Darbepoetin Alfa With or Without Iron in Treating Anemia Caused By Chemotherapy in Patients With Cancer
Sponsor
Mayo Clinic (Other)
Overall Status
Completed
CT.gov ID
NCT00661999
Collaborator
National Cancer Institute (NCI) (NIH)
502
2
3
37.9
251
6.6
Study Details
Study Description
Brief Summary
RATIONALE: Darbepoetin alfa may cause the body to make more red blood cells. Red blood cells contain iron that is needed to carry oxygen to the tissues. It is not yet known whether giving darbepoetin alfa (DA) together with intravenous iron or oral iron is more effective than giving darbepoetin alfa together with a placebo in treating anemia caused by chemotherapy.
PURPOSE: This randomized phase III trial is studying giving darbepoetin alfa together with iron to see how well it works compared with giving darbepoetin alfa together with a placebo in treating anemia caused by chemotherapy in patients with cancer.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 3 |
Detailed Description
OBJECTIVES:
Primary
- To compare the effects of IV iron, oral iron, or placebo in combination with darbepoetin alfa on the hematopoietic response rate, defined as a hemoglobin increment of ≥ 2.0 g/dL from baseline or achievement of hemoglobin of ≥ 11 g/dL in the absence of red blood cell transfusions (RBC) in the preceding 28 days of the treatment period, in cancer patients with chemotherapy-associated anemia.
Secondary
-
To compare the effects of these regimens on the mean hemoglobin increment from baseline to weeks 7 and 16 in these patients.
-
To compare the effects of these regimens on the percentage of patients maintaining an average hemoglobin level within the American Society of Hematology/American Society of Clinical Oncology (ASH/ASCO)and National Comprehensive Cancer Network(NCCN) guideline-based target hemoglobin range (11-13 g/dL), once achieving a hemoglobin of ≥ 11 g/dL from week 1 to week 16 in the absence of RBC transfusions in the preceding 28 days of the treatment period.
-
To compare the effects of intravenously (IV) iron, oral iron, or placebo on the response to darbepoetin alfa, in terms of time to achieving hemoglobin levels of ≥ 11g/dL.
-
To compare the effects of these regimens on the percentage of patients who require RBC transfusions and the total transfusion needs.
-
To compare the effects of these regimens on the change in hemoglobin week by week.
-
To compare the effects of these regimens on quality-of-life changes from baseline to weeks 7 and 16.
-
To identify if patients with inflammation (as indicated by elevated C-reactive protein (CRP) and serum hepcidin levels or low soluble transferrin receptor (sTfR)/log ferritin ratios) respond differently to darbepoetin alfa and iron therapy than patients without inflammation.
OUTLINE: Patients are stratified according to severity of anemia (mild [hemoglobin ≥ 9.5 g/dL] vs severe [hemoglobin < 9.5 g/dL]), treatment with a platinum-containing regimen (yes vs no), and gender. Patients are randomized to 1 of 3 treatment arms.
-
Arm I: Patients receive darbepoetin alfa subcutaneously and sodium ferric gluconate complex IV over 90 minutes on day 1.
-
Arm II: Patients receive darbepoetin alfa as in arm I and oral ferrous sulfate once daily on days 1-21.
-
Arm III: Patients receive darbepoetin alfa as in arm I and oral placebo once daily on days 1-21.
In all arms, treatment repeats every 21 days for up to 15 weeks in the absence of unacceptable toxicity.
Patients complete quality-of-life (QOL) questionnaires in weeks 1, 7, and 16.
Study Design
Study Type:
Interventional
Actual Enrollment
:
502 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Supportive Care
Official Title:
A Phase III, Randomized Study of the Effects of Parenteral Iron, Oral Iron, or No Iron Supplementation on the Erythropoietic Response to Darbepoetin Alfa for Cancer Patients With Chemotherapy-Associated Anemia
Study Start Date
:
Jan 1, 2006
Actual Primary Completion Date
:
Mar 1, 2009
Actual Study Completion Date
:
Mar 1, 2009
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Arm I Patients receive darbepoetin alfa subcutaneously and sodium ferric gluconate complex IV over 90 minutes on day 1. Treatment repeats every 21 days for up to 15 weeks in the absence of unacceptable toxicity. |
Biological: darbepoetin alfa
Given by injection
Drug: sodium ferric gluconate complex in sucrose
Given by IV
|
| Experimental: Arm II Patients receive darbepoetin alfa as in arm I and oral ferrous sulfate once daily on days 1-21. Treatment repeats every 21 days for up to 15 weeks in the absence of unacceptable toxicity. |
Biological: darbepoetin alfa
Given by injection
Dietary Supplement: ferrous sulfate
Given by mouth
|
| Experimental: Arm III Patients receive darbepoetin alfa as in arm I and oral placebo once daily on days 1-21. Treatment repeats every 21 days for up to 15 weeks in the absence of unacceptable toxicity. |
Biological: darbepoetin alfa
Given by injection
Other: placebo
Given by mouth
|
Outcome Measures
Primary Outcome Measures
- Hematopoietic Response Rate Defined as the Number of Participants Who Exhibit a Hematopoietic Response [16 Weeks]
Hematopoietic response was defined as Hemoglobin (Hb) increment of 2.0 g/dL from baseline or achievement of Hb >= 11 g/dL (whichever occurs first) in the absence of red blood cell transfusions during the preceding 28 days during the treatment period.
Secondary Outcome Measures
- Percentage of Patients Maintaining an Average Hemoglobin Level Within the National Comprehensive Cancer Network (NCCN) Range (11-13 g/dL) Through Week 16, Once Achieving a Hemoglobin of ≥ 11 g/dL [16 Weeks]
- Incidence of Patients Receiving at Least One Red Blood Cell (RBC) Transfusions [Week 1 to Week 16]
- Mean Increment in Hemoglobin Level at Week 7 [Baseline and 7 weeks]
Value at 7 weeks minus value at baseline.
- Mean Increment in Hemoglobin Level at Week 16 [Baseline and 16 weeks]
Value at 16 weeks minus value at baseline.
- Time to Hematopoietic Response [16 weeks]
Hematopoietic response was defined as Hb increment of 2.0 g/dL from baseline or achievement of Hb >= 11 g/dL (whichever occurs first) in the absence of red blood cell transfusions during the preceding 28 days during the treatment period.
- Time to First Red Blood Cell (RBC) Transfusions [16 weeks]
- Change From Baseline in Overall Quality of Life (QOL) Score as Measured by the Linear Analogue Self Assessment (LASA) [Baseline and 16 weeks]
Overall QOL item score range: 0 (Worst) to 10 (Best), ordinal. Change: score at 16 weeks minus score at baseline.
- Change From Baseline in Quality of Life (QOL) Score as Measured by Symptom Distress Scale (SDS) at End of Study [Baseline and 16 weeks]
SDS Scale range: 0 (Worst), 100 (Best), ordinal. Change: score at 16 weeks minus score at baseline. A clinically significant result will be defined as a shift of 10 points on a 0-100 point transformed scale between the average QOL scores of the 3 variants of iron therapy.
- Change From Baseline in Quality of Life (QOL) Score as Measured by Brief Fatigue Inventory(BFI) Fatigue Now Scale at End of Study [Baseline and 16 weeks]
Fatigue Now Scale range: 0 (No Fatigue) to 10 (Worst), ordinal. Change: score at 16 weeks minus score at baseline.
- Change From Baseline in Quality of Life (QOL) Score as Measured by The Functional Assessment of Cancer Therapy-Anemia (FACT-An) at End of Study [Baseline and 16 weeks]
FACT-AN Scale range: 0 (Worst) to 100 (Best), ordinal. Change: score at 16 weeks minus score at baseline. A clinically significant result will be defined as a shift of 10 points on a 0-100 point transformed scale between the average QOL scores of the 3 variants of iron therapy.
- C-reactive Protein (CRP) Level at Week 1, Week 7 and Week 16 [1 Week, 7 Weeks and 16 Weeks]
- Soluble Transferrin Receptor (sTfR)Level at Week 1, Week 7 and Week 16 [1 week, 7 weeks and 16 weeks]
- Ferritin Level at Baseline, Week 7 and Week 16 [Baseline, 7 weeks and 16 weeks]
- Mean Corpuscular Volume (MCV) Level at Baseline, Week 7 and Week 16 [Baseline, 7 weeks and 16 weeks]
MCV is a measure of the average red blood cell volume.
