Trial Outcomes & Findings for Lenalidomide With or Without Epoetin Alfa in Treating Patients With Myelodysplastic Syndrome and Anemia (NCT NCT00843882)
NCT ID: NCT00843882
Last Updated: 2025-11-24
Results Overview
Major erythroid response is defined as transfusion-independence for ≥ 8 consecutive weeks for patients who were red blood cell transfusion-dependent at baseline AND a ≥ 1 g/dL hemoglobin rise compared to mean pre-transfusion baseline value; or a \> 2 g/dL rise in hemoglobin without transfusion for non-transfusion dependent patients.
Recruitment status
ACTIVE_NOT_RECRUITING
Study phase
PHASE3
Target enrollment
247 participants
Primary outcome timeframe
Assessed after completion of 16 weeks of treatment
Results posted on
2025-11-24
Participant Flow
From January 2009 through May 2016, the trial enrolled a total of 247 patients.
Participant milestones
| Measure |
Arm A (Lenalidomide; Chromosome 5q31.1 Deletion)
Patients receive lenalidomide PO QD on days 1-21.
|
Arm A (Lenalidomide; Randomization)
Patients receive lenalidomide PO QD on days 1-21.
|
Arm B (Lenalidomide + Epoetin Alfa; Randomization)
Patients receive lenalidomide PO QD on days 1-21 and epoetin alfa SC once weekly.
|
|---|---|---|---|
|
Step 1
STARTED
|
38
|
103
|
106
|
|
Step 1
Treated Patients
|
36
|
103
|
106
|
|
Step 1
Evaluable Patients Included in Primary Analysis
|
0
|
96
|
99
|
|
Step 1
Patients With Cytogenetic Response Data Available
|
0
|
55
|
51
|
|
Step 1
COMPLETED
|
6
|
48
|
41
|
|
Step 1
NOT COMPLETED
|
32
|
55
|
65
|
|
Step 2 (Cross-over to Arm B)
STARTED
|
7
|
46
|
0
|
|
Step 2 (Cross-over to Arm B)
Evaluable Patients Included in Primary Analysis
|
7
|
37
|
0
|
|
Step 2 (Cross-over to Arm B)
COMPLETED
|
3
|
20
|
0
|
|
Step 2 (Cross-over to Arm B)
NOT COMPLETED
|
4
|
26
|
0
|
Reasons for withdrawal
| Measure |
Arm A (Lenalidomide; Chromosome 5q31.1 Deletion)
Patients receive lenalidomide PO QD on days 1-21.
|
Arm A (Lenalidomide; Randomization)
Patients receive lenalidomide PO QD on days 1-21.
|
Arm B (Lenalidomide + Epoetin Alfa; Randomization)
Patients receive lenalidomide PO QD on days 1-21 and epoetin alfa SC once weekly.
|
|---|---|---|---|
|
Step 2 (Cross-over to Arm B)
Prolonged wound healing
|
0
|
1
|
0
|
|
Step 1
Lack of Efficacy
|
14
|
10
|
21
|
|
Step 1
Adverse Event
|
8
|
17
|
20
|
|
Step 1
Death
|
1
|
2
|
4
|
|
Step 1
Withdrawal by Subject
|
6
|
12
|
9
|
|
Step 1
Physician Decision
|
0
|
5
|
1
|
|
Step 1
Patient and physician's decision
|
0
|
0
|
1
|
|
Step 1
Other complicating disease
|
1
|
3
|
4
|
|
Step 1
Alternative therapy
|
0
|
1
|
1
|
|
Step 1
Patient switched treatment early due to DSMC announcement
|
0
|
4
|
0
|
|
Step 1
Off treatment reason unknown
|
0
|
1
|
4
|
|
Step 1
Never started treatment
|
2
|
0
|
0
|
|
Step 2 (Cross-over to Arm B)
Lack of Efficacy
|
1
|
9
|
0
|
|
Step 2 (Cross-over to Arm B)
Adverse Event
|
0
|
6
|
0
|
|
Step 2 (Cross-over to Arm B)
Death
|
0
|
3
|
0
|
|
Step 2 (Cross-over to Arm B)
Withdrawal by Subject
|
2
|
5
|
0
|
|
Step 2 (Cross-over to Arm B)
Physician Decision
|
1
|
1
|
0
|
|
Step 2 (Cross-over to Arm B)
Alternative treatment
|
0
|
1
|
0
|
Baseline Characteristics
Lenalidomide With or Without Epoetin Alfa in Treating Patients With Myelodysplastic Syndrome and Anemia
Baseline characteristics by cohort
| Measure |
Arm A (Lenalidomide; Chromosome 5q31.1 Deletion)
n=38 Participants
Patients receive lenalidomide PO QD on days 1-21.
|
Arm A (Lenalidomide; Randomization)
n=103 Participants
Patients receive lenalidomide PO QD on days 1-21.
|
Arm B (Lenalidomide + Epoetin Alfa; Randomization)
n=106 Participants
Patients receive lenalidomide PO QD on days 1-21 and epoetin alfa SC once weekly.
