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 @ 7:58 PM
Ignite Modification Date: 2025-12-25 @ 5:32 PM
NCT ID: NCT00698204
Description: All events reported as serious adverse events resulted in hospitalization of the participant during the period of study participation. All adverse events were reviewed by an independent Data and Safety Monitoring Board (DSMB) and were determined to be unrelated to use of celecoxib.
Frequency Threshold: 0
Time Frame: Adverse event data was collected from the date of Informed Consent through 30 days after the last study intervention.
Study: NCT00698204
Study Brief: Cox-2 Inhibition in Radiation-induced Oral Mucositis
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
I- Celecoxib celecoxib: Subjects were randomized to take celecoxib each day that radiation therapy was given (6-7 week period). None None 6 20 1 20 View
II- Placebo placebo: Subject was randomized to take an identical placebo each day that radiation therapy was given (6-7 week period). None None 5 20 0 20 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Electrolyte abnormality NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders NCI-CTC View
Febrile neutropenia NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders NCI-CTC View
Fever NON_SYSTEMATIC_ASSESSMENT General disorders NCI-CTC View
Myocardial infarction NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders NCI-CTC View
Nausea/vomiting NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders NCI-CTC View
Pulmonary embolism NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders NCI-CTC View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
pruritus NON_SYSTEMATIC_ASSESSMENT Immune system disorders NCI-CTC View