TrialPanorama/TrialPanorama-database huggingface dataset:
Study: NCT02138136

Adverse event: Tonsillar haemorrhage
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 419 at risk

Adverse event: Conversion disorder
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 419 at risk

Adverse event: Depressed level of consciousness
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 419 at risk

Adverse event: Faecaloma
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 419 at risk

Adverse event: Irritable bowel syndrome
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 419 at risk

Adverse event: Abdominal pain
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 419 at risk

Adverse event: Anal incontinence
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 419 at risk

Adverse event: Constipation
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 419 at risk

Adverse event: Gastritis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 419 at risk

Adverse event: Gastrointestinal obstruction
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 419 at risk

Adverse event: Hepatotoxicity
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 419 at risk

Adverse event: Dehydration
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 419 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 33 affected / 419 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 36 affected / 419 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 47 affected / 419 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 33 affected / 419 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 27 affected / 419 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 31 affected / 419 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 19 affected / 419 at risk
Study: NCT02138253

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 9 affected / 41 at risk

Adverse event: Hypertension
Serious: no
Organ System: Vascular disorders
Frequency: 6 affected / 41 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 7 affected / 41 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 6 affected / 41 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 8 affected / 41 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 41 at risk

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

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 23 at risk

Adverse event: Hypertension
Serious: no
Organ System: Vascular disorders
Frequency: 4 affected / 23 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 23 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 23 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 6 affected / 23 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 23 at risk
Study: NCT02138747

Adverse event: Atrial fibrillation
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 319 at risk

Adverse event: Osteoarthritis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 319 at risk

Adverse event: Dry mouth
Serious: no
Organ System: Gastrointestinal disorders
Notes: If a patient reported a TEAE for the same treatment in 2 different periods, then that patient was counted once.
Frequency: 29 affected / 319 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Notes: If a patient reported a TEAE for the same treatment in 2 different periods, then that patient was counted once.
Frequency: 18 affected / 319 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Notes: If a patient reported a TEAE for the same treatment in 2 different periods, then that patient was counted once.
Frequency: 18 affected / 319 at risk

Adverse event: Atrial fibrillation
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 325 at risk

Adverse event: Small intestinal obstruction
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 325 at risk

Adverse event: Cholecystitis chronic
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 325 at risk

Adverse event: Staphylococcal sepsis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 325 at risk

Adverse event: Multiple injuries
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 325 at risk

Adverse event: Road traffic accident
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 325 at risk

Adverse event: Non-small cell lung cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 325 at risk

Adverse event: Pregnancy
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 325 at risk

Adverse event: Dry mouth
Serious: no
Organ System: Gastrointestinal disorders
Notes: If a patient reported a TEAE for the same treatment in 2 different periods, then that patient was counted once.
Frequency: 53 affected / 325 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Notes: If a patient reported a TEAE for the same treatment in 2 different periods, then that patient was counted once.
Frequency: 20 affected / 325 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Notes: If a patient reported a TEAE for the same treatment in 2 different periods, then that patient was counted once.
Frequency: 19 affected / 325 at risk
Study: NCT02139176

Adverse event: social disruptions reported by women
Serious: no
Organ System: Social circumstances
Notes: * Two couples separated and the woman reported this
* One female participant felt blamed for bringing HIV into the relationship and she reported this
* One male participant was upset when he misunderstood which partner he was being called about.
Frequency: 3 affected / 100 at risk

Adverse event: social disruption reported by men
Serious: no
Organ System: Social circumstances
Notes: Men who reported disruptions related to tracing or study participation.
Frequency: 1 affected / 100 at risk
Study: NCT02139280

Adverse event: Infection
Serious: yes
Organ System: Infections and infestations
Notes: Febrile neutropenia (fever of unknown origin without clinically or microbiologically documented infection)(ANC \<1.0 x 10e9/L, fever \>=38.5 degrees C)
Frequency: 1 affected / 33 at risk