|
Total
n=247 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
77 years
n=45 Participants
|
74 years
n=12929 Participants
|
73 years
n=6349 Participants
|
74 years
n=4548 Participants
|
|
Sex: Female, Male
Female
|
26 Participants
n=45 Participants
|
33 Participants
n=12929 Participants
|
28 Participants
n=6349 Participants
|
87 Participants
n=4548 Participants
|
|
Sex: Female, Male
Male
|
12 Participants
n=45 Participants
|
70 Participants
n=12929 Participants
|
78 Participants
n=6349 Participants
|
160 Participants
n=4548 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=45 Participants
|
2 Participants
n=12929 Participants
|
1 Participants
n=6349 Participants
|
5 Participants
n=4548 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
34 Participants
n=45 Participants
|
96 Participants
n=12929 Participants
|
97 Participants
n=6349 Participants
|
227 Participants
n=4548 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=45 Participants
|
5 Participants
n=12929 Participants
|
8 Participants
n=6349 Participants
|
15 Participants
n=4548 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=45 Participants
|
0 Participants
n=12929 Participants
|
0 Participants
n=6349 Participants
|
0 Participants
n=4548 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=45 Participants
|
1 Participants
n=12929 Participants
|
3 Participants
n=6349 Participants
|
5 Participants
n=4548 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=45 Participants
|
0 Participants
n=12929 Participants
|
0 Participants
n=6349 Participants
|
0 Participants
n=4548 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=45 Participants
|
1 Participants
n=12929 Participants
|
3 Participants
n=6349 Participants
|
4 Participants
n=4548 Participants
|
|
Race (NIH/OMB)
White
|
35 Participants
n=45 Participants
|
97 Participants
n=12929 Participants
|
96 Participants
n=6349 Participants
|
228 Participants
n=4548 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=45 Participants
|
0 Participants
n=12929 Participants
|
0 Participants
n=6349 Participants
|
0 Participants
n=4548 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=45 Participants
|
4 Participants
n=12929 Participants
|
4 Participants
n=6349 Participants
|
10 Participants
n=4548 Participants
|
PRIMARY outcome
Timeframe: Assessed after completion of 16 weeks of treatmentPopulation: Evaluable patients randomized to either arm A or arm B
Major erythroid response is defined as transfusion-independence for ≥ 8 consecutive weeks for patients who were red blood cell transfusion-dependent at baseline AND a ≥ 1 g/dL hemoglobin rise compared to mean pre-transfusion baseline value; or a \> 2 g/dL rise in hemoglobin without transfusion for non-transfusion dependent patients.
Outcome measures
| Measure |
Arm A (Lenalidomide; Randomization)
n=96 Participants
Patients receive lenalidomide PO QD on days 1-21.
|
Arm B (Lenalidomide + Epoetin Alfa; Randomization)
n=99 Participants
Patients receive lenalidomide PO QD on days 1-21 and epoetin alfa SC once weekly.
|
|---|---|---|
|
Proportion of Patients With Major Erythroid Response (MER)
|
0.115 proportion of participants
Interval 0.066 to 0.183
|
0.283 proportion of participants
Interval 0.209 to 0.367
|
SECONDARY outcome
Timeframe: Assessed every cycle during treatment and then 3 and 6 months after last protocol treatmentPopulation: Only evaluable patients who achieved MER among randomized patients were included in this analysis.
Time to major erythroid response (MER) is defined in responders as the time from randomization to the documented date of MER. For transfusion independent patients, the date of MER is the first date of the elevation in hemoglobin level of more than 2 g/dL that has been sustained for at least 8 weeks. For transfusion dependent patients, the date of MER is the beginning date of the time interval of transfusion independence that has been sustained for at least eight weeks.
Outcome measures
| Measure |
Arm A (Lenalidomide; Randomization)
n=11 Participants
Patients receive lenalidomide PO QD on days 1-21.
|
Arm B (Lenalidomide + Epoetin Alfa; Randomization)
n=28 Participants
Patients receive lenalidomide PO QD on days 1-21 and epoetin alfa SC once weekly.
|
|---|---|---|
|
Time to Major Erythroid Response (MER)
|
3.6 months
Interval 2.1 to 5.5
|
3.7 months
Interval 1.0 to 10.6
|
SECONDARY outcome
Timeframe: Assessed every cycle during treatment and then 3 and 6 months after last protocol treatmentPopulation: Only evaluable patients who achieved MER among randomized patients were included in this analysis.
Duration of major erythroid response (MER) is defined as the time interval between the documented date of MER and the earliest date of resumption of red blood cell transfusions ≥ 2 units in an 8-week period, a reduction in hemoglobin concentration ≥ 2 g/dL in the absence of acute infection, gastrointestinal bleeding and hemolysis, or death.
Outcome measures
| Measure |
Arm A (Lenalidomide; Randomization)
n=11 Participants
Patients receive lenalidomide PO QD on days 1-21.
|
Arm B (Lenalidomide + Epoetin Alfa; Randomization)
n=28 Participants
Patients receive lenalidomide PO QD on days 1-21 and epoetin alfa SC once weekly.
|
|---|---|---|
|
Duration of Major Erythroid Response (MER)
|
13 months
Interval 2.1 to 75.0
|
23.8 months
Interval 8.5 to
The upper limit of the 95% confidence interval was not calculable because an insufficient number of participants reached the event at the final time point for assessment.
|
SECONDARY outcome
Timeframe: Assessed after completion of 16 weeks of treatmentPopulation: Evaluable patients who fail to experience a MER with lenalidomide monotherapy and receive salvage combination therapy (crossover from arm A to arm B)
Major erythroid response is defined as transfusion-independence for ≥ 8 consecutive weeks for patients who were red blood cell transfusion-dependent at baseline AND a ≥ 1 g/dL hemoglobin rise compared to mean pre-transfusion baseline value; or a \> 2 g/dL rise in hemoglobin without transfusion for non-transfusion dependent patients.
Outcome measures
| Measure |
Arm A (Lenalidomide; Randomization)
n=44 Participants
Patients receive lenalidomide PO QD on days 1-21.
|
Arm B (Lenalidomide + Epoetin Alfa; Randomization)
Patients receive lenalidomide PO QD on days 1-21 and epoetin alfa SC once weekly.
|
|---|---|---|
|
Proportion of Patients With Major Erythroid Response (MER) to Salvage Combination Therapy
|
0.25 proportion of participants
Interval 0.13 to 0.4
|
—
|
SECONDARY outcome
Timeframe: Assessed every cycle during treatment and after completion of 16 weeks of treatmentPopulation: Evaluable patients randomized to either arm A or arm B
The definition of minor erythroid response: the mean hemoglobin is sustained 1.0 to 2.0 g/dL above the baseline value for a minimum of 8 weeks; or a 50% or greater decrease in 8-week red blood cell transfusion requirements compared to baseline.
