NCT04447027 · OUTCOME

Rate and Severity of Serious and/or Non-serious Adverse Events (AE's) by Grade and Type of Toxicity

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

Rate and severity of AEs will be summarized by grade and type of toxicity. Adverse events were assessed by the Common Terminology Criteria for Adverse Events (CTCAE v5.0). A non-serious adverse event is any untoward medical occurrence. A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life-threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the previous outcomes mentioned. Grade 1 is mild. Grade 2 is moderate. 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 Lenalidomide - Serious AE's

Arm 1, Cohort 1, Dose Level -1: Serious AE's

Arm 1, Cohort 1, Dose Level -1, Dose Escalation Lenalidomide - Non-Serious AE's

Arm 1, Cohort 1, Dose Level -1: Non-Serious AE's

Arm 1, Cohort 1, Dose Level 1, Dose Expansion Lenalidomide - Serious AE's

Arm 1, Cohort 1, Dose Level 1: Serious AE's

Arm 1, Cohort 1, Dose Level 1, Dose Expansion Lenalidomide - Non-Serious AE's

Arm 1, Cohort 1, Dose Level 1: Non-Serious AE's

Arm 1, Cohort 1, Dose Level 2, Dose Escalation Lenalidomide - Serious AE's

Arm 1, Cohort 1, Dose Level 2: Serious AE's

Arm 1, Cohort 1, Dose Level 2, Dose Escalation Lenalidomide - Non-Serious AE's

Arm 1, Cohort 1, Dose Level 2: Non-Serious AE's

Arm 1, Cohort 1, Dose Level 3 Dose Escalation - Serious AE's

Arm 1, Cohort 1, Dose Level 3: Serious AE's

Arm 1, Cohort 1, Dose Level 3 Dose Escalation - Non-Serious AE's

Arm 1, Cohort 1, Dose Level 3: Non-Serious AE's

Arm 1, Cohort 1, Dose Level 4, Dose Escalation Lenalidomide - Serious AE's

Arm 1, Cohort 1, Dose Level 4: Serious AE's

Arm 1, Cohort 1, Dose Level 4, Dose Escalation Lenalidomide - Non-Serious AE's

Arm 1, Cohort 1, Dose Level 4: Non-Serious AE's

Arm 2, Cohort 2, Dose Level 2, Dose Expansion Lenalidomide - Serious AE's

Arm 2, Cohort 2, Dose Level 2: Serious AE's

Arm 2, Cohort 2, Dose Level 2, Dose Expansion Lenalidomide - Non-Serious AE's

Arm 2, Cohort 2, Dose Level 2: Non-Serious AE's

Arm 2, Cohort 2, Dose Level 4, Dose Expansion Lenalidomide - Serious AE's

Arm 2, Cohort 2, Dose Level 4: Serious AE's

Arm 2, Cohort 2, Dose Level 4, Dose Expansion Lenalidomide - Non-Serious AE's

Arm 2, Cohort 2, Dose Level 4: Non-Serious AE's

Arm 3, Cohort 2, Dose Level 4, Dose Expansion Lenalidomide - Serious AE's

Arm 3, Cohort 2, Dose Level 4: Serious AE's

Arm 3, Cohort 2, Dose Level 4, Dose Expansion Lenalidomide - Non-Serious AE's

Arm 3, Cohort 2, Dose Level 4: Non-Serious AE's

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 -1, Dose Escalation Lenalidomide - Serious AE's	2
Arm 1, Cohort 1, Dose Level -1, Dose Escalation Lenalidomide - Non-Serious AE's	2
Arm 1, Cohort 1, Dose Level 1, Dose Expansion Lenalidomide - Serious AE's	6
Arm 1, Cohort 1, Dose Level 1, Dose Expansion Lenalidomide - Non-Serious AE's	6
Arm 1, Cohort 1, Dose Level 2, Dose Escalation Lenalidomide - Serious AE's	6
Arm 1, Cohort 1, Dose Level 2, Dose Escalation Lenalidomide - Non-Serious AE's	6
Arm 1, Cohort 1, Dose Level 3 Dose Escalation - Serious AE's	3
Arm 1, Cohort 1, Dose Level 3 Dose Escalation - Non-Serious AE's	3
Arm 1, Cohort 1, Dose Level 4, Dose Escalation Lenalidomide - Serious AE's	3
Arm 1, Cohort 1, Dose Level 4, Dose Escalation Lenalidomide - Non-Serious AE's	3
Arm 2, Cohort 2, Dose Level 2, Dose Expansion Lenalidomide - Serious AE's	2
Arm 2, Cohort 2, Dose Level 2, Dose Expansion Lenalidomide - Non-Serious AE's	2
Arm 2, Cohort 2, Dose Level 4, Dose Expansion Lenalidomide - Serious AE's	1
Arm 2, Cohort 2, Dose Level 4, Dose Expansion Lenalidomide - Non-Serious AE's	1
Arm 3, Cohort 2, Dose Level 4, Dose Expansion Lenalidomide - Serious AE's	3
Arm 3, Cohort 2, Dose Level 4, Dose Expansion Lenalidomide - Non-Serious AE's	3

Reported measurements

Grade 1 Heart failure

Values in adverse events · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Arm 1, Cohort 1, Dose Level -1, Dose Escalation Lenalidomide - Serious AE's	0	Not reported	Not reported	Not reported	Not reported
Arm 1, Cohort 1, Dose Level -1, Dose Escalation Lenalidomide - Non-Serious AE's	0	Not reported	Not reported	Not reported	Not reported
Arm 1, Cohort 1, Dose Level 1, Dose Expansion Lenalidomide - Serious AE's	1	Not reported	Not reported	Not reported	Not reported
Arm 1, Cohort 1, Dose Level 1, Dose Expansion Lenalidomide - Non-Serious AE's	1	Not reported	Not reported	Not reported	Not reported
Arm 1, Cohort 1, Dose Level 2, Dose Escalation Lenalidomide - Serious AE's	0	Not reported	Not reported	Not reported	Not reported
Arm 1, Cohort 1, Dose Level 2, Dose Escalation Lenalidomide - Non-Serious AE's	0	Not reported	Not reported	Not reported	Not reported
Arm 1, Cohort 1, Dose Level 3 Dose Escalation - Serious AE's	0	Not reported	Not reported	Not reported	Not reported
Arm 1, Cohort 1, Dose Level 3 Dose Escalation - Non-Serious AE's	0	Not reported	Not reported	Not reported	Not reported
Arm 1, Cohort 1, Dose Level 4, Dose Escalation Lenalidomide - Serious AE's	0	Not reported	Not reported	Not reported	Not reported
Arm 1, Cohort 1, Dose Level 4, Dose Escalation Lenalidomide - Non-Serious AE's	0	Not reported	Not reported	Not reported	Not reported
Arm 2, Cohort 2, Dose Level 2, Dose Expansion Lenalidomide - Serious AE's	0	Not reported	Not reported	Not reported	Not reported
Arm 2, Cohort 2, Dose Level 2, Dose Expansion Lenalidomide - Non-Serious AE's	0	Not reported	Not reported	Not reported	Not reported
Arm 2, Cohort 2, Dose Level 4, Dose Expansion Lenalidomide - Serious AE's	0	Not reported	Not reported	Not reported	Not reported
Arm 2, Cohort 2, Dose Level 4, Dose Expansion Lenalidomide - Non-Serious AE's	0	Not reported	Not reported	Not reported	Not reported
Arm 3, Cohort 2, Dose Level 4, Dose Expansion Lenalidomide - Serious AE's	0	Not reported	Not reported	Not reported	Not reported
Arm 3, Cohort 2, Dose Level 4, Dose Expansion Lenalidomide - Non-Serious AE's	0	Not reported	Not reported	Not reported	Not reported