Adverse event: Edema: limb
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 33 at risk

Adverse event: Sinus tachycardia
Serious: no
Organ System: Cardiac disorders
Notes: CARDIAC ARRHYTHMIA: Supraventricular and nodal arrhythmia - Sinus tachycardia
Frequency: 1 affected / 33 at risk

Adverse event: Hypotension
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 33 at risk

Adverse event: Pruritus/itching
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: DERMATOLOGY/SKIN: Pruritus/itching: Vaginal pruritus
Frequency: 1 affected / 33 at risk

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

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

Adverse event: Pain: Bone
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 6 affected / 33 at risk

Adverse event: Pain: Extremity-limb
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 33 at risk

Adverse event: Pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 3 affected / 33 at risk

Adverse event: Infection
Serious: yes
Organ System: Infections and infestations
Notes: Febrile neutropenia (fever of unknown origin without clinically or microbiologically documented infection)(ANC \<1.0 x 10e9/L, fever \>=38.5 degrees C)
Frequency: 2 affected / 20 at risk

Adverse event: Platelets
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: BLOOD/BONE MARROW: Platelets
Frequency: 5 affected / 20 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 20 at risk

Adverse event: Edema: limb
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 20 at risk

Adverse event: Pain: Back
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 20 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 20 at risk
Study: NCT02139397

Adverse event: Alanine aminotransferase increased
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 3 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 3 at risk

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

Adverse event: Neutropenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 3 at risk

Adverse event: Peripheral sensory neuropathy
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 3 at risk

Adverse event: Vomiting
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 7 at risk

Adverse event: Decreased appetite
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: Thrombocytopenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 6 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 6 at risk

Adverse event: Leukopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 6 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 6 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Frequency: 1 affected / 6 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 6 at risk

Adverse event: Hypoacusis
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 6 at risk
Study: NCT02139436

Adverse event: Hypotension
Serious: no
Organ System: Cardiac disorders
Notes: Low BP is common in individuals with SCI. Excluded from exercise if BP is low.
Frequency: 1 affected / 41 at risk

Adverse event: Skin ulcer
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Pressure ulcers are common in individuals with SCI
Frequency: 1 affected / 41 at risk

Adverse event: Elevated Blood Pressure
Serious: no
Organ System: Cardiac disorders
Notes: Temporary elevations in blood pressure, not related to autonomic dysreflexia, which subsides with 10 minutes of rest
Frequency: 1 affected / 41 at risk

Adverse event: Arthritis
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Inflammation of a joint.
Frequency: 2 affected / 41 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Notes: Reports of sickness following exercise/testing
Frequency: 3 affected / 41 at risk

Adverse event: Autonomic dysreflexia
Serious: yes
Organ System: Cardiac disorders
Notes: Autonomic dysreflexia (AD) characterized by a sudden abnormal elevation in blood pressure.
Frequency: 1 affected / 14 at risk

Adverse event: Autonomic dysreflexia
Serious: yes
Organ System: Cardiac disorders
Notes: Autonomic dysreflexia (AD) characterized by a sudden abnormal elevation in blood pressure.
Frequency: 1 affected / 13 at risk

Adverse event: Skin ulcer
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Pressure ulcers are common in individuals with SCI
Frequency: 1 affected / 13 at risk
Study: NCT02139540

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 20 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 20 at risk

Adverse event: Dizziness
Serious: no
Organ System: General disorders
Frequency: 1 affected / 20 at risk

Adverse event: Hypoaesthesia
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 20 at risk

Adverse event: Anxiety
Serious: no
Organ System: Psychiatric disorders
Frequency: 2 affected / 20 at risk

Adverse event: Panic attack
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 20 at risk

Adverse event: Claustrophobia
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 20 at risk

Adverse event: Hyperventilation
Serious: no
Organ System: General disorders
Frequency: 1 affected / 20 at risk

Adverse event: Regurgitation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 20 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 20 at risk