Outcome measures
| Measure |
Arm A (Lenalidomide; Randomization)
n=96 Participants
Patients receive lenalidomide PO QD on days 1-21.
|
Arm B (Lenalidomide + Epoetin Alfa; Randomization)
n=99 Participants
Patients receive lenalidomide PO QD on days 1-21 and epoetin alfa SC once weekly.
|
|---|---|---|
|
Proportion of Patients With Minor Erythroid Response
|
0.208 proportion of participants
Interval 0.142 to 0.288
|
0.182 proportion of participants
Interval 0.121 to 0.258
|
SECONDARY outcome
Timeframe: Assessed after completion of 16 weeks of treatmentPopulation: All patients with chromosome 5q31.1 deletion in arm A
Major erythroid response is defined as transfusion-independence for ≥ 8 consecutive weeks for patients who were red blood cell transfusion-dependent at baseline AND a ≥ 1 g/dL hemoglobin rise compared to mean pre-transfusion baseline value; or a \> 2 g/dL rise in hemoglobin without transfusion for non-transfusion dependent patients.
Outcome measures
| Measure |
Arm A (Lenalidomide; Randomization)
n=38 Participants
Patients receive lenalidomide PO QD on days 1-21.
|
Arm B (Lenalidomide + Epoetin Alfa; Randomization)
Patients receive lenalidomide PO QD on days 1-21 and epoetin alfa SC once weekly.
|
|---|---|---|
|
Proportion of Patients With Major Erythroid Response (MER) Among Those With Chromosome 5q31.1 Deletion
|
0.632 proportion of participants
Interval 0.46 to 0.782
|
—
|
SECONDARY outcome
Timeframe: Assessed at 16 weeksPopulation: Evaluable patients randomized to either arm A or arm B
Bone marrow response includes complete remission (CR) and partial remission (PR). Complete remission (CR): Bone marrow showing \< 5% myeloblasts with normal maturation of all cell lines, with no evidence for dysplasia. When erythroid precursors constitute \< 50% of bone marrow nucleated cells, the percent of blasts is based on all nucleated cells; when there are ≥ 50% erythroid cells, the percent blasts should be based on the non-erythroid cells. Partial remission (PR): All of the CR criteria (if abnormal prior to treatment), except blasts decreased by 50% over pre-treatment, or a less advanced Myelodysplastic Syndromes (MDS) World Health Organization (WHO) classification than pretreatment. Cellularity and morphology are not relevant.
Outcome measures
| Measure |
Arm A (Lenalidomide; Randomization)
n=96 Participants
Patients receive lenalidomide PO QD on days 1-21.
|
Arm B (Lenalidomide + Epoetin Alfa; Randomization)
n=99 Participants
Patients receive lenalidomide PO QD on days 1-21 and epoetin alfa SC once weekly.
|
|---|---|---|
|
Proportion of Patients With Bone Marrow Response
|
0.01 proportion of participants
Interval 0.0006 to 0.049
|
0.03 proportion of participants
Interval 0.008 to 0.077
|
SECONDARY outcome
Timeframe: Assessed at baseline and after completion of 16 weeks of treatmentPopulation: Evaluable patients randomized to either arm A or arm B who had cytogenetic response data
Evaluation of cytogenetic response requires 20 analyzable metaphases when using conventional techniques. Analysis of data will require 20 metaphases before and after treatment, which must be done on bone marrow only (peripheral blood is not a substitute). Fluorescent in situ hybridization (FISH) may be used as a supplement to follow a specifically defined cytogenetic abnormality, but it is not a substitute for conventional cytogenetic studies. Cytogenetic response is defined as follows: Complete response: Restoration of a normal karyotype in patients with a documented pre-existing clonal (\>2 metaphases abnormal) chromosome abnormalities. Partial response: \> 50% reduction in the percentage of bone marrow metaphases with only clonal abnormality.
Outcome measures
| Measure |
Arm A (Lenalidomide; Randomization)
n=55 Participants
Patients receive lenalidomide PO QD on days 1-21.
|
Arm B (Lenalidomide + Epoetin Alfa; Randomization)
n=51 Participants
Patients receive lenalidomide PO QD on days 1-21 and epoetin alfa SC once weekly.
|
|---|---|---|
|
Proportion of Patients With Cytogenetic Response
|
0.07 proportion of participants
Interval 0.02 to 0.18
|
0.10 proportion of participants
Interval 0.03 to 0.21
|
SECONDARY outcome
Timeframe: Assessed at baseline and after completion of 16 weeks of treatmentPopulation: Evaluable patients in both arms A and B who had both major erythroid response data and cytogenetic response data
Major erythroid response is defined as transfusion-independence for ≥ 8 consecutive weeks for patients who were red blood cell transfusion-dependent at baseline AND a ≥ 1 g/dL hemoglobin rise compared to mean pre-transfusion baseline value; or a \> 2 g/dL rise in hemoglobin without transfusion for non-transfusion dependent patients. Evaluation of cytogenetic response requires 20 analyzable metaphases before and after treatment, which must be done on bone marrow only. Fluorescent in situ hybridization (FISH) may be used as a supplement to follow a specifically defined cytogenetic abnormality, but it is not a substitute for conventional cytogenetic studies. Cytogenetic response is defined as follows: Complete response: Restoration of a normal karyotype in patients with a documented pre-existing clonal (\>2 metaphases abnormal) chromosome abnormalities. Partial response: \> 50% reduction in the percentage of bone marrow metaphases with only clonal abnormality.
Outcome measures
| Measure |
Arm A (Lenalidomide; Randomization)
n=23 Participants
Patients receive lenalidomide PO QD on days 1-21.
|
Arm B (Lenalidomide + Epoetin Alfa; Randomization)
n=83 Participants
Patients receive lenalidomide PO QD on days 1-21 and epoetin alfa SC once weekly.
|
|---|---|---|
|
Association Between Major Erythroid Response and Cytogenetic Response
Cytogenetic response
|
4 Participants
|
5 Participants
|
|
Association Between Major Erythroid Response and Cytogenetic Response
No cytogenetic response
|
19 Participants
|
78 Participants
|
SECONDARY outcome
Timeframe: Assessed at baseline and after completion of 16 weeks of treatmentPopulation: All patients randomized to arm A and all patients with 5q31.1 deletion that received lenalidomide alone
Pretreatment endogenous erythropoietin level was assessed at baseline. The association between pretreatment endogenous erythropoietin level and major erythroid response was evaluated among patients who received lenalidomide alone. Major erythroid response is defined as transfusion-independence for ≥ 8 consecutive weeks for patients who were red blood cell transfusion-dependent at baseline AND a ≥ 1 g/dL hemoglobin rise compared to mean pre-transfusion baseline value; or a \> 2 g/dL rise in hemoglobin without transfusion for non-transfusion dependent patients.