Grade 1 Hypotension

Values in adverse events · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Arm 1, Cohort 1, Dose Level -1, Dose Escalation Lenalidomide - Serious AE's	0	Not reported	Not reported	Not reported	Not reported
Arm 1, Cohort 1, Dose Level -1, Dose Escalation Lenalidomide - Non-Serious AE's	0	Not reported	Not reported	Not reported	Not reported
Arm 1, Cohort 1, Dose Level 1, Dose Expansion Lenalidomide - Serious AE's	1	Not reported	Not reported	Not reported	Not reported
Arm 1, Cohort 1, Dose Level 1, Dose Expansion Lenalidomide - Non-Serious AE's	0	Not reported	Not reported	Not reported	Not reported
Arm 1, Cohort 1, Dose Level 2, Dose Escalation Lenalidomide - Serious AE's	0	Not reported	Not reported	Not reported	Not reported
Arm 1, Cohort 1, Dose Level 2, Dose Escalation Lenalidomide - Non-Serious AE's	0	Not reported	Not reported	Not reported	Not reported
Arm 1, Cohort 1, Dose Level 3 Dose Escalation - Serious AE's	0	Not reported	Not reported	Not reported	Not reported
Arm 1, Cohort 1, Dose Level 3 Dose Escalation - Non-Serious AE's	0	Not reported	Not reported	Not reported	Not reported
Arm 1, Cohort 1, Dose Level 4, Dose Escalation Lenalidomide - Serious AE's	0	Not reported	Not reported	Not reported	Not reported
Arm 1, Cohort 1, Dose Level 4, Dose Escalation Lenalidomide - Non-Serious AE's	0	Not reported	Not reported	Not reported	Not reported
Arm 2, Cohort 2, Dose Level 2, Dose Expansion Lenalidomide - Serious AE's	0	Not reported	Not reported	Not reported	Not reported
Arm 2, Cohort 2, Dose Level 2, Dose Expansion Lenalidomide - Non-Serious AE's	0	Not reported	Not reported	Not reported	Not reported
Arm 2, Cohort 2, Dose Level 4, Dose Expansion Lenalidomide - Serious AE's	0	Not reported	Not reported	Not reported	Not reported
Arm 2, Cohort 2, Dose Level 4, Dose Expansion Lenalidomide - Non-Serious AE's	0	Not reported	Not reported	Not reported	Not reported
Arm 3, Cohort 2, Dose Level 4, Dose Expansion Lenalidomide - Serious AE's	0	Not reported	Not reported	Not reported	Not reported
Arm 3, Cohort 2, Dose Level 4, Dose Expansion Lenalidomide - Non-Serious AE's	0	Not reported	Not reported	Not reported	Not reported

Grade 2 Fatigue

Values in adverse events · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Arm 1, Cohort 1, Dose Level -1, Dose Escalation Lenalidomide - Serious AE's	0	Not reported	Not reported	Not reported	Not reported
Arm 1, Cohort 1, Dose Level -1, Dose Escalation Lenalidomide - Non-Serious AE's	0	Not reported	Not reported	Not reported	Not reported
Arm 1, Cohort 1, Dose Level 1, Dose Expansion Lenalidomide - Serious AE's	1	Not reported	Not reported	Not reported	Not reported
Arm 1, Cohort 1, Dose Level 1, Dose Expansion Lenalidomide - Non-Serious AE's	1	Not reported	Not reported	Not reported	Not reported
Arm 1, Cohort 1, Dose Level 2, Dose Escalation Lenalidomide - Serious AE's	1	Not reported	Not reported	Not reported	Not reported
Arm 1, Cohort 1, Dose Level 2, Dose Escalation Lenalidomide - Non-Serious AE's	3	Not reported	Not reported	Not reported	Not reported
Arm 1, Cohort 1, Dose Level 3 Dose Escalation - Serious AE's	0	Not reported	Not reported	Not reported	Not reported
Arm 1, Cohort 1, Dose Level 3 Dose Escalation - Non-Serious AE's	4	Not reported	Not reported	Not reported	Not reported
Arm 1, Cohort 1, Dose Level 4, Dose Escalation Lenalidomide - Serious AE's	0	Not reported	Not reported	Not reported	Not reported
Arm 1, Cohort 1, Dose Level 4, Dose Escalation Lenalidomide - Non-Serious AE's	5	Not reported	Not reported	Not reported	Not reported
Arm 2, Cohort 2, Dose Level 2, Dose Expansion Lenalidomide - Serious AE's	0	Not reported	Not reported	Not reported	Not reported
Arm 2, Cohort 2, Dose Level 2, Dose Expansion Lenalidomide - Non-Serious AE's	0	Not reported	Not reported	Not reported	Not reported
Arm 2, Cohort 2, Dose Level 4, Dose Expansion Lenalidomide - Serious AE's	0	Not reported	Not reported	Not reported	Not reported
Arm 2, Cohort 2, Dose Level 4, Dose Expansion Lenalidomide - Non-Serious AE's	0	Not reported	Not reported	Not reported	Not reported
Arm 3, Cohort 2, Dose Level 4, Dose Expansion Lenalidomide - Serious AE's	0	Not reported	Not reported	Not reported	Not reported
Arm 3, Cohort 2, Dose Level 4, Dose Expansion Lenalidomide - Non-Serious AE's	0	Not reported	Not reported	Not reported	Not reported

