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 @ 9:40 PM
Ignite Modification Date: 2025-12-25 @ 7:22 PM
NCT ID: NCT01904032
Description: None
Frequency Threshold: 5
Time Frame: Adverse event data were collected for seven months
Study: NCT01904032
Study Brief: Sunshine 2 Study for Women With Diabetes
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Low Dose 5,000 international units (IUs) of a weekly Vitamin D3 comparator 0 None 5 64 55 64 View
High Dose 50,000 international units (IUs) weekly Vitamin D3 0 None 7 65 60 65 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Right sided weakness NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Stroke SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Acoustic neuroma SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Severe abdominal pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Miscarriage SYSTEMATIC_ASSESSMENT Pregnancy, puerperium and perinatal conditions None View
Pregnancy SYSTEMATIC_ASSESSMENT Pregnancy, puerperium and perinatal conditions None View
Left tibia fracture SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Laparoscopic cholecystectomy SYSTEMATIC_ASSESSMENT Surgical and medical procedures None View
Hiatal Hernia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Cancer Diagnosis SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) None View
Right total knee replacement SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Worsening Diabetes SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Joint Pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Back Pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Generalized Pain SYSTEMATIC_ASSESSMENT General disorders None View
Abdominal Pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Upper Respiratory Symptoms SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Dizziness SYSTEMATIC_ASSESSMENT General disorders None View
Abnormal Kidney Function SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Elevated Glucose SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Diarrhea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Nausea SYSTEMATIC_ASSESSMENT General disorders None View
Influenza SYSTEMATIC_ASSESSMENT Infections and infestations None View
Headache SYSTEMATIC_ASSESSMENT General disorders None View
Routine Surgery SYSTEMATIC_ASSESSMENT Surgical and medical procedures None View
Worsening Mood SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Muscle Pain SYSTEMATIC_ASSESSMENT General disorders None View
Numbness SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Dyspnea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Lower Extremity Cramps SYSTEMATIC_ASSESSMENT General disorders None View
Menstrual Symptoms SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders None View
Fatigue SYSTEMATIC_ASSESSMENT General disorders None View
Generalized Soreness SYSTEMATIC_ASSESSMENT General disorders None View
Swelling SYSTEMATIC_ASSESSMENT General disorders None View
Fall SYSTEMATIC_ASSESSMENT General disorders None View
Hypertension SYSTEMATIC_ASSESSMENT General disorders None View