Trial Outcomes & Findings for Epoetin Alfa or Darbepoetin Alfa in Treating Patients With Anemia Caused by Chemotherapy (NCT NCT00416624)
NCT ID: NCT00416624
Last Updated: 2017-02-10
Results Overview
A hematopoietic response was defined as Hb rise \>2 g/dL from baseline or achieving Hb ≥ 11.5 g/dL, whichever occurs first, in the absence of RBC transfusions within 14 days of measurement) during the treatment period
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
239 participants
Primary outcome timeframe
20 weeks
Results posted on
2017-02-10
Participant Flow
Two hundred and thirty-nine (239) participants were enrolled at 10 Mayo Clinic Cancer Research Consortium (MCCRC) sites between February 2007 and December 2008.
There were two canceled participants and 1 ineligible participants prior to study medication begins. These three participants were excluded from all analysis.
Participant milestones
| Measure |
Epoetin Alfa - 40k Weekly
Patients receive Epoetin alfa 40,000 units subcutaneously every week for 15 weeks (15 doses)
|
Epoetin Alfa - 80k Every 3 Weeks
Patients receive Epoetin alfa 80,000 units subcutaneously every 3 weeks for 15 weeks (5 doses)
|
Epoetin Alfa - 120k Every 3 Weeks
Patients receive Epoetin alfa 120,000 units subcutaneously every 3 weeks for 15 weeks (5 doses)
|
Darbepoetin Alfa - 500 mcg Every 3 Weeks
Patients receive Darbepoetin alfa 500 micrograms (mcg) subcutaneously every 3 weeks for 15 weeks (5 doses)
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
61
|
60
|
58
|
57
|
|
Overall Study
COMPLETED
|
39
|
33
|
40
|
40
|
|
Overall Study
NOT COMPLETED
|
22
|
27
|
18
|
17
|
Reasons for withdrawal
| Measure |
Epoetin Alfa - 40k Weekly
Patients receive Epoetin alfa 40,000 units subcutaneously every week for 15 weeks (15 doses)
|
Epoetin Alfa - 80k Every 3 Weeks
Patients receive Epoetin alfa 80,000 units subcutaneously every 3 weeks for 15 weeks (5 doses)
|
Epoetin Alfa - 120k Every 3 Weeks
Patients receive Epoetin alfa 120,000 units subcutaneously every 3 weeks for 15 weeks (5 doses)
|
Darbepoetin Alfa - 500 mcg Every 3 Weeks
Patients receive Darbepoetin alfa 500 micrograms (mcg) subcutaneously every 3 weeks for 15 weeks (5 doses)
|
|---|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
6
|
4
|
9
|
|
Overall Study
Death
|
4
|
7
|
7
|
1
|
|
Overall Study
Adverse Event
|
8
|
3
|
2
|
2
|
|
Overall Study
Other
|
8
|
11
|
5
|
5
|
|
Overall Study
Cancel
|
1
|
0
|
0
|
0
|
Baseline Characteristics
Epoetin Alfa or Darbepoetin Alfa in Treating Patients With Anemia Caused by Chemotherapy
Baseline characteristics by cohort
| Measure |
Epoetin Alfa - 40k Weekly
n=61 Participants
Patients receive Epoetin alfa 40,000 units subcutaneously every week for 15 weeks (15 doses)
|
Epoetin Alfa - 80k Every 3 Weeks
n=60 Participants
Patients receive Epoetin alfa 80,000 units subcutaneously every 3 weeks for 15 weeks (5 doses)
|
Epoetin Alfa - 120k Every 3 Weeks
n=58 Participants
Patients receive Epoetin alfa 120,000 units subcutaneously every 3 weeks for 15 weeks (5 doses)
|
Darbepoetin Alfa - 500 mcg Every 3 Weeks
n=57 Participants
Patients receive Darbepoetin alfa 500 micrograms (mcg) subcutaneously every 3 weeks for 15 weeks (5 doses)
|
Total
n=236 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
65.0 years
n=5 Participants
|
68.0 years
n=7 Participants
|
65.0 years
n=5 Participants
|
67.0 years
n=4 Participants
|
66.0 years
n=21 Participants
|
|
Gender
Female
|
37 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
33 Participants
n=5 Participants
|
42 Participants
n=4 Participants
|
136 Participants
n=21 Participants
|
|
Gender
Male
|
24 Participants
n=5 Participants
|
36 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
15 Participants
n=4 Participants
|
100 Participants
n=21 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
2 Participants
n=21 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
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
14 Participants
n=21 Participants
|
|
Race (NIH/OMB)
White
|
58 Participants
n=5 Participants
|
57 Participants
n=7 Participants
|
52 Participants
n=5 Participants
|
52 Participants
n=4 Participants
|
219 Participants
n=21 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
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Region of Enrollment
United States
|
61 participants
n=5 Participants
|
60 participants
n=7 Participants
|
58 participants
n=5 Participants
|
57 participants
n=4 Participants
|
236 participants
n=21 Participants
|
|
Anemia
Mild: Hemoglobin of 9.5-11
|
45 participants
n=5 Participants
|
43 participants
n=7 Participants
|
43 participants
n=5 Participants
|
42 participants
n=4 Participants
|
173 participants
n=21 Participants
|
|
Anemia
Severe: Hemoglobin < 9.5
|
16 participants
n=5 Participants
|
17 participants
n=7 Participants
|
15 participants
n=5 Participants
|
15 participants
n=4 Participants
|
63 participants
n=21 Participants
|
|
Platinum Containing Regimen
Yes
|
27 participants
n=5 Participants
|
27 participants
n=7 Participants
|
27 participants
n=5 Participants
|
25 participants
n=4 Participants
|
106 participants
n=21 Participants
|
|
Platinum Containing Regimen
No
|
34 participants
n=5 Participants
|
33 participants
n=7 Participants
|
31 participants
n=5 Participants
|
32 participants
n=4 Participants
|
130 participants
n=21 Participants
|
|
Primary Tumor Type
Hematologic
|
5 participants
n=5 Participants
|
6 participants
n=7 Participants
|
5 participants
n=5 Participants
|
4 participants
n=4 Participants
|
20 participants
n=21 Participants
|
|
Primary Tumor Type
Solid Tumor
|
56 participants
n=5 Participants
|
54 participants
n=7 Participants
|
53 participants
n=5 Participants
|
53 participants
n=4 Participants
|
216 participants
n=21 Participants
|
|
Height
|
167.6 cm
n=5 Participants
|
168.0 cm
n=7 Participants
|
165.2 cm
n=5 Participants
|
166.5 cm
n=4 Participants
|
167.0 cm
n=21 Participants
|
|
Baseline Hemoglobin
|
10.1 g/dL
n=5 Participants
|
9.9 g/dL
n=7 Participants
|
9.9 g/dL
n=5 Participants
|
9.9 g/dL
n=4 Participants
|
9.9 g/dL
n=21 Participants
|
|
Weight
|
69.1 kg
n=5 Participants
|
72.6 kg
n=7 Participants
|
70.6 kg
n=5 Participants
|
71.0 kg
n=4 Participants
|
71.3 kg
n=21 Participants
|
PRIMARY outcome
Timeframe: 20 weeksPopulation: All patients that were evaluable per protocol.
A hematopoietic response was defined as Hb rise \>2 g/dL from baseline or achieving Hb ≥ 11.5 g/dL, whichever occurs first, in the absence of RBC transfusions within 14 days of measurement) during the treatment period
Outcome measures
| Measure |
Epoetin Alfa - 40k Weekly
n=61 Participants
Patients receive Epoetin alfa 40,000 units subcutaneously every week for 15 weeks (15 doses)
|
Epoetin Alfa - 80k Every 3 Weeks
n=60 Participants
Patients receive Epoetin alfa 80,000 units subcutaneously every 3 weeks for 15 weeks (5 doses)
|
Epoetin Alfa - 120k Every 3 Weeks
n=58 Participants
Patients receive Epoetin alfa 120,000 units subcutaneously every 3 weeks for 15 weeks (5 doses)
|
Darbepoetin Alfa - 500 mcg Every 3 Weeks
n=57 Participants
Patients receive Darbepoetin alfa 500 micrograms (mcg) subcutaneously every 3 weeks for 15 weeks (5 doses)
|
|---|---|---|---|---|
|
The Percentage of Participants Who Exhibit a Hematopoietic Response
|
68.9 Percentage of participants
|
61.7 Percentage of participants
|
65.5 Percentage of participants
|
66.7 Percentage of participants
|
SECONDARY outcome
Timeframe: Baseline and Week 4, 7, 10, 13, 16Population: All patients that were evaluable per protocol and had hemoglobin data at baseline, week 4, 7, 10, 13 or 16.
To compare the effects of the 3 different epoetin alfa dosing schedules and an every-3-weeks darbepoetin alfa schedule
Outcome measures
| Measure |
Epoetin Alfa - 40k Weekly
n=61 Participants
Patients receive Epoetin alfa 40,000 units subcutaneously every week for 15 weeks (15 doses)
|
Epoetin Alfa - 80k Every 3 Weeks
n=60 Participants
Patients receive Epoetin alfa 80,000 units subcutaneously every 3 weeks for 15 weeks (5 doses)
|
Epoetin Alfa - 120k Every 3 Weeks
n=58 Participants
Patients receive Epoetin alfa 120,000 units subcutaneously every 3 weeks for 15 weeks (5 doses)
|
Darbepoetin Alfa - 500 mcg Every 3 Weeks
n=57 Participants
Patients receive Darbepoetin alfa 500 micrograms (mcg) subcutaneously every 3 weeks for 15 weeks (5 doses)
|
|---|---|---|---|---|
|
Weekly Change in Hemoglobin Levels
Week 4 Minus Baseline
|
1.0 g/dL
Standard Deviation 1.26
|
0.6 g/dL
Standard Deviation 1.02
|
0.7 g/dL
Standard Deviation 1.21
|
0.4 g/dL
Standard Deviation 1.21
|
|
Weekly Change in Hemoglobin Levels
Week 7 Minus Baseline
|
1.7 g/dL
Standard Deviation 1.28
|
1.0 g/dL
Standard Deviation 1.58
|
1.1 g/dL
Standard Deviation 1.25
|
1.5 g/dL
Standard Deviation 1.59
|
|
Weekly Change in Hemoglobin Levels
Week 10 Minus Baseline
|
1.7 g/dL
Standard Deviation 1.39
|
1.2 g/dL
Standard Deviation 1.42
|
1.2 g/dL
Standard Deviation 1.37
|
1.5 g/dL
Standard Deviation 1.44
|
|
Weekly Change in Hemoglobin Levels
Week 13 Minus Baseline
|
2.1 g/dL
Standard Deviation 1.27
|
1.2 g/dL
Standard Deviation 1.51
|
1.3 g/dL
Standard Deviation 1.32
|
1.6 g/dL
Standard Deviation 1.65
|
|
Weekly Change in Hemoglobin Levels
Week 16 Minus Baseline
|
1.7 g/dL
Standard Deviation 1.67
|
1.2 g/dL
Standard Deviation 1.64
|
1.6 g/dL
Standard Deviation 1.44
|
1.9 g/dL
Standard Deviation 1.41
|
SECONDARY outcome
Timeframe: 16 weeksPopulation: All patients that were evaluable per protocol and had hemoglobin levels data.
To compare the effects of the 3 different epoetin alfa dosing schedules and a darbepoetin alfa schedule
Outcome measures
| Measure |
Epoetin Alfa - 40k Weekly
n=61 Participants
Patients receive Epoetin alfa 40,000 units subcutaneously every week for 15 weeks (15 doses)
|
Epoetin Alfa - 80k Every 3 Weeks
n=60 Participants
Patients receive Epoetin alfa 80,000 units subcutaneously every 3 weeks for 15 weeks (5 doses)
|
Epoetin Alfa - 120k Every 3 Weeks
n=58 Participants
Patients receive Epoetin alfa 120,000 units subcutaneously every 3 weeks for 15 weeks (5 doses)
|
Darbepoetin Alfa - 500 mcg Every 3 Weeks
n=57 Participants
Patients receive Darbepoetin alfa 500 micrograms (mcg) subcutaneously every 3 weeks for 15 weeks (5 doses)
|
|---|---|---|---|---|
|
Time Required to Achieve Hemoglobin Levels >= 11.5 g/dL
|
32 days
Interval 28.0 to 37.0
|
50 days
Interval 35.0 to 68.0
|
49 days
Interval 35.0 to 77.0
|
49 days
Interval 35.0 to 64.0
|
SECONDARY outcome
Timeframe: Week 1 and Week 16Population: All patients that were evaluable per protocol and had hemoglobin data.
To compare the effects of the 3 different epoetin alfa dosing schedules and an every-3-weeks darbepoetin alfa schedule. The positive numbers represent hemoglobin increases and negative numbers represent hemoglobin decreases.
Outcome measures
| Measure |
Epoetin Alfa - 40k Weekly
n=61 Participants
Patients receive Epoetin alfa 40,000 units subcutaneously every week for 15 weeks (15 doses)
|
Epoetin Alfa - 80k Every 3 Weeks
n=60 Participants
Patients receive Epoetin alfa 80,000 units subcutaneously every 3 weeks for 15 weeks (5 doses)
|
Epoetin Alfa - 120k Every 3 Weeks
n=58 Participants
Patients receive Epoetin alfa 120,000 units subcutaneously every 3 weeks for 15 weeks (5 doses)
|
Darbepoetin Alfa - 500 mcg Every 3 Weeks
n=57 Participants
Patients receive Darbepoetin alfa 500 micrograms (mcg) subcutaneously every 3 weeks for 15 weeks (5 doses)
|
|---|---|---|---|---|
|
Mean Hemoglobin Change From Week 1 to Week 16
|
11.0 g/dL
Standard Deviation 1.03
|
10.3 g/dL
Standard Deviation 1.04
|
10.6 g/dL
Standard Deviation 0.8
|
10.7 g/dL
Standard Deviation 0.96
|
SECONDARY outcome
Timeframe: 16 weeksPopulation: All patients that were evaluable per protocol and had RBC transfusions data.
To compare the effects of the 3 different epoetin alfa dosing schedules and a darbepoetin alfa schedule
Outcome measures
| Measure |
Epoetin Alfa - 40k Weekly
n=61 Participants
Patients receive Epoetin alfa 40,000 units subcutaneously every week for 15 weeks (15 doses)
|
Epoetin Alfa - 80k Every 3 Weeks
n=60 Participants
Patients receive Epoetin alfa 80,000 units subcutaneously every 3 weeks for 15 weeks (5 doses)
|
Epoetin Alfa - 120k Every 3 Weeks
n=58 Participants
Patients receive Epoetin alfa 120,000 units subcutaneously every 3 weeks for 15 weeks (5 doses)
|
Darbepoetin Alfa - 500 mcg Every 3 Weeks
n=57 Participants
Patients receive Darbepoetin alfa 500 micrograms (mcg) subcutaneously every 3 weeks for 15 weeks (5 doses)
|
|---|---|---|---|---|
|
The Percentage of Participants Requiring Red Blood Cell (RBC) Transfusions
|
27.9 percentage of participants
|
33.3 percentage of participants
|
22.4 percentage of participants
|
29.8 percentage of participants
|
SECONDARY outcome
Timeframe: 16 weeksPopulation: All patients that were evaluable per protocol and had RBC transfusions data.
To compare the effects of the 3 different epoetin alfa dosing schedules and a darbepoetin alfa schedule
Outcome measures
| Measure |
Epoetin Alfa - 40k Weekly
n=61 Participants
Patients receive Epoetin alfa 40,000 units subcutaneously every week for 15 weeks (15 doses)
|
Epoetin Alfa - 80k Every 3 Weeks
n=60 Participants
Patients receive Epoetin alfa 80,000 units subcutaneously every 3 weeks for 15 weeks (5 doses)
|
Epoetin Alfa - 120k Every 3 Weeks
n=58 Participants
Patients receive Epoetin alfa 120,000 units subcutaneously every 3 weeks for 15 weeks (5 doses)
|
Darbepoetin Alfa - 500 mcg Every 3 Weeks
n=57 Participants
Patients receive Darbepoetin alfa 500 micrograms (mcg) subcutaneously every 3 weeks for 15 weeks (5 doses)
|
|---|---|---|---|---|
|
The Total RBC Transfusion Needed
|
1.1 g/dL
Standard Deviation 2.33
|
1.2 g/dL
Standard Deviation 2.67
|
0.6 g/dL
Standard Deviation 1.20
|
1.1 g/dL
Standard Deviation 2.31
|
SECONDARY outcome
Timeframe: 16 WeeksPopulation: All patients that were evaluable per protocol.
To compare the effects of the 3 different epoetin alfa dosing schedules and a darbepoetin alfa schedule
Outcome measures
| Measure |
Epoetin Alfa - 40k Weekly
n=61 Participants
Patients receive Epoetin alfa 40,000 units subcutaneously every week for 15 weeks (15 doses)
|
Epoetin Alfa - 80k Every 3 Weeks
n=60 Participants
Patients receive Epoetin alfa 80,000 units subcutaneously every 3 weeks for 15 weeks (5 doses)
|
Epoetin Alfa - 120k Every 3 Weeks
n=58 Participants
Patients receive Epoetin alfa 120,000 units subcutaneously every 3 weeks for 15 weeks (5 doses)
|
Darbepoetin Alfa - 500 mcg Every 3 Weeks
n=57 Participants
Patients receive Darbepoetin alfa 500 micrograms (mcg) subcutaneously every 3 weeks for 15 weeks (5 doses)
|
|---|---|---|---|---|
|
The Percentage of Participants With Dose Omitted Due to Hematologic Reason
|
63.9 percentage of Participants
|
30 percentage of Participants
|
34.5 percentage of Participants
|
45.6 percentage of Participants
|
SECONDARY outcome
Timeframe: 16 weeksPopulation: All patients that were evaluable per protocol and reported at least one value after baseline.
To compare the effects of the 3 different epoetin alfa dosing schedules and a darbepoetin alfa schedule. Adverse events were measured by Common Terminology Criteria for Adverse Events (CTCAE) v3.0.
Outcome measures
| Measure |
Epoetin Alfa - 40k Weekly
n=60 Participants
Patients receive Epoetin alfa 40,000 units subcutaneously every week for 15 weeks (15 doses)
|
Epoetin Alfa - 80k Every 3 Weeks
n=60 Participants
Patients receive Epoetin alfa 80,000 units subcutaneously every 3 weeks for 15 weeks (5 doses)
|
Epoetin Alfa - 120k Every 3 Weeks
n=58 Participants
Patients receive Epoetin alfa 120,000 units subcutaneously every 3 weeks for 15 weeks (5 doses)
|
Darbepoetin Alfa - 500 mcg Every 3 Weeks
n=55 Participants
Patients receive Darbepoetin alfa 500 micrograms (mcg) subcutaneously every 3 weeks for 15 weeks (5 doses)
|
|---|---|---|---|---|
|
The Percentage of Participants Reported Grade 3 or 4 Adverse Events
|
22 percentage of participants
|
22 percentage of participants
|
17 percentage of participants
|
13 percentage of participants
|
SECONDARY outcome
Timeframe: Weeks 4, 7, 10, 13 and 16Population: All patients that were evaluable per protocol with QOL data.
To compare the effects of the 3 different epoetin alfa dosing schedules and a darbepoetin alfa schedule. FACT-AN consist of Fatigue concerns subscale and non-fatigue concerns subscale. FACT Total Anemia score was calculated by adding the two subscales scores and transformed into 0-100 scale. FACT Total Anemia, Fatigue concerns scale and Non-Fatigue concerns scale are all ranges: 0 (Worst QOL) to 100 (Best QOL). Average scores across all time points for each subscale and total scale were calculated.
