NCT00064038 · OUTCOME

Toxicity

S0232 Dexamethasone With or Without Lenalidomide in Treating Patients With Previously Untreated Stage I, Stage II, or Stage III Multiple Myeloma · Source last updated 2015-03-25

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Measure: NUMBER
Unit: Participants
Interval / dispersion: Not reported
Time frame: From time of initiating study treatment until discontinuation of study treatment or of open-label REVLIMID + LOW DOSE DEX, whichever comes last, up to 5 years

What was measured

Compare the toxicity profile of these regimens, including thrombotic complications, in these patients, based on CTCAE v. 3.0.

Analysis population: All participants receiving at least one dose of induction therapy

Groups in this outcome

Lenalidomide and Dexamethasone

Patients receive induction therapy comprising oral dexamethasone (DM) on days 1-4, 9-12, and 17-20 and oral lenalidomide on days 1-28. Treatment repeats every 35 days for up to 3 courses in the absence of disease progression or unacceptable toxicity. Patients then receive maintenance therapy comprising oral DM on days 1-4 and 15-18 and oral lenalidomide on days 1-21. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Dexamethasone

Patients receive induction therapy comprising DM as in arm I induction and oral placebo on days 1-28. Treatment repeats as in arm I induction. Some patients may then receive maintenance therapy comprising oral DM as in arm I maintenance and oral placebo on days 1-21. Courses repeat as in arm I maintenance.

Crossover to Rev+Dex

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
Lenalidomide and Dexamethasone	96
Dexamethasone	94
Crossover to Rev+Dex	40

Reported measurements

ALT, SGPT (serum glutamic pyruvic transaminase)

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Lenalidomide and Dexamethasone	1	Not reported	Not reported	Not reported	Not reported
Dexamethasone	1	Not reported	Not reported	Not reported	Not reported
Crossover to Rev+Dex	0	Not reported	Not reported	Not reported	Not reported

AST, SGOT

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Lenalidomide and Dexamethasone	2	Not reported	Not reported	Not reported	Not reported
Dexamethasone	0	Not reported	Not reported	Not reported	Not reported
Crossover to Rev+Dex	0	Not reported	Not reported	Not reported	Not reported

Albumin, serum-low (hypoalbuminemia)

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Lenalidomide and Dexamethasone	1	Not reported	Not reported	Not reported	Not reported
Dexamethasone	0	Not reported	Not reported	Not reported	Not reported
Crossover to Rev+Dex	2	Not reported	Not reported	Not reported	Not reported

Anorexia

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Lenalidomide and Dexamethasone	2	Not reported	Not reported	Not reported	Not reported
Dexamethasone	1	Not reported	Not reported	Not reported	Not reported
Crossover to Rev+Dex	1	Not reported	Not reported	Not reported	Not reported

Apnea

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Lenalidomide and Dexamethasone	1	Not reported	Not reported	Not reported	Not reported
Dexamethasone	0	Not reported	Not reported	Not reported	Not reported
Crossover to Rev+Dex	0	Not reported	Not reported	Not reported	Not reported

Arthritis (non-septic)

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Lenalidomide and Dexamethasone	1	Not reported	Not reported	Not reported	Not reported
Dexamethasone	0	Not reported	Not reported	Not reported	Not reported
Crossover to Rev+Dex	0	Not reported	Not reported	Not reported	Not reported

Aspiration

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Lenalidomide and Dexamethasone	1	Not reported	Not reported	Not reported	Not reported
Dexamethasone	0	Not reported	Not reported	Not reported	Not reported
Crossover to Rev+Dex	0	Not reported	Not reported	Not reported	Not reported

Ataxia (incoordination)

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Lenalidomide and Dexamethasone	0	Not reported	Not reported	Not reported	Not reported
Dexamethasone	1	Not reported	Not reported	Not reported	Not reported
Crossover to Rev+Dex	0	Not reported	Not reported	Not reported	Not reported

Bilirubin (hyperbilirubinemia)

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Lenalidomide and Dexamethasone	0	Not reported	Not reported	Not reported	Not reported
Dexamethasone	0	Not reported	Not reported	Not reported	Not reported
Crossover to Rev+Dex	1	Not reported	Not reported	Not reported	Not reported

CNS cerebrovascular ischemia

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Lenalidomide and Dexamethasone	1	Not reported	Not reported	Not reported	Not reported
Dexamethasone	2	Not reported	Not reported	Not reported	Not reported
Crossover to Rev+Dex	2	Not reported	Not reported	Not reported	Not reported

Calcium, serum-high (hypercalcemia)

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Lenalidomide and Dexamethasone	0	Not reported	Not reported	Not reported	Not reported
Dexamethasone	1	Not reported	Not reported	Not reported	Not reported
Crossover to Rev+Dex	0	Not reported	Not reported	Not reported	Not reported

Calcium, serum-low (hypocalcemia)

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Lenalidomide and Dexamethasone	7	Not reported	Not reported	Not reported	Not reported
Dexamethasone	2	Not reported	Not reported	Not reported	Not reported
Crossover to Rev+Dex	3	Not reported	Not reported	Not reported	Not reported

Cardiopulmonary arrest, cause unknown (non-fatal)

