TrialPanorama/TrialPanorama-database huggingface dataset:
Study: NCT01337973

Adverse event: Participant Death
Serious: yes
Organ System: Social circumstances
Notes: There were 4 serious adverse events involving participant deaths. These were immediately reported to our IRB, and none of the events was considered to be study related.
Frequency: 1 affected / 60 at risk

Adverse event: Participant Death
Serious: yes
Organ System: Social circumstances
Notes: There were 4 serious adverse events involving participant deaths. These were immediately reported to our IRB, and none of the events was considered to be study related.
Frequency: 2 affected / 60 at risk

Adverse event: Participant Death
Serious: yes
Organ System: Social circumstances
Notes: There were 4 serious adverse events involving participant deaths. These were immediately reported to our IRB, and none of the events was considered to be study related.
Frequency: 1 affected / 60 at risk
Study: NCT01337986

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 4 affected / 46 at risk
Study: NCT01338493

Adverse event: Abdominal wall related
Serious: yes
Organ System: General disorders
Frequency: 9 affected / 134 at risk

Adverse event: Neurologic - Access-related
Serious: yes
Organ System: Nervous system disorders
Frequency: 12 affected / 134 at risk

Adverse event: Neurologic - Late radiculopathy (not access-related)
Serious: yes
Organ System: Nervous system disorders
Frequency: 12 affected / 134 at risk

Adverse event: Vascular
Serious: yes
Organ System: Vascular disorders
Frequency: 3 affected / 134 at risk

Adverse event: Visceral - Bowel or Peritoneum
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 134 at risk

Adverse event: Visceral - Genito-Urinary tract
Serious: yes
Organ System: General disorders
Frequency: 5 affected / 134 at risk

Adverse event: Subsidence / Impaction
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 134 at risk

Adverse event: Early non-specific low BP
Serious: yes
Organ System: General disorders
Frequency: 5 affected / 134 at risk

Adverse event: Late non-specific low BP
Serious: yes
Organ System: General disorders
Frequency: 6 affected / 134 at risk

Adverse event: Foreign body reaction
Serious: yes
Organ System: Immune system disorders
Frequency: 1 affected / 134 at risk

Adverse event: Other events
Serious: yes
Organ System: General disorders
Frequency: 24 affected / 134 at risk
Study: NCT01338506

Adverse event: Hospitalisation
Serious: yes
Organ System: Psychiatric disorders
Notes: Hospitalized for suicidal ideation
Frequency: 1 affected / 54 at risk

Adverse event: Suicide attempt
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 27 at risk
Study: NCT01338636

Adverse event: Oedema peripheral
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 7 affected / 30 at risk

Adverse event: Nasal congestion
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 7 affected / 30 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 5 affected / 30 at risk

Adverse event: Flushing
Serious: no
Organ System: Vascular disorders
Frequency: 4 affected / 30 at risk

Adverse event: Increased cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 4 affected / 30 at risk

Adverse event: Joint and body pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 3 affected / 30 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 30 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 30 at risk

Adverse event: Gastrointestinal infection
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 30 at risk

Adverse event: Pain in jaw
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 30 at risk

Adverse event: Epistaxis
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 30 at risk

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

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 30 at risk

Adverse event: Worsening dyspnea on exertion
Serious: no
Organ System: Cardiac disorders
Frequency: 8 affected / 30 at risk
Study: NCT01338649

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 13 at risk

Adverse event: Somnolence
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 13 at risk

Adverse event: Eye pruritus
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 14 at risk
Study: NCT01338818

Adverse event: Pancreatitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 298 at risk

Adverse event: Exostosis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 298 at risk

Adverse event: Non-Hodgkin's lymphoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 298 at risk

Adverse event: Palpitations
Serious: no
Organ System: Cardiac disorders
Frequency: 6 affected / 298 at risk

Adverse event: Tachycardia
Serious: no
Organ System: Cardiac disorders
Frequency: 8 affected / 298 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 6 affected / 298 at risk

Adverse event: Dry mouth
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 20 affected / 298 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 15 affected / 298 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 9 affected / 298 at risk

