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 @ 11:31 PM
Ignite Modification Date: 2025-12-25 @ 9:19 PM
NCT ID: NCT00765856
Description: None
Frequency Threshold: 5
Time Frame: First dosing up to 30 days after the last dose of study medication, approximately 20 weeks (titration period of up to 4 weeks, the maintenance period of up to 12 weeks and 30 days post-last dose).
Study: NCT00765856
Study Brief: Open-Label Safety and Tolerability of Oxymorphone IR and ER in Opioid Tolerant Pediatric Subjects
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Titration Period Open-label dose titration period of up to 4 weeks 0 None 0 27 15 27 View
Maintenance Period Open-label maintenance period of up to 12 weeks plus 30 days post-last dose 0 None 3 24 7 24 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Sickle cell anemia with crisis SYSTEMATIC_ASSESSMENT Congenital, familial and genetic disorders MedDRA (11.1) View
Acute pancreatitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (11.1) View
Abdominal pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (11.1) View
Dyspnea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA (11.1) View
Increased alanine aminotransferase SYSTEMATIC_ASSESSMENT Investigations MedDRA (11.1) View
Increased aspartate aminotransferase SYSTEMATIC_ASSESSMENT Investigations MedDRA (11.1) View
Colitis ulcerative SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (11.1) View
Pouchitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (11.1) View
Pain SYSTEMATIC_ASSESSMENT General disorders MedDRA (11.1) View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Somnolence SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA (11.1) View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA (11.1) View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA (11.1) View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (11.1) View
Fatigue SYSTEMATIC_ASSESSMENT General disorders MedDRA (11.1) View
Dehydration SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA (11.1) View