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 @ 2:46 PM
Ignite Modification Date: 2025-12-25 @ 1:14 PM
NCT ID: NCT01435759
Description: Safety Analysis Set: All subjects who took at least 1 dose of randomized investigational product and who had at least 1 post-augmentation baseline safety assessment (e.g. coming back for any visit, reporting of an AE or reporting the absence of AEs). Subjects who received only single-blind placebo were not included in this group.
Frequency Threshold: 5
Time Frame: None
Study: NCT01435759
Study Brief: SPD489 in Combination With an Antidepressant in the Treatment of Adults With Major Depressive 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 + Double-blind SPD489 30mg Subjects received unblinded standard antidepressant therapy (either escitalopram oxalate or venlafaxine hydrochloride extended-release titrated to the maximum tolerated dose) plus oral, once daily over-encapsulated SPD489 as a 30mg dose. None None 0 76 29 76 View
Antidepressant + Double-blind Placebo Subjects received unblinded standard antidepressant therapy (either escitalopram oxalate or venlafaxine hydrochloride extended-release titrated to the maximum tolerated dose) plus oral, once daily double-blind placebo (matching SPD489). None None 0 78 20 78 View
Antidepressant + Double-blind SPD489 10mg Subjects received unblinded standard antidepressant therapy (either escitalopram oxalate or venlafaxine hydrochloride extended-release titrated to the maximum tolerated dose) plus oral, once daily over-encapsulated SPD489 as a 10mg dose. None None 0 77 30 77 View
Antidepressant + Double-blind SPD489 50mg Subjects received unblinded standard antidepressant therapy (either escitalopram oxalate or venlafaxine hydrochloride extended-release titrated to the maximum tolerated dose) plus oral, once daily over-encapsulated SPD489 as a 50mg dose. None None 0 78 36 78 View
Antidepressant + Double-blind SPD489 70mg Subjects received unblinded standard antidepressant therapy (either escitalopram oxalate or venlafaxine hydrochloride extended-release titrated to the maximum tolerated dose) plus oral, once daily over-encapsulated SPD489 as a 70mg dose. None None 1 80 44 80 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Cholecystitis None Hepatobiliary disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Diarrhoea None Gastrointestinal disorders None View
Dry mouth None Gastrointestinal disorders None View
Nausea None Gastrointestinal disorders None View
Fatigue None General disorders None View
Influenza None Infections and infestations None View
Nasopharyngitis None Infections and infestations None View
Upper respiratory tract infection None Infections and infestations None View
Urinary tract infection None Infections and infestations None View
Blood pressure increased None Investigations None View
Decreased appetite None Metabolism and nutrition disorders None View
Dizziness None Nervous system disorders None View
Headache None Nervous system disorders None View
Bruxism None Psychiatric disorders None View
Insomnia None Psychiatric disorders None View
Hyperhidrosis None Skin and subcutaneous tissue disorders None View