Trial Outcomes & Findings for Evaluation of Two Epoetin Alfa Dosing Strategies in Subjects With Chronic Kidney Disease Receiving Hemodialysis (NCT NCT02253654)

NCT ID: NCT02253654

Last Updated: 2017-05-19

Results Overview

Hemoglobin was measured every 2 weeks during the evaluation period. The percentage of these measurements that were within the range of 10-11 g/dL was calculated for each participant.

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 216 participants
• Primary outcome timeframe: The evaluation period (weeks 13-37)
• Results posted on: 2017-05-19

Participant Flow

This study was conducted at 31 centers in the United States. Participants were enrolled from 01 April 2015 to 17 August 2015.

Eligible participants with anemia and chronic kidney disease who were receiving hemodialysis were randomized in a 1:1 ratio to 1 of 2 dosing algorithms.

Participant milestones

Measure	Epoetin Alfa Alternative Titration Participants received epoetin alfa administered intravenously three times a week during hemodialysis for up to 37 weeks. For the first two weeks the dose of epoetin alfa was based on the dose at the time of screening. Beginning at week 3 dose changes may have occurred every 2 weeks according to the alternative dosing algorithm, where smaller, frequent dose adjustments were permitted based on six hemoglobin categories.	Epoetin Alfa USPI Titration Participants received epoetin alfa administered intravenously three times a week during hemodialysis for 37 weeks. For the first two weeks the dose of epoetin alfa was based on the dose at the time of screening. Beginning at week 3 dose decreases were permitted every 2 weeks and beginning at week 5 dose increases could only occur ≥ 4 weeks from the last dose increase, according to the United States package insert (USPI) dosing algorithm which includes four categories of hemoglobin levels.
Overall Study STARTED	108	108
Overall Study Received Treatment	104	107
Overall Study COMPLETED	85	90
Overall Study NOT COMPLETED	23	18

Reasons for withdrawal

Measure	Epoetin Alfa Alternative Titration Participants received epoetin alfa administered intravenously three times a week during hemodialysis for up to 37 weeks. For the first two weeks the dose of epoetin alfa was based on the dose at the time of screening. Beginning at week 3 dose changes may have occurred every 2 weeks according to the alternative dosing algorithm, where smaller, frequent dose adjustments were permitted based on six hemoglobin categories.	Epoetin Alfa USPI Titration Participants received epoetin alfa administered intravenously three times a week during hemodialysis for 37 weeks. For the first two weeks the dose of epoetin alfa was based on the dose at the time of screening. Beginning at week 3 dose decreases were permitted every 2 weeks and beginning at week 5 dose increases could only occur ≥ 4 weeks from the last dose increase, according to the United States package insert (USPI) dosing algorithm which includes four categories of hemoglobin levels.
Overall Study Withdrawal by Subject	12	4
Overall Study Decision by Sponsor	1	1
Overall Study Lost to Follow-up	2	5
Overall Study Death	4	7
Overall Study Did Not Receive Study Treatment	4	1

Baseline Characteristics

Evaluation of Two Epoetin Alfa Dosing Strategies in Subjects With Chronic Kidney Disease Receiving Hemodialysis

Baseline characteristics by cohort

Measure	Epoetin Alfa Alternative Titration n=108 Participants Participants received epoetin alfa administered intravenously three times a week during hemodialysis for up to 37 weeks. For the first two weeks the dose of epoetin alfa was based on the dose at the time of screening. Beginning at week 3 dose changes may have occurred every 2 weeks according to the alternative dosing algorithm, where smaller, frequent dose adjustments were permitted based on six hemoglobin categories.	Epoetin Alfa USPI Titration n=108 Participants Participants received epoetin alfa administered intravenously three times a week during hemodialysis for 37 weeks. For the first two weeks the dose of epoetin alfa was based on the dose at the time of screening. Beginning at week 3 dose decreases were permitted every 2 weeks and beginning at week 5 dose increases could only occur ≥ 4 weeks from the last dose increase, according to the United States package insert (USPI) dosing algorithm which includes four categories of hemoglobin levels.	Total n=216 Participants Total of all reporting groups
Age, Continuous	60.9 years STANDARD_DEVIATION 13.3 • n=5 Participants	58.7 years STANDARD_DEVIATION 14.2 • n=7 Participants	59.8 years STANDARD_DEVIATION 1.8 • n=5 Participants
Sex: Female, Male Female	48 Participants n=5 Participants	40 Participants n=7 Participants	88 Participants n=5 Participants
Sex: Female, Male Male	60 Participants n=5 Participants	68 Participants n=7 Participants	128 Participants n=5 Participants
Race/Ethnicity, Customized Asian	7 participants n=5 Participants	7 participants n=7 Participants	14 participants n=5 Participants
Race/Ethnicity, Customized Black	53 participants n=5 Participants	50 participants n=7 Participants	103 participants n=5 Participants
Race/Ethnicity, Customized Native Hawaiian or other Pacific Islander	0 participants n=5 Participants	1 participants n=7 Participants	1 participants n=5 Participants
Race/Ethnicity, Customized White	40 participants n=5 Participants	40 participants n=7 Participants	80 participants n=5 Participants
Race/Ethnicity, Customized Other	8 participants n=5 Participants	10 participants n=7 Participants	18 participants n=5 Participants
Race/Ethnicity, Customized Hispanic/Latino	30 participants n=5 Participants	39 participants n=7 Participants	69 participants n=5 Participants
Race/Ethnicity, Customized Not Hispanic/Latino	78 participants n=5 Participants	69 participants n=7 Participants	147 participants n=5 Participants

PRIMARY outcome

Timeframe: The evaluation period (weeks 13-37)

Population: The Primary Analysis Set which consists of all randomized participants who had at least 6 hemoglobin measurements during the evaluation period while on study and receiving investigational product.

Hemoglobin was measured every 2 weeks during the evaluation period. The percentage of these measurements that were within the range of 10-11 g/dL was calculated for each participant.

Outcome measures

Measure	Epoetin Alfa Alternative Titration n=89 Participants Participants received epoetin alfa administered intravenously three times a week during hemodialysis for up to 37 weeks. For the first two weeks the dose of epoetin alfa was based on the dose at the time of screening. Beginning at week 3 dose changes may have occurred every 2 weeks according to the alternative dosing algorithm, where smaller, frequent dose adjustments were permitted based on six hemoglobin categories.	Epoetin Alfa USPI Titration n=100 Participants Participants received epoetin alfa administered intravenously three times a week during hemodialysis for 37 weeks. For the first two weeks the dose of epoetin alfa was based on the dose at the time of screening. Beginning at week 3 dose decreases were permitted every 2 weeks and beginning at week 5 dose increases could only occur ≥ 4 weeks from the last dose increase, according to the United States package insert (USPI) dosing algorithm which includes four categories of hemoglobin levels.
Percentage of Hemoglobin Measurements Within 10 to 11 g/dL During the Evaluation Period	46.41 percentage of hemoglobin measurements Standard Deviation 2.39	46.02 percentage of hemoglobin measurements Standard Deviation 2.56

SECONDARY outcome

Timeframe: Baseline (screening visit) and weeks 3, 5, 7, 9, 11, 13, 15, 17, 19, 21, 23, 25, 27, 29, 31, 33, 35, and 37

