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 @ 2:51 AM
Ignite Modification Date: 2025-12-26 @ 1:32 AM
NCT ID: NCT02158533
Description: Safety population consists of all randomized subjects who received at least 1 dose of study drug.
Frequency Threshold: 5
Time Frame: 5 weeks for Stage 1 and 6 weeks for Stage 2
Study: NCT02158533
Study Brief: A Study of ALKS 5461 for the Treatment of Major Depressive Disorder (MDD) - the FORWARD-4 Study
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
ALKS 5461 2mg/2mg S1 Randomized to ALKS 5461 2mg/2mg in Stage 1 0 None 0 60 36 60 View
Placebo S1 Randomized to placebo in Stage 1 0 None 1 265 81 265 View
ALKS 5461 0.5mg/0.5mg S1 Randomized to ALKS 5461 0.5mg/0.5mg in Stage 1 0 None 0 59 32 59 View
Placebo S2 Randomized to placebo in Stage 2 0 None 0 56 11 56 View
ALKS 5461 0.5mg/0.5mg S2 Randomized to ALKS 5461 0.5mg/0.5mg in Stage 2 0 None 0 56 13 56 View
ALKS 5461 2mg/2mg S2 Randomized to ALKS 5461 2mg/2mg in Stage 2 0 None 0 56 22 56 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Hypoglycaemia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 18.0 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Nausea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 18.0 View
Constipation NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (18.0) View
Vomiting NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (18.0) View
Dry mouth NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (18.0) View
Fatigue NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA (18.0) View
Upper respiratory tract infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (18.0) View
Nasopharyngitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (18.0) View
Muscle spasms NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA (18.0) View
Dizziness NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA (18.0) View
Somnolence NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA (18.0) View
Headache NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA (18.0) View
Sedation NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA (18.0) View
Insomnia NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA (18.0) View
Abnormal dreams NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA (18.0) View
Irritability NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA (18.0) View
Hyperhidrosis NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA (18.0) View
Hot flush NON_SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA (18.0) View