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 @ 2:42 PM
Ignite Modification Date: 2025-12-25 @ 1:12 PM
NCT ID: NCT01559259
Description: None
Frequency Threshold: 0
Time Frame: None
Study: NCT01559259
Study Brief: Evaluation of the Efficacy of Novel Ibuprofen Acetaminophen Combination Formulations in the Treatment of Post-surgical 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
Placebo Participants received Placebo as single oral dose caplets during the 12 hours study. None None 0 30 15 30 View
Ibuprofen 200 mg + Acetaminophen 500 mg Participants received a single oral dose of a fixed dose combination of ibuprofen 200 mg and acetaminophen 500 mg caplets during the 12 hours study. None None 0 90 33 90 View
Ibuprofen 300 mg + Acetaminophen 500 mg Participants received a single oral dose of a fixed dose combination of ibuprofen 300 mg and acetaminophen 500 mg caplets during the 12 hours study. None None 0 89 22 89 View
Ibuprofen 400 mg Participants received single oral dose of ibuprofen 400 mg caplets during the 12 hours study. None None 0 92 30 92 View
Ibuprofen 250 mg + Acetaminophen 500 mg Participants received a single oral dose of a fixed dose combination of ibuprofen 250 mg and acetaminophen 500 mg caplets during the 12 hours study. None None 0 93 27 93 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Dizziness NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA v13.0 View
Diarrhoea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA v13.0 View
Alveolar osteitis NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA v13.0 View
Nausea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA v13.0 View
Vomiting NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA v13.0 View
Feeling hot NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA v13.0 View
Hyperhidrosis NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA v13.0 View
Muscular weakness NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA v13.0 View
Tension headache NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA v13.0 View
Paraesthesia NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA v13.0 View
Somnolence NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA v13.0 View
Tremor NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA v13.0 View
Post procedural haemorrhage NON_SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA v13.0 View