Population: Primary analysis set with available data at each time point

Outcome measures

Measure	Epoetin Alfa Alternative Titration n=89 Participants Participants received epoetin alfa administered intravenously three times a week during hemodialysis for up to 37 weeks. For the first two weeks the dose of epoetin alfa was based on the dose at the time of screening. Beginning at week 3 dose changes may have occurred every 2 weeks according to the alternative dosing algorithm, where smaller, frequent dose adjustments were permitted based on six hemoglobin categories.	Epoetin Alfa USPI Titration n=100 Participants Participants received epoetin alfa administered intravenously three times a week during hemodialysis for 37 weeks. For the first two weeks the dose of epoetin alfa was based on the dose at the time of screening. Beginning at week 3 dose decreases were permitted every 2 weeks and beginning at week 5 dose increases could only occur ≥ 4 weeks from the last dose increase, according to the United States package insert (USPI) dosing algorithm which includes four categories of hemoglobin levels.
Hemoglobin Concentration at Each Visit Week 37 (n = 87, 93)	10.10 g/dL Standard Deviation 1.11	9.86 g/dL Standard Deviation 0.85
Hemoglobin Concentration at Each Visit Baseline (n = 89, 100)	10.15 g/dL Standard Deviation 0.66	10.04 g/dL Standard Deviation 0.81
Hemoglobin Concentration at Each Visit Week 3 (n = 89, 100)	10.54 g/dL Standard Deviation 0.88	10.34 g/dL Standard Deviation 0.97
Hemoglobin Concentration at Each Visit Week 5 (n = 89, 99)	10.66 g/dL Standard Deviation 0.93	10.51 g/dL Standard Deviation 1.04
Hemoglobin Concentration at Each Visit Week 7 (n = 88, 97)	10.45 g/dL Standard Deviation 1.02	10.28 g/dL Standard Deviation 1.07
Hemoglobin Concentration at Each Visit Week 9 (n = 89, 100)	10.32 g/dL Standard Deviation 1.16	9.97 g/dL Standard Deviation 0.87
Hemoglobin Concentration at Each Visit Week 11 (n = 88, 99)	10.33 g/dL Standard Deviation 1.05	10.15 g/dL Standard Deviation 0.88
Hemoglobin Concentration at Each Visit Week 13 (n = 89, 100)	10.28 g/dL Standard Deviation 1.04	9.99 g/dL Standard Deviation 0.91
Hemoglobin Concentration at Each Visit Week 15 (n = 89, 100)	10.46 g/dL Standard Deviation 1.38	9.98 g/dL Standard Deviation 0.93
Hemoglobin Concentration at Each Visit Week 17 (n = 89, 100)	10.20 g/dL Standard Deviation 1.05	10.01 g/dL Standard Deviation 1.22
Hemoglobin Concentration at Each Visit Week 19 (n = 89, 100)	10.37 g/dL Standard Deviation 1.14	9.94 g/dL Standard Deviation 0.87
Hemoglobin Concentration at Each Visit Week 21 (n = 87, 99)	10.33 g/dL Standard Deviation 1.01	9.92 g/dL Standard Deviation 0.81
Hemoglobin Concentration at Each Visit Week 23 (n = 88, 98)	10.46 g/dL Standard Deviation 1.05	10.03 g/dL Standard Deviation 0.86
Hemoglobin Concentration at Each Visit Week 25 (n = 87, 98)	10.56 g/dL Standard Deviation 1.00	9.94 g/dL Standard Deviation 0.97
Hemoglobin Concentration at Each Visit Week 27 (n = 88, 94)	10.32 g/dL Standard Deviation 1.10	9.97 g/dL Standard Deviation 0.86
Hemoglobin Concentration at Each Visit Week 29 (n =89, 92)	10.34 g/dL Standard Deviation 1.01	10.02 g/dL Standard Deviation 1.07
Hemoglobin Concentration at Each Visit Week 31 (n = 85, 89)	10.34 g/dL Standard Deviation 0.95	9.96 g/dL Standard Deviation 1.07
Hemoglobin Concentration at Each Visit Week 33 (n = 86, 90)	10.18 g/dL Standard Deviation 1.00	10.05 g/dL Standard Deviation 0.92
Hemoglobin Concentration at Each Visit Week 35 (n = 87, 88)	10.12 g/dL Standard Deviation 1.23	9.94 g/dL Standard Deviation 0.90

SECONDARY outcome

Timeframe: Overall Study: Study week 1 to week 41; Titration Period: Study week 1 to week 12; Evaluation Period: Study week 13 to week 37; Safety Follow-up Period: Study week 38 to week 41

Population: Primary analysis set with available data in each study period

The percentage of participants who received red blood cell (RBC) transfusions during the study and during each study period.

Outcome measures

Measure	Epoetin Alfa Alternative Titration n=89 Participants Participants received epoetin alfa administered intravenously three times a week during hemodialysis for up to 37 weeks. For the first two weeks the dose of epoetin alfa was based on the dose at the time of screening. Beginning at week 3 dose changes may have occurred every 2 weeks according to the alternative dosing algorithm, where smaller, frequent dose adjustments were permitted based on six hemoglobin categories.	Epoetin Alfa USPI Titration n=100 Participants Participants received epoetin alfa administered intravenously three times a week during hemodialysis for 37 weeks. For the first two weeks the dose of epoetin alfa was based on the dose at the time of screening. Beginning at week 3 dose decreases were permitted every 2 weeks and beginning at week 5 dose increases could only occur ≥ 4 weeks from the last dose increase, according to the United States package insert (USPI) dosing algorithm which includes four categories of hemoglobin levels.
Percentage of Participants With Transfusion Events Overall and During Each Study Period Overall (n = 89, 100)	6.7 percentage of participants	12.0 percentage of participants
Percentage of Participants With Transfusion Events Overall and During Each Study Period Titration Period (n = 89, 100)	2.2 percentage of participants	1.0 percentage of participants
Percentage of Participants With Transfusion Events Overall and During Each Study Period Evaluation Period (n = 89, 100)	5.6 percentage of participants	10.0 percentage of participants
Percentage of Participants With Transfusion Events Overall and During Each Study Period Safety Follow-up Period (n = 83, 90)	1.2 percentage of participants	1.1 percentage of participants

SECONDARY outcome

Timeframe: Baseline (screening visit) and weeks 3, 5, 7, 9, 11, 13, 15, 17, 19, 21, 23, 25, 27, 29, 31, 33, 35, and 37

Population: Primary analysis set with available data at each time point

Hemoglobin rate of change (ROC) was calculated for each visit using the following formula: ROC = (current visit hemoglobin value - previous visit hemoglobin value) / number of days between each visit * 14. A positive value indicates a rate of rise and a negative value indicates a rate of decline.

