Trial Outcomes & Findings for Darbepoetin Alfa With or Without Iron in Treating Anemia Caused By Chemotherapy in Patients With Cancer (NCT NCT00661999)
NCT ID: NCT00661999
Last Updated: 2011-05-17
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
502 participants
Primary outcome timeframe
16 Weeks
Results posted on
2011-05-17
Participant Flow
Five-hundred and two (502) participants were recruited between February 2006 and December 2008 at Mayo Clinic Cancer Research Consortium (MCCRC) sites.
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.
Participant milestones
| Measure |
DA + IV Iron
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.
|
DA + Oral Iron
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.
|
DA + Placebo
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.
|
|---|---|---|---|
|
Overall Study
STARTED
|
164
|
163
|
163
|
|
Overall Study
COMPLETED
|
105
|
113
|
106
|
|
Overall Study
NOT COMPLETED
|
59
|
50
|
57
|
Reasons for withdrawal
| Measure |
DA + IV Iron
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.
|
DA + Oral Iron
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.
|
DA + Placebo
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.
|
|---|---|---|---|
|
Overall Study
Adverse Event
|
11
|
5
|
8
|
|
Overall Study
Death
|
8
|
6
|
3
|
|
Overall Study
Other Reasons
|
5
|
12
|
23
|
|
Overall Study
Withdrawal by Subject
|
30
|
23
|
14
|
|
Overall Study
Alternative Treatment
|
1
|
0
|
0
|
|
Overall Study
Other Medical Problems
|
4
|
4
|
9
|
Baseline Characteristics
Darbepoetin Alfa With or Without Iron in Treating Anemia Caused By Chemotherapy in Patients With Cancer
Baseline characteristics by cohort
| Measure |
DA + IV Iron
n=164 Participants
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.
|
DA + Oral Iron
n=163 Participants
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.
|
DA + Placebo
n=163 Participants
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
n=490 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age Continuous
|
64 years
STANDARD_DEVIATION 11 • n=5 Participants
|
63 years
STANDARD_DEVIATION 13 • n=7 Participants
|
63 years
STANDARD_DEVIATION 11 • n=5 Participants
|
63 years
STANDARD_DEVIATION 12 • n=4 Participants
|
|
Sex: Female, Male
Female
|
109 Participants
n=5 Participants
|
106 Participants
n=7 Participants
|
105 Participants
n=5 Participants
|
320 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
55 Participants
n=5 Participants
|
57 Participants
n=7 Participants
|
58 Participants
n=5 Participants
|
170 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
6 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
17 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
155 Participants
n=5 Participants
|
147 Participants
n=7 Participants
|
156 Participants
n=5 Participants
|
458 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
|
Degree of Anemia
Mild: Hemoglobin>=9.5
|
123 Participants
n=5 Participants
|
123 Participants
n=7 Participants
|
123 Participants
n=5 Participants
|
369 Participants
n=4 Participants
|
|
Degree of Anemia
Severe: Hemoglobin <9.5
|
41 Participants
n=5 Participants
|
40 Participants
n=7 Participants
|
40 Participants
n=5 Participants
|
121 Participants
n=4 Participants
|
|
Platinum-Containing Regimen
Yes
|
79 Participants
n=5 Participants
|
79 Participants
n=7 Participants
|
78 Participants
n=5 Participants
|
236 Participants
n=4 Participants
|
|
Platinum-Containing Regimen
No
|
85 Participants
n=5 Participants
|
84 Participants
n=7 Participants
|
85 Participants
n=5 Participants
|
254 Participants
n=4 Participants
|
|
Tumor Type
Hematologic Neoplasm
|
6 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
25 Participants
n=4 Participants
|
|
Tumor Type
Solid Tumor
|
157 Participants
n=5 Participants
|
154 Participants
n=7 Participants
|
151 Participants
n=5 Participants
|
462 Participants
n=4 Participants
|
|
Tumor Type
Both
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
|
Weight
|
77.4 kg
STANDARD_DEVIATION 18.74 • n=5 Participants
|
79.4 kg
STANDARD_DEVIATION 19.75 • n=7 Participants
|
76.4 kg
STANDARD_DEVIATION 17.68 • n=5 Participants
|
77.7 kg
STANDARD_DEVIATION 18.75 • n=4 Participants
|
|
Height
|
166.9 cm
STANDARD_DEVIATION 9.44 • n=5 Participants
|
167.7 cm
STANDARD_DEVIATION 8.93 • n=7 Participants
|
166.8 cm
STANDARD_DEVIATION 9.36 • n=5 Participants
|
167.1 cm
STANDARD_DEVIATION 9.24 • n=4 Participants
|
|
Baseline Ferritin
|
460.5 µg/L
STANDARD_DEVIATION 526.99 • n=5 Participants
|
479.5 µg/L
STANDARD_DEVIATION 484.15 • n=7 Participants
|
456.0 µg/L
STANDARD_DEVIATION 479.27 • n=5 Participants
|
465.3 µg/L
STANDARD_DEVIATION 496.41 • n=4 Participants
|
|
Baseline Transferrin Saturation
|
22.5 Percentage Saturation
STANDARD_DEVIATION 12.81 • n=5 Participants
|
19.6 Percentage Saturation
STANDARD_DEVIATION 11.7 • n=7 Participants
|
22.2 Percentage Saturation
STANDARD_DEVIATION 13.36 • n=5 Participants
|
21.5 Percentage Saturation
STANDARD_DEVIATION 12.69 • n=4 Participants
|
PRIMARY outcome
Timeframe: 16 WeeksHematopoietic 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.
