TrialPanorama/TrialPanorama-database huggingface dataset:
Study: NCT01799239

Adverse event: Itching in the peristomal area
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 32 at risk

Adverse event: red skin in the peristomal area
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 32 at risk

Adverse event: pain in the peristomal area
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 32 at risk

Adverse event: Itching in the peristomal area
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 32 at risk
Study: NCT01799265

Adverse event: Headache
Serious: no
Organ System: General disorders
Notes: headache and lightheadedness
Frequency: 1 affected / 20 at risk
Study: NCT01799720

Adverse event: Study abandonment
Serious: no
Organ System: Social circumstances
Notes: The participants lost interest in the diet and deciced to abandon the study
Frequency: 3 affected / 20 at risk

Adverse event: Violation of protocol norms
Serious: no
Organ System: Investigations
Notes: The participant did not follow the rules and the diet
Frequency: 1 affected / 19 at risk
Study: NCT01800058

Adverse event: Postoperative of colon volvulus
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 65 at risk

Adverse event: Lung neoplasm malignant
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 65 at risk

Adverse event: Sepsis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 65 at risk

Adverse event: Head and neck cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 65 at risk

Adverse event: Gastric adenocarcinoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 65 at risk

Adverse event: Acute myocardial infarction
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 65 at risk

Adverse event: Pneumomia
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 65 at risk

Adverse event: Bronchoaspiration
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 65 at risk

Adverse event: Gastric GIST
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 65 at risk

Adverse event: Ureteric cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 65 at risk

Adverse event: Urethral estenosis
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 65 at risk

Adverse event: Haematuria
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 65 at risk

Adverse event: Late urinary symptoms Grade >= 2
Serious: no
Organ System: Renal and urinary disorders
Frequency: 9 affected / 65 at risk

Adverse event: Late rectal symptoms Grade >= 2
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 6 affected / 65 at risk
Study: NCT01800201

Adverse event: Hepatic failure
Serious: yes
Organ System: Renal and urinary disorders
Notes: Liver Failure as defined by ICD-9: 570.0, 573.3
Frequency: 1 affected / 503 at risk

Adverse event: Atrioventricular block
Serious: yes
Organ System: Cardiac disorders
Notes: Heart Block as defined by following ICD-9: 426.9, 426.0, 426.12, 426.13
Frequency: 1 affected / 503 at risk

Adverse event: Rhabdomyolysis
Serious: yes
Organ System: Renal and urinary disorders
Notes: Rhabdomyolysis as defined by ICD-9: 728.88, 791.2, 791.3
Frequency: 1 affected / 503 at risk

Adverse event: GI Hemmorhage/Ulcer
Serious: yes
Organ System: Gastrointestinal disorders
Notes: GI Hemmorhage/Ulcer as identified by ICD-9: 578.0, 578.1, 578.9, 569.3, 531, 532, 533, 534:
Frequency: 12 affected / 503 at risk

Adverse event: Syncope
Serious: yes
Organ System: Blood and lymphatic system disorders
Notes: Synope as identifed by ICD-9: 780.2
Frequency: 6 affected / 503 at risk

Adverse event: Bradycardia
Serious: yes
Organ System: Cardiac disorders
Notes: Bradycardia as identified by ICD-9: 427.89
Frequency: 14 affected / 503 at risk

Adverse event: Unspecified Hemmorhage
Serious: yes
Organ System: Blood and lymphatic system disorders
Notes: Unspecified Hemmorhage as identified as ICD-9: 459.0
Frequency: 2 affected / 503 at risk

Adverse event: Intracranial Hemmorhage
Serious: yes
Organ System: Cardiac disorders
Notes: intracranial hemorrhage as identified by ICD-9: 430, 431,432.0, 432.9, 853, 430, 431
Frequency: 5 affected / 1000 at risk

Adverse event: Hepatic failure
Serious: yes
Organ System: Renal and urinary disorders
Notes: Liver Failure as defined by ICD-9: 570.0, 573.3
Frequency: 1 affected / 1000 at risk

Adverse event: Atrioventricular block
Serious: yes
Organ System: Cardiac disorders
Notes: Heart Block as defined by following ICD-9: 426.9, 426.0, 426.12, 426.13
Frequency: 4 affected / 1000 at risk

Adverse event: Rhabdomyolysis
Serious: yes
Organ System: Renal and urinary disorders
Notes: Rhabdomyolysis as defined by ICD-9: 728.88, 791.2, 791.3
Frequency: 4 affected / 1000 at risk

Adverse event: GI Hemmorhage/Ulcer
Serious: yes
Organ System: Gastrointestinal disorders
Notes: GI Hemmorhage/Ulcer as identified by ICD-9: 578.0, 578.1, 578.9, 569.3, 531, 532, 533, 534:
Frequency: 12 affected / 1000 at risk

Adverse event: Syncope
Serious: yes
Organ System: Blood and lymphatic system disorders
Notes: Synope as identifed by ICD-9: 780.2
Frequency: 13 affected / 1000 at risk

