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: 2025-12-26 @ 11:47 AM
Ignite Modification Date: 2025-12-26 @ 11:47 AM
NCT ID: NCT00806416
Description: 214 subjects were enrolled in Part I of the study \& 30 subjects were enrolled in Part II. All 214 subjects in the Alendronate arm \& 210 subjects from Part I and 30 subjects from Part II in the Alendronate/Vitamin D Combination are included in the analysis for safety. The 30 Vitamin D arm subjects that were enrolled in Part II are included.
Frequency Threshold: 0
Time Frame: None
Study: NCT00806416
Study Brief: A Study of the Bioequivalence of 70 mg Alendronate and 70 mg Alendronate in Combination With 2800 IU Vitamin 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
Alendronate/Vitamin D Combination 70 mg alendronate/2800-IU vitamin D3 combination tablet None None 0 240 55 240 View
Alendronate 70 mg alendronate tablet None None 0 214 39 214 View
Vitamin D 2800-IU vitamin D3 tablet None None 0 30 9 30 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Conjunctivitis NON_SYSTEMATIC_ASSESSMENT Eye disorders None View
Keratoconjunctivitis Sicca NON_SYSTEMATIC_ASSESSMENT Eye disorders None View
Abdominal Pain NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Abdominal Pain Upper NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Constipation NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Diarrhoea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Dyspepsia NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Flatulence NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Intestinal Functional Disorder NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Loose Stools NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Nausea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Retching NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Vomiting NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Chest Pain NON_SYSTEMATIC_ASSESSMENT General disorders None View
Pain NON_SYSTEMATIC_ASSESSMENT General disorders None View
Rigors NON_SYSTEMATIC_ASSESSMENT General disorders None View
Contusion NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Excoriation NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Injury NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Soft Tissue Injury NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Body Temperature Increased NON_SYSTEMATIC_ASSESSMENT Investigations None View
Haemoglobin Decreased NON_SYSTEMATIC_ASSESSMENT Investigations None View
White Blood Cells Urine Positive NON_SYSTEMATIC_ASSESSMENT Investigations None View
Arthralgia NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Back Pain NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Muscle Cramp NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Dizziness NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Headache NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Somnolence NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Haematospermia NON_SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders None View
Menstruation Irregular NON_SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders None View
Pharyngolaryngeal Pain NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Rhinitis NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Sinus Congestion NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Hot Flush NON_SYSTEMATIC_ASSESSMENT Vascular disorders None View