Adverse Events Module

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Adverse Events Module

For researchers submitting trial data to ClinicalTrials.gov, the Adverse Events module is one of four mandatory results sections. It requires reporting in three primary categories: All-Cause Mortality: A table tracking all deaths that occurred during the study, regardless of cause. Serious Adverse Events (SAEs): A tabular summary of events resulting in death, life-threatening conditions, hospitalization, or significant disability. Other Adverse Events: A table for non-serious events that exceed a specific frequency threshold, such as 5% within any study arm.

Adverse Events Module path is as follows:

Study -> Results Section -> Adverse Events Module -> Event Groups

Study -> Results Section -> Adverse Events Module -> Serious Events

Study -> Results Section -> Adverse Events Module -> Other Events

Adverse Events Module

Ignite Creation Date: 2025-12-25 @ 3:53 AM
Ignite Modification Date: 2025-12-26 @ 2:42 AM
NCT ID: NCT02599402
Description: None
Frequency Threshold: 5
Time Frame: From first dose to 30 days after last dose (up to approximately 37 months)
Study: NCT02599402
Study Brief: Nivolumab Combined With Ipilimumab Followed by Nivolumab Monotherapy as First-Line Treatment for Patients With Advanced Melanoma
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Nivolumab + Ipilimumab ECOG PS2 Nivolumab 1 mg/kg IV + Ipilimumab 3 mg/kg IV Q3W x 4 doses up to 3 months Then Part 2: Nivolumab (3mg/kg or 240mg) IV Q2W up to 21 months Participants were grouped in to Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 0-2 subgroup 29 None 31 55 49 55 View
Nivolumab + Ipilimumab Mucosal Nivolumab 1 mg/kg IV + Ipilimumab 3 mg/kg IV Q3W x 4 doses up to 3 months Then Part 2: Nivolumab (3mg/kg or 240mg) IV Q2W up to 21 months Participants were grouped in to Disease Subtype subgroup Mucosal 20 None 26 32 28 32 View
Nivolumab + Ipilimumab Total Part 1: Nivolumab 1 mg/kg IV + Ipilimumab 3 mg/kg IV Q3W x 4 up to 3 months Then Part 2: Nivolumab (3mg/kg or 240mg) IV Q2W up to 21 months 199 None 356 533 503 533 View
Nivolumab + Ipilimumab ECOG PS0-1 Part 1: Nivolumab 1 mg/kg IV + Ipilimumab 3 mg/kg IV Q3W x 4 doses up to 3 months Then Part 2: Nivolumab (3mg/kg or 240mg) IV Q2W up to 21 months Participants were grouped in to Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 0-1 subgroup 169 None 324 477 453 477 View
Nivolumab + Ipilimumab Brain Metastasis Nivolumab 1 mg/kg IV + Ipilimumab 3 mg/kg IV Q3W x 4 doses up to 3 months Then Part 2: Nivolumab (3mg/kg or 240mg) IV Q2W up to 21 months Participants were grouped in to Brain Metastasis subgroup 13 None 31 42 37 42 View
Nivolumab + Ipilimumab Ocular/Uveal Nivolumab 1 mg/kg IV + Ipilimumab 3 mg/kg IV Q3W x 4 doses up to 3 months Then Part 2: Nivolumab (3mg/kg or 240mg) IV Q2W up to 21 months Participants were grouped in to Disease Subtype subgroup Ocular/Uveal 41 None 40 64 61 64 View
Nivolumab + Ipilimumab Cutaneous Nivolumab 1 mg/kg IV + Ipilimumab 3 mg/kg IV Q3W x 4 doses up to 3 months Then Part 2: Nivolumab (3mg/kg or 240mg) IV Q2W up to 21 months Participants were grouped in to Disease Subtype subgroup Cutaneous 107 None 238 365 347 365 View
Nivolumab + Ipilimumab Acral Nivolumab 1 mg/kg IV + Ipilimumab 3 mg/kg IV Q3W x 4 doses up to 3 months Then Part 2: Nivolumab (3mg/kg or 240mg) IV Q2W up to 21 months Participants were grouped in to Disease Subtype subgroup Acral 6 None 9 10 10 10 View
Nivolumab + Ipilimumab Other Nivolumab 1 mg/kg IV + Ipilimumab 3 mg/kg IV Q3W x 4 doses up to 3 months Then Part 2: Nivolumab (3mg/kg or 240mg) IV Q2W up to 21 months Participants were grouped in to Disease Subtype subgroup Other 25 None 43 62 57 62 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Agranulocytosis SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 23.0 View
Anaemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 23.0 View
Aplastic anaemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 23.0 View
Autoimmune pancytopenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 23.0 View
Iron deficiency anaemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 23.0 View
Lymphopenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 23.0 View
Thrombocytopenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 23.0 View
Arrhythmia SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 23.0 View
Atrial fibrillation SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 23.0 View
Atrial flutter SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 23.0 View
Atrioventricular block SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 23.0 View
Cardiac failure congestive SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 23.0 View
Cardiogenic shock SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 23.0 View
Myocardial infarction SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 23.0 View
Myocarditis SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 23.0 View
Stress cardiomyopathy SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 23.0 View
Supraventricular tachycardia SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 23.0 View
Vertigo SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders MedDRA 23.0 View
Adrenal insufficiency SYSTEMATIC_ASSESSMENT Endocrine disorders MedDRA 23.0 View
Adrenocortical insufficiency acute SYSTEMATIC_ASSESSMENT Endocrine disorders MedDRA 23.0 View
Hyperthyroidism SYSTEMATIC_ASSESSMENT Endocrine disorders MedDRA 23.0 View
Hypophysitis SYSTEMATIC_ASSESSMENT Endocrine disorders MedDRA 23.0 View
Hypopituitarism SYSTEMATIC_ASSESSMENT Endocrine disorders MedDRA 23.0 View
Immune-mediated hyperthyroidism SYSTEMATIC_ASSESSMENT Endocrine disorders MedDRA 23.0 View
Lymphocytic hypophysitis SYSTEMATIC_ASSESSMENT Endocrine disorders MedDRA 23.0 View
Primary adrenal insufficiency SYSTEMATIC_ASSESSMENT Endocrine disorders MedDRA 23.0 View
Thyroiditis SYSTEMATIC_ASSESSMENT Endocrine disorders MedDRA 23.0 View
Thyroiditis acute SYSTEMATIC_ASSESSMENT Endocrine disorders MedDRA 23.0 View
Autoimmune uveitis SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 23.0 View
Diplopia SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 23.0 View
Photopsia SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 23.0 View
Retinal detachment SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 23.0 View
Abdominal pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 23.0 View
