Adverse Events Module

Home Icon Home Search Icon Search Certify Doc Icon Certify Doc Certify Doc Icon Genes Certify Doc Icon Clinical Trials Certify Doc Icon CompTox Processes Icon DrugMatrix Open Targets Icon Open Targets Processes Icon Products Support Icon Support Bugs Icon Bugs
Main Search Make This Study a Gene Therapy Make This Study a Not Gene Therapy Report Bug
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 @ 4:44 PM
Ignite Modification Date: 2025-12-25 @ 2:31 PM
NCT ID: NCT00504166
Description: None
Frequency Threshold: 0
Time Frame: None
Study: NCT00504166
Study Brief: Alendronate Prevents Microarchitectural Deterioration of Trabecular Bone in Early Postmenopausal Women
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 Sodium alendronate sodium 70 mg tablet once a week for 24 months None None 3 26 16 26 View
Placebo placebo to match alendronate sodium None None 4 27 19 27 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Anxiety attack NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Difficulty swallowing NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Vitamin D overdose NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
significant bone mineral loss SYSTEMATIC_ASSESSMENT Endocrine disorders None View
Malignant melanoma NON_SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) None View
Diverticulitis NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
high monocyte level SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Abnormal white cell count SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Broken tooth NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Hyperthyroidism NON_SYSTEMATIC_ASSESSMENT Endocrine disorders None View
mildly unpleasant feeling in the stomach NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
High calcium level SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Low neutrophil count SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
High cholesterol NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
osteoarthritis of the hip NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Sinus nasal congestion NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
sore throat NON_SYSTEMATIC_ASSESSMENT General disorders None View
Painful urination NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Blood-tinged urine NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
irregular heart beat NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
High Phosphorus level SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
vaginal odor NON_SYSTEMATIC_ASSESSMENT General disorders None View
heartburn NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Swelling, left ankle NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Conjunctivitis NON_SYSTEMATIC_ASSESSMENT Eye disorders None View
nausea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Patches of dry skin NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Lower respiratory tract infection NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
loose bowel movement NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Blood shot red eyes NON_SYSTEMATIC_ASSESSMENT Eye disorders None View
swollen tongue NON_SYSTEMATIC_ASSESSMENT General disorders None View
ear pain NON_SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders None View
Stomach upset NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
flu NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
neck pain NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
dry mouth NON_SYSTEMATIC_ASSESSMENT General disorders None View
diarrhea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
abdominal cramping NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
bladder infection NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
shingles, left forehead & scalp NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
cervical vertebral disk degeneration NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Stomach flu NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
palpitation NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
dental abscess NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Swelling, upper & lower eyelids NON_SYSTEMATIC_ASSESSMENT Eye disorders None View
high uric acid level SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
sleep apnea NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
abnormal red blood cell count SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
high alanine aminotransferase SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
high eosinophil count SYSTEMATIC_ASSESSMENT Infections and infestations None View
tooth infection #30 NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
dizziness NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
cough & colds NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Low Carbon Dioxide level SYSTEMATIC_ASSESSMENT General disorders None View
High creatinine SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View