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 @ 4:02 AM
Ignite Modification Date: 2025-12-26 @ 2:56 AM
NCT ID: NCT01786902
Description: None
Frequency Threshold: 0
Time Frame: None
Study: NCT01786902
Study Brief: Efficacy and Safety of DA-3002 in Children With Idiopathic Short Stature
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
DA-3002 Treatment Group 1.11 IU(0.37mg)/kg bodyweight of DA-3002 per week given by subcutaneous injections (six or seven times per week) DA-3002 None None 1 36 19 36 View
Non-treatment Control Group Height be measured with no treatment None None 1 31 14 31 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Pharyngotonsillitis None Infections and infestations None View
Strabismus correction None Surgical and medical procedures None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Upper respiratory tract infection None Infections and infestations None View
Enteritis None Gastrointestinal disorders None View
Nausea None Gastrointestinal disorders None View
Vomiting None Gastrointestinal disorders None View
Laceration None Injury, poisoning and procedural complications None View
Dizziness None Nervous system disorders None View
Headache None Nervous system disorders None View
Nasal congestion None Respiratory, thoracic and mediastinal disorders None View
Rash None Skin and subcutaneous tissue disorders None View
Strabismus correction None Surgical and medical procedures None View
Pyrexia None General disorders None View
Hypersensitivity None Immune system disorders None View