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 @ 4:46 PM
Ignite Modification Date: 2025-12-25 @ 2:32 PM
NCT ID: NCT05010850
Description: Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
Frequency Threshold: 0
Time Frame: 1 year
Study: NCT05010850
Study Brief: SafeHeal Colovac Colorectal Anastomosis Protection Device Evaluation (SAFE-2) Pivotal Study
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Standard of Care Patients receive the standard of care, a protective stoma, during colorectal surgery Stoma Creation: Protective ileostomy 1 None 7 8 6 8 View
Colovac Patients receive Colovac during colorectal surgery Colovac: A removable, temporary intraluminal bypass device designed to safely postpone the creation of a protective stoma until 10 days after surgery for only patients who need it (do not have a healed anastomosis) 0 None 6 10 7 10 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Undernutrition with Naso Gastric Tube SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Ileus SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
CRP Elevation SYSTEMATIC_ASSESSMENT Infections and infestations None View
Dehydration which resolved SYSTEMATIC_ASSESSMENT General disorders None View
General state of deterioration with dehydration, resulting in death SYSTEMATIC_ASSESSMENT General disorders Death View
Anastomosis Leakage SYSTEMATIC_ASSESSMENT General disorders None View
Colon Intussusception SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Acute Renal Failure SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Urinary Tract Infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Abdominal/ Anal pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Anastomosis leakage SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Diarrhea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Dyspnea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Heart Failure SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Ileus SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Infection of incision/surgery wound on left side SYSTEMATIC_ASSESSMENT Surgical and medical procedures None View
Inflammation of skin around the anus SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Nausea/vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Nerve Tissue Injury SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Other - Lymphopenia to Xeloda SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Other - Polyneuropathie SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Other - Renal Failure SYSTEMATIC_ASSESSMENT Endocrine disorders None View
Other - Worsening Hernia Inguinalis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Urinary Infection SYSTEMATIC_ASSESSMENT Endocrine disorders None View
Cholestasis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Haematuria SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Incisional hernia SYSTEMATIC_ASSESSMENT Surgical and medical procedures None View
Other - Denutrition SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Other - Epigastric Pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Parastomal hernia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View