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Lenalidomide and Dexamethasone	1	Not reported	Not reported	Not reported	Not reported
Dexamethasone	0	Not reported	Not reported	Not reported	Not reported
Crossover to Rev+Dex	0	Not reported	Not reported	Not reported	Not reported

Cataract

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Lenalidomide and Dexamethasone	1	Not reported	Not reported	Not reported	Not reported
Dexamethasone	1	Not reported	Not reported	Not reported	Not reported
Crossover to Rev+Dex	2	Not reported	Not reported	Not reported	Not reported

Cognitive disturbance

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Lenalidomide and Dexamethasone	1	Not reported	Not reported	Not reported	Not reported
Dexamethasone	1	Not reported	Not reported	Not reported	Not reported
Crossover to Rev+Dex	0	Not reported	Not reported	Not reported	Not reported

Colitis

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Lenalidomide and Dexamethasone	0	Not reported	Not reported	Not reported	Not reported
Dexamethasone	0	Not reported	Not reported	Not reported	Not reported
Crossover to Rev+Dex	1	Not reported	Not reported	Not reported	Not reported

Colitis, infectious (e.g., Clostridium difficile)

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Lenalidomide and Dexamethasone	0	Not reported	Not reported	Not reported	Not reported
Dexamethasone	0	Not reported	Not reported	Not reported	Not reported
Crossover to Rev+Dex	1	Not reported	Not reported	Not reported	Not reported

Confusion

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Lenalidomide and Dexamethasone	1	Not reported	Not reported	Not reported	Not reported
Dexamethasone	0	Not reported	Not reported	Not reported	Not reported
Crossover to Rev+Dex	0	Not reported	Not reported	Not reported	Not reported

Constipation

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Lenalidomide and Dexamethasone	0	Not reported	Not reported	Not reported	Not reported
Dexamethasone	2	Not reported	Not reported	Not reported	Not reported
Crossover to Rev+Dex	1	Not reported	Not reported	Not reported	Not reported

Creatinine

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Lenalidomide and Dexamethasone	0	Not reported	Not reported	Not reported	Not reported
Dexamethasone	0	Not reported	Not reported	Not reported	Not reported
Crossover to Rev+Dex	1	Not reported	Not reported	Not reported	Not reported

Cystitis

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Lenalidomide and Dexamethasone	0	Not reported	Not reported	Not reported	Not reported
Dexamethasone	1	Not reported	Not reported	Not reported	Not reported
Crossover to Rev+Dex	0	Not reported	Not reported	Not reported	Not reported

Dehydration

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Lenalidomide and Dexamethasone	1	Not reported	Not reported	Not reported	Not reported
Dexamethasone	0	Not reported	Not reported	Not reported	Not reported
Crossover to Rev+Dex	3	Not reported	Not reported	Not reported	Not reported

Dermatology/Skin-Other (Specify)

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Lenalidomide and Dexamethasone	0	Not reported	Not reported	Not reported	Not reported
Dexamethasone	1	Not reported	Not reported	Not reported	Not reported
Crossover to Rev+Dex	0	Not reported	Not reported	Not reported	Not reported

Diarrhea

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Lenalidomide and Dexamethasone	5	Not reported	Not reported	Not reported	Not reported
Dexamethasone	1	Not reported	Not reported	Not reported	Not reported
Crossover to Rev+Dex	1	Not reported	Not reported	Not reported	Not reported

Dizziness

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Lenalidomide and Dexamethasone	1	Not reported	Not reported	Not reported	Not reported
Dexamethasone	1	Not reported	Not reported	Not reported	Not reported
Crossover to Rev+Dex	2	Not reported	Not reported	Not reported	Not reported

Dyspnea (shortness of breath)

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Lenalidomide and Dexamethasone	4	Not reported	Not reported	Not reported	Not reported
Dexamethasone	2	Not reported	Not reported	Not reported	Not reported
Crossover to Rev+Dex	0	Not reported	Not reported	Not reported	Not reported

Edema: limb

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Lenalidomide and Dexamethasone	0	Not reported	Not reported	Not reported	Not reported
Dexamethasone	1	Not reported	Not reported	Not reported	Not reported
Crossover to Rev+Dex	2	Not reported	Not reported	Not reported	Not reported

Encephalopathy

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Lenalidomide and Dexamethasone	0	Not reported	Not reported	Not reported	Not reported
Dexamethasone	0	Not reported	Not reported	Not reported	Not reported
Crossover to Rev+Dex	1	Not reported	Not reported	Not reported	Not reported

Fatigue (asthenia, lethargy, malaise)

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Lenalidomide and Dexamethasone	19	Not reported	Not reported	Not reported	Not reported
Dexamethasone	12	Not reported	Not reported	Not reported	Not reported
Crossover to Rev+Dex	8	Not reported	Not reported	Not reported	Not reported

Febrile neutropenia

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Lenalidomide and Dexamethasone	1	Not reported	Not reported	Not reported	Not reported
Dexamethasone	0	Not reported	Not reported	Not reported	Not reported
Crossover to Rev+Dex	1	Not reported	Not reported	Not reported	Not reported

