Adverse Events Module

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 @ 5:11 AM
Ignite Modification Date: 2025-12-26 @ 4:17 AM
NCT ID: NCT04447027
Description: None
Frequency Threshold: 0
Time Frame: All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
Study: NCT04447027
Study Brief: Romidepsin, CC-486 (5-azacitidine), Dexamethasone, and Lenalidomide (RAdR) for Relapsed/Refractory T-cell 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
Arm 1, Cohort 1, Dose Level 1, Dose Expansion Lenalidomide T-cell Malignancies, Dose Escalation, Arm 1, Dose Level 1 Arm 1, Dose Level 1: Lenalidomide 5 mg Day 1-10 (7 days lead in for first cycle); CC-486 (5azacitidine) 300 mg by mouth (PO Day) 1 to 10; Romidepsin 12 mg/m\^2 intravenous (IV) Day 1 and day 10; Dexamethasone 40 mg PO Day 1 and day 10. Relapsed/refractory mature T cell malignancies for determination of maximum tolerated dose (MTD). 3 None 2 6 6 6 View
Arm 1, Cohort 1, Dose Level 2, Dose Escalation Lenalidomide T-cell Malignancies, Dose Escalation, Arm 1, Dose Level 2 Arm 1, Dose Level 2: Lenalidomide 10 mg Day 1-10 (7 days lead in for first cycle); CC-486 (5azacitidine) 300 mg by mouth (PO Day) 1 to 10; Romidepsin 12 mg/m\^2 intravenous (IV) Day 1 and day 10; Dexamethasone 40 mg PO Day 1 and day 10. Relapsed/refractory mature T cell malignancies for determination of maximum tolerated dose (MTD). 3 None 1 6 6 6 View
Arm 1, Cohort 1, Dose Level 3 Dose Escalation T-cell Malignancies, Dose Escalation, Arm 1, Dose Level 3 Arm 1, Dose Level 3: Lenalidomide 15 mg Day 1-10 (7 days lead in for first cycle); CC-486 (5azacitidine) 300 mg by mouth (PO Day) 1 to 10; Romidepsin 12 mg/m\^2 intravenous (IV) Day 1 and day 10; Dexamethasone 40 mg PO Day 1 and day 10. Relapsed/refractory mature T cell malignancies for determination of maximum tolerated dose (MTD). 1 None 2 3 3 3 View
Arm 1, Cohort 1, Dose Level 4, Dose Escalation Lenalidomide T-cell Malignancies, Dose Escalation, Arm 1, Dose Level 4 Arm 1, Dose Level 4: Lenalidomide 20 mg Day 1-10 (7 days lead in for first cycle); CC-486 (5azacitidine) 300 mg by mouth (PO Day) 1 to 10; Romidepsin 12 mg/m\^2 intravenous (IV) Day 1 and day 10; Dexamethasone 40 mg PO Day 1 and day 10. Relapsed/refractory mature T cell malignancies for determination of maximum tolerated dose (MTD). 0 None 0 3 3 3 View
Arm 2, Cohort 2, Dose Level 2, Dose Expansion Lenalidomide T-cell Malignancies, Dose Expansion, Arm 2, Dose Level 2 Arm 2, Dose Level 2: Lenalidomide by oral intake at maximum tolerated dose (MTD) on days -7 to 10 of each 21-day cycle (max 6 cycles) with CC-486 (5-azacitidine) at 300mg/day by oral intake on days 1-10, Romidepsin at 12 mg/m\^2 by intravenous (IV) infusion on Day 1 and day 10; and Dexamethasone at 40 mg by oral intake on days 1 and 10 of each cycle. Relapsed/refractory mature T cell malignancies enrolled after maximum tolerated dose (MTD) is determined. 1 None 0 2 2 2 View
Arm 2, Cohort 2, Dose Level 4, Dose Expansion Lenalidomide T-cell Malignancies, Dose Expansion, Arm 2, Dose Level 4 Arm 2, Dose Level 4: Lenalidomide by oral intake at maximum tolerated dose (MTD) Day 1-10 (7 days lead in for first cycle); CC-486 (5azacitidine) 300 mg by mouth (PO Day) 1 to 10; Romidepsin 12 mg/m\^2 intravenous (IV) Day 1 and day 10; Dexamethasone 40 mg PO Day 1 and day 10. Relapsed/refractory mature T cell malignancies enrolled after maximum tolerated dose (MTD) is determined. 1 None 0 1 1 1 View
Arm 1, Cohort 1, Dose Level -1, Dose Escalation Lenalidomide T-cell Malignancies, Dose Escalation, Arm 1, Dose Level -1 Arm 1, Dose Level-1: Lenalidomide 2.5 mg Day 1-10 (7 days lead in for first cycle); CC-486 (5azacitidine) 200 mg by mouth (PO Day) 1 to 10; Romidepsin 12 mg/m\^2 intravenous (IV) Day 1 and day 10; Dexamethasone 40 mg PO Day 1 and day 10. Relapsed/refractory mature T cell malignancies for determination of maximum tolerated dose (MTD). 2 None 0 2 2 2 View
Arm 3, Cohort 2, Dose Level 4, Dose Expansion Lenalidomide T-cell Malignancies, Dose Expansion, Arm 3, Dose Level 4 Arm 3, Dose Level 4: Lenalidomide 20 mg maximum tolerated dose (MTD) by oral intake at on days -7 to 10 of each 21-day cycle (max 6 cycles) with CC-486 (5-azacitidine) at 300mg/day by oral intake on days 1-10, Romidepsin at 12 mg/m\^2 by intravenous (IV) infusion on Day 1 and day 10; and Dexamethasone at 40 mg by oral intake on days 1 and 10 of each cycle. Relapsed/refractory mature T cell malignancies enrolled after maximum tolerated dose (MTD) is determined. 0 None 0 3 3 3 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Adrenal insufficiency SYSTEMATIC_ASSESSMENT Endocrine disorders CTCAE (5.0) View
Anemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders CTCAE (5.0) View
Anorexia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE (5.0) View
Atrial fibrillation SYSTEMATIC_ASSESSMENT Cardiac disorders CTCAE (5.0) View
Blood bilirubin increased SYSTEMATIC_ASSESSMENT Investigations CTCAE (5.0) View
Fatigue SYSTEMATIC_ASSESSMENT General disorders CTCAE (5.0) View
Heart failure SYSTEMATIC_ASSESSMENT Cardiac disorders CTCAE (5.0) View