Outcome measures

Measure	Epoetin Alfa Alternative Titration n=89 Participants Participants received epoetin alfa administered intravenously three times a week during hemodialysis for up to 37 weeks. For the first two weeks the dose of epoetin alfa was based on the dose at the time of screening. Beginning at week 3 dose changes may have occurred every 2 weeks according to the alternative dosing algorithm, where smaller, frequent dose adjustments were permitted based on six hemoglobin categories.	Epoetin Alfa USPI Titration n=100 Participants Participants received epoetin alfa administered intravenously three times a week during hemodialysis for 37 weeks. For the first two weeks the dose of epoetin alfa was based on the dose at the time of screening. Beginning at week 3 dose decreases were permitted every 2 weeks and beginning at week 5 dose increases could only occur ≥ 4 weeks from the last dose increase, according to the United States package insert (USPI) dosing algorithm which includes four categories of hemoglobin levels.
Hemoglobin Rate of Change at Each Visit Week 3 (n = 89, 100)	0.36 g/dL/2 weeks Standard Deviation 0.79	0.27 g/dL/2 weeks Standard Deviation 0.71
Hemoglobin Rate of Change at Each Visit Week 17 (n = 89, 100)	-0.22 g/dL/2 weeks Standard Deviation 1.08	0.02 g/dL/2 weeks Standard Deviation 1.07
Hemoglobin Rate of Change at Each Visit Week 21 (n = 87, 99)	-0.02 g/dL/2 weeks Standard Deviation 0.74	-0.06 g/dL/2 weeks Standard Deviation 0.72
Hemoglobin Rate of Change at Each Visit Week 23 (n = 88, 98)	0.16 g/dL/2 weeks Standard Deviation 0.87	0.09 g/dL/2 weeks Standard Deviation 0.78
Hemoglobin Rate of Change at Each Visit Week 25 (n = 87, 98)	0.07 g/dL/2 weeks Standard Deviation 0.78	-0.06 g/dL/2 weeks Standard Deviation 0.84
Hemoglobin Rate of Change at Each Visit Week 27 (n = 88, 94)	-0.18 g/dL/2 weeks Standard Deviation 0.77	0.01 g/dL/2 weeks Standard Deviation 0.85
Hemoglobin Rate of Change at Each Visit Week 29 (n =89, 92)	0.04 g/dL/2 weeks Standard Deviation 0.86	0.05 g/dL/2 weeks Standard Deviation 0.73
Hemoglobin Rate of Change at Each Visit Week 31 (n = 85, 89)	-0.02 g/dL/2 weeks Standard Deviation 0.72	-0.03 g/dL/2 weeks Standard Deviation 0.74
Hemoglobin Rate of Change at Each Visit Week 5 (n = 89, 99)	0.10 g/dL/2 weeks Standard Deviation 0.81	0.13 g/dL/2 weeks Standard Deviation 1.01
Hemoglobin Rate of Change at Each Visit Week 7 (n = 88, 97)	-0.22 g/dL/2 weeks Standard Deviation 0.90	-0.19 g/dL/2 weeks Standard Deviation 1.42
Hemoglobin Rate of Change at Each Visit Week 9 (n = 89, 100)	-0.12 g/dL/2 weeks Standard Deviation 0.93	-0.28 g/dL/2 weeks Standard Deviation 1.08
Hemoglobin Rate of Change at Each Visit Week 11 (n = 88, 99)	0.02 g/dL/2 weeks Standard Deviation 1.01	0.19 g/dL/2 weeks Standard Deviation 0.67
Hemoglobin Rate of Change at Each Visit Week 13 (n = 89, 100)	-0.05 g/dL/2 weeks Standard Deviation 0.93	-0.19 g/dL/2 weeks Standard Deviation 0.97
Hemoglobin Rate of Change at Each Visit Week 15 (n = 89, 100)	0.19 g/dL/2 weeks Standard Deviation 1.01	-0.01 g/dL/2 weeks Standard Deviation 0.87
Hemoglobin Rate of Change at Each Visit Week 19 (n = 89, 100)	0.18 g/dL/2 weeks Standard Deviation 0.97	-0.06 g/dL/2 weeks Standard Deviation 1.25
Hemoglobin Rate of Change at Each Visit Week 33 (n = 86, 90)	-0.16 g/dL/2 weeks Standard Deviation 0.82	0.06 g/dL/2 weeks Standard Deviation 0.74
Hemoglobin Rate of Change at Each Visit Week 35 (n = 87, 88)	-0.05 g/dL/2 weeks Standard Deviation 0.98	-0.13 g/dL/2 weeks Standard Deviation 0.72
Hemoglobin Rate of Change at Each Visit Week 37 (n = 87, 93)	-0.04 g/dL/2 weeks Standard Deviation 1.00	-0.03 g/dL/2 weeks Standard Deviation 0.64

SECONDARY outcome

Timeframe: The evaluation period (weeks 13 to 37)

Population: Primary analysis set

Intra-subject variability was defined for each participant as the standard deviation (SD) of all of the hemoglobin concentrations during the evaluation period for the participant. The mean intra-subject SD for all participants is the sum of the intra-subject SDs divided by the total number of participants evaluated.

Outcome measures

Measure	Epoetin Alfa Alternative Titration n=89 Participants Participants received epoetin alfa administered intravenously three times a week during hemodialysis for up to 37 weeks. For the first two weeks the dose of epoetin alfa was based on the dose at the time of screening. Beginning at week 3 dose changes may have occurred every 2 weeks according to the alternative dosing algorithm, where smaller, frequent dose adjustments were permitted based on six hemoglobin categories.	Epoetin Alfa USPI Titration n=100 Participants Participants received epoetin alfa administered intravenously three times a week during hemodialysis for 37 weeks. For the first two weeks the dose of epoetin alfa was based on the dose at the time of screening. Beginning at week 3 dose decreases were permitted every 2 weeks and beginning at week 5 dose increases could only occur ≥ 4 weeks from the last dose increase, according to the United States package insert (USPI) dosing algorithm which includes four categories of hemoglobin levels.
Hemoglobin Intra-subject Variability	0.74 g/dL Standard Deviation 0.30	0.70 g/dL Standard Deviation 0.32

SECONDARY outcome

Timeframe: Baseline (screening visit) and weeks 3, 5, 7, 9, 11, 13, 15, 17, 19, 21, 23, 25, 27, 29, 31, 33, 35, and 37

Population: Primary analysis set with available data at each time point

An excursion is identified as an event when a hemoglobin concentration fell below or exceeded the pre-specified thresholds of: - < 9.0 g/dL, or - > 11.0 g/dL, or - > 12.0 g/dL. The percentage of participants with any excursions and excursions in each subcategory at each time point and overall during the study are reported.