Outcome measures
| Measure |
Arm A (Lenalidomide; Randomization)
n=36 Participants
Patients receive lenalidomide PO QD on days 1-21.
|
Arm B (Lenalidomide + Epoetin Alfa; Randomization)
n=105 Participants
Patients receive lenalidomide PO QD on days 1-21 and epoetin alfa SC once weekly.
|
|---|---|---|
|
Pretreatment Endogenous Erythropoietin Level
|
514.5 mU/mL
Interval 82.0 to 3405.0
|
150 mU/mL
Interval 11.0 to 3048.0
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Assessed at baseline and after completion of 16 weeks of treatmentTo evaluate the effect of CD45 isoform profile on lenalidomide enhancement of erythropoietin-induced STAT5 phosphorylation in CD71Hi erythroid precursors and the relationship to erythroid response.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Assessed at baseline and after completion of 16 weeks of treatmentTo characterize molecular targets relevant to lenalidomide cytotoxicity in del5q31.1 cells.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Assessed at baseline and after completion of 16 weeks of treatmentTo evaluate the frequency of cryptic chromosome 5q31.1 deletions in patients with non-del5q31.1 MDS by array based genomic scan, and to determine the relationship to hematologic response.
Outcome measures
Outcome data not reported
Adverse Events
Arm A (Step 1; Regardless of Chromosome 5q31.1 Status)
Serious events: 123 serious events
Other events: 137 other events
Deaths: 29 deaths
Arm B (Step 1 Randomization; Lenalidomide + Epoetin Alfa)
Serious events: 98 serious events
Other events: 105 other events
Deaths: 29 deaths
Arm B (Step 2 Cross-over; Lenalidomide + Epoetin Alfa)
Serious events: 49 serious events
Other events: 52 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Arm A (Step 1; Regardless of Chromosome 5q31.1 Status)
n=139 participants at risk
Patients receive lenalidomide PO QD on days 1-21.
|
Arm B (Step 1 Randomization; Lenalidomide + Epoetin Alfa)
n=106 participants at risk
Patients receive lenalidomide PO QD on days 1-21 and epoetin alfa SC once weekly.
|
Arm B (Step 2 Cross-over; Lenalidomide + Epoetin Alfa)
n=53 participants at risk
Patients receive lenalidomide PO QD on days 1-21 and epoetin alfa SC once weekly.
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Anemia
|
57.6%
80/139 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed among patients who started protocol treatment. All-cause mortality was assessed among all registered patients.
|
61.3%
65/106 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed among patients who started protocol treatment. All-cause mortality was assessed among all registered patients.
|
56.6%
30/53 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed among patients who started protocol treatment. All-cause mortality was assessed among all registered patients.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
4.3%
6/139 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed among patients who started protocol treatment. All-cause mortality was assessed among all registered patients.
|
3.8%
4/106 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed among patients who started protocol treatment. All-cause mortality was assessed among all registered patients.
|
0.00%
0/53 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed among patients who started protocol treatment. All-cause mortality was assessed among all registered patients.
|
|
Cardiac disorders
Acute coronary syndrome
|
0.00%
0/139 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed among patients who started protocol treatment. All-cause mortality was assessed among all registered patients.
|
0.94%
1/106 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed among patients who started protocol treatment. All-cause mortality was assessed among all registered patients.
|
0.00%
0/53 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed among patients who started protocol treatment. All-cause mortality was assessed among all registered patients.
|
|
Cardiac disorders
Atrial fibrillation
|
1.4%
2/139 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed among patients who started protocol treatment. All-cause mortality was assessed among all registered patients.
|
0.94%
1/106 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed among patients who started protocol treatment. All-cause mortality was assessed among all registered patients.
|
0.00%
0/53 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed among patients who started protocol treatment. All-cause mortality was assessed among all registered patients.
|
|
Cardiac disorders
Chest pain - cardiac
|
0.00%
0/139 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed among patients who started protocol treatment. All-cause mortality was assessed among all registered patients.
|
0.94%
1/106 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed among patients who started protocol treatment. All-cause mortality was assessed among all registered patients.
|
0.00%
0/53 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed among patients who started protocol treatment. All-cause mortality was assessed among all registered patients.
|
|
Cardiac disorders
Heart failure
|
0.72%
1/139 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed among patients who started protocol treatment. All-cause mortality was assessed among all registered patients.
|
0.94%
1/106 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed among patients who started protocol treatment. All-cause mortality was assessed among all registered patients.
|
0.00%
0/53 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed among patients who started protocol treatment. All-cause mortality was assessed among all registered patients.
|
|
Cardiac disorders
Left ventricular systolic dysfunction
|
0.00%
0/139 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed among patients who started protocol treatment. All-cause mortality was assessed among all registered patients.
|
0.94%
1/106 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed among patients who started protocol treatment. All-cause mortality was assessed among all registered patients.
|
0.00%
0/53 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed among patients who started protocol treatment. All-cause mortality was assessed among all registered patients.
|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/139 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed among patients who started protocol treatment. All-cause mortality was assessed among all registered patients.
|
0.94%
1/106 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed among patients who started protocol treatment. All-cause mortality was assessed among all registered patients.
|
0.00%
0/53 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed among patients who started protocol treatment. All-cause mortality was assessed among all registered patients.
|
|
Cardiac disorders
Cardiac disorders - Other, specify
|
0.00%
0/139 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed among patients who started protocol treatment. All-cause mortality was assessed among all registered patients.
|
0.94%
1/106 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed among patients who started protocol treatment. All-cause mortality was assessed among all registered patients.
|
0.00%
0/53 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed among patients who started protocol treatment. All-cause mortality was assessed among all registered patients.
|
|
General disorders
Edema limbs
|
0.72%
1/139 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed among patients who started protocol treatment. All-cause mortality was assessed among all registered patients.
|
0.94%
1/106 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed among patients who started protocol treatment. All-cause mortality was assessed among all registered patients.
|
1.9%
1/53 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed among patients who started protocol treatment. All-cause mortality was assessed among all registered patients.