Abdominal pain upper SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 23.0 View
Ascites SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 23.0 View
Autoimmune colitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 23.0 View
Chronic gastritis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 23.0 View
Colitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 23.0 View
Colitis ulcerative SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 23.0 View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 23.0 View
Diarrhoea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 23.0 View
Dry mouth SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 23.0 View
Enteritis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 23.0 View
Enterocolitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 23.0 View
Gastritis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 23.0 View
Gastrointestinal toxicity SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 23.0 View
Immune-mediated enterocolitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 23.0 View
Inguinal hernia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 23.0 View
Intestinal obstruction SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 23.0 View
Intestinal perforation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 23.0 View
Mouth haemorrhage SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 23.0 View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 23.0 View
Pancreatic failure SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 23.0 View
Pancreatitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 23.0 View
Pancreatitis acute SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 23.0 View
Rectal haemorrhage SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 23.0 View
Small intestinal obstruction SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 23.0 View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 23.0 View
Asthenia SYSTEMATIC_ASSESSMENT General disorders MedDRA 23.0 View
Chest pain SYSTEMATIC_ASSESSMENT General disorders MedDRA 23.0 View
Fatigue SYSTEMATIC_ASSESSMENT General disorders MedDRA 23.0 View
General physical health deterioration SYSTEMATIC_ASSESSMENT General disorders MedDRA 23.0 View
Hyperthermia SYSTEMATIC_ASSESSMENT General disorders MedDRA 23.0 View
Non-cardiac chest pain SYSTEMATIC_ASSESSMENT General disorders MedDRA 23.0 View
Cholangitis SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 23.0 View
Cholestasis SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 23.0 View
Drug-induced liver injury SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 23.0 View
Hepatic failure SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 23.0 View
Hepatitis SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 23.0 View
Hepatitis acute SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 23.0 View
Hepatobiliary disease SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 23.0 View
Hepatocellular injury SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 23.0 View
Hepatotoxicity SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 23.0 View
Immune-mediated hepatitis SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 23.0 View
Anaphylactic shock SYSTEMATIC_ASSESSMENT Immune system disorders MedDRA 23.0 View
Cytokine release syndrome SYSTEMATIC_ASSESSMENT Immune system disorders MedDRA 23.0 View
Drug hypersensitivity SYSTEMATIC_ASSESSMENT Immune system disorders MedDRA 23.0 View
Haemophagocytic lymphohistiocytosis SYSTEMATIC_ASSESSMENT Immune system disorders MedDRA 23.0 View
Abscess limb SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 23.0 View
Alveolar osteitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 23.0 View
Bronchitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 23.0 View
Bronchitis viral SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 23.0 View
Campylobacter gastroenteritis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 23.0 View
Cellulitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 23.0 View
Clostridium difficile infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 23.0 View
Device related infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 23.0 View
Encephalitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 23.0 View
Endocarditis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 23.0 View
Enteritis infectious SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 23.0 View
Erysipelas SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 23.0 View
Gastroenteritis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 23.0 View
Gastrointestinal viral infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 23.0 View
Herpes zoster SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 23.0 View
Infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 23.0 View
Influenza SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 23.0 View
Lower respiratory tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 23.0 View
Meningitis aseptic SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 23.0 View
Pharyngitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 23.0 View
Pneumococcal infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 23.0 View
Pneumocystis jirovecii pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 23.0 View
Pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 23.0 View
Post procedural cellulitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 23.0 View
Pyoderma SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 23.0 View
Respiratory tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 23.0 View
Respiratory tract infection viral SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 23.0 View
Rhinovirus infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 23.0 View
Sepsis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 23.0 View
Septic arthritis streptococcal SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 23.0 View
Septic shock SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 23.0 View
Sinusitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 23.0 View
Staphylococcal bacteraemia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 23.0 View
Staphylococcal sepsis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 23.0 View
Upper respiratory tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 23.0 View