Outcome measures

Measure	Epoetin Alfa Alternative Titration n=89 Participants Participants received epoetin alfa administered intravenously three times a week during hemodialysis for up to 37 weeks. For the first two weeks the dose of epoetin alfa was based on the dose at the time of screening. Beginning at week 3 dose changes may have occurred every 2 weeks according to the alternative dosing algorithm, where smaller, frequent dose adjustments were permitted based on six hemoglobin categories.	Epoetin Alfa USPI Titration n=100 Participants Participants received epoetin alfa administered intravenously three times a week during hemodialysis for 37 weeks. For the first two weeks the dose of epoetin alfa was based on the dose at the time of screening. Beginning at week 3 dose decreases were permitted every 2 weeks and beginning at week 5 dose increases could only occur ≥ 4 weeks from the last dose increase, according to the United States package insert (USPI) dosing algorithm which includes four categories of hemoglobin levels.
Percentage of Participants With Hemoglobin Excursions at Each Visit Baseline Excursions (n = 89, 100)	3.4 percentage of participants	11.0 percentage of participants
Percentage of Participants With Hemoglobin Excursions at Each Visit Baseline Excursions > 11.0 (n = 89, 100)	0.0 percentage of participants	0.0 percentage of participants
Percentage of Participants With Hemoglobin Excursions at Each Visit Week 3 Excursions < 9.0 (n = 89, 100)	2.2 percentage of participants	6.0 percentage of participants
Percentage of Participants With Hemoglobin Excursions at Each Visit Week 9 Excursions (n = 89, 100)	29.2 percentage of participants	17.0 percentage of participants
Percentage of Participants With Hemoglobin Excursions at Each Visit Week 11 Excursions > 12.0 (n = 88, 99)	2.3 percentage of participants	1.0 percentage of participants
Percentage of Participants With Hemoglobin Excursions at Each Visit Week 29 Excursions (n = 89, 92)	25.8 percentage of participants	29.3 percentage of participants
Percentage of Participants With Hemoglobin Excursions at Each Visit Week 29 Excursions < 9.0 (n = 89, 92)	5.6 percentage of participants	16.3 percentage of participants
Percentage of Participants With Hemoglobin Excursions at Each Visit Week 31 Excursions < 9.0 (n = 85, 89)	4.7 percentage of participants	16.9 percentage of participants
Percentage of Participants With Hemoglobin Excursions at Each Visit Overall Excursions (n = 89, 100)	91.0 percentage of participants	93.0 percentage of participants
Percentage of Participants With Hemoglobin Excursions at Each Visit Overall Excursions < 9.0 (n = 89, 100)	48.3 percentage of participants	61.0 percentage of participants
Percentage of Participants With Hemoglobin Excursions at Each Visit Overall Excursions > 11.0 (n = 89, 100)	80.9 percentage of participants	83.0 percentage of participants
Percentage of Participants With Hemoglobin Excursions at Each Visit Overall Excursions > 12.0 (n = 89, 100)	25.8 percentage of participants	19.0 percentage of participants
Percentage of Participants With Hemoglobin Excursions at Each Visit Baseline Excursions < 9.0 (n = 89, 100)	3.4 percentage of participants	11.0 percentage of participants
Percentage of Participants With Hemoglobin Excursions at Each Visit Baseline Excursions > 12.0 (n = 89, 100)	0.0 percentage of participants	0.0 percentage of participants
Percentage of Participants With Hemoglobin Excursions at Each Visit Week 3 Excursions (n = 89, 100)	29.2 percentage of participants	27.0 percentage of participants
Percentage of Participants With Hemoglobin Excursions at Each Visit Week 3 Excursions > 11.0 (n = 89, 100)	27.0 percentage of participants	21.0 percentage of participants
Percentage of Participants With Hemoglobin Excursions at Each Visit Week 3 Excursions > 12.0 (n = 89, 100)	5.6 percentage of participants	5.0 percentage of participants
Percentage of Participants With Hemoglobin Excursions at Each Visit Week 5 Excursions (n = 89, 99)	36.0 percentage of participants	29.3 percentage of participants
Percentage of Participants With Hemoglobin Excursions at Each Visit Week 5 Excursions < 9.0 (n = 89, 99)	1.1 percentage of participants	4.0 percentage of participants
Percentage of Participants With Hemoglobin Excursions at Each Visit Week 5 Excursions > 11.0 (n = 89, 99)	34.8 percentage of participants	25.3 percentage of participants
Percentage of Participants With Hemoglobin Excursions at Each Visit Week 5 Excursions > 12.0 (n = 89, 99)	5.6 percentage of participants	7.1 percentage of participants
Percentage of Participants With Hemoglobin Excursions at Each Visit Week 7 Excursions (n = 88, 97)	27.3 percentage of participants	28.9 percentage of participants
Percentage of Participants With Hemoglobin Excursions at Each Visit Week 7 Excursions < 9.0 (n = 88, 97)	6.8 percentage of participants	8.2 percentage of participants
Percentage of Participants With Hemoglobin Excursions at Each Visit Week 7 Excursions > 11.0 (n = 88, 97)	20.5 percentage of participants	20.6 percentage of participants
Percentage of Participants With Hemoglobin Excursions at Each Visit Week 7 Excursions > 12.0 (n = 88, 97)	3.4 percentage of participants	4.1 percentage of participants
Percentage of Participants With Hemoglobin Excursions at Each Visit Week 9 Excursions < 9.0 (n = 89, 100)	9.0 percentage of participants	10.0 percentage of participants
Percentage of Participants With Hemoglobin Excursions at Each Visit Week 9 Excursions > 11.0 (n = 89, 100)	20.2 percentage of participants	7.0 percentage of participants
Percentage of Participants With Hemoglobin Excursions at Each Visit Week 9 Excursions > 12.0 (n = 89, 100)	3.4 percentage of participants	0.0 percentage of participants
Percentage of Participants With Hemoglobin Excursions at Each Visit Week 11 Excursions (n = 88, 99)	22.7 percentage of participants	23.2 percentage of participants
Percentage of Participants With Hemoglobin Excursions at Each Visit Week 11 Excursions < 9.0 (n = 88, 99)	4.5 percentage of participants	7.1 percentage of participants
Percentage of Participants With Hemoglobin Excursions at Each Visit Week 11 Excursions > 11.0 (n = 88, 99)	18.2 percentage of participants	16.2 percentage of participants
Percentage of Participants With Hemoglobin Excursions at Each Visit Week 13 Excursions (n = 89, 100)	25.8 percentage of participants	21.0 percentage of participants
Percentage of Participants With Hemoglobin Excursions at Each Visit Week 13 Excursions < 9.0 (n = 89, 100)	7.9 percentage of participants	9.0 percentage of participants
Percentage of Participants With Hemoglobin Excursions at Each Visit Week 13 Excursions > 11.0 (n = 89, 100)	18.0 percentage of participants	12.0 percentage of participants
Percentage of Participants With Hemoglobin Excursions at Each Visit Week 13 Excursions > 12.0 (n = 89, 100)	4.5 percentage of participants	1.0 percentage of participants
Percentage of Participants With Hemoglobin Excursions at Each Visit Week 15 Excursions (n = 89, 100)	27.0 percentage of participants	24.0 percentage of participants
Percentage of Participants With Hemoglobin Excursions at Each Visit Week 15 Excursions < 9.0 (n = 89, 100)	5.6 percentage of participants	13.0 percentage of participants