Grade 2 Nausea

Values in adverse events · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Arm 1, Cohort 1, Dose Level -1, Dose Escalation Lenalidomide - Serious AE's	0	Not reported	Not reported	Not reported	Not reported
Arm 1, Cohort 1, Dose Level -1, Dose Escalation Lenalidomide - Non-Serious AE's	0	Not reported	Not reported	Not reported	Not reported
Arm 1, Cohort 1, Dose Level 1, Dose Expansion Lenalidomide - Serious AE's	0	Not reported	Not reported	Not reported	Not reported
Arm 1, Cohort 1, Dose Level 1, Dose Expansion Lenalidomide - Non-Serious AE's	2	Not reported	Not reported	Not reported	Not reported
Arm 1, Cohort 1, Dose Level 2, Dose Escalation Lenalidomide - Serious AE's	1	Not reported	Not reported	Not reported	Not reported
Arm 1, Cohort 1, Dose Level 2, Dose Escalation Lenalidomide - Non-Serious AE's	1	Not reported	Not reported	Not reported	Not reported
Arm 1, Cohort 1, Dose Level 3 Dose Escalation - Serious AE's	0	Not reported	Not reported	Not reported	Not reported
Arm 1, Cohort 1, Dose Level 3 Dose Escalation - Non-Serious AE's	6	Not reported	Not reported	Not reported	Not reported
Arm 1, Cohort 1, Dose Level 4, Dose Escalation Lenalidomide - Serious AE's	0	Not reported	Not reported	Not reported	Not reported
Arm 1, Cohort 1, Dose Level 4, Dose Escalation Lenalidomide - Non-Serious AE's	3	Not reported	Not reported	Not reported	Not reported
Arm 2, Cohort 2, Dose Level 2, Dose Expansion Lenalidomide - Serious AE's	0	Not reported	Not reported	Not reported	Not reported
Arm 2, Cohort 2, Dose Level 2, Dose Expansion Lenalidomide - Non-Serious AE's	0	Not reported	Not reported	Not reported	Not reported
Arm 2, Cohort 2, Dose Level 4, Dose Expansion Lenalidomide - Serious AE's	0	Not reported	Not reported	Not reported	Not reported
Arm 2, Cohort 2, Dose Level 4, Dose Expansion Lenalidomide - Non-Serious AE's	0	Not reported	Not reported	Not reported	Not reported
Arm 3, Cohort 2, Dose Level 4, Dose Expansion Lenalidomide - Serious AE's	0	Not reported	Not reported	Not reported	Not reported
Arm 3, Cohort 2, Dose Level 4, Dose Expansion Lenalidomide - Non-Serious AE's	0	Not reported	Not reported	Not reported	Not reported

Grade 2 Vomiting

Values in adverse events · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Arm 1, Cohort 1, Dose Level -1, Dose Escalation Lenalidomide - Serious AE's	0	Not reported	Not reported	Not reported	Not reported
Arm 1, Cohort 1, Dose Level -1, Dose Escalation Lenalidomide - Non-Serious AE's	0	Not reported	Not reported	Not reported	Not reported
Arm 1, Cohort 1, Dose Level 1, Dose Expansion Lenalidomide - Serious AE's	0	Not reported	Not reported	Not reported	Not reported
Arm 1, Cohort 1, Dose Level 1, Dose Expansion Lenalidomide - Non-Serious AE's	3	Not reported	Not reported	Not reported	Not reported
Arm 1, Cohort 1, Dose Level 2, Dose Escalation Lenalidomide - Serious AE's	1	Not reported	Not reported	Not reported	Not reported
Arm 1, Cohort 1, Dose Level 2, Dose Escalation Lenalidomide - Non-Serious AE's	0	Not reported	Not reported	Not reported	Not reported
Arm 1, Cohort 1, Dose Level 3 Dose Escalation - Serious AE's	0	Not reported	Not reported	Not reported	Not reported
Arm 1, Cohort 1, Dose Level 3 Dose Escalation - Non-Serious AE's	5	Not reported	Not reported	Not reported	Not reported
Arm 1, Cohort 1, Dose Level 4, Dose Escalation Lenalidomide - Serious AE's	0	Not reported	Not reported	Not reported	Not reported
Arm 1, Cohort 1, Dose Level 4, Dose Escalation Lenalidomide - Non-Serious AE's	0	Not reported	Not reported	Not reported	Not reported
Arm 2, Cohort 2, Dose Level 2, Dose Expansion Lenalidomide - Serious AE's	0	Not reported	Not reported	Not reported	Not reported
Arm 2, Cohort 2, Dose Level 2, Dose Expansion Lenalidomide - Non-Serious AE's	0	Not reported	Not reported	Not reported	Not reported
Arm 2, Cohort 2, Dose Level 4, Dose Expansion Lenalidomide - Serious AE's	0	Not reported	Not reported	Not reported	Not reported
Arm 2, Cohort 2, Dose Level 4, Dose Expansion Lenalidomide - Non-Serious AE's	0	Not reported	Not reported	Not reported	Not reported
Arm 3, Cohort 2, Dose Level 4, Dose Expansion Lenalidomide - Serious AE's	0	Not reported	Not reported	Not reported	Not reported
Arm 3, Cohort 2, Dose Level 4, Dose Expansion Lenalidomide - Non-Serious AE's	0	Not reported	Not reported	Not reported	Not reported

Grade 2 Neoplasms benign, malignant&unspecified(incl cysts&polyps)Other specify tumor flare reaction

