Trial Outcomes & Findings for A Study of Subcutaneous Mircera for the Treatment of Anemia in Peritoneal Dialysis Patients. (NCT NCT00442416)

NCT ID: NCT00442416

Last Updated: 2016-08-17

Results Overview

Mean change in Hb concentration from Baseline (Day \[D\] 0) to average during the evaluation period (Month 7 to 9) is reported.

• Recruitment status: TERMINATED
• Study phase: PHASE3
• Target enrollment: 80 participants
• Primary outcome timeframe: From Baseline (D 0) to 9 months
• Results posted on: 2016-08-17

Participant Flow

This study was conducted in the United States from 27 February 2007 to 01 January 2008. The study was prematurely terminated during enrolment due to legal reasons.

A total of 80 participants were randomized, of which 78 participants received the study drug and 2 participants did not receive the study drug nor had post baseline safety assessments.

Participant milestones

Measure	RO0503821 Eligible participants were administered RO0503821 (methoxy polyethylene glycol-epoetin beta \[Mircera\]) subcutaneously (SC) every month for eight months (6 months of titration period \[TP\] and two months of evaluation period \[EP\] and 15-days following the final study visit (9 months post randomization). The first dose of Mircera (120, 200, or 360 mcg) was based upon the dose of epoetin alfa received 1 to 2 weeks prior to administration of study drug, while subsequent doses were adjusted to maintain haemoglobin (Hb) concentrations within target of \>=10.0 gram per decilitre (g/dL) and \<=12.0 g/dL. Participants who self-administered/visited to clinics for erythropoiesis stimulating agent (ESA) dosing prior to randomization continued to do so.	Epoetin Alfa Eligible participants were administered epoetin alfa SC as per the standard of care for eight months (TP and EP), and were followed-up for 15 days following the final study visit. Participants who self-administered/visited to clinics for ESA dosing prior to randomization continued to do so.
Overall Study STARTED	39	41
Overall Study COMPLETED	2	2
Overall Study NOT COMPLETED	37	39

Reasons for withdrawal

Measure	RO0503821 Eligible participants were administered RO0503821 (methoxy polyethylene glycol-epoetin beta \[Mircera\]) subcutaneously (SC) every month for eight months (6 months of titration period \[TP\] and two months of evaluation period \[EP\] and 15-days following the final study visit (9 months post randomization). The first dose of Mircera (120, 200, or 360 mcg) was based upon the dose of epoetin alfa received 1 to 2 weeks prior to administration of study drug, while subsequent doses were adjusted to maintain haemoglobin (Hb) concentrations within target of \>=10.0 gram per decilitre (g/dL) and \<=12.0 g/dL. Participants who self-administered/visited to clinics for erythropoiesis stimulating agent (ESA) dosing prior to randomization continued to do so.	Epoetin Alfa Eligible participants were administered epoetin alfa SC as per the standard of care for eight months (TP and EP), and were followed-up for 15 days following the final study visit. Participants who self-administered/visited to clinics for ESA dosing prior to randomization continued to do so.
Overall Study Adverse Event	4	1
Overall Study Death	1	0
Overall Study Lack of Efficacy	2	0
Overall Study Protocol Violation	2	3
Overall Study Withdrew consent	1	2
Overall Study Administrative/Other	27	33

Baseline Characteristics

A Study of Subcutaneous Mircera for the Treatment of Anemia in Peritoneal Dialysis Patients.

Baseline characteristics by cohort

Measure	RO0503821 n=38 Participants Eligible participants were administered RO0503821 (methoxy polyethylene glycol-epoetin beta \[Mircera\]) subcutaneously (SC) every month for eight months (6 months of titration period \[TP\] and two months of evaluation period \[EP\] and 15-days following the final study visit (9 months post randomization). The first dose of Mircera (120, 200, or 360 mcg) was based upon the dose of epoetin alfa received 1 to 2 weeks prior to administration of study drug, while subsequent doses were adjusted to maintain haemoglobin (Hb) concentrations within target of \>=10.0 gram per decilitre (g/dL) and \<=12.0 g/dL. Participants who self-administered/visited to clinics for erythropoiesis stimulating agent (ESA) dosing prior to randomization continued to do so.	Epoetin Alfa n=40 Participants Eligible participants were administered epoetin alfa SC as per the standard of care for eight months (TP and EP), and were followed-up for 15 days following the final study visit. Participants who self-administered/visited to clinics for ESA dosing prior to randomization continued to do so.	Total n=78 Participants Total of all reporting groups
Age, Continuous	58.5 Years STANDARD_DEVIATION 12.59 • n=5 Participants	53.6 Years STANDARD_DEVIATION 15.86 • n=7 Participants	56.0 Years STANDARD_DEVIATION 14.48 • n=5 Participants
Sex: Female, Male Female	18 Participants n=5 Participants	20 Participants n=7 Participants	38 Participants n=5 Participants
Sex: Female, Male Male	20 Participants n=5 Participants	20 Participants n=7 Participants	40 Participants n=5 Participants

