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 @ 7:03 PM
Ignite Modification Date: 2025-12-25 @ 4:36 PM
NCT ID: NCT00720057
Description: None
Frequency Threshold: 0
Time Frame: Adverse events were recorded throughout the treatment period through 5 days after investigational product or placebo administration. All Serious Adverse Events were collected through about 30 days after the last dose of investigational product or placebo.
Study: NCT00720057
Study Brief: Assessing the Analgesic Efficacy of Naproxen Sodium in Postsurgical Dental Pain.
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Naproxen Sodium ER (BAYH6689) single dose (1 tablet) ER Naproxen sodium 660 mg with a full glass of water (240ml) within 1 - 4 hours post dental surgery. None None 0 153 10 153 View
Placebo single dose (1 tablet) of placebo with a full glass of water (240ml) within 1 - 4 hours post dental surgery. None None 0 159 36 159 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Tinnitus NON_SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders MedDRA (11.0) View
Conjunctivitis NON_SYSTEMATIC_ASSESSMENT Eye disorders MedDRA (11.0) View
Eye Swelling NON_SYSTEMATIC_ASSESSMENT Eye disorders MedDRA (11.0) View
Scotoma NON_SYSTEMATIC_ASSESSMENT Eye disorders MedDRA (11.0) View
Abdominal Pain NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (11.0) View
Dyspepsia NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (11.0) View
Nausea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (11.0) View
Stomach Discomfort NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (11.0) View
Tooth Socket Haemorrhage NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (11.0) View
Vomiting NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (11.0) View
Pyrexia NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA (11.0) View
Abscess Oral NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (11.0) View
Tooth Abscess NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (11.0) View
Post Procedural Haemorrhage NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA (11.0) View
Dizziness NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA (11.0) View
Headache NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA (11.0) View
Syncope NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA (11.0) View
Pharyngolaryngeal Pain NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA (11.0) View
Hyperhidrosis NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA (11.0) View
Flushing NON_SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA (11.0) View