TrialPanorama/TrialPanorama-database huggingface dataset:
Study: NCT02927457

Adverse event: Ankle fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 11 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 11 at risk

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

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

Adverse event: Postoperative wound complication
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: 1 affected / 11 at risk

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

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

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

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

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

Adverse event: Diarrhoea
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: 1 affected / 11 at risk

Adverse event: Hot flush
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 11 at risk
Study: NCT02927795

Adverse event: Ischaemic stroke
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 253 at risk
Study: NCT02929056

Adverse event: contralateral leg venous ulcer infection
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Contralateral leg venous ulcer noted during office visit. Culture obtained and results were positive for infection. Pt was prescribed antibiotics.
Frequency: 1 affected / 1 at risk
Study: NCT02929069

Adverse event: Active Suicidality
Serious: yes
Organ System: Psychiatric disorders
Frequency: 4 affected / 100 at risk

Adverse event: Active Suicidality
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 102 at risk
Study: NCT02929407

Adverse event: Hypertension
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 4 at risk

Adverse event: Diarrhoea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 4 at risk

Adverse event: Hepatic encephalopathy
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 4 at risk

Adverse event: Pain in extremity
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 4 at risk

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

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

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

Adverse event: Hyponatraemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 4 at risk

Adverse event: Asterixis
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 4 at risk
Study: NCT02929589

Adverse event: Adverse event
Serious: no
Organ System: Gastrointestinal disorders
Notes: Subject had stomach cramps and decrease in bowel movements. He increased dietary fiber and took prescribed Colace and it resolved. Unclear if cause was surgery or study medications. These risks are in the Protocol and ICD as likely and not serious.
Frequency: 1 affected / 11 at risk
Study: NCT02929667

Adverse event: Moderate, probably related
Serious: no
Organ System: Nervous system disorders
Notes: A subject reported feeling jittery, increased sleepiness, swollen tongue. On exam tongue was normal without any signs of swelling or other lesions. She inadvertently took higher dose than scheduled. Symptoms resolved following proper titration again.
Frequency: 1 affected / 11 at risk
Study: NCT02930005

Adverse event: Hyperglycaemia
Serious: no
Organ System: Endocrine disorders
Frequency: 1 affected / 6 at risk
Study: NCT02930226

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

Adverse event: Temperature regulation disorder
Serious: no
Organ System: General disorders
Frequency: 1 affected / 4 at risk

Adverse event: Coombs direct test positive
Serious: no
Organ System: Investigations
Frequency: 1 affected / 4 at risk

Adverse event: Hyperglycaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 4 at risk

Adverse event: Glycosuria
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 4 at risk

Adverse event: Drug-induced liver injury
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 4 at risk

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

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

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

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

Adverse event: Blood thrombin increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 4 at risk

Adverse event: Thrombin-antithrombin III complex increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 4 at risk

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

Adverse event: Seasonal allergy
Serious: no
Organ System: Immune system disorders
Frequency: 1 affected / 4 at risk

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

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

Adverse event: Fibrin D dimer increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 4 at risk
Study: NCT02930343

Adverse event: Gastrointestinal adverse events
Serious: no
Organ System: Gastrointestinal disorders
Notes: Includes nausea, vomiting, abdominal pain and diarrhea
Frequency: 11 affected / 68 at risk

Adverse event: infections
Serious: no
Organ System: Infections and infestations
Notes: Any infection during study period was noted
Frequency: 6 affected / 68 at risk

Adverse event: Hypertension
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 68 at risk

Adverse event: Hairfall
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 68 at risk

Adverse event: Hepatic enzyme increased
Serious: no
Organ System: Hepatobiliary disorders
Notes: Liver enzymes \> 2 times upper limit normal
Frequency: 1 affected / 68 at risk

Adverse event: Switch to parenteral Methotrexate
Serious: no
Organ System: Product Issues
Notes: Patients intolerant to Methotrexate were switched to parenteral form as per study protocol
Frequency: 5 affected / 68 at risk

Adverse event: Gastrointestinal adverse events
Serious: no
Organ System: Gastrointestinal disorders
Notes: Includes nausea, vomiting, abdominal pain and diarrhea
Frequency: 16 affected / 68 at risk

Adverse event: infections
Serious: no
Organ System: Infections and infestations
Notes: Any infection during study period was noted
Frequency: 7 affected / 68 at risk

