TrialPanorama/TrialPanorama-database huggingface dataset:
Study: NCT01089023

Adverse event: Metabolism and nutrition disorders
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 3 affected / 95 at risk

Adverse event: Investigations
Serious: yes
Organ System: Investigations
Frequency: 2 affected / 95 at risk

Adverse event: Musculoskeletal and connective tissue disorder
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 95 at risk

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

Adverse event: Renal and urinary disorders
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 95 at risk

Adverse event: Investigations
Serious: no
Organ System: Investigations
Frequency: 29 affected / 95 at risk

Adverse event: Blood and lymphatic system disorders
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 7 affected / 95 at risk

Adverse event: Infections and infestations
Serious: no
Organ System: Infections and infestations
Frequency: 7 affected / 95 at risk

Adverse event: Metabolism and nutrition disorders
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 7 affected / 95 at risk

Adverse event: Skin and subcutaneous tissue disorders
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 5 affected / 95 at risk

Adverse event: Gastrointestinal disorders
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 95 at risk

Adverse event: Musculoskeletal and connective tissue disorders
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 4 affected / 95 at risk

Adverse event: General disorders and administration site conditions
Serious: no
Organ System: General disorders
Frequency: 3 affected / 95 at risk

Adverse event: Nervous system disorders
Serious: no
Organ System: Nervous system disorders
Frequency: 3 affected / 95 at risk

Adverse event: Respiratory, thoracic, and mediastinal disorders
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 95 at risk

Adverse event: Cardiac disorders
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 95 at risk

Adverse event: Injury, poisoning, and procedural complications
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 95 at risk

Adverse event: Renal and urinary disorders
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 95 at risk

Adverse event: Vascular disorders
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 95 at risk
Study: NCT01089127

Adverse event: Myocardial infarction
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 89 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 89 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 90 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 90 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 6 affected / 90 at risk

Adverse event: Blood creatine phosphokinase increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 94 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 7 affected / 94 at risk

Adverse event: Anaemia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 92 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 92 at risk

Adverse event: Blood creatine phosphokinase increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 92 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 92 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 91 at risk

Adverse event: Blood creatine phosphokinase increased
Serious: no
Organ System: Investigations
Frequency: 2 affected / 91 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 91 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 91 at risk

Adverse event: Oesophageal obstruction
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 91 at risk

Adverse event: Blood potassium increased
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 91 at risk

Adverse event: Chronic obstructive pulmonary disease
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 91 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 91 at risk

Adverse event: Blood creatine phosphokinase increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 91 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 91 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 91 at risk

Adverse event: Dermatitis contact
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 91 at risk
Study: NCT01089361

Adverse event: Death
Serious: yes
Organ System: General disorders
Notes: All deaths in this trial were expected based on patients' clinical course and followed withdrawal of clinical care. None were suspected of being related to trial participation.
Frequency: 4 affected / 9 at risk

Adverse event: Death
Serious: yes
Organ System: General disorders
Notes: All deaths in this trial were expected based on patients' clinical course and followed withdrawal of clinical care. None were suspected of being related to trial participation.
Frequency: 2 affected / 10 at risk

Adverse event: Pericardial effusion
Serious: yes
Organ System: Cardiac disorders
Notes: Pericardial effusion, possible tamponade. Treated with drainage.
Frequency: 1 affected / 10 at risk

Adverse event: Ventricular tachycardia
Serious: yes
Organ System: Cardiac disorders
Notes: Treated with antiarrythmics
Frequency: 1 affected / 10 at risk

Adverse event: Tachycardia (atrial fibrillation)
Serious: no
Organ System: Cardiac disorders
Notes: Clinically expected based on septic presentation. Treated with cardioversion and medication.
Frequency: 3 affected / 10 at risk

Adverse event: Delirium
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 10 at risk

Adverse event: Salivation, excessive
Serious: no
Organ System: Gastrointestinal disorders
Notes: Possibly related
Frequency: 1 affected / 10 at risk
Study: NCT01089374

Adverse event: Erythema
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 11 at risk
Study: NCT01089569

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Notes: 17 subjects on Exenatide experienced nausea and vomiting. All resolved except for 1 subject were it persisted through the end of the study.
Frequency: 17 affected / 20 at risk

Adverse event: Hypersensitivity
Serious: no
Organ System: Immune system disorders
Notes: Allergic reaction
Frequency: 1 affected / 20 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Notes: Symptoms resolved on their own.
Frequency: 2 affected / 20 at risk

Adverse event: Hypoglycaemia
Serious: no
Organ System: Endocrine disorders
Frequency: 4 affected / 20 at risk

