TrialPanorama/TrialPanorama-database huggingface dataset:
Study: NCT02316548

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 4 at risk

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

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

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

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

Adverse event: Oedema peripheral
Serious: no
Organ System: General disorders
Frequency: 1 affected / 4 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 4 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 4 at risk

Adverse event: Paraesthesia
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 4 at risk

Adverse event: Diarrhoea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 2 at risk

Adverse event: Anal fistula
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 2 at risk

Adverse event: Pelvic infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 2 at risk

Adverse event: Hyponatraemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 2 at risk

Adverse event: Acute kidney injury
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 2 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 2 at risk

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

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 2 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 2 at risk
Study: NCT02317042

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

Adverse event: SKIN ABRASION TO CHIN
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 25 at risk

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

Adverse event: Multiple Falls
Serious: yes
Organ System: General disorders
Notes: Subject admitted to hospital following multiple falls which occurred after Titration Night 1. A rib fracture as a result of the SAE was noted at a later date. SAE and secondary event not related to study device or disease targeted by the trial.
Frequency: 1 affected / 25 at risk

Adverse event: Discomfort
Serious: no
Organ System: General disorders
Frequency: 1 affected / 25 at risk

Adverse event: Headache
Serious: no
Organ System: General disorders
Frequency: 1 affected / 25 at risk

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

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

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 25 at risk
Study: NCT02317510

Adverse event: Hypotension
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 25 at risk

Adverse event: post-operative shoulder pain
Serious: no
Organ System: Nervous system disorders
Notes: post-operative shoulder pain;in both groups
Frequency: 15 affected / 25 at risk

Adverse event: Nausea/vomiting
Serious: no
Organ System: Gastrointestinal disorders
Notes: Nausea/vomiting;intraoperative ve postoperative
Frequency: 5 affected / 25 at risk

Adverse event: Hypotension
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 24 at risk

Adverse event: post-operative shoulder pain
Serious: no
Organ System: Nervous system disorders
Notes: post-operative shoulder pain;in both groups
Frequency: 6 affected / 24 at risk

Adverse event: Urinary retansion
Serious: no
Organ System: Renal and urinary disorders
Notes: Urinary retention;from end of the operation to postoperative 1 day
Frequency: 3 affected / 24 at risk

Adverse event: Nausea/vomiting
Serious: no
Organ System: Gastrointestinal disorders
Notes: Nausea/vomiting;intraoperative ve postoperative
Frequency: 1 affected / 24 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Notes: Headache;from end of the operation to postoperative 3 days
Frequency: 2 affected / 24 at risk

Adverse event: intra-operative shoulder pain
Serious: no
Organ System: Nervous system disorders
Notes: intra-operative shoulder pain:during operation time, up to 2 hours
Frequency: 3 affected / 24 at risk
Study: NCT02317575

Adverse event: Catheter site related reaction
Serious: no
Organ System: General disorders
Frequency: 5 affected / 27 at risk

Adverse event: Catheter site related reaction
Serious: no
Organ System: General disorders
Frequency: 5 affected / 27 at risk

Adverse event: Catheter site related reaction
Serious: no
Organ System: General disorders
Frequency: 2 affected / 28 at risk

Adverse event: Catheter site related reaction
Serious: no
Organ System: General disorders
Frequency: 6 affected / 27 at risk

Adverse event: Catheter site related reaction
Serious: no
Organ System: General disorders
Frequency: 2 affected / 27 at risk
Study: NCT02317614

Adverse event: Death
Serious: yes
Organ System: Immune system disorders
Frequency: 1 affected / 25 at risk

Adverse event: Hospitalisation
Serious: yes
Organ System: Immune system disorders
Frequency: 1 affected / 25 at risk

Adverse event: Death
Serious: yes
Organ System: Immune system disorders
Frequency: 1 affected / 25 at risk
Study: NCT02317744

Adverse event: Anxiety
Serious: no
Organ System: Psychiatric disorders
Notes: 1 participant discontinued NB because of anxiety; 1 participant discontinued placebo because of anxiety.
Frequency: 3 affected / 11 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Notes: 1 participant discontinued NB because of vomiting; 0 participants discontinued placebo because of vomiting.
Frequency: 3 affected / 11 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 11 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 11 at risk

Adverse event: Dizziness
Serious: no
Organ System: General disorders
Frequency: 5 affected / 11 at risk

Adverse event: Dry mouth
Serious: no
Organ System: General disorders
Frequency: 2 affected / 11 at risk

Adverse event: Headache
Serious: no
Organ System: General disorders
Frequency: 3 affected / 11 at risk

Adverse event: Insomnia
Serious: no
Organ System: General disorders
Frequency: 5 affected / 11 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 11 at risk

Adverse event: Hot flush
Serious: no
Organ System: General disorders
Frequency: 4 affected / 11 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 2 affected / 11 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: General disorders
Frequency: 1 affected / 11 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 11 at risk

