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 @ 4:16 PM
Ignite Modification Date: 2025-12-25 @ 2:14 PM
NCT ID: NCT00661466
Description: None
Frequency Threshold: 5
Time Frame: Information regarding AEs was collected from the time of hospital admission through Day 30. Normal postoperative sequelae were not considered to be AEs unless they occurred in a more severe form, as judged by the investigator. Information on AEs was also collected during the Day 8 and Day 30 follow-up calls.
Study: NCT00661466
Study Brief: Efficacy and Safety of A Collagen Bupivacaine Implant in Patients After Gastrointestinal Surgery
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
5x5-cm Bupivacaine Sponges Either three or four 5x5-cm bupivacaine sponges implanted at 2 sites within the surgical field (1) over the abdominal viscera and under the fascia prior to closing the fascia and (2) in the subcutaneous tissue just under the skin incision. Bupivacaine Collagen Sponge 0 None 1 4 1 4 View
5x5-cm Placebo Sponges Either three or four 5x5-cm placebo sponges implanted at 2 sites within the surgical field (1) over the abdominal viscera and under the fascia prior to closing the fascia and (2) in the subcutaneous tissue just under the skin incision. Placebo: placebo 0 None 0 3 2 3 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
hypotension SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Hypotension SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Arm Pain -IV Site SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
hypokalemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Rash SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Polyuria SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Marcaine Sensitivity SYSTEMATIC_ASSESSMENT Product Issues None View
Prolonged QT interval SYSTEMATIC_ASSESSMENT Cardiac disorders None View
shivering SYSTEMATIC_ASSESSMENT General disorders None View
elevated temperature SYSTEMATIC_ASSESSMENT General disorders None View
surgical wound seroma SYSTEMATIC_ASSESSMENT Surgical and medical procedures None View
shortness of breath SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View