Hepatobiliary disorders - Other, specify: Drug-Induced Liver Injury SYSTEMATIC_ASSESSMENT Hepatobiliary disorders CTCAE (5.0) View
Hypotension SYSTEMATIC_ASSESSMENT Vascular disorders CTCAE (5.0) View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (5.0) View
Neoplasms benign, malignant and unspecified SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) CTCAE (5.0) View
Pain in extremity SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders CTCAE (5.0) View
Rhabdomyolysis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders CTCAE (5.0) View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (5.0) View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Chills SYSTEMATIC_ASSESSMENT General disorders CTCAE (5.0) View
Nasal congestion SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE (5.0) View
Peripheral motor neuropathy SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE (5.0) View
Peripheral sensory neuropathy SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE (5.0) View
Phlebitis SYSTEMATIC_ASSESSMENT Vascular disorders CTCAE (5.0) View
Platelet count decreased SYSTEMATIC_ASSESSMENT Investigations CTCAE (5.0) View
Pleural effusion SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE (5.0) View
Sinus tachycardia SYSTEMATIC_ASSESSMENT Cardiac disorders CTCAE (5.0) View
Skin infection SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE (5.0) View
Soft tissue infection SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE (5.0) View
Somnolence SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE (5.0) View
Sore throat SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE (5.0) View
Supraventricular tachycardia SYSTEMATIC_ASSESSMENT Cardiac disorders CTCAE (5.0) View
Abdominal pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (5.0) View
Acute kidney injury SYSTEMATIC_ASSESSMENT Renal and urinary disorders CTCAE (5.0) View
Adrenal insufficiency SYSTEMATIC_ASSESSMENT Endocrine disorders CTCAE (5.0) View
Alanine aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations CTCAE (5.0) View
Alkaline phosphatase increased SYSTEMATIC_ASSESSMENT Investigations CTCAE (5.0) View
Allergic reaction SYSTEMATIC_ASSESSMENT Immune system disorders CTCAE (5.0) View
Anal hemorrhage SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (5.0) View
Anal pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (5.0) View
Anemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders CTCAE (5.0) View
Anorexia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE (5.0) View
Anxiety SYSTEMATIC_ASSESSMENT Psychiatric disorders CTCAE (5.0) View
Arthralgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders CTCAE (5.0) View
Aspartate aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations CTCAE (5.0) View
Atelectasis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE (5.0) View
Atrial fibrillation SYSTEMATIC_ASSESSMENT Cardiac disorders CTCAE (5.0) View
Blood and lymphatic system disorders - Other, specify: low iron level SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders CTCAE (5.0) View
Blood bilirubin increased SYSTEMATIC_ASSESSMENT Investigations CTCAE (5.0) View
CPK increased SYSTEMATIC_ASSESSMENT Investigations CTCAE (5.0) View
Confusion SYSTEMATIC_ASSESSMENT Psychiatric disorders CTCAE (5.0) View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (5.0) View
Cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE (5.0) View
Creatinine increased SYSTEMATIC_ASSESSMENT Investigations CTCAE (5.0) View
Dental caries SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (5.0) View
Depression SYSTEMATIC_ASSESSMENT Psychiatric disorders CTCAE (5.0) View
Diarrhea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (5.0) View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE (5.0) View
Dry eye SYSTEMATIC_ASSESSMENT Eye disorders CTCAE (5.0) View
Dysgeusia SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE (5.0) View
Dyspepsia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (5.0) View
Dysphagia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (5.0) View
Dyspnea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE (5.0) View
Edema limbs SYSTEMATIC_ASSESSMENT General disorders CTCAE (5.0) View
Ejection fraction decreased SYSTEMATIC_ASSESSMENT Investigations CTCAE (5.0) View
Electrocardiogram QT corrected interval prolonged SYSTEMATIC_ASSESSMENT Investigations CTCAE (5.0) View
Electrocardiogram T wave abnormal SYSTEMATIC_ASSESSMENT Investigations CTCAE (5.0) View
Enterocolitis infectious SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE (5.0) View
Epistaxis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE (5.0) View
Erectile dysfunction SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders CTCAE (5.0) View
Esophageal varices hemorrhage SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (5.0) View
Eye disorders - Other, specify: Corneal Thinning SYSTEMATIC_ASSESSMENT Eye disorders CTCAE (5.0) View
Eye disorders - Other, specify: Itchy eyes SYSTEMATIC_ASSESSMENT Eye disorders CTCAE (5.0) View
Eye disorders - Other, specify: Light Sensitivity SYSTEMATIC_ASSESSMENT Eye disorders CTCAE (5.0) View