Adverse event: Bradycardia
Serious: yes
Organ System: Cardiac disorders
Notes: Bradycardia as identified by ICD-9: 427.89
Frequency: 27 affected / 1000 at risk
Study: NCT01800838

Adverse event: Peeling Skin
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 11 at risk

Adverse event: Pain
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 11 affected / 11 at risk

Adverse event: Cracked Tooth
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 11 at risk

Adverse event: Atrial fibrillation
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 11 at risk

Adverse event: Pruritus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 11 at risk

Adverse event: Sutures Removed
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 11 at risk

Adverse event: Pruritus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 11 at risk

Adverse event: Elevated creatinine
Serious: no
Organ System: Investigations
Frequency: 2 affected / 11 at risk

Adverse event: Hypertension
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 11 at risk

Adverse event: Palpitations
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 11 at risk

Adverse event: Superficial ulceration
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 11 at risk

Adverse event: Epistaxis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 11 at risk

Adverse event: Sinusitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 11 at risk

Adverse event: Sinus bradycardia
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 11 at risk

Adverse event: Dermatitis
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 11 at risk

Adverse event: Skin abrasion
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 11 at risk
Study: NCT01800877

Adverse event: Cardiac arrythmia
Serious: no
Organ System: Cardiac disorders
Frequency: 21 affected / 60 at risk

Adverse event: Myocardial injury
Serious: no
Organ System: Cardiac disorders
Frequency: 9 affected / 60 at risk

Adverse event: Intestinal ischaemia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 60 at risk

Adverse event: Digit or limb necrosis
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 60 at risk

Adverse event: Gastric feeding intolerance
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 7 affected / 60 at risk

Adverse event: Venous thromboembolic event
Serious: no
Organ System: Vascular disorders
Frequency: 2 affected / 60 at risk

Adverse event: Major bleeding
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 3 affected / 60 at risk

Adverse event: Cardiac arrythmia
Serious: no
Organ System: Cardiac disorders
Frequency: 12 affected / 60 at risk

Adverse event: Myocardial injury
Serious: no
Organ System: Cardiac disorders
Frequency: 11 affected / 60 at risk

Adverse event: Intestinal ischaemia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 60 at risk

Adverse event: Digit or limb necrosis
Serious: no
Organ System: Vascular disorders
Frequency: 3 affected / 60 at risk

Adverse event: Gastric feeding intolerance
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 6 affected / 60 at risk

Adverse event: Venous thromboembolic event
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 60 at risk

Adverse event: Major bleeding
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 4 affected / 60 at risk
Study: NCT01800890

Adverse event: peristomal skin irritation
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 5 affected / 19 at risk

Adverse event: cramps in the right kidney with sever pain
Serious: no
Organ System: Renal and urinary disorders
Notes: not related to the product
Frequency: 1 affected / 19 at risk

Adverse event: peristomal skin irritation
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 5 affected / 19 at risk

Adverse event: Influenza
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 19 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 19 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 19 at risk

Adverse event: peristomal skin irritation
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 4 affected / 19 at risk

Adverse event: stinging skin by fistel
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 19 at risk

Adverse event: diarre due to food intolerance
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 19 at risk

Adverse event: stenosis of catherter in the right kidney
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 28 at risk

Adverse event: peristomal skin irritation
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 4 affected / 28 at risk

Adverse event: Cystitis
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 28 at risk

Adverse event: peristomal skin irritaion
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 28 at risk
Study: NCT01801072

Adverse event: Cerebrovascular accident
Serious: yes
Organ System: Vascular disorders
Frequency: 2 affected / 40 at risk

Adverse event: Unexplained Encephalopathy
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 40 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 40 at risk

Adverse event: Delirium
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 40 at risk

Adverse event: Patient received extra Keppra
Serious: no
Organ System: Product Issues
Notes: Participant was randomized to the Keppra arm. Patient was inadvertently discharged with a 30-day supply of Keppra. Once the study team became aware of this, the patient was fully instructed how to taper off Keppra.
Frequency: 1 affected / 40 at risk

Adverse event: Seizure
Serious: no
Organ System: Nervous system disorders
Frequency: 3 affected / 40 at risk

Adverse event: Acute Right Vision Loss
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 42 at risk

Adverse event: Cerebrovascular accident
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 42 at risk

Adverse event: Seizure
Serious: no
Organ System: Nervous system disorders
Frequency: 3 affected / 42 at risk
Study: NCT01801280

Adverse event: Noro virus infection
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 19 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Immune system disorders
Frequency: 4 affected / 19 at risk

Adverse event: Urinary tract infection
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 18 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Immune system disorders
Frequency: 3 affected / 18 at risk

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

Adverse event: Nasopharyngitis
Serious: no
Organ System: Immune system disorders
Frequency: 2 affected / 18 at risk
Study: NCT01801865

Adverse event: Respiration abnormal
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 615 at risk

Adverse event: Apnoeic attack
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 615 at risk

