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 @ 1:17 PM
Ignite Modification Date: 2025-12-26 @ 1:17 PM
NCT ID: NCT01334606
Description: None
Frequency Threshold: 4
Time Frame: Adverse Events were collected from the start of study participation until subjects completed, or were discontinued from the study. Subjects that participated in the study used each pen needle for up to 3 weeks.
Study: NCT01334606
Study Brief: Evaluation of a 4mmx32G Pen Needle for Injection of Basal Insulin Doses Above 40 Units
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
All Study Participants This includes all subjects that participated in the study. A total of 22 adverse events were reported. The investigator reported that 14 of 22 events were not related to the study product, and 8 of 22 events were unlikely related to the study product. None None 1 21 9 21 View
4mmx32G Pen Needle Subjects that used the 4mmx32G pen needle, either during Study Period 1 or Study Period 2 None None 1 21 6 21 View
8mmx31G Pen Needle Subjects that used the 8mmx31G pen needle, either during Study Period 1 or Study Period 2 None None 0 21 6 21 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Progressive Degeneration right knee NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Tennis Elbow NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
leg pain NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
hypoglycemia NON_SYSTEMATIC_ASSESSMENT Endocrine disorders None View
Allergic rhinitis NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
urinary tract infection NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Diarrhea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View