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 @ 3:48 AM
Ignite Modification Date: 2025-12-26 @ 2:36 AM
NCT ID: NCT02563002
Description: All-cause mortality (ACM)=all randomized participants. AEs=all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment are excluded. Per protocol, collection of AEs and ACM were planned to be done in first and second courses.
Frequency Threshold: 5
Time Frame: Up to approximately 91 months
Study: NCT02563002
Study Brief: Study of Pembrolizumab (MK-3475) vs Standard Therapy in Participants With Microsatellite Instability-High (MSI-H) or Mismatch Repair Deficient (dMMR) Stage IV Colorectal Carcinoma (MK-3475-177/KEYNOTE-177)
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Pembrolizumab First Course Participants received pembrolizumab 200 mg intravenously (IV) on Day 1 of each 21-day cycle (Q3W) for up to 35 treatments (approximately 2 years). 68 None 62 153 145 153 View
Standard of Care (SOC) First Course Participants received 1 of 6 possible standard chemotherapy regimens: mFOLFOX6, or mFOLFOX6+bevacizumab 5 mg/kg IV on Day 1 of each 2-week cycle, or mFOLFOX6+cetuximab 400 mg/m\^2 IV over 2 hours then 250 mg/m\^2 over 1 hour weekly in each 2-week cycle, or FOLFIRI, or FOLFIRI+bevacizumab 5 mg/kg IV on Day 1 of each 2-week cycle, or FOLFIRI+cetuximab 400 mg/m\^2 IV over 2 hours then 250 mg/m\^2 over 1 hour weekly in each 2-week cycle. 58 None 76 143 142 143 View
SOC Switched Over to Pembrolizumab Eligible participants with documented disease progression following chemotherapy in SOC arm switched over to receive pembrolizumab for up to 35 cycles (approximately 2 years). 30 None 27 57 53 57 View
Pembrolizumab Second Course Participants who received pembrolizumab as a first course and stopped the first course of pembrolizumab due to complete response (CR) or completed the first course of pembrolizumab and had stable disease but progressed after discontinuation, initiated a second course of pembrolizumab at the investigator's discretion for up to 17 cycles (approximately 1 year additional). 4 None 3 12 11 12 View
SOC Switched Over to Pembrolizumab-Second Course Participants who switched over from SOC and received pembrolizumab and subsequently stopped the first course of pembrolizumab due to complete response (CR) or completed the first course of pembrolizumab and had stable disease but progressed after discontinuation, initiated a second course of pembrolizumab at the investigator's discretion for up to 17 cycles (approximately 1 year additional). 2 None 1 5 4 5 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Anaemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 26.0 View
Febrile neutropenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 26.0 View
Leukocytosis SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 26.0 View
Neutropenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 26.0 View
Thrombocytopenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 26.0 View
Acute coronary syndrome SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 26.0 View
Acute myocardial infarction SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 26.0 View
Angina pectoris SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 26.0 View
Atrial fibrillation SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 26.0 View
Cardiac arrest SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 26.0 View
Myocardial infarction SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 26.0 View
Supraventricular tachycardia SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 26.0 View
Addison's disease SYSTEMATIC_ASSESSMENT Endocrine disorders MedDRA 26.0 View
Adrenal insufficiency SYSTEMATIC_ASSESSMENT Endocrine disorders MedDRA 26.0 View
Adrenocortical insufficiency acute SYSTEMATIC_ASSESSMENT Endocrine disorders MedDRA 26.0 View
Autoimmune thyroiditis SYSTEMATIC_ASSESSMENT Endocrine disorders MedDRA 26.0 View
Angle closure glaucoma SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 26.0 View
Vision blurred SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 26.0 View
Abdominal pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 26.0 View
Abdominal pain upper SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 26.0 View
Anal fistula SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 26.0 View
Autoimmune colitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 26.0 View
Colitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 26.0 View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 26.0 View
Diarrhoea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 26.0 View
Diarrhoea haemorrhagic SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 26.0 View
Diverticular perforation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 26.0 View
Duodenal perforation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 26.0 View
Duodenal ulcer SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 26.0 View
Enterocolitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 26.0 View
Faecaloma SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 26.0 View
Gastritis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 26.0 View
Gastrointestinal haemorrhage SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 26.0 View
Gastrointestinal inflammation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 26.0 View
Ileus SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 26.0 View
Impaired gastric emptying SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 26.0 View
Intestinal obstruction SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 26.0 View
Intestinal perforation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 26.0 View
Intra-abdominal haemorrhage SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 26.0 View
Large intestinal obstruction SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 26.0 View
Large intestine perforation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 26.0 View
Pancreatitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 26.0 View
Short-bowel syndrome SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 26.0 View
Small intestinal obstruction SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 26.0 View
Subileus SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 26.0 View
