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 @ 8:02 PM
Ignite Modification Date: 2025-12-25 @ 5:35 PM
NCT ID: NCT02277704
Description: All adverse events are reported for the Safety Population, which includes patients who took at least one dose of study medication. All-cause mortality is reported for all patients.
Frequency Threshold: 5
Time Frame: 12 weeks
Study: NCT02277704
Study Brief: Safety and Efficacy Study of TNX-102 SL in Subjects With Military-Related PTSD and Related Conditions
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Placebo 2 x placebo tablet ("placebo") to be taken sublingually once daily at bedtime. Placebo 0 None 3 94 36 94 View
TNX-102 SL, 2.8 mg 1 x TNX-102 SL 2.8mg tablet ("TNX-102 SL") and 1 x placebo tablet ("placebo") to be taken sublingually once daily at bedtime. TNX-102 SL Placebo 0 None 0 93 59 93 View
TNX-102 SL, 5.6 mg 2 x TNX-102 SL 2.8mg tablets ("TNX-102 SL") to be taken sublingually once daily at bedtime. TNX-102 SL 0 None 1 50 35 50 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Anaphylactic reaction NON_SYSTEMATIC_ASSESSMENT Immune system disorders None View
Proctitis NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Perirectal abscess NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Multiple sclerosis NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Suicidal Ideation SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Weight Increased SYSTEMATIC_ASSESSMENT Investigations None View
Hypoaesthesia Oral NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Dry mouth NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
paraesthesia oral NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Glossodynia NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Somnolence NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Headache NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Sedation NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Insomnia NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Abnormal dreams NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Upper respiratory tract infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View