Skip to content
Triangle logo TriangleGet started
← Full study record

NCT04447027 · OUTCOME

Arm 1, Cohort 1, Dose Level -1, 1, and 2 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 -1 Dose Escalation Related to Lenalidomide

Arm 1, Cohort 1, Dose Level -1: adverse events possibly related to lenalidomide.

Arm 1, Cohort 1, Dose Level -1 - Dose Escalation Related to Romidepsin

Arm 1, Cohort 1, Dose Level -1: adverse events possibly related to romidepsin.

Arm 1, Cohort 1, Dose Level -1 - Dose Escalation Related to CC-486 (5-azacitidine)

Arm 1, Cohort 1, Dose Level -1: adverse events possibly related to CC-486 (5-azacitidine).

Arm 1, Cohort 1, Dose Level -1: Dose Escalation Related to Any Combination

Arm 1, Cohort 1, Dose Level -1: adverse events possibly related to any combination.

Arm 1, Cohort 1, Dose Level 1 - Dose Expansion Related to Lenalidomide

Arm 1, Cohort 1, Dose Level 1: adverse events possibly related to lenalidomide.

Arm 1, Cohort 1, Dose Level 1 - Dose Expansion Related to Romidepsin

Arm 1, Cohort 1, Dose Level 1: adverse events possibly related to romidepsin.

Arm 1, Cohort 1, Dose Level 1 - Dose Expansion Related to CC-486 (5-azacitidine)

Arm 1, Cohort 1, Dose Level 1: adverse events possibly related to CC-486 (5-azacitidine).

Arm 1, Cohort 1, Dose Level 1 - Dose Expansion Related to Any Combination

Arm 1, Cohort 1, Dose Level 1: adverse events possibly related to any combination.

Arm 1, Cohort 1, Dose Level 2 - Dose Escalation Related to Lenalidomide

Arm 1, Cohort 1, Dose Level 2: adverse events possibly related to lenalidomide.

Arm 1, Cohort 1, Dose Level 2 - Dose Escalation Related to Romidepsin

Arm 1, Cohort 1, Dose Level 2: adverse events possibly related to romidepsin.

Arm 1, Cohort 1, Dose Level 2 - Dose Escalation Related to CC-486 (5-azacitidine)

Arm 1, Cohort 1, Dose Level 2: adverse events possibly related to CC-486 (5-azacitidine).

Arm 1, Cohort 1, Dose Level 2 - Dose Escalation Related to Any Combination

Arm 1, Cohort 1, Dose Level 2: 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

GroupSource count
Arm 1, Cohort 1, Dose Level -1 Dose Escalation Related to Lenalidomide2
Arm 1, Cohort 1, Dose Level -1 - Dose Escalation Related to Romidepsin2
Arm 1, Cohort 1, Dose Level -1 - Dose Escalation Related to CC-486 (5-azacitidine)2
Arm 1, Cohort 1, Dose Level -1: Dose Escalation Related to Any Combination2
Arm 1, Cohort 1, Dose Level 1 - Dose Expansion Related to Lenalidomide6
Arm 1, Cohort 1, Dose Level 1 - Dose Expansion Related to Romidepsin6
Arm 1, Cohort 1, Dose Level 1 - Dose Expansion Related to CC-486 (5-azacitidine)6
Arm 1, Cohort 1, Dose Level 1 - Dose Expansion Related to Any Combination6
Arm 1, Cohort 1, Dose Level 2 - Dose Escalation Related to Lenalidomide6
Arm 1, Cohort 1, Dose Level 2 - Dose Escalation Related to Romidepsin6
Arm 1, Cohort 1, Dose Level 2 - Dose Escalation Related to CC-486 (5-azacitidine)6
Arm 1, Cohort 1, Dose Level 2 - Dose Escalation Related to Any Combination6

