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 @ 11:32 PM
Ignite Modification Date:
2025-12-25 @ 9:20 PM
NCT ID:
NCT00299156
Description:
The first participant of the phase II portion of this study started treatment in August 2009.
Frequency Threshold:
5
Time Frame:
Adverse event collection with each 4-8 weeks course, up to a total of 12 courses of therapy. Overall study period, three years and four months.
Study:
NCT00299156
Study Brief:
Oral Clofarabine Study in Patients With Myelodysplastic Syndrome
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Oral Clofarabine | Original dose of 40 mg oral reduced to 30mg and than lower dose of either 10 mg (Group 1) or 20 mg (Group 2) tablets once a day for 5 days in a row and repeated every 4-8 week cycle. | None | None | 16 | 32 | 32 | 32 | View |
| Randomized, Oral Clofarabine 10mg | Arm A: 10 mg tablets once a day for 5 days in a row and repeated every 4-8 week cycle. | None | None | 8 | 16 | 16 | 16 | View |
| Randomized, Oral Clofarabine 20mg | Arm B: 20 mg tablets once a day for 5 days in a row and repeated every 4-8 week cycle. | None | None | 12 | 16 | 16 | 16 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Death | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (3.0) | View |
| Respiratory Failure | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | View |
| Renal Failure | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | CTCAE (3.0) | View |
| Tumor Lysis Syndrome | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (3.0) | View |
| Cerebrovascular Ischemia | SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAE (3.0) | View |
| Infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE (3.0) | View |
| Gastrointestinal Hemorrhage | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | CTCAE (3.0) | View |
| Vaginal Hemorrhage | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | CTCAE (3.0) | View |
| Cardiac Arrythmia | SYSTEMATIC_ASSESSMENT | Cardiac disorders | CTCAE (3.0) | View |
| Supraventricular Tachycardia | SYSTEMATIC_ASSESSMENT | Cardiac disorders | CTCAE (3.0) | View |
| Dehydration | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (3.0) | View |
| Diarrhea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (3.0) | View |
| Nausea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (3.0) | View |
| Abdominal Pain | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (3.0) | View |
| Fever | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (3.0) | View |
| Fungal Pneumonia | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE (3.0) | View |
| Pneumonia | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE (3.0) | View |
| Ataxia | SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAE (3.0) | View |
| Syncope | SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAE (3.0) | View |
| Elevated Creatinine | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | CTCAE (3.0) | View |
| Pericardial Effusion | SYSTEMATIC_ASSESSMENT | Cardiac disorders | CTCAE (3.0) | View |
| Constipation | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (3.0) | View |
| Bone Pain | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (3.0) | View |
| Chest Pain | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (3.0) | View |
| Fatigue | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (3.0) | View |
| Pain | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (3.0) | View |
| Cellulitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE (3.0) | View |
| E. Coli in Urine and Blood | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE (3.0) | View |
| Hemolytic Strep | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE (3.0) | View |
| Herpetic Mouth Sores | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE (3.0) | View |
| Neutropenic Fever | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE (3.0) | View |
| Pseudomonas | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE (3.0) | View |
| Altered Mental Status | SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAE (3.0) | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Palmoplantar Dysesthesia | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTCAE (3.0) | View |
| Myalgia | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | View |
| Acute Renal Failure | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | CTCAE (3.0) | View |
| Skin Rash | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTCAE (3.0) | View |
| Elevated Alkaline Phosphatase | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE (3.0) | View |
| Fatigue | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (3.0) | View |
| Nausea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (3.0) | View |
| Anorexia | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (3.0) | View |
| Headache | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (3.0) | View |
| Diarrhea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (3.0) | View |
| Abdominal Pain | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (3.0) | View |
| Elevated ALT | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE (3.0) | View |
| Elevated AST | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE (3.0) | View |
| Hyperbilirrubinemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE (3.0) | View |
| Constipation | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (3.0) | View |
| Elevated Creatinine | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | CTCAE (3.0) | View |
| Dermatology/Skin | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTCAE (3.0) | View |
| Dizziness | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (3.0) | View |
| Edema | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | CTCAE (3.0) | View |
| Insomnia | SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAE (3.0) | View |
| Iron Overload | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE (3.0) | View |
| Mucositis | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (3.0) | View |
| Musculoskeletal Other | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | View |
| Petechiae | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTCAE (3.0) | View |
| Pruritus | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTCAE (3.0) | View |
| Taste Alteration | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (3.0) | View |
| Urinary Frequency | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | CTCAE (3.0) | View |
| Emesis | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (3.0) | View |
| Gastrointestinal Hemorrhage | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | CTCAE (3.0) | View |
| Neutropenic Fever | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE (3.0) | View |
| Neutropenia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | CTCAE (3.0) | View |
| Thrombocytopenia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | CTCAE (3.0) | View |
| Elevated Amylase | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE (3.0) | View |