Outcome measures
| Measure |
DA + IV Iron
n=164 Participants
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.
|
DA + Oral Iron
n=163 Participants
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.
|
DA + Placebo
n=163 Participants
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.
|
|---|---|---|---|
|
Hematopoietic Response Rate Defined as the Number of Participants Who Exhibit a Hematopoietic Response
Yes
|
114 Participants
|
109 Participants
|
106 Participants
|
|
Hematopoietic Response Rate Defined as the Number of Participants Who Exhibit a Hematopoietic Response
No
|
50 Participants
|
54 Participants
|
57 Participants
|
SECONDARY outcome
Timeframe: 16 WeeksOutcome measures
| Measure |
DA + IV Iron
n=164 Participants
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.
|
DA + Oral Iron
n=163 Participants
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.
|
DA + Placebo
n=163 Participants
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.
|
|---|---|---|---|
|
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
|
10 Percentage of Participants
|
12 Percentage of Participants
|
11 Percentage of Participants
|
SECONDARY outcome
Timeframe: Week 1 to Week 16Outcome measures
| Measure |
DA + IV Iron
n=164 Participants
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.
|
DA + Oral Iron
n=163 Participants
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.
|
DA + Placebo
n=163 Participants
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.
|
|---|---|---|---|
|
Incidence of Patients Receiving at Least One Red Blood Cell (RBC) Transfusions
Yes
|
20 Participants
|
21 Participants
|
22 Participants
|
|
Incidence of Patients Receiving at Least One Red Blood Cell (RBC) Transfusions
No
|
144 Participants
|
142 Participants
|
141 Participants
|
SECONDARY outcome
Timeframe: Baseline and 7 weeksValue at 7 weeks minus value at baseline.
Outcome measures
| Measure |
DA + IV Iron
n=164 Participants
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.
|
DA + Oral Iron
n=163 Participants
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.
|
DA + Placebo
n=163 Participants
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.
|
|---|---|---|---|
|
Mean Increment in Hemoglobin Level at Week 7
|
1.3 g/dL
Standard Deviation 1.35
|
1.1 g/dL
Standard Deviation 1.37
|
1.2 g/dL
Standard Deviation 1.35
|
SECONDARY outcome
Timeframe: Baseline and 16 weeksValue at 16 weeks minus value at baseline.
Outcome measures
| Measure |
DA + IV Iron
n=164 Participants
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.
|
DA + Oral Iron
n=163 Participants
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.
|
DA + Placebo
n=163 Participants
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.
|
|---|---|---|---|
|
Mean Increment in Hemoglobin Level at Week 16
|
2.1 g/dL
Standard Deviation 1.46
|
2.0 g/dL
Standard Deviation 1.61
|
1.7 g/dL
Standard Deviation 1.64
|
SECONDARY outcome
Timeframe: 16 weeksHematopoietic 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.
Outcome measures
| Measure |
DA + IV Iron
n=164 Participants
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.
|
DA + Oral Iron
n=163 Participants
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.
|
DA + Placebo
n=163 Participants
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.
|
|---|---|---|---|
|
Time to Hematopoietic Response
|
43 Days
Interval 36.0 to 55.0
|
61 Days
Interval 55.0 to 73.0
|
50 Days
Interval 42.0 to 64.0
|
SECONDARY outcome
Timeframe: 16 weeksPopulation: 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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline and 16 weeksOverall QOL item score range: 0 (Worst) to 10 (Best), ordinal. Change: score at 16 weeks minus score at baseline.
Outcome measures
| Measure |
DA + IV Iron
n=164 Participants
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.
|
DA + Oral Iron
n=163 Participants
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.
|
DA + Placebo
n=163 Participants
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.
|
|---|---|---|---|
|
Change From Baseline in Overall Quality of Life (QOL) Score as Measured by the Linear Analogue Self Assessment (LASA)
|
0.4 Scores on a scale
Standard Deviation 2.18
|
0.2 Scores on a scale
Standard Deviation 2.23
|
0.5 Scores on a scale
Standard Deviation 2.28
|
SECONDARY outcome
Timeframe: Baseline and 16 weeksSDS 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.
Outcome measures
| Measure |
DA + IV Iron
n=164 Participants
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.
|
DA + Oral Iron
n=163 Participants
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.
|
DA + Placebo
n=163 Participants
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.
|
|---|---|---|---|
|
Change From Baseline in Quality of Life (QOL) Score as Measured by Symptom Distress Scale (SDS) at End of Study
|
6.0 Scores on a scale
Standard Deviation 11.73
|
3.5 Scores on a scale
Standard Deviation 11.54
|
5.4 Scores on a scale
Standard Deviation 10.50
|
SECONDARY outcome
Timeframe: Baseline and 16 weeksFatigue Now Scale range: 0 (No Fatigue) to 10 (Worst), ordinal. Change: score at 16 weeks minus score at baseline.
