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 @ 2:15 AM
Ignite Modification Date: 2025-12-26 @ 12:44 AM
NCT ID: NCT01222260
Description: None
Frequency Threshold: 5
Time Frame: 2 years
Study: NCT01222260
Study Brief: Bendamustine and Dexamethasone in Patients With Relapsed AL Amyloidosis
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 Arm Subjects with AL will receive Bendamustine and Dexamethasone Bendamustine: Patients will start bendamustine at dose level 0 and according to CrCl on day 1 and 2 of each cycle: * CrCl ≥ 60 mL/min: 100 mg/m2 IV on day 1 and 2 of each cycle * CrCl 59 - 30 mL/min: 90 mg/m2 IV on day 1 and 2 of each cycle Available to qualifying subjects is the option to dose escalate to dose level (+)1: * 120 mg/m2 (if CrCl ≥ 60 mL/min at the time of inclusion into the study) * 100 mg/m2 (if CrCl 59-30 mL/min at the time of inclusion into the study) Dexamethasone: 40 mg orally on days 1, 8, 15, 22 of each cycle 1 None 10 29 20 29 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Fatigue NON_SYSTEMATIC_ASSESSMENT General disorders CTCAE (4.0) View
Diarrhea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (4.0) View
Renal dysfunction NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders CTCAE (4.0) View
Infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE (4.0) View
Rash NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTCAE (4.0) View
Infusion-related reaction NON_SYSTEMATIC_ASSESSMENT General disorders CTCAE (4.0) View
Fever and chills NON_SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE (4.0) View
Atrial fibrillation NON_SYSTEMATIC_ASSESSMENT Cardiac disorders CTCAE (4.0) View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Fatigue NON_SYSTEMATIC_ASSESSMENT General disorders CTCAE (4.0) View
Decreased lymphocyte count NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders CTCAE (4.0) View
Chronic kidney disease NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders CTCAE (4.0) View
Hypotension NON_SYSTEMATIC_ASSESSMENT General disorders CTCAE (4.0) View
Hypertension NON_SYSTEMATIC_ASSESSMENT General disorders CTCAE (4.0) View
Decreased neutrophil count NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders CTCAE (4.0) View
Syncope NON_SYSTEMATIC_ASSESSMENT General disorders CTCAE (4.0) View
Nausea NON_SYSTEMATIC_ASSESSMENT General disorders CTCAE (4.0) View
Decreased white blood cell count NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders CTCAE (4.0) View
Anemia NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders CTCAE (4.0) View