Reported measurements

Grade 3 Serious Anorexia
Values in adverse events · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Arm 1, Cohort 1, Dose Level -1 Dose Escalation Related to Lenalidomide0Not reportedNot reportedNot reportedNot reported
Arm 1, Cohort 1, Dose Level -1 - Dose Escalation Related to Romidepsin0Not reportedNot reportedNot reportedNot reported
Arm 1, Cohort 1, Dose Level -1 - Dose Escalation Related to CC-486 (5-azacitidine)0Not reportedNot reportedNot reportedNot reported
Arm 1, Cohort 1, Dose Level -1: Dose Escalation Related to Any Combination0Not reportedNot reportedNot reportedNot reported
Arm 1, Cohort 1, Dose Level 1 - Dose Expansion Related to Lenalidomide0Not reportedNot reportedNot reportedNot reported
Arm 1, Cohort 1, Dose Level 1 - Dose Expansion Related to Romidepsin1Not reportedNot reportedNot reportedNot reported
Arm 1, Cohort 1, Dose Level 1 - Dose Expansion Related to CC-486 (5-azacitidine)0Not reportedNot reportedNot reportedNot reported
Arm 1, Cohort 1, Dose Level 1 - Dose Expansion Related to Any Combination0Not reportedNot reportedNot reportedNot reported
Arm 1, Cohort 1, Dose Level 2 - Dose Escalation Related to Lenalidomide0Not reportedNot reportedNot reportedNot reported
Arm 1, Cohort 1, Dose Level 2 - Dose Escalation Related to Romidepsin0Not reportedNot reportedNot reportedNot reported
Arm 1, Cohort 1, Dose Level 2 - Dose Escalation Related to CC-486 (5-azacitidine)0Not reportedNot reportedNot reportedNot reported
Arm 1, Cohort 1, Dose Level 2 - Dose Escalation Related to Any Combination0Not reportedNot reportedNot reportedNot reported
Grade 3 Serious Atrial fibrillation
Values in adverse events · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Arm 1, Cohort 1, Dose Level -1 Dose Escalation Related to Lenalidomide0Not reportedNot reportedNot reportedNot reported
Arm 1, Cohort 1, Dose Level -1 - Dose Escalation Related to Romidepsin0Not reportedNot reportedNot reportedNot reported
Arm 1, Cohort 1, Dose Level -1 - Dose Escalation Related to CC-486 (5-azacitidine)0Not reportedNot reportedNot reportedNot reported
Arm 1, Cohort 1, Dose Level -1: Dose Escalation Related to Any Combination0Not reportedNot reportedNot reportedNot reported
Arm 1, Cohort 1, Dose Level 1 - Dose Expansion Related to Lenalidomide0Not reportedNot reportedNot reportedNot reported
Arm 1, Cohort 1, Dose Level 1 - Dose Expansion Related to Romidepsin1Not reportedNot reportedNot reportedNot reported
Arm 1, Cohort 1, Dose Level 1 - Dose Expansion Related to CC-486 (5-azacitidine)0Not reportedNot reportedNot reportedNot reported
Arm 1, Cohort 1, Dose Level 1 - Dose Expansion Related to Any Combination0Not reportedNot reportedNot reportedNot reported
Arm 1, Cohort 1, Dose Level 2 - Dose Escalation Related to Lenalidomide0Not reportedNot reportedNot reportedNot reported
Arm 1, Cohort 1, Dose Level 2 - Dose Escalation Related to Romidepsin0Not reportedNot reportedNot reportedNot reported
Arm 1, Cohort 1, Dose Level 2 - Dose Escalation Related to CC-486 (5-azacitidine)0Not reportedNot reportedNot reportedNot reported
Arm 1, Cohort 1, Dose Level 2 - Dose Escalation Related to Any Combination0Not reportedNot reportedNot reportedNot reported
Grade 4 or 5 Any Serious Adverse Event
Values in adverse events · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Arm 1, Cohort 1, Dose Level -1 Dose Escalation Related to Lenalidomide0Not reportedNot reportedNot reportedNot reported
Arm 1, Cohort 1, Dose Level -1 - Dose Escalation Related to Romidepsin0Not reportedNot reportedNot reportedNot reported
Arm 1, Cohort 1, Dose Level -1 - Dose Escalation Related to CC-486 (5-azacitidine)0Not reportedNot reportedNot reportedNot reported
Arm 1, Cohort 1, Dose Level -1: Dose Escalation Related to Any Combination0Not reportedNot reportedNot reportedNot reported
Arm 1, Cohort 1, Dose Level 1 - Dose Expansion Related to Lenalidomide0Not reportedNot reportedNot reportedNot reported
Arm 1, Cohort 1, Dose Level 1 - Dose Expansion Related to Romidepsin0Not reportedNot reportedNot reportedNot reported
Arm 1, Cohort 1, Dose Level 1 - Dose Expansion Related to CC-486 (5-azacitidine)0Not reportedNot reportedNot reportedNot reported
Arm 1, Cohort 1, Dose Level 1 - Dose Expansion Related to Any Combination0Not reportedNot reportedNot reportedNot reported
Arm 1, Cohort 1, Dose Level 2 - Dose Escalation Related to Lenalidomide0Not reportedNot reportedNot reportedNot reported
Arm 1, Cohort 1, Dose Level 2 - Dose Escalation Related to Romidepsin0Not reportedNot reportedNot reportedNot reported
Arm 1, Cohort 1, Dose Level 2 - Dose Escalation Related to CC-486 (5-azacitidine)0Not reportedNot reportedNot reportedNot reported
Arm 1, Cohort 1, Dose Level 2 - Dose Escalation Related to Any Combination0Not reportedNot reportedNot reportedNot reported
Grade 3 Non-serious Anemia
Values in adverse events · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Arm 1, Cohort 1, Dose Level -1 Dose Escalation Related to Lenalidomide2Not reportedNot reportedNot reportedNot reported
Arm 1, Cohort 1, Dose Level -1 - Dose Escalation Related to Romidepsin2Not reportedNot reportedNot reportedNot reported
Arm 1, Cohort 1, Dose Level -1 - Dose Escalation Related to CC-486 (5-azacitidine)2Not reportedNot reportedNot reportedNot reported
