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: 2025-12-25 @ 5:09 AM
Ignite Modification Date: 2025-12-26 @ 4:13 AM
NCT ID: NCT01221727
Description: The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Frequency Threshold: 5
Time Frame: 47 days
Study: NCT01221727
Study Brief: The Effects of Denosumab on the Pharmacokinetics (PK) of Midazolam
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Midazolam With Denosumab Group With Denosumab 60mg on Day 2-15 None None None 0 18 6 18 View
Midazolam Only Group With Midazolam 2mg on Day 2-15 None None None 0 8 1 8 View
Midazolam Only Group With Midazolam 2mg on Day 16 None None None 0 8 1 8 View
Midazolam With Denosumab Group With Midazolam 2mg on Day 1 None None None 0 19 9 19 View
Midazolam With Denosumab Group With Midazolam 2mg on Day 16 None None None 0 18 10 18 View
Midazolam Only Group With Midazolam 2mg on Day 1 None None None 0 8 2 8 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 14.0 View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 14.0 View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 14.0 View
Chills SYSTEMATIC_ASSESSMENT General disorders MedDRA 14.0 View
Fatigue SYSTEMATIC_ASSESSMENT General disorders MedDRA 14.0 View
Injection site pain SYSTEMATIC_ASSESSMENT General disorders MedDRA 14.0 View
Nasopharyngitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 14.0 View
Laceration SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 14.0 View
Arthralgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 14.0 View
Musculoskeletal stiffness SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 14.0 View
Neck pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 14.0 View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 14.0 View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 14.0 View
Presyncope SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 14.0 View
Somnolence SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 14.0 View
Pollakiuria SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 14.0 View
Cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 14.0 View
Oropharyngeal pain SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 14.0 View
Ecchymosis SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 14.0 View