Percentage of Participants With Hemoglobin Excursions at Each Visit Week 15 Excursions > 11.0 (n = 89, 100)	21.3 percentage of participants	11.0 percentage of participants
Percentage of Participants With Hemoglobin Excursions at Each Visit Week 15 Excursions > 12.0 (n = 89, 100)	6.7 percentage of participants	0.0 percentage of participants
Percentage of Participants With Hemoglobin Excursions at Each Visit Week 17 Excursions (n = 89, 100)	23.6 percentage of participants	21.0 percentage of participants
Percentage of Participants With Hemoglobin Excursions at Each Visit Week 17 Excursions < 9.0 (n = 89, 100)	9.0 percentage of participants	12.0 percentage of participants
Percentage of Participants With Hemoglobin Excursions at Each Visit Week 17 Excursions > 11.0 (n = 89, 100)	14.6 percentage of participants	9.0 percentage of participants
Percentage of Participants With Hemoglobin Excursions at Each Visit Week 17 Excursions > 12.0 (n = 89, 100)	4.5 percentage of participants	3.0 percentage of participants
Percentage of Participants With Hemoglobin Excursions at Each Visit Week 19 Excursions (n = 89, 100)	28.1 percentage of participants	19.0 percentage of participants
Percentage of Participants With Hemoglobin Excursions at Each Visit Week 19 Excursions < 9.0 (n = 89, 100)	9.0 percentage of participants	13.0 percentage of participants
Percentage of Participants With Hemoglobin Excursions at Each Visit Week 19 Excursions > 11.0 (n = 89, 100)	19.1 percentage of participants	6.0 percentage of participants
Percentage of Participants With Hemoglobin Excursions at Each Visit Week 19 Excursions > 12.0 (n = 89, 100)	9.0 percentage of participants	0.0 percentage of participants
Percentage of Participants With Hemoglobin Excursions at Each Visit Week 21 Excursions (n = 87, 99)	27.6 percentage of participants	17.2 percentage of participants
Percentage of Participants With Hemoglobin Excursions at Each Visit Week 21 Excursions < 9.0 (n = 87, 99)	8.0 percentage of participants	12.1 percentage of participants
Percentage of Participants With Hemoglobin Excursions at Each Visit Week 21 Excursions > 11.0 (n = 87, 99)	19.5 percentage of participants	5.1 percentage of participants
Percentage of Participants With Hemoglobin Excursions at Each Visit Week 21 Excursions > 12.0 (n = 87, 99)	3.4 percentage of participants	0.0 percentage of participants
Percentage of Participants With Hemoglobin Excursions at Each Visit Week 23 Excursions (n = 88, 98)	29.5 percentage of participants	20.4 percentage of participants
Percentage of Participants With Hemoglobin Excursions at Each Visit Week 23 Excursions < 9.0 (n = 88, 98)	6.8 percentage of participants	10.2 percentage of participants
Percentage of Participants With Hemoglobin Excursions at Each Visit Week 23 Excursions > 11.0 (n = 88, 98)	22.7 percentage of participants	10.2 percentage of participants
Percentage of Participants With Hemoglobin Excursions at Each Visit Week 23 Excursions > 12.0 (n = 88, 98)	5.7 percentage of participants	0.0 percentage of participants
Percentage of Participants With Hemoglobin Excursions at Each Visit Week 25 Excursions (n = 87, 98)	28.7 percentage of participants	20.4 percentage of participants
Percentage of Participants With Hemoglobin Excursions at Each Visit Week 25 Excursions < 9.0 (n = 87, 98)	2.3 percentage of participants	13.3 percentage of participants
Percentage of Participants With Hemoglobin Excursions at Each Visit Week 25 Excursions > 11.0 (n = 87, 98)	26.4 percentage of participants	7.1 percentage of participants
Percentage of Participants With Hemoglobin Excursions at Each Visit Week 25 Excursions > 12.0 (n = 87, 98)	5.7 percentage of participants	2.0 percentage of participants
Percentage of Participants With Hemoglobin Excursions at Each Visit Week 27 Excursions (n = 88, 94)	29.5 percentage of participants	21.3 percentage of participants
Percentage of Participants With Hemoglobin Excursions at Each Visit Week 27 Excursions < 9.0 (n = 88, 94)	10.2 percentage of participants	16.0 percentage of participants
Percentage of Participants With Hemoglobin Excursions at Each Visit Week 27 Excursions > 11.0 (n = 88, 94)	19.3 percentage of participants	5.3 percentage of participants
Percentage of Participants With Hemoglobin Excursions at Each Visit Week 27 Excursions > 12.0 (n = 88, 94)	3.4 percentage of participants	0.0 percentage of participants
Percentage of Participants With Hemoglobin Excursions at Each Visit Week 29 Excursions > 11.0 (n = 89, 92)	20.2 percentage of participants	13.0 percentage of participants
Percentage of Participants With Hemoglobin Excursions at Each Visit Week 29 Excursions > 12.0 (n = 89, 92)	4.5 percentage of participants	2.2 percentage of participants
Percentage of Participants With Hemoglobin Excursions at Each Visit Week 31 Excursions (n = 85, 89)	20.0 percentage of participants	28.1 percentage of participants
Percentage of Participants With Hemoglobin Excursions at Each Visit Week 31 Excursions > 11.0 (n = 85, 89)	15.3 percentage of participants	11.2 percentage of participants
Percentage of Participants With Hemoglobin Excursions at Each Visit Week 31 Excursions > 12.0 (n = 85, 89)	5.9 percentage of participants	1.1 percentage of participants
Percentage of Participants With Hemoglobin Excursions at Each Visit Week 33 Excursions (n = 86, 90)	22.1 percentage of participants	22.2 percentage of participants
Percentage of Participants With Hemoglobin Excursions at Each Visit Week 33 Excursions < 9.0 (n = 86, 90)	7.0 percentage of participants	11.1 percentage of participants
Percentage of Participants With Hemoglobin Excursions at Each Visit Week 33 Excursions > 11.0 (n = 86, 90)	15.1 percentage of participants	11.1 percentage of participants
Percentage of Participants With Hemoglobin Excursions at Each Visit Week 33 Excursions > 12.0 (n = 86, 90)	3.5 percentage of participants	2.2 percentage of participants
Percentage of Participants With Hemoglobin Excursions at Each Visit Week 35 Excursions (n = 87, 88)	26.4 percentage of participants	21.6 percentage of participants
Percentage of Participants With Hemoglobin Excursions at Each Visit Week 35 Excursions < 9.0 (n = 87, 88)	11.5 percentage of participants	13.6 percentage of participants
Percentage of Participants With Hemoglobin Excursions at Each Visit Week 35 Excursions > 11.0 (n = 87, 88)	14.9 percentage of participants	8.0 percentage of participants
Percentage of Participants With Hemoglobin Excursions at Each Visit Week 35 Excursions > 12.0 (n = 87, 88)	4.6 percentage of participants	0.0 percentage of participants
Percentage of Participants With Hemoglobin Excursions at Each Visit Week 37 Excursions (n = 87, 93)	20.7 percentage of participants	17.2 percentage of participants
Percentage of Participants With Hemoglobin Excursions at Each Visit Week 37 Excursions < 9.0 (n = 87, 93)	8.0 percentage of participants	12.9 percentage of participants
Percentage of Participants With Hemoglobin Excursions at Each Visit Week 37 Excursions > 11.0 (n = 87, 93)	12.6 percentage of participants	4.3 percentage of participants
Percentage of Participants With Hemoglobin Excursions at Each Visit Week 37 Excursions > 12.0 (n = 87, 93)	3.4 percentage of participants	0.0 percentage of participants

