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 @ 11:38 PM
Ignite Modification Date: 2025-12-25 @ 9:28 PM
NCT ID: NCT01626456
Description: None
Frequency Threshold: 5
Time Frame: Adverse events were collected at every study visit for 1 year (365 days).
Study: NCT01626456
Study Brief: A Long-term Safety Study of ALKS 9072 (Also Known as ALKS 9070)
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 9072, High ALKS 9072, High: IM injection, given monthly None None 15 368 59 368 View
ALKS 9072, Low ALKS 9072, Low: IM injection, given monthly None None 0 110 16 110 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Cardiac failure congestive NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA View
Cardio-respiratory arrest NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA View
Squamous cell carcinoma NON_SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA View
Cerebrovascular accident NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Convulsion NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Aggression NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA View
Completed suicide NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA View
Drug abuse NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA View
Somatoform disorder cardiovascular NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA View
Adenomyosis NON_SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA View
Chronic obstructive pulmonary disease NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Asthma NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Acute myocardial infarction NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA View
Hyperglycaemia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA View
Schizophrenia NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA View
Depressed mood NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA View
Pulmonary mass NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Weight increased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA View
Headache NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Insomnia NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA View