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 @ 10:01 PM
Ignite Modification Date: 2025-12-25 @ 7:38 PM
NCT ID: NCT01663532
Description: One participant was randomly assigned to aripiprazole IM depot 400 mg/ 300 mg, but was not treated and did not have any post-randomization assessments and was not included in safety or efficacy assessments.
Frequency Threshold: 5
Time Frame: Adverse events were monitored from ICF signed untill Follow-up 14 (± 2) days.
Study: NCT01663532
Study Brief: Trial of Aripiprazole Intramuscular Depot (OPC-14597, Lu AF41155) in the Acute Treatment of Adults With Schizophrenia
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Aripiprazole IM Depot 400/300mg Participants randomized to aripiprazole IM depot received aripiprazole IM depot 400 mg as the initial dose with a single decrease to aripiprazole IM depot 300 mg permitted for tolerability per the study physician. The study treatment was injected into gluteal muscle every 4 weeks (Baseline/Day, Week 4, Week 8) during the 12-Week Acute Treatment Phase (ie, 3 IM depot injections). For 14 days beginning with the first injection, participants received concomitant oral aripiprazole (10 to 20 mg/day based on the study physician's clinical judgment). None None 8 167 91 167 View
Placebo Participants randomized to Placebo group received matching placebo. For 14 days beginning with the first injection, participants received concomitant oral placebo. None None 6 172 68 172 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Schizophrenia NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 15.0 View
Arthralgia NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 15.0 View
Agitation NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 15.0 View
Psychotic disorder NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 15.0 View
Substance abuse NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 15.0 View
Suicidal ideation NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 15.0 View
Hypotension NON_SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 15.0 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Constipation NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 15.0 View
Dyspepsia NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 15.0 View
Toothache NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 15.0 View
Injection site pain NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA 15.0 View
Weight increased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA 15.0 View
Akathisia NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 15.0 View
Headache NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 15.0 View
Sedation NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 15.0 View
Agitation NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 15.0 View
Cough NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 15.0 View