Outcome measures
| Measure |
Epoetin Alfa - 40k Weekly
n=61 Participants
Patients receive Epoetin alfa 40,000 units subcutaneously every week for 15 weeks (15 doses)
|
Epoetin Alfa - 80k Every 3 Weeks
n=60 Participants
Patients receive Epoetin alfa 80,000 units subcutaneously every 3 weeks for 15 weeks (5 doses)
|
Epoetin Alfa - 120k Every 3 Weeks
n=58 Participants
Patients receive Epoetin alfa 120,000 units subcutaneously every 3 weeks for 15 weeks (5 doses)
|
Darbepoetin Alfa - 500 mcg Every 3 Weeks
n=57 Participants
Patients receive Darbepoetin alfa 500 micrograms (mcg) subcutaneously every 3 weeks for 15 weeks (5 doses)
|
|---|---|---|---|---|
|
Quality of Life as Measured by Functional Assessment of Cancer Therapy Scales for Anemia (FACT-AN) Over All Follow-up Evaluations
FACT Fatigue Concerns
|
48.6 units on a scale
Standard Deviation 17.13
|
52.0 units on a scale
Standard Deviation 20.75
|
52.6 units on a scale
Standard Deviation 23.12
|
49.8 units on a scale
Standard Deviation 19.66
|
|
Quality of Life as Measured by Functional Assessment of Cancer Therapy Scales for Anemia (FACT-AN) Over All Follow-up Evaluations
FACT Nonfatigue Concerns
|
60.6 units on a scale
Standard Deviation 13.08
|
62.2 units on a scale
Standard Deviation 16.64
|
61.3 units on a scale
Standard Deviation 16.27
|
59.4 units on a scale
Standard Deviation 13.39
|
|
Quality of Life as Measured by Functional Assessment of Cancer Therapy Scales for Anemia (FACT-AN) Over All Follow-up Evaluations
FACT Total Anemia
|
52.8 units on a scale
Standard Deviation 14.58
|
55.6 units on a scale
Standard Deviation 18.08
|
55.6 units on a scale
Standard Deviation 19.85
|
53.1 units on a scale
Standard Deviation 16.24
|
SECONDARY outcome
Timeframe: Weeks 4, 7, 10, 13 and 16Population: All patients that were evaluable per protocol with QOL data.
To compare the effects of the 3 different epoetin alfa dosing schedules and a darbepoetin alfa schedule. Linear Analogue Self Assessment (LASA) consists of 10 single-item numeric analogue scales on a scale of 0 to 10. Higher scores indicate better quality of life (QOL) on overall QOL, mental, physical, emotional spiritual QOL and Social activity; and constant pain, highest pain severity, level of fatigue and anxiety. Average scores across all time points for each item were calculated.
Outcome measures
| Measure |
Epoetin Alfa - 40k Weekly
n=61 Participants
Patients receive Epoetin alfa 40,000 units subcutaneously every week for 15 weeks (15 doses)
|
Epoetin Alfa - 80k Every 3 Weeks
n=60 Participants
Patients receive Epoetin alfa 80,000 units subcutaneously every 3 weeks for 15 weeks (5 doses)
|
Epoetin Alfa - 120k Every 3 Weeks
n=58 Participants
Patients receive Epoetin alfa 120,000 units subcutaneously every 3 weeks for 15 weeks (5 doses)
|
Darbepoetin Alfa - 500 mcg Every 3 Weeks
n=57 Participants
Patients receive Darbepoetin alfa 500 micrograms (mcg) subcutaneously every 3 weeks for 15 weeks (5 doses)
|
|---|---|---|---|---|
|
Quality of Life as Measured by Linear Analogue Self Assessment Over All Follow-up Evaluation
Physical QOL
|
5.7 units on a scale
Standard Deviation 1.54
|
5.8 units on a scale
Standard Deviation 2.11
|
5.9 units on a scale
Standard Deviation 2.22
|
5.8 units on a scale
Standard Deviation 1.65
|
|
Quality of Life as Measured by Linear Analogue Self Assessment Over All Follow-up Evaluation
Emotional QOL
|
6.5 units on a scale
Standard Deviation 1.68
|
6.8 units on a scale
Standard Deviation 1.99
|
6.7 units on a scale
Standard Deviation 2.03
|
6.3 units on a scale
Standard Deviation 1.80
|
|
Quality of Life as Measured by Linear Analogue Self Assessment Over All Follow-up Evaluation
Anxiety
|
4.1 units on a scale
Standard Deviation 1.81
|
3.9 units on a scale
Standard Deviation 2.20
|
4.6 units on a scale
Standard Deviation 2.36
|
4.2 units on a scale
Standard Deviation 1.67
|
|
Quality of Life as Measured by Linear Analogue Self Assessment Over All Follow-up Evaluation
Overall QOL
|
6.4 units on a scale
Standard Deviation 1.59
|
6.5 units on a scale
Standard Deviation 2.00
|
6.6 units on a scale
Standard Deviation 2.17
|
6.1 units on a scale
Standard Deviation 1.61
|
|
Quality of Life as Measured by Linear Analogue Self Assessment Over All Follow-up Evaluation
Mental QOL
|
6.9 units on a scale
Standard Deviation 1.80
|
7.0 units on a scale
Standard Deviation 1.97
|
7.2 units on a scale
Standard Deviation 1.91
|
6.5 units on a scale
Standard Deviation 1.39
|
|
Quality of Life as Measured by Linear Analogue Self Assessment Over All Follow-up Evaluation
Social Activity Level
|
5.5 units on a scale
Standard Deviation 2.08
|
5.5 units on a scale
Standard Deviation 2.12
|
5.4 units on a scale
Standard Deviation 2.34
|
5.1 units on a scale
Standard Deviation 2.01
|
|
Quality of Life as Measured by Linear Analogue Self Assessment Over All Follow-up Evaluation
Spiritual QOL
|
7.4 units on a scale
Standard Deviation 1.54
|
7.4 units on a scale
Standard Deviation 1.81
|
7.3 units on a scale
Standard Deviation 2.07
|
6.8 units on a scale
Standard Deviation 1.99
|
|
Quality of Life as Measured by Linear Analogue Self Assessment Over All Follow-up Evaluation
Pain Frequency
|
4.5 units on a scale
Standard Deviation 2.46
|
4.3 units on a scale
Standard Deviation 2.96
|
3.9 units on a scale
Standard Deviation 3.02
|
4.2 units on a scale
Standard Deviation 2.42
|
|
Quality of Life as Measured by Linear Analogue Self Assessment Over All Follow-up Evaluation
Pain Severity
|
4.1 units on a scale
Standard Deviation 2.16
|
3.8 units on a scale
Standard Deviation 2.72
|
3.7 units on a scale
Standard Deviation 2.88
|
4.0 units on a scale
Standard Deviation 2.24
|
|
Quality of Life as Measured by Linear Analogue Self Assessment Over All Follow-up Evaluation
Fatigue
|
5.6 units on a scale
Standard Deviation 1.59
|
5.5 units on a scale
Standard Deviation 2.02
|
5.6 units on a scale
Standard Deviation 2.14
|
5.4 units on a scale
Standard Deviation 1.60
|
SECONDARY outcome
Timeframe: Weeks 4, 7, 10, 13 and 16Population: All patients that were evaluable per protocol with QOL data.
To compare the effects of the 3 different epoetin alfa dosing schedules and a darbepoetin alfa schedule. Brief Fatigue Inventory (BFI) consist of 3 single-item numeric analogue scales on a scale of 0 to 10; and an interference scale formed by 6 single-item numeric scales on a scale of 0 to 10. Higher scores indicate fatigue as bad as you can imagine for fatigue now, usual fatigue and worse fatigue; and completely interferes for BFI interference. Average scores across all time points for fatigue now, usual fatigue, worst fatigue and BFI interference subscale were calculated.
Outcome measures
| Measure |
Epoetin Alfa - 40k Weekly
n=61 Participants
Patients receive Epoetin alfa 40,000 units subcutaneously every week for 15 weeks (15 doses)
|
Epoetin Alfa - 80k Every 3 Weeks
n=60 Participants
Patients receive Epoetin alfa 80,000 units subcutaneously every 3 weeks for 15 weeks (5 doses)
|
Epoetin Alfa - 120k Every 3 Weeks
n=58 Participants
Patients receive Epoetin alfa 120,000 units subcutaneously every 3 weeks for 15 weeks (5 doses)
|
Darbepoetin Alfa - 500 mcg Every 3 Weeks
n=57 Participants
Patients receive Darbepoetin alfa 500 micrograms (mcg) subcutaneously every 3 weeks for 15 weeks (5 doses)
|
|---|---|---|---|---|
|
Quality of Life as Measured by Brief Fatigue Inventory Overall All Follow-up Evaluations
Fatigue Now
|
4.8 units on a scale
Standard Deviation 2.25
|
4.6 units on a scale
Standard Deviation 2.44
|
4.6 units on a scale
Standard Deviation 2.53
|
4.7 units on a scale
Standard Deviation 2.25
|
|
Quality of Life as Measured by Brief Fatigue Inventory Overall All Follow-up Evaluations
Usual Fatigue
|
4.7 units on a scale
Standard Deviation 2.12
|
4.7 units on a scale
Standard Deviation 2.40
|
4.7 units on a scale
Standard Deviation 2.53
|
4.7 units on a scale
Standard Deviation 2.24
|
|
Quality of Life as Measured by Brief Fatigue Inventory Overall All Follow-up Evaluations
Worst Fatigue
|
5.5 units on a scale
Standard Deviation 2.17
|
5.6 units on a scale
Standard Deviation 2.54
|
5.4 units on a scale
Standard Deviation 2.60
|
5.3 units on a scale
Standard Deviation 2.43
|
|
Quality of Life as Measured by Brief Fatigue Inventory Overall All Follow-up Evaluations
BFI Interference
|
4.3 units on a scale
Standard Deviation 1.95
|
4.1 units on a scale
Standard Deviation 2.42
|
4.3 units on a scale
Standard Deviation 2.60
|
4.4 units on a scale
Standard Deviation 2.17
|
SECONDARY outcome
Timeframe: Weeks 4, 7, 10, 13 and 16Population: All patients that were evaluable per protocol with QOL data.