Adverse event: Sedative therapy
Serious: no
Organ System: Surgical and medical procedures
Notes: The patient received 2 doses of PO versed. The patient recovered, no sequelae. The event was related to clinically indicated sedation given to the subject for a clinically indicated scan.
Frequency: 1 affected / 615 at risk
Study: NCT01802073

Adverse event: Biliary stricture requiring stent
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 14 at risk

Adverse event: Progression of PSC
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 14 at risk
Study: NCT01802151

Adverse event: Hypotension
Serious: yes
Organ System: Blood and lymphatic system disorders
Notes: One participant reported a serious adverse event of hospitalization with an admitting diagnosis of hypotension, but did not discontinue probiotic consumption and completed the study.
Frequency: 1 affected / 21 at risk

Adverse event: Diarrheal Symptoms
Serious: no
Organ System: Gastrointestinal disorders
Notes: One participant in the 0.1 billion CFU treatment group experienced diarrheal symptoms and completed the study, this event did not occur in any other participants and did not persist.
Frequency: 1 affected / 21 at risk

Adverse event: Itchiness and Redness Symptoms
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: A participant in the 10 billion CFU treatment group experienced itchiness/redness symptoms that were sporadic and persisted for several days. The participant voluntarily withdrew from the study, these symptoms did not occur in any other participants.
Frequency: 1 affected / 20 at risk
Study: NCT01802216

Adverse event: Minocycline Reaction
Serious: yes
Organ System: General disorders
Notes: Patient reported allergic reaction, bad taste in mouth, dry socket, foul breath odor, headache, numbness, painful gums, tooth sensitivity at 8 month visit.
Frequency: 1 affected / 34 at risk
Study: NCT01802437

Adverse event: Suicide attempt
Serious: yes
Organ System: Psychiatric disorders
Frequency: 2 affected / 20 at risk

Adverse event: Harm-related
Serious: no
Organ System: Psychiatric disorders
Frequency: 6 affected / 20 at risk

Adverse event: Suicide-Related
Serious: no
Organ System: Psychiatric disorders
Notes: A suicide-related adverse event was defined as worsening suicidal ideation, a suicide attempt, or both.
Frequency: 5 affected / 20 at risk

Adverse event: Suicide attempt
Serious: yes
Organ System: Psychiatric disorders
Frequency: 2 affected / 20 at risk

Adverse event: Harm-related
Serious: no
Organ System: Psychiatric disorders
Frequency: 8 affected / 20 at risk

Adverse event: Suicide-Related
Serious: no
Organ System: Psychiatric disorders
Notes: A suicide-related adverse event was defined as worsening suicidal ideation, a suicide attempt, or both.
Frequency: 4 affected / 20 at risk
Study: NCT01802580

Adverse event: Fungal infection
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Fungal infection
Frequency: 1 affected / 20 at risk

Adverse event: Burning sensation
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Burning sensation where drug is applied
Frequency: 1 affected / 20 at risk
Study: NCT01802879

Adverse event: Non-cardiac chest pain
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 8 at risk

Adverse event: Cerebrovascular accident
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 8 at risk

Adverse event: Neutropenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 8 at risk

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

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

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

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

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

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

Adverse event: Bone pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 8 at risk

Adverse event: Osteoarthritis
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 8 at risk

Adverse event: Benign muscle neoplasm
Serious: no
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 8 at risk

Adverse event: Neuropathy peripheral
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 8 at risk

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

Adverse event: Pruritus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 8 at risk
Study: NCT01803464

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Notes: Participants became nauseous while standing on the vibration platform during a 10 minute session.
Frequency: 3 affected / 10 at risk
Study: NCT01803555

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 303 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 31 affected / 303 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 18 affected / 303 at risk

Adverse event: Bradycardia
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 299 at risk

Adverse event: Supraventricular tachycardia
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 299 at risk

Adverse event: Intervertebral disc protrusion
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 299 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 25 affected / 299 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 24 affected / 299 at risk
Study: NCT01803607

Adverse event: Sinus bradycardia
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 67 at risk

Adverse event: Diverticulitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 67 at risk

Adverse event: Humerus fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 67 at risk

Adverse event: Pelvic fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 67 at risk

Adverse event: Tibia fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 67 at risk

Adverse event: Dehydration
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 67 at risk

Adverse event: Squamous cell carcinoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 67 at risk

Adverse event: Transient ischaemic attack
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 67 at risk

Adverse event: Urinary retention
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 67 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 5 affected / 67 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 6 affected / 67 at risk

Adverse event: Accidental overdose
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 4 affected / 67 at risk

Adverse event: Small intestinal obstruction
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 68 at risk

Adverse event: Hip fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 68 at risk

Adverse event: Breast cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 68 at risk

Adverse event: Dizziness
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 68 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 4 affected / 68 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 68 at risk

Adverse event: Accidental overdose
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 3 affected / 68 at risk
Study: NCT01803711

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Notes: Stomach upsets
Frequency: 1 affected / 2 at risk

Adverse event: Memory problems
Serious: no
Organ System: Nervous system disorders
Notes: Memory problems
Frequency: 1 affected / 3 at risk