Adverse event: Pruritus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Itching at the injection sites. Persisted through end of study.
Frequency: 1 affected / 20 at risk

Adverse event: Hypoglycaemia
Serious: no
Organ System: Endocrine disorders
Frequency: 9 affected / 20 at risk

Adverse event: Hypoglycaemia
Serious: no
Organ System: Endocrine disorders
Frequency: 13 affected / 20 at risk
Study: NCT01089582

Adverse event: Death
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 603 at risk

Adverse event: Cerebral haemorrhage
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 603 at risk

Adverse event: Bradycardia
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 603 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 8 affected / 603 at risk

Adverse event: Gastrointestinal disorder
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 603 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 6 affected / 603 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 6 affected / 603 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 1 affected / 603 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 603 at risk

Adverse event: International normalised ratio increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 603 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 603 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 4 affected / 603 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 6 affected / 603 at risk

Adverse event: Psychomotor hyperactivity
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 603 at risk

Adverse event: Aggression
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 603 at risk

Adverse event: Agitation
Serious: no
Organ System: Psychiatric disorders
Frequency: 2 affected / 603 at risk

Adverse event: Anxiety
Serious: no
Organ System: Psychiatric disorders
Frequency: 2 affected / 603 at risk

Adverse event: Neuropsychological symptoms
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 603 at risk

Adverse event: Confusional state
Serious: no
Organ System: Psychiatric disorders
Frequency: 2 affected / 603 at risk

Adverse event: Delusional disorder, unspecified type
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 603 at risk

Adverse event: Depression
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 603 at risk

Adverse event: Persistent depressive disorder
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 603 at risk

Adverse event: Hallucination
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 603 at risk

Adverse event: Illusion
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 603 at risk

Adverse event: Sleep disorder
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 603 at risk
Study: NCT01089595

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

Adverse event: Cholangitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 3 at risk

Adverse event: Dehydration
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 3 at risk

Adverse event: Gastroenteritis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 3 at risk
Study: NCT01089647

Adverse event: Epistaxis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: epistaxis
Frequency: 2 affected / 13 at risk

Adverse event: Epistaxis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: epistaxis
Frequency: 1 affected / 13 at risk

Adverse event: lower leg swelling
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 13 at risk
Study: NCT01089751

Adverse event: Anaemia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 162 at risk

Adverse event: Gastrooesophageal reflux disease
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 162 at risk

Adverse event: Gastroenteritis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 162 at risk

Adverse event: Dry mouth
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 11 affected / 162 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 9 affected / 162 at risk

Adverse event: Pericardial effusion
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 158 at risk

Adverse event: Pyelonephritis acute
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 158 at risk

Adverse event: Diabetes mellitus
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 158 at risk

Adverse event: Chronic obstructive pulmonary disease
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 158 at risk

Adverse event: Dry mouth
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 6 affected / 158 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 158 at risk
Study: NCT01090024

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 4 affected / 104 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 70 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 5 affected / 68 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 67 at risk
Study: NCT01090063

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Mild Self-Limited Upper Respiratory Infection
Frequency: 4 affected / 24 at risk

Adverse event: Dermatitis acneiform
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Mild Acneiform Eruption, Self Limited
Frequency: 2 affected / 24 at risk
Study: NCT01090102

Adverse event: Death
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 31 at risk

Adverse event: Hepatic cirrhosis
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 31 at risk

Adverse event: Drug relapse
Serious: no
Organ System: General disorders
Frequency: 1 affected / 31 at risk

Adverse event: Death
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 29 at risk
Study: NCT01090180

Adverse event: Presented to ER with swelling in leg
Serious: yes
Organ System: Infections and infestations
Notes: Diagnosed with cellulitis at the ER. Determined to be possibly related due to potential immunosuppression from study medication. Reported to IRB and informed consent was updated accordingly.
Frequency: 1 affected / 33 at risk
Study: NCT01090739

Adverse event: Pain/discomfort - buttock
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Notes: Exacerbation of sciatic pain
Frequency: 1 affected / 152 at risk

Adverse event: Worsening Pelvic Organ Prolapse
Serious: yes
Organ System: Reproductive system and breast disorders
Notes: Recurrent rectal prolapse
Frequency: 1 affected / 152 at risk

Adverse event: De novo pelvic organ prolapse
Serious: yes
Organ System: Reproductive system and breast disorders
Notes: Mild cystocele / enterocele / rectocele
Frequency: 1 affected / 152 at risk

Adverse event: Exacerbated post traumatic stress disorder
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 152 at risk

Adverse event: Deep vein thrombosis
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 152 at risk

Adverse event: Worsening chronic obstructive pulmonary disease
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 152 at risk

