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 @ 4:13 AM
Ignite Modification Date: 2025-12-26 @ 3:11 AM
NCT ID: NCT01323920
Description: AEs grade 3-5 \& SAEs whether reported by the participant, discovered during questioning, directly observed, or detected by physical examination, laboratory test or other means, will be recorded in the participant's medical record and on the appropriate study-specific case report forms. Participants removed from study treatment for unacceptable AEs will be followed until resolution or stabilization of the AE. One participant was enrolled but immediately taken off study for alternative therapy.
Frequency Threshold: 0
Time Frame: All adverse events experienced by participants will be collected from the time of the first dose of study treatment, through the study and until the final study visit. Participants continuing to experience toxicity at the off study visit may be contacted for additional assessments until the toxicity has resolved or is deemed irreversible.Participants will be followed for 1 year after transplantation or until death, whichever occurs first.
Study: NCT01323920
Study Brief: Bortezomib-based GVHD Prophylaxis After Allogeneic Transplant for Patients Without Matched Related Donors
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Velcade/Tac/MTX Drug: Bortezomib, Tacrolimus, Methotrexate Other Names: Velcade Bortezomib 1.3 mg/m\^2 IV Tacrolimus 0.05 mg/kg PO bid Methotrexate 15 mg/m\^2 IV None None 5 34 0 34 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
GVHD SYSTEMATIC_ASSESSMENT Immune system disorders CTCAE v4 View
HHV6/high LFTs SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE v4 View
Sepsis SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE v4 View
Relapse SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) CTCAE v4 View
Other Events(If Any):