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 @ 12:22 AM
Ignite Modification Date: 2025-12-25 @ 10:26 PM
NCT ID: NCT01495858
Description: None
Frequency Threshold: 0
Time Frame: Treatment emergent adverse events (TEAEs) were collected from the date of the first dose of study drug in the treatment period for 2 days, or for 30 days after the last study drug administration if they were serious adverse events (SAEs).
Study: NCT01495858
Study Brief: Evaluate Analgesic / Sedative Efficacy of Naproxen Sodium and Diphenhydramine in Patients With 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 440 mg / DPH 25 mg (BAY98-7111) Participants received one tablet of Naproxen Sodium 220 mg / Diphenhydramine hydrochloride (DPH) 25 mg and one tablet of Naproxen Sodium 220 mg, single dose, orally None None 0 107 21 107 View
DPH 50 mg Participants received two tablets of Diphenhydramine hydrochloride (DPH) 25 mg, single dose, orally. None None 0 54 17 54 View
Naproxen Sodium 440 mg (BAYH6689) Participants received two tablets of Naproxen Sodium 220 mg, single dose, orally None None 0 106 14 106 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Deafness NON_SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders MedDRA (13.0) View
Tinnitus NON_SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders MedDRA (13.0) View
Vision blurred NON_SYSTEMATIC_ASSESSMENT Eye disorders MedDRA (13.0) View
Nausea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (13.0) View
Vomiting NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (13.0) View
Hypoaesthesia oral NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (13.0) View
Chest discomfort NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA (13.0) View
Feeling hot NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA (13.0) View
Feeling jittery NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA (13.0) View
Post procedural haemorrhage NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA (13.0) View
Procedural complication NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA (13.0) View
Blood pressure increased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA (13.0) View
Cardiac murmur NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA (13.0) View
Dizziness NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA (13.0) View
Headache NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA (13.0) View
Hypoaesthesia NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA (13.0) View
Syncope NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA (13.0) View
Pollakiuria NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA (13.0) View
Nasal congestion NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA (13.0) View
Oropharyngeal pain NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA (13.0) View
Cold sweat NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA (13.0) View
Hyperhidrosis NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA (13.0) View
Pruritus NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA (13.0) View
Flushing NON_SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA (13.0) View