Fever in absence of neutropenia, ANC lt1.0x10e9/L

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Lenalidomide and Dexamethasone	1	Not reported	Not reported	Not reported	Not reported
Dexamethasone	1	Not reported	Not reported	Not reported	Not reported
Crossover to Rev+Dex	0	Not reported	Not reported	Not reported	Not reported

Fracture

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Lenalidomide and Dexamethasone	0	Not reported	Not reported	Not reported	Not reported
Dexamethasone	1	Not reported	Not reported	Not reported	Not reported
Crossover to Rev+Dex	0	Not reported	Not reported	Not reported	Not reported

Gastritis (including bile reflux gastritis)

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Lenalidomide and Dexamethasone	0	Not reported	Not reported	Not reported	Not reported
Dexamethasone	0	Not reported	Not reported	Not reported	Not reported
Crossover to Rev+Dex	1	Not reported	Not reported	Not reported	Not reported

Gastrointestinal-Other (Specify)

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Lenalidomide and Dexamethasone	1	Not reported	Not reported	Not reported	Not reported
Dexamethasone	0	Not reported	Not reported	Not reported	Not reported
Crossover to Rev+Dex	0	Not reported	Not reported	Not reported	Not reported

Glomerular filtration rate

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Lenalidomide and Dexamethasone	0	Not reported	Not reported	Not reported	Not reported
Dexamethasone	0	Not reported	Not reported	Not reported	Not reported
Crossover to Rev+Dex	1	Not reported	Not reported	Not reported	Not reported

Glucose, serum-high (hyperglycemia)

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Lenalidomide and Dexamethasone	5	Not reported	Not reported	Not reported	Not reported
Dexamethasone	18	Not reported	Not reported	Not reported	Not reported
Crossover to Rev+Dex	2	Not reported	Not reported	Not reported	Not reported

Glucose, serum-low (hypoglycemia)

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Lenalidomide and Dexamethasone	1	Not reported	Not reported	Not reported	Not reported
Dexamethasone	0	Not reported	Not reported	Not reported	Not reported
Crossover to Rev+Dex	0	Not reported	Not reported	Not reported	Not reported

Heartburn/dyspepsia

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Lenalidomide and Dexamethasone	0	Not reported	Not reported	Not reported	Not reported
Dexamethasone	1	Not reported	Not reported	Not reported	Not reported
Crossover to Rev+Dex	0	Not reported	Not reported	Not reported	Not reported

Hemoglobin

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Lenalidomide and Dexamethasone	6	Not reported	Not reported	Not reported	Not reported
Dexamethasone	5	Not reported	Not reported	Not reported	Not reported
Crossover to Rev+Dex	6	Not reported	Not reported	Not reported	Not reported

Hemorrhage, CNS

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Lenalidomide and Dexamethasone	1	Not reported	Not reported	Not reported	Not reported
Dexamethasone	0	Not reported	Not reported	Not reported	Not reported
Crossover to Rev+Dex	0	Not reported	Not reported	Not reported	Not reported

Hemorrhage, GI - Colon

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Lenalidomide and Dexamethasone	1	Not reported	Not reported	Not reported	Not reported
Dexamethasone	0	Not reported	Not reported	Not reported	Not reported
Crossover to Rev+Dex	0	Not reported	Not reported	Not reported	Not reported

Hypertension

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Lenalidomide and Dexamethasone	0	Not reported	Not reported	Not reported	Not reported
Dexamethasone	3	Not reported	Not reported	Not reported	Not reported
Crossover to Rev+Dex	0	Not reported	Not reported	Not reported	Not reported

Hypotension

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Lenalidomide and Dexamethasone	3	Not reported	Not reported	Not reported	Not reported
Dexamethasone	0	Not reported	Not reported	Not reported	Not reported
Crossover to Rev+Dex	0	Not reported	Not reported	Not reported	Not reported

Hypoxia

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Lenalidomide and Dexamethasone	4	Not reported	Not reported	Not reported	Not reported
Dexamethasone	1	Not reported	Not reported	Not reported	Not reported
Crossover to Rev+Dex	1	Not reported	Not reported	Not reported	Not reported

INR (of prothrombin time)

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Lenalidomide and Dexamethasone	1	Not reported	Not reported	Not reported	Not reported
Dexamethasone	2	Not reported	Not reported	Not reported	Not reported
Crossover to Rev+Dex	0	Not reported	Not reported	Not reported	Not reported

Inf (clin/microbio) w/Gr 3-4 neuts - Blood

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Lenalidomide and Dexamethasone	1	Not reported	Not reported	Not reported	Not reported
Dexamethasone	0	Not reported	Not reported	Not reported	Not reported
Crossover to Rev+Dex	1	Not reported	Not reported	Not reported	Not reported

Inf (clin/microbio) w/Gr 3-4 neuts - Bronchus

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Lenalidomide and Dexamethasone	1	Not reported	Not reported	Not reported	Not reported
Dexamethasone	0	Not reported	Not reported	Not reported	Not reported
Crossover to Rev+Dex	0	Not reported	Not reported	Not reported	Not reported

Inf (clin/microbio) w/Gr 3-4 neuts - Lung

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Lenalidomide and Dexamethasone	5	Not reported	Not reported	Not reported	Not reported
Dexamethasone	0	Not reported	Not reported	Not reported	Not reported
Crossover to Rev+Dex	0	Not reported	Not reported	Not reported	Not reported

