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 @ 1:29 PM
Ignite Modification Date: 2025-12-25 @ 12:32 PM
NCT ID: NCT02195895
Description: None
Frequency Threshold: 0
Time Frame: 12 months
Study: NCT02195895
Study Brief: Effect of Alendronate on Bone in People With Chronic Spinal Cord Injury (SCI) Previously Treated With Teriparatide
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Alendronate, Calcium, Vitamin D Drug: Weekly oral alendronate 70 mg for 12 months Supplements: Calcium and Vitamin D daily for 12 months Alendronate: Weekly oral alendronate 70 mg for 12 months Calcium: Daily Oral 1000 mg Vitamin D: Daily Oral 1000 IU 0 None 4 17 13 17 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Urinary Tract Infection (UTI) SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Kidney stone SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Sepsis SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Inferior Vena Cava (IVC) filter shifted SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Spinal cord cysts SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Pressure sore SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Abdominal pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Abscess (perineal) SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Bacteremia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Blister SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Blood clot SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Cold SYSTEMATIC_ASSESSMENT Infections and infestations None View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Cyst SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Decrease sensation SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Dizziness SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Eye stye SYSTEMATIC_ASSESSMENT Eye disorders None View
Food poisoning SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Hernia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Heterotopic Ossification SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Hypercholesterolemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Hypertension SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Hypocalcemia SYSTEMATIC_ASSESSMENT Endocrine disorders None View
Hypokalemia SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Infection (MRSA) SYSTEMATIC_ASSESSMENT Infections and infestations None View
Loose tooth SYSTEMATIC_ASSESSMENT General disorders None View
Lower extremity fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Musculoskeletal Pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Pressure sore SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Ruptured stitches SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Soreness SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Spasms SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Benign mass removal SYSTEMATIC_ASSESSMENT Surgical and medical procedures None View
Tooth extraction SYSTEMATIC_ASSESSMENT Surgical and medical procedures None View
Urinary Tract Infection (UTI) SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Worsened vision SYSTEMATIC_ASSESSMENT Eye disorders None View