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 @ 3:00 AM
Ignite Modification Date: 2025-12-26 @ 1:40 AM
NCT ID: NCT02400333
Description: None
Frequency Threshold: 0
Time Frame: Serious adverse events were recorded from the signing of the informed consent and adverse events were recorded from randomization until the final follow-up visit.
Study: NCT02400333
Study Brief: Study to Assess the Bioavailability of Ticagrelor OD Tablet vs. IR Tablet
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Treatment A Participants received Ticagrelor OD tablets administered with water. The OD tablet was placed on the tongue to disintegrate and be swallowed subsequently with 200 mL noncarbonated water at room temperature. None None 0 31 3 31 View
Treatment B Participants received Ticagrelor OD tablets administered without water. The OD tablet was placed on the tongue to disintegrate and be swallowed subsequently with saliva. None None 0 32 5 32 View
Treatment C Participants received Ticagrelor OD tablets suspended in water to be administered through a NG tube into the stomach (total of 200 mL of water). None None 0 34 3 34 View
Treatment D Participants received Ticagrelor IR tablets administered orally with 200 mL of water. None None 0 33 2 33 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Dizziness NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 18.0 View
Headache NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 18.0 View
Paraesthesia NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 18.0 View
Diarrhoea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 18.0 View
Nausea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 18.0 View
Chest pain NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA 18.0 View
Fatigue NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA 18.0 View
Dyspnoea NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 18.0 View
Throat irritation NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 18.0 View
Thrombophlebitis NON_SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 18.0 View
Haematoma NON_SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 18.0 View
Rash NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 18.0 View