Adverse Events Module

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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 @ 10:13 PM
Ignite Modification Date: 2025-12-25 @ 7:48 PM
NCT ID: NCT01998035
Description: Adverse events were only recorded/collected as the combined total from participants per study phase. Adverse events were not collected per dose level and thus cannot be reported per dose level. For Phase 1, adverse events were collected from the 26 participants who received the study interventions and completed the study.
Frequency Threshold: 5
Time Frame: 1.5 years
Study: NCT01998035
Study Brief: Romidepsin Plus Oral 5-Azacitidine in Relapsed/Refractory Lymphoid Malignancies
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 Phase 1 is to determine the maximum tolerated dose (MTD) and dose limiting toxicity (DLT) of the combinations of oral 5-azacitidine and romidepsin in patients with lymphoma. Patients will be administered the study drugs in a 3 + 3 dose-escalation study. Romidepsin is an anti-cancer ("antineoplastic" or "cytotoxic") chemotherapy drug. Romidepsin is classified as a "Histone Deacetylase Inhibitor". Dose escalation: 10, 14 mg/m2 Oral 5-Azacitidine is a pyrimidine nucleoside analogue of cytidine with antineoplastic activity. Dose escalation: 100, 200, 300 mg 11 None 11 26 26 26 View
Phase 2 Patients will be treated with oral 5-azacytidine and romidepsin at the MTD. The treatment will be administered as follows: oral 5-azacytidine 300 mg (flat dose) on Days 1-14 and romidepsin 14 mg/m2 (flat dose) on Days 8, 15, and 22 on a 35-day cycle. 0 None 12 25 25 25 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Alkaline phosphatase elevation SYSTEMATIC_ASSESSMENT General disorders None View
Anemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Febrile neutropenia SYSTEMATIC_ASSESSMENT General disorders None View
Hyperglycemia (Grade 3 and 4) SYSTEMATIC_ASSESSMENT Endocrine disorders None View
Hypermagnesemia SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Hypokalemia SYSTEMATIC_ASSESSMENT General disorders None View
Hyponatremia SYSTEMATIC_ASSESSMENT General disorders None View
Hypotension SYSTEMATIC_ASSESSMENT General disorders None View
Lymphocyte count decrease SYSTEMATIC_ASSESSMENT Immune system disorders None View
Neutrophil count decrease SYSTEMATIC_ASSESSMENT Immune system disorders None View
Platelet count decrease SYSTEMATIC_ASSESSMENT Immune system disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Fatigue SYSTEMATIC_ASSESSMENT General disorders None View
Nausea SYSTEMATIC_ASSESSMENT General disorders None View
Vomiting SYSTEMATIC_ASSESSMENT General disorders None View
Creatinine elevation SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Diarrhea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Fever SYSTEMATIC_ASSESSMENT General disorders None View
Hypercalcemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Hypoalbuminemia SYSTEMATIC_ASSESSMENT General disorders None View
Hypocalcemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Hypoglycemia SYSTEMATIC_ASSESSMENT General disorders None View
Hyperglycemia (Grade 1 and 2) SYSTEMATIC_ASSESSMENT Endocrine disorders None View