Values in adverse events · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Arm 1, Cohort 1, Dose Level -1, Dose Escalation Lenalidomide - Serious AE's	0	Not reported	Not reported	Not reported	Not reported
Arm 1, Cohort 1, Dose Level -1, Dose Escalation Lenalidomide - Non-Serious AE's	0	Not reported	Not reported	Not reported	Not reported
Arm 1, Cohort 1, Dose Level 1, Dose Expansion Lenalidomide - Serious AE's	0	Not reported	Not reported	Not reported	Not reported
Arm 1, Cohort 1, Dose Level 1, Dose Expansion Lenalidomide - Non-Serious AE's	0	Not reported	Not reported	Not reported	Not reported
Arm 1, Cohort 1, Dose Level 2, Dose Escalation Lenalidomide - Serious AE's	0	Not reported	Not reported	Not reported	Not reported
Arm 1, Cohort 1, Dose Level 2, Dose Escalation Lenalidomide - Non-Serious AE's	0	Not reported	Not reported	Not reported	Not reported
Arm 1, Cohort 1, Dose Level 3 Dose Escalation - Serious AE's	1	Not reported	Not reported	Not reported	Not reported
Arm 1, Cohort 1, Dose Level 3 Dose Escalation - Non-Serious AE's	0	Not reported	Not reported	Not reported	Not reported
Arm 1, Cohort 1, Dose Level 4, Dose Escalation Lenalidomide - Serious AE's	0	Not reported	Not reported	Not reported	Not reported
Arm 1, Cohort 1, Dose Level 4, Dose Escalation Lenalidomide - Non-Serious AE's	0	Not reported	Not reported	Not reported	Not reported
Arm 2, Cohort 2, Dose Level 2, Dose Expansion Lenalidomide - Serious AE's	0	Not reported	Not reported	Not reported	Not reported
Arm 2, Cohort 2, Dose Level 2, Dose Expansion Lenalidomide - Non-Serious AE's	0	Not reported	Not reported	Not reported	Not reported
Arm 2, Cohort 2, Dose Level 4, Dose Expansion Lenalidomide - Serious AE's	0	Not reported	Not reported	Not reported	Not reported
Arm 2, Cohort 2, Dose Level 4, Dose Expansion Lenalidomide - Non-Serious AE's	0	Not reported	Not reported	Not reported	Not reported
Arm 3, Cohort 2, Dose Level 4, Dose Expansion Lenalidomide - Serious AE's	0	Not reported	Not reported	Not reported	Not reported
Arm 3, Cohort 2, Dose Level 4, Dose Expansion Lenalidomide - Non-Serious AE's	0	Not reported	Not reported	Not reported	Not reported

Grade 2 Pain in extremity

Values in adverse events · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Arm 1, Cohort 1, Dose Level -1, Dose Escalation Lenalidomide - Serious AE's	0	Not reported	Not reported	Not reported	Not reported
Arm 1, Cohort 1, Dose Level -1, Dose Escalation Lenalidomide - Non-Serious AE's	0	Not reported	Not reported	Not reported	Not reported
Arm 1, Cohort 1, Dose Level 1, Dose Expansion Lenalidomide - Serious AE's	0	Not reported	Not reported	Not reported	Not reported
Arm 1, Cohort 1, Dose Level 1, Dose Expansion Lenalidomide - Non-Serious AE's	1	Not reported	Not reported	Not reported	Not reported
Arm 1, Cohort 1, Dose Level 2, Dose Escalation Lenalidomide - Serious AE's	0	Not reported	Not reported	Not reported	Not reported
Arm 1, Cohort 1, Dose Level 2, Dose Escalation Lenalidomide - Non-Serious AE's	0	Not reported	Not reported	Not reported	Not reported
Arm 1, Cohort 1, Dose Level 3 Dose Escalation - Serious AE's	1	Not reported	Not reported	Not reported	Not reported
Arm 1, Cohort 1, Dose Level 3 Dose Escalation - Non-Serious AE's	0	Not reported	Not reported	Not reported	Not reported
Arm 1, Cohort 1, Dose Level 4, Dose Escalation Lenalidomide - Serious AE's	0	Not reported	Not reported	Not reported	Not reported
Arm 1, Cohort 1, Dose Level 4, Dose Escalation Lenalidomide - Non-Serious AE's	0	Not reported	Not reported	Not reported	Not reported
Arm 2, Cohort 2, Dose Level 2, Dose Expansion Lenalidomide - Serious AE's	0	Not reported	Not reported	Not reported	Not reported
Arm 2, Cohort 2, Dose Level 2, Dose Expansion Lenalidomide - Non-Serious AE's	0	Not reported	Not reported	Not reported	Not reported
Arm 2, Cohort 2, Dose Level 4, Dose Expansion Lenalidomide - Serious AE's	0	Not reported	Not reported	Not reported	Not reported
Arm 2, Cohort 2, Dose Level 4, Dose Expansion Lenalidomide - Non-Serious AE's	0	Not reported	Not reported	Not reported	Not reported
Arm 3, Cohort 2, Dose Level 4, Dose Expansion Lenalidomide - Serious AE's	0	Not reported	Not reported	Not reported	Not reported
Arm 3, Cohort 2, Dose Level 4, Dose Expansion Lenalidomide - Non-Serious AE's	0	Not reported	Not reported	Not reported	Not reported

Grade 3 Anemia

Values in adverse events · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Arm 1, Cohort 1, Dose Level -1, Dose Escalation Lenalidomide - Serious AE's	0	Not reported	Not reported	Not reported	Not reported
Arm 1, Cohort 1, Dose Level -1, Dose Escalation Lenalidomide - Non-Serious AE's	0	Not reported	Not reported	Not reported	Not reported
Arm 1, Cohort 1, Dose Level 1, Dose Expansion Lenalidomide - Serious AE's	1	Not reported	Not reported	Not reported	Not reported
Arm 1, Cohort 1, Dose Level 1, Dose Expansion Lenalidomide - Non-Serious AE's	4	Not reported	Not reported	Not reported	Not reported
Arm 1, Cohort 1, Dose Level 2, Dose Escalation Lenalidomide - Serious AE's	0	Not reported	Not reported	Not reported	Not reported
Arm 1, Cohort 1, Dose Level 2, Dose Escalation Lenalidomide - Non-Serious AE's	0	Not reported	Not reported	Not reported	Not reported
Arm 1, Cohort 1, Dose Level 3 Dose Escalation - Serious AE's	0	Not reported	Not reported	Not reported	Not reported
Arm 1, Cohort 1, Dose Level 3 Dose Escalation - Non-Serious AE's	7	Not reported	Not reported	Not reported	Not reported
Arm 1, Cohort 1, Dose Level 4, Dose Escalation Lenalidomide - Serious AE's	0	Not reported	Not reported	Not reported	Not reported
Arm 1, Cohort 1, Dose Level 4, Dose Escalation Lenalidomide - Non-Serious AE's	6	Not reported	Not reported	Not reported	Not reported
Arm 2, Cohort 2, Dose Level 2, Dose Expansion Lenalidomide - Serious AE's	0	Not reported	Not reported	Not reported	Not reported
Arm 2, Cohort 2, Dose Level 2, Dose Expansion Lenalidomide - Non-Serious AE's	3	Not reported	Not reported	Not reported	Not reported
Arm 2, Cohort 2, Dose Level 4, Dose Expansion Lenalidomide - Serious AE's	0	Not reported	Not reported	Not reported	Not reported
Arm 2, Cohort 2, Dose Level 4, Dose Expansion Lenalidomide - Non-Serious AE's	0	Not reported	Not reported	Not reported	Not reported
Arm 3, Cohort 2, Dose Level 4, Dose Expansion Lenalidomide - Serious AE's	0	Not reported	Not reported	Not reported	Not reported
Arm 3, Cohort 2, Dose Level 4, Dose Expansion Lenalidomide - Non-Serious AE's	0	Not reported	Not reported	Not reported	Not reported