Arm 1, Cohort 1, Dose Level -1: Dose Escalation Related to Any Combination2Not reportedNot reportedNot reportedNot reported
Arm 1, Cohort 1, Dose Level 1 - Dose Expansion Related to Lenalidomide1Not reportedNot reportedNot reportedNot reported
Arm 1, Cohort 1, Dose Level 1 - Dose Expansion Related to Romidepsin1Not reportedNot reportedNot reportedNot reported
Arm 1, Cohort 1, Dose Level 1 - Dose Expansion Related to CC-486 (5-azacitidine)1Not reportedNot reportedNot reportedNot reported
Arm 1, Cohort 1, Dose Level 1 - Dose Expansion Related to Any Combination1Not reportedNot reportedNot reportedNot reported
Arm 1, Cohort 1, Dose Level 2 - Dose Escalation Related to Lenalidomide0Not reportedNot reportedNot reportedNot reported
Arm 1, Cohort 1, Dose Level 2 - Dose Escalation Related to Romidepsin0Not reportedNot reportedNot reportedNot reported
Arm 1, Cohort 1, Dose Level 2 - Dose Escalation Related to CC-486 (5-azacitidine)0Not reportedNot reportedNot reportedNot reported
Arm 1, Cohort 1, Dose Level 2 - Dose Escalation Related to Any Combination0Not reportedNot reportedNot reportedNot reported
Grade 3 Non-serious Lymphocyte count decreased
Values in adverse events · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Arm 1, Cohort 1, Dose Level -1 Dose Escalation Related to Lenalidomide1Not reportedNot reportedNot reportedNot reported
Arm 1, Cohort 1, Dose Level -1 - Dose Escalation Related to Romidepsin1Not reportedNot reportedNot reportedNot reported
Arm 1, Cohort 1, Dose Level -1 - Dose Escalation Related to CC-486 (5-azacitidine)1Not reportedNot reportedNot reportedNot reported
Arm 1, Cohort 1, Dose Level -1: Dose Escalation Related to Any Combination1Not reportedNot reportedNot reportedNot reported
Arm 1, Cohort 1, Dose Level 1 - Dose Expansion Related to Lenalidomide0Not reportedNot reportedNot reportedNot reported
Arm 1, Cohort 1, Dose Level 1 - Dose Expansion Related to Romidepsin0Not reportedNot reportedNot reportedNot reported
Arm 1, Cohort 1, Dose Level 1 - Dose Expansion Related to CC-486 (5-azacitidine)0Not reportedNot reportedNot reportedNot reported
Arm 1, Cohort 1, Dose Level 1 - Dose Expansion Related to Any Combination0Not reportedNot reportedNot reportedNot reported
Arm 1, Cohort 1, Dose Level 2 - Dose Escalation Related to Lenalidomide0Not reportedNot reportedNot reportedNot reported
Arm 1, Cohort 1, Dose Level 2 - Dose Escalation Related to Romidepsin0Not reportedNot reportedNot reportedNot reported
Arm 1, Cohort 1, Dose Level 2 - Dose Escalation Related to CC-486 (5-azacitidine)0Not reportedNot reportedNot reportedNot reported
Arm 1, Cohort 1, Dose Level 2 - Dose Escalation Related to Any Combination0Not reportedNot reportedNot reportedNot reported
Grade 3 Non-serious Platelet count decreased
Values in adverse events · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Arm 1, Cohort 1, Dose Level -1 Dose Escalation Related to Lenalidomide1Not reportedNot reportedNot reportedNot reported
Arm 1, Cohort 1, Dose Level -1 - Dose Escalation Related to Romidepsin1Not reportedNot reportedNot reportedNot reported
Arm 1, Cohort 1, Dose Level -1 - Dose Escalation Related to CC-486 (5-azacitidine)1Not reportedNot reportedNot reportedNot reported
Arm 1, Cohort 1, Dose Level -1: Dose Escalation Related to Any Combination1Not reportedNot reportedNot reportedNot reported
Arm 1, Cohort 1, Dose Level 1 - Dose Expansion Related to Lenalidomide0Not reportedNot reportedNot reportedNot reported
Arm 1, Cohort 1, Dose Level 1 - Dose Expansion Related to Romidepsin0Not reportedNot reportedNot reportedNot reported
Arm 1, Cohort 1, Dose Level 1 - Dose Expansion Related to CC-486 (5-azacitidine)0Not reportedNot reportedNot reportedNot reported
Arm 1, Cohort 1, Dose Level 1 - Dose Expansion Related to Any Combination0Not reportedNot reportedNot reportedNot reported
Arm 1, Cohort 1, Dose Level 2 - Dose Escalation Related to Lenalidomide0Not reportedNot reportedNot reportedNot reported
Arm 1, Cohort 1, Dose Level 2 - Dose Escalation Related to Romidepsin0Not reportedNot reportedNot reportedNot reported
Arm 1, Cohort 1, Dose Level 2 - Dose Escalation Related to CC-486 (5-azacitidine)0Not reportedNot reportedNot reportedNot reported
Arm 1, Cohort 1, Dose Level 2 - Dose Escalation Related to Any Combination0Not reportedNot reportedNot reportedNot reported
Grade 3 Non-serious Ejection fraction decreased
Values in adverse events · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Arm 1, Cohort 1, Dose Level -1 Dose Escalation Related to Lenalidomide0Not reportedNot reportedNot reportedNot reported
Arm 1, Cohort 1, Dose Level -1 - Dose Escalation Related to Romidepsin0Not reportedNot reportedNot reportedNot reported
Arm 1, Cohort 1, Dose Level -1 - Dose Escalation Related to CC-486 (5-azacitidine)0Not reportedNot reportedNot reportedNot reported
Arm 1, Cohort 1, Dose Level -1: Dose Escalation Related to Any Combination0Not reportedNot reportedNot reportedNot reported
Arm 1, Cohort 1, Dose Level 1 - Dose Expansion Related to Lenalidomide0Not reportedNot reportedNot reportedNot reported
Arm 1, Cohort 1, Dose Level 1 - Dose Expansion Related to Romidepsin0Not reportedNot reportedNot reportedNot reported
