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 @ 3:57 AM
Ignite Modification Date: 2025-12-26 @ 2:49 AM
NCT ID: NCT01809002
Description: None
Frequency Threshold: 2
Time Frame: 12 months
Study: NCT01809002
Study Brief: Comparison of Processed Nerve Allograft and Collagen Nerve Cuffs for Peripheral Nerve Repair
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Processed Nerve Allograft Processed Nerve Allograft Processed Nerve Allograft (human) 1 None 6 112 12 112 View
Collagen Nerve Cuff Collagen Nerve Cuff: Bovine collagen based nerve cuff 1 None 2 108 15 108 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Acute kidney injury - Unrelated SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Staphylococcal bacteraemia - Unrelated SYSTEMATIC_ASSESSMENT Infections and infestations None View
Retroperitonial haemorrhage - Unrelated SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Septic shock - Unrelated SYSTEMATIC_ASSESSMENT Infections and infestations None View
Embolic stroke - Unrelated SYSTEMATIC_ASSESSMENT Hepatobiliary disorders None View
Deep vein thrombosis - Unrelated SYSTEMATIC_ASSESSMENT Vascular disorders None View
Respiratory failure - Unrelated SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Leukocytosis - Unrelated SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Malignant hypertension - Unrelated SYSTEMATIC_ASSESSMENT Vascular disorders None View
COVID-19 - Unrelated SYSTEMATIC_ASSESSMENT Infections and infestations None View
Localized infection - Unrelated SYSTEMATIC_ASSESSMENT Infections and infestations None View
Overdose - Unrelated SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Completed suicide - Unrelated SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Wound dehiscence SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Tendon rupture - Unrelated SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Cholecystitis - Unrelated SYSTEMATIC_ASSESSMENT Hepatobiliary disorders None View
Sickle cell anaemia with crisis - Unrelated SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Pain in extremity SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Implant site hypersensitivity SYSTEMATIC_ASSESSMENT General disorders None View
Tendon rupture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Procedural pain SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View