Adverse event: Hairfall
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 68 at risk

Adverse event: Hepatic enzyme increased
Serious: no
Organ System: Hepatobiliary disorders
Notes: Liver enzymes \> 2 times upper limit normal
Frequency: 1 affected / 68 at risk

Adverse event: Switch to parenteral Methotrexate
Serious: no
Organ System: Product Issues
Notes: Patients intolerant to Methotrexate were switched to parenteral form as per study protocol
Frequency: 14 affected / 68 at risk
Study: NCT02930837

Adverse event: Acute left ventricular failure
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 120 at risk

Adverse event: Brain herniation
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 120 at risk

Adverse event: Haemorrhage intracranial
Serious: yes
Organ System: Nervous system disorders
Frequency: 3 affected / 120 at risk

Adverse event: Cerebral haemorrhage
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 120 at risk

Adverse event: Cerebral infarction
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 120 at risk

Adverse event: Stroke in evolution
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 120 at risk

Adverse event: Respiratory failure
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 120 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 22 affected / 120 at risk

Adverse event: Hypokalaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 15 affected / 120 at risk

Adverse event: Hyperhomocysteinaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 15 affected / 120 at risk

Adverse event: Pneumonia
Serious: no
Organ System: Infections and infestations
Frequency: 10 affected / 120 at risk

Adverse event: Hepatic function abnormal
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 9 affected / 120 at risk

Adverse event: Pneumonia
Serious: no
Organ System: Infections and infestations
Frequency: 10 affected / 120 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 9 affected / 120 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 9 affected / 120 at risk

Adverse event: Vitamin B12 deficiency
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 7 affected / 120 at risk

Adverse event: Cerebral artery stenosis
Serious: no
Organ System: Nervous system disorders
Frequency: 7 affected / 120 at risk

Adverse event: Cerebrovascular stenosis
Serious: no
Organ System: Nervous system disorders
Frequency: 7 affected / 120 at risk
Study: NCT02930889

Adverse event: Prostate cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 5 at risk

Adverse event: Loose Stool
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 5 at risk

Adverse event: Burning Sensation While Urinating
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 5 at risk

Adverse event: Post Procedure Penile Pain
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 5 at risk

Adverse event: Blood urine present
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 5 at risk
Study: NCT02930941

Adverse event: Nasal discomfort
Serious: no
Organ System: General disorders
Frequency: 2 affected / 17 at risk

Adverse event: Unpleasant taste
Serious: no
Organ System: General disorders
Frequency: 1 affected / 17 at risk

Adverse event: Rhinorrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 17 at risk
Study: NCT02931045

Adverse event: One major bleeding event from the gynecologic tract
Serious: yes
Organ System: Reproductive system and breast disorders
Notes: In a patient who was eventually diagnosed with endometrial cancer.
Frequency: 1 affected / 30 at risk

Adverse event: One major bleeding event from a diabetic foot ulcer
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Notes: In a male patient who had dysregulated diabetes and infection of a diabetic foot.
Frequency: 1 affected / 30 at risk

Adverse event: One major bleeding event from the gynecologic tract
Serious: yes
Organ System: Reproductive system and breast disorders
Notes: In a patient who was eventually diagnosed with endometrial cancer.
Frequency: 1 affected / 30 at risk

Adverse event: One major bleeding event from a diabetic foot ulcer
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Notes: In a male patient who had dysregulated diabetes and infection of a diabetic foot.
Frequency: 1 affected / 30 at risk
Study: NCT02931565

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 2 at risk

Adverse event: Presyncope
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 7 at risk

Adverse event: Oropharyngeal pain
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 7 at risk
Study: NCT02932267

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 2 affected / 50 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 3 affected / 50 at risk

Adverse event: Post inflammatory pigmentation change
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 50 at risk

Adverse event: Pruritus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 50 at risk
Study: NCT02932306

Adverse event: Pregnancy
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Notes: This is a gender-specific AE. Only female participants were at risk.
Frequency: 2 affected / 229 at risk

Adverse event: Appendicitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 378 at risk

Adverse event: Ureterolithiasis
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 378 at risk

Adverse event: Asthma
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 378 at risk

Adverse event: Pregnancy
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Notes: This is a gender-specific AE. Only female participants were at risk.
Frequency: 1 affected / 247 at risk