To compare the effects of the 3 different epoetin alfa dosing schedules and a darbepoetin alfa schedule. SDS Scale range: 1 (No Symptom), 5 (Worst Symptom). Average scores across all time points for each item were calculated.
Outcome measures
| Measure |
Epoetin Alfa - 40k Weekly
n=61 Participants
Patients receive Epoetin alfa 40,000 units subcutaneously every week for 15 weeks (15 doses)
|
Epoetin Alfa - 80k Every 3 Weeks
n=60 Participants
Patients receive Epoetin alfa 80,000 units subcutaneously every 3 weeks for 15 weeks (5 doses)
|
Epoetin Alfa - 120k Every 3 Weeks
n=58 Participants
Patients receive Epoetin alfa 120,000 units subcutaneously every 3 weeks for 15 weeks (5 doses)
|
Darbepoetin Alfa - 500 mcg Every 3 Weeks
n=57 Participants
Patients receive Darbepoetin alfa 500 micrograms (mcg) subcutaneously every 3 weeks for 15 weeks (5 doses)
|
|---|---|---|---|---|
|
Quality of Life as Measured by Symptom Distress Scale (SDS) Over All Follow-up Evaluations
Nausea Frequency
|
1.6 units on a scale
Standard Deviation 0.64
|
1.5 units on a scale
Standard Deviation 0.67
|
1.6 units on a scale
Standard Deviation 0.56
|
1.6 units on a scale
Standard Deviation 0.73
|
|
Quality of Life as Measured by Symptom Distress Scale (SDS) Over All Follow-up Evaluations
Fatigue
|
3.1 units on a scale
Standard Deviation 0.82
|
3.0 units on a scale
Standard Deviation 0.94
|
2.8 units on a scale
Standard Deviation 0.97
|
2.9 units on a scale
Standard Deviation 0.91
|
|
Quality of Life as Measured by Symptom Distress Scale (SDS) Over All Follow-up Evaluations
Nausea Severity
|
1.5 units on a scale
Standard Deviation 0.59
|
1.4 units on a scale
Standard Deviation 0.62
|
1.4 units on a scale
Standard Deviation 0.61
|
1.6 units on a scale
Standard Deviation 0.73
|
|
Quality of Life as Measured by Symptom Distress Scale (SDS) Over All Follow-up Evaluations
Appetite
|
2.3 units on a scale
Standard Deviation 0.96
|
2.3 units on a scale
Standard Deviation 0.94
|
2.2 units on a scale
Standard Deviation 0.98
|
2.4 units on a scale
Standard Deviation 0.91
|
|
Quality of Life as Measured by Symptom Distress Scale (SDS) Over All Follow-up Evaluations
Insomnia
|
2.4 units on a scale
Standard Deviation 0.99
|
2.0 units on a scale
Standard Deviation 0.88
|
2.3 units on a scale
Standard Deviation 0.89
|
2.4 units on a scale
Standard Deviation 0.91
|
|
Quality of Life as Measured by Symptom Distress Scale (SDS) Over All Follow-up Evaluations
Pain Frequency
|
2.7 units on a scale
Standard Deviation 1.12
|
2.5 units on a scale
Standard Deviation 1.15
|
2.4 units on a scale
Standard Deviation 1.22
|
2.7 units on a scale
Standard Deviation 1.16
|
|
Quality of Life as Measured by Symptom Distress Scale (SDS) Over All Follow-up Evaluations
Pain Severity
|
2.2 units on a scale
Standard Deviation 0.97
|
2.0 units on a scale
Standard Deviation 1.02
|
2.0 units on a scale
Standard Deviation 1.05
|
2.1 units on a scale
Standard Deviation 0.88
|
|
Quality of Life as Measured by Symptom Distress Scale (SDS) Over All Follow-up Evaluations
Bowel
|
2.2 units on a scale
Standard Deviation 1.00
|
2.4 units on a scale
Standard Deviation 1.20
|
2.3 units on a scale
Standard Deviation 1.05
|
2.3 units on a scale
Standard Deviation 0.95
|
|
Quality of Life as Measured by Symptom Distress Scale (SDS) Over All Follow-up Evaluations
Concentration
|
2.2 units on a scale
Standard Deviation 0.99
|
2.0 units on a scale
Standard Deviation 1.00
|
1.9 units on a scale
Standard Deviation 0.89
|
2.2 units on a scale
Standard Deviation 0.96
|
|
Quality of Life as Measured by Symptom Distress Scale (SDS) Over All Follow-up Evaluations
Appearance
|
2.1 units on a scale
Standard Deviation 0.89
|
2.2 units on a scale
Standard Deviation 1.05
|
2.0 units on a scale
Standard Deviation 1.09
|
2.2 units on a scale
Standard Deviation 0.97
|
|
Quality of Life as Measured by Symptom Distress Scale (SDS) Over All Follow-up Evaluations
Breathing
|
1.5 units on a scale
Standard Deviation 0.54
|
1.6 units on a scale
Standard Deviation 0.64
|
1.6 units on a scale
Standard Deviation 0.82
|
1.7 units on a scale
Standard Deviation 1.01
|
|
Quality of Life as Measured by Symptom Distress Scale (SDS) Over All Follow-up Evaluations
Outlook
|
2.2 units on a scale
Standard Deviation 0.98
|
2.1 units on a scale
Standard Deviation 0.99
|
2.1 units on a scale
Standard Deviation 0.91
|
2.4 units on a scale
Standard Deviation 1.02
|
|
Quality of Life as Measured by Symptom Distress Scale (SDS) Over All Follow-up Evaluations
Cough
|
1.8 units on a scale
Standard Deviation 0.77
|
1.7 units on a scale
Standard Deviation 0.66
|
1.8 units on a scale
Standard Deviation 0.69
|
2.0 units on a scale
Standard Deviation 0.84
|
|
Quality of Life as Measured by Symptom Distress Scale (SDS) Over All Follow-up Evaluations
Depression
|
1.8 units on a scale
Standard Deviation 0.64
|
1.7 units on a scale
Standard Deviation 0.79
|
1.8 units on a scale
Standard Deviation 0.65
|
2.0 units on a scale
Standard Deviation 0.90
|
Adverse Events
Epoetin Alfa - 40k Weekly
Serious events: 4 serious events
Other events: 21 other events
Deaths: 0 deaths
Epoetin Alfa - 80k Every 3 Weeks
Serious events: 7 serious events
Other events: 16 other events
Deaths: 0 deaths
Epoetin Alfa - 120k Every 3 Weeks
Serious events: 4 serious events
Other events: 16 other events
Deaths: 0 deaths
Darbepoetin Alfa - 500 mcg Every 3 Weeks
Serious events: 2 serious events
Other events: 7 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Epoetin Alfa - 40k Weekly
n=60 participants at risk
Patients receive Epoetin alfa 40,000 units subcutaneously every week for 15 weeks (15 doses)
|
Epoetin Alfa - 80k Every 3 Weeks
n=60 participants at risk
Patients receive Epoetin alfa 80,000 units subcutaneously every 3 weeks for 15 weeks (5 doses)
|
Epoetin Alfa - 120k Every 3 Weeks
n=58 participants at risk
Patients receive Epoetin alfa 120,000 units subcutaneously every 3 weeks for 15 weeks (5 doses)
|
Darbepoetin Alfa - 500 mcg Every 3 Weeks
n=56 participants at risk
Patients receive Darbepoetin alfa 500 micrograms (mcg) subcutaneously every 3 weeks for 15 weeks (5 doses)
|
|---|---|---|---|---|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.00%
0/60 • 16 Weeks
All evaluable patients per protocol that reported at least one value after baseline.
|
1.7%
1/60 • Number of events 1 • 16 Weeks
All evaluable patients per protocol that reported at least one value after baseline.
|
0.00%
0/58 • 16 Weeks
All evaluable patients per protocol that reported at least one value after baseline.
|
0.00%
0/56 • 16 Weeks
All evaluable patients per protocol that reported at least one value after baseline.
|
|
Gastrointestinal disorders
Diarrhea
|
0.00%
0/60 • 16 Weeks
All evaluable patients per protocol that reported at least one value after baseline.
|
1.7%
1/60 • Number of events 1 • 16 Weeks
All evaluable patients per protocol that reported at least one value after baseline.
|
0.00%
0/58 • 16 Weeks
All evaluable patients per protocol that reported at least one value after baseline.
|
0.00%
0/56 • 16 Weeks
All evaluable patients per protocol that reported at least one value after baseline.
|
|
Gastrointestinal disorders
Rectal stenosis
|
1.7%
1/60 • Number of events 1 • 16 Weeks
All evaluable patients per protocol that reported at least one value after baseline.
|
0.00%
0/60 • 16 Weeks
All evaluable patients per protocol that reported at least one value after baseline.
|
0.00%
0/58 • 16 Weeks
All evaluable patients per protocol that reported at least one value after baseline.
|
0.00%
0/56 • 16 Weeks
All evaluable patients per protocol that reported at least one value after baseline.
|
|
General disorders
Disease progression
|
3.3%
2/60 • Number of events 2 • 16 Weeks
All evaluable patients per protocol that reported at least one value after baseline.
|
3.3%
2/60 • Number of events 2 • 16 Weeks
All evaluable patients per protocol that reported at least one value after baseline.
|
1.7%
1/58 • Number of events 1 • 16 Weeks
All evaluable patients per protocol that reported at least one value after baseline.
|
0.00%
0/56 • 16 Weeks
All evaluable patients per protocol that reported at least one value after baseline.
|
|
General disorders
Sudden death
|
0.00%
0/60 • 16 Weeks
All evaluable patients per protocol that reported at least one value after baseline.
|
1.7%
1/60 • Number of events 1 • 16 Weeks
All evaluable patients per protocol that reported at least one value after baseline.
|
0.00%
0/58 • 16 Weeks
All evaluable patients per protocol that reported at least one value after baseline.
|
0.00%
0/56 • 16 Weeks
All evaluable patients per protocol that reported at least one value after baseline.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/60 • 16 Weeks
All evaluable patients per protocol that reported at least one value after baseline.