SECONDARY outcome

Timeframe: Weeks 1, 3, 5, 7, 9, 11, 13, 15, 17, 19, 21, 23, 25, 27, 29, 31, 33, and 35

Population: Primary analysis set with available data at each time point

Outcome measures

Measure	Epoetin Alfa Alternative Titration n=89 Participants Participants received epoetin alfa administered intravenously three times a week during hemodialysis for up to 37 weeks. For the first two weeks the dose of epoetin alfa was based on the dose at the time of screening. Beginning at week 3 dose changes may have occurred every 2 weeks according to the alternative dosing algorithm, where smaller, frequent dose adjustments were permitted based on six hemoglobin categories.	Epoetin Alfa USPI Titration n=100 Participants Participants received epoetin alfa administered intravenously three times a week during hemodialysis for 37 weeks. For the first two weeks the dose of epoetin alfa was based on the dose at the time of screening. Beginning at week 3 dose decreases were permitted every 2 weeks and beginning at week 5 dose increases could only occur ≥ 4 weeks from the last dose increase, according to the United States package insert (USPI) dosing algorithm which includes four categories of hemoglobin levels.
Weekly Epoetin Alfa Dose at Each Visit Week 1 (n = 89, 100)	13139.9 units Standard Deviation 9360.1	10400 units Standard Deviation 8439.9
Weekly Epoetin Alfa Dose at Each Visit Week 3 (n = 89, 100)	9683.7 units Standard Deviation 9162.9	6912.5 units Standard Deviation 7459.4
Weekly Epoetin Alfa Dose at Each Visit Week 5 (n = 89, 100)	8324.2 units Standard Deviation 8689.7	6874.0 units Standard Deviation 8204.3
Weekly Epoetin Alfa Dose at Each Visit Week 7 (n = 89, 100)	9319.1 units Standard Deviation 7977.5	6411.0 units Standard Deviation 7040.6
Weekly Epoetin Alfa Dose at Each Visit Week 9 (n = 89, 100)	9253.4 units Standard Deviation 8536.9	8003.0 units Standard Deviation 7292.8
Weekly Epoetin Alfa Dose at Each Visit Week 11 (n = 89, 100)	10039.3 units Standard Deviation 9194.1	6483.0 units Standard Deviation 6854.9
Weekly Epoetin Alfa Dose at Each Visit Week 13 (n = 89, 100)	10358.4 units Standard Deviation 10247.7	7387.5 units Standard Deviation 7271.6
Weekly Epoetin Alfa Dose at Each Visit Week 15 (n = 89, 100)	8889.3 units Standard Deviation 8316.8	6874.5 units Standard Deviation 5952.9
Weekly Epoetin Alfa Dose at Each Visit Week 17 (n = 89, 100)	10251.7 units Standard Deviation 9973.7	6924.5 units Standard Deviation 6211.1
Weekly Epoetin Alfa Dose at Each Visit Week 19 (n = 89, 100)	10475.8 units Standard Deviation 10437.0	7112.5 units Standard Deviation 6300.4
Weekly Epoetin Alfa Dose at Each Visit Week 21 (n = 89, 99)	9605.1 units Standard Deviation 8225.0	6909.6 units Standard Deviation 6102.5
Weekly Epoetin Alfa Dose at Each Visit Week 23 (n = 89, 98)	8905.1 units Standard Deviation 7748.3	6830.1 units Standard Deviation 6397.0
Weekly Epoetin Alfa Dose at Each Visit Week 25 (n = 89, 98)	7543.8 units Standard Deviation 7225.1	7486.7 units Standard Deviation 6676.2
Weekly Epoetin Alfa Dose at Each Visit Week 27 (n = 89, 96)	9765.7 units Standard Deviation 12013.7	6662.5 units Standard Deviation 6362.8
Weekly Epoetin Alfa Dose at Each Visit Week 29 (n =89, 94)	9088.8 units Standard Deviation 10146.9	6083.0 units Standard Deviation 6149.1
Weekly Epoetin Alfa Dose at Each Visit Week 31 (n = 88, 91)	8543.2 units Standard Deviation 10821.7	6673.1 units Standard Deviation 6277.6
Weekly Epoetin Alfa Dose at Each Visit Week 33 (n = 87, 90)	9019.0 units Standard Deviation 10466.9	6235.6 units Standard Deviation 6041.6
Weekly Epoetin Alfa Dose at Each Visit Week 35 (n = 87, 90)	8709.2 units Standard Deviation 8631.9	5950.6 units Standard Deviation 5364.6

SECONDARY outcome

Timeframe: Overall Study: Study week 1 to week 41; Titration Period: Study week 1 to week 12; Evaluation Period: Study week 13 to week 37; Safety Follow-up Period: Study week 38 to week 41

Population: Primary analysis set with available data in each study period

The number of red blood cell (RBC) units transfused during the study and during each study period.

Outcome measures

Measure	Epoetin Alfa Alternative Titration n=89 Participants Participants received epoetin alfa administered intravenously three times a week during hemodialysis for up to 37 weeks. For the first two weeks the dose of epoetin alfa was based on the dose at the time of screening. Beginning at week 3 dose changes may have occurred every 2 weeks according to the alternative dosing algorithm, where smaller, frequent dose adjustments were permitted based on six hemoglobin categories.	Epoetin Alfa USPI Titration n=100 Participants Participants received epoetin alfa administered intravenously three times a week during hemodialysis for 37 weeks. For the first two weeks the dose of epoetin alfa was based on the dose at the time of screening. Beginning at week 3 dose decreases were permitted every 2 weeks and beginning at week 5 dose increases could only occur ≥ 4 weeks from the last dose increase, according to the United States package insert (USPI) dosing algorithm which includes four categories of hemoglobin levels.
Number of RBC Units Transfused Overall and During Each Study Period Overall Study: 1 RBC Unit (n = 89, 100)	1 participants	4 participants
Number of RBC Units Transfused Overall and During Each Study Period Safety Follow-up Period: >3 RBC Units (n = 83, 90)	0 participants	0 participants
Number of RBC Units Transfused Overall and During Each Study Period Overall Study: 2 RBC Units (n = 89, 100)	2 participants	5 participants
Number of RBC Units Transfused Overall and During Each Study Period Overall Study: 3 RBC Units (n = 89, 100)	1 participants	2 participants
Number of RBC Units Transfused Overall and During Each Study Period Overall Study: > 3 RBC Units (n = 89, 100)	2 participants	1 participants
Number of RBC Units Transfused Overall and During Each Study Period Titration Period: 1 RBC Unit (n = 89, 100)	0 participants	1 participants
Number of RBC Units Transfused Overall and During Each Study Period Titration Period: 2 RBC Units (n = 89, 100)	1 participants	0 participants
Number of RBC Units Transfused Overall and During Each Study Period Titration Period: 3 RBC Units (n = 89, 100)	1 participants	0 participants
Number of RBC Units Transfused Overall and During Each Study Period Titration Period: > 3 RBC Units (n = 89, 100)	0 participants	0 participants
Number of RBC Units Transfused Overall and During Each Study Period Evaluation Period: 1 RBC Unit (n = 89, 100)	1 participants	3 participants
Number of RBC Units Transfused Overall and During Each Study Period Evaluation Period: 2 RBC Units (n = 89, 100)	3 participants	4 participants
Number of RBC Units Transfused Overall and During Each Study Period Evaluation Period: 3 RBC Units (n = 89, 100)	1 participants	2 participants
Number of RBC Units Transfused Overall and During Each Study Period Evaluation Period: > 3 RBC Units (n = 89, 100)	0 participants	1 participants
Number of RBC Units Transfused Overall and During Each Study Period Safety Follow-up Period: 1 RBC Unit (n = 83, 90)	0 participants	0 participants
Number of RBC Units Transfused Overall and During Each Study Period Safety Follow-up Period: 2 RBC Units (n = 83, 90)	1 participants	1 participants
Number of RBC Units Transfused Overall and During Each Study Period Safety Follow-up Period: 3 RBC Units (n = 83, 90)	0 participants	0 participants

