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 @ 9:28 PM
Ignite Modification Date: 2025-12-25 @ 7:14 PM
NCT ID: NCT01083732
Description: For patients with multiple dosing, all AEs with an onset date after the date of first dose until the end of trial treatment including 3 days after the last treatment and for patients with single dosing, all AEs with an onset during the 48-h-period after study medication intake were assigned to the on-treatment period.
Frequency Threshold: 5
Time Frame: All adverse events (AEs) during the treatment period, up to 6 days.
Study: NCT01083732
Study Brief: Safety and Tolerability of Dabigatran Etexilate Solution in Children 1 to < 12 Years of Age
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Dabigatran Etexilate (Single Dose, Age Group 1 to <2 Years) The patients aged 1 to \<2 years were orally administered a single dose of dabigatran etexilate (Dabigatran etexilate oral liquid formulation (6.25 mg/mL) after reconstitution from dabigatran etexilate granules (167.5 mg) and solvent for oral liquid formulation) None None 0 6 0 6 View
Dabigatran Etexilate (Single Dose, Age Group 2 to <12 Years) The patients aged 2 to \<12 years were orally administered a single dose of dabigatran etexilate (Dabigatran etexilate oral liquid formulation (6.25 mg/mL) after reconstitution from dabigatran etexilate granules (167.5 mg) and solvent for oral liquid formulation) None None 0 9 0 9 View
Dabigatran Etexilate (Multiple Dose, Age Group 2 to <12 Years) The patients aged 2 to \<12 years were orally administered a multiple dose (3 days, twice daily) of dabigatran etexilate (Dabigatran etexilate oral liquid formulation (6.25 mg/mL) after reconstitution from dabigatran etexilate granules (167.5 mg) and solvent for oral liquid formulation) None None 0 3 1 3 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Leukopenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 18.1 View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 18.1 View