Inf (clin/microbio) w/Gr 3-4 neuts - Up aerodigest

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Lenalidomide and Dexamethasone	1	Not reported	Not reported	Not reported	Not reported
Dexamethasone	0	Not reported	Not reported	Not reported	Not reported
Crossover to Rev+Dex	0	Not reported	Not reported	Not reported	Not reported

Inf (clin/microbio) w/Gr 3-4 neuts - Upper airway

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Lenalidomide and Dexamethasone	1	Not reported	Not reported	Not reported	Not reported
Dexamethasone	2	Not reported	Not reported	Not reported	Not reported
Crossover to Rev+Dex	0	Not reported	Not reported	Not reported	Not reported

Inf w/normal ANC or Gr 1-2 neutrophils - Bladder

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Lenalidomide and Dexamethasone	2	Not reported	Not reported	Not reported	Not reported
Dexamethasone	0	Not reported	Not reported	Not reported	Not reported
Crossover to Rev+Dex	0	Not reported	Not reported	Not reported	Not reported

Inf w/normal ANC or Gr 1-2 neutrophils - Bronchus

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Lenalidomide and Dexamethasone	0	Not reported	Not reported	Not reported	Not reported
Dexamethasone	1	Not reported	Not reported	Not reported	Not reported
Crossover to Rev+Dex	0	Not reported	Not reported	Not reported	Not reported

Inf w/normal ANC or Gr 1-2 neutrophils - Colon

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Lenalidomide and Dexamethasone	1	Not reported	Not reported	Not reported	Not reported
Dexamethasone	1	Not reported	Not reported	Not reported	Not reported
Crossover to Rev+Dex	0	Not reported	Not reported	Not reported	Not reported

Inf w/normal ANC or Gr 1-2 neutrophils - Lung

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Lenalidomide and Dexamethasone	1	Not reported	Not reported	Not reported	Not reported
Dexamethasone	3	Not reported	Not reported	Not reported	Not reported
Crossover to Rev+Dex	0	Not reported	Not reported	Not reported	Not reported

Inf w/normal ANC or Gr 1-2 neutrophils - Skin

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Lenalidomide and Dexamethasone	2	Not reported	Not reported	Not reported	Not reported
Dexamethasone	1	Not reported	Not reported	Not reported	Not reported
Crossover to Rev+Dex	0	Not reported	Not reported	Not reported	Not reported

Inf w/normal ANC or Gr 1-2 neutrophils - UTI

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Lenalidomide and Dexamethasone	2	Not reported	Not reported	Not reported	Not reported
Dexamethasone	2	Not reported	Not reported	Not reported	Not reported
Crossover to Rev+Dex	0	Not reported	Not reported	Not reported	Not reported

Inf w/normal ANC or Gr 1-2 neutrophils - Up airway

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Lenalidomide and Dexamethasone	3	Not reported	Not reported	Not reported	Not reported
Dexamethasone	1	Not reported	Not reported	Not reported	Not reported
Crossover to Rev+Dex	0	Not reported	Not reported	Not reported	Not reported

Inf w/normal ANC or Gr 1-2 neutrophils - Wound

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Lenalidomide and Dexamethasone	1	Not reported	Not reported	Not reported	Not reported
Dexamethasone	0	Not reported	Not reported	Not reported	Not reported
Crossover to Rev+Dex	0	Not reported	Not reported	Not reported	Not reported

Inf w/normal ANC or Gr 1-2 neutrophils -Nerve-cran

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Lenalidomide and Dexamethasone	0	Not reported	Not reported	Not reported	Not reported
Dexamethasone	0	Not reported	Not reported	Not reported	Not reported
Crossover to Rev+Dex	1	Not reported	Not reported	Not reported	Not reported

Infection with unknown ANC - Lung (pneumonia)

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Lenalidomide and Dexamethasone	1	Not reported	Not reported	Not reported	Not reported
Dexamethasone	0	Not reported	Not reported	Not reported	Not reported
Crossover to Rev+Dex	0	Not reported	Not reported	Not reported	Not reported

Infection with unknown ANC - Upper airway NOS

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Lenalidomide and Dexamethasone	1	Not reported	Not reported	Not reported	Not reported
Dexamethasone	1	Not reported	Not reported	Not reported	Not reported
Crossover to Rev+Dex	0	Not reported	Not reported	Not reported	Not reported

Infection-Other (Specify)

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Lenalidomide and Dexamethasone	0	Not reported	Not reported	Not reported	Not reported
Dexamethasone	1	Not reported	Not reported	Not reported	Not reported
Crossover to Rev+Dex	0	Not reported	Not reported	Not reported	Not reported

Insomnia

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Lenalidomide and Dexamethasone	4	Not reported	Not reported	Not reported	Not reported
Dexamethasone	6	Not reported	Not reported	Not reported	Not reported
Crossover to Rev+Dex	0	Not reported	Not reported	Not reported	Not reported

Joint-function

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Lenalidomide and Dexamethasone	1	Not reported	Not reported	Not reported	Not reported
Dexamethasone	0	Not reported	Not reported	Not reported	Not reported
Crossover to Rev+Dex	0	Not reported	Not reported	Not reported	Not reported

