TrialPanorama/TrialPanorama-database huggingface dataset:
Study: NCT01787279

Adverse event: Asthenia
Serious: no
Organ System: General disorders
Frequency: 23 affected / 59 at risk

Adverse event: Arthralgia
Serious: no
Organ System: General disorders
Frequency: 4 affected / 59 at risk

Adverse event: Anxiety
Serious: no
Organ System: Psychiatric disorders
Frequency: 5 affected / 59 at risk

Adverse event: Insomnia
Serious: no
Organ System: Psychiatric disorders
Frequency: 7 affected / 59 at risk

Adverse event: Neutropenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 9 affected / 59 at risk

Adverse event: Myalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 4 affected / 59 at risk
Study: NCT01787760

Adverse event: Slit-lamp finding
Serious: no
Organ System: Eye disorders
Notes: Slit Lamp findings Grade 2 or less requiring treatment.
Frequency: 7 affected / 51 at risk

Adverse event: Slit-lamp finding
Serious: no
Organ System: Eye disorders
Notes: Slit Lamp findings Grade 2 or less requiring treatment.
Frequency: 4 affected / 50 at risk
Study: NCT01787825

Adverse event: Capsule Endoscope Retention
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Capsule Endoscopes (Both CapsoCam SV-1 and PillCam SB2) retained within the small bowel of each of two (2) enrolled subjects. Capsules were removed via surgical intervention.
Frequency: 2 affected / 120 at risk

Adverse event: GI Tract discomfort or pain and nausea
Serious: no
Organ System: Gastrointestinal disorders
Notes: GI Tract discomfort or pain and nausea attributed to bowel preparation for the procedures by study investigators
Frequency: 6 affected / 120 at risk

Adverse event: Malaise
Serious: no
Organ System: Gastrointestinal disorders
Notes: Malaise in one (1) subject
Frequency: 1 affected / 120 at risk

Adverse event: Skin Irritation and Itchiness
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Skin Irritation and itchiness secondary to adhesive tape used to secure PillCam SB2 wireless receiver
Frequency: 2 affected / 120 at risk

Adverse event: Delayed Capsule Excretion
Serious: no
Organ System: Gastrointestinal disorders
Notes: Delayed Capsule Excretion: Capsule s not retrieved and returned to investigator/research site for analysis
Frequency: 1 affected / 120 at risk

Adverse event: Right Kidney Pain
Serious: no
Organ System: Renal and urinary disorders
Notes: Right Kidney Pain: Cause unknown
Frequency: 1 affected / 120 at risk

Adverse event: Migraine
Serious: no
Organ System: Nervous system disorders
Notes: Migraine Headache in one (1) subject
Frequency: 1 affected / 120 at risk
Study: NCT01787916

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 13 affected / 15 at risk
Study: NCT01788228

Adverse event: Pain
Serious: no
Organ System: General disorders
Frequency: 45 affected / 49 at risk

Adverse event: Erythema
Serious: no
Organ System: General disorders
Frequency: 6 affected / 49 at risk

Adverse event: Swelling
Serious: no
Organ System: General disorders
Frequency: 7 affected / 49 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 27 affected / 49 at risk

Adverse event: Gastrointestinal symptoms
Serious: no
Organ System: General disorders
Frequency: 12 affected / 49 at risk

Adverse event: Headache
Serious: no
Organ System: General disorders
Frequency: 20 affected / 49 at risk

Adverse event: Arthralgia
Serious: no
Organ System: General disorders
Frequency: 14 affected / 49 at risk

Adverse event: Myalgia
Serious: no
Organ System: General disorders
Frequency: 33 affected / 49 at risk

Adverse event: Chills
Serious: no
Organ System: General disorders
Frequency: 10 affected / 49 at risk

Adverse event: Hyperhidrosis
Serious: no
Organ System: General disorders
Frequency: 7 affected / 49 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Frequency: 1 affected / 1 at risk
Study: NCT01788358

Adverse event: Aplastic anaemia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 508 at risk

Adverse event: Acute myocardial infarction
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 508 at risk

Adverse event: Coronary artery disease
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 508 at risk

Adverse event: Supraventricular tachycardia
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 508 at risk

Adverse event: Colitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 508 at risk

Adverse event: Chest pain
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 508 at risk

Adverse event: Pyrexia
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 508 at risk

Adverse event: Chronic sinusitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 508 at risk

Adverse event: Ankle fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 508 at risk

Adverse event: Joint dislocation
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 508 at risk

Adverse event: Back pain
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 508 at risk

Adverse event: Acute myeloid leukaemia
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 508 at risk

Adverse event: Malignant melanoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 508 at risk

Adverse event: Prostate cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 508 at risk

Adverse event: Syncope
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 508 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 18 affected / 508 at risk

Adverse event: Oedema
Serious: no
Organ System: General disorders
Frequency: 55 affected / 508 at risk