|
|
General disorders
Fatigue
|
2.9%
4/139 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed among patients who started protocol treatment. All-cause mortality was assessed among all registered patients.
|
7.5%
8/106 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed among patients who started protocol treatment. All-cause mortality was assessed among all registered patients.
|
3.8%
2/53 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed among patients who started protocol treatment. All-cause mortality was assessed among all registered patients.
|
|
General disorders
Fever
|
0.00%
0/139 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed among patients who started protocol treatment. All-cause mortality was assessed among all registered patients.
|
1.9%
2/106 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed among patients who started protocol treatment. All-cause mortality was assessed among all registered patients.
|
0.00%
0/53 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed among patients who started protocol treatment. All-cause mortality was assessed among all registered patients.
|
|
General disorders
Multi-organ failure
|
0.00%
0/139 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed among patients who started protocol treatment. All-cause mortality was assessed among all registered patients.
|
0.00%
0/106 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed among patients who started protocol treatment. All-cause mortality was assessed among all registered patients.
|
1.9%
1/53 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed among patients who started protocol treatment. All-cause mortality was assessed among all registered patients.
|
|
General disorders
Non-cardiac chest pain
|
0.72%
1/139 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed among patients who started protocol treatment. All-cause mortality was assessed among all registered patients.
|
0.00%
0/106 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed among patients who started protocol treatment. All-cause mortality was assessed among all registered patients.
|
0.00%
0/53 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed among patients who started protocol treatment. All-cause mortality was assessed among all registered patients.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
1.4%
2/139 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed among patients who started protocol treatment. All-cause mortality was assessed among all registered patients.
|
0.94%
1/106 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed among patients who started protocol treatment. All-cause mortality was assessed among all registered patients.
|
1.9%
1/53 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed among patients who started protocol treatment. All-cause mortality was assessed among all registered patients.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
5.0%
7/139 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed among patients who started protocol treatment. All-cause mortality was assessed among all registered patients.
|
2.8%
3/106 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed among patients who started protocol treatment. All-cause mortality was assessed among all registered patients.
|
1.9%
1/53 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed among patients who started protocol treatment. All-cause mortality was assessed among all registered patients.
|
|
Skin and subcutaneous tissue disorders
Skin ulceration
|
0.72%
1/139 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed among patients who started protocol treatment. All-cause mortality was assessed among all registered patients.
|
0.00%
0/106 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed among patients who started protocol treatment. All-cause mortality was assessed among all registered patients.
|
0.00%
0/53 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed among patients who started protocol treatment. All-cause mortality was assessed among all registered patients.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.72%
1/139 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed among patients who started protocol treatment. All-cause mortality was assessed among all registered patients.
|
0.94%
1/106 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed among patients who started protocol treatment. All-cause mortality was assessed among all registered patients.
|
0.00%
0/53 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed among patients who started protocol treatment. All-cause mortality was assessed among all registered patients.
|
|
Gastrointestinal disorders
Colitis
|
0.72%
1/139 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed among patients who started protocol treatment. All-cause mortality was assessed among all registered patients.
|
0.94%
1/106 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed among patients who started protocol treatment. All-cause mortality was assessed among all registered patients.
|
0.00%
0/53 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed among patients who started protocol treatment. All-cause mortality was assessed among all registered patients.
|
|
Gastrointestinal disorders
Colonic obstruction
|
0.72%
1/139 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed among patients who started protocol treatment. All-cause mortality was assessed among all registered patients.
|
0.00%
0/106 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed among patients who started protocol treatment. All-cause mortality was assessed among all registered patients.
|
0.00%
0/53 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed among patients who started protocol treatment. All-cause mortality was assessed among all registered patients.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/139 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed among patients who started protocol treatment. All-cause mortality was assessed among all registered patients.
|
0.94%
1/106 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed among patients who started protocol treatment. All-cause mortality was assessed among all registered patients.
|
1.9%
1/53 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed among patients who started protocol treatment. All-cause mortality was assessed among all registered patients.
|
|
Gastrointestinal disorders
Diarrhea
|
2.9%
4/139 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed among patients who started protocol treatment. All-cause mortality was assessed among all registered patients.
|
2.8%
3/106 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed among patients who started protocol treatment. All-cause mortality was assessed among all registered patients.
|
1.9%
1/53 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed among patients who started protocol treatment. All-cause mortality was assessed among all registered patients.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/139 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed among patients who started protocol treatment. All-cause mortality was assessed among all registered patients.
|
0.94%
1/106 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed among patients who started protocol treatment. All-cause mortality was assessed among all registered patients.
|
0.00%
0/53 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed among patients who started protocol treatment. All-cause mortality was assessed among all registered patients.
|
|
Gastrointestinal disorders
Vomiting
|
0.72%
1/139 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed among patients who started protocol treatment. All-cause mortality was assessed among all registered patients.
|
0.94%
1/106 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed among patients who started protocol treatment. All-cause mortality was assessed among all registered patients.
|
0.00%
0/53 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed among patients who started protocol treatment. All-cause mortality was assessed among all registered patients.
|
|
Immune system disorders
Anaphylaxis
|
0.00%
0/139 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed among patients who started protocol treatment. All-cause mortality was assessed among all registered patients.
|
0.94%
1/106 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed among patients who started protocol treatment. All-cause mortality was assessed among all registered patients.
|
0.00%
0/53 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed among patients who started protocol treatment. All-cause mortality was assessed among all registered patients.
|
|
Immune system disorders
Immune system disorders - Other, specify
|
0.00%
0/139 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed among patients who started protocol treatment. All-cause mortality was assessed among all registered patients.
|
0.94%
1/106 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed among patients who started protocol treatment. All-cause mortality was assessed among all registered patients.
|
0.00%
0/53 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed among patients who started protocol treatment. All-cause mortality was assessed among all registered patients.
|
|
Infections and infestations
Bronchial infection
|
0.72%
1/139 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed among patients who started protocol treatment. All-cause mortality was assessed among all registered patients.