Grade 3 Anorexia

Values in adverse events · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Arm 1, Cohort 1, Dose Level -1, Dose Escalation Lenalidomide - Serious AE's	0	Not reported	Not reported	Not reported	Not reported
Arm 1, Cohort 1, Dose Level -1, Dose Escalation Lenalidomide - Non-Serious AE's	0	Not reported	Not reported	Not reported	Not reported
Arm 1, Cohort 1, Dose Level 1, Dose Expansion Lenalidomide - Serious AE's	1	Not reported	Not reported	Not reported	Not reported
Arm 1, Cohort 1, Dose Level 1, Dose Expansion Lenalidomide - Non-Serious AE's	0	Not reported	Not reported	Not reported	Not reported
Arm 1, Cohort 1, Dose Level 2, Dose Escalation Lenalidomide - Serious AE's	0	Not reported	Not reported	Not reported	Not reported
Arm 1, Cohort 1, Dose Level 2, Dose Escalation Lenalidomide - Non-Serious AE's	0	Not reported	Not reported	Not reported	Not reported
Arm 1, Cohort 1, Dose Level 3 Dose Escalation - Serious AE's	0	Not reported	Not reported	Not reported	Not reported
Arm 1, Cohort 1, Dose Level 3 Dose Escalation - Non-Serious AE's	0	Not reported	Not reported	Not reported	Not reported
Arm 1, Cohort 1, Dose Level 4, Dose Escalation Lenalidomide - Serious AE's	0	Not reported	Not reported	Not reported	Not reported
Arm 1, Cohort 1, Dose Level 4, Dose Escalation Lenalidomide - Non-Serious AE's	1	Not reported	Not reported	Not reported	Not reported
Arm 2, Cohort 2, Dose Level 2, Dose Expansion Lenalidomide - Serious AE's	0	Not reported	Not reported	Not reported	Not reported
Arm 2, Cohort 2, Dose Level 2, Dose Expansion Lenalidomide - Non-Serious AE's	0	Not reported	Not reported	Not reported	Not reported
Arm 2, Cohort 2, Dose Level 4, Dose Expansion Lenalidomide - Serious AE's	0	Not reported	Not reported	Not reported	Not reported
Arm 2, Cohort 2, Dose Level 4, Dose Expansion Lenalidomide - Non-Serious AE's	0	Not reported	Not reported	Not reported	Not reported
Arm 3, Cohort 2, Dose Level 4, Dose Expansion Lenalidomide - Serious AE's	0	Not reported	Not reported	Not reported	Not reported
Arm 3, Cohort 2, Dose Level 4, Dose Expansion Lenalidomide - Non-Serious AE's	0	Not reported	Not reported	Not reported	Not reported

Grade 3 Atrial fibrillation

Values in adverse events · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Arm 1, Cohort 1, Dose Level -1, Dose Escalation Lenalidomide - Serious AE's	0	Not reported	Not reported	Not reported	Not reported
Arm 1, Cohort 1, Dose Level -1, Dose Escalation Lenalidomide - Non-Serious AE's	0	Not reported	Not reported	Not reported	Not reported
Arm 1, Cohort 1, Dose Level 1, Dose Expansion Lenalidomide - Serious AE's	1	Not reported	Not reported	Not reported	Not reported
Arm 1, Cohort 1, Dose Level 1, Dose Expansion Lenalidomide - Non-Serious AE's	0	Not reported	Not reported	Not reported	Not reported
Arm 1, Cohort 1, Dose Level 2, Dose Escalation Lenalidomide - Serious AE's	0	Not reported	Not reported	Not reported	Not reported
Arm 1, Cohort 1, Dose Level 2, Dose Escalation Lenalidomide - Non-Serious AE's	0	Not reported	Not reported	Not reported	Not reported
Arm 1, Cohort 1, Dose Level 3 Dose Escalation - Serious AE's	0	Not reported	Not reported	Not reported	Not reported
Arm 1, Cohort 1, Dose Level 3 Dose Escalation - Non-Serious AE's	0	Not reported	Not reported	Not reported	Not reported
Arm 1, Cohort 1, Dose Level 4, Dose Escalation Lenalidomide - Serious AE's	0	Not reported	Not reported	Not reported	Not reported
Arm 1, Cohort 1, Dose Level 4, Dose Escalation Lenalidomide - Non-Serious AE's	0	Not reported	Not reported	Not reported	Not reported
Arm 2, Cohort 2, Dose Level 2, Dose Expansion Lenalidomide - Serious AE's	0	Not reported	Not reported	Not reported	Not reported
Arm 2, Cohort 2, Dose Level 2, Dose Expansion Lenalidomide - Non-Serious AE's	0	Not reported	Not reported	Not reported	Not reported
Arm 2, Cohort 2, Dose Level 4, Dose Expansion Lenalidomide - Serious AE's	0	Not reported	Not reported	Not reported	Not reported
Arm 2, Cohort 2, Dose Level 4, Dose Expansion Lenalidomide - Non-Serious AE's	0	Not reported	Not reported	Not reported	Not reported
Arm 3, Cohort 2, Dose Level 4, Dose Expansion Lenalidomide - Serious AE's	0	Not reported	Not reported	Not reported	Not reported
Arm 3, Cohort 2, Dose Level 4, Dose Expansion Lenalidomide - Non-Serious AE's	0	Not reported	Not reported	Not reported	Not reported