Upper gastrointestinal haemorrhage SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 26.0 View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 26.0 View
Asthenia SYSTEMATIC_ASSESSMENT General disorders MedDRA 26.0 View
Chest pain SYSTEMATIC_ASSESSMENT General disorders MedDRA 26.0 View
Death SYSTEMATIC_ASSESSMENT General disorders MedDRA 26.0 View
Device related thrombosis SYSTEMATIC_ASSESSMENT General disorders MedDRA 26.0 View
Fatigue SYSTEMATIC_ASSESSMENT General disorders MedDRA 26.0 View
Gait disturbance SYSTEMATIC_ASSESSMENT General disorders MedDRA 26.0 View
General physical health deterioration SYSTEMATIC_ASSESSMENT General disorders MedDRA 26.0 View
Mucosal inflammation SYSTEMATIC_ASSESSMENT General disorders MedDRA 26.0 View
Oedema peripheral SYSTEMATIC_ASSESSMENT General disorders MedDRA 26.0 View
Pyrexia SYSTEMATIC_ASSESSMENT General disorders MedDRA 26.0 View
Acute hepatic failure SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 26.0 View
Autoimmune hepatitis SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 26.0 View
Bile duct stenosis SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 26.0 View
Biliary dilatation SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 26.0 View
Cholangitis SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 26.0 View
Cholangitis acute SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 26.0 View
Cholecystitis SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 26.0 View
Cholecystitis acute SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 26.0 View
Cholestasis SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 26.0 View
Hepatic failure SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 26.0 View
Hepatitis SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 26.0 View
Immune-mediated hepatitis SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 26.0 View
Jaundice cholestatic SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 26.0 View
Cytokine release syndrome SYSTEMATIC_ASSESSMENT Immune system disorders MedDRA 26.0 View
Hypersensitivity SYSTEMATIC_ASSESSMENT Immune system disorders MedDRA 26.0 View
Abdominal sepsis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 26.0 View
COVID-19 SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 26.0 View
Cellulitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 26.0 View
Cholecystitis infective SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 26.0 View
Clostridium difficile colitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 26.0 View
Clostridium difficile infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 26.0 View
Device related infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 26.0 View
Diverticulitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 26.0 View
Endophthalmitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 26.0 View
Escherichia pyelonephritis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 26.0 View
Escherichia sepsis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 26.0 View
Gastroenteritis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 26.0 View
Gastrointestinal infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 26.0 View
Infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 26.0 View
Influenza SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 26.0 View
Lower respiratory tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 26.0 View
Lymph gland infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 26.0 View
Meningoencephalitis viral SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 26.0 View
Pelvic infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 26.0 View
Pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 26.0 View
Pneumonia streptococcal SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 26.0 View
Pyelonephritis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 26.0 View
Pyelonephritis acute SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 26.0 View
Respiratory tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 26.0 View
Sepsis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 26.0 View
Stoma site abscess SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 26.0 View
Stoma site infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 26.0 View
Urinary tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 26.0 View
Urosepsis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 26.0 View
Vascular device infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 26.0 View
Viral infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 26.0 View
Accidental overdose SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 26.0 View
Gastrointestinal stoma complication SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 26.0 View
Head injury SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 26.0 View
Hip fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 26.0 View
Stoma site haemorrhage SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 26.0 View
Subdural haematoma SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 26.0 View
Tibia fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 26.0 View
Urinary tract stoma complication SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 26.0 View
Liver function test increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 26.0 View
Neutrophil count decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 26.0 View
Norovirus test positive SYSTEMATIC_ASSESSMENT Investigations MedDRA 26.0 View
Decreased appetite SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 26.0 View
Dehydration SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 26.0 View
Failure to thrive SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 26.0 View
Hyperglycaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 26.0 View
Hypoalbuminaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 26.0 View
Hypoglycaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 26.0 View
Hypokalaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 26.0 View
Hypomagnesaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 26.0 View
Hyponatraemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 26.0 View
Type 2 diabetes mellitus SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 26.0 View
Arthralgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 26.0 View
Autoimmune arthritis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 26.0 View
Back pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 26.0 View
Myositis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 26.0 View
Pain in jaw SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 26.0 View
Basal cell carcinoma SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 26.0 View
Bladder neoplasm SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 26.0 View
Breast cancer SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 26.0 View
Cancer pain SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 26.0 View
Colorectal adenoma SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 26.0 View
Infected neoplasm SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 26.0 View
Lung carcinoma cell type unspecified recurrent SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 26.0 View
Oropharyngeal cancer SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 26.0 View
Rectal neoplasm SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 26.0 View
Squamous cell carcinoma SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 26.0 View
Tumour associated fever SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 26.0 View
Tumour pain SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 26.0 View
Vaginal neoplasm SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 26.0 View
Amnesia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 26.0 View
Aphasia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 26.0 View
Carotid artery stenosis SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 26.0 View
Cerebral infarction SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 26.0 View
Cerebrovascular accident SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 26.0 View
Occipital neuralgia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 26.0 View
Pseudobulbar palsy SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 26.0 View
Syncope SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 26.0 View
Transient ischaemic attack SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 26.0 View
Confusional state SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 26.0 View
Depression SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 26.0 View
Suicide attempt SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 26.0 View
Acute kidney injury SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 26.0 View
Autoimmune nephritis SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 26.0 View
Glomerulonephritis SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 26.0 View
Hydronephrosis SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 26.0 View
Prerenal failure SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 26.0 View
Renal failure SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 26.0 View
Renal impairment SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 26.0 View
Aspiration SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 26.0 View
Chronic obstructive pulmonary disease SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 26.0 View
Dyspnoea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 26.0 View
Hyperventilation SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 26.0 View
Interstitial lung disease SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 26.0 View
Pneumonitis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 26.0 View
Pulmonary embolism SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 26.0 View
Respiratory failure SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 26.0 View
Diabetic foot SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 26.0 View
Rash SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 26.0 View
Skin erosion SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 26.0 View
Skin ulcer SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 26.0 View
Aortic dissection SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 26.0 View
Deep vein thrombosis SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 26.0 View
Embolism SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 26.0 View
Hypertension SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 26.0 View
Superior vena cava syndrome SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 26.0 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Anaemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 26.0 View
Leukopenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 26.0 View
Lymphadenopathy SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 26.0 View
Neutropenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 26.0 View
Thrombocytopenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 26.0 View
Atrial fibrillation SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 26.0 View
Hyperthyroidism SYSTEMATIC_ASSESSMENT Endocrine disorders MedDRA 26.0 View
Hypothyroidism SYSTEMATIC_ASSESSMENT Endocrine disorders MedDRA 26.0 View
Dry eye SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 26.0 View
Ocular hyperaemia SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 26.0 View
Vision blurred SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 26.0 View
Abdominal pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 26.0 View
Abdominal pain upper SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 26.0 View
Ascites SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 26.0 View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 26.0 View
Diarrhoea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 26.0 View
Dry mouth SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 26.0 View
Dyspepsia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 26.0 View
Gastrooesophageal reflux disease SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 26.0 View
Haemorrhoids SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 26.0 View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 26.0 View
Stomatitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 26.0 View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 26.0 View
Asthenia SYSTEMATIC_ASSESSMENT General disorders MedDRA 26.0 View
Chest pain SYSTEMATIC_ASSESSMENT General disorders MedDRA 26.0 View