Adverse Events

Epoetin Alfa Alternative Titration

Serious events: 37 serious events

Other events: 19 other events

Deaths: 0 deaths

Epoetin Alfa USPI Titration

Serious events: 39 serious events

Other events: 26 other events

Deaths: 0 deaths

Serious adverse events

Measure	Epoetin Alfa Alternative Titration n=104 participants at risk Participants received epoetin alfa administered intravenously three times a week during hemodialysis for up to 37 weeks. For the first two weeks the dose of epoetin alfa was based on the dose at the time of screening. Beginning at week 3 dose changes may have occurred every 2 weeks according to the alternative dosing algorithm, where smaller, frequent dose adjustments were permitted based on six hemoglobin categories.	Epoetin Alfa USPI Titration n=107 participants at risk Participants received epoetin alfa administered intravenously three times a week during hemodialysis for 37 weeks. For the first two weeks the dose of epoetin alfa was based on the dose at the time of screening. Beginning at week 3 dose decreases were permitted every 2 weeks and beginning at week 5 dose increases could only occur ≥ 4 weeks from the last dose increase, according to the United States package insert (USPI) dosing algorithm which includes four categories of hemoglobin levels.
Gastrointestinal disorders Abdominal pain	0.96% 1/104 • 41 Weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/107 • 41 Weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Gastrointestinal disorders Colitis	0.00% 0/104 • 41 Weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.93% 1/107 • 41 Weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Gastrointestinal disorders Constipation	0.96% 1/104 • 41 Weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/107 • 41 Weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Gastrointestinal disorders Diabetic gastroparesis	0.00% 0/104 • 41 Weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.93% 1/107 • 41 Weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Gastrointestinal disorders Diverticulum	0.96% 1/104 • 41 Weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/107 • 41 Weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Gastrointestinal disorders Duodenal ulcer	0.96% 1/104 • 41 Weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/107 • 41 Weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Gastrointestinal disorders Gastric ulcer	0.00% 0/104 • 41 Weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.93% 1/107 • 41 Weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Gastrointestinal disorders Gastritis erosive	0.96% 1/104 • 41 Weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/107 • 41 Weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Gastrointestinal disorders Gastrointestinal haemorrhage	1.9% 2/104 • 41 Weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	2.8% 3/107 • 41 Weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Gastrointestinal disorders Intestinal obstruction	0.00% 0/104 • 41 Weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.93% 1/107 • 41 Weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Gastrointestinal disorders Small intestinal obstruction	0.00% 0/104 • 41 Weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.93% 1/107 • 41 Weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Gastrointestinal disorders Vomiting	0.00% 0/104 • 41 Weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.93% 1/107 • 41 Weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Blood and lymphatic system disorders Anaemia	0.96% 1/104 • 41 Weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/107 • 41 Weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Blood and lymphatic system disorders Immune thrombocytopenic purpura	0.00% 0/104 • 41 Weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.93% 1/107 • 41 Weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Cardiac disorders Acute myocardial infarction	0.96% 1/104 • 41 Weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.93% 1/107 • 41 Weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Cardiac disorders Angina pectoris	0.96% 1/104 • 41 Weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	1.9% 2/107 • 41 Weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Cardiac disorders Atrial fibrillation	0.00% 0/104 • 41 Weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	1.9% 2/107 • 41 Weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Cardiac disorders Cardiac arrest	2.9% 3/104 • 41 Weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.93% 1/107 • 41 Weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Cardiac disorders Cardiac failure	0.96% 1/104 • 41 Weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/107 • 41 Weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Cardiac disorders Cardiac failure acute	0.00% 0/104 • 41 Weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.93% 1/107 • 41 Weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Cardiac disorders Cardiac failure congestive	2.9% 3/104 • 41 Weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	1.9% 2/107 • 41 Weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Cardiac disorders Cardiac valve disease	0.96% 1/104 • 41 Weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/107 • 41 Weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Cardiac disorders Coronary artery disease	0.00% 0/104 • 41 Weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	1.9% 2/107 • 41 Weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Cardiac disorders Myocardial infarction	0.96% 1/104 • 41 Weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.93% 1/107 • 41 Weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Cardiac disorders Supraventricular tachycardia	0.00% 0/104 • 41 Weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.93% 1/107 • 41 Weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Ear and labyrinth disorders Vertigo	0.00% 0/104 • 41 Weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.93% 1/107 • 41 Weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Endocrine disorders Hyperparathyroidism secondary	0.96% 1/104 • 41 Weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/107 • 41 Weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
General disorders Asthenia	0.96% 1/104 • 41 Weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.93% 1/107 • 41 Weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
General disorders Catheter site haemorrhage	0.96% 1/104 • 41 Weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/107 • 41 Weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
General disorders Chest pain	0.00% 0/104 • 41 Weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.93% 1/107 • 41 Weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
General disorders Death	0.00% 0/104 • 41 Weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.93% 1/107 • 41 Weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
General disorders Non-cardiac chest pain	1.9% 2/104 • 41 Weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/107 • 41 Weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
General disorders Pyrexia	0.96% 1/104 • 41 Weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/107 • 41 Weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
General disorders Vascular stent restenosis	0.00% 0/104 • 41 Weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.93% 1/107 • 41 Weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Hepatobiliary disorders Cholecystitis acute	1.9% 2/104 • 41 Weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/107 • 41 Weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Hepatobiliary disorders Cholelithiasis	0.96% 1/104 • 41 Weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/107 • 41 Weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Hepatobiliary disorders Haemorrhagic hepatic cyst	0.96% 1/104 • 41 Weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/107 • 41 Weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Infections and infestations Abscess limb	0.96% 1/104 • 41 Weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/107 • 41 Weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Infections and infestations Arthritis bacterial	1.9% 2/104 • 41 Weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/107 • 41 Weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Infections and infestations Atypical pneumonia	0.00% 0/104 • 41 Weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.93% 1/107 • 41 Weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Infections and infestations Bronchitis	1.9% 2/104 • 41 Weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/107 • 41 Weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Infections and infestations Cellulitis	1.9% 2/104 • 41 Weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/107 • 41 Weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Infections and infestations Clostridium difficile colitis	0.96% 1/104 • 41 Weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/107 • 41 Weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Infections and infestations Cystitis escherichia	0.00% 0/104 • 41 Weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.93% 1/107 • 41 Weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Infections and infestations Device related infection	0.96% 1/104 • 41 Weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/107 • 41 Weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Infections and infestations Endocarditis	0.96% 1/104 • 41 Weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/107 • 41 Weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Infections and infestations Gastroenteritis	0.96% 1/104 • 41 Weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.93% 1/107 • 41 Weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Infections and infestations Gastroenteritis viral	0.96% 1/104 • 41 Weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/107 • 41 Weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Infections and infestations Hepatitis C	0.00% 0/104 • 41 Weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.93% 1/107 • 41 Weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Infections and infestations Herpes zoster	0.96% 1/104 • 41 Weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/107 • 41 Weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Infections and infestations Infected skin ulcer	0.00% 0/104 • 41 Weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.93% 1/107 • 41 Weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Infections and infestations Pneumonia	1.9% 2/104 • 41 Weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	5.6% 6/107 • 41 Weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Infections and infestations Scrotal abscess	0.00% 0/104 • 41 Weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.93% 1/107 • 41 Weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Infections and infestations Sepsis	0.96% 1/104 • 41 Weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.93% 1/107 • 41 Weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Infections and infestations Sepsis syndrome	0.96% 1/104 • 41 Weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/107 • 41 Weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Infections and infestations Staphylococcal bacteraemia	0.00% 0/104 • 41 Weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.93% 1/107 • 41 Weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Infections and infestations Staphylococcal sepsis	0.00% 0/104 • 41 Weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.93% 1/107 • 41 Weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Injury, poisoning and procedural complications Arteriovenous fistula occlusion	0.00% 0/104 • 41 Weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.93% 1/107 • 41 Weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Injury, poisoning and procedural complications Arteriovenous fistula site haemorrhage	0.00% 0/104 • 41 Weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	1.9% 2/107 • 41 Weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Injury, poisoning and procedural complications Arteriovenous fistula thrombosis	0.00% 0/104 • 41 Weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.93% 1/107 • 41 Weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Injury, poisoning and procedural complications Graft haemorrhage	0.00% 0/104 • 41 Weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.93% 1/107 • 41 Weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Injury, poisoning and procedural complications Hip fracture	0.96% 1/104 • 41 Weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/107 • 41 Weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Injury, poisoning and procedural complications Rib fracture	0.00% 0/104 • 41 Weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.93% 1/107 • 41 Weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Injury, poisoning and procedural complications Spinal compression fracture	0.96% 1/104 • 41 Weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/107 • 41 Weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Injury, poisoning and procedural complications Subdural haematoma	0.00% 0/104 • 41 Weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.93% 1/107 • 41 Weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Injury, poisoning and procedural complications Thoracic vertebral fracture	0.00% 0/104 • 41 Weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.93% 1/107 • 41 Weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Metabolism and nutrition disorders Diabetic complication	0.96% 1/104 • 41 Weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/107 • 41 Weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Metabolism and nutrition disorders Fluid overload	2.9% 3/104 • 41 Weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	8.4% 9/107 • 41 Weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Metabolism and nutrition disorders Hyperkalaemia	2.9% 3/104 • 41 Weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.93% 1/107 • 41 Weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Metabolism and nutrition disorders Hypoglycaemia	1.9% 2/104 • 41 Weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/107 • 41 Weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Musculoskeletal and connective tissue disorders Back pain	0.00% 0/104 • 41 Weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.93% 1/107 • 41 Weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Musculoskeletal and connective tissue disorders Bone disorder	0.00% 0/104 • 41 Weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.93% 1/107 • 41 Weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Musculoskeletal and connective tissue disorders Joint instability	0.96% 1/104 • 41 Weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/107 • 41 Weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Musculoskeletal and connective tissue disorders Osteoarthritis	0.96% 1/104 • 41 Weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/107 • 41 Weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Musculoskeletal and connective tissue disorders Pain in extremity	0.00% 0/104 • 41 Weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.93% 1/107 • 41 Weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastatic neoplasm	0.00% 0/104 • 41 Weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.93% 1/107 • 41 Weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Nervous system disorders Cerebrovascular accident	0.00% 0/104 • 41 Weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	3.7% 4/107 • 41 Weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Nervous system disorders Encephalopathy	0.00% 0/104 • 41 Weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.93% 1/107 • 41 Weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Nervous system disorders Hemiparesis	0.00% 0/104 • 41 Weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.93% 1/107 • 41 Weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Nervous system disorders Hemiplegia	0.00% 0/104 • 41 Weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.93% 1/107 • 41 Weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Psychiatric disorders Delirium	0.00% 0/104 • 41 Weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.93% 1/107 • 41 Weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Psychiatric disorders Mental status changes	0.00% 0/104 • 41 Weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	1.9% 2/107 • 41 Weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Renal and urinary disorders End stage renal disease	0.00% 0/104 • 41 Weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.93% 1/107 • 41 Weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Renal and urinary disorders Nephrolithiasis	0.00% 0/104 • 41 Weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.93% 1/107 • 41 Weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Respiratory, thoracic and mediastinal disorders Acute respiratory failure	0.00% 0/104 • 41 Weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.93% 1/107 • 41 Weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Respiratory, thoracic and mediastinal disorders Asthma	0.96% 1/104 • 41 Weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/107 • 41 Weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Respiratory, thoracic and mediastinal disorders Bronchitis chronic	0.96% 1/104 • 41 Weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/107 • 41 Weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Respiratory, thoracic and mediastinal disorders Chronic obstructive pulmonary disease	0.96% 1/104 • 41 Weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/107 • 41 Weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.96% 1/104 • 41 Weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	1.9% 2/107 • 41 Weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Respiratory, thoracic and mediastinal disorders Haemothorax	0.96% 1/104 • 41 Weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.93% 1/107 • 41 Weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Respiratory, thoracic and mediastinal disorders Pleural effusion	0.96% 1/104 • 41 Weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	2.8% 3/107 • 41 Weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Respiratory, thoracic and mediastinal disorders Pneumothorax	0.00% 0/104 • 41 Weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.93% 1/107 • 41 Weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	0.96% 1/104 • 41 Weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.93% 1/107 • 41 Weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Respiratory, thoracic and mediastinal disorders Pulmonary oedema	1.9% 2/104 • 41 Weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/107 • 41 Weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Respiratory, thoracic and mediastinal disorders Respiratory arrest	0.96% 1/104 • 41 Weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/107 • 41 Weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Respiratory, thoracic and mediastinal disorders Respiratory failure	0.00% 0/104 • 41 Weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.93% 1/107 • 41 Weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Skin and subcutaneous tissue disorders Diabetic foot	0.00% 0/104 • 41 Weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.93% 1/107 • 41 Weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Skin and subcutaneous tissue disorders Skin ulcer	0.96% 1/104 • 41 Weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/107 • 41 Weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Vascular disorders Arteriosclerosis	0.96% 1/104 • 41 Weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/107 • 41 Weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Vascular disorders Deep vein thrombosis	1.9% 2/104 • 41 Weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/107 • 41 Weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Vascular disorders Embolism	0.96% 1/104 • 41 Weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/107 • 41 Weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Vascular disorders Hypertension	0.00% 0/104 • 41 Weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	1.9% 2/107 • 41 Weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Vascular disorders Hypertensive crisis	0.96% 1/104 • 41 Weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.93% 1/107 • 41 Weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Vascular disorders Hypotension	1.9% 2/104 • 41 Weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	1.9% 2/107 • 41 Weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Vascular disorders Peripheral vascular disorder	0.00% 0/104 • 41 Weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.93% 1/107 • 41 Weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Vascular disorders Steal syndrome	0.96% 1/104 • 41 Weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/107 • 41 Weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Vascular disorders Superior vena cava syndrome	0.00% 0/104 • 41 Weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.93% 1/107 • 41 Weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.