Adverse event: Gastroenteritis
Serious: no
Organ System: Infections and infestations
Frequency: 10 affected / 298 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 57 affected / 298 at risk

Adverse event: Sinusitis
Serious: no
Organ System: Infections and infestations
Frequency: 11 affected / 298 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 14 affected / 298 at risk

Adverse event: Weight decreased
Serious: no
Organ System: Investigations
Frequency: 6 affected / 298 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 23 affected / 298 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 42 affected / 298 at risk

Adverse event: Agitation
Serious: no
Organ System: Psychiatric disorders
Frequency: 7 affected / 298 at risk

Adverse event: Anxiety
Serious: no
Organ System: Psychiatric disorders
Frequency: 11 affected / 298 at risk

Adverse event: Depressed mood
Serious: no
Organ System: Psychiatric disorders
Frequency: 6 affected / 298 at risk

Adverse event: Initial insomnia
Serious: no
Organ System: Psychiatric disorders
Frequency: 8 affected / 298 at risk

Adverse event: Insomnia
Serious: no
Organ System: Psychiatric disorders
Frequency: 11 affected / 298 at risk

Adverse event: Sleep disorder
Serious: no
Organ System: Psychiatric disorders
Frequency: 7 affected / 298 at risk

Adverse event: Dysmenorrhoea
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 6 affected / 298 at risk

Adverse event: Oropharyngeal pain
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 8 affected / 298 at risk

Adverse event: Hyperhidrosis
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 7 affected / 298 at risk
Study: NCT01339390

Adverse event: Death at 12 months
Serious: yes
Organ System: General disorders
Notes: Mortality as ascertained by VA reporting system. This is believed to be very accurate for veterans who are actively involved in care in VHA.
Frequency: 7 affected / 1571 at risk

Adverse event: Death at 24 months
Serious: yes
Organ System: General disorders
Notes: Mortality as ascertained by VA reporting system. This is believed to be very accurate for veterans who are actively involved in care in VHA.
Frequency: 25 affected / 1571 at risk

Adverse event: Death at 12 months
Serious: yes
Organ System: General disorders
Notes: Mortality as ascertained by VA reporting system. This is believed to be very accurate for veterans who are actively involved in care in VHA.
Frequency: 6 affected / 1598 at risk

Adverse event: Death at 24 months
Serious: yes
Organ System: General disorders
Notes: Mortality as ascertained by VA reporting system. This is believed to be very accurate for veterans who are actively involved in care in VHA.
Frequency: 23 affected / 1598 at risk
Study: NCT01339429

Adverse event: Pyrexia
Serious: no
Organ System: Immune system disorders
Notes: Fever in an immunocompromised patient after discontinuation of the sNPWT device. Deemed not to be serious nor unexpected by IRB.
Frequency: 1 affected / 41 at risk
Study: NCT01339832

Adverse event: Polyneuropathy
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 51 at risk

Adverse event: Palmar-plantar erythrodysaesthesia syndrome
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 51 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 51 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 51 at risk

Adverse event: Palmar-plantar erythrodysaesthesia syndrome
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 51 at risk

Adverse event: Hypersensitivity
Serious: no
Organ System: Immune system disorders
Frequency: 1 affected / 51 at risk
Study: NCT01339936

Adverse event: Hordeolum
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 36 at risk

Adverse event: Allergic response
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 36 at risk

Adverse event: Bunion surgery
Serious: no
Organ System: Surgical and medical procedures
Frequency: 1 affected / 36 at risk
Study: NCT01340053

Adverse event: Cholecystitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 46 at risk

Adverse event: Appendicitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 46 at risk
Study: NCT01340066

Adverse event: Atrial fibrillation
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 34 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 34 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 34 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 34 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 34 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 5 affected / 34 at risk

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

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 33 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 33 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 33 at risk
Study: NCT01340586

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

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 8 at risk

Adverse event: Influenza like illness
Serious: no
Organ System: General disorders
Frequency: 1 affected / 8 at risk

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

Adverse event: Procedural hypotension
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
Study: NCT01340625

