NCT04447027 · OUTCOME
Arm 1, Cohort 1, Dose Level 3, and Arm 1, Cohort 1, Dose Level 4 Treatment Emergent Serious Grades 3, 4, and/or 5 Adverse Events Possibly Related to Drug Grouped by Relationship to the Study Drug and/or Combination Romidepsin, CC-486 (5-azacitidine), Dexamethasone, and Lenalidomide (RAdR) for Relapsed/Refractory T-cell Malignancies · Source last updated 2026-08-13
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
Measure NUMBER
Unit adverse events
Interval / dispersion Not reported
Time frame 6 cycles (each cycle is 28 days) What was measured Treatment emergent grades 3, 4, and/or 5 adverse events possibly related grouped by relationship to the study drug (e.g., lenalidomide, romidepsin, CC-486 (5-azacitidine) in any combinations) assessed by the Common Terminology Criteria for Adverse Events (CTCAE v5.0). Grade 3 is severe. Grade 4 is life threatening. Grade 5 is death related to adverse event.
Groups in this outcome Arm 1, Cohort 1, Dose Level 3 Dose Escalation Related to Lenalidomide Arm 1, Cohort 1, Dose Level 3: adverse events possibly related to lenalidomide.
Arm 1, Cohort 1, Dose Level 3 - Dose Escalation Related to Romidepsin Arm 1, Cohort 1, Dose Level 3: adverse events possibly related to romidepsin.
Arm 1, Cohort 1, Dose Level 3 - Dose Escalation Related to CC-486 (5-azacitidine) Arm 1, Cohort 1, Dose Level 3: adverse events possibly related to CC-486 (5-azacitidine).
Arm 1, Cohort 1, Dose Level 3: Dose Escalation Related to Any Combination Arm 1, Cohort 1, Dose Level 3: adverse events possibly related to any combination.
Arm 1, Cohort 1, Dose Level 4 - Dose Escalation Related to Lenalidomide Arm 1, Cohort 1, Dose Level 4: adverse events possibly related to lenalidomide.
Arm 1, Cohort 1, Dose Level 4 - Dose Escalation Related to Romidepsin Arm 1, Cohort 1, Dose Level 4: adverse events possibly related to romidepsin.
Arm 1, Cohort 1, Dose Level 4 - Dose Escalation Related to CC-486 (5-azacitidine) Arm 1, Cohort 1, Dose Level 4: adverse events possibly related to CC-486 (5-azacitidine).
Arm 1, Cohort 1, Dose Level 4 - Dose Escalation Related to Any Combination Arm 1, Cohort 1, Dose Level 4: adverse events possibly related to any combination.
Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.
Analysis denominator · Participants
Group Source count Arm 1, Cohort 1, Dose Level 3 Dose Escalation Related to Lenalidomide 3 Arm 1, Cohort 1, Dose Level 3 - Dose Escalation Related to Romidepsin 3 Arm 1, Cohort 1, Dose Level 3 - Dose Escalation Related to CC-486 (5-azacitidine) 3 Arm 1, Cohort 1, Dose Level 3: Dose Escalation Related to Any Combination 3 Arm 1, Cohort 1, Dose Level 4 - Dose Escalation Related to Lenalidomide 3 Arm 1, Cohort 1, Dose Level 4 - Dose Escalation Related to Romidepsin 3 Arm 1, Cohort 1, Dose Level 4 - Dose Escalation Related to CC-486 (5-azacitidine) 3 Arm 1, Cohort 1, Dose Level 4 - Dose Escalation Related to Any Combination 3
Reported measurements Grade 3 Serious Blood bilirubin increased Values in adverse events · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment Arm 1, Cohort 1, Dose Level 3 Dose Escalation Related to Lenalidomide 1 Not reported Not reported Not reported Not reported Arm 1, Cohort 1, Dose Level 3 - Dose Escalation Related to Romidepsin 1 Not reported Not reported Not reported Not reported Arm 1, Cohort 1, Dose Level 3 - Dose Escalation Related to CC-486 (5-azacitidine) 1 Not reported Not reported Not reported Not reported Arm 1, Cohort 1, Dose Level 3: Dose Escalation Related to Any Combination 1 Not reported Not reported Not reported Not reported Arm 1, Cohort 1, Dose Level 4 - Dose Escalation Related to Lenalidomide 0 Not reported Not reported Not reported Not reported Arm 1, Cohort 1, Dose Level 4 - Dose Escalation Related to Romidepsin 0 Not reported Not reported Not reported Not reported Arm 1, Cohort 1, Dose Level 4 - Dose Escalation Related to CC-486 (5-azacitidine) 0 Not reported Not reported Not reported Not reported Arm 1, Cohort 1, Dose Level 4 - Dose Escalation Related to Any Combination 0 Not reported Not reported Not reported Not reported