Grade 3 Adrenal insufficiency

Values in adverse events · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Arm 1, Cohort 1, Dose Level -1, Dose Escalation Lenalidomide - Serious AE's	0	Not reported	Not reported	Not reported	Not reported
Arm 1, Cohort 1, Dose Level -1, Dose Escalation Lenalidomide - Non-Serious AE's	0	Not reported	Not reported	Not reported	Not reported
Arm 1, Cohort 1, Dose Level 1, Dose Expansion Lenalidomide - Serious AE's	0	Not reported	Not reported	Not reported	Not reported
Arm 1, Cohort 1, Dose Level 1, Dose Expansion Lenalidomide - Non-Serious AE's	0	Not reported	Not reported	Not reported	Not reported
Arm 1, Cohort 1, Dose Level 2, Dose Escalation Lenalidomide - Serious AE's	0	Not reported	Not reported	Not reported	Not reported
Arm 1, Cohort 1, Dose Level 2, Dose Escalation Lenalidomide - Non-Serious AE's	0	Not reported	Not reported	Not reported	Not reported
Arm 1, Cohort 1, Dose Level 3 Dose Escalation - Serious AE's	1	Not reported	Not reported	Not reported	Not reported
Arm 1, Cohort 1, Dose Level 3 Dose Escalation - Non-Serious AE's	1	Not reported	Not reported	Not reported	Not reported
Arm 1, Cohort 1, Dose Level 4, Dose Escalation Lenalidomide - Serious AE's	0	Not reported	Not reported	Not reported	Not reported
Arm 1, Cohort 1, Dose Level 4, Dose Escalation Lenalidomide - Non-Serious AE's	0	Not reported	Not reported	Not reported	Not reported
Arm 2, Cohort 2, Dose Level 2, Dose Expansion Lenalidomide - Serious AE's	0	Not reported	Not reported	Not reported	Not reported
Arm 2, Cohort 2, Dose Level 2, Dose Expansion Lenalidomide - Non-Serious AE's	0	Not reported	Not reported	Not reported	Not reported
Arm 2, Cohort 2, Dose Level 4, Dose Expansion Lenalidomide - Serious AE's	0	Not reported	Not reported	Not reported	Not reported
Arm 2, Cohort 2, Dose Level 4, Dose Expansion Lenalidomide - Non-Serious AE's	0	Not reported	Not reported	Not reported	Not reported
Arm 3, Cohort 2, Dose Level 4, Dose Expansion Lenalidomide - Serious AE's	0	Not reported	Not reported	Not reported	Not reported
Arm 3, Cohort 2, Dose Level 4, Dose Expansion Lenalidomide - Non-Serious AE's	0	Not reported	Not reported	Not reported	Not reported

Grade 3 Blood bilirubin increased

Values in adverse events · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Arm 1, Cohort 1, Dose Level -1, Dose Escalation Lenalidomide - Serious AE's	0	Not reported	Not reported	Not reported	Not reported
Arm 1, Cohort 1, Dose Level -1, Dose Escalation Lenalidomide - Non-Serious AE's	0	Not reported	Not reported	Not reported	Not reported
Arm 1, Cohort 1, Dose Level 1, Dose Expansion Lenalidomide - Serious AE's	0	Not reported	Not reported	Not reported	Not reported
Arm 1, Cohort 1, Dose Level 1, Dose Expansion Lenalidomide - Non-Serious AE's	0	Not reported	Not reported	Not reported	Not reported
Arm 1, Cohort 1, Dose Level 2, Dose Escalation Lenalidomide - Serious AE's	0	Not reported	Not reported	Not reported	Not reported
Arm 1, Cohort 1, Dose Level 2, Dose Escalation Lenalidomide - Non-Serious AE's	0	Not reported	Not reported	Not reported	Not reported
Arm 1, Cohort 1, Dose Level 3 Dose Escalation - Serious AE's	2	Not reported	Not reported	Not reported	Not reported
Arm 1, Cohort 1, Dose Level 3 Dose Escalation - Non-Serious AE's	1	Not reported	Not reported	Not reported	Not reported
Arm 1, Cohort 1, Dose Level 4, Dose Escalation Lenalidomide - Serious AE's	0	Not reported	Not reported	Not reported	Not reported
Arm 1, Cohort 1, Dose Level 4, Dose Escalation Lenalidomide - Non-Serious AE's	0	Not reported	Not reported	Not reported	Not reported
Arm 2, Cohort 2, Dose Level 2, Dose Expansion Lenalidomide - Serious AE's	0	Not reported	Not reported	Not reported	Not reported
Arm 2, Cohort 2, Dose Level 2, Dose Expansion Lenalidomide - Non-Serious AE's	0	Not reported	Not reported	Not reported	Not reported
Arm 2, Cohort 2, Dose Level 4, Dose Expansion Lenalidomide - Serious AE's	0	Not reported	Not reported	Not reported	Not reported
Arm 2, Cohort 2, Dose Level 4, Dose Expansion Lenalidomide - Non-Serious AE's	0	Not reported	Not reported	Not reported	Not reported
Arm 3, Cohort 2, Dose Level 4, Dose Expansion Lenalidomide - Serious AE's	0	Not reported	Not reported	Not reported	Not reported
Arm 3, Cohort 2, Dose Level 4, Dose Expansion Lenalidomide - Non-Serious AE's	0	Not reported	Not reported	Not reported	Not reported

Grade 3 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 -1, Dose Escalation Lenalidomide - Serious AE's	0	Not reported	Not reported	Not reported	Not reported
Arm 1, Cohort 1, Dose Level -1, Dose Escalation Lenalidomide - Non-Serious AE's	0	Not reported	Not reported	Not reported	Not reported
Arm 1, Cohort 1, Dose Level 1, Dose Expansion Lenalidomide - Serious AE's	0	Not reported	Not reported	Not reported	Not reported
Arm 1, Cohort 1, Dose Level 1, Dose Expansion Lenalidomide - Non-Serious AE's	0	Not reported	Not reported	Not reported	Not reported
Arm 1, Cohort 1, Dose Level 2, Dose Escalation Lenalidomide - Serious AE's	0	Not reported	Not reported	Not reported	Not reported
Arm 1, Cohort 1, Dose Level 2, Dose Escalation Lenalidomide - Non-Serious AE's	0	Not reported	Not reported	Not reported	Not reported
Arm 1, Cohort 1, Dose Level 3 Dose Escalation - Serious AE's	1	Not reported	Not reported	Not reported	Not reported
Arm 1, Cohort 1, Dose Level 3 Dose Escalation - Non-Serious AE's	0	Not reported	Not reported	Not reported	Not reported
Arm 1, Cohort 1, Dose Level 4, Dose Escalation Lenalidomide - Serious AE's	0	Not reported	Not reported	Not reported	Not reported
Arm 1, Cohort 1, Dose Level 4, Dose Escalation Lenalidomide - Non-Serious AE's	0	Not reported	Not reported	Not reported	Not reported
Arm 2, Cohort 2, Dose Level 2, Dose Expansion Lenalidomide - Serious AE's	0	Not reported	Not reported	Not reported	Not reported
Arm 2, Cohort 2, Dose Level 2, Dose Expansion Lenalidomide - Non-Serious AE's	0	Not reported	Not reported	Not reported	Not reported
Arm 2, Cohort 2, Dose Level 4, Dose Expansion Lenalidomide - Serious AE's	0	Not reported	Not reported	Not reported	Not reported
Arm 2, Cohort 2, Dose Level 4, Dose Expansion Lenalidomide - Non-Serious AE's	0	Not reported	Not reported	Not reported	Not reported
Arm 3, Cohort 2, Dose Level 4, Dose Expansion Lenalidomide - Serious AE's	0	Not reported	Not reported	Not reported	Not reported
Arm 3, Cohort 2, Dose Level 4, Dose Expansion Lenalidomide - Non-Serious AE's	0	Not reported	Not reported	Not reported	Not reported