Arm 1, Cohort 1, Dose Level 1 - Dose Expansion Related to CC-486 (5-azacitidine)0Not reportedNot reportedNot reportedNot reported
Arm 1, Cohort 1, Dose Level 1 - Dose Expansion Related to Any Combination0Not reportedNot reportedNot reportedNot reported
Arm 1, Cohort 1, Dose Level 2 - Dose Escalation Related to Lenalidomide0Not reportedNot reportedNot reportedNot reported
Arm 1, Cohort 1, Dose Level 2 - Dose Escalation Related to Romidepsin0Not reportedNot reportedNot reportedNot reported
Arm 1, Cohort 1, Dose Level 2 - Dose Escalation Related to CC-486 (5-azacitidine)0Not reportedNot reportedNot reportedNot reported
Arm 1, Cohort 1, Dose Level 2 - Dose Escalation Related to Any Combination0Not reportedNot reportedNot reportedNot reported
Grade 3 Non-serious Hypokalemia
Values in adverse events · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Arm 1, Cohort 1, Dose Level -1 Dose Escalation Related to Lenalidomide0Not reportedNot reportedNot reportedNot reported
Arm 1, Cohort 1, Dose Level -1 - Dose Escalation Related to Romidepsin0Not reportedNot reportedNot reportedNot reported
Arm 1, Cohort 1, Dose Level -1 - Dose Escalation Related to CC-486 (5-azacitidine)0Not reportedNot reportedNot reportedNot reported
Arm 1, Cohort 1, Dose Level -1: Dose Escalation Related to Any Combination0Not reportedNot reportedNot reportedNot reported
Arm 1, Cohort 1, Dose Level 1 - Dose Expansion Related to Lenalidomide1Not reportedNot reportedNot reportedNot reported
Arm 1, Cohort 1, Dose Level 1 - Dose Expansion Related to Romidepsin1Not reportedNot reportedNot reportedNot reported
Arm 1, Cohort 1, Dose Level 1 - Dose Expansion Related to CC-486 (5-azacitidine)1Not reportedNot reportedNot reportedNot reported
Arm 1, Cohort 1, Dose Level 1 - Dose Expansion Related to Any Combination1Not reportedNot reportedNot reportedNot reported
Arm 1, Cohort 1, Dose Level 2 - Dose Escalation Related to Lenalidomide0Not reportedNot reportedNot reportedNot reported
Arm 1, Cohort 1, Dose Level 2 - Dose Escalation Related to Romidepsin0Not reportedNot reportedNot reportedNot reported
Arm 1, Cohort 1, Dose Level 2 - Dose Escalation Related to CC-486 (5-azacitidine)0Not reportedNot reportedNot reportedNot reported
Arm 1, Cohort 1, Dose Level 2 - Dose Escalation Related to Any Combination0Not reportedNot reportedNot reportedNot reported
Grade 3 Non-serious Neutrophil count decreased
Values in adverse events · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Arm 1, Cohort 1, Dose Level -1 Dose Escalation Related to Lenalidomide0Not reportedNot reportedNot reportedNot reported
Arm 1, Cohort 1, Dose Level -1 - Dose Escalation Related to Romidepsin0Not reportedNot reportedNot reportedNot reported
Arm 1, Cohort 1, Dose Level -1 - Dose Escalation Related to CC-486 (5-azacitidine)0Not reportedNot reportedNot reportedNot reported
Arm 1, Cohort 1, Dose Level -1: Dose Escalation Related to Any Combination0Not reportedNot reportedNot reportedNot reported
Arm 1, Cohort 1, Dose Level 1 - Dose Expansion Related to Lenalidomide4Not reportedNot reportedNot reportedNot reported
Arm 1, Cohort 1, Dose Level 1 - Dose Expansion Related to Romidepsin4Not reportedNot reportedNot reportedNot reported
Arm 1, Cohort 1, Dose Level 1 - Dose Expansion Related to CC-486 (5-azacitidine)4Not reportedNot reportedNot reportedNot reported
Arm 1, Cohort 1, Dose Level 1 - Dose Expansion Related to Any Combination4Not reportedNot reportedNot reportedNot reported
Arm 1, Cohort 1, Dose Level 2 - Dose Escalation Related to Lenalidomide1Not reportedNot reportedNot reportedNot reported
Arm 1, Cohort 1, Dose Level 2 - Dose Escalation Related to Romidepsin1Not reportedNot reportedNot reportedNot reported
Arm 1, Cohort 1, Dose Level 2 - Dose Escalation Related to CC-486 (5-azacitidine)1Not reportedNot reportedNot reportedNot reported
Arm 1, Cohort 1, Dose Level 2 - Dose Escalation Related to Any Combination1Not reportedNot reportedNot reportedNot reported
Grade 3 Non-Serious Platelet count decreased
Values in adverse events · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Arm 1, Cohort 1, Dose Level -1 Dose Escalation Related to Lenalidomide0Not reportedNot reportedNot reportedNot reported
Arm 1, Cohort 1, Dose Level -1 - Dose Escalation Related to Romidepsin0Not reportedNot reportedNot reportedNot reported
Arm 1, Cohort 1, Dose Level -1 - Dose Escalation Related to CC-486 (5-azacitidine)0Not reportedNot reportedNot reportedNot reported
Arm 1, Cohort 1, Dose Level -1: Dose Escalation Related to Any Combination0Not reportedNot reportedNot reportedNot reported
Arm 1, Cohort 1, Dose Level 1 - Dose Expansion Related to Lenalidomide3Not reportedNot reportedNot reportedNot reported
Arm 1, Cohort 1, Dose Level 1 - Dose Expansion Related to Romidepsin3Not reportedNot reportedNot reportedNot reported
Arm 1, Cohort 1, Dose Level 1 - Dose Expansion Related to CC-486 (5-azacitidine)3Not reportedNot reportedNot reportedNot reported
Arm 1, Cohort 1, Dose Level 1 - Dose Expansion Related to Any Combination3Not reportedNot reportedNot reportedNot reported
Arm 1, Cohort 1, Dose Level 2 - Dose Escalation Related to Lenalidomide1Not reportedNot reportedNot reportedNot reported
Arm 1, Cohort 1, Dose Level 2 - Dose Escalation Related to Romidepsin0Not reportedNot reportedNot reportedNot reported