Urinary tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 23.0 View
Urosepsis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 23.0 View
Viral infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 23.0 View
Wound infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 23.0 View
Wound infection staphylococcal SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 23.0 View
Accidental overdose SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 23.0 View
Clavicle fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 23.0 View
Infusion related reaction SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 23.0 View
Overdose SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 23.0 View
Post procedural fever SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 23.0 View
Subdural haematoma SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 23.0 View
Alanine aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 23.0 View
Aspartate aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 23.0 View
C-reactive protein increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 23.0 View
General physical condition abnormal SYSTEMATIC_ASSESSMENT Investigations MedDRA 23.0 View
Liver function test increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 23.0 View
Oxygen saturation decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 23.0 View
Transaminases increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 23.0 View
White blood cells urine positive SYSTEMATIC_ASSESSMENT Investigations MedDRA 23.0 View
Dehydration SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 23.0 View
Diabetes mellitus SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 23.0 View
Diabetic ketoacidosis SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 23.0 View
Electrolyte imbalance SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 23.0 View
Hypercalcaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 23.0 View
Hyperglycaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 23.0 View
Hyperkalaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 23.0 View
Hypokalaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 23.0 View
Hyponatraemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 23.0 View
Ketoacidosis SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 23.0 View
Malnutrition SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 23.0 View
Type 1 diabetes mellitus SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 23.0 View
Type 2 diabetes mellitus SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 23.0 View
Arthralgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 23.0 View
Arthritis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 23.0 View
Back pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 23.0 View
Bursitis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 23.0 View
Intervertebral disc degeneration SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 23.0 View
Intervertebral disc protrusion SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 23.0 View
Jaw cyst SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 23.0 View
Musculoskeletal chest pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 23.0 View
Pain in extremity SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 23.0 View
Pathological fracture SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 23.0 View
Rhabdomyolysis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 23.0 View
Rheumatic disorder SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 23.0 View
Spinal pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 23.0 View
Basal cell carcinoma SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 23.0 View
Cancer pain SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 23.0 View
Chronic myeloid leukaemia SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 23.0 View
Malignant neoplasm progression SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 23.0 View
Metastases to liver SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 23.0 View
Metastatic malignant melanoma SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 23.0 View
Neoplasm malignant SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 23.0 View
Prostate cancer SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 23.0 View
Squamous cell carcinoma SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 23.0 View
Tumour haemorrhage SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 23.0 View
Ataxia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 23.0 View
Autoimmune neuropathy SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 23.0 View
Autonomic neuropathy SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 23.0 View
Carpal tunnel syndrome SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 23.0 View
Cerebral haemorrhage SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 23.0 View
Cerebrospinal fluid leakage SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 23.0 View
Cerebrovascular accident SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 23.0 View
Cubital tunnel syndrome SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 23.0 View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 23.0 View
Facial paralysis SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 23.0 View
Guillain-Barre syndrome SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 23.0 View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 23.0 View
Intercostal neuralgia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 23.0 View
Peripheral sensory neuropathy SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 23.0 View
Petit mal epilepsy SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 23.0 View
Seizure SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 23.0 View
Spinal cord compression SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 23.0 View
Syncope SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 23.0 View
Anxiety SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 23.0 View
Confusional state SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 23.0 View
Psychotic disorder SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 23.0 View
Acute kidney injury SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 23.0 View
Haematuria SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 23.0 View
Immune-mediated renal disorder SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 23.0 View