PRIMARY outcome

Timeframe: From Baseline (D 0) to 9 months

Population: Per-protocol population included all randomized participants who received at least one dose of the study drug and met all study entry criteria with no major protocol violations. Participants with available data at the time of evaluation were analyzed.

Mean change in Hb concentration from Baseline (Day [D] 0) to average during the evaluation period (Month 7 to 9) is reported.

Outcome measures

Measure	RO0503821 n=33 Participants Eligible participants were administered RO0503821 (methoxy polyethylene glycol-epoetin beta \[Mircera\]) subcutaneously (SC) every month for eight months (6 months of titration period \[TP\] and two months of evaluation period \[EP\] and 15-days following the final study visit (9 months post randomization). The first dose of Mircera (120, 200, or 360 mcg) was based upon the dose of epoetin alfa received 1 to 2 weeks prior to administration of study drug, while subsequent doses were adjusted to maintain haemoglobin (Hb) concentrations within target of \>=10.0 gram per decilitre (g/dL) and \<=12.0 g/dL. Participants who self-administered/visited to clinics for erythropoiesis stimulating agent (ESA) dosing prior to randomization continued to do so.	Epoetin Alfa n=35 Participants Eligible participants were administered epoetin alfa SC as per the standard of care for eight months (TP and EP), and were followed-up for 15 days following the final study visit. Participants who self-administered/visited to clinics for ESA dosing prior to randomization continued to do so.
Mean Change From Baseline in Hb Concentration to Average Over the Evaluation Period	-0.32 g/dL Standard Deviation 1.31	0.51 g/dL Standard Deviation 1.33

SECONDARY outcome

Timeframe: Up to Month 9

Population: Safety population included all participants who received at least one dose of the study drug and had at least one post-baseline safety assessment.

Safety-related Hb measures included percentage of participants with Hb value > 13 g/dL, 13.5 g/dL, increase in Hb value from baseline by > 2 g/dL or decrease in Hb value from baseline by > 2 g/dL at any time during the study.

Outcome measures

Measure	RO0503821 n=38 Participants Eligible participants were administered RO0503821 (methoxy polyethylene glycol-epoetin beta \[Mircera\]) subcutaneously (SC) every month for eight months (6 months of titration period \[TP\] and two months of evaluation period \[EP\] and 15-days following the final study visit (9 months post randomization). The first dose of Mircera (120, 200, or 360 mcg) was based upon the dose of epoetin alfa received 1 to 2 weeks prior to administration of study drug, while subsequent doses were adjusted to maintain haemoglobin (Hb) concentrations within target of \>=10.0 gram per decilitre (g/dL) and \<=12.0 g/dL. Participants who self-administered/visited to clinics for erythropoiesis stimulating agent (ESA) dosing prior to randomization continued to do so.	Epoetin Alfa n=40 Participants Eligible participants were administered epoetin alfa SC as per the standard of care for eight months (TP and EP), and were followed-up for 15 days following the final study visit. Participants who self-administered/visited to clinics for ESA dosing prior to randomization continued to do so.
Percentage of Participants With Safety-Related Hb Measures Hb value > 13 g/dL	34 Percentage of participants	33 Percentage of participants
Percentage of Participants With Safety-Related Hb Measures Hb value > 13.5 g/dL	13 Percentage of participants	13 Percentage of participants
Percentage of Participants With Safety-Related Hb Measures Increase in Hb value > 2 g/dL	24 Percentage of participants	20 Percentage of participants
Percentage of Participants With Safety-Related Hb Measures Decrease in Hb value > 2 g/dL	16 Percentage of participants	5 Percentage of participants

SECONDARY outcome

Timeframe: Up to Month 9

Population: Safety population included all participants who received at least one dose of the study drug and had at least one post-baseline safety assessment. Participants with available data at the time of evaluation were denoted as 'n'.

