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:
2025-12-26 @ 10:57 AM
Ignite Modification Date:
2025-12-26 @ 10:57 AM
NCT ID:
NCT00867308
Description:
Due to significant cytopenias in all participants at presentation and throughout the trial, hematologic toxicity was only reported where bone marrow aplasia lasted for \>3 weeks from last dose of lenalidomide with a bone marrow cellularity of \<5% without evidence of leukemia. Adverse events were collected weekly throughout the trial.
Frequency Threshold:
5
Time Frame:
Up to 8 months
Study:
NCT00867308
Study Brief:
Trial of High Dose Lenalidomide in Patients With MDS and AML With Trilineage Dysplasia
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Lenalidomide 15 mg | Patients diagnosed with high risk Myelodysplastic syndrome (MDS), regardless of 5q deletion status, will receive lenalidomide 15 mg per day orally, on days 1-28 of a 42 day cycle for 2 cycles. At this point, patients meeting protocol specified response criteria will proceed to Continuing Therapy on a reduced dose of lenalidomide until progression. Patients not achieving response will receive 2 additional cycles of treatment, whereupon response will again be assessed. Patients achieving response at this point will proceed to Continuing Therapy as described. Patients without evidence of response after 4 cycles will be taken off-study. | 3 | None | 3 | 9 | 7 | 9 | View |
| Lenalidomide 50 mg | Patients diagnosed with high risk Myelodysplastic syndrome (MDS), regardless of 5q deletion status, will receive lenalidomide 50 mg per day orally, on days 1-28 of a 42 day cycle for 2 cycles. At this point, patients meeting protocol specified response criteria will proceed to Continuing Therapy on a reduced dose of lenalidomide until progression. Patients not achieving response will receive 2 additional cycles of treatment, whereupon response will again be assessed. Patients achieving response at this point will proceed to Continuing Therapy as described. Patients without evidence of response after 4 cycles will be taken off-study. | 2 | None | 9 | 18 | 13 | 18 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Acute kidney injury | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | CTCAE (3.0) | View |
| Weakness - leg | SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAE (3.0) | View |
| Clostridium difficile infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE (3.0) | View |
| Endocarditis | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE (3.0) | View |
| Epistaxis | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (3.0) | View |
| Febrile neutropenia | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE (3.0) | View |
| Fungal pneumonia | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE (3.0) | View |
| Hypotension | SYSTEMATIC_ASSESSMENT | Cardiac disorders | CTCAE (3.0) | View |
| Hypoxia | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | View |
| Meningitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE (3.0) | View |
| Pericarditis | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE (3.0) | View |
| Pneumonia | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE (3.0) | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Anemia | SYSTEMATIC_ASSESSMENT | Investigations | CTCAE (3.0) | View |
| Anorexia | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (3.0) | View |
| Arthralgia | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | View |
| Atrial fibrillation | SYSTEMATIC_ASSESSMENT | Cardiac disorders | CTCAE (3.0) | View |
| Bleeding | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | CTCAE (3.0) | View |
| Bruising | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | CTCAE (3.0) | View |
| Confusion | SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAE (3.0) | View |
| Constipation | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (3.0) | View |
| Cough | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (3.0) | View |
| Diarrhea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (3.0) | View |
| Dyspnea | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | View |
| Edema | SYSTEMATIC_ASSESSMENT | Cardiac disorders | CTCAE (3.0) | View |
| Epistaxis | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | CTCAE (3.0) | View |
| Fatigue | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (3.0) | View |
| Febrile neutropenia | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE (3.0) | View |
| Fever | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE (3.0) | View |
| Hallucination | SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAE (3.0) | View |
| Headache | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (3.0) | View |
| Hematuria | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | CTCAE (3.0) | View |
| Hoarseness | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (3.0) | View |
| Hyperbilirubinemia | SYSTEMATIC_ASSESSMENT | Investigations | CTCAE (3.0) | View |
| Hypokalemia | SYSTEMATIC_ASSESSMENT | Investigations | CTCAE (3.0) | View |
| Hyponatremia | SYSTEMATIC_ASSESSMENT | Investigations | CTCAE (3.0) | View |
| Leukopenia | SYSTEMATIC_ASSESSMENT | Investigations | CTCAE (3.0) | View |
| Lightheadedness | SYSTEMATIC_ASSESSMENT | Cardiac disorders | CTCAE (3.0) | View |
| Myalgia | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (3.0) | View |
| Nausea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (3.0) | View |
| Neuropathy | SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAE (3.0) | View |
| Pain - back | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (3.0) | View |
| Pain - chest | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (3.0) | View |
| Pain - tooth | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (3.0) | View |
| Pruritis | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTCAE (3.0) | View |
| Rash | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTCAE (3.0) | View |
| Stomatitis | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (3.0) | View |
| Thrombocytopenia | SYSTEMATIC_ASSESSMENT | Investigations | CTCAE (3.0) | View |
| Thrush | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE (3.0) | View |
| Vomiting | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (3.0) | View |
| Weakness | SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAE (3.0) | View |
| Xerosis | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTCAE (3.0) | View |
| Xerostomia | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (3.0) | View |