Grade 3 Rhabdomyolysis

Values in adverse events · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Arm 1, Cohort 1, Dose Level -1, Dose Escalation Lenalidomide - Serious AE's	0	Not reported	Not reported	Not reported	Not reported
Arm 1, Cohort 1, Dose Level -1, Dose Escalation Lenalidomide - Non-Serious AE's	0	Not reported	Not reported	Not reported	Not reported
Arm 1, Cohort 1, Dose Level 1, Dose Expansion Lenalidomide - Serious AE's	0	Not reported	Not reported	Not reported	Not reported
Arm 1, Cohort 1, Dose Level 1, Dose Expansion Lenalidomide - Non-Serious AE's	0	Not reported	Not reported	Not reported	Not reported
Arm 1, Cohort 1, Dose Level 2, Dose Escalation Lenalidomide - Serious AE's	0	Not reported	Not reported	Not reported	Not reported
Arm 1, Cohort 1, Dose Level 2, Dose Escalation Lenalidomide - Non-Serious AE's	0	Not reported	Not reported	Not reported	Not reported
Arm 1, Cohort 1, Dose Level 3 Dose Escalation - Serious AE's	2	Not reported	Not reported	Not reported	Not reported
Arm 1, Cohort 1, Dose Level 3 Dose Escalation - Non-Serious AE's	0	Not reported	Not reported	Not reported	Not reported
Arm 1, Cohort 1, Dose Level 4, Dose Escalation Lenalidomide - Serious AE's	0	Not reported	Not reported	Not reported	Not reported
Arm 1, Cohort 1, Dose Level 4, Dose Escalation Lenalidomide - Non-Serious AE's	0	Not reported	Not reported	Not reported	Not reported
Arm 2, Cohort 2, Dose Level 2, Dose Expansion Lenalidomide - Serious AE's	0	Not reported	Not reported	Not reported	Not reported
Arm 2, Cohort 2, Dose Level 2, Dose Expansion Lenalidomide - Non-Serious AE's	0	Not reported	Not reported	Not reported	Not reported
Arm 2, Cohort 2, Dose Level 4, Dose Expansion Lenalidomide - Serious AE's	0	Not reported	Not reported	Not reported	Not reported
Arm 2, Cohort 2, Dose Level 4, Dose Expansion Lenalidomide - Non-Serious AE's	0	Not reported	Not reported	Not reported	Not reported
Arm 3, Cohort 2, Dose Level 4, Dose Expansion Lenalidomide - Serious AE's	0	Not reported	Not reported	Not reported	Not reported
Arm 3, Cohort 2, Dose Level 4, Dose Expansion Lenalidomide - Non-Serious AE's	0	Not reported	Not reported	Not reported	Not reported

Grade 4 Adrenal insufficiency

Values in adverse events · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Arm 1, Cohort 1, Dose Level -1, Dose Escalation Lenalidomide - Serious AE's	0	Not reported	Not reported	Not reported	Not reported
Arm 1, Cohort 1, Dose Level -1, Dose Escalation Lenalidomide - Non-Serious AE's	0	Not reported	Not reported	Not reported	Not reported
Arm 1, Cohort 1, Dose Level 1, Dose Expansion Lenalidomide - Serious AE's	0	Not reported	Not reported	Not reported	Not reported
Arm 1, Cohort 1, Dose Level 1, Dose Expansion Lenalidomide - Non-Serious AE's	0	Not reported	Not reported	Not reported	Not reported
Arm 1, Cohort 1, Dose Level 2, Dose Escalation Lenalidomide - Serious AE's	0	Not reported	Not reported	Not reported	Not reported
Arm 1, Cohort 1, Dose Level 2, Dose Escalation Lenalidomide - Non-Serious AE's	0	Not reported	Not reported	Not reported	Not reported
Arm 1, Cohort 1, Dose Level 3 Dose Escalation - Serious AE's	1	Not reported	Not reported	Not reported	Not reported
Arm 1, Cohort 1, Dose Level 3 Dose Escalation - Non-Serious AE's	0	Not reported	Not reported	Not reported	Not reported
Arm 1, Cohort 1, Dose Level 4, Dose Escalation Lenalidomide - Serious AE's	0	Not reported	Not reported	Not reported	Not reported
Arm 1, Cohort 1, Dose Level 4, Dose Escalation Lenalidomide - Non-Serious AE's	0	Not reported	Not reported	Not reported	Not reported
Arm 2, Cohort 2, Dose Level 2, Dose Expansion Lenalidomide - Serious AE's	0	Not reported	Not reported	Not reported	Not reported
Arm 2, Cohort 2, Dose Level 2, Dose Expansion Lenalidomide - Non-Serious AE's	0	Not reported	Not reported	Not reported	Not reported
Arm 2, Cohort 2, Dose Level 4, Dose Expansion Lenalidomide - Serious AE's	0	Not reported	Not reported	Not reported	Not reported
Arm 2, Cohort 2, Dose Level 4, Dose Expansion Lenalidomide - Non-Serious AE's	0	Not reported	Not reported	Not reported	Not reported
Arm 3, Cohort 2, Dose Level 4, Dose Expansion Lenalidomide - Serious AE's	0	Not reported	Not reported	Not reported	Not reported
Arm 3, Cohort 2, Dose Level 4, Dose Expansion Lenalidomide - Non-Serious AE's	0	Not reported	Not reported	Not reported	Not reported

