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 @ 10:02 PM
Ignite Modification Date: 2025-12-25 @ 7:39 PM
NCT ID: NCT04489732
Description: Follow up for serious adverse events continues through 24 months post injection (up to 26 months from participant consent).
Frequency Threshold: 0
Time Frame: Toxicities regardless of attribution were recorded through the 3 month post injection visit per protocol (up to 5 months from participant consent) for primary outcomes.
Study: NCT04489732
Study Brief: MSC in Patients With Xerostomia Post XRT in Head and Neck Cancer
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Treatment With MSCs A single dose of MSCs injected into the submandibular glands of patients with radiation-induced xerostomia Autologous bone-marrow derived, interferon gamma stimulated mesenchymal stromal cells: Single dose, starting at * Dose Level 0: 10 x 10\^6 injected into one submandibular gland on Day 1 0 None 0 6 6 6 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Injection Site reaction (pain) SYSTEMATIC_ASSESSMENT General disorders CTCAE (5.0) View
Vaccine site lymphadenopathy SYSTEMATIC_ASSESSMENT General disorders CTCAE (5.0) View
Lymphocyte decrease SYSTEMATIC_ASSESSMENT Investigations CTCAE (5.0) View
Bone pain (bone marrow aspiration) SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders CTCAE (5.0) View
Neck Pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders CTCAE (5.0) View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE (5.0) View
Lymphedema SYSTEMATIC_ASSESSMENT Vascular disorders CTCAE (5.0) View
Platelet Count Decrease SYSTEMATIC_ASSESSMENT Investigations CTCAE (5.0) View
Cardiac Troponin 1 increase SYSTEMATIC_ASSESSMENT Investigations CTCAE (5.0) View
Anemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders CTCAE (5.0) View
Eosinophilia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders CTCAE (5.0) View
Telangiectasia SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTCAE (5.0) View