Participants with marked laboratory abnormalities in hematology and clinical chemistry parameters are reported. Hematology laboratory parameters included hematocrit fraction, hemoglobin, platelets, white blood cells (WBCs) and clinical chemistry parameters included aspartate aminotransferase ([AST], alanine aminotransferase ([ALT], creatine phosphokinase (CPK), alkaline phosphatase, albumin, potassium, fasting glucose and phosphate.

Outcome measures

Measure	RO0503821 n=38 Participants Eligible participants were administered RO0503821 (methoxy polyethylene glycol-epoetin beta \[Mircera\]) subcutaneously (SC) every month for eight months (6 months of titration period \[TP\] and two months of evaluation period \[EP\] and 15-days following the final study visit (9 months post randomization). The first dose of Mircera (120, 200, or 360 mcg) was based upon the dose of epoetin alfa received 1 to 2 weeks prior to administration of study drug, while subsequent doses were adjusted to maintain haemoglobin (Hb) concentrations within target of \>=10.0 gram per decilitre (g/dL) and \<=12.0 g/dL. Participants who self-administered/visited to clinics for erythropoiesis stimulating agent (ESA) dosing prior to randomization continued to do so.	Epoetin Alfa n=40 Participants Eligible participants were administered epoetin alfa SC as per the standard of care for eight months (TP and EP), and were followed-up for 15 days following the final study visit. Participants who self-administered/visited to clinics for ESA dosing prior to randomization continued to do so.
Number of Participants With Marked Laboratory Abnormalities Hematocrit - Low (n = 38, 40)	8 Participants	3 Participants
Number of Participants With Marked Laboratory Abnormalities Hemoglobin - Low (n = 38, 40)	11 Participants	3 Participants
Number of Participants With Marked Laboratory Abnormalities Platelets - High (n = 38, 40)	0 Participants	1 Participants
Number of Participants With Marked Laboratory Abnormalities Platelets - Low (n = 38, 40)	1 Participants	0 Participants
Number of Participants With Marked Laboratory Abnormalities WBCs - Low (n = 38, 40)	0 Participants	1 Participants
Number of Participants With Marked Laboratory Abnormalities AST - High (n = 37, 40)	0 Participants	2 Participants
Number of Participants With Marked Laboratory Abnormalities ALT - High (n = 38, 40)	1 Participants	2 Participants
Number of Participants With Marked Laboratory Abnormalities CPK- High (n = 37, 40)	7 Participants	3 Participants
Number of Participants With Marked Laboratory Abnormalities Alkaline phosphatase - High, (n = 37, 40)	1 Participants	1 Participants
Number of Participants With Marked Laboratory Abnormalities Albumin - Low (n = 38, 40)	6 Participants	0 Participants
Number of Participants With Marked Laboratory Abnormalities Potassium - High (n = 38, 40)	3 Participants	4 Participants
Number of Participants With Marked Laboratory Abnormalities Fasting glucose - High (n = 38, 40)	6 Participants	5 Participants
Number of Participants With Marked Laboratory Abnormalities Fasting glucose - Low (n = 38, 40)	0 Participants	1 Participants
Number of Participants With Marked Laboratory Abnormalities Phosphate - High (n = 38, 40)	17 Participants	7 Participants

SECONDARY outcome

Timeframe: From Baseline (D 0) to Month (M) 2, M3, M4, M5, M6, M7, M8

Population: Safety population included all participants who received at least one dose of the study drug and had at least one post-baseline safety assessment. Participants with available data at the time of evaluation were denoted as 'n'.

Adequate iron status is prerequisite to achieve and maintain target Hb levels. Mean change from Baseline (D 0) in iron to D1 of Months 2, 3, 4, 5, 6, 7, 8 is reported.