Grade 3 Serious Hepatobiliary disorders - Other specify, Drug-Induced liver injury Values in adverse events · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment Arm 1, Cohort 1, Dose Level 3 Dose Escalation Related to Lenalidomide 1 Not reported Not reported Not reported Not reported Arm 1, Cohort 1, Dose Level 3 - Dose Escalation Related to Romidepsin 1 Not reported Not reported Not reported Not reported Arm 1, Cohort 1, Dose Level 3 - Dose Escalation Related to CC-486 (5-azacitidine) 1 Not reported Not reported Not reported Not reported Arm 1, Cohort 1, Dose Level 3: Dose Escalation Related to Any Combination 1 Not reported Not reported Not reported Not reported Arm 1, Cohort 1, Dose Level 4 - Dose Escalation Related to Lenalidomide 0 Not reported Not reported Not reported Not reported Arm 1, Cohort 1, Dose Level 4 - Dose Escalation Related to Romidepsin 0 Not reported Not reported Not reported Not reported Arm 1, Cohort 1, Dose Level 4 - Dose Escalation Related to CC-486 (5-azacitidine) 0 Not reported Not reported Not reported Not reported Arm 1, Cohort 1, Dose Level 4 - Dose Escalation Related to Any Combination 0 Not reported Not reported Not reported Not reported
Grade 3 Serious Rhabdomyolysis Values in adverse events · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment Arm 1, Cohort 1, Dose Level 3 Dose Escalation Related to Lenalidomide 2 Not reported Not reported Not reported Not reported Arm 1, Cohort 1, Dose Level 3 - Dose Escalation Related to Romidepsin 0 Not reported Not reported Not reported Not reported Arm 1, Cohort 1, Dose Level 3 - Dose Escalation Related to CC-486 (5-azacitidine) 2 Not reported Not reported Not reported Not reported Arm 1, Cohort 1, Dose Level 3: Dose Escalation Related to Any Combination 2 Not reported Not reported Not reported Not reported Arm 1, Cohort 1, Dose Level 4 - Dose Escalation Related to Lenalidomide 0 Not reported Not reported Not reported Not reported Arm 1, Cohort 1, Dose Level 4 - Dose Escalation Related to Romidepsin 0 Not reported Not reported Not reported Not reported Arm 1, Cohort 1, Dose Level 4 - Dose Escalation Related to CC-486 (5-azacitidine) 0 Not reported Not reported Not reported Not reported Arm 1, Cohort 1, Dose Level 4 - Dose Escalation Related to Any Combination 0 Not reported Not reported Not reported Not reported
Any Grade 4 and/or 5 Serious Adverse Event Values in adverse events · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment Arm 1, Cohort 1, Dose Level 3 Dose Escalation Related to Lenalidomide 0 Not reported Not reported Not reported Not reported Arm 1, Cohort 1, Dose Level 3 - Dose Escalation Related to Romidepsin 0 Not reported Not reported Not reported Not reported Arm 1, Cohort 1, Dose Level 3 - Dose Escalation Related to CC-486 (5-azacitidine) 0 Not reported Not reported Not reported Not reported Arm 1, Cohort 1, Dose Level 3: Dose Escalation Related to Any Combination 0 Not reported Not reported Not reported Not reported Arm 1, Cohort 1, Dose Level 4 - Dose Escalation Related to Lenalidomide 0 Not reported Not reported Not reported Not reported Arm 1, Cohort 1, Dose Level 4 - Dose Escalation Related to Romidepsin 0 Not reported Not reported Not reported Not reported Arm 1, Cohort 1, Dose Level 4 - Dose Escalation Related to CC-486 (5-azacitidine) 0 Not reported Not reported Not reported Not reported Arm 1, Cohort 1, Dose Level 4 - Dose Escalation Related to Any Combination 0 Not reported Not reported Not reported Not reported
