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 @ 2:15 AM
Ignite Modification Date: 2025-12-26 @ 12:45 AM
NCT ID: NCT03453060
Description: Subjects were monitored throughout confinement for adverse reactions to the study drug and/or procedures. Subjects were asked how they are feeling and were encouraged to report AEs during confinement and at each follow-up visit.
Frequency Threshold: 0
Time Frame: Adverse events were recorded from subject check-in through follow up which occurred on Day 28.
Study: NCT03453060
Study Brief: Safety and Tolerability Study of E-WE Thrombin in Healthy Adult Subjects
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
E-WE Thrombin Dose 1 Participants received a single intravenous dose of 0.5 mcg/kg E-WE Thrombin. 0 None 0 4 0 4 View
E-WE Thrombin Dose 2 Participants received a single intravenous dose of 1.0 mcg/kg E-WE Thrombin. 0 None 0 4 0 4 View
E-WE Thrombin Dose 3 Participants received a single intravenous dose of 2.0 mcg/kg E-WE Thrombin. 0 None 0 4 0 4 View
E-WE Thrombin Dose 4 Participants received a single intravenous dose of 4.0 mcg/kg E-WE Thrombin. 0 None 0 4 3 4 View
Placebo Participants received a single intravenous dose of placebo. 0 None 0 5 1 5 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Vessel puncture site haemorrhage SYSTEMATIC_ASSESSMENT General disorders MedDRA (21.0) View
Insomnia SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA (21.0) View
Pruritus SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA (21.0) View
Back pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA (21.0) View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA (21.0) View
Rash papular SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA (21.0) View
Skin exfoliation SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA (21.0) View