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 @ 3:51 PM
Ignite Modification Date: 2025-12-25 @ 1:57 PM
NCT ID: NCT02970292
Description: The analysis population were those patients who received at least one dose of the study drug. Patients were classified according to the actual treatment received.
Frequency Threshold: 5
Time Frame: From baseline to Week 6
Study: NCT02970292
Study Brief: Efficacy and Safety of Adjunctive Pimavanserin for the Treatment of Schizophrenia (ENHANCE-1)
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Pimavanserin Patients started treatment with pimavanserin 20 mg once daily (QD). At the Week 1, Week 2 and Week 3 visit, the dose could be increased to 34 mg QD or decreased to 10 mg QD at the investigator's discretion (to improve symptom reliev or tolerability, respectively). Thereafter, the daily dose was to remain the same for the remainder of the study. Patients were to continue their background antipsychotic treatment. 0 None 2 198 31 198 View
Placebo Pimavanserin-matching Placebo. Patients were to continue their background antipsychotic treatment. 0 None 2 198 31 198 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Schizophrenia NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 22.0 View
Hallucination auditory NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 22.0 View
Psychotic symptom NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 22.0 View
Self-injurious ideation NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 22.0 View
Suicidal ideation NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 22.0 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Headache NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 22.0 View
Somnolence NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 22.0 View
Insomnia NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 22.0 View