Adverse event: Anxiety
Serious: no
Organ System: Psychiatric disorders
Notes: 1 participant discontinued NB because of anxiety; 1 participant discontinued placebo because of anxiety.
Frequency: 5 affected / 8 at risk

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

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 8 at risk

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

Adverse event: Dry mouth
Serious: no
Organ System: General disorders
Frequency: 2 affected / 8 at risk

Adverse event: Headache
Serious: no
Organ System: General disorders
Frequency: 4 affected / 8 at risk

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

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 8 at risk

Adverse event: Hot flush
Serious: no
Organ System: General disorders
Frequency: 1 affected / 8 at risk

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

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

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

Adverse event: Depression
Serious: no
Organ System: General disorders
Frequency: 1 affected / 8 at risk
Study: NCT02317809

Adverse event: Non-Hodgkin's lymphoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 34 at risk

Adverse event: Lymphadenopathy
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 34 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 34 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 34 at risk

Adverse event: Abdominal discomfort
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 34 at risk

Adverse event: Injection site discolouration
Serious: no
Organ System: General disorders
Frequency: 1 affected / 34 at risk

Adverse event: Catheter site related reaction
Serious: no
Organ System: General disorders
Frequency: 1 affected / 34 at risk

Adverse event: Rhinitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 34 at risk

Adverse event: Presyncope
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 34 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 6 affected / 34 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 34 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 34 at risk

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

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 31 at risk

Adverse event: Abdominal discomfort
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 31 at risk

Adverse event: Catheter site related reaction
Serious: no
Organ System: General disorders
Frequency: 4 affected / 31 at risk

Adverse event: Catheter site pain
Serious: no
Organ System: General disorders
Frequency: 1 affected / 31 at risk

Adverse event: Rhinitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 31 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 31 at risk

Adverse event: Paraesthesia
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 31 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 4 affected / 31 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 3 affected / 31 at risk

Adverse event: Vaginal haemorrhage
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 31 at risk

Adverse event: Breast tenderness
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 31 at risk

Adverse event: Dysphonia
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 31 at risk
Study: NCT02318303

Adverse event: Gastrointestinal ulcer and Gastritis
Serious: yes
Organ System: Gastrointestinal disorders
Notes: There were two SAEs (gastrointestinal ulcer and gastritis) reported both in the same subject.
Frequency: 1 affected / 158 at risk
Study: NCT02318550

Adverse event: Burning/pulling sensation
Serious: no
Organ System: Product Issues
Notes: Burning/pulling sensation in device pocket/chest during MRI
Frequency: 3 affected / 262 at risk

Adverse event: Chest pain
Serious: no
Organ System: Cardiac disorders
Notes: Pain in chest during MRI
Frequency: 1 affected / 262 at risk
Study: NCT02318667

Adverse event: Colitis ulcerative
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 38 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 38 at risk

Adverse event: Colitis ulcerative
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 38 at risk
Study: NCT02318693

Adverse event: Periodontitis
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 26 at risk

Adverse event: Hypoglycaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 26 at risk

Adverse event: Erythema
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 10 affected / 26 at risk

Adverse event: Pruritus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 26 at risk

Adverse event: Hypoglycaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 3 affected / 26 at risk

Adverse event: Dermatitis contact
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 26 at risk

Adverse event: Erythema
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 6 affected / 26 at risk

Adverse event: Pruritus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 26 at risk
Study: NCT02318797

Adverse event: Death - not associated with study activities
Serious: yes
Organ System: General disorders
Frequency: 3 affected / 516 at risk

Adverse event: Death - not associated with study activities
Serious: yes
Organ System: General disorders
Frequency: 6 affected / 713 at risk
Study: NCT02318992

Adverse event: gastrointestinal complaints
Serious: no
Organ System: Gastrointestinal disorders
Notes: gastrointestinal complaints including abdominal cramps, lost appetite, nausea, vomiting
Frequency: 1 affected / 26 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 26 at risk

Adverse event: Colitis and enteritis with cholelithiasis
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Six days after FMT patient developed acute stomach pain and fever with white blood cell (WBC) 40K. Computed tomography (CT) showed colitis and enteritis with cholelithiasis. Stool was negative for C. difficile toxin.
Frequency: 1 affected / 27 at risk

Adverse event: gastrointestinal complaints
Serious: no
Organ System: Gastrointestinal disorders
Notes: gastrointestinal complaints including abdominal cramps, lost appetite, nausea, vomiting
Frequency: 1 affected / 27 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 27 at risk

Adverse event: Urosepsis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 24 at risk

Adverse event: gastrointestinal complaints
Serious: no
Organ System: Gastrointestinal disorders
Notes: gastrointestinal complaints including abdominal cramps, lost appetite, nausea, vomiting
Frequency: 5 affected / 24 at risk

Adverse event: blood clot
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: subject had blood clot rectally
Frequency: 1 affected / 24 at risk
Study: NCT02319304