|
0.00%
0/106 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed among patients who started protocol treatment. All-cause mortality was assessed among all registered patients.
|
0.00%
0/53 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed among patients who started protocol treatment. All-cause mortality was assessed among all registered patients.
|
|
Infections and infestations
Lung infection
|
1.4%
2/139 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed among patients who started protocol treatment. All-cause mortality was assessed among all registered patients.
|
1.9%
2/106 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed among patients who started protocol treatment. All-cause mortality was assessed among all registered patients.
|
0.00%
0/53 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed among patients who started protocol treatment. All-cause mortality was assessed among all registered patients.
|
|
Infections and infestations
Sepsis
|
0.72%
1/139 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed among patients who started protocol treatment. All-cause mortality was assessed among all registered patients.
|
1.9%
2/106 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed among patients who started protocol treatment. All-cause mortality was assessed among all registered patients.
|
0.00%
0/53 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed among patients who started protocol treatment. All-cause mortality was assessed among all registered patients.
|
|
Infections and infestations
Soft tissue infection
|
0.72%
1/139 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed among patients who started protocol treatment. All-cause mortality was assessed among all registered patients.
|
0.94%
1/106 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed among patients who started protocol treatment. All-cause mortality was assessed among all registered patients.
|
0.00%
0/53 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed among patients who started protocol treatment. All-cause mortality was assessed among all registered patients.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/139 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed among patients who started protocol treatment. All-cause mortality was assessed among all registered patients.
|
0.94%
1/106 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed among patients who started protocol treatment. All-cause mortality was assessed among all registered patients.
|
0.00%
0/53 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed among patients who started protocol treatment. All-cause mortality was assessed among all registered patients.
|
|
Infections and infestations
Wound infection
|
0.00%
0/139 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed among patients who started protocol treatment. All-cause mortality was assessed among all registered patients.
|
0.00%
0/106 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed among patients who started protocol treatment. All-cause mortality was assessed among all registered patients.
|
1.9%
1/53 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed among patients who started protocol treatment. All-cause mortality was assessed among all registered patients.
|
|
Infections and infestations
Infections and infestations - Other
|
0.00%
0/139 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed among patients who started protocol treatment. All-cause mortality was assessed among all registered patients.
|
0.94%
1/106 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed among patients who started protocol treatment. All-cause mortality was assessed among all registered patients.
|
0.00%
0/53 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed among patients who started protocol treatment. All-cause mortality was assessed among all registered patients.
|
|
Investigations
Blood bilirubin increased
|
0.72%
1/139 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed among patients who started protocol treatment. All-cause mortality was assessed among all registered patients.
|
0.94%
1/106 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed among patients who started protocol treatment. All-cause mortality was assessed among all registered patients.
|
0.00%
0/53 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed among patients who started protocol treatment. All-cause mortality was assessed among all registered patients.
|
|
Investigations
Creatinine increased
|
2.2%
3/139 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed among patients who started protocol treatment. All-cause mortality was assessed among all registered patients.
|
4.7%
5/106 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed among patients who started protocol treatment. All-cause mortality was assessed among all registered patients.
|
1.9%
1/53 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed among patients who started protocol treatment. All-cause mortality was assessed among all registered patients.
|
|
Investigations
Hemoglobin increased
|
0.72%
1/139 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed among patients who started protocol treatment. All-cause mortality was assessed among all registered patients.
|
0.00%
0/106 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed among patients who started protocol treatment. All-cause mortality was assessed among all registered patients.
|
0.00%
0/53 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed among patients who started protocol treatment. All-cause mortality was assessed among all registered patients.
|
|
Investigations
Lymphocyte count decreased
|
2.9%
4/139 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed among patients who started protocol treatment. All-cause mortality was assessed among all registered patients.
|
4.7%
5/106 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed among patients who started protocol treatment. All-cause mortality was assessed among all registered patients.
|
3.8%
2/53 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed among patients who started protocol treatment. All-cause mortality was assessed among all registered patients.
|
|
Investigations
Neutrophil count decreased
|
66.2%
92/139 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed among patients who started protocol treatment. All-cause mortality was assessed among all registered patients.
|
65.1%
69/106 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed among patients who started protocol treatment. All-cause mortality was assessed among all registered patients.
|
73.6%
39/53 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed among patients who started protocol treatment. All-cause mortality was assessed among all registered patients.
|
|
Investigations
Platelet count decreased
|
32.4%
45/139 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed among patients who started protocol treatment. All-cause mortality was assessed among all registered patients.
|
26.4%
28/106 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed among patients who started protocol treatment. All-cause mortality was assessed among all registered patients.
|
17.0%
9/53 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed among patients who started protocol treatment. All-cause mortality was assessed among all registered patients.
|
|
Investigations
Weight gain
|
0.00%
0/139 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed among patients who started protocol treatment. All-cause mortality was assessed among all registered patients.
|
0.94%
1/106 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed among patients who started protocol treatment. All-cause mortality was assessed among all registered patients.
|
0.00%
0/53 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed among patients who started protocol treatment. All-cause mortality was assessed among all registered patients.
|
|
Investigations
White blood cell decreased
|
36.0%
50/139 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed among patients who started protocol treatment. All-cause mortality was assessed among all registered patients.
|
34.0%
36/106 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed among patients who started protocol treatment. All-cause mortality was assessed among all registered patients.
|
45.3%
24/53 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed among patients who started protocol treatment. All-cause mortality was assessed among all registered patients.
|
|
Investigations
Investigations - Other, specify
|
0.00%
0/139 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed among patients who started protocol treatment. All-cause mortality was assessed among all registered patients.
|
0.94%
1/106 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed among patients who started protocol treatment. All-cause mortality was assessed among all registered patients.
|
1.9%
1/53 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed among patients who started protocol treatment. All-cause mortality was assessed among all registered patients.
|
|
Metabolism and nutrition disorders
Anorexia
|
0.00%
0/139 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed among patients who started protocol treatment. All-cause mortality was assessed among all registered patients.
|
0.94%
1/106 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed among patients who started protocol treatment. All-cause mortality was assessed among all registered patients.
|
0.00%
0/53 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed among patients who started protocol treatment. All-cause mortality was assessed among all registered patients.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.72%
1/139 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed among patients who started protocol treatment. All-cause mortality was assessed among all registered patients.
|
0.94%
1/106 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed among patients who started protocol treatment. All-cause mortality was assessed among all registered patients.
|
0.00%
0/53 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed among patients who started protocol treatment. All-cause mortality was assessed among all registered patients.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
0.00%
0/139 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed among patients who started protocol treatment. All-cause mortality was assessed among all registered patients.
|
0.00%
0/106 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed among patients who started protocol treatment. All-cause mortality was assessed among all registered patients.
|
1.9%
1/53 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed among patients who started protocol treatment. All-cause mortality was assessed among all registered patients.