Left ventricular diastolic dysfunction

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Lenalidomide and Dexamethasone	0	Not reported	Not reported	Not reported	Not reported
Dexamethasone	0	Not reported	Not reported	Not reported	Not reported
Crossover to Rev+Dex	1	Not reported	Not reported	Not reported	Not reported

Left ventricular systolic dysfunction

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Lenalidomide and Dexamethasone	1	Not reported	Not reported	Not reported	Not reported
Dexamethasone	0	Not reported	Not reported	Not reported	Not reported
Crossover to Rev+Dex	0	Not reported	Not reported	Not reported	Not reported

Leukocytes (total WBC)

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Lenalidomide and Dexamethasone	14	Not reported	Not reported	Not reported	Not reported
Dexamethasone	5	Not reported	Not reported	Not reported	Not reported
Crossover to Rev+Dex	4	Not reported	Not reported	Not reported	Not reported

Lymphopenia

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Lenalidomide and Dexamethasone	10	Not reported	Not reported	Not reported	Not reported
Dexamethasone	5	Not reported	Not reported	Not reported	Not reported
Crossover to Rev+Dex	8	Not reported	Not reported	Not reported	Not reported

Mood alteration - agitation

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Lenalidomide and Dexamethasone	1	Not reported	Not reported	Not reported	Not reported
Dexamethasone	1	Not reported	Not reported	Not reported	Not reported
Crossover to Rev+Dex	1	Not reported	Not reported	Not reported	Not reported

Mood alteration - anxiety

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Lenalidomide and Dexamethasone	1	Not reported	Not reported	Not reported	Not reported
Dexamethasone	1	Not reported	Not reported	Not reported	Not reported
Crossover to Rev+Dex	0	Not reported	Not reported	Not reported	Not reported

Mood alteration - depression

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Lenalidomide and Dexamethasone	11	Not reported	Not reported	Not reported	Not reported
Dexamethasone	8	Not reported	Not reported	Not reported	Not reported
Crossover to Rev+Dex	2	Not reported	Not reported	Not reported	Not reported

Mucositis/stomatitis (clinical exam) - Oral cavity

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Lenalidomide and Dexamethasone	0	Not reported	Not reported	Not reported	Not reported
Dexamethasone	1	Not reported	Not reported	Not reported	Not reported
Crossover to Rev+Dex	0	Not reported	Not reported	Not reported	Not reported

Muscle weakness, not d/t neuropathy - Extrem-lower

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Lenalidomide and Dexamethasone	1	Not reported	Not reported	Not reported	Not reported
Dexamethasone	3	Not reported	Not reported	Not reported	Not reported
Crossover to Rev+Dex	1	Not reported	Not reported	Not reported	Not reported

Muscle weakness, not d/t neuropathy - body/general

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Lenalidomide and Dexamethasone	9	Not reported	Not reported	Not reported	Not reported
Dexamethasone	4	Not reported	Not reported	Not reported	Not reported
Crossover to Rev+Dex	3	Not reported	Not reported	Not reported	Not reported

Musculoskeletal/Soft Tissue-Other (Specify)

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Lenalidomide and Dexamethasone	0	Not reported	Not reported	Not reported	Not reported
Dexamethasone	2	Not reported	Not reported	Not reported	Not reported
Crossover to Rev+Dex	0	Not reported	Not reported	Not reported	Not reported

Nausea

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Lenalidomide and Dexamethasone	2	Not reported	Not reported	Not reported	Not reported
Dexamethasone	1	Not reported	Not reported	Not reported	Not reported
Crossover to Rev+Dex	0	Not reported	Not reported	Not reported	Not reported

Neuropathy: motor

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Lenalidomide and Dexamethasone	0	Not reported	Not reported	Not reported	Not reported
Dexamethasone	1	Not reported	Not reported	Not reported	Not reported
Crossover to Rev+Dex	0	Not reported	Not reported	Not reported	Not reported

Neuropathy: sensory

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Lenalidomide and Dexamethasone	3	Not reported	Not reported	Not reported	Not reported
Dexamethasone	4	Not reported	Not reported	Not reported	Not reported
Crossover to Rev+Dex	0	Not reported	Not reported	Not reported	Not reported

Neutrophils/granulocytes (ANC/AGC)

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Lenalidomide and Dexamethasone	21	Not reported	Not reported	Not reported	Not reported
Dexamethasone	6	Not reported	Not reported	Not reported	Not reported
Crossover to Rev+Dex	7	Not reported	Not reported	Not reported	Not reported

Ocular/Visual-Other (Specify)

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Lenalidomide and Dexamethasone	1	Not reported	Not reported	Not reported	Not reported
Dexamethasone	0	Not reported	Not reported	Not reported	Not reported
Crossover to Rev+Dex	1	Not reported	Not reported	Not reported	Not reported

Ophthalmoplegia/diplopia (double vision)

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Lenalidomide and Dexamethasone	0	Not reported	Not reported	Not reported	Not reported
Dexamethasone	1	Not reported	Not reported	Not reported	Not reported
Crossover to Rev+Dex	0	Not reported	Not reported	Not reported	Not reported

