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 @ 2:23 AM
Ignite Modification Date: 2025-12-26 @ 12:55 AM
NCT ID: NCT00375934
Description: None
Frequency Threshold: 2
Time Frame: None
Study: NCT00375934
Study Brief: Multicenter Study to Evaluate the Analgesic Efficacy of XP21L in Subjects With Pain Following Bunionectomy Surgery
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Zipsor (Diclofenac Potassium) Liquid Filled Capsule 25 mg capsule, every 6 hours None None 0 99 46 99 View
Placebo Oral placebo capsule, every 6 hours None None 1 101 63 101 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Deep vein thrombosis SYSTEMATIC_ASSESSMENT Vascular disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Diarrhea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Musculoskeletal stiffness SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Somnolence SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Pruritus generalized SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Rash SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Dry Mouth SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Dyspepsia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Flatulence SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Feeling Hot SYSTEMATIC_ASSESSMENT General disorders None View
Injection site pain SYSTEMATIC_ASSESSMENT General disorders None View
Alanine aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations None View
Nightmare SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Hyperhidrosis SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Pruritus SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Abdominal Discomfort SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Abdominal Pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View