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 @ 5:08 PM
Ignite Modification Date: 2025-12-25 @ 2:46 PM
NCT ID: NCT01372150
Description: The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
Frequency Threshold: 5
Time Frame: Adverse events (AEs) were recorded from informed consent and assent through the first follow up visit (Week 11) for non-serious AEs; the second follow up visit (Week 13) for serious AEs (SAEs); or at Week 9 for participants entering the extension study.
Study: NCT01372150
Study Brief: A Study Of DVS SR In Treatment Of Children And Adolescent Outpatients With MDD
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 Placebo tablets and capsules administered once daily for 8 weeks (treatment phase), followed by placebo tablets and capsules administered once daily as appropriate for 1 week (taper/transition phase). None None 0 112 44 112 View
Fluoxetine Fluoxetine capsules 10 mg administered once daily for the first week of treatment (titration phase) then 20 mg administered once daily for the next 7 weeks of treatment, followed by placebo capsules administered once daily for 1 week as appropriate (taper/transition phase). None None 2 112 39 112 View
DVS SR DVS SR capsules 10 or 20 mg (based on weight at the baseline visit) administered once daily for the first week of treatment (titration phase) then 25, 35 or 50 mg (based on weight at the baseline visit) administered once daily for the next 7 weeks of treatment, followed by 10 or 20 mg (based on weight at the baseline visit) (taper phase) or 25 mg (transition phase) administered once daily as appropriate for 1 week. None None 2 115 47 115 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Disinhibition NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 17.1 View
Suicidal ideation NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 17.1 View
Suicide attempt NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 17.1 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Abdominal pain upper NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 17.1 View
Nausea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 17.1 View
Vomiting NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 17.1 View
Fatigue NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA 17.1 View
Influenza NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 17.1 View
Nasopharyngitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 17.1 View
Upper respiratory tract infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 17.1 View
Dizziness NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 17.1 View
Headache NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 17.1 View