|
0.00%
0/60 • 16 Weeks
All evaluable patients per protocol that reported at least one value after baseline.
|
1.7%
1/58 • Number of events 1 • 16 Weeks
All evaluable patients per protocol that reported at least one value after baseline.
|
0.00%
0/56 • 16 Weeks
All evaluable patients per protocol that reported at least one value after baseline.
|
|
Investigations
Neutrophil count decreased
|
0.00%
0/60 • 16 Weeks
All evaluable patients per protocol that reported at least one value after baseline.
|
1.7%
1/60 • Number of events 1 • 16 Weeks
All evaluable patients per protocol that reported at least one value after baseline.
|
0.00%
0/58 • 16 Weeks
All evaluable patients per protocol that reported at least one value after baseline.
|
0.00%
0/56 • 16 Weeks
All evaluable patients per protocol that reported at least one value after baseline.
|
|
Metabolism and nutrition disorders
Anorexia
|
1.7%
1/60 • Number of events 1 • 16 Weeks
All evaluable patients per protocol that reported at least one value after baseline.
|
1.7%
1/60 • Number of events 1 • 16 Weeks
All evaluable patients per protocol that reported at least one value after baseline.
|
0.00%
0/58 • 16 Weeks
All evaluable patients per protocol that reported at least one value after baseline.
|
0.00%
0/56 • 16 Weeks
All evaluable patients per protocol that reported at least one value after baseline.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/60 • 16 Weeks
All evaluable patients per protocol that reported at least one value after baseline.
|
1.7%
1/60 • Number of events 1 • 16 Weeks
All evaluable patients per protocol that reported at least one value after baseline.
|
0.00%
0/58 • 16 Weeks
All evaluable patients per protocol that reported at least one value after baseline.
|
0.00%
0/56 • 16 Weeks
All evaluable patients per protocol that reported at least one value after baseline.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
0.00%
0/60 • 16 Weeks
All evaluable patients per protocol that reported at least one value after baseline.
|
0.00%
0/60 • 16 Weeks
All evaluable patients per protocol that reported at least one value after baseline.
|
1.7%
1/58 • Number of events 1 • 16 Weeks
All evaluable patients per protocol that reported at least one value after baseline.
|
0.00%
0/56 • 16 Weeks
All evaluable patients per protocol that reported at least one value after baseline.
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness
|
1.7%
1/60 • Number of events 1 • 16 Weeks
All evaluable patients per protocol that reported at least one value after baseline.
|
0.00%
0/60 • 16 Weeks
All evaluable patients per protocol that reported at least one value after baseline.
|
0.00%
0/58 • 16 Weeks
All evaluable patients per protocol that reported at least one value after baseline.
|
0.00%
0/56 • 16 Weeks
All evaluable patients per protocol that reported at least one value after baseline.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/60 • 16 Weeks
All evaluable patients per protocol that reported at least one value after baseline.
|
0.00%
0/60 • 16 Weeks
All evaluable patients per protocol that reported at least one value after baseline.
|
0.00%
0/58 • 16 Weeks
All evaluable patients per protocol that reported at least one value after baseline.
|
1.8%
1/56 • Number of events 1 • 16 Weeks
All evaluable patients per protocol that reported at least one value after baseline.
|
|
Renal and urinary disorders
Hemorrhage urinary tract
|
1.7%
1/60 • Number of events 1 • 16 Weeks
All evaluable patients per protocol that reported at least one value after baseline.
|
0.00%
0/60 • 16 Weeks
All evaluable patients per protocol that reported at least one value after baseline.
|
0.00%
0/58 • 16 Weeks
All evaluable patients per protocol that reported at least one value after baseline.
|
0.00%
0/56 • 16 Weeks
All evaluable patients per protocol that reported at least one value after baseline.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
0.00%
0/60 • 16 Weeks
All evaluable patients per protocol that reported at least one value after baseline.
|
1.7%
1/60 • Number of events 1 • 16 Weeks
All evaluable patients per protocol that reported at least one value after baseline.
|
0.00%
0/58 • 16 Weeks
All evaluable patients per protocol that reported at least one value after baseline.
|
0.00%
0/56 • 16 Weeks
All evaluable patients per protocol that reported at least one value after baseline.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/60 • 16 Weeks
All evaluable patients per protocol that reported at least one value after baseline.
|
1.7%
1/60 • Number of events 1 • 16 Weeks
All evaluable patients per protocol that reported at least one value after baseline.
|
0.00%
0/58 • 16 Weeks
All evaluable patients per protocol that reported at least one value after baseline.
|
0.00%
0/56 • 16 Weeks
All evaluable patients per protocol that reported at least one value after baseline.
|
|
Vascular disorders
Hypertension
|
0.00%
0/60 • 16 Weeks
All evaluable patients per protocol that reported at least one value after baseline.
|
0.00%
0/60 • 16 Weeks
All evaluable patients per protocol that reported at least one value after baseline.
|
1.7%
1/58 • Number of events 1 • 16 Weeks
All evaluable patients per protocol that reported at least one value after baseline.
|
0.00%
0/56 • 16 Weeks
All evaluable patients per protocol that reported at least one value after baseline.
|
|
Vascular disorders
Thrombosis
|
1.7%
1/60 • Number of events 1 • 16 Weeks
All evaluable patients per protocol that reported at least one value after baseline.
|
1.7%
1/60 • Number of events 1 • 16 Weeks
All evaluable patients per protocol that reported at least one value after baseline.
|
3.4%
2/58 • Number of events 2 • 16 Weeks
All evaluable patients per protocol that reported at least one value after baseline.
|
1.8%
1/56 • Number of events 1 • 16 Weeks
All evaluable patients per protocol that reported at least one value after baseline.
|
Other adverse events
| Measure |
Epoetin Alfa - 40k Weekly
n=60 participants at risk
Patients receive Epoetin alfa 40,000 units subcutaneously every week for 15 weeks (15 doses)
|
Epoetin Alfa - 80k Every 3 Weeks
n=60 participants at risk
Patients receive Epoetin alfa 80,000 units subcutaneously every 3 weeks for 15 weeks (5 doses)
|
Epoetin Alfa - 120k Every 3 Weeks
n=58 participants at risk
Patients receive Epoetin alfa 120,000 units subcutaneously every 3 weeks for 15 weeks (5 doses)
|
Darbepoetin Alfa - 500 mcg Every 3 Weeks
n=56 participants at risk
Patients receive Darbepoetin alfa 500 micrograms (mcg) subcutaneously every 3 weeks for 15 weeks (5 doses)
|
|---|---|---|---|---|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.00%
0/60 • 16 Weeks
All evaluable patients per protocol that reported at least one value after baseline.
|
1.7%
1/60 • Number of events 1 • 16 Weeks
All evaluable patients per protocol that reported at least one value after baseline.
|
0.00%
0/58 • 16 Weeks
All evaluable patients per protocol that reported at least one value after baseline.
|
0.00%
0/56 • 16 Weeks
All evaluable patients per protocol that reported at least one value after baseline.
|
|
Blood and lymphatic system disorders
Hemoglobin decreased
|
0.00%
0/60 • 16 Weeks
All evaluable patients per protocol that reported at least one value after baseline.
|
8.3%
5/60 • Number of events 6 • 16 Weeks
All evaluable patients per protocol that reported at least one value after baseline.
|
5.2%
3/58 • Number of events 3 • 16 Weeks
All evaluable patients per protocol that reported at least one value after baseline.
|
3.6%
2/56 • Number of events 3 • 16 Weeks
All evaluable patients per protocol that reported at least one value after baseline.
|
|
Cardiac disorders
Atrial flutter
|
1.7%
1/60 • Number of events 1 • 16 Weeks
All evaluable patients per protocol that reported at least one value after baseline.
|
0.00%
0/60 • 16 Weeks
All evaluable patients per protocol that reported at least one value after baseline.
|
0.00%
0/58 • 16 Weeks
All evaluable patients per protocol that reported at least one value after baseline.
|
0.00%
0/56 • 16 Weeks
All evaluable patients per protocol that reported at least one value after baseline.
|
|
Cardiac disorders
Atrial tachycardia
|
0.00%
0/60 • 16 Weeks
All evaluable patients per protocol that reported at least one value after baseline.
|
0.00%
0/60 • 16 Weeks
All evaluable patients per protocol that reported at least one value after baseline.
|
0.00%
0/58 • 16 Weeks
All evaluable patients per protocol that reported at least one value after baseline.
|
1.8%
1/56 • Number of events 1 • 16 Weeks
All evaluable patients per protocol that reported at least one value after baseline.
|
|
Cardiac disorders
Left ventricular failure
|
0.00%
0/60 • 16 Weeks
All evaluable patients per protocol that reported at least one value after baseline.
|
0.00%
0/60 • 16 Weeks
All evaluable patients per protocol that reported at least one value after baseline.
|
0.00%
0/58 • 16 Weeks
All evaluable patients per protocol that reported at least one value after baseline.
|
1.8%
1/56 • Number of events 1 • 16 Weeks
All evaluable patients per protocol that reported at least one value after baseline.
|
|
Cardiac disorders
Myocardial ischemia
|
0.00%
0/60 • 16 Weeks
All evaluable patients per protocol that reported at least one value after baseline.
|
0.00%
0/60 • 16 Weeks
All evaluable patients per protocol that reported at least one value after baseline.
|
1.7%
1/58 • Number of events 1 • 16 Weeks
All evaluable patients per protocol that reported at least one value after baseline.
|
0.00%
0/56 • 16 Weeks
All evaluable patients per protocol that reported at least one value after baseline.
|
|
Eye disorders
Extraocular muscle paresis
|
0.00%
0/60 • 16 Weeks
All evaluable patients per protocol that reported at least one value after baseline.
|
1.7%
1/60 • Number of events 1 • 16 Weeks
All evaluable patients per protocol that reported at least one value after baseline.
|
0.00%
0/58 • 16 Weeks
All evaluable patients per protocol that reported at least one value after baseline.
|
0.00%
0/56 • 16 Weeks
All evaluable patients per protocol that reported at least one value after baseline.
