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: 2025-12-26 @ 10:34 AM
Ignite Modification Date: 2025-12-26 @ 10:34 AM
NCT ID: NCT01729728
Description: For tapentadol oral solution, the therapeutic reach is defined as 48 hours after intake. The age groups reported were prespecified in the protocol.
Frequency Threshold: 3.6
Time Frame: Any adverse event that started on the intake of tapentadol up to 48 hours thereafter.
Study: NCT01729728
Study Brief: Pharmacokinetic, Efficacy and Safety Study of Tapentadol Oral Solution in Children With Postoperative 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
Adolescents Single Dose of Tapentadol Oral Solution in Adolescents Age 12 to Less Than 18 Years. Tapentadol oral solution single dose (1mg/kg body weight). None None 0 21 12 21 View
Older Children Single Dose of Tapentadol Oral Solution in Children Age 6 to Less Than 12 Years. Tapentadol oral solution single dose (1mg/kg body weight). None None 1 28 20 28 View
Young and Very Young Children Single Dose of Tapentadol Oral Solution in Children Age 2 to Less Than 6 Years. Tapentadol oral solution single dose (1mg/kg body weight). None None 0 17 6 17 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
post-procedural hemorrhage NON_SYSTEMATIC_ASSESSMENT Surgical and medical procedures MedDRA 16.1 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Nausea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 16.1 View
Vomiting NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 16.1 View
Dizziness NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 16.1 View
Headache NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 16.1 View
Infusion site irritation NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA 16.1 View
Vessel puncture site bruise NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA 16.1 View
Cardiac murmur SYSTEMATIC_ASSESSMENT Investigations MedDRA 16.1 View
Cough NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 16.1 View
Nasal discomfort NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 16.1 View
Enlarged uvula NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 16.1 View
Abdominal pain upper NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 16.1 View
Pyrexia NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA 16.1 View
Somnolence NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 16.1 View
Aspartate aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 16.1 View
Blood creatine phosphokinase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 16.1 View
Chest pain NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA 16.1 View
Constipation NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 16.1 View
Diplopia NON_SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 16.1 View
Epistaxis NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 16.1 View
Hot flush NON_SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 16.1 View
Hyperhidrosis NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 16.1 View
Otitis media NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 16.1 View
Otitis media viral NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 16.1 View
Pruritus NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 16.1 View
Rash NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 16.1 View
Tremor NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 16.1 View