Complete source fields

classes

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
group Id
OG008
value
0
group Id
OG009
value
0
group Id
OG010
value
0
group Id
OG011
value
0
title
Grade 1 Heart failure
categories
measurements
group Id
OG000
value
0
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
group Id
OG008
value
0
group Id
OG009
value
0
group Id
OG010
value
0
group Id
OG011
value
0
title
Grade 1 Hypotension
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
1
group Id
OG005
value
3
group Id
OG006
value
0
group Id
OG007
value
4
group Id
OG008
value
0
group Id
OG009
value
5
group Id
OG010
value
0
group Id
OG011
value
0
title
Grade 2 Fatigue
categories
measurements
group Id
OG000
value
0
group Id
OG001
value
0
group Id
OG002
value
0
group Id
OG003
value
2
group Id
OG004
value
1
group Id
OG005
value
1
group Id
OG006
value
0
group Id
OG007
value
6
group Id
OG008
value
0
group Id
OG009
value
3
group Id
OG010
value
0
group Id
OG011
value
0
title
Grade 2 Nausea
categories
measurements
group Id
OG000
value
0
group Id
OG001
value
0
group Id
OG002
value
0
group Id
OG003
value
3
group Id
OG004
value
1
group Id
OG005
value
0
group Id
OG006
value
0
group Id
OG007
value
5
group Id
OG008
value
0
group Id
OG009
value
0
group Id
OG010
value
0
group Id
OG011
value
0
title
Grade 2 Vomiting
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
1
group Id
OG007
value
0
group Id
OG008
value
0
group Id
OG009
value
0
group Id
OG010
value
0
group Id
OG011
value
0
title
Grade 2 Neoplasms benign, malignant&unspecified(incl cysts&polyps)Other specify tumor flare reaction
categories
measurements
group Id
OG000
value
0
group Id
OG001
value
0
group Id
OG002
value
0
group Id
OG003
value
1
group Id
OG004
value
0
group Id
OG005
value
0
group Id
OG006
value
1
group Id
OG007
value
0
group Id
OG008
value
0
group Id
OG009
value
0
group Id
OG010
value
0
group Id
OG011
value
0
title
Grade 2 Pain in extremity
categories
measurements
group Id
OG000
value
0
group Id
OG001
value
0
group Id
OG002
value
1
group Id
OG003
value
4
group Id
OG004
value
0
group Id
OG005
value
0
group Id
OG006
value
0
group Id
OG007
value
7
group Id
OG008
value
0
group Id
OG009
value
6
group Id
OG010
value
0
group Id
OG011
value
3
title
Grade 3 Anemia
categories
measurements
group Id
OG000
value
0
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
group Id
OG008
value
0
group Id
OG009
value
1
group Id
OG010
value
0
group Id
OG011
value
0
title
Grade 3 Anorexia
categories
measurements
group Id
OG000
value
0
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
group Id
OG008
value
0
group Id
OG009
value
0
group Id
OG010
value
0
group Id
OG011
value
0
title
Grade 3 Atrial fibrillation
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
1
group Id
OG007
value
1
group Id
OG008
value
0
group Id
OG009
value
0
group Id
OG010
value
0
group Id
OG011
value
0
title
Grade 3 Adrenal insufficiency
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
2
group Id
OG007
value
1
group Id
OG008
value
0
group Id
OG009
value
0
group Id
OG010
value
0
group Id
OG011
value
0
title
Grade 3 Blood bilirubin increased

denoms

counts
group Id
OG000
value
2
group Id
OG001
value
2
group Id
OG002
value
6
group Id
OG003
value
6
group Id
OG004
value
6
group Id
OG005
value
6
group Id
OG006
value
3
group Id
OG007
value
3
group Id
OG008
value
3
group Id
OG009
value
3
group Id
OG010
value
2
group Id
OG011
value
2
units
Participants

description

groups

description
Arm 1, Cohort 1, Dose Level -1: Serious AE's
id
OG000
title
Arm 1, Cohort 1, Dose Level -1, Dose Escalation Lenalidomide - Serious AE's
description
Arm 1, Cohort 1, Dose Level -1: Non-Serious AE's
id
OG001
title
Arm 1, Cohort 1, Dose Level -1, Dose Escalation Lenalidomide - Non-Serious AE's
description
Arm 1, Cohort 1, Dose Level 1: Serious AE's
id
OG002
title
Arm 1, Cohort 1, Dose Level 1, Dose Expansion Lenalidomide - Serious AE's
description
Arm 1, Cohort 1, Dose Level 1: Non-Serious AE's
id
OG003
title
Arm 1, Cohort 1, Dose Level 1, Dose Expansion Lenalidomide - Non-Serious AE's
description
Arm 1, Cohort 1, Dose Level 2: Serious AE's
id
OG004
title
Arm 1, Cohort 1, Dose Level 2, Dose Escalation Lenalidomide - Serious AE's
description
Arm 1, Cohort 1, Dose Level 2: Non-Serious AE's
id
OG005
title
Arm 1, Cohort 1, Dose Level 2, Dose Escalation Lenalidomide - Non-Serious AE's
description
Arm 1, Cohort 1, Dose Level 3: Serious AE's
id
OG006
title
Arm 1, Cohort 1, Dose Level 3 Dose Escalation - Serious AE's
description
Arm 1, Cohort 1, Dose Level 3: Non-Serious AE's
id
OG007
title
Arm 1, Cohort 1, Dose Level 3 Dose Escalation - Non-Serious AE's
description
Arm 1, Cohort 1, Dose Level 4: Serious AE's
id
OG008
title
Arm 1, Cohort 1, Dose Level 4, Dose Escalation Lenalidomide - Serious AE's
description
Arm 1, Cohort 1, Dose Level 4: Non-Serious AE's
id
OG009
title
Arm 1, Cohort 1, Dose Level 4, Dose Escalation Lenalidomide - Non-Serious AE's
description
Arm 2, Cohort 2, Dose Level 2: Serious AE's
id
OG010
title
Arm 2, Cohort 2, Dose Level 2, Dose Expansion Lenalidomide - Serious AE's
description
Arm 2, Cohort 2, Dose Level 2: Non-Serious AE's
id
OG011
title
Arm 2, Cohort 2, Dose Level 2, Dose Expansion Lenalidomide - Non-Serious AE's

param Type

NUMBER

reporting Status

POSTED

time Frame

6 cycles (each cycle is 28 days)

title

Rate and Severity of Serious and/or Non-serious Adverse Events (AE's) by Grade and Type of Toxicity

type

PRIMARY

unit Of Measure

adverse events

Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f

Preserved source evidence · Not medical advice