Grade 3 Non-serious Acute kidney injury Values in adverse events · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment Arm 1, Cohort 1, Dose Level 3 Dose Escalation Related to Lenalidomide 1 Not reported Not reported Not reported Not reported Arm 1, Cohort 1, Dose Level 3 - Dose Escalation Related to Romidepsin 0 Not reported Not reported Not reported Not reported Arm 1, Cohort 1, Dose Level 3 - Dose Escalation Related to CC-486 (5-azacitidine) 1 Not reported Not reported Not reported Not reported Arm 1, Cohort 1, Dose Level 3: Dose Escalation Related to Any Combination 0 Not reported Not reported Not reported Not reported Arm 1, Cohort 1, Dose Level 4 - Dose Escalation Related to Lenalidomide 0 Not reported Not reported Not reported Not reported Arm 1, Cohort 1, Dose Level 4 - Dose Escalation Related to Romidepsin 0 Not reported Not reported Not reported Not reported Arm 1, Cohort 1, Dose Level 4 - Dose Escalation Related to CC-486 (5-azacitidine) 0 Not reported Not reported Not reported Not reported Arm 1, Cohort 1, Dose Level 4 - Dose Escalation Related to Any Combination 0 Not reported Not reported Not reported Not reported
Grade 3 Non-serious Alanine aminotransferase increased Values in adverse events · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment Arm 1, Cohort 1, Dose Level 3 Dose Escalation Related to Lenalidomide 0 Not reported Not reported Not reported Not reported Arm 1, Cohort 1, Dose Level 3 - Dose Escalation Related to Romidepsin 1 Not reported Not reported Not reported Not reported Arm 1, Cohort 1, Dose Level 3 - Dose Escalation Related to CC-486 (5-azacitidine) 0 Not reported Not reported Not reported Not reported Arm 1, Cohort 1, Dose Level 3: Dose Escalation Related to Any Combination 0 Not reported Not reported Not reported Not reported Arm 1, Cohort 1, Dose Level 4 - Dose Escalation Related to Lenalidomide 0 Not reported Not reported Not reported Not reported Arm 1, Cohort 1, Dose Level 4 - Dose Escalation Related to Romidepsin 0 Not reported Not reported Not reported Not reported Arm 1, Cohort 1, Dose Level 4 - Dose Escalation Related to CC-486 (5-azacitidine) 0 Not reported Not reported Not reported Not reported Arm 1, Cohort 1, Dose Level 4 - Dose Escalation Related to Any Combination 0 Not reported Not reported Not reported Not reported
Grade 3 Non-serious Anemia Values in adverse events · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment Arm 1, Cohort 1, Dose Level 3 Dose Escalation Related to Lenalidomide 1 Not reported Not reported Not reported Not reported Arm 1, Cohort 1, Dose Level 3 - Dose Escalation Related to Romidepsin 0 Not reported Not reported Not reported Not reported Arm 1, Cohort 1, Dose Level 3 - Dose Escalation Related to CC-486 (5-azacitidine) 0 Not reported Not reported Not reported Not reported Arm 1, Cohort 1, Dose Level 3: Dose Escalation Related to Any Combination 0 Not reported Not reported Not reported Not reported Arm 1, Cohort 1, Dose Level 4 - Dose Escalation Related to Lenalidomide 0 Not reported Not reported Not reported Not reported Arm 1, Cohort 1, Dose Level 4 - Dose Escalation Related to Romidepsin 0 Not reported Not reported Not reported Not reported Arm 1, Cohort 1, Dose Level 4 - Dose Escalation Related to CC-486 (5-azacitidine) 0 Not reported Not reported Not reported Not reported Arm 1, Cohort 1, Dose Level 4 - Dose Escalation Related to Any Combination 0 Not reported Not reported Not reported Not reported