Outcome measures
| Measure |
DA + IV Iron
n=164 Participants
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.
|
DA + Oral Iron
n=163 Participants
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.
|
DA + Placebo
n=163 Participants
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.
|
|---|---|---|---|
|
Change From Baseline in Quality of Life (QOL) Score as Measured by Brief Fatigue Inventory(BFI) Fatigue Now Scale at End of Study
|
-1.1 Scores on a scale
Standard Deviation 3.08
|
-1.1 Scores on a scale
Standard Deviation 2.95
|
-1.6 Scores on a scale
Standard Deviation 2.82
|
SECONDARY outcome
Timeframe: Baseline and 16 weeksFACT-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.
Outcome measures
| Measure |
DA + IV Iron
n=164 Participants
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.
|
DA + Oral Iron
n=163 Participants
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.
|
DA + Placebo
n=163 Participants
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.
|
|---|---|---|---|
|
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
|
8.1 Scores on a scale
Standard Deviation 16.57
|
8.9 Scores on a scale
Standard Deviation 18.97
|
9.5 Scores on a scale
Standard Deviation 18.79
|
SECONDARY outcome
Timeframe: 1 Week, 7 Weeks and 16 WeeksOutcome measures
| Measure |
DA + IV Iron
n=164 Participants
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.
|
DA + Oral Iron
n=163 Participants
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.
|
DA + Placebo
n=163 Participants
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.
|
|---|---|---|---|
|
C-reactive Protein (CRP) Level at Week 1, Week 7 and Week 16
Week 1
|
24.8 mg/L
Standard Deviation 38.12
|
25.4 mg/L
Standard Deviation 36.36
|
31.6 mg/L
Standard Deviation 58.68
|
|
C-reactive Protein (CRP) Level at Week 1, Week 7 and Week 16
Week 7
|
28.6 mg/L
Standard Deviation 51.09
|
16.6 mg/L
Standard Deviation 25.25
|
27.0 mg/L
Standard Deviation 49.20
|
|
C-reactive Protein (CRP) Level at Week 1, Week 7 and Week 16
Week 16
|
25.6 mg/L
Standard Deviation 46.30
|
16.7 mg/L
Standard Deviation 36.98
|
21.2 mg/L
Standard Deviation 39.07
|
SECONDARY outcome
Timeframe: 1 week, 7 weeks and 16 weeksOutcome measures
| Measure |
DA + IV Iron
n=164 Participants
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.
|
DA + Oral Iron
n=163 Participants
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.
|
DA + Placebo
n=163 Participants
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.
|
|---|---|---|---|
|
Soluble Transferrin Receptor (sTfR)Level at Week 1, Week 7 and Week 16
Week 1
|
3.9 mg/L
Standard Deviation 2.14
|
4.0 mg/L
Standard Deviation 1.99
|
4.5 mg/L
Standard Deviation 4.52
|
|
Soluble Transferrin Receptor (sTfR)Level at Week 1, Week 7 and Week 16
Week 7
|
6.1 mg/L
Standard Deviation 3.04
|
6.2 mg/L
Standard Deviation 2.4
|
7.1 mg/L
Standard Deviation 2.92
|
|
Soluble Transferrin Receptor (sTfR)Level at Week 1, Week 7 and Week 16
Week 16
|
5.1 mg/L
Standard Deviation 3.07
|
5.2 mg/L
Standard Deviation 2.19
|
5.6 mg/L
Standard Deviation 2.6
|
SECONDARY outcome
Timeframe: Baseline, 7 weeks and 16 weeksOutcome measures
| Measure |
DA + IV Iron
n=164 Participants
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.
|
DA + Oral Iron
n=163 Participants
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.
|
DA + Placebo
n=163 Participants
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.
|
|---|---|---|---|
|
Ferritin Level at Baseline, Week 7 and Week 16
Baseline
|
460.5 µg/L
Standard Deviation 526.99
|
479.5 µg/L
Standard Deviation 484.15
|
456.0 µg/L
Standard Deviation 479.27
|
|
Ferritin Level at Baseline, Week 7 and Week 16
Week 7
|
699.1 µg/L
Standard Deviation 645.31
|
420.6 µg/L
Standard Deviation 498.24
|
478.4 µg/L
Standard Deviation 607.89
|
|
Ferritin Level at Baseline, Week 7 and Week 16
Week 16
|
726.0 µg/L
Standard Deviation 1037.43
|
425.9 µg/L
Standard Deviation 717.43
|
371.5 µg/L
Standard Deviation 479.87
|
SECONDARY outcome
Timeframe: Baseline, 7 weeks and 16 weeksMCV is a measure of the average red blood cell volume.