Other adverse events

Measure	Epoetin Alfa Alternative Titration n=104 participants at risk Participants received epoetin alfa administered intravenously three times a week during hemodialysis for up to 37 weeks. For the first two weeks the dose of epoetin alfa was based on the dose at the time of screening. Beginning at week 3 dose changes may have occurred every 2 weeks according to the alternative dosing algorithm, where smaller, frequent dose adjustments were permitted based on six hemoglobin categories.	Epoetin Alfa USPI Titration n=107 participants at risk Participants received epoetin alfa administered intravenously three times a week during hemodialysis for 37 weeks. For the first two weeks the dose of epoetin alfa was based on the dose at the time of screening. Beginning at week 3 dose decreases were permitted every 2 weeks and beginning at week 5 dose increases could only occur ≥ 4 weeks from the last dose increase, according to the United States package insert (USPI) dosing algorithm which includes four categories of hemoglobin levels.
Blood and lymphatic system disorders Anaemia	1.9% 2/104 • 41 Weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	6.5% 7/107 • 41 Weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Gastrointestinal disorders Diarrhoea	7.7% 8/104 • 41 Weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	7.5% 8/107 • 41 Weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Investigations Haemoglobin increased	2.9% 3/104 • 41 Weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	5.6% 6/107 • 41 Weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Respiratory, thoracic and mediastinal disorders Dyspnoea	5.8% 6/104 • 41 Weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	3.7% 4/107 • 41 Weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Vascular disorders Hypertension	4.8% 5/104 • 41 Weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	7.5% 8/107 • 41 Weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.

Additional Information

Study Director

Amgen Inc.

Phone: 866-572-6436

Results disclosure agreements

• Principal investigator is a sponsor employee The Clinical Trial Agreement generally does not restrict an investigator's discussion of trial results after completion. The Agreement permits Amgen a limited period of time to review material discussing trial results (typically up to 45 days and possible extension). Amgen may remove confidential information, but authors have final control and approval of publication content. For multicenter studies, the investigator agrees not to publish any results before the first multi-center publication.
• Publication restrictions are in place

Restriction type: OTHER