Arm 1, Cohort 1, Dose Level 2 - Dose Escalation Related to CC-486 (5-azacitidine)0Not reportedNot reportedNot reportedNot reported
Arm 1, Cohort 1, Dose Level 2 - Dose Escalation Related to Any Combination1Not reportedNot reportedNot reportedNot reported
Grade 3 Non-serious White blood cell decreased
Values in adverse events · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Arm 1, Cohort 1, Dose Level -1 Dose Escalation Related to Lenalidomide0Not reportedNot reportedNot reportedNot reported
Arm 1, Cohort 1, Dose Level -1 - Dose Escalation Related to Romidepsin0Not reportedNot reportedNot reportedNot reported
Arm 1, Cohort 1, Dose Level -1 - Dose Escalation Related to CC-486 (5-azacitidine)0Not reportedNot reportedNot reportedNot reported
Arm 1, Cohort 1, Dose Level -1: Dose Escalation Related to Any Combination0Not reportedNot reportedNot reportedNot reported
Arm 1, Cohort 1, Dose Level 1 - Dose Expansion Related to Lenalidomide1Not reportedNot reportedNot reportedNot reported
Arm 1, Cohort 1, Dose Level 1 - Dose Expansion Related to Romidepsin1Not reportedNot reportedNot reportedNot reported
Arm 1, Cohort 1, Dose Level 1 - Dose Expansion Related to CC-486 (5-azacitidine)1Not reportedNot reportedNot reportedNot reported
Arm 1, Cohort 1, Dose Level 1 - Dose Expansion Related to Any Combination1Not reportedNot reportedNot reportedNot reported
Arm 1, Cohort 1, Dose Level 2 - Dose Escalation Related to Lenalidomide0Not reportedNot reportedNot reportedNot reported
Arm 1, Cohort 1, Dose Level 2 - Dose Escalation Related to Romidepsin0Not reportedNot reportedNot reportedNot reported
Arm 1, Cohort 1, Dose Level 2 - Dose Escalation Related to CC-486 (5-azacitidine)0Not reportedNot reportedNot reportedNot reported
Arm 1, Cohort 1, Dose Level 2 - Dose Escalation Related to Any Combination0Not reportedNot reportedNot reportedNot reported
Grade 3 Non-serious Fatigue
Values in adverse events · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Arm 1, Cohort 1, Dose Level -1 Dose Escalation Related to Lenalidomide0Not reportedNot reportedNot reportedNot reported
Arm 1, Cohort 1, Dose Level -1 - Dose Escalation Related to Romidepsin0Not reportedNot reportedNot reportedNot reported
Arm 1, Cohort 1, Dose Level -1 - Dose Escalation Related to CC-486 (5-azacitidine)0Not reportedNot reportedNot reportedNot reported
Arm 1, Cohort 1, Dose Level -1: Dose Escalation Related to Any Combination0Not reportedNot reportedNot reportedNot reported
Arm 1, Cohort 1, Dose Level 1 - Dose Expansion Related to Lenalidomide0Not reportedNot reportedNot reportedNot reported
Arm 1, Cohort 1, Dose Level 1 - Dose Expansion Related to Romidepsin0Not reportedNot reportedNot reportedNot reported
Arm 1, Cohort 1, Dose Level 1 - Dose Expansion Related to CC-486 (5-azacitidine)0Not reportedNot reportedNot reportedNot reported
Arm 1, Cohort 1, Dose Level 1 - Dose Expansion Related to Any Combination0Not reportedNot reportedNot reportedNot reported
Arm 1, Cohort 1, Dose Level 2 - Dose Escalation Related to Lenalidomide1Not reportedNot reportedNot reportedNot reported
Arm 1, Cohort 1, Dose Level 2 - Dose Escalation Related to Romidepsin1Not reportedNot reportedNot reportedNot reported
Arm 1, Cohort 1, Dose Level 2 - Dose Escalation Related to CC-486 (5-azacitidine)1Not reportedNot reportedNot reportedNot reported
Arm 1, Cohort 1, Dose Level 2 - Dose Escalation Related to Any Combination1Not reportedNot reportedNot reportedNot reported
Grade 3 Non-serious Weight loss
Values in adverse events · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Arm 1, Cohort 1, Dose Level -1 Dose Escalation Related to Lenalidomide0Not reportedNot reportedNot reportedNot reported
Arm 1, Cohort 1, Dose Level -1 - Dose Escalation Related to Romidepsin0Not reportedNot reportedNot reportedNot reported
Arm 1, Cohort 1, Dose Level -1 - Dose Escalation Related to CC-486 (5-azacitidine)0Not reportedNot reportedNot reportedNot reported
Arm 1, Cohort 1, Dose Level -1: Dose Escalation Related to Any Combination0Not reportedNot reportedNot reportedNot reported
Arm 1, Cohort 1, Dose Level 1 - Dose Expansion Related to Lenalidomide0Not reportedNot reportedNot reportedNot reported
Arm 1, Cohort 1, Dose Level 1 - Dose Expansion Related to Romidepsin0Not reportedNot reportedNot reportedNot reported
Arm 1, Cohort 1, Dose Level 1 - Dose Expansion Related to CC-486 (5-azacitidine)0Not reportedNot reportedNot reportedNot reported
Arm 1, Cohort 1, Dose Level 1 - Dose Expansion Related to Any Combination0Not reportedNot reportedNot reportedNot reported
Arm 1, Cohort 1, Dose Level 2 - Dose Escalation Related to Lenalidomide0Not reportedNot reportedNot reportedNot reported
Arm 1, Cohort 1, Dose Level 2 - Dose Escalation Related to Romidepsin1Not reportedNot reportedNot reportedNot reported
Arm 1, Cohort 1, Dose Level 2 - Dose Escalation Related to CC-486 (5-azacitidine)1Not reportedNot reportedNot reportedNot reported
Arm 1, Cohort 1, Dose Level 2 - Dose Escalation Related to Any Combination1Not reportedNot reportedNot reportedNot reported
Grade 4 Non-serious Platelet count decreased
Values in adverse events · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Arm 1, Cohort 1, Dose Level -1 Dose Escalation Related to Lenalidomide1Not reportedNot reportedNot reportedNot reported