Outcome measures
| Measure |
DA + IV Iron
n=164 Participants
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.
|
DA + Oral Iron
n=163 Participants
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.
|
DA + Placebo
n=163 Participants
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.
|
|---|---|---|---|
|
Mean Corpuscular Volume (MCV) Level at Baseline, Week 7 and Week 16
Baseline
|
90.0 fL
Standard Deviation 5.92
|
88.5 fL
Standard Deviation 9.05
|
90.1 fL
Standard Deviation 8.19
|
|
Mean Corpuscular Volume (MCV) Level at Baseline, Week 7 and Week 16
Week 7
|
93.0 fL
Standard Deviation 9.21
|
92.3 fL
Standard Deviation 9.70
|
92.8 fL
Standard Deviation 8.56
|
|
Mean Corpuscular Volume (MCV) Level at Baseline, Week 7 and Week 16
Week 16
|
94.0 fL
Standard Deviation 11.37
|
94.4 fL
Standard Deviation 7.55
|
92.3 fL
Standard Deviation 9.31
|
SECONDARY outcome
Timeframe: Baseline, 7 weeks and 16 weeksOutcome measures
| Measure |
DA + IV Iron
n=164 Participants
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.
|
DA + Oral Iron
n=163 Participants
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.
|
DA + Placebo
n=163 Participants
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.
|
|---|---|---|---|
|
Transferrin Saturation at Baseline, Week 7 and Week 16
Baseline
|
22.5 Percentage Saturation
Standard Deviation 12.81
|
19.6 Percentage Saturation
Standard Deviation 11.7
|
22.2 Percentage Saturation
Standard Deviation 13.36
|
|
Transferrin Saturation at Baseline, Week 7 and Week 16
Week 7
|
25.6 Percentage Saturation
Standard Deviation 17.48
|
26.4 Percentage Saturation
Standard Deviation 23.56
|
21.2 Percentage Saturation
Standard Deviation 13.12
|
|
Transferrin Saturation at Baseline, Week 7 and Week 16
Week 16
|
26.9 Percentage Saturation
Standard Deviation 14.16
|
27.6 Percentage Saturation
Standard Deviation 17.81
|
23.9 Percentage Saturation
Standard Deviation 15.54
|
Adverse Events
DA + IV Iron
Serious events: 5 serious events
Other events: 150 other events
Deaths: 0 deaths
DA + Oral Iron
Serious events: 3 serious events
Other events: 147 other events
Deaths: 0 deaths
DA + Placebo
Serious events: 2 serious events
Other events: 141 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
DA + IV Iron
n=164 participants at risk
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.
|
DA + Oral Iron
n=163 participants at risk
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.
|
DA + Placebo
n=163 participants at risk
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.
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.61%
1/164 • Number of events 1
|
0.00%
0/163
|
0.00%
0/163
|
|
Gastrointestinal disorders
Fistula-intestinal
|
0.00%
0/164
|
0.00%
0/163
|
0.61%
1/163 • Number of events 1
|
|
General disorders
Fatigue
|
0.00%
0/164
|
0.00%
0/163
|
0.61%
1/163 • Number of events 1
|
|
General disorders
Syndromes
|
0.61%
1/164 • Number of events 1
|
0.00%
0/163
|
0.00%
0/163
|
|
Infections and infestations
Pneumonia
|
0.61%
1/164 • Number of events 1
|
0.00%
0/163
|
0.00%
0/163
|
|
Investigations
Activated partial thromboplastin time prolonged
|
0.00%
0/164
|
0.61%
1/163 • Number of events 1
|
0.00%
0/163
|
|
Investigations
Leukopenia
|
0.00%
0/164
|
0.61%
1/163 • Number of events 1
|
0.00%
0/163
|
|
Investigations
Neutropenia
|
1.2%
2/164 • Number of events 2
|
0.00%
0/163
|
0.00%
0/163
|
|
Investigations
Platelet count decreased
|
0.61%
1/164 • Number of events 1
|
0.00%
0/163
|
0.00%
0/163
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/164
|
0.61%
1/163 • Number of events 1
|
0.00%
0/163
|
|
Psychiatric disorders
Confusion
|
0.61%
1/164 • Number of events 2
|
0.00%
0/163
|
0.00%
0/163
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
0.00%
0/164
|
1.2%
2/163 • Number of events 2
|
0.00%
0/163
|
|
Vascular disorders
Thrombosis
|
0.00%
0/164
|
0.61%
1/163 • Number of events 1
|
0.00%
0/163
|
Other adverse events
| Measure |
DA + IV Iron
n=164 participants at risk
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.
|
DA + Oral Iron
n=163 participants at risk
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.
|
DA + Placebo
n=163 participants at risk
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.