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
0.72%
1/139 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed among patients who started protocol treatment. All-cause mortality was assessed among all registered patients.
|
0.00%
0/106 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed among patients who started protocol treatment. All-cause mortality was assessed among all registered patients.
|
0.00%
0/53 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed among patients who started protocol treatment. All-cause mortality was assessed among all registered patients.
|
|
Metabolism and nutrition disorders
Hypokalemia
|
0.72%
1/139 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed among patients who started protocol treatment. All-cause mortality was assessed among all registered patients.
|
0.00%
0/106 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed among patients who started protocol treatment. All-cause mortality was assessed among all registered patients.
|
0.00%
0/53 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed among patients who started protocol treatment. All-cause mortality was assessed among all registered patients.
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
0.72%
1/139 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed among patients who started protocol treatment. All-cause mortality was assessed among all registered patients.
|
0.00%
0/106 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed among patients who started protocol treatment. All-cause mortality was assessed among all registered patients.
|
0.00%
0/53 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed among patients who started protocol treatment. All-cause mortality was assessed among all registered patients.
|
|
Metabolism and nutrition disorders
Iron overload
|
0.00%
0/139 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed among patients who started protocol treatment. All-cause mortality was assessed among all registered patients.
|
0.94%
1/106 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed among patients who started protocol treatment. All-cause mortality was assessed among all registered patients.
|
0.00%
0/53 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed among patients who started protocol treatment. All-cause mortality was assessed among all registered patients.
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.72%
1/139 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed among patients who started protocol treatment. All-cause mortality was assessed among all registered patients.
|
0.00%
0/106 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed among patients who started protocol treatment. All-cause mortality was assessed among all registered patients.
|
0.00%
0/53 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed among patients who started protocol treatment. All-cause mortality was assessed among all registered patients.
|
|
Musculoskeletal and connective tissue disorders
Chest wall pain
|
0.72%
1/139 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed among patients who started protocol treatment. All-cause mortality was assessed among all registered patients.
|
0.00%
0/106 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed among patients who started protocol treatment. All-cause mortality was assessed among all registered patients.
|
0.00%
0/53 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed among patients who started protocol treatment. All-cause mortality was assessed among all registered patients.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.72%
1/139 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed among patients who started protocol treatment. All-cause mortality was assessed among all registered patients.
|
0.00%
0/106 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed among patients who started protocol treatment. All-cause mortality was assessed among all registered patients.
|
0.00%
0/53 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed among patients who started protocol treatment. All-cause mortality was assessed among all registered patients.
|
|
Nervous system disorders
Ataxia
|
0.00%
0/139 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed among patients who started protocol treatment. All-cause mortality was assessed among all registered patients.
|
0.94%
1/106 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed among patients who started protocol treatment. All-cause mortality was assessed among all registered patients.
|
0.00%
0/53 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed among patients who started protocol treatment. All-cause mortality was assessed among all registered patients.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/139 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed among patients who started protocol treatment. All-cause mortality was assessed among all registered patients.
|
0.94%
1/106 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed among patients who started protocol treatment. All-cause mortality was assessed among all registered patients.
|
0.00%
0/53 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed among patients who started protocol treatment. All-cause mortality was assessed among all registered patients.
|
|
Nervous system disorders
Peripheral motor neuropathy
|
0.72%
1/139 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed among patients who started protocol treatment. All-cause mortality was assessed among all registered patients.
|
0.00%
0/106 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed among patients who started protocol treatment. All-cause mortality was assessed among all registered patients.
|
0.00%
0/53 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed among patients who started protocol treatment. All-cause mortality was assessed among all registered patients.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
0.72%
1/139 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed among patients who started protocol treatment. All-cause mortality was assessed among all registered patients.
|
0.00%
0/106 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed among patients who started protocol treatment. All-cause mortality was assessed among all registered patients.
|
1.9%
1/53 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed among patients who started protocol treatment. All-cause mortality was assessed among all registered patients.
|
|
Nervous system disorders
Syncope
|
0.72%
1/139 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed among patients who started protocol treatment. All-cause mortality was assessed among all registered patients.
|
0.00%
0/106 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed among patients who started protocol treatment. All-cause mortality was assessed among all registered patients.
|
0.00%
0/53 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed among patients who started protocol treatment. All-cause mortality was assessed among all registered patients.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Leukemia secondary to oncology chemo
|
1.4%
2/139 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed among patients who started protocol treatment. All-cause mortality was assessed among all registered patients.
|
0.00%
0/106 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed among patients who started protocol treatment. All-cause mortality was assessed among all registered patients.
|
0.00%
0/53 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed among patients who started protocol treatment. All-cause mortality was assessed among all registered patients.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Treatment related secondary malignancy
|
0.72%
1/139 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed among patients who started protocol treatment. All-cause mortality was assessed among all registered patients.
|
0.00%
0/106 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed among patients who started protocol treatment. All-cause mortality was assessed among all registered patients.
|
0.00%
0/53 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed among patients who started protocol treatment. All-cause mortality was assessed among all registered patients.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasms - Other
|
0.00%
0/139 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed among patients who started protocol treatment. All-cause mortality was assessed among all registered patients.
|
0.94%
1/106 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed among patients who started protocol treatment. All-cause mortality was assessed among all registered patients.
|
0.00%
0/53 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed among patients who started protocol treatment. All-cause mortality was assessed among all registered patients.