Adverse event: Headache
Serious: no
Organ System: General disorders
Frequency: 9 affected / 36 at risk

Adverse event: Nausea
Serious: no
Organ System: General disorders
Frequency: 8 affected / 36 at risk

Adverse event: Pallor
Serious: no
Organ System: General disorders
Frequency: 2 affected / 36 at risk

Adverse event: Syncope
Serious: no
Organ System: General disorders
Frequency: 2 affected / 36 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: General disorders
Frequency: 2 affected / 36 at risk

Adverse event: Headache
Serious: no
Organ System: General disorders
Frequency: 9 affected / 36 at risk

Adverse event: Nausea
Serious: no
Organ System: General disorders
Frequency: 1 affected / 36 at risk
Study: NCT01340664

Adverse event: Abnormal uterine bleeding
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 93 at risk

Adverse event: Oroantral fistula
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 93 at risk

Adverse event: Pyelonephritis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 93 at risk

Adverse event: Postoperative wound complication
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 93 at risk

Adverse event: Colon cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 93 at risk

Adverse event: Nephrolithiasis
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 93 at risk
Study: NCT01340768

Adverse event: Road traffic accident
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 421 at risk

Adverse event: Hypoglycaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: Hypoglycemia includes both symptomatic hypoglycemia and asymptomatic hypoglycemia.
Frequency: 16 affected / 421 at risk

Adverse event: Hypoglycaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: Hypoglycemia includes both symptomatic hypoglycemia and asymptomatic hypoglycemia.
Frequency: 33 affected / 427 at risk
Study: NCT01341067

Adverse event: Insertion site irritation
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Includes mild irritation at the site of insertion that has been deemed to be device related by the Primary Investigator.
Frequency: 3 affected / 30 at risk
Study: NCT01341405

Adverse event: Abdominal pain upper
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 40 at risk

Adverse event: Dyspepsia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 40 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 40 at risk

Adverse event: Face oedema
Serious: no
Organ System: General disorders
Frequency: 1 affected / 40 at risk

Adverse event: Oropharyngeal pain
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 40 at risk

Adverse event: Abdominal pain upper
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 6 affected / 42 at risk

Adverse event: Dyspepsia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 9 affected / 42 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 42 at risk

Adverse event: Chest discomfort
Serious: no
Organ System: General disorders
Frequency: 3 affected / 42 at risk

Adverse event: Face oedema
Serious: no
Organ System: General disorders
Frequency: 3 affected / 42 at risk

Adverse event: Abdominal pain upper
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 43 at risk

Adverse event: Dyspepsia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 43 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 43 at risk

Adverse event: Oropharyngeal pain
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 43 at risk
Study: NCT01341600

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

Adverse event: Rash maculo-papular
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: poison ivy
Frequency: 1 affected / 6 at risk

Adverse event: Skin infection
Serious: no
Organ System: Infections and infestations
Notes: Fifths disease
Frequency: 1 affected / 6 at risk
Study: NCT01341977

Adverse event: Gastrointestinal haemorrhage
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Unrelated to Test Article
Frequency: 1 affected / 285 at risk
Study: NCT01342029

Adverse event: Acute myocardial infarction
Serious: yes
Organ System: Cardiac disorders
Notes: Hospitalization
Frequency: 1 affected / 142 at risk

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

Adverse event: Chest pain, dizziness, and pre-syncope
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 142 at risk

Adverse event: Syncope
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 142 at risk

Adverse event: Chest pain
Serious: yes
Organ System: Cardiac disorders
Notes: washout
Frequency: 1 affected / 142 at risk

Adverse event: Nausea and dizziness
Serious: no
Organ System: General disorders
Frequency: 3 affected / 142 at risk

Adverse event: Arm shaking
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 142 at risk

Adverse event: Back pain
Serious: no
Organ System: General disorders
Frequency: 1 affected / 142 at risk

Adverse event: Renal change
Serious: no
Organ System: Endocrine disorders
Frequency: 1 affected / 142 at risk