Grade 3 Non-serious Aspartate aminotransferase increased Values in adverse events · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment Arm 1, Cohort 1, Dose Level 3 Dose Escalation Related to Lenalidomide 1 Not reported Not reported Not reported Not reported Arm 1, Cohort 1, Dose Level 3 - Dose Escalation Related to Romidepsin 1 Not reported Not reported Not reported Not reported Arm 1, Cohort 1, Dose Level 3 - Dose Escalation Related to CC-486 (5-azacitidine) 0 Not reported Not reported Not reported Not reported Arm 1, Cohort 1, Dose Level 3: Dose Escalation Related to Any Combination 0 Not reported Not reported Not reported Not reported Arm 1, Cohort 1, Dose Level 4 - Dose Escalation Related to Lenalidomide 0 Not reported Not reported Not reported Not reported Arm 1, Cohort 1, Dose Level 4 - Dose Escalation Related to Romidepsin 0 Not reported Not reported Not reported Not reported Arm 1, Cohort 1, Dose Level 4 - Dose Escalation Related to CC-486 (5-azacitidine) 0 Not reported Not reported Not reported Not reported Arm 1, Cohort 1, Dose Level 4 - Dose Escalation Related to Any Combination 0 Not reported Not reported Not reported Not reported
Grade 3 Non-serious Blood bilirubin increased Values in adverse events · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment Arm 1, Cohort 1, Dose Level 3 Dose Escalation Related to Lenalidomide 1 Not reported Not reported Not reported Not reported Arm 1, Cohort 1, Dose Level 3 - Dose Escalation Related to Romidepsin 1 Not reported Not reported Not reported Not reported Arm 1, Cohort 1, Dose Level 3 - Dose Escalation Related to CC-486 (5-azacitidine) 1 Not reported Not reported Not reported Not reported Arm 1, Cohort 1, Dose Level 3: Dose Escalation Related to Any Combination 1 Not reported Not reported Not reported Not reported Arm 1, Cohort 1, Dose Level 4 - Dose Escalation Related to Lenalidomide 0 Not reported Not reported Not reported Not reported Arm 1, Cohort 1, Dose Level 4 - Dose Escalation Related to Romidepsin 0 Not reported Not reported Not reported Not reported Arm 1, Cohort 1, Dose Level 4 - Dose Escalation Related to CC-486 (5-azacitidine) 0 Not reported Not reported Not reported Not reported Arm 1, Cohort 1, Dose Level 4 - Dose Escalation Related to Any Combination 0 Not reported Not reported Not reported Not reported
Grade 3 Non-serious CPK increased Values in adverse events · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment Arm 1, Cohort 1, Dose Level 3 Dose Escalation Related to Lenalidomide 0 Not reported Not reported Not reported Not reported Arm 1, Cohort 1, Dose Level 3 - Dose Escalation Related to Romidepsin 0 Not reported Not reported Not reported Not reported Arm 1, Cohort 1, Dose Level 3 - Dose Escalation Related to CC-486 (5-azacitidine) 1 Not reported Not reported Not reported Not reported Arm 1, Cohort 1, Dose Level 3: Dose Escalation Related to Any Combination 1 Not reported Not reported Not reported Not reported Arm 1, Cohort 1, Dose Level 4 - Dose Escalation Related to Lenalidomide 0 Not reported Not reported Not reported Not reported Arm 1, Cohort 1, Dose Level 4 - Dose Escalation Related to Romidepsin 0 Not reported Not reported Not reported Not reported Arm 1, Cohort 1, Dose Level 4 - Dose Escalation Related to CC-486 (5-azacitidine) 0 Not reported Not reported Not reported Not reported Arm 1, Cohort 1, Dose Level 4 - Dose Escalation Related to Any Combination 0 Not reported Not reported Not reported Not reported