- Transferrin Saturation at Baseline, Week 7 and Week 16 [Baseline, 7 weeks and 16 weeks]
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
DISEASE CHARACTERISTICS:
-
Diagnosis of a non-myeloid cancer (other than non-melanomatous skin cancer)
-
Receiving or scheduled to receive chemotherapy (biological agents, such as small molecules/tyrosine kinase inhibitors and antibody-based therapies, are allowed)
-
Has chemotherapy-related anemia (hemoglobin < 11 g/dL)
-
No anemia known to be secondary to gastrointestinal bleeding or hemolysis
-
No anemia known to be secondary to vitamin B12 or folic acid deficiency
- Vitamin B12 and folic acid deficiency must be ruled out if the mean corpuscular volume (MCV) is > 100 fL
-
No anemia secondary to chemotherapy-induced myelodysplastic syndromes
-
No primary hematologic disorder causing moderate to severe anemia (e.g., congenital dyserythropoietic anemia, homozygous hemoglobin S disease or compound heterozygous sickling states, or thalassemia major)
-
Carriers for these disease states are eligible
-
No first-degree relative with primary hemochromatosis (unless the patient has undergone HFE genotyping and was found to have at least one wild-type allele, while the proband in the family demonstrated to have either the common C282Y or H63D mutation)
PATIENT CHARACTERISTICS:
-
ECOG performance status 0-2
-
Ferritin > 20 mcg/L (i.e., not obviously iron deficient)
-
ALT or AST < 5 times upper limit of normal
-
Alert, mentally competent, and able to sign informed consent
-
Not pregnant or nursing
-
Negative pregnancy test
-
Fertile patients must use effective contraception during and for 3 months after completion of study treatment
-
Willing or able to be randomized and undergo study treatment
-
Willing or able to fill out quality-of-life forms
-
No uncontrolled hypertension (i.e., systolic blood pressure [BP] ≥ 180 mm Hg or diastolic BP ≥ 100 mm Hg)
-
No history of uncontrolled cardiac arrhythmias
-
No pulmonary embolism or deep venous thrombosis within the past year (unless the patient is on anticoagulation therapy and planning to continue it during study participation)
-
No known hypersensitivity to darbepoetin alfa, erythropoietin, mammalian cell-derived products, iron, or human albumin
-
No seizures within the past 3 months
-
No gastrointestinal conditions expected to cause significant impairment of oral iron, such as untreated celiac disease or amyloidosis involving the gut - Patients with celiac disease who are adhering to a gluten-free diet are eligible
PRIOR CONCURRENT THERAPY:
-
See Disease Characteristics
-
More than 3 months since prior darbepoetin alfa, epoetin alfa, or any investigational forms of erythropoietin (e.g., gene-activated erythropoietin or novel erythropoiesis-stimulating protein)
-
More than 1 year since prior peripheral blood stem cell or bone marrow transplantation
-
More than 2 weeks since prior red blood cell transfusions
-
More than 14 days since prior major surgery
-
No prior gastrectomy or resection of > 100 cm of small intestine
-
Not planning to undergo stem cell or bone marrow transplantation within the next 6 months
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Mayo Clinic in Arizona | Scottsdale | Arizona | United States | |
| 2 | Mayo Clinic | Rochester | Minnesota | United States | 55905 |
Sponsors and Collaborators
- Mayo Clinic
- National Cancer Institute (NCI)
Investigators
- Study Chair: Charles L. Loprinzi, MD, Mayo Clinic
- Principal Investigator: Tom R. Fitch, M.D., Mayo Clinic
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
,
,
ClinicalTrials.gov Identifier:
NCT00661999
Other Study ID Numbers:
- CDR0000593480
- P30CA015083
- MC04CC
- NCI-2009-01226
- 1713-05
First Posted:
Apr 21, 2008
Last Update Posted:
May 17, 2011
Last Verified:
May 1, 2011
Keywords provided by ,
,
Additional relevant MeSH terms:
Study Results
Participant Flow
| Recruitment Details | Five-hundred and two (502) participants were recruited between February 2006 and December 2008 at Mayo Clinic Cancer Research Consortium (MCCRC) sites. |
|---|---|
| Pre-assignment Detail | Eight patients canceled before the first dose of darbepoetin alfa (DA) (3 DA + Intravenously (IV) Iron, 3 DA + Oral Iron and 2 DA + Placebo); and 4 patients were ineligible (2 DA + Oral Iron, 2 DA + Placebo). These 12 patients were excluded from all analysis. |
| Arm/Group Title | DA + IV Iron | DA + Oral Iron | DA + Placebo |
|---|---|---|---|
| Arm/Group Description | Patients receive darbepoetin alfa (DA) subcutaneously and sodium ferric gluconate complex intravenously (IV) over 90 minutes on day 1. Treatment repeats every 21 days for up to 15 weeks in the absence of unacceptable toxicity. | Patients receive darbepoetin alfa (DA) as in arm I and oral ferrous sulfate once daily on days 1-21. Treatment repeats every 21 days for up to 15 weeks in the absence of unacceptable toxicity. | Patients receive darbepoetin alfa (DA) as in arm I and oral placebo once daily on days 1-21. Treatment repeats every 21 days for up to 15 weeks in the absence of unacceptable toxicity. |
| Period Title: Overall Study | |||
| STARTED | 164 | 163 | 163 |
| COMPLETED | 105 | 113 | 106 |
| NOT COMPLETED | 59 | 50 | 57 |
Baseline Characteristics
| Arm/Group Title | DA + IV Iron | DA + Oral Iron | DA + Placebo | Total |
|---|---|---|---|---|
| Arm/Group Description | Patients receive darbepoetin alfa (DA) subcutaneously and sodium ferric gluconate complex intravenously (IV) over 90 minutes on day 1. Treatment repeats every 21 days for up to 15 weeks in the absence of unacceptable toxicity. | Patients receive darbepoetin alfa (DA) as in arm I and oral ferrous sulfate once daily on days 1-21. Treatment repeats every 21 days for up to 15 weeks in the absence of unacceptable toxicity. | Patients receive darbepoetin alfa (DA) as in arm I and oral placebo once daily on days 1-21. Treatment repeats every 21 days for up to 15 weeks in the absence of unacceptable toxicity. | Total of all reporting groups |
| Overall Participants | 164 | 163 | 163 | 490 |
| Age (years) [Mean (Standard Deviation) ] | ||||
| Mean (Standard Deviation) [years] |
64
(11)
|
63
(13)
|
63
(11)
|
63
(12)
|
| Sex: Female, Male (Count of Participants) | ||||
| Female |
109
66.5%
|
106
65%
|
105
64.4%
|
320
65.3%
|
| Male |
55
33.5%
|
57
35%
|
58
35.6%
|
170
34.7%
|
| Race (NIH/OMB) (Count of Participants) | ||||
| American Indian or Alaska Native |
0
0%
|
3
1.8%
|
1
0.6%
|
4
0.8%
|
| Asian |
0
0%
|
3
1.8%
|
1
0.6%
|
4
0.8%
|
| Native Hawaiian or Other Pacific Islander |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Black or African American |
6
3.7%
|
7
4.3%
|
4
2.5%
|
17
3.5%
|
| White |
155
94.5%
|
147
90.2%
|
156
95.7%
|
458
93.5%
|
| More than one race |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Unknown or Not Reported |
3
1.8%
|
3
1.8%
|
1
0.6%
|
7
1.4%
|
| Degree of Anemia (Number) [Number] | ||||
| Mild: Hemoglobin>=9.5 |
123
75%
|
123
75.5%
|
123
75.5%
|
369
75.3%
|
| Severe: Hemoglobin <9.5 |
41
25%
|
40
24.5%
|
40
24.5%
|
121
24.7%
|
| Platinum-Containing Regimen (Number) [Number] | ||||
| Yes |
79
48.2%
|
79
48.5%
|
78
47.9%
|
236
48.2%
|
| No |
85
51.8%
|
84
51.5%
|
85
52.1%
|
254
51.8%
|
| Tumor Type (Number) [Number] | ||||
| Hematologic Neoplasm |
6
3.7%
|
8
4.9%
|
11
6.7%
|
25
5.1%
|
| Solid Tumor |
157
95.7%
|
154
94.5%
|
151
92.6%
|
462
94.3%
|
| Both |
1
0.6%
|
1
0.6%
|
1
0.6%
|
3
0.6%
|
| Weight (kg) [Mean (Standard Deviation) ] | ||||
| Mean (Standard Deviation) [kg] |
77.4
(18.74)
|
79.4
(19.75)
|
76.4
(17.68)
|
77.7
(18.75)
|
| Height (cm) [Mean (Standard Deviation) ] | ||||
| Mean (Standard Deviation) [cm] |
166.9
(9.44)
|
167.7
(8.93)
|
166.8
(9.36)
|
167.1
(9.24)
|
| Baseline Ferritin (µg/L) [Mean (Standard Deviation) ] | ||||
| Mean (Standard Deviation) [µg/L] |