Adverse event: Throat pain, swelling and tightness
Serious: no
Organ System: General disorders
Frequency: 1 affected / 142 at risk

Adverse event: Excessive Sweating
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 142 at risk

Adverse event: Bradycardia
Serious: yes
Organ System: Cardiac disorders
Notes: Placebo washout
Frequency: 1 affected / 142 at risk

Adverse event: Throat pain, swelling and tightness
Serious: no
Organ System: General disorders
Frequency: 1 affected / 142 at risk

Adverse event: Rectocele
Serious: no
Organ System: Endocrine disorders
Frequency: 1 affected / 142 at risk

Adverse event: Cough
Serious: no
Organ System: General disorders
Frequency: 1 affected / 142 at risk

Adverse event: Sinusitis
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 142 at risk

Adverse event: Chest pain
Serious: no
Organ System: Cardiac disorders
Frequency: 4 affected / 142 at risk

Adverse event: Haematemesis
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 142 at risk

Adverse event: Palpitations and Afib
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 142 at risk
Study: NCT01342094

Adverse event: Ocular hyperaemia
Serious: no
Organ System: Eye disorders
Frequency: 6 affected / 82 at risk

Adverse event: Conjunctival hyperaemia
Serious: no
Organ System: Eye disorders
Frequency: 5 affected / 82 at risk

Adverse event: Ocular hyperaemia
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 84 at risk

Adverse event: Conjunctival hyperaemia
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 84 at risk
Study: NCT01342367

Adverse event: GI Toxicity
Serious: yes
Organ System: Gastrointestinal disorders
Notes: GI bleeding and ulceration
Frequency: 2 affected / 30 at risk

Adverse event: GI Toxicity
Serious: no
Organ System: Gastrointestinal disorders
Notes: Diarrhea, Abdominal pain
Frequency: 10 affected / 30 at risk

Adverse event: GU toxicity
Serious: no
Organ System: Renal and urinary disorders
Notes: Frequency, incontinence, urgency
Frequency: 14 affected / 30 at risk

Adverse event: GI Toxicity
Serious: yes
Organ System: Gastrointestinal disorders
Notes: GI bleeding and ulceration
Frequency: 2 affected / 40 at risk

Adverse event: GI Toxicity
Serious: no
Organ System: Gastrointestinal disorders
Notes: Diarrhea, Abdominal pain
Frequency: 12 affected / 40 at risk

Adverse event: GU toxicity
Serious: no
Organ System: Renal and urinary disorders
Notes: Frequency, incontinence, urgency
Frequency: 18 affected / 40 at risk
Study: NCT01342445

Adverse event: Possible Heart Palpitations
Serious: no
Organ System: Cardiac disorders
Notes: This was the adverse event for both participants. This occurred during week 1 of the medication trial in which both participants were taking an active dosage of 30mg.
Frequency: 2 affected / 24 at risk
Study: NCT01342458

Adverse event: Keratosis on metatarsal head
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Keratosis on the head of the fifth metatarsal in left foot .
Frequency: 1 affected / 28 at risk
Study: NCT01342510

Adverse event: Pain with injection of propofol
Serious: no
Organ System: General disorders
Frequency: 11 affected / 50 at risk

Adverse event: Pain with injection of propofol
Serious: no
Organ System: General disorders
Frequency: 25 affected / 50 at risk

Adverse event: Pain with injection of propofol
Serious: no
Organ System: General disorders
Frequency: 15 affected / 50 at risk

Adverse event: Pain with injection of propofol
Serious: no
Organ System: General disorders
Frequency: 18 affected / 50 at risk
Study: NCT01342549

Adverse event: Somnolence
Serious: no
Organ System: Nervous system disorders
Frequency: 12 affected / 31 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 31 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 10 affected / 31 at risk

Adverse event: Hyperhidrosis
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 5 affected / 31 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 31 at risk

Adverse event: Somnolence
Serious: no
Organ System: Nervous system disorders
Frequency: 10 affected / 31 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 9 affected / 31 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 9 affected / 31 at risk

Adverse event: Hyperhidrosis
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 10 affected / 31 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 31 at risk