Opportunistic inf associated w/gt=Gr 2 lymphopenia

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Lenalidomide and Dexamethasone	2	Not reported	Not reported	Not reported	Not reported
Dexamethasone	0	Not reported	Not reported	Not reported	Not reported
Crossover to Rev+Dex	1	Not reported	Not reported	Not reported	Not reported

PTT (Partial thromboplastin time)

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Lenalidomide and Dexamethasone	0	Not reported	Not reported	Not reported	Not reported
Dexamethasone	1	Not reported	Not reported	Not reported	Not reported
Crossover to Rev+Dex	0	Not reported	Not reported	Not reported	Not reported

Pain - Abdomen NOS

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Lenalidomide and Dexamethasone	0	Not reported	Not reported	Not reported	Not reported
Dexamethasone	2	Not reported	Not reported	Not reported	Not reported
Crossover to Rev+Dex	0	Not reported	Not reported	Not reported	Not reported

Pain - Back

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Lenalidomide and Dexamethasone	1	Not reported	Not reported	Not reported	Not reported
Dexamethasone	2	Not reported	Not reported	Not reported	Not reported
Crossover to Rev+Dex	1	Not reported	Not reported	Not reported	Not reported

Pain - Bladder

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Lenalidomide and Dexamethasone	0	Not reported	Not reported	Not reported	Not reported
Dexamethasone	0	Not reported	Not reported	Not reported	Not reported
Crossover to Rev+Dex	1	Not reported	Not reported	Not reported	Not reported

Pain - Bone

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Lenalidomide and Dexamethasone	1	Not reported	Not reported	Not reported	Not reported
Dexamethasone	3	Not reported	Not reported	Not reported	Not reported
Crossover to Rev+Dex	0	Not reported	Not reported	Not reported	Not reported

Pain - Extremity-limb

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Lenalidomide and Dexamethasone	1	Not reported	Not reported	Not reported	Not reported
Dexamethasone	0	Not reported	Not reported	Not reported	Not reported
Crossover to Rev+Dex	0	Not reported	Not reported	Not reported	Not reported

Pain - Head/headache

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Lenalidomide and Dexamethasone	0	Not reported	Not reported	Not reported	Not reported
Dexamethasone	1	Not reported	Not reported	Not reported	Not reported
Crossover to Rev+Dex	0	Not reported	Not reported	Not reported	Not reported

Pain - Joint

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Lenalidomide and Dexamethasone	3	Not reported	Not reported	Not reported	Not reported
Dexamethasone	1	Not reported	Not reported	Not reported	Not reported
Crossover to Rev+Dex	0	Not reported	Not reported	Not reported	Not reported

Pain - Muscle

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Lenalidomide and Dexamethasone	3	Not reported	Not reported	Not reported	Not reported
Dexamethasone	1	Not reported	Not reported	Not reported	Not reported
Crossover to Rev+Dex	1	Not reported	Not reported	Not reported	Not reported

Pain - Pain NOS

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Lenalidomide and Dexamethasone	1	Not reported	Not reported	Not reported	Not reported
Dexamethasone	0	Not reported	Not reported	Not reported	Not reported
Crossover to Rev+Dex	0	Not reported	Not reported	Not reported	Not reported

Pain - Stomach

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Lenalidomide and Dexamethasone	0	Not reported	Not reported	Not reported	Not reported
Dexamethasone	1	Not reported	Not reported	Not reported	Not reported
Crossover to Rev+Dex	0	Not reported	Not reported	Not reported	Not reported

Pain-Other (Specify)

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Lenalidomide and Dexamethasone	0	Not reported	Not reported	Not reported	Not reported
Dexamethasone	1	Not reported	Not reported	Not reported	Not reported
Crossover to Rev+Dex	1	Not reported	Not reported	Not reported	Not reported

Pancreatic endocrine: glucose intolerance

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Lenalidomide and Dexamethasone	0	Not reported	Not reported	Not reported	Not reported
Dexamethasone	1	Not reported	Not reported	Not reported	Not reported
Crossover to Rev+Dex	0	Not reported	Not reported	Not reported	Not reported

Perforation, GI - Colon

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Lenalidomide and Dexamethasone	1	Not reported	Not reported	Not reported	Not reported
Dexamethasone	0	Not reported	Not reported	Not reported	Not reported
Crossover to Rev+Dex	0	Not reported	Not reported	Not reported	Not reported

Perforation, GI - Small bowel NOS

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Lenalidomide and Dexamethasone	0	Not reported	Not reported	Not reported	Not reported
Dexamethasone	1	Not reported	Not reported	Not reported	Not reported
Crossover to Rev+Dex	0	Not reported	Not reported	Not reported	Not reported

Phosphate, serum-low (hypophosphatemia)

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Lenalidomide and Dexamethasone	5	Not reported	Not reported	Not reported	Not reported
Dexamethasone	4	Not reported	Not reported	Not reported	Not reported
Crossover to Rev+Dex	2	Not reported	Not reported	Not reported	Not reported

Platelets

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Lenalidomide and Dexamethasone	7	Not reported	Not reported	Not reported	Not reported
Dexamethasone	4	Not reported	Not reported	Not reported	Not reported
Crossover to Rev+Dex	3	Not reported	Not reported	Not reported	Not reported