Grade 3 Non-serious Fatigue Values in adverse events · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment Arm 1, Cohort 1, Dose Level 3 Dose Escalation Related to Lenalidomide 1 Not reported Not reported Not reported Not reported Arm 1, Cohort 1, Dose Level 3 - Dose Escalation Related to Romidepsin 0 Not reported Not reported Not reported Not reported Arm 1, Cohort 1, Dose Level 3 - Dose Escalation Related to CC-486 (5-azacitidine) 1 Not reported Not reported Not reported Not reported Arm 1, Cohort 1, Dose Level 3: Dose Escalation Related to Any Combination 1 Not reported Not reported Not reported Not reported Arm 1, Cohort 1, Dose Level 4 - Dose Escalation Related to Lenalidomide 0 Not reported Not reported Not reported Not reported Arm 1, Cohort 1, Dose Level 4 - Dose Escalation Related to Romidepsin 0 Not reported Not reported Not reported Not reported Arm 1, Cohort 1, Dose Level 4 - Dose Escalation Related to CC-486 (5-azacitidine) 0 Not reported Not reported Not reported Not reported Arm 1, Cohort 1, Dose Level 4 - Dose Escalation Related to Any Combination 0 Not reported Not reported Not reported Not reported
Grade 3 Non-serious Hypotension Values in adverse events · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment Arm 1, Cohort 1, Dose Level 3 Dose Escalation Related to Lenalidomide 1 Not reported Not reported Not reported Not reported Arm 1, Cohort 1, Dose Level 3 - Dose Escalation Related to Romidepsin 0 Not reported Not reported Not reported Not reported Arm 1, Cohort 1, Dose Level 3 - Dose Escalation Related to CC-486 (5-azacitidine) 1 Not reported Not reported Not reported Not reported Arm 1, Cohort 1, Dose Level 3: Dose Escalation Related to Any Combination 1 Not reported Not reported Not reported Not reported Arm 1, Cohort 1, Dose Level 4 - Dose Escalation Related to Lenalidomide 0 Not reported Not reported Not reported Not reported Arm 1, Cohort 1, Dose Level 4 - Dose Escalation Related to Romidepsin 0 Not reported Not reported Not reported Not reported Arm 1, Cohort 1, Dose Level 4 - Dose Escalation Related to CC-486 (5-azacitidine) 0 Not reported Not reported Not reported Not reported Arm 1, Cohort 1, Dose Level 4 - Dose Escalation Related to Any Combination 0 Not reported Not reported Not reported Not reported
Grade 3 Non-serious Lymphocyte count decreased Values in adverse events · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment Arm 1, Cohort 1, Dose Level 3 Dose Escalation Related to Lenalidomide 4 Not reported Not reported Not reported Not reported Arm 1, Cohort 1, Dose Level 3 - Dose Escalation Related to Romidepsin 4 Not reported Not reported Not reported Not reported Arm 1, Cohort 1, Dose Level 3 - Dose Escalation Related to CC-486 (5-azacitidine) 4 Not reported Not reported Not reported Not reported Arm 1, Cohort 1, Dose Level 3: Dose Escalation Related to Any Combination 4 Not reported Not reported Not reported Not reported Arm 1, Cohort 1, Dose Level 4 - Dose Escalation Related to Lenalidomide 0 Not reported Not reported Not reported Not reported Arm 1, Cohort 1, Dose Level 4 - Dose Escalation Related to Romidepsin 0 Not reported Not reported Not reported Not reported Arm 1, Cohort 1, Dose Level 4 - Dose Escalation Related to CC-486 (5-azacitidine) 0 Not reported Not reported Not reported Not reported Arm 1, Cohort 1, Dose Level 4 - Dose Escalation Related to Any Combination 0 Not reported Not reported Not reported Not reported
