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 @ 3:22 PM
Ignite Modification Date:
2025-12-25 @ 1:41 PM
NCT ID:
NCT01096992
Description:
None
Frequency Threshold:
5
Time Frame:
Adverse events captured from the time of participant consent until 30 days after the last dose of drug.
Study:
NCT01096992
Study Brief:
Fludarabine, Bendamustine, and Rituximab (FBR) for Relapsed Chronic Lymphocytic Leukemia (CLL)
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Phase 1 50 mg/m^2 | Bendamustine, Fludarabine + Rituximab Bendamustine: Phase 1: 50 mg/m\^2 IV on Days 1,2,3 (after fludarabine) Fludarabine: Course 1: 20 mg/m\^2 intravenous (IV) on Days 2,3,4 Courses 2-6: 20 mg/m\^2 IV, Days 1,2,3 Rituximab: Course 1: 375 mg/m\^2 IV, Day 4 (after fludarabine) Courses 2-6: 500 mg/m\^2 IV, Day 1 | 0 | None | 5 | 6 | 6 | 6 | View |
| Phase 2 | Bendamustine 30 mg/m\^2 by vein (fixed), Days 1,2,3 + Fludarabine + Rituximab Phase 2: 30 mg/m\^2 by vein (fixed) on Days 1,2,3 (after fludarabine) Fludarabine: Course 1: 20 mg/m\^2 intravenous (IV) on Days 2,3,4 Courses 2-6: 20 mg/m\^2 IV, Days 1,2,3 Rituximab: Course 1: 375 mg/m\^2 IV, Day 4 (after fludarabine) Courses 2-6: 500 mg/m\^2 IV, Day 1 | 1 | None | 16 | 30 | 30 | 30 | View |
| Phase 1 40 mg/m^2 | Bendamustine, Fludarabine + Rituximab Bendamustine: Phase 1: 40 mg/m\^2 IV on Days 1,2,3 (after fludarabine) Fludarabine: Course 1: 20 mg/m\^2 intravenous (IV) on Days 2,3,4 Courses 2-6: 20 mg/m\^2 IV, Days 1,2,3 Rituximab: Course 1: 375 mg/m\^2 IV, Day 4 (after fludarabine) Courses 2-6: 500 mg/m\^2 IV, Day 1 | 0 | None | 4 | 6 | 6 | 6 | View |
| Phase 1 20 mg/m^2 | Bendamustine, Fludarabine + Rituximab Bendamustine: Phase 1: 20 mg/m\^2 IV on Days 1,2,3 (after fludarabine) Fludarabine: Course 1: 20 mg/m\^2 intravenous (IV) on Days 2,3,4 Courses 2-6: 20 mg/m\^2 IV, Days 1,2,3 Rituximab: Course 1: 375 mg/m\^2 IV, Day 4 (after fludarabine) Courses 2-6: 500 mg/m\^2 IV, Day 1 | 2 | None | 4 | 6 | 6 | 6 | View |
| Phase 1 30 mg/m^2 | Bendamustine, Fludarabine + Rituximab Bendamustine: Phase 1: 30 mg/m\^2 IV on Days 1,2,3 (after fludarabine) Fludarabine: Course 1: 20 mg/m\^2 intravenous (IV) on Days 2,3,4 Courses 2-6: 20 mg/m\^2 IV, Days 1,2,3 Rituximab: Course 1: 375 mg/m\^2 IV, Day 4 (after fludarabine) Courses 2-6: 500 mg/m\^2 IV, Day 1 | 0 | None | 0 | 3 | 3 | 3 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Neutropenia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | CTCAE (3.0) | View |
| Neutropenic Fever | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE (3.0) | View |
| Pain | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (3.0) | View |
| Pneumonia | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE (3.0) | View |
| Rash | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTCAE (3.0) | View |
| Tumor Flare | SYSTEMATIC_ASSESSMENT | Investigations | CTCAE (3.0) | View |
| Tumor Lysis | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE (3.0) | View |
| Acites | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (3.0) | View |
| Fever | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (3.0) | View |
| Gout | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | View |
| Growth Neck | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (3.0) | View |
| Hemorrhage | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | CTCAE (3.0) | View |
| Hemorrhage Bladder | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | CTCAE (3.0) | View |
| Hyperphosphatemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE (3.0) | View |
| Hypotension | SYSTEMATIC_ASSESSMENT | Cardiac disorders | CTCAE (3.0) | View |
| Subdural Hematoma | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | CTCAE (3.0) | View |
| Thrombocytopenia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | CTCAE (3.0) | View |
| Urinary Tract Infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE (3.0) | View |
| Anorexia | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (3.0) | View |
| Cellulitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE (3.0) | View |
| Dehydration | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (3.0) | View |
| Drug Rash | SYSTEMATIC_ASSESSMENT | Investigations | CTCAE (3.0) | View |
| Fainting | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (3.0) | View |
| Fall | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (3.0) | View |
| Fatigue | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (3.0) | View |
| Hemolysis | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | CTCAE (3.0) | View |
| Infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE (3.0) | View |
| Nausea and Vomiting | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (3.0) | View |
| Allergic Reaction Investigational Product | SYSTEMATIC_ASSESSMENT | Investigations | CTCAE (3.0) | View |
| Bladder Infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE (3.0) | View |
| Chills | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (3.0) | View |
| Elevated BUN | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | CTCAE (3.0) | View |
| Phlebitis | SYSTEMATIC_ASSESSMENT | Vascular disorders | CTCAE (3.0) | View |
| Renal Failure | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | CTCAE (3.0) | View |
| Sepsis | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE (3.0) | View |
| Squamous Cell Carcinoma | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | CTCAE (3.0) | View |
| Amloidosis | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (3.0) | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Dehydration | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (3.0) | View |
| Neutropenia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | CTCAE (3.0) | View |
| Fatigue | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (3.0) | View |
| Hyperglycemia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | CTCAE (3.0) | View |
| Nausea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (3.0) | View |
| Thrombocytopenia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | CTCAE (3.0) | View |
| Vomiting | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (3.0) | View |
| Anemia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | CTCAE (3.0) | View |
| Infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE (3.0) | View |
| Edema | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (3.0) | View |
| Anorexia | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (3.0) | View |
| Tumor Lysis | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE (3.0) | View |
| Atrial Fibrillation | SYSTEMATIC_ASSESSMENT | Cardiac disorders | CTCAE (3.0) | View |
| Deep Vein Thrombosis | SYSTEMATIC_ASSESSMENT | Vascular disorders | CTCAE (3.0) | View |