Eye disorders - Other, specify: double vision SYSTEMATIC_ASSESSMENT Eye disorders CTCAE (5.0) View
Fall SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications CTCAE (5.0) View
Fatigue SYSTEMATIC_ASSESSMENT General disorders CTCAE (5.0) View
Fever SYSTEMATIC_ASSESSMENT General disorders CTCAE (5.0) View
Flushing SYSTEMATIC_ASSESSMENT Vascular disorders CTCAE (5.0) View
Folliculitis SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE (5.0) View
Gastroesophageal reflux disease SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (5.0) View
Gastrointestinal disorders - Other, specify: Increased thirst, Intermittent SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (5.0) View
Generalized muscle weakness SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders CTCAE (5.0) View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE (5.0) View
Hematoma SYSTEMATIC_ASSESSMENT Vascular disorders CTCAE (5.0) View
Hemorrhoids SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (5.0) View
Herpes simplex reactivation SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE (5.0) View
Hiccups SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE (5.0) View
Hoarseness SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE (5.0) View
Hyperhidrosis SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTCAE (5.0) View
Hyperkalemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE (5.0) View
Hypermagnesemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE (5.0) View
Hyperphosphatemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE (5.0) View
Hypertension SYSTEMATIC_ASSESSMENT Vascular disorders CTCAE (5.0) View
Hyperuricemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE (5.0) View
Hypoalbuminemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE (5.0) View
Hypocalcemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE (5.0) View
Hypoglycemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE (5.0) View
Hypokalemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE (5.0) View
Hypomagnesemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE (5.0) View
Hyponatremia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE (5.0) View
Hypophosphatemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE (5.0) View
Hypotension SYSTEMATIC_ASSESSMENT Vascular disorders CTCAE (5.0) View
Infusion site extravasation SYSTEMATIC_ASSESSMENT General disorders CTCAE (5.0) View
Injection site reaction SYSTEMATIC_ASSESSMENT General disorders CTCAE (5.0) View
Investigations - Other, specify: Decreased iron SYSTEMATIC_ASSESSMENT Investigations CTCAE (5.0) View
Laryngeal inflammation SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE (5.0) View
Localized edema SYSTEMATIC_ASSESSMENT General disorders CTCAE (5.0) View
Lymphedema SYSTEMATIC_ASSESSMENT Vascular disorders CTCAE (5.0) View
Lymphocyte count decreased SYSTEMATIC_ASSESSMENT Investigations CTCAE (5.0) View
Mucosal infection SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE (5.0) View
Mucositis oral SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (5.0) View
Muscle cramp SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders CTCAE (5.0) View
Musculoskeletal and connective tissue disorder - Other, specify: Fracture, compression SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders CTCAE (5.0) View
Myalgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders CTCAE (5.0) View
Nail infection SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE (5.0) View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (5.0) View
Nervous system disorders - Other, specify: Migraine SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE (5.0) View
Neutrophil count decreased SYSTEMATIC_ASSESSMENT Investigations CTCAE (5.0) View
Non-cardiac chest pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders CTCAE (5.0) View
Oral pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (5.0) View
Pain SYSTEMATIC_ASSESSMENT General disorders CTCAE (5.0) View
Paresthesia SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE (5.0) View
Pruritus SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTCAE (5.0) View
Pulmonary hypertension SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE (5.0) View
Rash maculo-papular SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTCAE (5.0) View
Rectal hemorrhage SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (5.0) View
Rhinorrhea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE (5.0) View
Sinus bradycardia SYSTEMATIC_ASSESSMENT Cardiac disorders CTCAE (5.0) View
Tremor SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE (5.0) View
Tumor pain SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) CTCAE (5.0) View
Upper respiratory infection SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE (5.0) View
Uveitis SYSTEMATIC_ASSESSMENT Eye disorders CTCAE (5.0) View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (5.0) View
Vulval infection SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE (5.0) View
Weight loss SYSTEMATIC_ASSESSMENT Investigations CTCAE (5.0) View
White blood cell decreased SYSTEMATIC_ASSESSMENT Investigations CTCAE (5.0) View