Grade 3 Non-serious Neutrophil count decreased Values in adverse events · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment Arm 1, Cohort 1, Dose Level 3 Dose Escalation Related to Lenalidomide 3 Not reported Not reported Not reported Not reported Arm 1, Cohort 1, Dose Level 3 - Dose Escalation Related to Romidepsin 3 Not reported Not reported Not reported Not reported Arm 1, Cohort 1, Dose Level 3 - Dose Escalation Related to CC-486 (5-azacitidine) 3 Not reported Not reported Not reported Not reported Arm 1, Cohort 1, Dose Level 3: Dose Escalation Related to Any Combination 3 Not reported Not reported Not reported Not reported Arm 1, Cohort 1, Dose Level 4 - Dose Escalation Related to Lenalidomide 2 Not reported Not reported Not reported Not reported Arm 1, Cohort 1, Dose Level 4 - Dose Escalation Related to Romidepsin 2 Not reported Not reported Not reported Not reported Arm 1, Cohort 1, Dose Level 4 - Dose Escalation Related to CC-486 (5-azacitidine) 2 Not reported Not reported Not reported Not reported Arm 1, Cohort 1, Dose Level 4 - Dose Escalation Related to Any Combination 2 Not reported Not reported Not reported Not reported
Grade 3 Platelet count decreased Values in adverse events · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment Arm 1, Cohort 1, Dose Level 3 Dose Escalation Related to Lenalidomide 1 Not reported Not reported Not reported Not reported Arm 1, Cohort 1, Dose Level 3 - Dose Escalation Related to Romidepsin 1 Not reported Not reported Not reported Not reported Arm 1, Cohort 1, Dose Level 3 - Dose Escalation Related to CC-486 (5-azacitidine) 0 Not reported Not reported Not reported Not reported Arm 1, Cohort 1, Dose Level 3: Dose Escalation Related to Any Combination 0 Not reported Not reported Not reported Not reported Arm 1, Cohort 1, Dose Level 4 - Dose Escalation Related to Lenalidomide 0 Not reported Not reported Not reported Not reported Arm 1, Cohort 1, Dose Level 4 - Dose Escalation Related to Romidepsin 0 Not reported Not reported Not reported Not reported Arm 1, Cohort 1, Dose Level 4 - Dose Escalation Related to CC-486 (5-azacitidine) 0 Not reported Not reported Not reported Not reported Arm 1, Cohort 1, Dose Level 4 - Dose Escalation Related to Any Combination 0 Not reported Not reported Not reported Not reported
Grade 3 White blood cell decreased Values in adverse events · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment Arm 1, Cohort 1, Dose Level 3 Dose Escalation Related to Lenalidomide 3 Not reported Not reported Not reported Not reported Arm 1, Cohort 1, Dose Level 3 - Dose Escalation Related to Romidepsin 3 Not reported Not reported Not reported Not reported Arm 1, Cohort 1, Dose Level 3 - Dose Escalation Related to CC-486 (5-azacitidine) 0 Not reported Not reported Not reported Not reported Arm 1, Cohort 1, Dose Level 3: Dose Escalation Related to Any Combination 0 Not reported Not reported Not reported Not reported Arm 1, Cohort 1, Dose Level 4 - Dose Escalation Related to Lenalidomide 1 Not reported Not reported Not reported Not reported Arm 1, Cohort 1, Dose Level 4 - Dose Escalation Related to Romidepsin 1 Not reported Not reported Not reported Not reported Arm 1, Cohort 1, Dose Level 4 - Dose Escalation Related to CC-486 (5-azacitidine) 1 Not reported Not reported Not reported Not reported Arm 1, Cohort 1, Dose Level 4 - Dose Escalation Related to Any Combination 1 Not reported Not reported Not reported Not reported
Grade 4 CPK increased Values in adverse events · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment Arm 1, Cohort 1, Dose Level 3 Dose Escalation Related to Lenalidomide 0 Not reported Not reported Not reported Not reported Arm 1, Cohort 1, Dose Level 3 - Dose Escalation Related to Romidepsin 0 Not reported Not reported Not reported Not reported Arm 1, Cohort 1, Dose Level 3 - Dose Escalation Related to CC-486 (5-azacitidine) 0 Not reported Not reported Not reported Not reported Arm 1, Cohort 1, Dose Level 3: Dose Escalation Related to Any Combination 0 Not