event: Myalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 49 at risk

Adverse event: Presyncope
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 49 at risk

Adverse event: Anxiety
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 49 at risk

Adverse event: Throat irritation
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 49 at risk

Adverse event: Hiccups
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 50 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 50 at risk

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

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 50 at risk

Adverse event: Diarrhorea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 50 at risk

Adverse event: Myalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 50 at risk

Adverse event: Application site warmth
Serious: no
Organ System: General disorders
Frequency: 1 affected / 50 at risk

Adverse event: Vessel puncture site bruise
Serious: no
Organ System: General disorders
Frequency: 1 affected / 50 at risk

Adverse event: Insomnia
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 50 at risk
Study: NCT03087851

Adverse event: Flu-like symptoms after ZOL treatment
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 13 affected / 20 at risk

Adverse event: Infection (unspecified) + Musculoskeletal symptoms
Serious: no
Organ System: Infections and infestations
Frequency: 13 affected / 20 at risk

Adverse event: Fracture
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 20 at risk

Adverse event: Neoplasm malignant
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 20 at risk

Adverse event: Flu-like symptoms after ZOL treatment
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 8 affected / 20 at risk

Adverse event: Infection (unspecified) + Musculoskeletal symptoms
Serious: no
Organ System: Infections and infestations
Frequency: 18 affected / 20 at risk

Adverse event: Fracture
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 20 at risk

Adverse event: Neoplasm malignant
Serious: yes
Organ System: Investigations
Frequency: 4 affected / 21 at risk

Adverse event: Flu-like symptoms after ZOL treatment
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 16 affected / 21 at risk

Adverse event: Infection (unspecified) + Musculoskeletal symptoms
Serious: no
Organ System: Infections and infestations
Frequency: 15 affected / 21 at risk

Adverse event: Fracture
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 21 at risk
Study: NCT03088267

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 4 affected / 18 at risk

Adverse event: Bronchitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 18 at risk

Adverse event: Respiratory tract viral infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 18 at risk

Adverse event: Abdominal pain, upper
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 18 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 18 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 3 affected / 18 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 18 at risk

Adverse event: Motion sickness
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 18 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 18 at risk

Adverse event: Affect lability
Serious: no
Organ System: Psychiatric disorders
Frequency: 2 affected / 18 at risk

Adverse event: Constricted affect
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 18 at risk

Adverse event: Visioned blurred
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 18 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 18 at risk
Study: NCT03088605

Adverse event: Visual acuity reduced
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 37 at risk

Adverse event: Vision blurred
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 37 at risk

Adverse event: Vitreous floaters
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 37 at risk

Adverse event: Eye pruritus
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 37 at risk

Adverse event: Instillation site pain
Serious: no
Organ System: General disorders
Frequency: 1 affected / 37 at risk

Adverse event: Procedural pain
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 37 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 37 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 37 at risk

Adverse event: Visual acuity reduced
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 32 at risk

Adverse event: Eye discharge
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 32 at risk

Adverse event: Instillation site pain
Serious: no
Organ System: General disorders
Frequency: 2 affected / 32 at risk

Adverse event: Instillation site discomfort
Serious: no
Organ System: General disorders
Frequency: 1 affected / 32 at risk
Study: NCT03088930

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

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 3 at risk

Adverse event: Insomnia
Serious: no
Organ System: General disorders
Frequency: 1 affected / 3 at risk

Adverse event: Influenza
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 3 at risk

Adverse event: Blood creatinine increased
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 3 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 3 at risk

Adverse event: Vision blurred
Serious: no
Organ System: Eye disorders
Frequency: 2 affected / 3 at risk

Adverse event: Headache
Serious: no
Organ System: General disorders
Frequency: 1 affected / 3 at risk

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

Adverse event: Bradycardia
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 3 at risk

Adverse event: Alanine aminotransferase increased
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 3 at risk

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

Adverse event: Dermatitis
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 3 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 1 affected / 3 at risk
Study: NCT03089216

Adverse event: Tooth Sensitivity (Score of >3)
Serious: yes
Organ System: Investigations
Frequency: 22 affected / 27 at risk

Adverse event: Tooth Sensitivity (Score of <3)
Serious: no
Organ System: Investigations
Frequency: 22 affected / 27 at risk