|
|
Eye disorders
Optic nerve disorder
|
0.00%
0/139 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed among patients who started protocol treatment. All-cause mortality was assessed among all registered patients.
|
0.94%
1/106 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed among patients who started protocol treatment. All-cause mortality was assessed among all registered patients.
|
0.00%
0/53 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed among patients who started protocol treatment. All-cause mortality was assessed among all registered patients.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
1.4%
2/139 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed among patients who started protocol treatment. All-cause mortality was assessed among all registered patients.
|
3.8%
4/106 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed among patients who started protocol treatment. All-cause mortality was assessed among all registered patients.
|
0.00%
0/53 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed among patients who started protocol treatment. All-cause mortality was assessed among all registered patients.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/139 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed among patients who started protocol treatment. All-cause mortality was assessed among all registered patients.
|
0.94%
1/106 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed among patients who started protocol treatment. All-cause mortality was assessed among all registered patients.
|
0.00%
0/53 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed among patients who started protocol treatment. All-cause mortality was assessed among all registered patients.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory thoracic mediastinal - Other
|
0.00%
0/139 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed among patients who started protocol treatment. All-cause mortality was assessed among all registered patients.
|
0.94%
1/106 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed among patients who started protocol treatment. All-cause mortality was assessed among all registered patients.
|
0.00%
0/53 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed among patients who started protocol treatment. All-cause mortality was assessed among all registered patients.
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/139 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed among patients who started protocol treatment. All-cause mortality was assessed among all registered patients.
|
0.00%
0/106 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed among patients who started protocol treatment. All-cause mortality was assessed among all registered patients.
|
1.9%
1/53 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed among patients who started protocol treatment. All-cause mortality was assessed among all registered patients.
|
|
Renal and urinary disorders
Renal and urinary disorders - Other
|
0.00%
0/139 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed among patients who started protocol treatment. All-cause mortality was assessed among all registered patients.
|
0.94%
1/106 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed among patients who started protocol treatment. All-cause mortality was assessed among all registered patients.
|
0.00%
0/53 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed among patients who started protocol treatment. All-cause mortality was assessed among all registered patients.
|
|
Vascular disorders
Thromboembolic event
|
0.72%
1/139 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed among patients who started protocol treatment. All-cause mortality was assessed among all registered patients.
|
0.00%
0/106 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed among patients who started protocol treatment. All-cause mortality was assessed among all registered patients.
|
0.00%
0/53 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed among patients who started protocol treatment. All-cause mortality was assessed among all registered patients.
|
Other adverse events
| Measure |
Arm A (Step 1; Regardless of Chromosome 5q31.1 Status)
n=139 participants at risk
Patients receive lenalidomide PO QD on days 1-21.
|
Arm B (Step 1 Randomization; Lenalidomide + Epoetin Alfa)
n=106 participants at risk
Patients receive lenalidomide PO QD on days 1-21 and epoetin alfa SC once weekly.
|
Arm B (Step 2 Cross-over; Lenalidomide + Epoetin Alfa)
n=53 participants at risk
Patients receive lenalidomide PO QD on days 1-21 and epoetin alfa SC once weekly.
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Anemia
|
77.7%
108/139 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed among patients who started protocol treatment. All-cause mortality was assessed among all registered patients.
|
86.8%
92/106 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed among patients who started protocol treatment. All-cause mortality was assessed among all registered patients.
|
81.1%
43/53 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed among patients who started protocol treatment. All-cause mortality was assessed among all registered patients.
|
|
General disorders
Fatigue
|
7.9%
11/139 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed among patients who started protocol treatment. All-cause mortality was assessed among all registered patients.
|
9.4%
10/106 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed among patients who started protocol treatment. All-cause mortality was assessed among all registered patients.
|
7.5%
4/53 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed among patients who started protocol treatment. All-cause mortality was assessed among all registered patients.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
6.5%
9/139 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed among patients who started protocol treatment. All-cause mortality was assessed among all registered patients.
|
4.7%
5/106 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed among patients who started protocol treatment. All-cause mortality was assessed among all registered patients.
|
0.00%
0/53 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed among patients who started protocol treatment. All-cause mortality was assessed among all registered patients.
|
|
Gastrointestinal disorders
Diarrhea
|
5.0%
7/139 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed among patients who started protocol treatment. All-cause mortality was assessed among all registered patients.
|
2.8%
3/106 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed among patients who started protocol treatment. All-cause mortality was assessed among all registered patients.
|
0.00%
0/53 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed among patients who started protocol treatment. All-cause mortality was assessed among all registered patients.
|
|
Investigations
Creatinine increased
|
44.6%
62/139 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed among patients who started protocol treatment. All-cause mortality was assessed among all registered patients.
|
47.2%
50/106 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed among patients who started protocol treatment. All-cause mortality was assessed among all registered patients.
|
28.3%
15/53 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed among patients who started protocol treatment. All-cause mortality was assessed among all registered patients.
|
|
Investigations
Neutrophil count decreased
|
71.2%
99/139 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed among patients who started protocol treatment. All-cause mortality was assessed among all registered patients.
|
68.9%
73/106 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed among patients who started protocol treatment. All-cause mortality was assessed among all registered patients.
|
81.1%
43/53 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed among patients who started protocol treatment. All-cause mortality was assessed among all registered patients.
|
|
Investigations
Platelet count decreased
|
77.7%
108/139 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed among patients who started protocol treatment. All-cause mortality was assessed among all registered patients.
|
72.6%
77/106 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed among patients who started protocol treatment. All-cause mortality was assessed among all registered patients.
|
71.7%
38/53 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed among patients who started protocol treatment. All-cause mortality was assessed among all registered patients.
|
|
Investigations
White blood cell decreased
|
82.0%
114/139 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed among patients who started protocol treatment. All-cause mortality was assessed among all registered patients.
|
85.8%
91/106 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed among patients who started protocol treatment. All-cause mortality was assessed among all registered patients.
|
88.7%
47/53 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
Adverse events were assessed among patients who started protocol treatment. All-cause mortality was assessed among all registered patients.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60