reported Not reported Not reported Not reported Arm 1, Cohort 1, Dose Level 4 - Dose Escalation Related to Lenalidomide 0 Not reported Not reported Not reported Not reported Arm 1, Cohort 1, Dose Level 4 - Dose Escalation Related to Romidepsin 0 Not reported Not reported Not reported Not reported Arm 1, Cohort 1, Dose Level 4 - Dose Escalation Related to CC-486 (5-azacitidine) 2 Not reported Not reported Not reported Not reported Arm 1, Cohort 1, Dose Level 4 - Dose Escalation Related to Any Combination 2 Not reported Not reported Not reported Not reported
Grade 4 Lymphocyte count decreased Values in adverse events · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment Arm 1, Cohort 1, Dose Level 3 Dose Escalation Related to Lenalidomide 0 Not reported Not reported Not reported Not reported Arm 1, Cohort 1, Dose Level 3 - Dose Escalation Related to Romidepsin 0 Not reported Not reported Not reported Not reported Arm 1, Cohort 1, Dose Level 3 - Dose Escalation Related to CC-486 (5-azacitidine) 0 Not reported Not reported Not reported Not reported Arm 1, Cohort 1, Dose Level 3: Dose Escalation Related to Any Combination 0 Not reported Not reported Not reported Not reported Arm 1, Cohort 1, Dose Level 4 - Dose Escalation Related to Lenalidomide 2 Not reported Not reported Not reported Not reported Arm 1, Cohort 1, Dose Level 4 - Dose Escalation Related to Romidepsin 2 Not reported Not reported Not reported Not reported Arm 1, Cohort 1, Dose Level 4 - Dose Escalation Related to CC-486 (5-azacitidine) 2 Not reported Not reported Not reported Not reported Arm 1, Cohort 1, Dose Level 4 - Dose Escalation Related to Any Combination 2 Not reported Not reported Not reported Not reported
Complete source fields classes categories measurements
group Id OG000
value 1
group Id OG001
value 1
group Id OG002
value 1
group Id OG003
value 1
group Id OG004
value 0
group Id OG005
value 0
group Id OG006
value 0
group Id OG007
value 0
title Grade 3 Serious Blood bilirubin increased categories measurements
group Id OG000
value 1
group Id OG001
value 1
group Id OG002
value 1
group Id OG003
value 1
group Id OG004
value 0
group Id OG005
value 0
group Id OG006
value 0
group Id OG007
value 0
title Grade 3 Serious Hepatobiliary disorders - Other specify, Drug-Induced liver injury categories measurements
group Id OG000
value 2
group Id OG001
value 0
group Id OG002
value 2
group Id OG003
value 2
group Id OG004
value 0
group Id OG005
value 0
group Id OG006
value 0
group Id OG007
value 0
title Grade 3 Serious Rhabdomyolysis categories measurements
group Id OG000
value 0
group Id OG001
value 0
group Id OG002
value 0
group Id OG003
value 0
group Id OG004
value 0
group Id OG005
value 0
group Id OG006
value 0
group Id OG007
value 0
title Any Grade 4 and/or 5 Serious Adverse Event categories measurements
group Id OG000
value 1
group Id OG001
value 0
group Id OG002
value 1
group Id OG003
value 0
group Id OG004
value 0
group Id OG005
value 0
group Id OG006
value 0
group Id OG007
value 0
title Grade 3 Non-serious Acute kidney injury categories measurements
group Id OG000
value 0
group Id OG001
value 1
group Id OG002
value 0
group Id OG003
value 0
group Id OG004
value 0
group Id OG005
value 0
group Id OG006
value 0
group Id OG007
value 0
title Grade 3 Non-serious Alanine aminotransferase increased categories measurements
group Id OG000
value 1
group Id OG001
value 0
group Id OG002
value 0
group Id OG003
value 0
group Id OG004
value 0
group Id OG005
value 0
group Id OG006
value 0
group Id OG007
value 0
title Grade 3 Non-serious Anemia categories measurements
group Id OG000
value 1
group Id OG001
value 1
group Id OG002
value 0
group Id OG003
