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 @ 1:18 AM
Ignite Modification Date: 2025-12-25 @ 11:26 PM
NCT ID: NCT02416193
Description: None
Frequency Threshold: 0
Time Frame: Adverse event data were collected for 20 weeks
Study: NCT02416193
Study Brief: Can Vitamin D3 Improve Cognitive Function in Individuals With Type 2 Diabetes? (THINK-D)
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
High Dose 50,000 IU cholecalciferol once weekly for three months 0 None 1 15 9 15 View
Low Dose 5,000 IU cholecalciferol once weekly for three months 0 None 0 15 12 15 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Stroke NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Cold virus NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Short menstrual period NON_SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders None View
Menstrual cramps NON_SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders None View
Arm pain NON_SYSTEMATIC_ASSESSMENT General disorders None View
Toothache NON_SYSTEMATIC_ASSESSMENT General disorders None View
Nausea NON_SYSTEMATIC_ASSESSMENT General disorders None View
Constipation NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Cataracts NON_SYSTEMATIC_ASSESSMENT Eye disorders None View
Hypercalcemia NON_SYSTEMATIC_ASSESSMENT Endocrine disorders None View
Hemorrhoids NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Poor appetite NON_SYSTEMATIC_ASSESSMENT General disorders None View
Dark stools NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Asthma NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Sinus infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Strep throat NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Sore throat NON_SYSTEMATIC_ASSESSMENT General disorders None View
Fall NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Tiredness NON_SYSTEMATIC_ASSESSMENT General disorders None View
Muscle aches NON_SYSTEMATIC_ASSESSMENT General disorders None View
Goiter NON_SYSTEMATIC_ASSESSMENT Endocrine disorders None View
Arhritis NON_SYSTEMATIC_ASSESSMENT General disorders None View
Foot pain NON_SYSTEMATIC_ASSESSMENT General disorders None View
Restlessness NON_SYSTEMATIC_ASSESSMENT General disorders None View
Shoulder pain NON_SYSTEMATIC_ASSESSMENT General disorders None View
Knee cyst NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Leg cramps NON_SYSTEMATIC_ASSESSMENT General disorders None View
Motor vehicle accident NON_SYSTEMATIC_ASSESSMENT Social circumstances None View
Hypertension NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View