Arm 1, Cohort 1, Dose Level -1 - Dose Escalation Related to Romidepsin1Not reportedNot reportedNot reportedNot reported
Arm 1, Cohort 1, Dose Level -1 - Dose Escalation Related to CC-486 (5-azacitidine)1Not reportedNot reportedNot reportedNot reported
Arm 1, Cohort 1, Dose Level -1: Dose Escalation Related to Any Combination1Not reportedNot reportedNot reportedNot reported
Arm 1, Cohort 1, Dose Level 1 - Dose Expansion Related to Lenalidomide1Not reportedNot reportedNot reportedNot reported
Arm 1, Cohort 1, Dose Level 1 - Dose Expansion Related to Romidepsin1Not reportedNot reportedNot reportedNot reported
Arm 1, Cohort 1, Dose Level 1 - Dose Expansion Related to CC-486 (5-azacitidine)1Not reportedNot reportedNot reportedNot reported
Arm 1, Cohort 1, Dose Level 1 - Dose Expansion Related to Any Combination1Not reportedNot reportedNot reportedNot reported
Arm 1, Cohort 1, Dose Level 2 - Dose Escalation Related to Lenalidomide0Not reportedNot reportedNot reportedNot reported
Arm 1, Cohort 1, Dose Level 2 - Dose Escalation Related to Romidepsin0Not reportedNot reportedNot reportedNot reported
Arm 1, Cohort 1, Dose Level 2 - Dose Escalation Related to CC-486 (5-azacitidine)0Not reportedNot reportedNot reportedNot reported
Arm 1, Cohort 1, Dose Level 2 - Dose Escalation Related to Any Combination0Not reportedNot reportedNot reportedNot reported
Grade 4 Non-serious Neutrophil count decreased
Values in adverse events · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Arm 1, Cohort 1, Dose Level -1 Dose Escalation Related to Lenalidomide0Not reportedNot reportedNot reportedNot reported
Arm 1, Cohort 1, Dose Level -1 - Dose Escalation Related to Romidepsin0Not reportedNot reportedNot reportedNot reported
Arm 1, Cohort 1, Dose Level -1 - Dose Escalation Related to CC-486 (5-azacitidine)0Not reportedNot reportedNot reportedNot reported
Arm 1, Cohort 1, Dose Level -1: Dose Escalation Related to Any Combination0Not reportedNot reportedNot reportedNot reported
Arm 1, Cohort 1, Dose Level 1 - Dose Expansion Related to Lenalidomide2Not reportedNot reportedNot reportedNot reported
Arm 1, Cohort 1, Dose Level 1 - Dose Expansion Related to Romidepsin2Not reportedNot reportedNot reportedNot reported
Arm 1, Cohort 1, Dose Level 1 - Dose Expansion Related to CC-486 (5-azacitidine)2Not reportedNot reportedNot reportedNot reported
Arm 1, Cohort 1, Dose Level 1 - Dose Expansion Related to Any Combination2Not reportedNot reportedNot reportedNot reported
Arm 1, Cohort 1, Dose Level 2 - Dose Escalation Related to Lenalidomide0Not reportedNot reportedNot reportedNot reported
Arm 1, Cohort 1, Dose Level 2 - Dose Escalation Related to Romidepsin0Not reportedNot reportedNot reportedNot reported
Arm 1, Cohort 1, Dose Level 2 - Dose Escalation Related to CC-486 (5-azacitidine)0Not reportedNot reportedNot reportedNot reported
Arm 1, Cohort 1, Dose Level 2 - Dose Escalation Related to Any Combination0Not reportedNot reportedNot reportedNot reported
Grade 4 White blood cell decreased
Values in adverse events · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Arm 1, Cohort 1, Dose Level -1 Dose Escalation Related to Lenalidomide0Not reportedNot reportedNot reportedNot reported
Arm 1, Cohort 1, Dose Level -1 - Dose Escalation Related to Romidepsin0Not reportedNot reportedNot reportedNot reported
Arm 1, Cohort 1, Dose Level -1 - Dose Escalation Related to CC-486 (5-azacitidine)0Not reportedNot reportedNot reportedNot reported
Arm 1, Cohort 1, Dose Level -1: Dose Escalation Related to Any Combination0Not reportedNot reportedNot reportedNot reported
Arm 1, Cohort 1, Dose Level 1 - Dose Expansion Related to Lenalidomide2Not reportedNot reportedNot reportedNot reported
Arm 1, Cohort 1, Dose Level 1 - Dose Expansion Related to Romidepsin2Not reportedNot reportedNot reportedNot reported
Arm 1, Cohort 1, Dose Level 1 - Dose Expansion Related to CC-486 (5-azacitidine)2Not reportedNot reportedNot reportedNot reported
Arm 1, Cohort 1, Dose Level 1 - Dose Expansion Related to Any Combination2Not reportedNot reportedNot reportedNot reported
Arm 1, Cohort 1, Dose Level 2 - Dose Escalation Related to Lenalidomide0Not reportedNot reportedNot reportedNot reported
Arm 1, Cohort 1, Dose Level 2 - Dose Escalation Related to Romidepsin0Not reportedNot reportedNot reportedNot reported
Arm 1, Cohort 1, Dose Level 2 - Dose Escalation Related to CC-486 (5-azacitidine)0Not reportedNot reportedNot reportedNot reported
Arm 1, Cohort 1, Dose Level 2 - Dose Escalation Related to Any Combination0Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        0
      4. group Id
        OG003
        value
        0
      5. group Id
        OG004
        value
        0
      6. group Id
        OG005
        value
        1
      7. group Id
        OG006
        value
        0
      8. group Id
        OG007
        value
        0
      9. group Id
        OG008
        value
        0
      10. group Id
        OG009
        value
        0
      11. group Id
        OG010
        value
        0
      12. group Id
        OG011
        value
        0
    title
    Grade 3 Serious Anorexia
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        0