Adverse event: Dizziness
Serious: no
Organ System: General disorders
Frequency: 2 affected / 20 at risk

Adverse event: Hypercapnia
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 20 at risk
Study: NCT02139644

Adverse event: Pancreatitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 126 at risk

Adverse event: Cholecystitis
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 126 at risk

Adverse event: Cholelithiasis
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 126 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 126 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 126 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 7 affected / 126 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 11 affected / 128 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 6 affected / 128 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 7 affected / 128 at risk

Adverse event: Plasma cell myeloma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 129 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 9 affected / 129 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 4 affected / 129 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 9 affected / 129 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 7 affected / 129 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 7 affected / 129 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 129 at risk

Adverse event: Abortion spontaneous
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 129 at risk

Adverse event: Asthma
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 129 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 4 affected / 129 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 6 affected / 129 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 5 affected / 129 at risk
Study: NCT02139800

Adverse event: Death
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Notes: Within the first 48 hours post delivery
Frequency: 3 affected / 211 at risk

Adverse event: Administration of epinephrine or chest compressions
Serious: yes
Organ System: Surgical and medical procedures
Notes: Within the first 48 hours post delivery
Frequency: 8 affected / 211 at risk

Adverse event: Pneumothorax
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Notes: Within the first 10 days of life
Frequency: 19 affected / 211 at risk

Adverse event: Pulmonary Interstitial Emphysemia (PIE)
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Within the first 10 days of life
Frequency: 6 affected / 211 at risk

Adverse event: Grade 3 or 4 IVH
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Notes: Within the first 10 days of life
Frequency: 22 affected / 211 at risk

Adverse event: FiO2>=0.4 for >=2 hrs in first 2 DOL
Serious: no
Organ System: Surgical and medical procedures
Frequency: 52 affected / 211 at risk

Adverse event: IVH Grade 1/2 within first 10 days of life
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 44 affected / 211 at risk

Adverse event: >30% oxygen at 28 days of life
Serious: no
Organ System: Surgical and medical procedures
Frequency: 76 affected / 211 at risk

Adverse event: Mechanical support at 28 days of life
Serious: no
Organ System: Surgical and medical procedures
Frequency: 91 affected / 211 at risk

Adverse event: Death
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Notes: Within the first 48 hours post delivery
Frequency: 16 affected / 215 at risk

Adverse event: Administration of epinephrine or chest compressions
Serious: yes
Organ System: Surgical and medical procedures
Notes: Within the first 48 hours post delivery
Frequency: 6 affected / 215 at risk

Adverse event: Pneumothorax
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Notes: Within the first 10 days of life
Frequency: 11 affected / 215 at risk

Adverse event: Pulmonary Interstitial Emphysemia (PIE)
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Within the first 10 days of life
Frequency: 7 affected / 215 at risk

Adverse event: Grade 3 or 4 IVH
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Notes: Within the first 10 days of life
Frequency: 21 affected / 215 at risk

Adverse event: FiO2>=0.4 for >=2 hrs in first 2 DOL
Serious: no
Organ System: Surgical and medical procedures
Frequency: 50 affected / 215 at risk

Adverse event: IVH Grade 1/2 within first 10 days of life
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 51 affected / 215 at risk

Adverse event: >30% oxygen at 28 days of life
Serious: no
Organ System: Surgical and medical procedures
Frequency: 66 affected / 215 at risk

Adverse event: Mechanical support at 28 days of life
Serious: no
Organ System: Surgical and medical procedures
Frequency: 84 affected / 215 at risk
Study: NCT02139826

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

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 11 at risk

Adverse event: Presyncope
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 11 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 11 at risk

Adverse event: Somnolence
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 11 at risk

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

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 4 affected / 11 at risk

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

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 11 at risk

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

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

Adverse event: Atrioventricular block second degree
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 12 at risk

Adverse event: Oropharyngeal pain
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 12 at risk

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

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

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 12 at risk

Adverse event: Myalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 12 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 12 at risk