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 @ 11:33 PM
Ignite Modification Date: 2025-12-25 @ 9:22 PM
NCT ID: NCT04026256
Description: None
Frequency Threshold: 5
Time Frame: adverse event data was collected from baseline to approximately 1 month after study completion, for an average duration of 5 months per participant (assuming that the participant completed the whole study).
Study: NCT04026256
Study Brief: Bone Modeling Effects of Combined Anabolic/Antiresorptive Administration
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Teriparatide Only daily subcutaneous injection teriparatide for 3 months Teriparatide: teriparatide daily subcutaneous injection 0 None 1 13 5 13 View
Denosumab Only one dose of subcutaneous injection denosumab Denosumab: denosumab subcutaneous injection 0 None 0 9 6 9 View
Denosumab and Teriparatide daily subcutaneous injection teriparatide for 3 months plus one dose of subcutaneous injection denosumab Teriparatide: teriparatide daily subcutaneous injection Denosumab: denosumab subcutaneous injection 0 None 1 12 9 12 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
phototoxic dermatitis NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
transient syncopal event NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
myalgia NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
propagation of fracture at biopsy site 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
pruritus NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
fatigue NON_SYSTEMATIC_ASSESSMENT General disorders None View
rhinorrhea NON_SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders None View
nausea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
joint pain NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View