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 @ 3:58 PM
Ignite Modification Date:
2025-12-25 @ 2:01 PM
NCT ID:
NCT00522392
Description:
None
Frequency Threshold:
5
Time Frame:
Assessed every 21 days while on treatment and for 30 days after the end of treatment
Study:
NCT00522392
Study Brief:
Bortezomib and Dexamethasone With or Without Lenalidomide in Treating Patients With Multiple Myeloma Previously Treated With Dexamethasone
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Arm A (VRd Regimen) | Arm A (VRd Regimen) Patients were given consolidation therapy for 8 cycles (1 cycle = 21 days) with the combination bortezomib, dexamethasone and lenalidomide. Patients received each cycle: the standard dose of bortezomib (1.3 mg/m2) on days 1, 4, 8 and 11; fixed dose of lenalidomide at 15 mg orally on days 1-14; and 3 days of dexamethasone at 40 mg total dose per day given on days 1, 8 and 15. Aspirin 325 mg/day orally on days 1-21 of each cycle was required unless the patient was treated with alternate prophylaxis of either low molecular weight heparin or coumadin. | None | None | 15 | 23 | 8 | 23 | View |
| Arm B (Vd Regimen) | Arm B (Vd Regimen) Patients were given consolidation therapy for 8 cycles (1 cycle = 21 days) with the combination bortezomib plus dexamethasone. Patients received each cycle: the standard dose of bortezomib (1.3 mg/m2) on days 1, 4, 8 and 11 and 3 days of dexamethasone at 40 mg total dose per day given on days 1, 8 and 15. | None | None | 16 | 25 | 11 | 25 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Hemoglobin | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | CTCAE (3.0) | View |
| Leukocytes | SYSTEMATIC_ASSESSMENT | Investigations | CTCAE (3.0) | View |
| Lymphopenia | SYSTEMATIC_ASSESSMENT | Investigations | CTCAE (3.0) | View |
| Neutrophils | SYSTEMATIC_ASSESSMENT | Investigations | CTCAE (3.0) | View |
| Platelets | SYSTEMATIC_ASSESSMENT | Investigations | CTCAE (3.0) | View |
| Sinus bradycardia | SYSTEMATIC_ASSESSMENT | Cardiac disorders | CTCAE (3.0) | View |
| Hypotension | SYSTEMATIC_ASSESSMENT | Vascular disorders | CTCAE (3.0) | View |
| Fatigue | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (3.0) | View |
| Fever w/o neutropenia | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (3.0) | View |
| Insomnia | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | CTCAE (3.0) | View |
| Pruritus/itching | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTCAE (3.0) | View |
| Rash/desquamation | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTCAE (3.0) | View |
| Constipation | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (3.0) | View |
| Diarrhea w/o prior colostomy | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (3.0) | View |
| Nausea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (3.0) | View |
| Vomiting | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (3.0) | View |
| Infection w/ gr3-4 neut, lung | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE (3.0) | View |
| Infection Gr0-2 neut, colon | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE (3.0) | View |
| Infection Gr0-2 neut, lung | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE (3.0) | View |
| ALT, SGPT | SYSTEMATIC_ASSESSMENT | Investigations | CTCAE (3.0) | View |
| Hypokalemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE (3.0) | View |
| Nonneuropathic lower extr muscle weak | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | View |
| Neuropathy-motor | SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAE (3.0) | View |
| Neuropathy-sensory | SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAE (3.0) | View |
| Psychosis | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | CTCAE (3.0) | View |
| Syncope | SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAE (3.0) | View |
| Cataract | SYSTEMATIC_ASSESSMENT | Eye disorders | CTCAE (3.0) | View |
| Abdomen, pain | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (3.0) | View |
| Extremity-limb, pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | View |
| Joint, pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | View |
| Dyspnea | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Leukocytes | SYSTEMATIC_ASSESSMENT | Investigations | CTCAE (3.0) | View |
| Lymphopenia | SYSTEMATIC_ASSESSMENT | Investigations | CTCAE (3.0) | View |
| Neutrophils | SYSTEMATIC_ASSESSMENT | Investigations | CTCAE (3.0) | View |
| Platelets | SYSTEMATIC_ASSESSMENT | Investigations | CTCAE (3.0) | View |
| Fatigue | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (3.0) | View |
| Insomnia | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | CTCAE (3.0) | View |
| Rash/desquamation | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTCAE (3.0) | View |
| Constipation | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (3.0) | View |
| Hyperglycemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE (3.0) | View |
| Neuropathy-sensory | SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAE (3.0) | View |
| Hemoglobin | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | CTCAE (3.0) | View |