Nephritis SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 23.0 View
Renal failure SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 23.0 View
Tubulointerstitial nephritis SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 23.0 View
Urinary tract obstruction SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 23.0 View
Metrorrhagia SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA 23.0 View
Chronic obstructive pulmonary disease SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 23.0 View
Dyspnoea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 23.0 View
Interstitial lung disease SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 23.0 View
Pleural effusion SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 23.0 View
Pleurisy SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 23.0 View
Pneumonia aspiration SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 23.0 View
Pneumonitis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 23.0 View
Pulmonary embolism SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 23.0 View
Pulmonary haematoma SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 23.0 View
Pulmonary oedema SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 23.0 View
Respiratory failure SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 23.0 View
Dermatitis SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 23.0 View
Dermatitis allergic SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 23.0 View
Drug eruption SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 23.0 View
Drug reaction with eosinophilia and systemic symptoms SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 23.0 View
Erythema SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 23.0 View
Lichen planus SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 23.0 View
Pemphigoid SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 23.0 View
Psoriasis SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 23.0 View
Rash SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 23.0 View
Rash maculo-papular SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 23.0 View
Stevens-Johnson syndrome SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 23.0 View
Deep vein thrombosis SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 23.0 View
Hypertension SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 23.0 View
Hypotension SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 23.0 View
Peripheral arterial occlusive disease SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 23.0 View
Shock SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 23.0 View
Vasculitis SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 23.0 View
Vein collapse SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 23.0 View
Venous thrombosis SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 23.0 View
Polyserositis SYSTEMATIC_ASSESSMENT General disorders MedDRA 23.0 View
Pyrexia SYSTEMATIC_ASSESSMENT General disorders MedDRA 23.0 View
Autoimmune hepatitis SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 23.0 View
Enterocolitis infectious SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 23.0 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Oedema peripheral SYSTEMATIC_ASSESSMENT General disorders MedDRA 23.0 View
Pyrexia SYSTEMATIC_ASSESSMENT General disorders MedDRA 23.0 View
Nasopharyngitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 23.0 View
Alanine aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 23.0 View
Amylase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 23.0 View
Aspartate aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 23.0 View
Blood alkaline phosphatase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 23.0 View
Gamma-glutamyltransferase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 23.0 View
Lipase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 23.0 View
Weight decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 23.0 View
Decreased appetite SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 23.0 View
Hypokalaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 23.0 View
Arthralgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 23.0 View
Back pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 23.0 View
Musculoskeletal pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 23.0 View
Myalgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 23.0 View
Pain in extremity SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 23.0 View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 23.0 View
Insomnia SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 23.0 View
Cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 23.0 View
Dyspnoea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 23.0 View
Pruritus SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 23.0 View
Rash SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 23.0 View
Rash macular SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 23.0 View
Rash maculo-papular SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 23.0 View
Rash pruritic SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 23.0 View
Vitiligo SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 23.0 View
Hypertension SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 23.0 View
Influenza like illness SYSTEMATIC_ASSESSMENT General disorders MedDRA 23.0 View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 23.0 View
Chills SYSTEMATIC_ASSESSMENT General disorders MedDRA 23.0 View
Fatigue SYSTEMATIC_ASSESSMENT General disorders MedDRA 23.0 View
Anaemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 23.0 View
Hyperthyroidism SYSTEMATIC_ASSESSMENT Endocrine disorders MedDRA 23.0 View
Hypophysitis SYSTEMATIC_ASSESSMENT Endocrine disorders MedDRA 23.0 View
Hypothyroidism SYSTEMATIC_ASSESSMENT Endocrine disorders MedDRA 23.0 View
Abdominal pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 23.0 View
Abdominal pain upper SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 23.0 View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 23.0 View
Diarrhoea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 23.0 View
Dry mouth SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 23.0 View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 23.0 View
Asthenia SYSTEMATIC_ASSESSMENT General disorders MedDRA 23.0 View