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Anemia
|
3.7%
6/164 • Number of events 9
|
8.0%
13/163 • Number of events 14
|
4.9%
8/163 • Number of events 9
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
1.8%
3/164 • Number of events 3
|
0.61%
1/163 • Number of events 1
|
1.2%
2/163 • Number of events 4
|
|
Cardiac disorders
Atrial fibrillation
|
0.61%
1/164 • Number of events 1
|
0.00%
0/163
|
0.61%
1/163 • Number of events 1
|
|
Cardiac disorders
Ischemia/Infarction
|
0.00%
0/164
|
0.00%
0/163
|
0.61%
1/163 • Number of events 1
|
|
Cardiac disorders
Pericardial effusion
|
0.61%
1/164 • Number of events 1
|
0.00%
0/163
|
0.00%
0/163
|
|
Cardiac disorders
Restrictive cardiomyopathy
|
0.00%
0/164
|
0.00%
0/163
|
0.61%
1/163 • Number of events 1
|
|
Cardiac disorders
Right ventricular dysfunction
|
0.00%
0/164
|
0.00%
0/163
|
0.61%
1/163 • Number of events 1
|
|
Cardiac disorders
Sinus tachycardia
|
1.2%
2/164 • Number of events 2
|
0.00%
0/163
|
0.00%
0/163
|
|
Cardiac disorders
Supraventricular tachycardia
|
0.00%
0/164
|
0.00%
0/163
|
0.61%
1/163 • Number of events 1
|
|
Cardiac disorders
Valvular heart disease
|
0.00%
0/164
|
0.00%
0/163
|
0.61%
1/163 • Number of events 1
|
|
Eye disorders
Extraocular muscle disorder
|
0.00%
0/164
|
0.00%
0/163
|
0.61%
1/163 • Number of events 1
|
|
Eye disorders
Ocular weakness
|
0.61%
1/164 • Number of events 1
|
0.00%
0/163
|
0.00%
0/163
|
|
Eye disorders
Vision-Blurred
|
0.61%
1/164 • Number of events 1
|
0.00%
0/163
|
0.00%
0/163
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/164
|
0.61%
1/163 • Number of events 1
|
0.00%
0/163
|
|
Gastrointestinal disorders
Anus Mucositis/stomatitis (clinical exam)
|
0.61%
1/164 • Number of events 1
|
0.00%
0/163
|
0.00%
0/163
|
|
Gastrointestinal disorders
Ascites
|
0.00%
0/164
|
0.61%
1/163 • Number of events 1
|
0.00%
0/163
|
|
Gastrointestinal disorders
Colonic hemorrhage
|
0.00%
0/164
|
0.61%
1/163 • Number of events 1
|
0.00%
0/163
|
|
Gastrointestinal disorders
Colonic perforation
|
0.61%
1/164 • Number of events 1
|
0.00%
0/163
|
0.00%
0/163
|
|
Gastrointestinal disorders
Constipation
|
46.3%
76/164 • Number of events 163
|
44.2%
72/163 • Number of events 166
|
48.5%
79/163 • Number of events 182
|
|
Gastrointestinal disorders
Diarrhea-No Colostom
|
39.0%
64/164 • Number of events 131
|
39.3%
64/163 • Number of events 129
|
41.7%
68/163 • Number of events 131
|
|
Gastrointestinal disorders
Dyspepsia
|
1.8%
3/164 • Number of events 4
|
0.61%
1/163 • Number of events 1
|
0.61%
1/163 • Number of events 1
|
|
Gastrointestinal disorders
Dysphagia
|
0.61%
1/164 • Number of events 2
|
0.00%
0/163
|
0.00%
0/163
|
|
Gastrointestinal disorders
Flatulence
|
0.00%
0/164
|
0.00%
0/163
|
0.61%
1/163 • Number of events 1
|
|
Gastrointestinal disorders
Gastritis
|
0.61%
1/164 • Number of events 1
|
0.00%
0/163
|
0.00%
0/163
|
|
Gastrointestinal disorders
Gastrointestinal disorder
|
0.61%
1/164 • Number of events 1
|
0.00%
0/163
|
0.00%
0/163
|
|
Gastrointestinal disorders
Ileus
|
0.61%
1/164 • Number of events 1
|
0.00%
0/163
|
0.00%
0/163
|
|
Gastrointestinal disorders
Nausea
|
46.3%
76/164 • Number of events 165
|
50.9%
83/163 • Number of events 164
|
50.3%
82/163 • Number of events 171
|
|
Gastrointestinal disorders
Oral cavity Mucositis/stomatitis (functional/symptomatic)
|
0.00%
0/164
|
0.61%
1/163 • Number of events 1
|
0.61%
1/163 • Number of events 2
|
|
Gastrointestinal disorders
Pain-Abdominal
|
1.8%
3/164 • Number of events 3
|
3.1%
5/163 • Number of events 5
|
3.7%
6/163 • Number of events 6
|
|
Gastrointestinal disorders
Pain-Stomach
|
0.00%
0/164
|
0.00%
0/163
|
0.61%
1/163 • Number of events 2
|
|
Gastrointestinal disorders
Rectal hemorrhage
|
0.00%
0/164
|
0.61%
1/163 • Number of events 1
|
0.00%
0/163
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
1.2%
2/164 • Number of events 2
|
0.00%
0/163
|
0.61%
1/163 • Number of events 1
|
|
Gastrointestinal disorders
Small intestinal stenosis
|
0.00%
0/164
|
0.00%
0/163
|
0.61%
1/163 • Number of events 1
|
|
Gastrointestinal disorders
Vomiting
|
25.0%
41/164 • Number of events 69
|
22.7%
37/163 • Number of events 70
|
22.1%
36/163 • Number of events 57
|
|
General disorders
Disease Progression
|
3.0%
5/164 • Number of events 5
|
2.5%
4/163 • Number of events 4
|
0.61%
1/163 • Number of events 1
|
|
General disorders
Edema: Limb
|
0.00%
0/164
|
0.61%
1/163 • Number of events 2
|
0.00%
0/163
|
|
