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 @ 12:05 PM
Ignite Modification Date: 2025-12-25 @ 11:58 AM
NCT ID: NCT00713661
Description: The safety population consists of all 25 subjects that received trial treatment. SAE/AE assessment by neutral questioning "Have you experienced any health problems since the last contact?" by the investigator at each contact (visit or phone).
Frequency Threshold: 5
Time Frame: None
Study: NCT00713661
Study Brief: Evaluation of TachoSil® Application on a Colorectal Anastomosis (TC-029-IM)
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Group 1: Open Surgery Lower None None None 3 7 3 7 View
Group 3: Laparoscopic Surgery Lower None None None 3 4 1 4 View
Group 4: Laparoscopic Surgery Middle/Upper None None None 0 5 1 5 View
Group 2: Open Surgery Middle/Upper None None None 1 9 3 9 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Atrial fibrillation SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA View
Small bowel obstruction caused by adhesions requiring small bowel resection done open SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Anastomotic leakage SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View
Minor anastomotic leakage SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View
Renal failure SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA View
Aspiration pneumonia SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Presacral haematoma SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA View
Urinary tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Stomaprolaps SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View
Pelvic haematoma SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View