Adverse event: De novo rectal prolapse
Serious: yes
Organ System: Reproductive system and breast disorders
Notes: Mucosal prolapse
Frequency: 1 affected / 152 at risk

Adverse event: Staphylococcal infection
Serious: yes
Organ System: Infections and infestations
Notes: Hospital acquired - Left hand
Frequency: 1 affected / 152 at risk

Adverse event: Pelvic area pain
Serious: no
Organ System: Reproductive system and breast disorders
Notes: Pain/discomfort in the general pelvic region including the buttocks, groin, pelvis, upper leg, urogenitals and abdomen.
Frequency: 43 affected / 152 at risk

Adverse event: Infection
Serious: no
Organ System: Infections and infestations
Notes: Includes incision site infection, abscess, UTIs, and fungal infections
Frequency: 22 affected / 152 at risk

Adverse event: Urinary problems
Serious: no
Organ System: Renal and urinary disorders
Notes: Includes de novo and worsening urinary incontinence and retention
Frequency: 8 affected / 152 at risk

Adverse event: Pelvic organ prolapse
Serious: no
Organ System: Reproductive system and breast disorders
Notes: Includes de novo and worsening vaginal and rectal prolapse
Frequency: 9 affected / 152 at risk

Adverse event: Haemorrhage
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 152 at risk

Adverse event: Defecatory problems
Serious: no
Organ System: Gastrointestinal disorders
Notes: includes worsening fecal incontinence and constipation
Frequency: 4 affected / 152 at risk

Adverse event: Other
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: Includes Allergic Reaction / Hypersensitivity Reaction, Diarrhea, Headache, Deep Venous Thrombosis, COPD, Nausea, Post-Traumatic Stress Disorder, Rectal Discharge, Skin Irritation, and Wound Dehiscence
Frequency: 14 affected / 152 at risk
Study: NCT01090921

Adverse event: Anaemia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 50 at risk

Adverse event: Thrombocytopenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 50 at risk

Adverse event: Lymphopenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 9 affected / 50 at risk

Adverse event: Diarrhoea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 50 at risk

Adverse event: Constipation
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 50 at risk

Adverse event: Vomiting/Nausea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 50 at risk

Adverse event: Elevated creatinine
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 50 at risk

Adverse event: Acute kidney injury
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 2 affected / 50 at risk

Adverse event: Asthenia
Serious: yes
Organ System: General disorders
Frequency: 4 affected / 50 at risk

Adverse event: Hyperglycaemia
Serious: yes
Organ System: Endocrine disorders
Frequency: 9 affected / 50 at risk
Study: NCT01090973

Adverse event: Death not associated with CTCAE term - Disease progression NOS
Serious: yes
Organ System: Blood and lymphatic system disorders
Notes: Grade 5. Unrelated to study drug.
Frequency: 1 affected / 1 at risk

Adverse event: Hemorrhage, GI - Upper GI NOS
Serious: no
Organ System: Gastrointestinal disorders
Notes: Grade 3. Unrelated to study drug.
Frequency: 1 affected / 1 at risk
Study: NCT01091155

Adverse event: Leak
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 16 affected / 279 at risk

Adverse event: Abscess
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 8 affected / 279 at risk

Adverse event: Fistula
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 2 affected / 279 at risk
Study: NCT01091363

Adverse event: Skin reaction
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 3 affected / 3 at risk

Adverse event: Skin reaction
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 2 at risk
Study: NCT01091675

Adverse event: cavernous hemangioma
Serious: yes
Organ System: Vascular disorders
Notes: The investigator evaluated this serious adverse event SAE, as possibly related to the study drug, The patient already suffered from cavernoma pedunculi left quadrigeminy but was unknown until symptoms appearance. Was withdrawn from the study.
Frequency: 1 affected / 57 at risk

Adverse event: Hypertension
Serious: no
Organ System: General disorders
Notes: 7 patients were withdrew from the study due to hypertension. 1 case certainly related to the study drug. 3 patients demonstrate seriousness grade 1, and grade 2 in 4 patients
Frequency: 7 affected / 57 at risk

Adverse event: Tachycardia
Serious: no
Organ System: Cardiac disorders
Frequency: 3 affected / 57 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 57 at risk

Adverse event: Anxiety
Serious: no
Organ System: General disorders
Frequency: 2 affected / 57 at risk

Adverse event: Nervousness
Serious: no
Organ System: General disorders
Frequency: 2 affected / 57 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: General disorders
Frequency: 2 affected / 57 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 57 at risk

Adverse event: Weight increased
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 57 at risk
Study: NCT01091974

Adverse event: Headache
Serious: no
Organ System: General disorders
Frequency: 2 affected / 23 at risk

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