General disorders
Edema: Viscera
|
0.00%
0/164
|
0.61%
1/163 • Number of events 1
|
0.00%
0/163
|
|
General disorders
Fatigue
|
12.2%
20/164 • Number of events 32
|
10.4%
17/163 • Number of events 26
|
11.0%
18/163 • Number of events 27
|
|
General disorders
Multi-organ failure
|
0.61%
1/164 • Number of events 1
|
0.00%
0/163
|
0.61%
1/163 • Number of events 1
|
|
General disorders
Pain
|
1.8%
3/164 • Number of events 3
|
0.00%
0/163
|
0.00%
0/163
|
|
Hepatobiliary disorders
Cholecystitis
|
0.00%
0/164
|
0.61%
1/163 • Number of events 1
|
0.00%
0/163
|
|
Immune system disorders
Cytokine release syndrome
|
0.61%
1/164 • Number of events 1
|
0.00%
0/163
|
0.61%
1/163 • Number of events 1
|
|
Immune system disorders
Hypersensitivity
|
0.61%
1/164 • Number of events 1
|
0.00%
0/163
|
0.00%
0/163
|
|
Infections and infestations
Abdominal infection
|
1.2%
2/164 • Number of events 2
|
0.00%
0/163
|
0.61%
1/163 • Number of events 1
|
|
Infections and infestations
Anal infection
|
0.61%
1/164 • Number of events 1
|
0.00%
0/163
|
0.00%
0/163
|
|
Infections and infestations
Bladder (urinary) infection
|
0.61%
1/164 • Number of events 1
|
0.61%
1/163 • Number of events 1
|
0.00%
0/163
|
|
Infections and infestations
Bladder infection
|
1.2%
2/164 • Number of events 2
|
0.00%
0/163
|
0.61%
1/163 • Number of events 1
|
|
Infections and infestations
Blood Infection
|
1.2%
2/164 • Number of events 2
|
0.00%
0/163
|
1.2%
2/163 • Number of events 2
|
|
Infections and infestations
Bronchus infection
|
0.61%
1/164 • Number of events 1
|
0.00%
0/163
|
0.00%
0/163
|
|
Infections and infestations
Colon infection
|
0.61%
1/164 • Number of events 1
|
0.00%
0/163
|
0.00%
0/163
|
|
Infections and infestations
Infection
|
0.00%
0/164
|
0.61%
1/163 • Number of events 1
|
0.61%
1/163 • Number of events 1
|
|
Infections and infestations
Lung (pneumonia) infection
|
0.61%
1/164 • Number of events 1
|
0.61%
1/163 • Number of events 1
|
1.2%
2/163 • Number of events 2
|
|
Infections and infestations
Pharyngitis
|
0.61%
1/164 • Number of events 1
|
0.00%
0/163
|
0.00%
0/163
|
|
Infections and infestations
Pneumonia
|
1.8%
3/164 • Number of events 3
|
1.8%
3/163 • Number of events 3
|
1.8%
3/163 • Number of events 3
|
|
Infections and infestations
Rectum infection
|
0.61%
1/164 • Number of events 1
|
0.00%
0/163
|
0.00%
0/163
|
|
Infections and infestations
Salivary gland infection
|
0.00%
0/164
|
0.00%
0/163
|
0.61%
1/163 • Number of events 1
|
|
Infections and infestations
Sepsis
|
0.61%
1/164 • Number of events 1
|
0.00%
0/163
|
0.00%
0/163
|
|
Infections and infestations
Skin (cellulites) infection
|
0.00%
0/164
|
0.61%
1/163 • Number of events 1
|
0.00%
0/163
|
|
Infections and infestations
Skin infection
|
1.8%
3/164 • Number of events 5
|
0.61%
1/163 • Number of events 1
|
1.2%
2/163 • Number of events 4
|
|
Infections and infestations
Upper airway infection
|
0.61%
1/164 • Number of events 1
|
0.00%
0/163
|
0.00%
0/163
|
|
Infections and infestations
Urinary tract infection
|
1.8%
3/164 • Number of events 3
|
0.61%
1/163 • Number of events 2
|
0.00%
0/163
|
|
Infections and infestations
Vaginal infection
|
0.00%
0/164
|
0.00%
0/163
|
0.61%
1/163 • Number of events 1
|
|
Injury, poisoning and procedural complications
Fracture
|
0.00%
0/164
|
0.00%
0/163
|
0.61%
1/163 • Number of events 1
|
|
Injury, poisoning and procedural complications
Vascular access complication
|
0.00%
0/164
|
0.00%
0/163
|
0.61%
1/163 • Number of events 1
|
|
Investigations
Alanine aminotransferase increased
|
0.61%
1/164 • Number of events 1
|
0.00%
0/163
|
0.61%
1/163 • Number of events 2
|
|
Investigations
Alkaline phosphatase
|
0.61%
1/164 • Number of events 1
|
0.61%
1/163 • Number of events 1
|
1.2%
2/163 • Number of events 2
|
|
Investigations
Aspartate aminotransferase increased
|
0.61%
1/164 • Number of events 1
|
0.61%
1/163 • Number of events 1
|
1.2%
2/163 • Number of events 2
|
|
Investigations
Blood bilirubin increased
|
1.2%
2/164 • Number of events 2
|
0.00%
0/163
|
1.8%
3/163 • Number of events 3
|
|
Investigations
CPK (creatine phosphokinase)
|
0.00%
0/164
|
0.00%
0/163
|
0.61%
1/163 • Number of events 1
|
|
Investigations
Creatinine
|
0.00%
0/164
|
1.8%
3/163 • Number of events 4
|
1.2%
2/163 • Number of events 2
|
|
Investigations
Leukopenia
|
7.9%
13/164 • Number of events 19
|
10.4%
17/163 • Number of events 25
|
17.2%
28/163 • Number of events 52
|
|
Investigations
Lymphopenia
|
5.5%