      4. group Id
        OG003
        value
        0
      5. group Id
        OG004
        value
        0
      6. group Id
        OG005
        value
        1
      7. group Id
        OG006
        value
        0
      8. group Id
        OG007
        value
        0
      9. group Id
        OG008
        value
        0
      10. group Id
        OG009
        value
        0
      11. group Id
        OG010
        value
        0
      12. group Id
        OG011
        value
        0
    title
    Grade 3 Serious Atrial fibrillation
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        0
      4. group Id
        OG003
        value
        0
      5. group Id
        OG004
        value
        0
      6. group Id
        OG005
        value
        0
      7. group Id
        OG006
        value
        0
      8. group Id
        OG007
        value
        0
      9. group Id
        OG008
        value
        0
      10. group Id
        OG009
        value
        0
      11. group Id
        OG010
        value
        0
      12. group Id
        OG011
        value
        0
    title
    Grade 4 or 5 Any Serious Adverse Event
  4. categories
    1. measurements
      1. group Id
        OG000
        value
        2
      2. group Id
        OG001
        value
        2
      3. group Id
        OG002
        value
        2
      4. group Id
        OG003
        value
        2
      5. group Id
        OG004
        value
        1
      6. group Id
        OG005
        value
        1
      7. group Id
        OG006
        value
        1
      8. group Id
        OG007
        value
        1
      9. group Id
        OG008
        value
        0
      10. group Id
        OG009
        value
        0
      11. group Id
        OG010
        value
        0
      12. group Id
        OG011
        value
        0
    title
    Grade 3 Non-serious Anemia
  5. categories
    1. measurements
      1. group Id
        OG000
        value
        1
      2. group Id
        OG001
        value
        1
      3. group Id
        OG002
        value
        1
      4. group Id
        OG003
        value
        1
      5. group Id
        OG004
        value
        0
      6. group Id
        OG005
        value
        0
      7. group Id
        OG006
        value
        0
      8. group Id
        OG007
        value
        0
      9. group Id
        OG008
        value
        0
      10. group Id
        OG009
        value
        0
      11. group Id
        OG010
        value
        0
      12. group Id
        OG011
        value
        0
    title
    Grade 3 Non-serious Lymphocyte count decreased
  6. categories
    1. measurements
      1. group Id
        OG000
        value
        1
      2. group Id
        OG001
        value
        1
      3. group Id
        OG002
        value
        1
      4. group Id
        OG003
        value
        1
      5. group Id
        OG004
        value
        0
      6. group Id
        OG005
        value
        0
      7. group Id
        OG006
        value
        0
      8. group Id
        OG007
        value
        0
      9. group Id
        OG008
        value
        0
      10. group Id
        OG009
        value
        0
      11. group Id
        OG010
        value
        0
      12. group Id
        OG011
        value
        0
    title
    Grade 3 Non-serious Platelet count decreased
  7. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        0
      4. group Id
        OG003
        value
        0
      5. group Id
        OG004
        value
        0
      6. group Id
        OG005
        value
        0
      7. group Id
        OG006
        value
        0
      8. group Id
        OG007
        value
        0
      9. group Id
        OG008
        value
        0
      10. group Id
        OG009
        value
        0
      11. group Id
        OG010
        value
        0
      12. group Id
        OG011
        value
        0
    title
    Grade 3 Non-serious Ejection fraction decreased
  8. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        0
      4. group Id
        OG003
        value
        0
      5. group Id
        OG004
        value
        1
      6. group Id
        OG005
        value
        1
      7. group Id
        OG006
        value
        1
      8. group Id
        OG007
        value
        1
      9. group Id
        OG008
        value
        0
      10. group Id
        OG009
        value
        0
      11. group Id
        OG010
        value
        0
      12. group Id
        OG011
        value
        0
    title
    Grade 3 Non-serious Hypokalemia
  9. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        0
      4. group Id
        OG003
        value
        0
      5. group Id
        OG004
        value
        4
      6. group Id
        OG005
        value
        4
      7. group Id
        OG006
        value
        4
      8. group Id
        OG007
        value
        4
      9. group Id
        OG008
        value
        1
      10. group Id
        OG009
        value
        1
      11. group Id
        OG010
        value
        1
