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 @ 5:04 AM
Ignite Modification Date: 2025-12-26 @ 4:07 AM
NCT ID: NCT01204918
Description: These are events that were deemed to not be present at or before baseline and were verified by the study team. These data are not to be confused with the SAFTEE secondary outcome reporting, which was self reported and not verified nor attributed to the study. The SAE's reported in this table occurred after discontinuing the study medication.
Frequency Threshold: 5
Time Frame: 8 weeks
Study: NCT01204918
Study Brief: Efficacy and Tolerability of Riluzole in Treatment Resistant Depression
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Riluzole Addition to SSRI Antidepressant Riluzole 100mg added to ongoing SSRI or SNRI antidepressant for 8 weeks Riluzole: Riluzole 100mg PO 0 None 1 25 19 25 View
Riluzole/Placebo Addition to SSRI Antidepressant Riluzole 100mg added to ongoing SSRI or SNRI antidepressant for 4 weeks and placebo will added to ongoing SSRI or SNRI antidepressant treatment for 4 weeks Riluzole: Riluzole 100mg PO placebo: placebo 0 None 0 39 31 39 View
Placebo Addition to Standard SSRI Antidepressant Placebo will be added to ongoing SSRI or SNRI antidepressant treatment for 8 weeks placebo: placebo 0 None 2 40 34 40 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Global Amnesia NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Bronchitis NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Suicide Attempt NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Abdominal Pain SYSTEMATIC_ASSESSMENT General disorders None View
Anxiety SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Back Pain SYSTEMATIC_ASSESSMENT General disorders None View
Blurred Vision SYSTEMATIC_ASSESSMENT Eye disorders None View
Body Aches SYSTEMATIC_ASSESSMENT General disorders None View
Bruising SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Clenching Teeth SYSTEMATIC_ASSESSMENT General disorders None View
Cold/Flu Symptoms SYSTEMATIC_ASSESSMENT Infections and infestations None View
Cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Diarrhea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Dizziness SYSTEMATIC_ASSESSMENT General disorders None View
Fall SYSTEMATIC_ASSESSMENT General disorders None View
Fatigue SYSTEMATIC_ASSESSMENT General disorders None View
Frequent Urination SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
GI Issues SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Headache SYSTEMATIC_ASSESSMENT General disorders None View
Insomnia SYSTEMATIC_ASSESSMENT General disorders None View
Leg Pain/Stiffness SYSTEMATIC_ASSESSMENT General disorders None View
Muscle Pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Nasal Congestion/Pain SYSTEMATIC_ASSESSMENT Infections and infestations None View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Nightmares SYSTEMATIC_ASSESSMENT General disorders None View
Numbness SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Palpitations SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Rash SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Sexual Dysfunction SYSTEMATIC_ASSESSMENT General disorders None View
Sleep Disturbance SYSTEMATIC_ASSESSMENT General disorders None View
Drowsiness SYSTEMATIC_ASSESSMENT General disorders None View
Stomach Pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Sweating SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Tingling Sensation SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Toothache SYSTEMATIC_ASSESSMENT General disorders None View
Vivid Dreams SYSTEMATIC_ASSESSMENT General disorders None View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View