TrialPanorama/TrialPanorama-database huggingface dataset:
Study: NCT03016403

Adverse event: Death
Serious: yes
Organ System: General disorders
Notes: Head-and-neck/lung cancer or complications related to the diagnoses
Frequency: 13 affected / 139 at risk

Adverse event: Death
Serious: yes
Organ System: General disorders
Notes: Head-and-neck/lung cancer or complications related to the diagnoses
Frequency: 18 affected / 147 at risk

Adverse event: Respiratory failure with hypoxia
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 147 at risk

Adverse event: Death
Serious: yes
Organ System: General disorders
Notes: Head-and-neck/lung cancer or complications related to the diagnoses
Frequency: 1 affected / 118 at risk
Study: NCT03016598

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Notes: Participant (Subject Identifier (ID)# 730) was admitted to the San Francisco Veteran Affairs (SFVA) ER for constipation on 3/30/2019 and 4/10/2019. He was discharged on the same day for both events.
Frequency: 1 affected / 18 at risk

Adverse event: Stinging sensation
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Participant (Subject ID# 730) reported a stinging sensation and was examined by study physician, who did not observe irritation. Participant said sensation subsided, and remarked. 'It must've been a zit'.
Frequency: 1 affected / 18 at risk

Adverse event: Hallucination
Serious: no
Organ System: Psychiatric disorders
Notes: Participant (Subject ID# 731) reported dream-like hallucination that subsided after 2 seconds. Participant reported methamphetamine use prior to hallucination, and the event did not result in participant injury.
Frequency: 1 affected / 22 at risk
Study: NCT03016754

Adverse event: Skin irritation
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Skin irritation with LifeVest
Frequency: 7 affected / 279 at risk

Adverse event: Discomfort
Serious: no
Organ System: Product Issues
Notes: Discomfort or pain from WCD
Frequency: 1 affected / 279 at risk

Adverse event: Asystole with Inappropriate shock
Serious: yes
Organ System: Cardiac disorders
Notes: Inappropriate shock during asystole, occurring with hospitalization or death. Anticipated ADE.
Frequency: 1 affected / 214 at risk

Adverse event: Skin irritation
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Skin irritation with LifeVest
Frequency: 12 affected / 214 at risk

Adverse event: Discomfort
Serious: no
Organ System: Product Issues
Notes: Discomfort or pain from WCD
Frequency: 1 affected / 214 at risk

Adverse event: Inappropriate shock
Serious: no
Organ System: Product Issues
Notes: Inappropriate shock. Anticipated ADE
Frequency: 1 affected / 214 at risk

Adverse event: Frustration tolerance decreased
Serious: no
Organ System: Product Issues
Notes: Frustration with alarms. Anticipated ADE
Frequency: 1 affected / 214 at risk

Adverse event: Skin irritation
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Skin irritation with LifeVest
Frequency: 2 affected / 90 at risk

Adverse event: Inappropriate shock
Serious: no
Organ System: Product Issues
Notes: Inappropriate shock. Anticipated ADE
Frequency: 1 affected / 90 at risk
Study: NCT03017508

Adverse event: Temporary perioral numbing
Serious: no
Organ System: General disorders
Frequency: 13 affected / 22 at risk
Study: NCT03017612

Adverse event: Hospitalization due to triple arthrodesis surgery (secondary to muscular dystrophy)
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 13 at risk

Adverse event: Increase in intraocular pressure > 10mmHg above baseline
Serious: no
Organ System: Eye disorders
Frequency: 2 affected / 13 at risk

Adverse event: Inlay explant
Serious: no
Organ System: Eye disorders
Frequency: 2 affected / 13 at risk

Adverse event: Diffuse Lamellar Keratitis (DLK)
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 13 at risk

Adverse event: Loss of BCVA due to late onset of haze
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 13 at risk

Adverse event: Epiretinal membrane
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 13 at risk
Study: NCT03017846

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 30 at risk

Adverse event: Tooth fracture
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 30 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Frequency: 2 affected / 30 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 3 affected / 30 at risk

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

Adverse event: Pharyngitis streptococcal
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 30 at risk

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

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

Adverse event: Oropharyngeal pain
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 30 at risk

Adverse event: Application site discolouration
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 12 affected / 30 at risk

Adverse event: Application site vesicles
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 21 affected / 30 at risk

Adverse event: Dermatitis atopic
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 30 at risk

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

Adverse event: Erythema
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 6 affected / 30 at risk

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

Adverse event: Impetigo
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 30 at risk