Chills SYSTEMATIC_ASSESSMENT General disorders MedDRA 26.0 View
Fatigue SYSTEMATIC_ASSESSMENT General disorders MedDRA 26.0 View
Impaired healing SYSTEMATIC_ASSESSMENT General disorders MedDRA 26.0 View
Influenza like illness SYSTEMATIC_ASSESSMENT General disorders MedDRA 26.0 View
Malaise SYSTEMATIC_ASSESSMENT General disorders MedDRA 26.0 View
Mucosal inflammation SYSTEMATIC_ASSESSMENT General disorders MedDRA 26.0 View
Oedema peripheral SYSTEMATIC_ASSESSMENT General disorders MedDRA 26.0 View
Pain SYSTEMATIC_ASSESSMENT General disorders MedDRA 26.0 View
Peripheral swelling SYSTEMATIC_ASSESSMENT General disorders MedDRA 26.0 View
Pyrexia SYSTEMATIC_ASSESSMENT General disorders MedDRA 26.0 View
Temperature intolerance SYSTEMATIC_ASSESSMENT General disorders MedDRA 26.0 View
Candida infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 26.0 View
Cystitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 26.0 View
Influenza SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 26.0 View
Nasopharyngitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 26.0 View
Oral candidiasis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 26.0 View
Paronychia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 26.0 View
Tooth infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 26.0 View
Upper respiratory tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 26.0 View
Urinary tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 26.0 View
Fall SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 26.0 View
Alanine aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 26.0 View
Aspartate aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 26.0 View
Blood alkaline phosphatase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 26.0 View
Blood creatine phosphokinase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 26.0 View
Blood creatinine increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 26.0 View
Cardiac murmur SYSTEMATIC_ASSESSMENT Investigations MedDRA 26.0 View
Gamma-glutamyltransferase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 26.0 View
Neutrophil count decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 26.0 View
Platelet count decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 26.0 View
Weight decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 26.0 View
White blood cell count decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 26.0 View
Decreased appetite SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 26.0 View
Dehydration SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 26.0 View
Hypercalcaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 26.0 View
Hyperglycaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 26.0 View
Hypoalbuminaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 26.0 View
Hypokalaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 26.0 View
Hyponatraemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 26.0 View
Arthralgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 26.0 View
Back pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 26.0 View
Muscle spasms SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 26.0 View
Muscular weakness SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 26.0 View
Myalgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 26.0 View
Neck pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 26.0 View
Pain in extremity SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 26.0 View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 26.0 View
Dysgeusia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 26.0 View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 26.0 View
Hemiparaesthesia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 26.0 View
Hypoaesthesia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 26.0 View
Neuropathy peripheral SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 26.0 View
Paraesthesia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 26.0 View
Peripheral sensory neuropathy SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 26.0 View
Anger SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 26.0 View
Anxiety SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 26.0 View
Depression SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 26.0 View
Discouragement SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 26.0 View
Insomnia SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 26.0 View
Proteinuria SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 26.0 View
Renal impairment SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 26.0 View
Cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 26.0 View
Dysphonia SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 26.0 View
Dyspnoea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 26.0 View
Epistaxis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 26.0 View
Hiccups SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 26.0 View
Oropharyngeal pain SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 26.0 View
Productive cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 26.0 View
Rhinorrhoea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 26.0 View
Alopecia SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 26.0 View
Dermatitis acneiform SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 26.0 View
Dry skin SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 26.0 View
Palmar-plantar erythrodysaesthesia syndrome SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 26.0 View
Pruritus SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 26.0 View
Psoriasis SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 26.0 View
Rash SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 26.0 View
Rash maculo-papular SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 26.0 View
Skin hyperpigmentation SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 26.0 View
Superficial inflammatory dermatosis SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 26.0 View
Embolism SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 26.0 View
Hypertension SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 26.0 View
Hypotension SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 26.0 View