Adverse event: Oedema peripheral
Serious: no
Organ System: General disorders
Frequency: 150 affected / 508 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 27 affected / 508 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 25 affected / 508 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 47 affected / 508 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 47 affected / 508 at risk
Study: NCT01789346

Adverse event: Erythema
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 9 affected / 19 at risk

Adverse event: Oedema
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 19 at risk

Adverse event: Purpura
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 3 affected / 19 at risk

Adverse event: Crusting
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 19 at risk

Adverse event: Burning sensation
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 19 at risk

Adverse event: Erythema
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 7 affected / 19 at risk

Adverse event: Oedema
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 19 at risk

Adverse event: Purpura
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 19 at risk

Adverse event: Burning sensation
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 19 at risk
Study: NCT01789775

Adverse event: Angiodema
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 57 at risk

Adverse event: Erythema
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 3 affected / 57 at risk

Adverse event: Rosacea
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 7 affected / 57 at risk
Study: NCT01790685

Adverse event: Patient fell down the stairs and was hospitalized for a cerebral bleed.
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 23 at risk

Adverse event: Increase in IOP in study eye
Serious: no
Organ System: Eye disorders
Frequency: 3 affected / 23 at risk

Adverse event: Redness of study eye after drug injection
Serious: no
Organ System: Eye disorders
Frequency: 2 affected / 23 at risk

Adverse event: Patient had an uneventful fall
Serious: no
Organ System: General disorders
Frequency: 3 affected / 23 at risk

Adverse event: The patient was hospitalized for an infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 17 at risk

Adverse event: Patient fell and hit head on the back of a chair resulting in trauma and infection in the study eye
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 17 at risk

Adverse event: The patient was hospitalized for stomach pain
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 17 at risk

Adverse event: Increase in IOP in study eye
Serious: no
Organ System: Eye disorders
Frequency: 3 affected / 17 at risk

Adverse event: Redness of study eye after drug injection
Serious: no
Organ System: Eye disorders
Frequency: 2 affected / 17 at risk
Study: NCT01790828

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 42 at risk

Adverse event: Dyspepsia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 42 at risk

Adverse event: Gastritis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 42 at risk

Adverse event: Irritable bowel syndrome
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 42 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 42 at risk

Adverse event: Haemarthrosis
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 42 at risk

Adverse event: Ligament disorder
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 42 at risk

Adverse event: Muscle haemorrhage
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 42 at risk

Adverse event: Myalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 42 at risk

Adverse event: Intervertebral disc disorder
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 42 at risk

Adverse event: Dermatitis
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 42 at risk

Adverse event: Fungal skin infection
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 42 at risk

Adverse event: Nephrolithiasis
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 42 at risk

Adverse event: Xerophthalmia
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 42 at risk
Study: NCT01791465

Adverse event: Fatigue and weakness
Serious: no
Organ System: General disorders
Notes: Self-reported
Frequency: 2 affected / 6 at risk
Study: NCT01791491

Adverse event: Gastroenteritis
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 9 at risk

Adverse event: Blood creatinine increased
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 9 at risk

Adverse event: Acute kidney injury
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 9 at risk

Adverse event: Pyelonephritis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 9 at risk

Adverse event: Pyelonephritis acute
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 9 at risk

Adverse event: Urinary tract infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 9 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 9 at risk

Adverse event: Abdominal pain upper
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 9 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 9 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 9 at risk

Adverse event: Asthenia
Serious: no
Organ System: General disorders
Frequency: 1 affected / 9 at risk

Adverse event: Gastroenteritis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 9 at risk
Study: NCT01791517

Adverse event: Retro-peritoneal abscess in the kidney area.
Serious: yes
Organ System: Infections and infestations
Notes: According to the participant, his doctors hypothesized that the development of the abscess may be related to a perforated appendix he had in November 2011. This adverse event was deemed unrelated to the study by the investigator.
Frequency: 1 affected / 78 at risk

Adverse event: Meningitis viral
Serious: yes
Organ System: Infections and infestations
Notes: Suspect viral meningitis. Had severe vomiting and headaches. Subject admitted to hospital. This was deemed unrelated to the study by the investigator.
Frequency: 1 affected / 78 at risk

Adverse event: Seizure
Serious: yes
Organ System: Nervous system disorders
Notes: Subject experienced two seizures, on August 03, 2013 to August 04, 2013. Subject has a history of seizures and stopped taking medicine(without doctor's approval). The adverse event was deemed unrelated to the study by the investigator.
Frequency: 1 affected / 80 at risk

Adverse event: Mental Health / Phychiatric Hospital Admission
Serious: yes
Organ System: Psychiatric disorders
Notes: Subject's discontinuation of seizure medication and mental health status and was admitted to the hospital on August 03, 2013. The adverse event was deemed unrelated to the study by the investigator.
Frequency: 1 affected / 80 at risk

Adverse event: Reconstructive Surgery on Left Upper Arm
Serious: yes
Organ System: Surgical and medical procedures
Notes: This event was deemed unrelated to the study by the investigator.
Frequency: 1 affected / 78 at risk
Study: NCT01791543