Adverse event: Pain of skin
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 3 affected / 30 at risk

Adverse event: Pruritus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 8 affected / 30 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 3 affected / 30 at risk

Adverse event: Rash erythematous
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 30 at risk

Adverse event: Rash papular
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 30 at risk

Adverse event: Scab
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 30 at risk
Study: NCT03017885

Adverse event: Gastroenteritis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 23 at risk

Adverse event: Oedema peripheral
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 23 at risk

Adverse event: Pyrexia
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 23 at risk

Adverse event: Lung adenocarcinoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 23 at risk

Adverse event: Malignant neoplasm progression
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 5 affected / 23 at risk

Adverse event: Loss of consciousness
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 23 at risk

Adverse event: Unresponsive to stimuli
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 23 at risk

Adverse event: Cough
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 23 at risk

Adverse event: Dyspnoea
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 23 at risk

Adverse event: Pulmonary embolism
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 23 at risk
Study: NCT03018340

Adverse event: Acute myocardial infarction
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 52 at risk

Adverse event: Dry mouth
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 52 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 52 at risk

Adverse event: Sinusitis
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 52 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 52 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 52 at risk

Adverse event: Increased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 3 affected / 52 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 5 affected / 52 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 4 affected / 52 at risk

Adverse event: Sedation
Serious: no
Organ System: Nervous system disorders
Frequency: 4 affected / 52 at risk

Adverse event: Prostate cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 155 at risk

Adverse event: Calculus bladder
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 155 at risk

Adverse event: Dry mouth
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 155 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 7 affected / 155 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 7 affected / 155 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 155 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 14 affected / 155 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 9 affected / 155 at risk

Adverse event: Sedation
Serious: no
Organ System: Nervous system disorders
Frequency: 4 affected / 155 at risk

Adverse event: Sinusitis
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 29 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 29 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 29 at risk
Study: NCT03018392

Adverse event: Extension of fusion
Serious: yes
Organ System: Surgical and medical procedures
Notes: 1 subject had a locked pseudoarthrosis with progressive isthmic spondylolisthesis at an adjacent level. This necessitated an extension of fusion.
Frequency: 1 affected / 20 at risk

Adverse event: Cage Fracture
Serious: no
Organ System: Product Issues
Notes: One incidental cage fracture in a setting of solid fusion was noted in the CT analysis. No intervention was necessary as the subject was doing well.
Frequency: 1 affected / 20 at risk
Study: NCT03018587

Adverse event: Erythema
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 21 affected / 23 at risk

Adverse event: Oedema
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 11 affected / 23 at risk

Adverse event: Nodules
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Palpable firm lumps within subcutaneous fat developing 2-3 days after radiofrequency treatment in some areas treated which self-resolve typically within 4 to 8 weeks without intervention
Frequency: 14 affected / 23 at risk

Adverse event: Post treatment pain/discomfort
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 6 affected / 23 at risk

Adverse event: Purpura
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 4 affected / 23 at risk
Study: NCT03018691

Adverse event: Influenza
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 24 at risk

Adverse event: Viral upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 24 at risk

Adverse event: Upper respiratory tract inflammation
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 24 at risk

Adverse event: Dermatitis atopic
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 24 at risk

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

Adverse event: Blood alkaline phosphatase increased
Serious: no
Organ System: Investigations
Frequency: 2 affected / 25 at risk

Adverse event: Upper respiratory tract inflammation
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 6 affected / 25 at risk

Adverse event: Dermatitis atopic
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 25 at risk

Adverse event: Viral upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 24 at risk

Adverse event: Upper respiratory tract inflammation
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 24 at risk

Adverse event: Dermatitis atopic
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 4 affected / 24 at risk
Study: NCT03018730

Adverse event: Type I hypersensitivity
Serious: yes
Organ System: Immune system disorders
Frequency: 2 affected / 22 at risk

Adverse event: Infectious mononucleosis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 22 at risk

Adverse event: Urinary tract infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 22 at risk

Adverse event: Contusion
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 22 at risk

Adverse event: Infusion related reaction
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 22 at risk

Adverse event: Palpitations
Serious: no
Organ System: Cardiac disorders
Frequency: 2 affected / 22 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 22 at risk

Adverse event: Oropharyngeal pain
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 22 at risk

Adverse event: Type 1 hypersensitivity
Serious: no
Organ System: Immune system disorders
Frequency: 2 affected / 22 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 5 affected / 22 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 22 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 2 affected / 22 at risk