|
|
Gastrointestinal disorders
Abdominal pain
|
1.7%
1/60 • Number of events 1 • 16 Weeks
All evaluable patients per protocol that reported at least one value after baseline.
|
1.7%
1/60 • Number of events 1 • 16 Weeks
All evaluable patients per protocol that reported at least one value after baseline.
|
0.00%
0/58 • 16 Weeks
All evaluable patients per protocol that reported at least one value after baseline.
|
0.00%
0/56 • 16 Weeks
All evaluable patients per protocol that reported at least one value after baseline.
|
|
Gastrointestinal disorders
Colonic hemorrhage
|
0.00%
0/60 • 16 Weeks
All evaluable patients per protocol that reported at least one value after baseline.
|
0.00%
0/60 • 16 Weeks
All evaluable patients per protocol that reported at least one value after baseline.
|
1.7%
1/58 • Number of events 1 • 16 Weeks
All evaluable patients per protocol that reported at least one value after baseline.
|
0.00%
0/56 • 16 Weeks
All evaluable patients per protocol that reported at least one value after baseline.
|
|
Gastrointestinal disorders
Constipation
|
3.3%
2/60 • Number of events 2 • 16 Weeks
All evaluable patients per protocol that reported at least one value after baseline.
|
1.7%
1/60 • Number of events 1 • 16 Weeks
All evaluable patients per protocol that reported at least one value after baseline.
|
1.7%
1/58 • Number of events 1 • 16 Weeks
All evaluable patients per protocol that reported at least one value after baseline.
|
0.00%
0/56 • 16 Weeks
All evaluable patients per protocol that reported at least one value after baseline.
|
|
Gastrointestinal disorders
Diarrhea
|
0.00%
0/60 • 16 Weeks
All evaluable patients per protocol that reported at least one value after baseline.
|
1.7%
1/60 • Number of events 1 • 16 Weeks
All evaluable patients per protocol that reported at least one value after baseline.
|
3.4%
2/58 • Number of events 3 • 16 Weeks
All evaluable patients per protocol that reported at least one value after baseline.
|
0.00%
0/56 • 16 Weeks
All evaluable patients per protocol that reported at least one value after baseline.
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/60 • 16 Weeks
All evaluable patients per protocol that reported at least one value after baseline.
|
1.7%
1/60 • Number of events 1 • 16 Weeks
All evaluable patients per protocol that reported at least one value after baseline.
|
0.00%
0/58 • 16 Weeks
All evaluable patients per protocol that reported at least one value after baseline.
|
0.00%
0/56 • 16 Weeks
All evaluable patients per protocol that reported at least one value after baseline.
|
|
Gastrointestinal disorders
Flatulence
|
0.00%
0/60 • 16 Weeks
All evaluable patients per protocol that reported at least one value after baseline.
|
0.00%
0/60 • 16 Weeks
All evaluable patients per protocol that reported at least one value after baseline.
|
1.7%
1/58 • Number of events 1 • 16 Weeks
All evaluable patients per protocol that reported at least one value after baseline.
|
0.00%
0/56 • 16 Weeks
All evaluable patients per protocol that reported at least one value after baseline.
|
|
Gastrointestinal disorders
Lower gastrointestinal hemorrhage
|
0.00%
0/60 • 16 Weeks
All evaluable patients per protocol that reported at least one value after baseline.
|
1.7%
1/60 • Number of events 1 • 16 Weeks
All evaluable patients per protocol that reported at least one value after baseline.
|
0.00%
0/58 • 16 Weeks
All evaluable patients per protocol that reported at least one value after baseline.
|
0.00%
0/56 • 16 Weeks
All evaluable patients per protocol that reported at least one value after baseline.
|
|
Gastrointestinal disorders
Mucositis oral
|
0.00%
0/60 • 16 Weeks
All evaluable patients per protocol that reported at least one value after baseline.
|
1.7%
1/60 • Number of events 1 • 16 Weeks
All evaluable patients per protocol that reported at least one value after baseline.
|
0.00%
0/58 • 16 Weeks
All evaluable patients per protocol that reported at least one value after baseline.
|
0.00%
0/56 • 16 Weeks
All evaluable patients per protocol that reported at least one value after baseline.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/60 • 16 Weeks
All evaluable patients per protocol that reported at least one value after baseline.
|
1.7%
1/60 • Number of events 1 • 16 Weeks
All evaluable patients per protocol that reported at least one value after baseline.
|
3.4%
2/58 • Number of events 2 • 16 Weeks
All evaluable patients per protocol that reported at least one value after baseline.
|
0.00%
0/56 • 16 Weeks
All evaluable patients per protocol that reported at least one value after baseline.
|
|
Gastrointestinal disorders
Rectal hemorrhage
|
0.00%
0/60 • 16 Weeks
All evaluable patients per protocol that reported at least one value after baseline.
|
0.00%
0/60 • 16 Weeks
All evaluable patients per protocol that reported at least one value after baseline.
|
0.00%
0/58 • 16 Weeks
All evaluable patients per protocol that reported at least one value after baseline.
|
1.8%
1/56 • Number of events 1 • 16 Weeks
All evaluable patients per protocol that reported at least one value after baseline.
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/60 • 16 Weeks
All evaluable patients per protocol that reported at least one value after baseline.
|
0.00%
0/60 • 16 Weeks
All evaluable patients per protocol that reported at least one value after baseline.
|
0.00%
0/58 • 16 Weeks
All evaluable patients per protocol that reported at least one value after baseline.
|
1.8%
1/56 • Number of events 1 • 16 Weeks
All evaluable patients per protocol that reported at least one value after baseline.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/60 • 16 Weeks
All evaluable patients per protocol that reported at least one value after baseline.
|
1.7%
1/60 • Number of events 1 • 16 Weeks
All evaluable patients per protocol that reported at least one value after baseline.
|
1.7%
1/58 • Number of events 1 • 16 Weeks
All evaluable patients per protocol that reported at least one value after baseline.
|
0.00%
0/56 • 16 Weeks
All evaluable patients per protocol that reported at least one value after baseline.
|
|
General disorders
Chest pain
|
0.00%
0/60 • 16 Weeks
All evaluable patients per protocol that reported at least one value after baseline.
|
0.00%
0/60 • 16 Weeks
All evaluable patients per protocol that reported at least one value after baseline.
|
0.00%
0/58 • 16 Weeks
All evaluable patients per protocol that reported at least one value after baseline.
|
1.8%
1/56 • Number of events 1 • 16 Weeks
All evaluable patients per protocol that reported at least one value after baseline.
|
|
General disorders
Disease progression
|
1.7%
1/60 • Number of events 1 • 16 Weeks
All evaluable patients per protocol that reported at least one value after baseline.
|
1.7%
1/60 • Number of events 1 • 16 Weeks
All evaluable patients per protocol that reported at least one value after baseline.
|
5.2%
3/58 • Number of events 3 • 16 Weeks
All evaluable patients per protocol that reported at least one value after baseline.
|
1.8%
1/56 • Number of events 1 • 16 Weeks
All evaluable patients per protocol that reported at least one value after baseline.
|
|
General disorders
Fatigue
|
5.0%
3/60 • Number of events 3 • 16 Weeks
All evaluable patients per protocol that reported at least one value after baseline.
|
6.7%
4/60 • Number of events 12 • 16 Weeks
All evaluable patients per protocol that reported at least one value after baseline.
|
6.9%
4/58 • Number of events 6 • 16 Weeks
All evaluable patients per protocol that reported at least one value after baseline.
|
1.8%
1/56 • Number of events 1 • 16 Weeks
All evaluable patients per protocol that reported at least one value after baseline.
|
|
General disorders
Pain
|
0.00%
0/60 • 16 Weeks
All evaluable patients per protocol that reported at least one value after baseline.
|
0.00%
0/60 • 16 Weeks
All evaluable patients per protocol that reported at least one value after baseline.
|
1.7%
1/58 • Number of events 1 • 16 Weeks
All evaluable patients per protocol that reported at least one value after baseline.
|
0.00%
0/56 • 16 Weeks
All evaluable patients per protocol that reported at least one value after baseline.
|
|
Infections and infestations
Bladder infection
|
0.00%
0/60 • 16 Weeks
All evaluable patients per protocol that reported at least one value after baseline.
|
1.7%
1/60 • Number of events 1 • 16 Weeks
All evaluable patients per protocol that reported at least one value after baseline.
|
0.00%
0/58 • 16 Weeks
All evaluable patients per protocol that reported at least one value after baseline.
|
0.00%
0/56 • 16 Weeks
All evaluable patients per protocol that reported at least one value after baseline.
|
|
Infections and infestations
Colitis, infectious (e.g., Clostridium difficile)
|
0.00%
0/60 • 16 Weeks
All evaluable patients per protocol that reported at least one value after baseline.
|
0.00%
0/60 • 16 Weeks
All evaluable patients per protocol that reported at least one value after baseline.
|
0.00%
0/58 • 16 Weeks
All evaluable patients per protocol that reported at least one value after baseline.
|
1.8%
1/56 • Number of events 1 • 16 Weeks
All evaluable patients per protocol that reported at least one value after baseline.
|
|
Infections and infestations
Infectious meningitis
|
0.00%
0/60 • 16 Weeks
All evaluable patients per protocol that reported at least one value after baseline.
|
1.7%
1/60 • Number of events 1 • 16 Weeks
All evaluable patients per protocol that reported at least one value after baseline.
|
0.00%
0/58 • 16 Weeks
All evaluable patients per protocol that reported at least one value after baseline.
|
0.00%
0/56 • 16 Weeks
All evaluable patients per protocol that reported at least one value after baseline.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/60 • 16 Weeks
All evaluable patients per protocol that reported at least one value after baseline.
|
0.00%
0/60 • 16 Weeks
All evaluable patients per protocol that reported at least one value after baseline.
|
1.7%
1/58 • Number of events 1 • 16 Weeks
All evaluable patients per protocol that reported at least one value after baseline.
|
0.00%
0/56 • 16 Weeks
All evaluable patients per protocol that reported at least one value after baseline.
