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: NCT01215032
Description: None
Frequency Threshold: 5
Time Frame: None
Study: NCT01215032
Study Brief: Metformin in Castration-Resistant Prostate Cancer
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Metformin This is the only arm of this phase 2 open label study Metformin: Taken orally twice daily each 28-day cycle None None 0 21 16 21 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
abdominal pain NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (4.0) View
vomiting NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (4.0) View
Non-cardiac chest pain NON_SYSTEMATIC_ASSESSMENT General disorders CTCAE (4.0) View
Bone pain NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders CTCAE (4.0) View
Urinary frequency NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders CTCAE (4.0) View
Rash maculo-papular NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTCAE (4.0) View
Hypothyroidism NON_SYSTEMATIC_ASSESSMENT Endocrine disorders CTCAE (4.0) View
cataract NON_SYSTEMATIC_ASSESSMENT Eye disorders CTCAE (4.0) View
diarrhea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (4.0) View
flatulence NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (4.0) View
frequent bowel movements NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (4.0) View
nausea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (4.0) View
chills NON_SYSTEMATIC_ASSESSMENT General disorders CTCAE (4.0) View
fatigue NON_SYSTEMATIC_ASSESSMENT General disorders CTCAE (4.0) View
fever NON_SYSTEMATIC_ASSESSMENT General disorders CTCAE (4.0) View
Generalized achiness NON_SYSTEMATIC_ASSESSMENT General disorders CTCAE (4.0) View
anorexia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE (4.0) View
hyperglycemia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE (4.0) View
Vitamin D deficiency NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE (4.0) View
Back pain NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders CTCAE (4.0) View
Buttock pain NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders CTCAE (4.0) View
Chest wall pain NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders CTCAE (4.0) View
Pain in extremity NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders CTCAE (4.0) View
Numbness in Toes NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders CTCAE (4.0) View
Numbness - buttocks NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders CTCAE (4.0) View
Urinary incontinence NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders CTCAE (4.0) View
Sore throat NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE (4.0) View
Hypertension NON_SYSTEMATIC_ASSESSMENT Vascular disorders CTCAE (4.0) View