Adverse event: Gastrooesophageal reflux disease
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 22 at risk

Adverse event: Toothache
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 22 at risk

Adverse event: Rash pruritic
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 22 at risk

Adverse event: Erythema
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 22 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 22 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 22 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 22 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 7 affected / 22 at risk

Adverse event: Lower respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 22 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 22 at risk
Study: NCT03019107

Adverse event: Mean arterial pressure
Serious: no
Organ System: Cardiac disorders
Notes: Mean arterial pressure was elevated to 128 mmHg prior to initiation of treatment. Adverse event was assessed with Moderate severity, no relationship with study device, and was resolved with no sequel.
Frequency: 1 affected / 1 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Adverse event was assessed with Moderate severity and unrelated to study intervention. Resolved with no sequel.
Frequency: 1 affected / 1 at risk

Adverse event: Abdominal muscle soreness
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Adverse event was rated with Mild severity and Definitely related to study intervention. Resolved with no sequel
Frequency: 1 affected / 1 at risk
Study: NCT03019289

Adverse event: Haemoglobin decreased
Serious: no
Organ System: Investigations
Frequency: 2 affected / 5 at risk

Adverse event: Haematocrit decreased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 5 at risk

Adverse event: Red blood cell count decreased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 5 at risk

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

Adverse event: Skin abrasion
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 3 at risk

Adverse event: Sports injury
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 3 at risk

Adverse event: Conjunctivitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 3 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 3 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 4 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 4 at risk

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

Adverse event: Catheter site haematoma
Serious: no
Organ System: General disorders
Frequency: 3 affected / 3 at risk

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

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

Adverse event: Vessel puncture site haematoma
Serious: no
Organ System: General disorders
Frequency: 1 affected / 3 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 3 at risk
Study: NCT03019458

Adverse event: Intolerance to taking MINGO
Serious: no
Organ System: Gastrointestinal disorders
Notes: Any intolerance to taking MINGO that caused the subject to stop taking the supplement including 1 due to vomiting, 1 due to the subjective sensation to fullness, and 2 due to the fact they did not like the taste of MINGO.
Frequency: 4 affected / 24 at risk

Adverse event: GI symptoms
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 26 at risk
Study: NCT03019549

Adverse event: Surgical skin tear
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 29 at risk

Adverse event: Dizziness postural
Serious: no
Organ System: Nervous system disorders
Frequency: 3 affected / 26 at risk
Study: NCT03019887

Adverse event: increase in the total PANSS score from baseline
Serious: no
Organ System: Psychiatric disorders
Frequency: 51 affected / 130 at risk

Adverse event: Aggression
Serious: no
Organ System: Psychiatric disorders
Frequency: 15 affected / 130 at risk
Study: NCT03019965

Adverse event: moderate adverse event
Serious: no
Organ System: Gastrointestinal disorders
Notes: vomiting, diarrhea
Frequency: 1 affected / 201 at risk

Adverse event: moderate adverse event
Serious: no
Organ System: Gastrointestinal disorders
Notes: vomiting, diarrhea
Frequency: 3 affected / 202 at risk
Study: NCT03020004

Adverse event: Pancreatitis acute
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 70 at risk

Adverse event: Neutrophil count decreased
Serious: no
Organ System: Investigations
Frequency: 63 affected / 70 at risk

Adverse event: White blood cell count decreased
Serious: no
Organ System: Investigations
Frequency: 58 affected / 70 at risk
Study: NCT03020017

Adverse event: Cerebrospinal fluid leakage
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 8 at risk

Adverse event: Blood alkaline phosphatase increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 8 at risk

Adverse event: Lymphocyte count decreased
Serious: no
Organ System: Investigations
Frequency: 2 affected / 8 at risk

Adverse event: Platelet count decreased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 8 at risk

Adverse event: White blood cell count decreased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 8 at risk

Adverse event: Hypophosphataemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 8 at risk

Adverse event: Hypertension
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 8 at risk
Study: NCT03020082

Adverse event: Neutropenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 141 at risk

Adverse event: Ventricular tachyarrhythmia
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 141 at risk

Adverse event: Tuberculosis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 141 at risk

Adverse event: Transient ischaemic attack
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 141 at risk

Adverse event: Acquired digital fibrokeratoma
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 141 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 76 affected / 141 at risk

Adverse event: Pyrexia
Serious: no
Organ System: Infections and infestations
Frequency: 53 affected / 141 at risk
Study: NCT03020095

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 10 affected / 38 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 6 affected / 38 at risk