      12. group Id
        OG011
        value
        1
    title
    Grade 3 Non-serious Neutrophil count decreased
  10. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        0
      4. group Id
        OG003
        value
        0
      5. group Id
        OG004
        value
        3
      6. group Id
        OG005
        value
        3
      7. group Id
        OG006
        value
        3
      8. group Id
        OG007
        value
        3
      9. group Id
        OG008
        value
        1
      10. group Id
        OG009
        value
        0
      11. group Id
        OG010
        value
        0
      12. group Id
        OG011
        value
        1
    title
    Grade 3 Non-Serious Platelet count decreased
  11. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        0
      4. group Id
        OG003
        value
        0
      5. group Id
        OG004
        value
        1
      6. group Id
        OG005
        value
        1
      7. group Id
        OG006
        value
        1
      8. group Id
        OG007
        value
        1
      9. group Id
        OG008
        value
        0
      10. group Id
        OG009
        value
        0
      11. group Id
        OG010
        value
        0
      12. group Id
        OG011
        value
        0
    title
    Grade 3 Non-serious White blood cell decreased
  12. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        0
      4. group Id
        OG003
        value
        0
      5. group Id
        OG004
        value
        0
      6. group Id
        OG005
        value
        0
      7. group Id
        OG006
        value
        0
      8. group Id
        OG007
        value
        0
      9. group Id
        OG008
        value
        1
      10. group Id
        OG009
        value
        1
      11. group Id
        OG010
        value
        1
      12. group Id
        OG011
        value
        1
    title
    Grade 3 Non-serious Fatigue
denoms
  1. counts
    1. group Id
      OG000
      value
      2
    2. group Id
      OG001
      value
      2
    3. group Id
      OG002
      value
      2
    4. group Id
      OG003
      value
      2
    5. group Id
      OG004
      value
      6
    6. group Id
      OG005
      value
      6
    7. group Id
      OG006
      value
      6
    8. group Id
      OG007
      value
      6
    9. group Id
      OG008
      value
      6
    10. group Id
      OG009
      value
      6
    11. group Id
      OG010
      value
      6
    12. group Id
      OG011
      value
      6
    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
  1. description
    Arm 1, Cohort 1, Dose Level -1: adverse events possibly related to lenalidomide.
    id
    OG000
    title
    Arm 1, Cohort 1, Dose Level -1 Dose Escalation Related to Lenalidomide
  2. description
    Arm 1, Cohort 1, Dose Level -1: adverse events possibly related to romidepsin.
    id
    OG001
    title
    Arm 1, Cohort 1, Dose Level -1 - Dose Escalation Related to Romidepsin
  3. description
    Arm 1, Cohort 1, Dose Level -1: adverse events possibly related to CC-486 (5-azacitidine).
    id
    OG002
    title
    Arm 1, Cohort 1, Dose Level -1 - Dose Escalation Related to CC-486 (5-azacitidine)
  4. description
    Arm 1, Cohort 1, Dose Level -1: adverse events possibly related to any combination.
    id
    OG003
    title
    Arm 1, Cohort 1, Dose Level -1: Dose Escalation Related to Any Combination
  5. description
    Arm 1, Cohort 1, Dose Level 1: adverse events possibly related to lenalidomide.
    id
    OG004
    title
    Arm 1, Cohort 1, Dose Level 1 - Dose Expansion Related to Lenalidomide
  6. description
    Arm 1, Cohort 1, Dose Level 1: adverse events possibly related to romidepsin.
    id
    OG005
    title
    Arm 1, Cohort 1, Dose Level 1 - Dose Expansion Related to Romidepsin
  7. description
    Arm 1, Cohort 1, Dose Level 1: adverse events possibly related to CC-486 (5-azacitidine).
    id
    OG006
    title
    Arm 1, Cohort 1, Dose Level 1 - Dose Expansion Related to CC-486 (5-azacitidine)
  8. description
    Arm 1, Cohort 1, Dose Level 1: adverse events possibly related to any combination.
    id
    OG007
    title
    Arm 1, Cohort 1, Dose Level 1 - Dose Expansion Related to Any Combination
  9. description
    Arm 1, Cohort 1, Dose Level 2: adverse events possibly related to lenalidomide.
    id
    OG008
    title
    Arm 1, Cohort 1, Dose Level 2 - Dose Escalation Related to Lenalidomide
  10. description
    Arm 1, Cohort 1, Dose Level 2: adverse events possibly related to romidepsin.
    id
    OG009
    title
    Arm 1, Cohort 1, Dose Level 2 - Dose Escalation Related to Romidepsin
  11. description
    Arm 1, Cohort 1, Dose Level 2: adverse events possibly related to CC-486 (5-azacitidine).
    id
    OG010
    title
    Arm 1, Cohort 1, Dose Level 2 - Dose Escalation Related to CC-486 (5-azacitidine)
  12. description
    Arm 1, Cohort 1, Dose Level 2: adverse events possibly related to any combination.
    id
    OG011
    title
    Arm 1, Cohort 1, Dose Level 2 - 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 -1, 1, and 2 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