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 @ 4:29 AM
Ignite Modification Date: 2025-12-26 @ 3:32 AM
NCT ID: NCT01587118
Description: None
Frequency Threshold: 0
Time Frame: Adverse events were collected for the 12 weeks of active study participation; Serious adverse events were collected for the 12 weeks of study and one additional post-study month.
Study: NCT01587118
Study Brief: An Open Label Pilot Study of Adjunctive Asenapine for the Treatment of Posttraumatic Stress Disorder
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Antidepressant Plus Asenapine adjunctive asenapine Adjunctive asenapine: participants who are not responding fully to antidepressant therapy for PTSD will receive adjunctive asenapine (flexible dosing beginning with 5 mg sublingual once per day, titrated up to 10 mg twice per day, as tolerated) for a total of 12 weeks. None None 1 18 6 18 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Psychiatric hospitalization SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA (10.0) View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
sedation with syncope SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA (10.0) View
weight gain SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA (10.0) View
sedation SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA (10.0) View
extrapyramidal side effect SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA (10.0) View
sinus infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (10.0) View
upset stomach SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (10.0) View
agitation SYSTEMATIC_ASSESSMENT General disorders MedDRA (10.0) View
fatigue SYSTEMATIC_ASSESSMENT General disorders MedDRA (10.0) View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA (10.0) View