Adverse event: Abortion missed
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Notes: This is a gender-specific AE. Only female participants were at risk.
Frequency: 1 affected / 247 at risk

Adverse event: Alcoholic pancreatitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 385 at risk

Adverse event: Post procedural haemorrhage
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 385 at risk
Study: NCT02932579

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 10 affected / 29 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 7 affected / 25 at risk
Study: NCT02932748

Adverse event: Hypersensitivity
Serious: yes
Organ System: Immune system disorders
Frequency: 1 affected / 80 at risk

Adverse event: Cancer, breast
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 36 at risk
Study: NCT02932891

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 28 at risk

Adverse event: Neck pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 28 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 28 at risk

Adverse event: Oropharyngeal pain
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 28 at risk
Study: NCT02932943

Adverse event: Basal cell carcinoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 226 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 12 affected / 226 at risk

Adverse event: Diverticulitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 231 at risk

Adverse event: Dysgeusia
Serious: no
Organ System: Nervous system disorders
Frequency: 12 affected / 231 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 16 affected / 231 at risk
Study: NCT02933034

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

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 33 at risk

Adverse event: Anxiety
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 33 at risk

Adverse event: Chest pain
Serious: no
Organ System: General disorders
Frequency: 2 affected / 33 at risk

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

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 2 affected / 33 at risk

Adverse event: Flushing
Serious: no
Organ System: Vascular disorders
Frequency: 9 affected / 33 at risk

Adverse event: Hypoglycaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 33 at risk

Adverse event: lip numbness
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 33 at risk

Adverse event: Malaise
Serious: no
Organ System: General disorders
Frequency: 1 affected / 33 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 33 at risk

Adverse event: mild discomfort
Serious: no
Organ System: General disorders
Frequency: 1 affected / 33 at risk

Adverse event: mild jaw pain
Serious: no
Organ System: General disorders
Frequency: 1 affected / 33 at risk

Adverse event: mild weakness of feet
Serious: no
Organ System: General disorders
Frequency: 1 affected / 33 at risk
Study: NCT02933372

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 15 at risk

Adverse event: Fall
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 15 at risk

Adverse event: Stomach cramping
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 15 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 15 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 15 at risk

Adverse event: Blood urine present
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 15 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 1 affected / 15 at risk

Adverse event: ended PET scan prior to completion
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 15 at risk
Study: NCT02933450

Adverse event: GI Side Effects
Serious: no
Organ System: Gastrointestinal disorders
Notes: Nausea, vomiting, diarrhea, constipation, abdominal bloating or pain
Frequency: 1 affected / 15 at risk

Adverse event: Hypoglycaemia
Serious: no
Organ System: General disorders
Notes: Blood sugar \< 70 mg/dL
Frequency: 3 affected / 15 at risk

Adverse event: GI Side Effects
Serious: no
Organ System: Gastrointestinal disorders
Notes: Nausea, vomiting, diarrhea, constipation, abdominal bloating or pain
Frequency: 2 affected / 15 at risk

Adverse event: Hypoglycaemia
Serious: no
Organ System: General disorders
Notes: Blood sugar \< 70 mg/dL
Frequency: 3 affected / 15 at risk
Study: NCT02933528

Adverse event: Abortion spontaneous
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 23 at risk

Adverse event: Conjunctival haemorrhage
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 23 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 23 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 23 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 23 at risk

Adverse event: Application site alopecia
Serious: no
Organ System: General disorders
Frequency: 1 affected / 23 at risk

Adverse event: Chest pain
Serious: no
Organ System: General disorders
Frequency: 1 affected / 23 at risk

Adverse event: Chemical burn of skin
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 23 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 23 at risk

Adverse event: Sinus headache
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 23 at risk

Adverse event: Pregnancy
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 23 at risk

Adverse event: Dysmenorrhoea
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 23 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 23 at risk

Adverse event: Oropharyngeal pain
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 23 at risk

Adverse event: Respiratory tract congestion
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 23 at risk

Adverse event: Rhinorrhoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 23 at risk
Study: NCT02933671

Adverse event: Motor weakness in the quadriceps and adductor group muscles
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Found to be complication of blind acetabular retractor which caused \>24hr palsy in the quadriceps and adductor group muscles. Non-intervention induced.
Frequency: 1 affected / 5 at risk