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 @ 7:58 PM
Ignite Modification Date: 2025-12-25 @ 5:32 PM
NCT ID: NCT01959204
Description: None
Frequency Threshold: 0
Time Frame: Adverse events were collected over the course of the study (4 years)
Study: NCT01959204
Study Brief: Evaluate The Pharmacokinetics and Safety Of Oxycodone Oral Solution In Pediatric and Adolescent 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
Active Open label pharmacokinetic study of oxycodone. Oxycodone: Pain 21 None 0 97 20 97 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Pyrexia NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA (10.0) View
Pruritus NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA (10.0) View
Anaemia NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA (10.0) View
abdominal Pain Upper NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (10.0) View
nausea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (10.0) View
Vomiting NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (10.0) View
application site pruritus NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA (10.0) View
Chills NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA (10.0) View
Injection site erythema NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA (10.0) View
Drug Hypersenstivity NON_SYSTEMATIC_ASSESSMENT Immune system disorders MedDRA (10.0) View
Alanine amniotransferase increased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA (10.0) View
Blood phosphorus decreased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA (10.0) View
Haematocrit decreased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA (10.0) View
Liver function test increased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA (10.0) View
Oxygen saturation decreased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA (10.0) View
Red blood cell count decreased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA (10.0) View
Neck Pain NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA (10.0) View
Dizziness NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA (10.0) View
Headache NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA (10.0) View
Anxiety NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA (10.0) View
Erythema NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA (10.0) View
Pruritus generalized NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA (10.0) View