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 @ 10:33 PM
Ignite Modification Date: 2025-12-25 @ 8:05 PM
NCT ID: NCT02508935
Description: A treatment-emergent adverse event (TEAE) is defined as an evat that emerges during treatment having been absent pre-treatment or worsens relative to the pre-treatment state. Any TEAE determined as possibly related or related to the study drug is considered a treatment-related TEAE. All serious adverse events are reported, as well as all treatment-related TEAEs.
Frequency Threshold: 0
Time Frame: Up to 17 months.
Study: NCT02508935
Study Brief: Pharmacokinetics (PK) and Safety Study of XARTEMIS® XR in Postsurgical Adolescent Subjects With Moderate to Severe Acute Pain
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
XARTEMIS XR XARTEMIS XR is a combination of oxycodone and acetaminophen administered to postsurgical adolescent participants with moderate to severe acute pain. 0 None 3 23 7 23 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Severe pneumothorax SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA (16.1) View
Moderate Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (16.1) View
Severe delirium SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA (16.1) View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (16.1) View
Pruritis SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA (16.1) View
Asthenia SYSTEMATIC_ASSESSMENT General disorders MedDRA (16.1) View