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 @ 11:21 PM
Ignite Modification Date: 2025-12-25 @ 9:04 PM
NCT ID: NCT03086356
Description: None
Frequency Threshold: 5
Time Frame: Adverse events from the first intake of treatment until the end of treatment visit; up to 23 days
Study: NCT03086356
Study Brief: Study to Investigate the Pharmacokinetics (PK) and Pharmacodynamics (PD) of Idarucizumab in Chinese Healthy Male and Female Volunteers Who Had Taken Dabigatran Etexilate and Whose Plasma Concentrations of Dabigatran Were at or Close to Steady State
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+Idarucizumab During the first part of the treatment period, dabigatran etexilate was administered alone. All subjects received 220 milligram (mg) dabigatran etexilate (capsule) orally twice daily for 3 days (from Days 1 to 3) and a single 220 mg dose on Day 4. During the second part of the treatment period, after a washout period of 3 days, subjects again received dabigatran etexilate (capsule) orally twice daily for 3 days (from Days 8 to 10) and a single 220 mg dose on Day 11. Idarucizumab (solution for infusion) 2 short infusions of 2.5 grams (g) each, with a 15 minute (min)interval was administered intravenously approximately 2 hours (h) after the last dabigatran etexilate administration. 0 None 0 12 12 12 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Haematoma SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 20.0 View
Diarrhoea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 20.0 View
Albumin urine present SYSTEMATIC_ASSESSMENT Investigations MedDRA 20.0 View
Alpha 1 microglobulin increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 20.0 View
Protein urine present SYSTEMATIC_ASSESSMENT Investigations MedDRA 20.0 View
Activated partial thromboplastin time prolonged SYSTEMATIC_ASSESSMENT Investigations MedDRA 20.0 View
Urine electrophoresis abnormal SYSTEMATIC_ASSESSMENT Investigations MedDRA 20.0 View
Prothrombin level decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 20.0 View
Blood triglycerides increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 20.0 View