Pneumonitis/pulmonary infiltrates

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Lenalidomide and Dexamethasone	3	Not reported	Not reported	Not reported	Not reported
Dexamethasone	2	Not reported	Not reported	Not reported	Not reported
Crossover to Rev+Dex	2	Not reported	Not reported	Not reported	Not reported

Potassium, serum-low (hypokalemia)

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Lenalidomide and Dexamethasone	6	Not reported	Not reported	Not reported	Not reported
Dexamethasone	2	Not reported	Not reported	Not reported	Not reported
Crossover to Rev+Dex	3	Not reported	Not reported	Not reported	Not reported

Prolonged QTc interval

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Lenalidomide and Dexamethasone	1	Not reported	Not reported	Not reported	Not reported
Dexamethasone	0	Not reported	Not reported	Not reported	Not reported
Crossover to Rev+Dex	0	Not reported	Not reported	Not reported	Not reported

Proteinuria

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Lenalidomide and Dexamethasone	1	Not reported	Not reported	Not reported	Not reported
Dexamethasone	0	Not reported	Not reported	Not reported	Not reported
Crossover to Rev+Dex	0	Not reported	Not reported	Not reported	Not reported

Pulmonary/Upper Respiratory-Other (Specify)

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Lenalidomide and Dexamethasone	1	Not reported	Not reported	Not reported	Not reported
Dexamethasone	0	Not reported	Not reported	Not reported	Not reported
Crossover to Rev+Dex	0	Not reported	Not reported	Not reported	Not reported

Rash/desquamation

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Lenalidomide and Dexamethasone	1	Not reported	Not reported	Not reported	Not reported
Dexamethasone	1	Not reported	Not reported	Not reported	Not reported
Crossover to Rev+Dex	1	Not reported	Not reported	Not reported	Not reported

Rash: acne/acneiform

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Lenalidomide and Dexamethasone	0	Not reported	Not reported	Not reported	Not reported
Dexamethasone	1	Not reported	Not reported	Not reported	Not reported
Crossover to Rev+Dex	1	Not reported	Not reported	Not reported	Not reported

Rash: erythema multiforme

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Lenalidomide and Dexamethasone	0	Not reported	Not reported	Not reported	Not reported
Dexamethasone	0	Not reported	Not reported	Not reported	Not reported
Crossover to Rev+Dex	1	Not reported	Not reported	Not reported	Not reported

Renal failure

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Lenalidomide and Dexamethasone	0	Not reported	Not reported	Not reported	Not reported
Dexamethasone	1	Not reported	Not reported	Not reported	Not reported
Crossover to Rev+Dex	2	Not reported	Not reported	Not reported	Not reported

SVT and nodal arrhythmia - Atrial fibrillation

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Lenalidomide and Dexamethasone	0	Not reported	Not reported	Not reported	Not reported
Dexamethasone	2	Not reported	Not reported	Not reported	Not reported
Crossover to Rev+Dex	0	Not reported	Not reported	Not reported	Not reported

Sodium, serum-high (hypernatremia)

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Lenalidomide and Dexamethasone	0	Not reported	Not reported	Not reported	Not reported
Dexamethasone	1	Not reported	Not reported	Not reported	Not reported
Crossover to Rev+Dex	0	Not reported	Not reported	Not reported	Not reported

Sodium, serum-low (hyponatremia)

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Lenalidomide and Dexamethasone	3	Not reported	Not reported	Not reported	Not reported
Dexamethasone	2	Not reported	Not reported	Not reported	Not reported
Crossover to Rev+Dex	3	Not reported	Not reported	Not reported	Not reported

Somnolence/depressed level of consciousness

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Lenalidomide and Dexamethasone	0	Not reported	Not reported	Not reported	Not reported
Dexamethasone	0	Not reported	Not reported	Not reported	Not reported
Crossover to Rev+Dex	1	Not reported	Not reported	Not reported	Not reported

Speech impairment (e.g., dysphasia or aphasia)

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Lenalidomide and Dexamethasone	0	Not reported	Not reported	Not reported	Not reported
Dexamethasone	0	Not reported	Not reported	Not reported	Not reported
Crossover to Rev+Dex	1	Not reported	Not reported	Not reported	Not reported

Syncope (fainting)

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Lenalidomide and Dexamethasone	1	Not reported	Not reported	Not reported	Not reported
Dexamethasone	0	Not reported	Not reported	Not reported	Not reported
Crossover to Rev+Dex	0	Not reported	Not reported	Not reported	Not reported

Thrombosis/embolism (vascular access-related)

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Lenalidomide and Dexamethasone	2	Not reported	Not reported	Not reported	Not reported
Dexamethasone	0	Not reported	Not reported	Not reported	Not reported
Crossover to Rev+Dex	0	Not reported	Not reported	Not reported	Not reported

Thrombosis/thrombus/embolism

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Lenalidomide and Dexamethasone	19	Not reported	Not reported	Not reported	Not reported
Dexamethasone	5	Not reported	Not reported	Not reported	Not reported
Crossover to Rev+Dex	5	Not reported	Not reported	Not reported	Not reported