9/164 • Number of events 16
|
6.7%
11/163 • Number of events 22
|
6.1%
10/163 • Number of events 22
|
|
Investigations
Neutropenia
|
10.4%
17/164 • Number of events 24
|
10.4%
17/163 • Number of events 21
|
12.9%
21/163 • Number of events 37
|
|
Investigations
Platelet count decreased
|
5.5%
9/164 • Number of events 13
|
9.2%
15/163 • Number of events 23
|
8.6%
14/163 • Number of events 24
|
|
Investigations
Prothrombin Time
|
1.2%
2/164 • Number of events 5
|
0.00%
0/163
|
1.2%
2/163 • Number of events 2
|
|
Investigations
Weight gain
|
0.61%
1/164 • Number of events 1
|
0.00%
0/163
|
0.00%
0/163
|
|
Investigations
Weight loss
|
0.00%
0/164
|
0.61%
1/163 • Number of events 2
|
0.00%
0/163
|
|
Metabolism and nutrition disorders
Anorexia
|
3.0%
5/164 • Number of events 6
|
1.8%
3/163 • Number of events 8
|
1.8%
3/163 • Number of events 3
|
|
Metabolism and nutrition disorders
Dehydration
|
6.7%
11/164 • Number of events 12
|
4.9%
8/163 • Number of events 9
|
4.3%
7/163 • Number of events 7
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
0.61%
1/164 • Number of events 1
|
0.61%
1/163 • Number of events 1
|
0.00%
0/163
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
1.8%
3/164 • Number of events 3
|
6.1%
10/163 • Number of events 16
|
3.7%
6/163 • Number of events 7
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
0.00%
0/164
|
0.00%
0/163
|
1.2%
2/163 • Number of events 2
|
|
Metabolism and nutrition disorders
Hyperuricemia
|
0.00%
0/164
|
0.61%
1/163 • Number of events 1
|
0.00%
0/163
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
0.61%
1/164 • Number of events 1
|
0.61%
1/163 • Number of events 1
|
1.8%
3/163 • Number of events 3
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
1.8%
3/164 • Number of events 3
|
0.00%
0/163
|
0.61%
1/163 • Number of events 1
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
0.61%
1/164 • Number of events 1
|
1.2%
2/163 • Number of events 2
|
0.00%
0/163
|
|
Metabolism and nutrition disorders
Hypokalemia
|
4.3%
7/164 • Number of events 8
|
2.5%
4/163 • Number of events 4
|
3.1%
5/163 • Number of events 7
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
0.61%
1/164 • Number of events 1
|
0.00%
0/163
|
0.61%
1/163 • Number of events 1
|
|
Metabolism and nutrition disorders
Hyponatremia
|
3.0%
5/164 • Number of events 5
|
1.8%
3/163 • Number of events 4
|
2.5%
4/163 • Number of events 6
|
|
Metabolism and nutrition disorders
Iron increased
|
0.00%
0/164
|
0.61%
1/163 • Number of events 1
|
0.00%
0/163
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/164
|
0.00%
0/163
|
0.61%
1/163 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
3.0%
5/164 • Number of events 5
|
1.2%
2/163 • Number of events 4
|
0.00%
0/163
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
1.2%
2/164 • Number of events 2
|
1.8%
3/163 • Number of events 5
|
1.2%
2/163 • Number of events 2
|
|
Musculoskeletal and connective tissue disorders
Chest wall pain
|
0.61%
1/164 • Number of events 1
|
0.00%
0/163
|
0.00%
0/163
|
|
Musculoskeletal and connective tissue disorders
Extremity-lower weakness
|
0.00%
0/164
|
0.00%
0/163
|
0.61%
1/163 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Muscle Weakness
|
2.4%
4/164 • Number of events 5
|
1.2%
2/163 • Number of events 2
|
1.2%
2/163 • Number of events 2
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal
|
0.00%
0/164
|
0.61%
1/163 • Number of events 1
|
0.61%
1/163 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.61%
1/164 • Number of events 1
|
0.61%
1/163 • Number of events 1
|
0.61%
1/163 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.61%
1/164 • Number of events 1
|
0.00%
0/163
|
0.61%
1/163 • Number of events 2
|
|
Musculoskeletal and connective tissue disorders
Trunk weakness
|
0.00%
0/164
|
0.00%
0/163
|
0.61%
1/163 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pain-Anal
|
0.00%
0/164
|
0.00%
0/163
|
0.61%
1/163 • Number of events 1
|
|
Nervous system disorders
Depressed level of consciousness
|
0.00%
0/164
|
0.00%
0/163
|
0.61%
1/163 • Number of events 1
|
|
Nervous system disorders
Dizziness
|
0.61%
1/164 • Number of events 1
|
1.8%
3/163 • Number of events 3
|
1.2%
2/163 • Number of events 2
|
|
Nervous system disorders
Dysgeusia
|
0.61%
1/164 • Number of events 1
|
0.61%
1/163 • Number of events 1
|
0.00%
0/163
|
|
Nervous system disorders
Ischemia-Cerebral
|
0.61%
1/164 • Number of events 1
|
0.61%
1/163 • Number of events 1
|
0.00%