|
|
Infections and infestations
Sepsis
|
3.3%
2/60 • Number of events 3 • 16 Weeks
All evaluable patients per protocol that reported at least one value after baseline.
|
0.00%
0/60 • 16 Weeks
All evaluable patients per protocol that reported at least one value after baseline.
|
0.00%
0/58 • 16 Weeks
All evaluable patients per protocol that reported at least one value after baseline.
|
0.00%
0/56 • 16 Weeks
All evaluable patients per protocol that reported at least one value after baseline.
|
|
Infections and infestations
Sinusitis
|
0.00%
0/60 • 16 Weeks
All evaluable patients per protocol that reported at least one value after baseline.
|
1.7%
1/60 • Number of events 1 • 16 Weeks
All evaluable patients per protocol that reported at least one value after baseline.
|
0.00%
0/58 • 16 Weeks
All evaluable patients per protocol that reported at least one value after baseline.
|
0.00%
0/56 • 16 Weeks
All evaluable patients per protocol that reported at least one value after baseline.
|
|
Infections and infestations
Tooth infection
|
0.00%
0/60 • 16 Weeks
All evaluable patients per protocol that reported at least one value after baseline.
|
0.00%
0/60 • 16 Weeks
All evaluable patients per protocol that reported at least one value after baseline.
|
0.00%
0/58 • 16 Weeks
All evaluable patients per protocol that reported at least one value after baseline.
|
1.8%
1/56 • Number of events 1 • 16 Weeks
All evaluable patients per protocol that reported at least one value after baseline.
|
|
Infections and infestations
Wound infection
|
1.7%
1/60 • Number of events 1 • 16 Weeks
All evaluable patients per protocol that reported at least one value after baseline.
|
0.00%
0/60 • 16 Weeks
All evaluable patients per protocol that reported at least one value after baseline.
|
0.00%
0/58 • 16 Weeks
All evaluable patients per protocol that reported at least one value after baseline.
|
0.00%
0/56 • 16 Weeks
All evaluable patients per protocol that reported at least one value after baseline.
|
|
Investigations
Activated partial thromboplastin time prolonged
|
0.00%
0/60 • 16 Weeks
All evaluable patients per protocol that reported at least one value after baseline.
|
0.00%
0/60 • 16 Weeks
All evaluable patients per protocol that reported at least one value after baseline.
|
1.7%
1/58 • Number of events 1 • 16 Weeks
All evaluable patients per protocol that reported at least one value after baseline.
|
0.00%
0/56 • 16 Weeks
All evaluable patients per protocol that reported at least one value after baseline.
|
|
Investigations
CD4 lymphocytes decreased
|
0.00%
0/60 • 16 Weeks
All evaluable patients per protocol that reported at least one value after baseline.
|
1.7%
1/60 • Number of events 1 • 16 Weeks
All evaluable patients per protocol that reported at least one value after baseline.
|
0.00%
0/58 • 16 Weeks
All evaluable patients per protocol that reported at least one value after baseline.
|
0.00%
0/56 • 16 Weeks
All evaluable patients per protocol that reported at least one value after baseline.
|
|
Investigations
INR increased
|
0.00%
0/60 • 16 Weeks
All evaluable patients per protocol that reported at least one value after baseline.
|
0.00%
0/60 • 16 Weeks
All evaluable patients per protocol that reported at least one value after baseline.
|
1.7%
1/58 • Number of events 5 • 16 Weeks
All evaluable patients per protocol that reported at least one value after baseline.
|
0.00%
0/56 • 16 Weeks
All evaluable patients per protocol that reported at least one value after baseline.
|
|
Investigations
Leukocyte count decreased
|
0.00%
0/60 • 16 Weeks
All evaluable patients per protocol that reported at least one value after baseline.
|
3.3%
2/60 • Number of events 3 • 16 Weeks
All evaluable patients per protocol that reported at least one value after baseline.
|
1.7%
1/58 • Number of events 1 • 16 Weeks
All evaluable patients per protocol that reported at least one value after baseline.
|
1.8%
1/56 • Number of events 1 • 16 Weeks
All evaluable patients per protocol that reported at least one value after baseline.
|
|
Investigations
Lymphocyte count decreased
|
0.00%
0/60 • 16 Weeks
All evaluable patients per protocol that reported at least one value after baseline.
|
3.3%
2/60 • Number of events 5 • 16 Weeks
All evaluable patients per protocol that reported at least one value after baseline.
|
3.4%
2/58 • Number of events 4 • 16 Weeks
All evaluable patients per protocol that reported at least one value after baseline.
|
0.00%
0/56 • 16 Weeks
All evaluable patients per protocol that reported at least one value after baseline.
|
|
Investigations
Neutrophil count decreased
|
0.00%
0/60 • 16 Weeks
All evaluable patients per protocol that reported at least one value after baseline.
|
5.0%
3/60 • Number of events 4 • 16 Weeks
All evaluable patients per protocol that reported at least one value after baseline.
|
1.7%
1/58 • Number of events 1 • 16 Weeks
All evaluable patients per protocol that reported at least one value after baseline.
|
3.6%
2/56 • Number of events 2 • 16 Weeks
All evaluable patients per protocol that reported at least one value after baseline.
|
|
Investigations
Platelet count decreased
|
0.00%
0/60 • 16 Weeks
All evaluable patients per protocol that reported at least one value after baseline.
|
6.7%
4/60 • Number of events 5 • 16 Weeks
All evaluable patients per protocol that reported at least one value after baseline.
|
0.00%
0/58 • 16 Weeks
All evaluable patients per protocol that reported at least one value after baseline.
|
1.8%
1/56 • Number of events 1 • 16 Weeks
All evaluable patients per protocol that reported at least one value after baseline.
|
|
Investigations
Weight loss
|
0.00%
0/60 • 16 Weeks
All evaluable patients per protocol that reported at least one value after baseline.
|
1.7%
1/60 • Number of events 2 • 16 Weeks
All evaluable patients per protocol that reported at least one value after baseline.
|
0.00%
0/58 • 16 Weeks
All evaluable patients per protocol that reported at least one value after baseline.
|
0.00%
0/56 • 16 Weeks
All evaluable patients per protocol that reported at least one value after baseline.
|
|
Metabolism and nutrition disorders
Acidosis
|
0.00%
0/60 • 16 Weeks
All evaluable patients per protocol that reported at least one value after baseline.
|
0.00%
0/60 • 16 Weeks
All evaluable patients per protocol that reported at least one value after baseline.
|
1.7%
1/58 • Number of events 1 • 16 Weeks
All evaluable patients per protocol that reported at least one value after baseline.
|
0.00%
0/56 • 16 Weeks
All evaluable patients per protocol that reported at least one value after baseline.
|
|
Metabolism and nutrition disorders
Anorexia
|
1.7%
1/60 • Number of events 1 • 16 Weeks
All evaluable patients per protocol that reported at least one value after baseline.
|
3.3%
2/60 • Number of events 3 • 16 Weeks
All evaluable patients per protocol that reported at least one value after baseline.
|
0.00%
0/58 • 16 Weeks
All evaluable patients per protocol that reported at least one value after baseline.
|
1.8%
1/56 • Number of events 1 • 16 Weeks
All evaluable patients per protocol that reported at least one value after baseline.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/60 • 16 Weeks
All evaluable patients per protocol that reported at least one value after baseline.
|
3.3%
2/60 • Number of events 2 • 16 Weeks
All evaluable patients per protocol that reported at least one value after baseline.
|
1.7%
1/58 • Number of events 1 • 16 Weeks
All evaluable patients per protocol that reported at least one value after baseline.
|
3.6%
2/56 • Number of events 2 • 16 Weeks
All evaluable patients per protocol that reported at least one value after baseline.
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
0.00%
0/60 • 16 Weeks
All evaluable patients per protocol that reported at least one value after baseline.
|
1.7%
1/60 • Number of events 2 • 16 Weeks
All evaluable patients per protocol that reported at least one value after baseline.
|
0.00%
0/58 • 16 Weeks
All evaluable patients per protocol that reported at least one value after baseline.
|
3.6%
2/56 • Number of events 2 • 16 Weeks
All evaluable patients per protocol that reported at least one value after baseline.
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
1.7%
1/60 • Number of events 1 • 16 Weeks
All evaluable patients per protocol that reported at least one value after baseline.
|
0.00%
0/60 • 16 Weeks
All evaluable patients per protocol that reported at least one value after baseline.
|
0.00%
0/58 • 16 Weeks
All evaluable patients per protocol that reported at least one value after baseline.
|
0.00%
0/56 • 16 Weeks
All evaluable patients per protocol that reported at least one value after baseline.
|
|
Metabolism and nutrition disorders
Hypokalemia
|
0.00%
0/60 • 16 Weeks
All evaluable patients per protocol that reported at least one value after baseline.
|
1.7%
1/60 • Number of events 2 • 16 Weeks
All evaluable patients per protocol that reported at least one value after baseline.
|
0.00%
0/58 • 16 Weeks
All evaluable patients per protocol that reported at least one value after baseline.
|
1.8%
1/56 • Number of events 1 • 16 Weeks
All evaluable patients per protocol that reported at least one value after baseline.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
1.7%
1/60 • Number of events 1 • 16 Weeks
All evaluable patients per protocol that reported at least one value after baseline.
|
1.7%
1/60 • Number of events 2 • 16 Weeks
All evaluable patients per protocol that reported at least one value after baseline.
|
1.7%
1/58 • Number of events 1 • 16 Weeks
All evaluable patients per protocol that reported at least one value after baseline.
|
0.00%
0/56 • 16 Weeks
All evaluable patients per protocol that reported at least one value after baseline.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/60 • 16 Weeks
All evaluable patients per protocol that reported at least one value after baseline.
|
0.00%
0/60 • 16 Weeks
All evaluable patients per protocol that reported at least one value after baseline.
|
3.4%
2/58 • Number of events 2 • 16 Weeks
All evaluable patients per protocol that reported at least one value after baseline.
|
0.00%
0/56 • 16 Weeks
All evaluable patients per protocol that reported at least one value after baseline.
