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 @ 4:03 PM
Ignite Modification Date: 2025-12-25 @ 2:05 PM
NCT ID: NCT01458366
Description: adverse events are presented as a cumulative across both the Phase I and Phase II portions of the study to illustrate the overall safety of the combination of bendamustine, ofatumumab, carboplatin, and etoposide.
Frequency Threshold: 5
Time Frame: 2 years from baseline
Study: NCT01458366
Study Brief: Phase I/II Study of Bendamustine in Combination With Ofatumumab, Carboplatin and Etoposide
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Bendamustine 70 mg/m2 Combination of Bendamustine, Ofatumumab, Carboplatin, and Etoposide Bendamustine: Phase 1: Given via IV at the following dose levels: \- Level 1: 70 mg/m2 4 None 4 5 3 5 View
Bendamustine 50 mg/m2 Combination of Bendamustine, Ofatumumab, Carboplatin, and Etoposide Bendamustine: Phase 1: Given via IV at the following dose levels: \- Level -1: 50 mg/m2 0 None 0 0 0 0 View
Bendamustine 120 mg/m2 Combination of Bendamustine, Ofatumumab, Carboplatin, and Etoposide Bendamustine: Phase 1: Given via IV at the following dose levels: \- Level 3: 120 mg/m2 1 None 3 3 3 3 View
Bendamustine 90 mg/m2 Combination of Bendamustine, Ofatumumab, Carboplatin, and Etoposide Bendamustine: Phase 1: Given via IV at the following dose levels: \- Level 2: 90 mg/m2 1 None 3 3 3 3 View
Bendamustine at MTD Phase II: Given via IV on Days 1 and 2 of each cycle at the maximum-tolerated dose level found in the Phase I portion of the study. Ofatumumab: Phase II * Cycle 1: 300 mg via IV on Day 1 and 1000 mg via IV on Day 3 * Cycles 2 and 3: 1000 mg via IV on Day 1 Carboplatin: Phase II: AUC 5 via IV on Day 2 of each cycle Etoposide: Phase II: 100 mg/m2 via IV on Days 1, 2, and 3 of each cycle 16 None 11 27 11 27 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Neutropenic Fever NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
thrombocytopenia NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
thromboembolic event NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Diarrhea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Hyperglycemia NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Hyperkalemia NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Hyperurecemia NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Dyspnea NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Increase Bilirubin NON_SYSTEMATIC_ASSESSMENT Hepatobiliary disorders None View
Syncope NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Anemia NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Decreased ANC NON_SYSTEMATIC_ASSESSMENT Hepatobiliary disorders None View
Hypophosphatemia NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Increased AST NON_SYSTEMATIC_ASSESSMENT Hepatobiliary disorders None View
Hyponatremia NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Decreased ALC NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Tumor Lysis Syndrome NON_SYSTEMATIC_ASSESSMENT General disorders None View
Decreased White Blood Cell Count NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Anemia NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Fatigue NON_SYSTEMATIC_ASSESSMENT General disorders None View