0/163
|
|
Nervous system disorders
Mental status changes
|
0.61%
1/164 • Number of events 1
|
0.00%
0/163
|
0.00%
0/163
|
|
Nervous system disorders
Neuralgia
|
1.2%
2/164 • Number of events 3
|
0.00%
0/163
|
0.00%
0/163
|
|
Nervous system disorders
Neuro
|
0.00%
0/164
|
0.61%
1/163 • Number of events 1
|
0.00%
0/163
|
|
Nervous system disorders
Peripheral motor neuropathy
|
0.61%
1/164 • Number of events 1
|
1.2%
2/163 • Number of events 2
|
0.00%
0/163
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
3.0%
5/164 • Number of events 8
|
1.2%
2/163 • Number of events 2
|
2.5%
4/163 • Number of events 6
|
|
Nervous system disorders
Seizure
|
0.61%
1/164 • Number of events 1
|
0.00%
0/163
|
0.00%
0/163
|
|
Nervous system disorders
Syncope
|
2.4%
4/164 • Number of events 4
|
0.61%
1/163 • Number of events 1
|
1.8%
3/163 • Number of events 3
|
|
Nervous system disorders
Syncope Vasovagal
|
0.61%
1/164 • Number of events 1
|
0.00%
0/163
|
0.00%
0/163
|
|
Nervous system disorders
Tremor
|
0.00%
0/164
|
0.00%
0/163
|
0.61%
1/163 • Number of events 1
|
|
Psychiatric disorders
Anxiety
|
0.61%
1/164 • Number of events 1
|
0.00%
0/163
|
0.00%
0/163
|
|
Psychiatric disorders
Confusion
|
0.00%
0/164
|
0.00%
0/163
|
0.61%
1/163 • Number of events 1
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/164
|
0.00%
0/163
|
1.2%
2/163 • Number of events 2
|
|
Renal and urinary disorders
Glomerular filtration rate
|
0.00%
0/164
|
0.00%
0/163
|
0.61%
1/163 • Number of events 1
|
|
Renal and urinary disorders
Renal Failure
|
0.00%
0/164
|
0.61%
1/163 • Number of events 2
|
0.00%
0/163
|
|
Reproductive system and breast disorders
Pelvic pain
|
0.61%
1/164 • Number of events 1
|
0.00%
0/163
|
0.00%
0/163
|
|
Reproductive system and breast disorders
Vaginal fistula
|
0.00%
0/164
|
0.00%
0/163
|
0.61%
1/163 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Adult respiratory distress syndrome (ARDS)
|
0.61%
1/164 • Number of events 1
|
0.00%
0/163
|
0.00%
0/163
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
0.61%
1/164 • Number of events 1
|
0.00%
0/163
|
0.00%
0/163
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/164
|
0.61%
1/163 • Number of events 1
|
1.2%
2/163 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
7.9%
13/164 • Number of events 21
|
4.9%
8/163 • Number of events 9
|
9.8%
16/163 • Number of events 19
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
1.8%
3/164 • Number of events 5
|
1.2%
2/163 • Number of events 2
|
1.8%
3/163 • Number of events 3
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/164
|
0.61%
1/163 • Number of events 1
|
1.2%
2/163 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary
|
0.61%
1/164 • Number of events 1
|
0.00%
0/163
|
0.00%
0/163
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary hypertension
|
0.00%
0/164
|
0.61%
1/163 • Number of events 1
|
0.61%
1/163 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Acne
|
0.00%
0/164
|
0.61%
1/163 • Number of events 2
|
0.00%
0/163
|
|
Skin and subcutaneous tissue disorders
Hand-foot skin reaction
|
0.00%
0/164
|
0.00%
0/163
|
1.2%
2/163 • Number of events 4
|
|
Skin and subcutaneous tissue disorders
Pain of skin
|
0.61%
1/164 • Number of events 2
|
0.00%
0/163
|
0.00%
0/163
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
26.8%
44/164 • Number of events 77
|
29.4%
48/163 • Number of events 91
|
28.2%
46/163 • Number of events 77
|
|
Skin and subcutaneous tissue disorders
Rash/Desquamation
|
0.61%
1/164 • Number of events 1
|
0.00%
0/163
|
0.00%
0/163
|
|
Skin and subcutaneous tissue disorders
Sweating
|
0.00%
0/164
|
0.00%
0/163
|
0.61%
1/163 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.61%
1/164 • Number of events 1
|
0.00%
0/163
|
0.00%
0/163
|
|
Vascular disorders
Flushing
|
20.7%
34/164 • Number of events 66
|
18.4%
30/163 • Number of events 55
|
20.2%
33/163 • Number of events 58
|
|
Vascular disorders
Hypertension
|
10.4%
17/164 • Number of events 28
|
12.3%
20/163 • Number of events 29
|
8.6%
14/163 • Number of events 16
|
|
Vascular disorders
Hypotension
|
14.0%
23/164 • Number of events 34
|
8.0%
13/163 • Number of events 19
|
14.7%
24/163 • Number of events 31
|
|
Vascular disorders
Phlebitis
|
0.00%
0/164
|
0.00%
0/163
|
0.61%
1/163 • Number of events 1
|
|
Vascular disorders
Thrombosis
|
4.3%
7/164 • Number of events 7
|
0.00%
0/163
|
4.9%
8/163 • Number of events 8
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place