460.5
(526.99)
|
479.5
(484.15)
|
456.0
(479.27)
|
465.3
(496.41)
|
| Baseline Transferrin Saturation (Percentage Saturation) [Mean (Standard Deviation) ] | ||||
| Mean (Standard Deviation) [Percentage Saturation] |
22.5
(12.81)
|
19.6
(11.7)
|
22.2
(13.36)
|
21.5
(12.69)
|
Outcome Measures
| Title | Hematopoietic Response Rate Defined as the Number of Participants Who Exhibit a Hematopoietic Response |
|---|---|
| Description | Hematopoietic response was defined as Hemoglobin (Hb) increment of 2.0 g/dL from baseline or achievement of Hb >= 11 g/dL (whichever occurs first) in the absence of red blood cell transfusions during the preceding 28 days during the treatment period. |
| Time Frame | 16 Weeks |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | DA + IV Iron | DA + Oral Iron | DA + Placebo |
|---|---|---|---|
| Arm/Group Description | Patients receive darbepoetin alfa (DA) subcutaneously and sodium ferric gluconate complex intravenously (IV) over 90 minutes on day 1. Treatment repeats every 21 days for up to 15 weeks in the absence of unacceptable toxicity. | Patients receive darbepoetin alfa (DA) as in arm I and oral ferrous sulfate once daily on days 1-21. Treatment repeats every 21 days for up to 15 weeks in the absence of unacceptable toxicity. | Patients receive darbepoetin alfa (DA) as in arm I and oral placebo once daily on days 1-21. Treatment repeats every 21 days for up to 15 weeks in the absence of unacceptable toxicity. |
| Measure Participants | 164 | 163 | 163 |
| Yes |
114
69.5%
|
109
66.9%
|
106
65%
|
| No |
50
30.5%
|
54
33.1%
|
57
35%
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | DA + IV Iron, DA + Placebo |
|---|---|---|
| Comments | With 176 evaluable participants per treatment arm, there would have been >=80% power to detect a difference across two treatment arms of 15% in the primary hematopoietic response endpoint through Fisher's exact test, if the true percentage of patients that experience a hematopoietic response was at least 30% in the superior group, with a 2.5% type I error rate. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.39 |
| Comments | ||
| Method | Fisher Exact | |
| Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | DA + Oral Iron, DA + Placebo |
|---|---|---|
| Comments | With 176 evaluable participants per treatment arm, there would have been >=80% power to detect a difference across two treatment arms of 15% in the primary hematopoietic response endpoint through Fisher's exact test, if the true percentage of patients that experience a hematopoietic response was at least 30% in the superior group, with a 2.5% type I error rate. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.73 |
| Comments | ||
| Method | Fisher Exact | |
| Comments | ||
| Title | Percentage of Patients Maintaining an Average Hemoglobin Level Within the National Comprehensive Cancer Network (NCCN) Range (11-13 g/dL) Through Week 16, Once Achieving a Hemoglobin of ≥ 11 g/dL |
|---|---|
| Description | |
| Time Frame | 16 Weeks |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | DA + IV Iron | DA + Oral Iron | DA + Placebo |
|---|---|---|---|
| Arm/Group Description | Patients receive darbepoetin alfa (DA) subcutaneously and sodium ferric gluconate complex intravenously (IV) over 90 minutes on day 1. Treatment repeats every 21 days for up to 15 weeks in the absence of unacceptable toxicity. | Patients receive darbepoetin alfa (DA) as in arm I and oral ferrous sulfate once daily on days 1-21. Treatment repeats every 21 days for up to 15 weeks in the absence of unacceptable toxicity. | Patients receive darbepoetin alfa (DA) as in arm I and oral placebo once daily on days 1-21. Treatment repeats every 21 days for up to 15 weeks in the absence of unacceptable toxicity. |
| Measure Participants | 164 | 163 | 163 |
| Number [Percentage of Participants] |
10
6.1%
|
12
7.4%
|
11
6.7%
|
| Title | Incidence of Patients Receiving at Least One Red Blood Cell (RBC) Transfusions |
|---|---|
| Description | |
| Time Frame | Week 1 to Week 16 |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | DA + IV Iron | DA + Oral Iron | DA + Placebo |
|---|---|---|---|
| Arm/Group Description | Patients receive darbepoetin alfa (DA) subcutaneously and sodium ferric gluconate complex intravenously (IV) over 90 minutes on day 1. Treatment repeats every 21 days for up to 15 weeks in the absence of unacceptable toxicity. | Patients receive darbepoetin alfa (DA) as in arm I and oral ferrous sulfate once daily on days 1-21. Treatment repeats every 21 days for up to 15 weeks in the absence of unacceptable toxicity. | Patients receive darbepoetin alfa (DA) as in arm I and oral placebo once daily on days 1-21. Treatment repeats every 21 days for up to 15 weeks in the absence of unacceptable toxicity. |
| Measure Participants | 164 | 163 | 163 |
| Yes |
20
12.2%
|
21
12.9%
|
22
13.5%
|
| No |
144
87.8%
|
142
87.1%
|
141
86.5%
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | DA + IV Iron, DA + Placebo |
|---|---|---|
| Comments | With 176 evaluable participants per treatment arm, there would have been >=80% power to detect a difference across two treatment arms of 15% in the true percentage of patients that need transfusion was at least 30% in the superior group, with a 2.5% type I error rate. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.7250 |
| Comments | ||
| Method | Fisher Exact | |
| Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | DA + Oral Iron, DA + Placebo |
|---|---|---|
| Comments | With 176 evaluable participants per treatment arm, there would have been >=80% power to detect a difference across two treatment arms of 15% in the true percentage of patients that need transfusion was at least 30% in the superior group, with a 2.5% type I error rate. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.8700 |
| Comments | ||
| Method | Fisher Exact | |
| Comments | ||
| Title | Mean Increment in Hemoglobin Level at Week 7 |
|---|---|
| Description | Value at 7 weeks minus value at baseline. |
| Time Frame | Baseline and 7 weeks |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | DA + IV Iron | DA + Oral Iron | DA + Placebo |
|---|---|---|---|
| Arm/Group Description | Patients receive darbepoetin alfa (DA) subcutaneously and sodium ferric gluconate complex intravenously (IV) over 90 minutes on day 1. Treatment repeats every 21 days for up to 15 weeks in the absence of unacceptable toxicity. | Patients receive darbepoetin alfa (DA) as in arm I and oral ferrous sulfate once daily on days 1-21. Treatment repeats every 21 days for up to 15 weeks in the absence of unacceptable toxicity. | Patients receive darbepoetin alfa (DA) as in arm I and oral placebo once daily on days 1-21. Treatment repeats every 21 days for up to 15 weeks in the absence of unacceptable toxicity. |
| Measure Participants | 164 | 163 | 163 |
| Mean (Standard Deviation) [g/dL] |
1.3
(1.35)
|
1.1
(1.37)
|
1.2
(1.35)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | DA + IV Iron, DA + Placebo |
|---|---|---|
| Comments | With 176 evaluable participants per treatment arm, there would have been >=80% power to detect a difference across two treatment arms of 33% of the standard deviation in average hemoglobin levels through two-sided alternative, with a 2.5% type I error rate. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.6639 |
| Comments | ||
| Method | t-test, 2 sided | |
| Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | DA + Oral Iron, DA + Placebo |
|---|---|---|
| Comments | With 176 evaluable participants per treatment arm, there would have been >=80% power to detect a difference across two treatment arms of 33% of the standard deviation in average hemoglobin levels through two-sided alternative, with a 2.5% type I error rate. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.5660 |
