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: 2025-12-25 @ 3:52 AM
Ignite Modification Date: 2025-12-26 @ 2:41 AM
NCT ID: NCT02121002
Description: None
Frequency Threshold: 0
Time Frame: The over all time frame for any the Adverse Events is maximum 9days starting from date of appearance to date of disappearance.
Study: NCT02121002
Study Brief: Study Comparing a Generic Diclofenac Sodium Topical Gel, 1% to Voltaren in the Treatment of Subjects With Osteoarthritis of the Knee
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Vehicle Diclofenac Sodium Topical Gel Vehicle Diclofenac Sodium Topical Gel. 4 gm, 4 times a day for 4 weeks Vehicle Diclofenac Sodium Topical Gel: Opaque, white gel 0 None 0 391 3 391 View
Diclofenac Sodium Topical Gel, 1% Diclofenac Sodium Topical Gel, 1%. 4 gm, 4 times a day for 4 weeks Diclofenac Sodium Topical Gel, 1%: Opaque, white gel 0 None 0 391 2 391 View
Voltaren Topical Gel, 1% Voltaren Topical Gel, 1%. 4 gm, 4 times a day for 4 weeks Voltaren Topical Gel, 1%: Opaque, white gel 0 None 0 393 2 393 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Gastrooesophageal reflux disease NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (Unspecified) View
Oedema, NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA (Unspecified) View
Nasopharyngitis Cough NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (Unspecified) View
Pyrexia NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA (Unspecified) View
Pruritus and Rash Pruritic NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA (Unspecified) View
Headache NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA (Unspecified) View