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: 2025-12-24 @ 12:43 PM
Ignite Modification Date: 2025-12-25 @ 12:13 PM
NCT ID: NCT03824561
Description: At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the study treatment.
Frequency Threshold: 1
Time Frame: Up to Week 54
Study: NCT03824561
Study Brief: Special Drug-Use Surveillance Study on Vedolizumab for IV Infusion 300 mg [Ulcerative Colitis]
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Vedolizumab 300 mg Vedolizumab IV infusion 300 mg, at Weeks 0, 2 and 6, and every 8 weeks thereafter, for up to 54 weeks. Participants received IV infusion as part of routine normal practice. 5 None 82 1091 29 1091 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Appendicitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA version 27.1 View
Atypical pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA version 27.1 View
Gastroenteritis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA version 27.1 View
Gastroenteritis Escherichia coli SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA version 27.1 View
Liver abscess SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA version 27.1 View
Pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA version 27.1 View
Cytomegalovirus enterocolitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA version 27.1 View
Enteritis infectious SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA version 27.1 View
Pneumonia bacterial SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA version 27.1 View
Herpes zoster oticus SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA version 27.1 View
COVID-19 SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA version 27.1 View
Adenocarcinoma of colon SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA version 27.1 View
Colon cancer SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA version 27.1 View
Metastases to bone SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA version 27.1 View
Metastases to lung SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA version 27.1 View
Hepatocellular carcinoma SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA version 27.1 View
Appendix cancer SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA version 27.1 View
Follicular lymphoma SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA version 27.1 View
Anaemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA version 27.1 View
Cerebral infarction SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA version 27.1 View
Cataract SYSTEMATIC_ASSESSMENT Eye disorders MedDRA version 27.1 View
Coronary artery stenosis SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA version 27.1 View
Myocardial infarction SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA version 27.1 View
Peripheral arterial occlusive disease SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA version 27.1 View
Bronchiectasis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA version 27.1 View
Eosinophilic pneumonia SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA version 27.1 View
Organising pneumonia SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA version 27.1 View
Colitis ulcerative SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA version 27.1 View
Haematochezia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA version 27.1 View
Intussusception SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA version 27.1 View
Melaena SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA version 27.1 View
Oesophageal stenosis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA version 27.1 View
Pancreatitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA version 27.1 View
Pancreatitis acute SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA version 27.1 View
Bile duct stone SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA version 27.1 View
Cholecystitis acute SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA version 27.1 View
Dermal cyst SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA version 27.1 View
Arthralgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA version 27.1 View
Polyarthritis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA version 27.1 View
Paroxysmal nocturnal haemoglobinuria SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA version 27.1 View
Diabetic nephropathy SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA version 27.1 View
Foetal death SYSTEMATIC_ASSESSMENT Pregnancy, puerperium and perinatal conditions MedDRA version 27.1 View
Pyrexia SYSTEMATIC_ASSESSMENT General disorders MedDRA version 27.1 View
Neutrophil toxic granulation present SYSTEMATIC_ASSESSMENT Investigations MedDRA version 27.1 View
C-reactive protein increased SYSTEMATIC_ASSESSMENT Investigations MedDRA version 27.1 View
Femoral neck fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA version 27.1 View
Femur fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA version 27.1 View
Spinal compression fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA version 27.1 View
Infusion related reaction SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA version 27.1 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Nasopharyngitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA version 27.1 View
Infusion related reaction SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA version 27.1 View