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:
2025-12-25 @ 1:41 AM
Ignite Modification Date:
2025-12-25 @ 11:57 PM
NCT ID:
NCT01738594
Description:
None
Frequency Threshold:
0
Time Frame:
Adverse events were collected for the study over a 2 and half year period. Adverse events were collected for up to 30 days post 4 cycles ( the most time any patient received treatment on study)
Study:
NCT01738594
Study Brief:
Dose-Escalation Trial of Carfilzomib With and Without Romidepsin in Cutaneous T-Cell Lymphoma
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 B Cohort -1 (Carfilzomib + Romidepsin) | Patients receive carfilzomib IV over 2-10 minutes on days 1, 2, 8, 9, 15, and 16 of each 28 day cycle. Cycle 1 day 1 dose will be 20 mg/m2, all subsequent doses (of cycle 1 and future cycles) will be stepped up to 27 mg/m2. and romidepsin IV over 4 hours on days 1, 8, and 15 of each 28 day cycle. carfilzomib: Given IV romidepsin: Given IV laboratory biomarker analysis: Correlative studies | 0 | None | 0 | 1 | 1 | 1 | View |
| Arm B Cohort 1 (Carfilzomib + Romidepsin | Patients receive carfilzomib IV over 2-10 minutes on days 1, 2, 8, 9, 15, and 16 of each 28 day cycle. Cycle 1 day 1 dose will be 20 mg/m2, all subsequent doses (of cycle 1 and future cycles) will be stepped up to 36 mg/m2. and romidepsin IV over 4 hours on days 1, 8, and 15 of each 28 day cycle. carfilzomib: Given IV romidepsin: Given IV laboratory biomarker analysis: Correlative studies | 1 | None | 2 | 3 | 3 | 3 | View |
| Arm A, Cohort 1 (Carfilzomib) | Patients receive carfilzomib IV over 2-10 minutes on days 1, 2, 8, 9, 15, and 16 of each 28 day cycle. Cycle 1 day 1 dose will be 20 mg/m2, all subsequent doses (of cycle 1 and future cycles) will be stepped up to 36 mg/m2. carfilzomib: Given IV laboratory biomarker analysis: Correlative studies | 0 | None | 0 | 2 | 2 | 2 | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Creatinine increased | SYSTEMATIC_ASSESSMENT | Investigations | CTCAE (4.03) | View |
| Lymphocyte count decreased | SYSTEMATIC_ASSESSMENT | Investigations | CTCAE (4.03) | View |
| Lymphocyte count increased | SYSTEMATIC_ASSESSMENT | Investigations | CTCAE (4.03) | View |
| Platelet count decreased | SYSTEMATIC_ASSESSMENT | Investigations | CTCAE (4.03) | View |
| Weight loss | SYSTEMATIC_ASSESSMENT | Investigations | CTCAE (4.03) | View |
| White blood cell decreased | SYSTEMATIC_ASSESSMENT | Investigations | CTCAE (4.03) | View |
| Hyperglycemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE (4.03) | View |
| Hyperkalemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE (4.03) | View |
| Hypermagnesemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE (4.03) | View |
| Hypernatremia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE (4.03) | View |
| Hyperuricemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE (4.03) | View |
| Hypoalbuminemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE (4.03) | View |
| Hypocalcemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE (4.03) | View |
| Hypoglycemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE (4.03) | View |
| Hyponatremia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE (4.03) | View |
| Bronchopulmonary hemorrhage | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE (4.03) | View |
| Dyspnea | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE (4.03) | View |
| Hypoxia | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE (4.03) | View |
| Pulmonary edema | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE (4.03) | View |
| Dry skin | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTCAE (4.03) | View |
| Erythroderma | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTCAE (4.03) | View |
| Pruritus | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTCAE (4.03) | View |
| Hypertension | SYSTEMATIC_ASSESSMENT | Vascular disorders | CTCAE (4.03) | View |
| Hypomagnesemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE (4.03) | View |
| Anemia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | CTCAE (4.03) | View |
| palpitations | SYSTEMATIC_ASSESSMENT | Cardiac disorders | CTCAE (4.03) | View |
| Sinus tachycardia | SYSTEMATIC_ASSESSMENT | Cardiac disorders | CTCAE (4.03) | View |
| Constipation | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (4.03) | View |
| Diarrhea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (4.03) | View |
| Dry mouth | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (4.03) | View |
| Nausea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (4.03) | View |
| Vomiting | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (4.03) | View |
| Chills | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (4.03) | View |
| Edema limbs | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (4.03) | View |
| Edema trunk | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (4.03) | View |
| Fatigue | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (4.03) | View |
| Fever | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (4.03) | View |
| Tooth infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE (4.03) | View |
| Alanine aminotransferase increased | SYSTEMATIC_ASSESSMENT | Investigations | CTCAE (4.03) | View |
| Aspartate aminotransferase increased | SYSTEMATIC_ASSESSMENT | Investigations | CTCAE (4.03) | View |
| Blood bilirubin increased | SYSTEMATIC_ASSESSMENT | Investigations | CTCAE (4.03) | View |