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 @ 9:21 PM
Ignite Modification Date: 2025-12-25 @ 7:08 PM
NCT ID: NCT00813904
Description: None
Frequency Threshold: 5
Time Frame: None
Study: NCT00813904
Study Brief: Immunogenicity and Safety Study of rThrombin in Surgical Hemostasis
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
TOTAL None None None 6 31 29 31 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
PROCEDURAL HYPOTENSION SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 13.1 View
CHEST PAIN SYSTEMATIC_ASSESSMENT General disorders MedDRA 13.1 View
OSTEOMYELITIS SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 13.1 View
SEPSIS SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 13.1 View
ARTERIAL THROMBOSIS LIMB SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 13.1 View
HYPOTENSION SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 13.1 View
PERIPHERAL ISCHAEMIA SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 13.1 View
OVERDOSE SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 13.1 View
SYNCOPE SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 13.1 View
RENAL FAILURE SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 13.1 View
RENAL FAILURE CHRONIC SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 13.1 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
ANAEMIA SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 13.1 View
TACHYCARDIA SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 13.1 View
CONSTIPATION SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 13.1 View
NAUSEA SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 13.1 View
VOMITING SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 13.1 View
PYREXIA SYSTEMATIC_ASSESSMENT General disorders MedDRA 13.1 View
ANAEMIA POSTOPERATIVE SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 13.1 View
INCISION SITE PAIN SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 13.1 View
PROCEDURAL HYPOTENSION SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 13.1 View
PROCEDURAL PAIN SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 13.1 View
HYPOKALAEMIA SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 13.1 View
MUSCLE SPASMS SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 13.1 View
PAIN IN EXTREMITY SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 13.1 View
HYPOAESTHESIA SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 13.1 View
RADICULOPATHY SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 13.1 View
INSOMNIA SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 13.1 View
DYSPHONIA SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 13.1 View
HYPOXIA SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 13.1 View
OROPHARYNGEAL PAIN SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 13.1 View
PRURITUS SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 13.1 View
HYPERTENSION SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 13.1 View