| Comments | ||
| Method | t-test, 2 sided | |
| Comments | ||
| Title | Mean Increment in Hemoglobin Level at Week 16 |
|---|---|
| Description | Value at 16 weeks minus value at baseline. |
| Time Frame | Baseline and 16 weeks |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | DA + IV Iron | DA + Oral Iron | DA + Placebo |
|---|---|---|---|
| Arm/Group Description | Patients receive darbepoetin alfa (DA) subcutaneously and sodium ferric gluconate complex intravenously (IV) over 90 minutes on day 1. Treatment repeats every 21 days for up to 15 weeks in the absence of unacceptable toxicity. | Patients receive darbepoetin alfa (DA) as in arm I and oral ferrous sulfate once daily on days 1-21. Treatment repeats every 21 days for up to 15 weeks in the absence of unacceptable toxicity. | Patients receive darbepoetin alfa (DA) as in arm I and oral placebo once daily on days 1-21. Treatment repeats every 21 days for up to 15 weeks in the absence of unacceptable toxicity. |
| Measure Participants | 164 | 163 | 163 |
| Mean (Standard Deviation) [g/dL] |
2.1
(1.46)
|
2.0
(1.61)
|
1.7
(1.64)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | DA + IV Iron, DA + Placebo |
|---|---|---|
| Comments | With 176 evaluable participants per treatment arm, there would have been >=80% power to detect a difference across two treatment arms of 33% of the standard deviation in average hemoglobin levels through two-sided alternative, with a 2.5% type I error rate. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.1124 |
| Comments | ||
| Method | t-test, 2 sided | |
| Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | DA + Oral Iron, DA + Placebo |
|---|---|---|
| Comments | With 176 evaluable participants per treatment arm, there would have been >=80% power to detect a difference across two treatment arms of 33% of the standard deviation in average hemoglobin levels through two-sided alternative, with a 2.5% type I error rate. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.2051 |
| Comments | ||
| Method | t-test, 2 sided | |
| Comments | ||
| Title | Time to Hematopoietic Response |
|---|---|
| Description | Hematopoietic response was defined as Hb increment of 2.0 g/dL from baseline or achievement of Hb >= 11 g/dL (whichever occurs first) in the absence of red blood cell transfusions during the preceding 28 days during the treatment period. |
| Time Frame | 16 weeks |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | DA + IV Iron | DA + Oral Iron | DA + Placebo |
|---|---|---|---|
| Arm/Group Description | Patients receive darbepoetin alfa (DA) subcutaneously and sodium ferric gluconate complex intravenously (IV) over 90 minutes on day 1. Treatment repeats every 21 days for up to 15 weeks in the absence of unacceptable toxicity. | Patients receive darbepoetin alfa (DA) as in arm I and oral ferrous sulfate once daily on days 1-21. Treatment repeats every 21 days for up to 15 weeks in the absence of unacceptable toxicity. | Patients receive darbepoetin alfa (DA) as in arm I and oral placebo once daily on days 1-21. Treatment repeats every 21 days for up to 15 weeks in the absence of unacceptable toxicity. |
| Measure Participants | 164 | 163 | 163 |
| Median (95% Confidence Interval) [Days] |
43
|
61
|
50
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | DA + IV Iron, DA + Oral Iron, DA + Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.0648 |
| Comments | ||
| Method | Log Rank | |
| Comments | ||
| Title | Time to First Red Blood Cell (RBC) Transfusions |
|---|---|
| Description | |
| Time Frame | 16 weeks |
Outcome Measure Data
| Analysis Population Description |
|---|
| Only 63 participants (20 DA + IV Iron, 21 DA + Oral Iron and 22 DA + Placebo) needed RBC transfusion during 16 weeks of treatment period. Thus, median of time to first RBC transfusion and 95 % confidence interval are not attainable. |
| Arm/Group Title | DA + IV Iron | DA + Oral Iron | DA + Placebo |
|---|---|---|---|
| Arm/Group Description | Patients receive darbepoetin alfa (DA) subcutaneously and sodium ferric gluconate complex intravenously (IV) over 90 minutes on day 1. Treatment repeats every 21 days for up to 15 weeks in the absence of unacceptable toxicity. | Patients receive darbepoetin alfa (DA) as in arm I and oral ferrous sulfate once daily on days 1-21. Treatment repeats every 21 days for up to 15 weeks in the absence of unacceptable toxicity. | Patients receive darbepoetin alfa (DA) as in arm I and oral placebo once daily on days 1-21. Treatment repeats every 21 days for up to 15 weeks in the absence of unacceptable toxicity. |
| Measure Participants | 0 | 0 | 0 |
| Title | Change From Baseline in Overall Quality of Life (QOL) Score as Measured by the Linear Analogue Self Assessment (LASA) |
|---|---|
| Description | Overall QOL item score range: 0 (Worst) to 10 (Best), ordinal. Change: score at 16 weeks minus score at baseline. |
| Time Frame | Baseline and 16 weeks |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | DA + IV Iron | DA + Oral Iron | DA + Placebo |
|---|---|---|---|
| Arm/Group Description | Patients receive darbepoetin alfa (DA) subcutaneously and sodium ferric gluconate complex intravenously (IV) over 90 minutes on day 1. Treatment repeats every 21 days for up to 15 weeks in the absence of unacceptable toxicity. | Patients receive darbepoetin alfa (DA) as in arm I and oral ferrous sulfate once daily on days 1-21. Treatment repeats every 21 days for up to 15 weeks in the absence of unacceptable toxicity. | Patients receive darbepoetin alfa (DA) as in arm I and oral placebo once daily on days 1-21. Treatment repeats every 21 days for up to 15 weeks in the absence of unacceptable toxicity. |
| Measure Participants | 164 | 163 | 163 |
| Mean (Standard Deviation) [Scores on a scale] |
0.4
(2.18)
|
0.2
(2.23)
|
0.5
(2.28)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | DA + IV Iron, DA + Placebo |
|---|---|---|
| Comments | With 176 evaluable participants per treatment arm, there would have been >=80% power to detect a difference across two treatment arms of 33% of the standard deviation in participant QOL through t-test/Wilcoxon test, with a 2.5% type I error rate. A 10 points shift on a 0-100 point scale in QOL measures is generally considered clinically relevant and specifically important in the use of UNISCALE, BFI and FACT-An. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.61 |
| Comments | ||
| Method | t-test, 2 sided | |
| Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | DA + Oral Iron, DA + Placebo |
|---|---|---|
| Comments | With 176 evaluable participants per treatment arm, there would have been >=80% power to detect a difference across two treatment arms of 33% of the standard deviation in participant QOL through t-test/Wilcoxon test, with a 2.5% type I error rate. A 10 points shift on a 0-100 point scale in QOL measures is generally considered clinically relevant and specifically important in the use of UNISCALE, BFI and FACT-An. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.44 |
| Comments | ||
| Method | t-test, 2 sided | |
| Comments | ||
| Title | Change From Baseline in Quality of Life (QOL) Score as Measured by Symptom Distress Scale (SDS) at End of Study |
|---|---|
| Description | SDS Scale range: 0 (Worst), 100 (Best), ordinal. Change: score at 16 weeks minus score at baseline. A clinically significant result will be defined as a shift of 10 points on a 0-100 point transformed scale between the average QOL scores of the 3 variants of iron therapy. |
| Time Frame | Baseline and 16 weeks |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | DA + IV Iron | DA + Oral Iron | DA + Placebo |
|---|---|---|---|