Adverse event: Pericardial effusion
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 76 at risk

Adverse event: Pulmonary embolism
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 76 at risk

Adverse event: Retroperitoneal haematoma
Serious: yes
Organ System: Vascular disorders
Frequency: 2 affected / 76 at risk

Adverse event: Urinary tract infection
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 76 at risk

Adverse event: Ventricular fibrillation
Serious: yes
Organ System: Cardiac disorders
Notes: During catheter manipulation
Frequency: 1 affected / 76 at risk

Adverse event: Hypersensitivity
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 76 at risk

Adverse event: Pericarditis
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 76 at risk

Adverse event: Pulmonary haemorrhage
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 76 at risk

Adverse event: Atrioventricular block
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 76 at risk

Adverse event: Gastrointestinal haemorrhage
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 76 at risk

Adverse event: Heart Failure Exacerbation
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 76 at risk

Adverse event: Intraperitoneal bleeding
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 76 at risk

Adverse event: atrial fibrillation with rapid response
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 76 at risk

Adverse event: Femoral hematoma
Serious: no
Organ System: Vascular disorders
Frequency: 5 affected / 76 at risk
Study: NCT01791725

Adverse event: Bradycardia
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 12 at risk

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

Adverse event: Seasonal allergy
Serious: no
Organ System: Immune system disorders
Frequency: 1 affected / 12 at risk

Adverse event: Resting tremor
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 12 at risk

Adverse event: Pseudofolliculitis
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 12 at risk

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

Adverse event: Restless legs syndrome
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 12 at risk

Adverse event: Catheter site pain
Serious: no
Organ System: General disorders
Frequency: 1 affected / 5 at risk

Adverse event: Muscle strain
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 5 at risk

Adverse event: Electrocardiogram abnormal
Serious: no
Organ System: Investigations
Frequency: 1 affected / 5 at risk

Adverse event: Anger
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 5 at risk
Study: NCT01791855

Adverse event: Pyrexia
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 7 at risk

Adverse event: Tachycardia
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 7 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 7 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 7 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 7 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 7 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 7 at risk

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

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

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

Adverse event: Pulmonary mass
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 7 at risk
Study: NCT01791894

Adverse event: grade 3 infection
Serious: yes
Organ System: Blood and lymphatic system disorders
Notes: Patient had a grade 3 infection after the cycle 3 arsenic trioxide infusion. Patient recovered after hospital admission and IV antibiotic treatment
Frequency: 1 affected / 5 at risk

Adverse event: grade 4 leukopenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Notes: grade 4 leukopenia after the cycle 3 arsenic trioxide infusion. Patient recovered after hospital admission and IV antibiotic treatment
Frequency: 1 affected / 5 at risk

Adverse event: grade 1 asymptomatic atrial flutter
Serious: no
Organ System: Cardiac disorders
Notes: Patient 5discontinued treatment after the first cycle owing to grade 1 asymptomatic atrial flutter. He underwent repeated electrocardiography during a 1-week period, and the arrhythmia spontaneously resolved.
Frequency: 1 affected / 5 at risk

Adverse event: Hypertransaminasaemia
Serious: no
Organ System: Investigations
Notes: grade 2 transaminitis
Frequency: 1 affected / 5 at risk
Study: NCT01792024

Adverse event: Bleeding per rectum
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 27 at risk

Adverse event: Pyrexia
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 27 at risk

Adverse event: Hypersensitivity
Serious: no
Organ System: Immune system disorders
Frequency: 2 affected / 27 at risk

Adverse event: Erectile dysfunction
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 5 affected / 27 at risk

Adverse event: Haematuria
Serious: no
Organ System: Renal and urinary disorders
Frequency: 9 affected / 27 at risk

Adverse event: Renal and urinary disorders - Other, specify
Serious: no
Organ System: Renal and urinary disorders
Frequency: 3 affected / 27 at risk

Adverse event: Scrotal pain
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 2 affected / 27 at risk

Adverse event: Skin and subcutaneous tissue disorders - Other, specify
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 6 affected / 27 at risk

Adverse event: Pollakiuria
Serious: no
Organ System: Renal and urinary disorders
Frequency: 2 affected / 27 at risk

Adverse event: Urinary incontinence
Serious: no
Organ System: Renal and urinary disorders
Frequency: 2 affected / 27 at risk

Adverse event: Urinary retention
Serious: no
Organ System: Renal and urinary disorders
Frequency: 4 affected / 27 at risk
Study: NCT01792635

Adverse event: Thrombocytopenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 7 at risk

Adverse event: Lacrimation increased
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 7 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 7 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 7 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 7 at risk

Adverse event: Hyperglycaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 7 at risk

Adverse event: Blister
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 7 at risk

Adverse event: Pruritus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 7 at risk

Adverse event: Pruritus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 6 at risk