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 @ 7:36 PM
Ignite Modification Date: 2025-12-25 @ 5:17 PM
NCT ID: NCT06107803
Description: None
Frequency Threshold: 0
Time Frame: Treatment through end of study (Day 17).
Study: NCT06107803
Study Brief: A Study to Evaluate the Safety, Tolerability, Pharmacodynamics, and Pharmacokinetics of Co-Administration of Roluperidone and Olanzapine in Adult Subjects With Moderate to Severe Negative Symptoms of 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
Treatment Phase 1 Roluperidone 64 mg monotherapy administered as an oral dose daily for 7 days on Days 1-7. Roluperidone 64 mg: 64 mg/day oral 0 None 1 17 5 17 View
Treatment Phase 2 Roluperidone 64 mg oral and olanzapine 10 mg oral administered at the same time daily for 10 days on Days 8-17. Roluperidone 64 mg: 64 mg/day oral Olanzapine 10 MG: 10 mg/day oral 0 None 0 15 5 15 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Rhabdomyolysis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 26.1 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 26.1 View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 26.1 View
Somnolence SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 26.1 View
Presyncope SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 26.1 View
Syncope SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 26.1 View
Alanine aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 26.1 View
Blood creatine phosphokinase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 26.1 View
Electrocardiogram T wave inversion SYSTEMATIC_ASSESSMENT Investigations MedDRA 26.1 View
Heart rate increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 26.1 View
Agitation SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 26.1 View