| Arm/Group Description | Patients receive darbepoetin alfa (DA) subcutaneously and sodium ferric gluconate complex intravenously (IV) over 90 minutes on day 1. Treatment repeats every 21 days for up to 15 weeks in the absence of unacceptable toxicity. | Patients receive darbepoetin alfa (DA) as in arm I and oral ferrous sulfate once daily on days 1-21. Treatment repeats every 21 days for up to 15 weeks in the absence of unacceptable toxicity. | Patients receive darbepoetin alfa (DA) as in arm I and oral placebo once daily on days 1-21. Treatment repeats every 21 days for up to 15 weeks in the absence of unacceptable toxicity. |
| Measure Participants | 164 | 163 | 163 |
| Mean (Standard Deviation) [Scores on a scale] |
6.0
(11.73)
|
3.5
(11.54)
|
5.4
(10.50)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | DA + IV Iron, DA + Placebo |
|---|---|---|
| Comments | With 176 evaluable participants per treatment arm, there would have been >=80% power to detect a difference across two treatment arms of 33% of the standard deviation in participant QOL through t-test/Wilcoxon test, with a 2.5% type I error rate. A 10 points shift on a 0-100 point scale in QOL measures is generally considered clinically relevant and specifically important in the use of UNISCALE, BFI and FACT-An. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.62 |
| Comments | ||
| Method | t-test, 2 sided | |
| Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | DA + Oral Iron, DA + Placebo |
|---|---|---|
| Comments | With 176 evaluable participants per treatment arm, there would have been >=80% power to detect a difference across two treatment arms of 33% of the standard deviation in participant QOL through t-test/Wilcoxon test, with a 2.5% type I error rate. A 10 points shift on a 0-100 point scale in QOL measures is generally considered clinically relevant and specifically important in the use of UNISCALE, BFI and FACT-An. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.30 |
| Comments | ||
| Method | t-test, 2 sided | |
| Comments | ||
| Title | Change From Baseline in Quality of Life (QOL) Score as Measured by Brief Fatigue Inventory(BFI) Fatigue Now Scale at End of Study |
|---|---|
| Description | Fatigue Now Scale range: 0 (No Fatigue) to 10 (Worst), ordinal. Change: score at 16 weeks minus score at baseline. |
| Time Frame | Baseline and 16 weeks |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | DA + IV Iron | DA + Oral Iron | DA + Placebo |
|---|---|---|---|
| Arm/Group Description | Patients receive darbepoetin alfa (DA) subcutaneously and sodium ferric gluconate complex intravenously (IV) over 90 minutes on day 1. Treatment repeats every 21 days for up to 15 weeks in the absence of unacceptable toxicity. | Patients receive darbepoetin alfa (DA) as in arm I and oral ferrous sulfate once daily on days 1-21. Treatment repeats every 21 days for up to 15 weeks in the absence of unacceptable toxicity. | Patients receive darbepoetin alfa (DA) as in arm I and oral placebo once daily on days 1-21. Treatment repeats every 21 days for up to 15 weeks in the absence of unacceptable toxicity. |
| Measure Participants | 164 | 163 | 163 |
| Mean (Standard Deviation) [Scores on a scale] |
-1.1
(3.08)
|
-1.1
(2.95)
|
-1.6
(2.82)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | DA + IV Iron, DA + Placebo |
|---|---|---|
| Comments | With 176 evaluable participants per treatment arm, there would have been >=80% power to detect a difference across two treatment arms of 33% of the standard deviation in participant QOL through t-test/Wilcoxon test, with a 2.5% type I error rate. A 10 points shift on a 0-100 point scale in QOL measures is generally considered clinically relevant and specifically important in the use of UNISCALE, BFI and FACT-An. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.19 |
| Comments | ||
| Method | t-test, 2 sided | |
| Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | DA + Oral Iron, DA + Placebo |
|---|---|---|
| Comments | With 176 evaluable participants per treatment arm, there would have been >=80% power to detect a difference across two treatment arms of 33% of the standard deviation in participant QOL through t-test/Wilcoxon test, with a 2.5% type I error rate. A 10 points shift on a 0-100 point scale in QOL measures is generally considered clinically relevant and specifically important in the use of UNISCALE, BFI and FACT-An. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.17 |
| Comments | ||
| Method | t-test, 2 sided | |
| Comments | ||
| Title | Change From Baseline in Quality of Life (QOL) Score as Measured by The Functional Assessment of Cancer Therapy-Anemia (FACT-An) at End of Study |
|---|---|
| Description | FACT-AN Scale range: 0 (Worst) to 100 (Best), ordinal. Change: score at 16 weeks minus score at baseline. A clinically significant result will be defined as a shift of 10 points on a 0-100 point transformed scale between the average QOL scores of the 3 variants of iron therapy. |
| Time Frame | Baseline and 16 weeks |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | DA + IV Iron | DA + Oral Iron | DA + Placebo |
|---|---|---|---|
| Arm/Group Description | Patients receive darbepoetin alfa (DA) subcutaneously and sodium ferric gluconate complex intravenously (IV) over 90 minutes on day 1. Treatment repeats every 21 days for up to 15 weeks in the absence of unacceptable toxicity. | Patients receive darbepoetin alfa (DA) as in arm I and oral ferrous sulfate once daily on days 1-21. Treatment repeats every 21 days for up to 15 weeks in the absence of unacceptable toxicity. | Patients receive darbepoetin alfa (DA) as in arm I and oral placebo once daily on days 1-21. Treatment repeats every 21 days for up to 15 weeks in the absence of unacceptable toxicity. |
| Measure Participants | 164 | 163 | 163 |
| Mean (Standard Deviation) [Scores on a scale] |
8.1
(16.57)
|
8.9
(18.97)
|
9.5
(18.79)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | DA + IV Iron, DA + Placebo |
|---|---|---|
| Comments | With 176 evaluable participants per treatment arm, there would have been >=80% power to detect a difference across two treatment arms of 33% of the standard deviation in participant QOL through t-test/Wilcoxon test, with a 2.5% type I error rate. A 10 points shift on a 0-100 point scale in QOL measures is generally considered clinically relevant and specifically important in the use of UNISCALE, BFI and FACT-An. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.73 |
| Comments | ||
| Method | t-test, 2 sided | |
| Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | DA + Oral Iron, DA + Placebo |
|---|---|---|
| Comments | With 176 evaluable participants per treatment arm, there would have been >=80% power to detect a difference across two treatment arms of 33% of the standard deviation in participant QOL through t-test/Wilcoxon test, with a 2.5% type I error rate. A 10 points shift on a 0-100 point scale in QOL measures is generally considered clinically relevant and specifically important in the use of UNISCALE, BFI and FACT-An. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.83 |
| Comments | ||
| Method | t-test, 2 sided | |
| Comments | ||
| Title | C-reactive Protein (CRP) Level at Week 1, Week 7 and Week 16 |
|---|---|
| Description | |
| Time Frame | 1 Week, 7 Weeks and 16 Weeks |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | DA + IV Iron | DA + Oral Iron | DA + Placebo |
|---|---|---|---|
| Arm/Group Description | Patients receive darbepoetin alfa (DA) subcutaneously and sodium ferric gluconate complex intravenously (IV) over 90 minutes on day 1. Treatment repeats every 21 days for up to 15 weeks in the absence of unacceptable toxicity. | Patients receive darbepoetin alfa (DA) as in arm I and oral ferrous sulfate once daily on days 1-21. Treatment repeats every 21 days for up to 15 weeks in the absence of unacceptable toxicity. | Patients receive darbepoetin alfa (DA) as in arm I and oral placebo once daily on days 1-21. Treatment repeats every 21 days for up to 15 weeks in the absence of unacceptable toxicity. |
