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: 2025-12-25 @ 12:20 AM
Ignite Modification Date: 2025-12-25 @ 10:24 PM
NCT ID: NCT00713258
Description: The safety analysis set was defined as all subjects that were randomized and given at least 1 dose of the Investigational Medicinal Product (IMP). Subjects were analysed as treated. The safety set is equivalent with the Intention-to-treat (ITT) set.
Frequency Threshold: 5
Time Frame: 24 weeks
Study: NCT00713258
Study Brief: The Effect of PTH(1-84) or Alendronate on Reduction of Back Pain in Postmenopausal Women With an Osteoporosis Related Vertebral Fracture(s) (FP-005-IM)
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
PTH (1-84) PTH (1-84) + placebo alendronate * PTH (1-84): powder and solvent for solution for injection * placebo alendronate: capsule None None 1 41 18 41 View
Alendronate PTH (1-84) placebo + alendronate * PTH (1-84) placebo: powder and solvent for solution for injection * alendronate: capsule None None 5 34 13 34 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Abdominal pain upper SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (12.0) View
Bursitis infective SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (12.0) View
Gastric cancer SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA (12.0) View
Humerus fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA (12.0) View
Ovarian cancer SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA (12.0) View
Pancreatic carcinoma SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA (12.0) View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Fall SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA (12.0) View
Hypercalcaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA (12.0) View
Nasopharyngitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (12.0) View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (12.0) View
Vitamin D deficiency SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA (12.0) View
Abdominal pain upper SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (12.0) View
Back pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA (12.0) View