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 @ 1:31 PM
Ignite Modification Date: 2025-12-25 @ 12:33 PM
NCT ID: NCT01226095
Description: None
Frequency Threshold: 0
Time Frame: All adverse events that occurred during the course of the study were reported. Adverse events occurring during the study were reported up to 30 days after the last dose of open-label ibuprofen sustained release form.
Study: NCT01226095
Study Brief: Evaluation of the Effectiveness, Compliance of Ibuprofen in a Sustained Release Form in the Treatment of Egyptian Osteoarthritic Patients
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Brufen Retard Male or female participants ≥ 18 years of age in Egypt with osteoarthritis who took Brufen Retard (open-label ibuprofen in a sustained release form) administered per the Prescribing Information for 4 weeks. None None 0 519 41 519 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Abdominal discomfort NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (13.1) View
Abdominal pain NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (13.1) View
Abdominal pain upper NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (13.1) View
Diarrhoea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (13.1) View
Dyspepsia NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (13.1) View
Gastritis NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (13.1) View
Gastrointestinal pain NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (13.1) View
Nausea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (13.1) View
Reflux oesophagitis NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (13.1) View
Vomiting NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (13.1) View
Oedema peripheral NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA (13.1) View
Headache NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA (13.1) View
Pruritus NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA (13.1) View