| Measure Participants | 164 | 163 | 163 |
| Week 1 |
24.8
(38.12)
|
25.4
(36.36)
|
31.6
(58.68)
|
| Week 7 |
28.6
(51.09)
|
16.6
(25.25)
|
27.0
(49.20)
|
| Week 16 |
25.6
(46.30)
|
16.7
(36.98)
|
21.2
(39.07)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | DA + IV Iron, DA + Oral Iron, DA + Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.3852 |
| Comments | Test Comparison for Week 1 Level | |
| Method | Kruskal-Wallis | |
| Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | DA + IV Iron, DA + Oral Iron, DA + Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.0663 |
| Comments | Test Comparison for Week 7 Level. | |
| Method | Kruskal-Wallis | |
| Comments | ||
Statistical Analysis 3
| Statistical Analysis Overview | Comparison Group Selection | DA + IV Iron, DA + Oral Iron, DA + Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.3220 |
| Comments | Test Comparison for Week 16 Level | |
| Method | Kruskal-Wallis | |
| Comments | ||
| Title | Soluble Transferrin Receptor (sTfR)Level at Week 1, Week 7 and Week 16 |
|---|---|
| Description | |
| Time Frame | 1 week, 7 weeks and 16 weeks |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | DA + IV Iron | DA + Oral Iron | DA + Placebo |
|---|---|---|---|
| Arm/Group Description | Patients receive darbepoetin alfa (DA) subcutaneously and sodium ferric gluconate complex intravenously (IV) over 90 minutes on day 1. Treatment repeats every 21 days for up to 15 weeks in the absence of unacceptable toxicity. | Patients receive darbepoetin alfa (DA) as in arm I and oral ferrous sulfate once daily on days 1-21. Treatment repeats every 21 days for up to 15 weeks in the absence of unacceptable toxicity. | Patients receive darbepoetin alfa (DA) as in arm I and oral placebo once daily on days 1-21. Treatment repeats every 21 days for up to 15 weeks in the absence of unacceptable toxicity. |
| Measure Participants | 164 | 163 | 163 |
| Week 1 |
3.9
(2.14)
|
4.0
(1.99)
|
4.5
(4.52)
|
| Week 7 |
6.1
(3.04)
|
6.2
(2.4)
|
7.1
(2.92)
|
| Week 16 |
5.1
(3.07)
|
5.2
(2.19)
|
5.6
(2.6)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | DA + IV Iron, DA + Oral Iron, DA + Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.1826 |
| Comments | Test Comparison for Week 1 Level. | |
| Method | Kruskal-Wallis | |
| Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | DA + IV Iron, DA + Oral Iron, DA + Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.0113 |
| Comments | Test comparison for week 7 level | |
| Method | Kruskal-Wallis | |
| Comments | ||
Statistical Analysis 3
| Statistical Analysis Overview | Comparison Group Selection | DA + IV Iron, DA + Oral Iron, DA + Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.3358 |
| Comments | Test Comparison for week 16 level | |
| Method | Kruskal-Wallis | |
| Comments | ||
| Title | Ferritin Level at Baseline, Week 7 and Week 16 |
|---|---|
| Description | |
| Time Frame | Baseline, 7 weeks and 16 weeks |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | DA + IV Iron | DA + Oral Iron | DA + Placebo |
|---|---|---|---|
| Arm/Group Description | Patients receive darbepoetin alfa (DA) subcutaneously and sodium ferric gluconate complex intravenously (IV) over 90 minutes on day 1. Treatment repeats every 21 days for up to 15 weeks in the absence of unacceptable toxicity. | Patients receive darbepoetin alfa (DA) as in arm I and oral ferrous sulfate once daily on days 1-21. Treatment repeats every 21 days for up to 15 weeks in the absence of unacceptable toxicity. | Patients receive darbepoetin alfa (DA) as in arm I and oral placebo once daily on days 1-21. Treatment repeats every 21 days for up to 15 weeks in the absence of unacceptable toxicity. |
| Measure Participants | 164 | 163 | 163 |
| Baseline |
460.5
(526.99)
|
479.5
(484.15)
|
456.0
(479.27)
|
| Week 7 |
699.1
(645.31)
|
420.6
(498.24)
|
478.4
(607.89)
|
| Week 16 |
726.0
(1037.43)
|
425.9
(717.43)
|
371.5
(479.87)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | DA + IV Iron, DA + Oral Iron, DA + Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.9022 |
| Comments | Test comparison for Baseline level. | |
| Method | Kruskal-Wallis | |
| Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | DA + IV Iron, DA + Oral Iron, DA + Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.0002 |
| Comments | Test Comparison for Week 7 Level. | |
| Method | Kruskal-Wallis | |
| Comments | ||
Statistical Analysis 3
| Statistical Analysis Overview | Comparison Group Selection | DA + IV Iron, DA + Oral Iron, DA + Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.0022 |
| Comments | Test Comparison for Week 16 Level. | |
| Method | Kruskal-Wallis | |
| Comments | ||
| Title | Mean Corpuscular Volume (MCV) Level at Baseline, Week 7 and Week 16 |
|---|---|
| Description | MCV is a measure of the average red blood cell volume. |
| Time Frame | Baseline, 7 weeks and 16 weeks |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | DA + IV Iron | DA + Oral Iron | DA + Placebo |
|---|---|---|---|
| Arm/Group Description | Patients receive darbepoetin alfa (DA) subcutaneously and sodium ferric gluconate complex intravenously (IV) over 90 minutes on day 1. Treatment repeats every 21 days for up to 15 weeks in the absence of unacceptable toxicity. | Patients receive darbepoetin alfa (DA) as in arm I and oral ferrous sulfate once daily on days 1-21. Treatment repeats every 21 days for up to 15 weeks in the absence of unacceptable toxicity. | Patients receive darbepoetin alfa (DA) as in arm I and oral placebo once daily on days 1-21. Treatment repeats every 21 days for up to 15 weeks in the absence of unacceptable toxicity. |
| Measure Participants | 164 | 163 | 163 |
| Baseline |
90.0
(5.92)
|
88.5
(9.05)
|
90.1
(8.19)
|
| Week 7 |
93.0
(9.21)
|
92.3
(9.70)
|
92.8
(8.56)
|
| Week 16 |
94.0
(11.37)
|
94.4
(7.55)
|
92.3
(9.31)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | DA + IV Iron, DA + Oral Iron, DA + Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.1137 |
| Comments | Test comparison for baseline level. | |
| Method | Kruskal-Wallis | |
| Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | DA + IV Iron, DA + Oral Iron, DA + Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.8042 |
| Comments | Test comparison for week 7 level. | |
| Method | Kruskal-Wallis | |
| Comments | ||
Statistical Analysis 3
| Statistical Analysis Overview | Comparison Group Selection | DA + IV Iron, DA + Oral Iron, DA + Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.2016 |
| Comments | Test comparison for week 16 level. | |
| Method | Kruskal-Wallis | |
| Comments | ||
| Title | Transferrin Saturation at Baseline, Week 7 and Week 16 |
|---|---|
| Description | |
| Time Frame | Baseline, 7 weeks and 16 weeks |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | DA + IV Iron | DA + Oral Iron | DA + Placebo |
|---|---|---|---|
| Arm/Group Description | Patients receive darbepoetin alfa (DA) subcutaneously and sodium ferric gluconate complex intravenously (IV) over 90 minutes on day 1. Treatment repeats every 21 days for up to 15 weeks in the absence of unacceptable toxicity. | Patients receive darbepoetin alfa (DA) as in arm I and oral ferrous sulfate once daily on days 1-21. Treatment repeats every 21 days for up to 15 weeks in the absence of unacceptable toxicity. | Patients receive darbepoetin alfa (DA) as in arm I and oral placebo once daily on days 1-21. Treatment repeats every 21 days for up to 15 weeks in the absence of unacceptable toxicity. |
| Measure Participants | 164 | 163 | 163 |
| Baseline |
22.5