Adverse event: Tooth Sensitivity (Score of >3)
Serious: yes
Organ System: Investigations
Frequency: 16 affected / 27 at risk

Adverse event: Tooth Sensitivity (Score of <3)
Serious: no
Organ System: Investigations
Frequency: 16 affected / 27 at risk

Adverse event: Tooth Sensitivity (Score of >3)
Serious: yes
Organ System: Investigations
Frequency: 23 affected / 27 at risk

Adverse event: Tooth Sensitivity (Score of <3)
Serious: no
Organ System: Investigations
Frequency: 23 affected / 27 at risk

Adverse event: Tooth Sensitivity (Score of >3)
Serious: yes
Organ System: Investigations
Frequency: 16 affected / 27 at risk

Adverse event: Tooth Sensitivity (Score of <3)
Serious: no
Organ System: Investigations
Frequency: 18 affected / 27 at risk
Study: NCT03089320

Adverse event: Other SAEs
Serious: yes
Organ System: General disorders
Notes: Other SAEs, organ system not reported
Frequency: 1 affected / 60 at risk

Adverse event: Respiratory SAE
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 60 at risk

Adverse event: Other AE
Serious: no
Organ System: General disorders
Notes: Other AE, organ system not recorded
Frequency: 2 affected / 60 at risk

Adverse event: Psychiatric AE
Serious: no
Organ System: Psychiatric disorders
Frequency: 2 affected / 60 at risk

Adverse event: Death
Serious: yes
Organ System: General disorders
Notes: Death, unrelated to study
Frequency: 2 affected / 60 at risk

Adverse event: Other SAEs
Serious: yes
Organ System: General disorders
Notes: Other SAEs, organ system not reported
Frequency: 5 affected / 60 at risk

Adverse event: Other AE
Serious: no
Organ System: General disorders
Notes: Other AE, organ system not recorded
Frequency: 2 affected / 60 at risk

Adverse event: Respiratory AE
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Respiratory adverse event
Frequency: 1 affected / 60 at risk
Study: NCT03089580

Adverse event: Conjunctival haemorrhage
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 14 at risk
Study: NCT03089879

Adverse event: Chills
Serious: no
Organ System: General disorders
Frequency: 1 affected / 7 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 3 affected / 7 at risk

Adverse event: Injection site erythema
Serious: no
Organ System: General disorders
Frequency: 2 affected / 7 at risk

Adverse event: Injection site induration
Serious: no
Organ System: General disorders
Frequency: 2 affected / 7 at risk

Adverse event: Injection site pain
Serious: no
Organ System: General disorders
Frequency: 6 affected / 7 at risk

Adverse event: Malaise
Serious: no
Organ System: General disorders
Frequency: 1 affected / 7 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 7 at risk

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

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

Adverse event: Myalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 7 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 7 at risk

Adverse event: Dysmenorrhoea
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 7 at risk

Adverse event: Chills
Serious: no
Organ System: General disorders
Frequency: 1 affected / 28 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 11 affected / 28 at risk

Adverse event: Injection site erythema
Serious: no
Organ System: General disorders
Frequency: 8 affected / 28 at risk

Adverse event: Injection site induration
Serious: no
Organ System: General disorders
Frequency: 10 affected / 28 at risk

Adverse event: Injection site pain
Serious: no
Organ System: General disorders
Frequency: 24 affected / 28 at risk

Adverse event: Malaise
Serious: no
Organ System: General disorders
Frequency: 2 affected / 28 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 3 affected / 28 at risk

Adverse event: Myalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 8 affected / 28 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 6 affected / 28 at risk

Adverse event: Dysmenorrhoea
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 28 at risk
Study: NCT03089944

Adverse event: Atrial fibrillation
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 343 at risk

Adverse event: Cardiac failure
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 343 at risk

Adverse event: Duodenal ulcer haemorrhage
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 343 at risk

Adverse event: Oedema peripheral
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 343 at risk

Adverse event: Bronchitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 343 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 343 at risk

Adverse event: Pyelonephritis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 343 at risk

Adverse event: Adenocarcinoma gastric
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 343 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 19 affected / 343 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 30 affected / 343 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 28 affected / 343 at risk

Adverse event: Pruritus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 29 affected / 343 at risk