value 0
group Id OG004
value 0
group Id OG005
value 0
group Id OG006
value 0
group Id OG007
value 0
title Grade 3 Non-serious Aspartate aminotransferase increased categories measurements
group Id OG000
value 1
group Id OG001
value 1
group Id OG002
value 1
group Id OG003
value 1
group Id OG004
value 0
group Id OG005
value 0
group Id OG006
value 0
group Id OG007
value 0
title Grade 3 Non-serious Blood bilirubin increased categories measurements
group Id OG000
value 0
group Id OG001
value 0
group Id OG002
value 1
group Id OG003
value 1
group Id OG004
value 0
group Id OG005
value 0
group Id OG006
value 0
group Id OG007
value 0
title Grade 3 Non-serious CPK increased categories measurements
group Id OG000
value 1
group Id OG001
value 0
group Id OG002
value 1
group Id OG003
value 1
group Id OG004
value 0
group Id OG005
value 0
group Id OG006
value 0
group Id OG007
value 0
title Grade 3 Non-serious Fatigue categories measurements
group Id OG000
value 1
group Id OG001
value 0
group Id OG002
value 1
group Id OG003
value 1
group Id OG004
value 0
group Id OG005
value 0
group Id OG006
value 0
group Id OG007
value 0
title Grade 3 Non-serious Hypotension Show more (12 of 18) denoms counts
group Id OG000
value 3
group Id OG001
value 3
group Id OG002
value 3
group Id OG003
value 3
group Id OG004
value 3
group Id OG005
value 3
group Id OG006
value 3
group Id OG007
value 3
units Participants
description Treatment emergent grades 3, 4, and/or 5 adverse events possibly related grouped by relationship to the study drug (e.g., lenalidomide, romidepsin, CC-486 (5-azacitidine) in any combinations) assessed by the Common Terminology Criteria for Adverse Events (CTCAE v5.0). Grade 3 is severe. Grade 4 is life threatening. Grade 5 is death related to adverse event. groups
description Arm 1, Cohort 1, Dose Level 3: adverse events possibly related to lenalidomide.
id OG000
title Arm 1, Cohort 1, Dose Level 3 Dose Escalation Related to Lenalidomide
description Arm 1, Cohort 1, Dose Level 3: adverse events possibly related to romidepsin.
id OG001
title Arm 1, Cohort 1, Dose Level 3 - Dose Escalation Related to Romidepsin
description Arm 1, Cohort 1, Dose Level 3: adverse events possibly related to CC-486 (5-azacitidine).
id OG002
title Arm 1, Cohort 1, Dose Level 3 - Dose Escalation Related to CC-486 (5-azacitidine)
description Arm 1, Cohort 1, Dose Level 3: adverse events possibly related to any combination.
id OG003
title Arm 1, Cohort 1, Dose Level 3: Dose Escalation Related to Any Combination
description Arm 1, Cohort 1, Dose Level 4: adverse events possibly related to lenalidomide.
id OG004
title Arm 1, Cohort 1, Dose Level 4 - Dose Escalation Related to Lenalidomide
description Arm 1, Cohort 1, Dose Level 4: adverse events possibly related to romidepsin.
id OG005
title Arm 1, Cohort 1, Dose Level 4 - Dose Escalation Related to Romidepsin
description Arm 1, Cohort 1, Dose Level 4: adverse events possibly related to CC-486 (5-azacitidine).
id OG006
title Arm 1, Cohort 1, Dose Level 4 - Dose Escalation Related to CC-486 (5-azacitidine)
description Arm 1, Cohort 1, Dose Level 4: adverse events possibly related to any combination.
id OG007
title Arm 1, Cohort 1, Dose Level 4 - Dose Escalation Related to Any Combination
param Type NUMBER
reporting Status POSTED
time Frame 6 cycles (each cycle is 28 days)
title Arm 1, Cohort 1, Dose Level 3, and Arm 1, Cohort 1, Dose Level 4 Treatment Emergent Serious Grades 3, 4, and/or 5 Adverse Events Possibly Related to Drug Grouped by Relationship to the Study Drug and/or Combination
type PRIMARY
unit Of Measure adverse events Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice
Triangle