Adverse event: Neutrophil count decreased
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 3 at risk

Adverse event: White blood cell count decreased
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 3 at risk

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

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

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

Adverse event: Platelet count decreased
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 3 affected / 3 at risk

Adverse event: White blood cell count decreased
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 3 affected / 3 at risk

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

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 3 at risk
Study: NCT02319317

Adverse event: Discomfort during/after driving simulation
Serious: no
Organ System: General disorders
Notes: Dizziness or Nausea during/after driving simulation
Frequency: 2 affected / 31 at risk
Study: NCT02319486

Adverse event: central nervous system metastasis
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 9 at risk

Adverse event: central nervous system metastasis
Serious: yes
Organ System: Nervous system disorders
Frequency: 10 affected / 17 at risk

Adverse event: Orbit Relapse
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 17 at risk

Adverse event: central nervous system metastasis and orbit relapse
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 17 at risk
Study: NCT02319525

Adverse event: Right ventricular failure
Serious: yes
Organ System: Vascular disorders
Notes: 1. Decision-aid: Patient with mitral regurgitation died due of right ventricular failure after cardiovascular surgery (Day 53).
Frequency: 1 affected / 151 at risk

Adverse event: Subarachnoid haemorrhage
Serious: yes
Organ System: Vascular disorders
Notes: 1. Pamphlet: Subarachnoid hemorrhage from posterior circulation aneurysm. Patient died due to central herniation (Day 22)
Frequency: 1 affected / 147 at risk
Study: NCT02319642

Adverse event: Pancreatitis acute
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 95 at risk

Adverse event: Duodenal ulcer haemorrhage
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 95 at risk

Adverse event: Mouth ulceration
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 95 at risk

Adverse event: Cholecystitis
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 95 at risk

Adverse event: Cholelithiasis
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 95 at risk

Adverse event: Herpes zoster
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 95 at risk

Adverse event: Compression fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 95 at risk

Adverse event: Hospitalisation
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 95 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 5 affected / 95 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 13 affected / 95 at risk

Adverse event: Liver function test abnormal
Serious: no
Organ System: Investigations
Frequency: 5 affected / 95 at risk

Adverse event: Appendiceal abscess
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 251 at risk

Adverse event: Tuberculosis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 251 at risk

Adverse event: Clavicle fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 251 at risk

Adverse event: Intervertebral disc protrusion
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 251 at risk

Adverse event: Rheumatoid arthritis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 251 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 14 affected / 251 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 39 affected / 251 at risk

Adverse event: Liver function test abnormal
Serious: no
Organ System: Investigations
Frequency: 11 affected / 251 at risk
Study: NCT02319824

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: grade 1
Frequency: 1 affected / 2 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: 2 separate events in 1 patient, one grade 1 and one grade 2
Frequency: 1 affected / 2 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: grade 2
Frequency: 1 affected / 2 at risk
Study: NCT02320149

Adverse event: Alanine aminotransferase increased
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 481 at risk

Adverse event: Aspartate aminotransferase increased
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 481 at risk

Adverse event: Gamma-glutamyltransferase increased
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 481 at risk

Adverse event: Diabetic ketoacidosis
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 481 at risk

Adverse event: Nephrolithiasis
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 481 at risk

Adverse event: Appendicitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 483 at risk

Adverse event: Cellulitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 483 at risk

Adverse event: Abortion spontaneous
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 2 affected / 483 at risk

Adverse event: Suicide attempt
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 483 at risk

Adverse event: Miscarriage of partner
Serious: yes
Organ System: Social circumstances
Frequency: 1 affected / 483 at risk
Study: NCT02320175

Adverse event: Serious Adverse Events
Serious: yes
Organ System: General disorders
Notes: These adverse events are not related to the intervention and are adverse events captured system-wide as part of the study's main outcome.
Frequency: 165 affected / 1574 at risk

Adverse event: Serious Adverse Events
Serious: yes
Organ System: General disorders
Notes: These adverse events are not related to the intervention and are adverse events captured system-wide as part of the study's main outcome.
Frequency: 95 affected / 1532 at risk
Study: NCT02320253

Adverse event: Hospital admission
Serious: yes
Organ System: General disorders
Notes: For this lifestyle intervention study, we tracked al hospital admissions as SAEs. None of the SAEs were deemed to be related to the intervention.
Frequency: 18 affected / 66 at risk

Adverse event: Hospital admission
Serious: yes
Organ System: General disorders
Notes: For this lifestyle intervention study, we tracked al hospital admissions as SAEs. None of the SAEs were deemed to be related to the intervention.
Frequency: 16 affected / 70 at risk

Adverse event: Hospital admission
Serious: yes
Organ System: General disorders
Notes: For this lifestyle intervention study, we tracked al hospital admissions as SAEs. None of the SAEs were deemed to be related to the intervention.
Frequency: 12 affected / 72 at risk