Thrombotic microangiopathy

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Lenalidomide and Dexamethasone	1	Not reported	Not reported	Not reported	Not reported
Dexamethasone	0	Not reported	Not reported	Not reported	Not reported
Crossover to Rev+Dex	0	Not reported	Not reported	Not reported	Not reported

Thyroid function, low (hypothyroidism)

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Lenalidomide and Dexamethasone	1	Not reported	Not reported	Not reported	Not reported
Dexamethasone	0	Not reported	Not reported	Not reported	Not reported
Crossover to Rev+Dex	0	Not reported	Not reported	Not reported	Not reported

Tinnitus

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Lenalidomide and Dexamethasone	1	Not reported	Not reported	Not reported	Not reported
Dexamethasone	0	Not reported	Not reported	Not reported	Not reported
Crossover to Rev+Dex	0	Not reported	Not reported	Not reported	Not reported

Vision-blurred vision

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Lenalidomide and Dexamethasone	2	Not reported	Not reported	Not reported	Not reported
Dexamethasone	3	Not reported	Not reported	Not reported	Not reported
Crossover to Rev+Dex	1	Not reported	Not reported	Not reported	Not reported

Vomiting

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Lenalidomide and Dexamethasone	2	Not reported	Not reported	Not reported	Not reported
Dexamethasone	1	Not reported	Not reported	Not reported	Not reported
Crossover to Rev+Dex	0	Not reported	Not reported	Not reported	Not reported

Weight loss

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Lenalidomide and Dexamethasone	0	Not reported	Not reported	Not reported	Not reported
Dexamethasone	0	Not reported	Not reported	Not reported	Not reported
Crossover to Rev+Dex	1	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
0
title
ALT, SGPT (serum glutamic pyruvic transaminase)
categories
measurements
group Id
OG000
value
2
group Id
OG001
value
0
group Id
OG002
value
0
title
AST, SGOT
categories
measurements
group Id
OG000
value
1
group Id
OG001
value
0
group Id
OG002
value
2
title
Albumin, serum-low (hypoalbuminemia)
categories
measurements
group Id
OG000
value
2
group Id
OG001
value
1
group Id
OG002
value
1
title
Anorexia
categories
measurements
group Id
OG000
value
1
group Id
OG001
value
0
group Id
OG002
value
0
title
Apnea
categories
measurements
group Id
OG000
value
1
group Id
OG001
value
0
group Id
OG002
value
0
title
Arthritis (non-septic)
categories
measurements
group Id
OG000
value
1
group Id
OG001
value
0
group Id
OG002
value
0
title
Aspiration
categories
measurements
group Id
OG000
value
0
group Id
OG001
value
1
group Id
OG002
value
0
title
Ataxia (incoordination)
categories
measurements
group Id
OG000
value
0
group Id
OG001
value
0
group Id
OG002
value
1
title
Bilirubin (hyperbilirubinemia)
categories
measurements
group Id
OG000
value
1
group Id
OG001
value
2
group Id
OG002
value
2
title
CNS cerebrovascular ischemia
categories
measurements
group Id
OG000
value
0
group Id
OG001
value
1
group Id
OG002
value
0
title
Calcium, serum-high (hypercalcemia)
categories
measurements
group Id
OG000
value
7
group Id
OG001
value
2
group Id
OG002
value
3
title
Calcium, serum-low (hypocalcemia)

denoms

counts
group Id
OG000
value
96
group Id
OG001
value
94
group Id
OG002
value
40
units
Participants

description

Compare the toxicity profile of these regimens, including thrombotic complications, in these patients, based on CTCAE v. 3.0.

groups

description
Patients receive induction therapy comprising oral dexamethasone (DM) on days 1-4, 9-12, and 17-20 and oral lenalidomide on days 1-28. Treatment repeats every 35 days for up to 3 courses in the absence of disease progression or unacceptable toxicity. Patients then receive maintenance therapy comprising oral DM on days 1-4 and 15-18 and oral lenalidomide on days 1-21. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
id
OG000
title
Lenalidomide and Dexamethasone
description
Patients receive induction therapy comprising DM as in arm I induction and oral placebo on days 1-28. Treatment repeats as in arm I induction. Some patients may then receive maintenance therapy comprising oral DM as in arm I maintenance and oral placebo on days 1-21. Courses repeat as in arm I maintenance.
id
OG001
title
Dexamethasone
description
Patients receive induction therapy comprising oral dexamethasone (DM) on days 1-4, 9-12, and 17-20 and oral lenalidomide on days 1-28. Treatment repeats every 35 days for up to 3 courses in the absence of disease progression or unacceptable toxicity. Patients then receive maintenance therapy comprising oral DM on days 1-4 and 15-18 and oral lenalidomide on days 1-21. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
id
OG002
title
Crossover to Rev+Dex

param Type

NUMBER

population Description

All participants receiving at least one dose of induction therapy

reporting Status

POSTED

time Frame

From time of initiating study treatment until discontinuation of study treatment or of open-label REVLIMID + LOW DOSE DEX, whichever comes last, up to 5 years

title

Toxicity

type

SECONDARY

unit Of Measure

Participants

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

Preserved source evidence · Not medical advice