(12.81)
|
19.6
(11.7)
|
22.2
(13.36)
|
| Week 7 |
25.6
(17.48)
|
26.4
(23.56)
|
21.2
(13.12)
|
| Week 16 |
26.9
(14.16)
|
27.6
(17.81)
|
23.9
(15.54)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | DA + IV Iron, DA + Oral Iron, DA + Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.1139 |
| Comments | Test comparison for baseline level. | |
| Method | Kruskal-Wallis | |
| Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | DA + IV Iron, DA + Oral Iron, DA + Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.0424 |
| Comments | Test comparison for week 7 level. | |
| Method | Kruskal-Wallis | |
| Comments | ||
Statistical Analysis 3
| Statistical Analysis Overview | Comparison Group Selection | DA + IV Iron, DA + Oral Iron, DA + Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.2025 |
| Comments | Test comparison for week 16 level. | |
| Method | Kruskal-Wallis | |
| Comments | ||
Adverse Events
| Time Frame | ||||||
|---|---|---|---|---|---|---|
| Adverse Event Reporting Description | ||||||
| Arm/Group Title | DA + IV Iron | DA + Oral Iron | DA + Placebo | |||
| Arm/Group Description | Patients receive darbepoetin alfa (DA) subcutaneously and sodium ferric gluconate complex intravenously (IV) over 90 minutes on day 1. Treatment repeats every 21 days for up to 15 weeks in the absence of unacceptable toxicity. | Patients receive darbepoetin alfa (DA) as in arm I and oral ferrous sulfate once daily on days 1-21. Treatment repeats every 21 days for up to 15 weeks in the absence of unacceptable toxicity. | Patients receive darbepoetin alfa (DA) as in arm I and oral placebo once daily on days 1-21. Treatment repeats every 21 days for up to 15 weeks in the absence of unacceptable toxicity. | |||
All Cause Mortality |
||||||
| DA + IV Iron | DA + Oral Iron | DA + Placebo | ||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | / (NaN) | / (NaN) | / (NaN) | |||
Serious Adverse Events |
||||||
| DA + IV Iron | DA + Oral Iron | DA + Placebo | ||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 5/164 (3%) | 3/163 (1.8%) | 2/163 (1.2%) | |||
| Blood and lymphatic system disorders | ||||||
| Febrile neutropenia | 1/164 (0.6%) | 1 | 0/163 (0%) | 0 | 0/163 (0%) | 0 |
| Gastrointestinal disorders | ||||||
| Fistula-intestinal | 0/164 (0%) | 0 | 0/163 (0%) | 0 | 1/163 (0.6%) | 1 |
| General disorders | ||||||
| Fatigue | 0/164 (0%) | 0 | 0/163 (0%) | 0 | 1/163 (0.6%) | 1 |
| Syndromes | 1/164 (0.6%) | 1 | 0/163 (0%) | 0 | 0/163 (0%) | 0 |
| Infections and infestations | ||||||
| Pneumonia | 1/164 (0.6%) | 1 | 0/163 (0%) | 0 | 0/163 (0%) | 0 |
| Investigations | ||||||
| Activated partial thromboplastin time prolonged | 0/164 (0%) | 0 | 1/163 (0.6%) | 1 | 0/163 (0%) | 0 |
| Leukopenia | 0/164 (0%) | 0 | 1/163 (0.6%) | 1 | 0/163 (0%) | 0 |
| Neutropenia | 2/164 (1.2%) | 2 | 0/163 (0%) | 0 | 0/163 (0%) | 0 |
| Platelet count decreased | 1/164 (0.6%) | 1 | 0/163 (0%) | 0 | 0/163 (0%) | 0 |
| Musculoskeletal and connective tissue disorders | ||||||
| Arthralgia | 0/164 (0%) | 0 | 1/163 (0.6%) | 1 | 0/163 (0%) | 0 |
| Psychiatric disorders | ||||||
| Confusion | 1/164 (0.6%) | 2 | 0/163 (0%) | 0 | 0/163 (0%) | 0 |
| Respiratory, thoracic and mediastinal disorders | ||||||
| Dyspnea | 0/164 (0%) | 0 | 2/163 (1.2%) | 2 | 0/163 (0%) | 0 |
| Vascular disorders | ||||||
| Thrombosis | 0/164 (0%) | 0 | 1/163 (0.6%) | 1 | 0/163 (0%) | 0 |
Other (Not Including Serious) Adverse Events |
||||||
| DA + IV Iron | DA + Oral Iron | DA + Placebo | ||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 150/164 (91.5%) | 147/163 (90.2%) | 141/163 (86.5%) | |||
| Blood and lymphatic system disorders | ||||||
| Anemia | 6/164 (3.7%) | 9 | 13/163 (8%) | 14 | 8/163 (4.9%) | 9 |
| Febrile neutropenia | 3/164 (1.8%) | 3 | 1/163 (0.6%) | 1 | 2/163 (1.2%) | 4 |
| Cardiac disorders | ||||||
| Atrial fibrillation | 1/164 (0.6%) | 1 | 0/163 (0%) | 0 | 1/163 (0.6%) | 1 |
| Ischemia/Infarction | 0/164 (0%) | 0 | 0/163 (0%) | 0 | 1/163 (0.6%) | 1 |
| Pericardial effusion | 1/164 (0.6%) | 1 | 0/163 (0%) | 0 | 0/163 (0%) | 0 |
| Restrictive cardiomyopathy | 0/164 (0%) | 0 | 0/163 (0%) | 0 | 1/163 (0.6%) | 1 |
| Right ventricular dysfunction | 0/164 (0%) | 0 | 0/163 (0%) | 0 | 1/163 (0.6%) | 1 |
| Sinus tachycardia | 2/164 (1.2%) | 2 | 0/163 (0%) | 0 | 0/163 (0%) | 0 |
| Supraventricular tachycardia | 0/164 (0%) | 0 | 0/163 (0%) | 0 | 1/163 (0.6%) | 1 |
| Valvular heart disease | 0/164 (0%) | 0 | 0/163 (0%) | 0 | 1/163 (0.6%) | 1 |
| Eye disorders | ||||||
| Extraocular muscle disorder | 0/164 (0%) | 0 | 0/163 (0%) | 0 | 1/163 (0.6%) | 1 |
| Ocular weakness | 1/164 (0.6%) | 1 | 0/163 (0%) | 0 | 0/163 (0%) | 0 |
| Vision-Blurred | 1/164 (0.6%) | 1 | 0/163 (0%) | 0 | 0/163 (0%) | 0 |
| Gastrointestinal disorders | ||||||
| Abdominal distension | 0/164 (0%) | 0 | 1/163 (0.6%) | 1 | 0/163 (0%) | 0 |
| Anus Mucositis/stomatitis (clinical exam) | 1/164 (0.6%) | 1 | 0/163 (0%) | 0 | 0/163 (0%) | 0 |
| Ascites | 0/164 (0%) | 0 | 1/163 (0.6%) | 1 | 0/163 (0%) | 0 |
| Colonic hemorrhage | 0/164 (0%) | 0 | 1/163 (0.6%) | 1 | 0/163 (0%) | 0 |
| Colonic perforation | 1/164 (0.6%) | 1 | 0/163 (0%) | 0 | 0/163 (0%) | 0 |
| Constipation | 76/164 (46.3%) | 163 | 72/163 (44.2%) | 166 | 79/163 (48.5%) | 182 |
| Diarrhea-No Colostom | 64/164 (39%) | 131 | 64/163 (39.3%) | 129 | 68/163 (41.7%) | 131 |
| Dyspepsia | 3/164 (1.8%) | 4 | 1/163 (0.6%) | 1 | 1/163 (0.6%) | 1 |
| Dysphagia | 1/164 (0.6%) | 2 | 0/163 (0%) | 0 | 0/163 (0%) | 0 |
| Flatulence | 0/164 (0%) | 0 | 0/163 (0%) | 0 | 1/163 (0.6%) | 1 |
| Gastritis | 1/164 (0.6%) | 1 | 0/163 (0%) | 0 | 0/163 (0%) | 0 |
| Gastrointestinal disorder | 1/164 (0.6%) | 1 | 0/163 (0%) | 0 | 0/163 (0%) | 0 |
| Ileus | 1/164 (0.6%) | 1 | 0/163 (0%) | 0 | 0/163 (0%) | 0 |
| Nausea | 76/164 (46.3%) | 165 | 83/163 (50.9%) | 164 | 82/163 (50.3%) | 171 |
| Oral cavity Mucositis/stomatitis (functional/symptomatic) | 0/164 (0%) | 0 | 1/163 (0.6%) | 1 | 1/163 (0.6%) | 2 |
| Pain-Abdominal | 3/164 (1.8%) | 3 | 5/163 (3.1%) | 5 | 6/163 (3.7%) | 6 |
| Pain-Stomach | 0/164 (0%) | 0 | 0/163 (0%) | 0 | 1/163 (0.6%) | 2 |
| Rectal hemorrhage | 0/164 (0%) | 0 | 1/163 (0.6%) | 1 | 0/163 (0%) | 0 |
| Small intestinal obstruction | 2/164 (1.2%) | 2 | 0/163 (0%) | 0 | 1/163 (0.6%) | 1 |
| Small intestinal stenosis | 0/164 (0%) | 0 | 0/163 (0%) | 0 | 1/163 (0.6%) | 1 |
| Vomiting | 41/164 (25%) | 69 | 37/163 (22.7%) | 70 | 36/163 (22.1%) | 57 |
| General disorders | ||||||
| Disease Progression | 5/164 (3%) | 5 | 4/163 (2.5%) | 4 | 1/163 (0.6%) | 1 |
| Edema: Limb | 0/164 (0%) | 0 | 1/163 (0.6%) | 2 | 0/163 (0%) | 0 |
| Edema: Viscera | 0/164 (0%) | 0 | 1/163 (0.6%) | 1 | 0/163 (0%) | 0 |
| Fatigue | 20/164 (12.2%) | 32 | 17/163 (10.4%) | 26 | 18/163 (11%) | 27 |
| Multi-organ failure | 1/164 (0.6%) | 1 | 0/163 (0%) | 0 | 1/163 (0.6%) | 1 |
| Pain | 3/164 (1.8%) | 3 | 0/163 (0%) | 0 | 0/163 (0%) | 0 |
| Hepatobiliary disorders | ||||||
| Cholecystitis | 0/164 (0%) | 0 | 1/163 (0.6%) | 1 | 0/163 (0%) | 0 |
| Immune system disorders | ||||||
| Cytokine release syndrome | 1/164 (0.6%) | 1 | 0/163 (0%) | 0 | 1/163 (0.6%) | 1 |
| Hypersensitivity | 1/164 (0.6%) | 1 | 0/163 (0%) | 0 | 0/163 (0%) | 0 |
| Infections and infestations | ||||||
| Abdominal infection | 2/164 (1.2%) | 2 | 0/163 (0%) | 0 | 1/163 (0.6%) | 1 |
| Anal infection | 1/164 (0.6%) | 1 | 0/163 (0%) | 0 | 0/163 (0%) | 0 |
| Bladder (urinary) infection | 1/164 (0.6%) | 1 | 1/163 (0.6%) | 1 | 0/163 (0%) | 0 |
| Bladder infection | 2/164 (1.2%) | 2 | 0/163 (0%) | 0 | 1/163 (0.6%) | 1 |
| Blood Infection | 2/164 (1.2%) | 2 | 0/163 (0%) | 0 | 2/163 (1.2%) | 2 |
| Bronchus infection | 1/164 (0.6%) | 1 | 0/163 (0%) | 0 | 0/163 (0%) | 0 |
| Colon infection | 1/164 (0.6%) | 1 | 0/163 (0%) | 0 | 0/163 (0%) | 0 |
| Infection | 0/164 (0%) | 0 | 1/163 (0.6%) | 1 | 1/163 (0.6%) | 1 |
