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 @ 11:05 PM
Ignite Modification Date: 2025-12-25 @ 8:36 PM
NCT ID: NCT01983969
Description: None
Frequency Threshold: 5
Time Frame: Up to 100 Days post autologous transplant.
Study: NCT01983969
Study Brief: Aza-SAHA-GBM With AutoSCT for Refractory Lymphoma
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Azacitidine Dose Level 3 Azacitidine 35 mg/m2 IV for 10 days+Vorinostat 1000 mg PO for 10 days+ Busulfan (adjusted PK dosing) IV for 4 days+Gemcitabine 2775 mg/m2 IV for 2 days+Melphalan 60 mg/m2 IV for 2 days +/- Rituximab 375 mg/m2 IV for 1 day (for CD20 positive tumors)+ Auto SCT 1 None 0 5 5 5 View
Azacitidine Dose Level 1 Azacitidine 15 mg/m2 IV for 10 days+Vorinostat 1000 mg PO for 10 days+ Busulfan (adjusted PK dosing) IV for 4 days+Gemcitabine 2775 mg/m2 IV for 2 days+Melphalan 60 mg/m2 IV for 2 days +/- Rituximab 375 mg/m2 IV for 1 day (for CD20 positive tumors)+ Auto SCT 1 None 0 37 37 37 View
Azacitidine Dose Level 2 Azacitidine 25 mg/m2 IV for 10 days+Vorinostat 1000 mg PO for 10 days+ Busulfan (adjusted PK dosing) IV for 4 days+Gemcitabine 2775 mg/m2 IV for 2 days+Melphalan 60 mg/m2 IV for 2 days +/- Rituximab 375 mg/m2 IV for 1 day (for CD20 positive tumors)+ Auto SCT 0 None 0 18 18 18 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Hypertension SYSTEMATIC_ASSESSMENT Cardiac disorders CTCAE (4.0) View
DVT SYSTEMATIC_ASSESSMENT Cardiac disorders CTCAE (4.0) View
Fever SYSTEMATIC_ASSESSMENT General disorders CTCAE (4.0) View
Fluid Overload SYSTEMATIC_ASSESSMENT General disorders CTCAE (4.0) View
Diarrhea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (4.0) View
Mucositis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (4.0) View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (4.0) View
Elevated Creatinine SYSTEMATIC_ASSESSMENT Renal and urinary disorders CTCAE (4.0) View
Hemorrhagic Cystitis SYSTEMATIC_ASSESSMENT Renal and urinary disorders CTCAE (4.0) View
Transaminitis SYSTEMATIC_ASSESSMENT Hepatobiliary disorders CTCAE (4.0) View
Elevated Bilirubin SYSTEMATIC_ASSESSMENT Hepatobiliary disorders CTCAE (4.0) View
Infection SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE (4.0) View
Neutropenic Fever SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE (4.0) View
Pneumonitis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE (4.0) View
Skin Rash SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTCAE (4.0) View