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 @ 6:34 PM
Ignite Modification Date: 2025-12-25 @ 4:04 PM
NCT ID: NCT00928057
Description: Adverse events collection began once subjects were enrolled and continued throughout the 6 week randomized intervention period. The Investigator considered all Serious Adverse Events as unlikely to be related to, or not related to, the study devices or procedures.
Frequency Threshold: 4
Time Frame: upon enrollment to study completion
Study: NCT00928057
Study Brief: Comparison of Glycemic Control Among Diabetics Using Three Different Pen Needles
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
8mm PN All randomized subjects that used the 8 mm pen needle. None None 2 84 24 84 View
5mm PN All randomized subjects that used the 5 mm pen needle. None None 0 89 23 89 View
4mm PN All randomized subjects that used the 4mm pen needle. None None 4 173 40 173 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Dyspnea NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Hypoglycemia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Hypoglycemic seizure NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Myocardial infarction NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Dyspepsia NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Non-Hodgkins lymphoma NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
hypoglycemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
hyperglycemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Pain at injection site SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View