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 @ 11:30 PM
Ignite Modification Date: 2025-12-25 @ 9:17 PM
NCT ID: NCT01692756
Description: Patients were approached and asked about any adverse events at regular study and/or clinic visits.
Frequency Threshold: 0
Time Frame: Over the course of 12months.
Study: NCT01692756
Study Brief: Early Treatment for Acute ACL Tear
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Kenalog or Placebo Kenalog® (40mg) or saline placebo injection 1-2 days after ACL injury and 12-14 days later. Kenalog or placebo 0 None 0 11 7 11 View
Kenalog Then Placebo Subjects will initially receive 40mg injection of Kenalog® 1-2 days after injury and saline placebo at 12-14 days post injury. Kenalog then Placebo 0 None 0 11 4 11 View
Kenalog Only Subjects will receive two consecutive (40 mg) intra-articular injections of Kenalog® Kenalog 0 None 0 11 6 11 View
Placebo subjects will receive two consecutive intra-articular saline placebo injections at the same time periods. Placebo 0 None 0 12 5 12 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Nausea or Hives/Rash from post op pain meds SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
ACL Re-Tear SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Knee Effusion Post-Op SYSTEMATIC_ASSESSMENT General disorders None View
Knee Effusion from Unanticipated Accident SYSTEMATIC_ASSESSMENT General disorders None View
Arthrofibrosis SYSTEMATIC_ASSESSMENT General disorders None View
Cervical Strain after Motor Vehicle Accident SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Nosebleed SYSTEMATIC_ASSESSMENT General disorders None View
Infrapatella scarring/pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Strep Throat SYSTEMATIC_ASSESSMENT General disorders None View
Persistent Low Leg Pain SYSTEMATIC_ASSESSMENT General disorders None View
Stitch Abscess SYSTEMATIC_ASSESSMENT General disorders None View