| Lung (pneumonia) infection | 1/164 (0.6%) | 1 | 1/163 (0.6%) | 1 | 2/163 (1.2%) | 2 |
| Pharyngitis | 1/164 (0.6%) | 1 | 0/163 (0%) | 0 | 0/163 (0%) | 0 |
| Pneumonia | 3/164 (1.8%) | 3 | 3/163 (1.8%) | 3 | 3/163 (1.8%) | 3 |
| Rectum infection | 1/164 (0.6%) | 1 | 0/163 (0%) | 0 | 0/163 (0%) | 0 |
| Salivary gland infection | 0/164 (0%) | 0 | 0/163 (0%) | 0 | 1/163 (0.6%) | 1 |
| Sepsis | 1/164 (0.6%) | 1 | 0/163 (0%) | 0 | 0/163 (0%) | 0 |
| Skin (cellulites) infection | 0/164 (0%) | 0 | 1/163 (0.6%) | 1 | 0/163 (0%) | 0 |
| Skin infection | 3/164 (1.8%) | 5 | 1/163 (0.6%) | 1 | 2/163 (1.2%) | 4 |
| Upper airway infection | 1/164 (0.6%) | 1 | 0/163 (0%) | 0 | 0/163 (0%) | 0 |
| Urinary tract infection | 3/164 (1.8%) | 3 | 1/163 (0.6%) | 2 | 0/163 (0%) | 0 |
| Vaginal infection | 0/164 (0%) | 0 | 0/163 (0%) | 0 | 1/163 (0.6%) | 1 |
| Injury, poisoning and procedural complications | ||||||
| Fracture | 0/164 (0%) | 0 | 0/163 (0%) | 0 | 1/163 (0.6%) | 1 |
| Vascular access complication | 0/164 (0%) | 0 | 0/163 (0%) | 0 | 1/163 (0.6%) | 1 |
| Investigations | ||||||
| Alanine aminotransferase increased | 1/164 (0.6%) | 1 | 0/163 (0%) | 0 | 1/163 (0.6%) | 2 |
| Alkaline phosphatase | 1/164 (0.6%) | 1 | 1/163 (0.6%) | 1 | 2/163 (1.2%) | 2 |
| Aspartate aminotransferase increased | 1/164 (0.6%) | 1 | 1/163 (0.6%) | 1 | 2/163 (1.2%) | 2 |
| Blood bilirubin increased | 2/164 (1.2%) | 2 | 0/163 (0%) | 0 | 3/163 (1.8%) | 3 |
| CPK (creatine phosphokinase) | 0/164 (0%) | 0 | 0/163 (0%) | 0 | 1/163 (0.6%) | 1 |
| Creatinine | 0/164 (0%) | 0 | 3/163 (1.8%) | 4 | 2/163 (1.2%) | 2 |
| Leukopenia | 13/164 (7.9%) | 19 | 17/163 (10.4%) | 25 | 28/163 (17.2%) | 52 |
| Lymphopenia | 9/164 (5.5%) | 16 | 11/163 (6.7%) | 22 | 10/163 (6.1%) | 22 |
| Neutropenia | 17/164 (10.4%) | 24 | 17/163 (10.4%) | 21 | 21/163 (12.9%) | 37 |
| Platelet count decreased | 9/164 (5.5%) | 13 | 15/163 (9.2%) | 23 | 14/163 (8.6%) | 24 |
| Prothrombin Time | 2/164 (1.2%) | 5 | 0/163 (0%) | 0 | 2/163 (1.2%) | 2 |
| Weight gain | 1/164 (0.6%) | 1 | 0/163 (0%) | 0 | 0/163 (0%) | 0 |
| Weight loss | 0/164 (0%) | 0 | 1/163 (0.6%) | 2 | 0/163 (0%) | 0 |
| Metabolism and nutrition disorders | ||||||
| Anorexia | 5/164 (3%) | 6 | 3/163 (1.8%) | 8 | 3/163 (1.8%) | 3 |
| Dehydration | 11/164 (6.7%) | 12 | 8/163 (4.9%) | 9 | 7/163 (4.3%) | 7 |
| Hypercalcemia | 1/164 (0.6%) | 1 | 1/163 (0.6%) | 1 | 0/163 (0%) | 0 |
| Hyperglycemia | 3/164 (1.8%) | 3 | 10/163 (6.1%) | 16 | 6/163 (3.7%) | 7 |
| Hyperkalemia | 0/164 (0%) | 0 | 0/163 (0%) | 0 | 2/163 (1.2%) | 2 |
| Hyperuricemia | 0/164 (0%) | 0 | 1/163 (0.6%) | 1 | 0/163 (0%) | 0 |
| Hypoalbuminemia | 1/164 (0.6%) | 1 | 1/163 (0.6%) | 1 | 3/163 (1.8%) | 3 |
| Hypocalcemia | 3/164 (1.8%) | 3 | 0/163 (0%) | 0 | 1/163 (0.6%) | 1 |
| Hypoglycemia | 1/164 (0.6%) | 1 | 2/163 (1.2%) | 2 | 0/163 (0%) | 0 |
| Hypokalemia | 7/164 (4.3%) | 8 | 4/163 (2.5%) | 4 | 5/163 (3.1%) | 7 |
| Hypomagnesemia | 1/164 (0.6%) | 1 | 0/163 (0%) | 0 | 1/163 (0.6%) | 1 |
| Hyponatremia | 5/164 (3%) | 5 | 3/163 (1.8%) | 4 | 4/163 (2.5%) | 6 |
| Iron increased | 0/164 (0%) | 0 | 1/163 (0.6%) | 1 | 0/163 (0%) | 0 |
| Musculoskeletal and connective tissue disorders | ||||||
| Arthralgia | 0/164 (0%) | 0 | 0/163 (0%) | 0 | 1/163 (0.6%) | 1 |
| Back pain | 5/164 (3%) | 5 | 2/163 (1.2%) | 4 | 0/163 (0%) | 0 |
| Bone pain | 2/164 (1.2%) | 2 | 3/163 (1.8%) | 5 | 2/163 (1.2%) | 2 |
| Chest wall pain | 1/164 (0.6%) | 1 | 0/163 (0%) | 0 | 0/163 (0%) | 0 |
| Extremity-lower weakness | 0/164 (0%) | 0 | 0/163 (0%) | 0 | 1/163 (0.6%) | 1 |
| Muscle Weakness | 4/164 (2.4%) | 5 | 2/163 (1.2%) | 2 | 2/163 (1.2%) | 2 |
| Musculoskeletal | 0/164 (0%) | 0 | 1/163 (0.6%) | 1 | 1/163 (0.6%) | 1 |
| Myalgia | 1/164 (0.6%) | 1 | 1/163 (0.6%) | 1 | 1/163 (0.6%) | 1 |
| Pain in extremity | 1/164 (0.6%) | 1 | 0/163 (0%) | 0 | 1/163 (0.6%) | 2 |
| Trunk weakness | 0/164 (0%) | 0 | 0/163 (0%) | 0 | 1/163 (0.6%) | 1 |
| Neoplasms benign, malignant and unspecified (incl cysts and polyps) | ||||||
| Pain-Anal | 0/164 (0%) | 0 | 0/163 (0%) | 0 | 1/163 (0.6%) | 1 |
| Nervous system disorders | ||||||
| Depressed level of consciousness | 0/164 (0%) | 0 | 0/163 (0%) | 0 | 1/163 (0.6%) | 1 |
| Dizziness | 1/164 (0.6%) | 1 | 3/163 (1.8%) | 3 | 2/163 (1.2%) | 2 |
| Dysgeusia | 1/164 (0.6%) | 1 | 1/163 (0.6%) | 1 | 0/163 (0%) | 0 |
| Ischemia-Cerebral | 1/164 (0.6%) | 1 | 1/163 (0.6%) | 1 | 0/163 (0%) | 0 |
| Mental status changes | 1/164 (0.6%) | 1 | 0/163 (0%) | 0 | 0/163 (0%) | 0 |
| Neuralgia | 2/164 (1.2%) | 3 | 0/163 (0%) | 0 | 0/163 (0%) | 0 |
| Neuro | 0/164 (0%) | 0 | 1/163 (0.6%) | 1 | 0/163 (0%) | 0 |
| Peripheral motor neuropathy | 1/164 (0.6%) | 1 | 2/163 (1.2%) | 2 | 0/163 (0%) | 0 |
| Peripheral sensory neuropathy | 5/164 (3%) | 8 | 2/163 (1.2%) | 2 | 4/163 (2.5%) | 6 |
| Seizure | 1/164 (0.6%) | 1 | 0/163 (0%) | 0 | 0/163 (0%) | 0 |
| Syncope | 4/164 (2.4%) | 4 | 1/163 (0.6%) | 1 | 3/163 (1.8%) | 3 |
| Syncope Vasovagal | 1/164 (0.6%) | 1 | 0/163 (0%) | 0 | 0/163 (0%) | 0 |
| Tremor | 0/164 (0%) | 0 | 0/163 (0%) | 0 | 1/163 (0.6%) | 1 |
| Psychiatric disorders | ||||||
| Anxiety | 1/164 (0.6%) | 1 | 0/163 (0%) | 0 | 0/163 (0%) | 0 |
| Confusion | 0/164 (0%) | 0 | 0/163 (0%) | 0 | 1/163 (0.6%) | 1 |
| Insomnia | 0/164 (0%) | 0 | 0/163 (0%) | 0 | 2/163 (1.2%) | 2 |
| Renal and urinary disorders | ||||||
| Glomerular filtration rate | 0/164 (0%) | 0 | 0/163 (0%) | 0 | 1/163 (0.6%) | 1 |
| Renal Failure | 0/164 (0%) | 0 | 1/163 (0.6%) | 2 | 0/163 (0%) | 0 |
| Reproductive system and breast disorders | ||||||
| Pelvic pain | 1/164 (0.6%) | 1 | 0/163 (0%) | 0 | 0/163 (0%) | 0 |
| Vaginal fistula | 0/164 (0%) | 0 | 0/163 (0%) | 0 | 1/163 (0.6%) | 1 |
| Respiratory, thoracic and mediastinal disorders | ||||||
| Adult respiratory distress syndrome (ARDS) | 1/164 (0.6%) | 1 | 0/163 (0%) | 0 | 0/163 (0%) | 0 |
| Atelectasis | 1/164 (0.6%) | 1 | 0/163 (0%) | 0 | 0/163 (0%) | 0 |
| Cough | 0/164 (0%) | 0 | 1/163 (0.6%) | 1 | 2/163 (1.2%) | 2 |
| Dyspnea | 13/164 (7.9%) | 21 | 8/163 (4.9%) | 9 | 16/163 (9.8%) | 19 |
| Hypoxia | 3/164 (1.8%) | 5 | 2/163 (1.2%) | 2 | 3/163 (1.8%) | 3 |
| Pleural effusion | 0/164 (0%) | 0 | 1/163 (0.6%) | 1 | 2/163 (1.2%) | 2 |
| Pulmonary | 1/164 (0.6%) | 1 | 0/163 (0%) | 0 | 0/163 (0%) | 0 |
| Pulmonary hypertension | 0/164 (0%) | 0 | 1/163 (0.6%) | 1 | 1/163 (0.6%) | 1 |
| Skin and subcutaneous tissue disorders | ||||||
| Acne | 0/164 (0%) | 0 | 1/163 (0.6%) | 2 | 0/163 (0%) | 0 |
| Hand-foot skin reaction | 0/164 (0%) | 0 | 0/163 (0%) | 0 | 2/163 (1.2%) | 4 |
| Pain of skin | 1/164 (0.6%) | 2 | 0/163 (0%) | 0 | 0/163 (0%) | 0 |
| Pruritus | 44/164 (26.8%) | 77 | 48/163 (29.4%) | 91 | 46/163 (28.2%) | 77 |
| Rash/Desquamation | 1/164 (0.6%) | 1 | 0/163 (0%) | 0 | 0/163 (0%) | 0 |
| Sweating | 0/164 (0%) | 0 | 0/163 (0%) | 0 | 1/163 (0.6%) | 1 |
| Urticaria | 1/164 (0.6%) | 1 | 0/163 (0%) | 0 | 0/163 (0%) | 0 |
| Vascular disorders | ||||||
| Flushing | 34/164 (20.7%) | 66 | 30/163 (18.4%) | 55 | 33/163 (20.2%) | 58 |
| Hypertension | 17/164 (10.4%) | 28 | 20/163 (12.3%) | 29 | 14/163 (8.6%) | 16 |
| Hypotension | 23/164 (14%) | 34 | 13/163 (8%) | 19 | 24/163 (14.7%) | 31 |
| Phlebitis | 0/164 (0%) | 0 | 0/163 (0%) | 0 | 1/163 (0.6%) | 1 |
| Thrombosis | 7/164 (4.3%) | 7 | 0/163 (0%) | 0 | 8/163 (4.9%) | 8 |
Limitations/Caveats
[Not Specified]
More Information
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
| Name/Title | Dr. Charles L. Loprinzi |
|---|---|
| Organization | Mayo Clinic Rochester |
| Phone | 507-284-8666 |
| cloprinzi@mayo.edu |
Responsible Party:
,
,
ClinicalTrials.gov Identifier:
NCT00661999
Other Study ID Numbers:
- CDR0000593480
- P30CA015083
- MC04CC
- NCI-2009-01226
- 1713-05
First Posted:
Apr 21, 2008
Last Update Posted:
May 17, 2011
Last Verified:
May 1, 2011