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness
|
0.00%
0/60 • 16 Weeks
All evaluable patients per protocol that reported at least one value after baseline.
|
3.3%
2/60 • Number of events 2 • 16 Weeks
All evaluable patients per protocol that reported at least one value after baseline.
|
1.7%
1/58 • Number of events 1 • 16 Weeks
All evaluable patients per protocol that reported at least one value after baseline.
|
0.00%
0/56 • 16 Weeks
All evaluable patients per protocol that reported at least one value after baseline.
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness lower limb
|
0.00%
0/60 • 16 Weeks
All evaluable patients per protocol that reported at least one value after baseline.
|
0.00%
0/60 • 16 Weeks
All evaluable patients per protocol that reported at least one value after baseline.
|
1.7%
1/58 • Number of events 1 • 16 Weeks
All evaluable patients per protocol that reported at least one value after baseline.
|
0.00%
0/56 • 16 Weeks
All evaluable patients per protocol that reported at least one value after baseline.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/60 • 16 Weeks
All evaluable patients per protocol that reported at least one value after baseline.
|
1.7%
1/60 • Number of events 1 • 16 Weeks
All evaluable patients per protocol that reported at least one value after baseline.
|
0.00%
0/58 • 16 Weeks
All evaluable patients per protocol that reported at least one value after baseline.
|
0.00%
0/56 • 16 Weeks
All evaluable patients per protocol that reported at least one value after baseline.
|
|
Nervous system disorders
Headache
|
0.00%
0/60 • 16 Weeks
All evaluable patients per protocol that reported at least one value after baseline.
|
1.7%
1/60 • Number of events 1 • 16 Weeks
All evaluable patients per protocol that reported at least one value after baseline.
|
1.7%
1/58 • Number of events 1 • 16 Weeks
All evaluable patients per protocol that reported at least one value after baseline.
|
0.00%
0/56 • 16 Weeks
All evaluable patients per protocol that reported at least one value after baseline.
|
|
Nervous system disorders
Mini mental status examination abnormal
|
0.00%
0/60 • 16 Weeks
All evaluable patients per protocol that reported at least one value after baseline.
|
0.00%
0/60 • 16 Weeks
All evaluable patients per protocol that reported at least one value after baseline.
|
0.00%
0/58 • 16 Weeks
All evaluable patients per protocol that reported at least one value after baseline.
|
1.8%
1/56 • Number of events 1 • 16 Weeks
All evaluable patients per protocol that reported at least one value after baseline.
|
|
Nervous system disorders
Peripheral motor neuropathy
|
1.7%
1/60 • Number of events 1 • 16 Weeks
All evaluable patients per protocol that reported at least one value after baseline.
|
0.00%
0/60 • 16 Weeks
All evaluable patients per protocol that reported at least one value after baseline.
|
0.00%
0/58 • 16 Weeks
All evaluable patients per protocol that reported at least one value after baseline.
|
0.00%
0/56 • 16 Weeks
All evaluable patients per protocol that reported at least one value after baseline.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
0.00%
0/60 • 16 Weeks
All evaluable patients per protocol that reported at least one value after baseline.
|
0.00%
0/60 • 16 Weeks
All evaluable patients per protocol that reported at least one value after baseline.
|
0.00%
0/58 • 16 Weeks
All evaluable patients per protocol that reported at least one value after baseline.
|
1.8%
1/56 • Number of events 1 • 16 Weeks
All evaluable patients per protocol that reported at least one value after baseline.
|
|
Nervous system disorders
Syncope
|
0.00%
0/60 • 16 Weeks
All evaluable patients per protocol that reported at least one value after baseline.
|
1.7%
1/60 • Number of events 1 • 16 Weeks
All evaluable patients per protocol that reported at least one value after baseline.
|
0.00%
0/58 • 16 Weeks
All evaluable patients per protocol that reported at least one value after baseline.
|
0.00%
0/56 • 16 Weeks
All evaluable patients per protocol that reported at least one value after baseline.
|
|
Psychiatric disorders
Confusion
|
0.00%
0/60 • 16 Weeks
All evaluable patients per protocol that reported at least one value after baseline.
|
0.00%
0/60 • 16 Weeks
All evaluable patients per protocol that reported at least one value after baseline.
|
3.4%
2/58 • Number of events 2 • 16 Weeks
All evaluable patients per protocol that reported at least one value after baseline.
|
0.00%
0/56 • 16 Weeks
All evaluable patients per protocol that reported at least one value after baseline.
|
|
Renal and urinary disorders
Renal failure
|
1.7%
1/60 • Number of events 1 • 16 Weeks
All evaluable patients per protocol that reported at least one value after baseline.
|
0.00%
0/60 • 16 Weeks
All evaluable patients per protocol that reported at least one value after baseline.
|
1.7%
1/58 • Number of events 1 • 16 Weeks
All evaluable patients per protocol that reported at least one value after baseline.
|
1.8%
1/56 • Number of events 1 • 16 Weeks
All evaluable patients per protocol that reported at least one value after baseline.
|
|
Renal and urinary disorders
Renal pelvis fistula
|
1.7%
1/60 • Number of events 1 • 16 Weeks
All evaluable patients per protocol that reported at least one value after baseline.
|
0.00%
0/60 • 16 Weeks
All evaluable patients per protocol that reported at least one value after baseline.
|
0.00%
0/58 • 16 Weeks
All evaluable patients per protocol that reported at least one value after baseline.
|
0.00%
0/56 • 16 Weeks
All evaluable patients per protocol that reported at least one value after baseline.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
0.00%
0/60 • 16 Weeks
All evaluable patients per protocol that reported at least one value after baseline.
|
5.0%
3/60 • Number of events 4 • 16 Weeks
All evaluable patients per protocol that reported at least one value after baseline.
|
1.7%
1/58 • Number of events 1 • 16 Weeks
All evaluable patients per protocol that reported at least one value after baseline.
|
3.6%
2/56 • Number of events 2 • 16 Weeks
All evaluable patients per protocol that reported at least one value after baseline.
|
|
Respiratory, thoracic and mediastinal disorders
Hemorrhage nasal
|
0.00%
0/60 • 16 Weeks
All evaluable patients per protocol that reported at least one value after baseline.
|
3.3%
2/60 • Number of events 2 • 16 Weeks
All evaluable patients per protocol that reported at least one value after baseline.
|
1.7%
1/58 • Number of events 1 • 16 Weeks
All evaluable patients per protocol that reported at least one value after baseline.
|
0.00%
0/56 • 16 Weeks
All evaluable patients per protocol that reported at least one value after baseline.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
1.7%
1/60 • Number of events 1 • 16 Weeks
All evaluable patients per protocol that reported at least one value after baseline.
|
0.00%
0/60 • 16 Weeks
All evaluable patients per protocol that reported at least one value after baseline.
|
1.7%
1/58 • Number of events 1 • 16 Weeks
All evaluable patients per protocol that reported at least one value after baseline.
|
0.00%
0/56 • 16 Weeks
All evaluable patients per protocol that reported at least one value after baseline.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory disorder
|
1.7%
1/60 • Number of events 1 • 16 Weeks
All evaluable patients per protocol that reported at least one value after baseline.
|
0.00%
0/60 • 16 Weeks
All evaluable patients per protocol that reported at least one value after baseline.
|
0.00%
0/58 • 16 Weeks
All evaluable patients per protocol that reported at least one value after baseline.
|
0.00%
0/56 • 16 Weeks
All evaluable patients per protocol that reported at least one value after baseline.
|
|
Skin and subcutaneous tissue disorders
Hand-and-foot syndrome
|
1.7%
1/60 • Number of events 1 • 16 Weeks
All evaluable patients per protocol that reported at least one value after baseline.
|
0.00%
0/60 • 16 Weeks
All evaluable patients per protocol that reported at least one value after baseline.
|
0.00%
0/58 • 16 Weeks
All evaluable patients per protocol that reported at least one value after baseline.
|
0.00%
0/56 • 16 Weeks
All evaluable patients per protocol that reported at least one value after baseline.
|
|
Skin and subcutaneous tissue disorders
Skin disorder
|
0.00%
0/60 • 16 Weeks
All evaluable patients per protocol that reported at least one value after baseline.
|
1.7%
1/60 • Number of events 1 • 16 Weeks
All evaluable patients per protocol that reported at least one value after baseline.
|
0.00%
0/58 • 16 Weeks
All evaluable patients per protocol that reported at least one value after baseline.
|
0.00%
0/56 • 16 Weeks
All evaluable patients per protocol that reported at least one value after baseline.
|
|
Vascular disorders
Hypertension
|
1.7%
1/60 • Number of events 1 • 16 Weeks
All evaluable patients per protocol that reported at least one value after baseline.
|
0.00%
0/60 • 16 Weeks
All evaluable patients per protocol that reported at least one value after baseline.
|
0.00%
0/58 • 16 Weeks
All evaluable patients per protocol that reported at least one value after baseline.
|
1.8%
1/56 • Number of events 1 • 16 Weeks
All evaluable patients per protocol that reported at least one value after baseline.
|
|
Vascular disorders
Peripheral ischemia
|
1.7%
1/60 • Number of events 1 • 16 Weeks
All evaluable patients per protocol that reported at least one value after baseline.
|
0.00%
0/60 • 16 Weeks
All evaluable patients per protocol that reported at least one value after baseline.
|
0.00%
0/58 • 16 Weeks
All evaluable patients per protocol that reported at least one value after baseline.
|
0.00%
0/56 • 16 Weeks
All evaluable patients per protocol that reported at least one value after baseline.
|
|
Vascular disorders
Thrombosis
|
8.3%
5/60 • Number of events 5 • 16 Weeks
All evaluable patients per protocol that reported at least one value after baseline.
|
0.00%
0/60 • 16 Weeks
All evaluable patients per protocol that reported at least one value after baseline.
|
3.4%
2/58 • Number of events 2 • 16 Weeks
All evaluable patients per protocol that reported at least one value after baseline.
|
0.00%
0/56 • 16 Weeks
All evaluable patients per protocol that reported at least one value after baseline.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place