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 @ 10:15 PM
Ignite Modification Date: 2025-12-25 @ 7:49 PM
NCT ID: NCT02739035
Description: All sites conducted monitoring for adverse events.
Frequency Threshold: 0
Time Frame: Adverse events were monitored throughout the study from the beginning of enrollment until both the 6-months post-manipulation under anesthesia and 1-year post-manipulation under anesthesia timepoints had been reached. Approximately 1 year.
Study: NCT02739035
Study Brief: MUA to Treat Postoperative Stiffness After Total Knee Arthroplasty
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
MUA Alone Subjects will be given manipulation under anesthesia, will fill out questionnaires about their knee and quality of life and will be followed throughout their routine follow up to assess their continued process. Subjects will fill out questionnaires at the time of their consent and their 6-week and 1-year follow up visits. The questionnaires will take about 15-20 minutes to complete. 0 None 0 59 0 59 View
MUA With Dexamethasone and Celecoxib For subjects assigned to the MUA with anti-inflammatory medication group, an intravenous (into the vein) dose of dexamethasone will be given at the time of MUA. Subjects in this group will also receive celecoxib. They will be asked to take the medicine one time daily either at morning or night time with food and water for 2 weeks following MUA. Subjects will also be followed throughout their routine follow up to assess their continued process, and they will fill out questionnaires at the time of their consent and their 6-week and 1-year follow up visits. The questionnaires will take about 15-20 minutes to complete. Dexamethasone: 8 mg of IV dexamethasone immediately before MUA. Celecoxib: 2 weeks per mouth of celecoxib (200 mg daily) 0 None 0 72 1 72 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Head Injury SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View