Outcome measures

Measure	RO0503821 n=38 Participants Eligible participants were administered RO0503821 (methoxy polyethylene glycol-epoetin beta \[Mircera\]) subcutaneously (SC) every month for eight months (6 months of titration period \[TP\] and two months of evaluation period \[EP\] and 15-days following the final study visit (9 months post randomization). The first dose of Mircera (120, 200, or 360 mcg) was based upon the dose of epoetin alfa received 1 to 2 weeks prior to administration of study drug, while subsequent doses were adjusted to maintain haemoglobin (Hb) concentrations within target of \>=10.0 gram per decilitre (g/dL) and \<=12.0 g/dL. Participants who self-administered/visited to clinics for erythropoiesis stimulating agent (ESA) dosing prior to randomization continued to do so.	Epoetin Alfa n=40 Participants Eligible participants were administered epoetin alfa SC as per the standard of care for eight months (TP and EP), and were followed-up for 15 days following the final study visit. Participants who self-administered/visited to clinics for ESA dosing prior to randomization continued to do so.
Mean Change From Baseline in Iron M2 (n = 33, 31)	3.4 micromole per litre Standard Deviation 7.25	1.8 micromole per litre Standard Deviation 5.07
Mean Change From Baseline in Iron M3 (n = 29, 29)	3.9 micromole per litre Standard Deviation 5.39	-1.3 micromole per litre Standard Deviation 5.87
Mean Change From Baseline in Iron M4 ( n = 22,24)	2.0 micromole per litre Standard Deviation 6.97	0.2 micromole per litre Standard Deviation 3.26
Mean Change From Baseline in Iron M5 (n = 18, 17)	3.1 micromole per litre Standard Deviation 7.66	0.9 micromole per litre Standard Deviation 2.54
Mean Change From Baseline in Iron M6 (n = 13, 10)	2.9 micromole per litre Standard Deviation 8.33	0.6 micromole per litre Standard Deviation 3.94
Mean Change From Baseline in Iron M7 (n = 8, 6)	3.4 micromole per litre Standard Deviation 5.94	-1.3 micromole per litre Standard Deviation 4.84
Mean Change From Baseline in Iron M8 (n = 2, 3)	11.0 micromole per litre Standard Deviation 13.80	7.7 micromole per litre Standard Deviation 13.80

SECONDARY outcome

Timeframe: From Baseline (D 0) to M2, M3, M4, M5, M6, M7, M8

Population: Safety population included all participants who received at least one dose of the study drug and had at least one post-baseline safety assessment. Participants with available data at the time of evaluation were denoted as 'n'.

Adequate iron status is prerequisite to achieve and maintain target Hb levels. Mean change from Baseline (D 0) in ferritin to D1 of M2, 3, 4, 5, 6, 7, and 8 is reported.

Outcome measures

Measure	RO0503821 n=38 Participants Eligible participants were administered RO0503821 (methoxy polyethylene glycol-epoetin beta \[Mircera\]) subcutaneously (SC) every month for eight months (6 months of titration period \[TP\] and two months of evaluation period \[EP\] and 15-days following the final study visit (9 months post randomization). The first dose of Mircera (120, 200, or 360 mcg) was based upon the dose of epoetin alfa received 1 to 2 weeks prior to administration of study drug, while subsequent doses were adjusted to maintain haemoglobin (Hb) concentrations within target of \>=10.0 gram per decilitre (g/dL) and \<=12.0 g/dL. Participants who self-administered/visited to clinics for erythropoiesis stimulating agent (ESA) dosing prior to randomization continued to do so.	Epoetin Alfa n=40 Participants Eligible participants were administered epoetin alfa SC as per the standard of care for eight months (TP and EP), and were followed-up for 15 days following the final study visit. Participants who self-administered/visited to clinics for ESA dosing prior to randomization continued to do so.
Mean Change From Baseline in Ferritin M6 (n = 12, 9)	86 microgram per litre Standard Deviation 226.1	-105 microgram per litre Standard Deviation 187.8
Mean Change From Baseline in Ferritin M7 (n = 7, 6)	55 microgram per litre Standard Deviation 117.1	-120 microgram per litre Standard Deviation 166.3
Mean Change From Baseline in Ferritin M2 (n = 32, 29)	59 microgram per litre Standard Deviation 128.8	-1 microgram per litre Standard Deviation 129.5
Mean Change From Baseline in Ferritin M3 (n = 28, 27)	83 microgram per litre Standard Deviation 195.1	-37 microgram per litre Standard Deviation 114.2
Mean Change From Baseline in Ferritin M4 ( n = 21,22)	48 microgram per litre Standard Deviation 319.7	-24 microgram per litre Standard Deviation 155.4
Mean Change From Baseline in Ferritin M5 (n = 17, 16)	85 microgram per litre Standard Deviation 242.0	-70 microgram per litre Standard Deviation 149.6
Mean Change From Baseline in Ferritin M8 (n = 2, 3)	-59 microgram per litre Standard Deviation 176.8	-99 microgram per litre Standard Deviation 36.8

SECONDARY outcome

Timeframe: From Baseline (D 0) to M2, M3, M4, M5, M6, M7, M8

Population: Safety population included all participants who received at least one dose of the study drug and had at least one post-baseline safety assessment. Participants with available data at the time of evaluation were denoted as 'n'.

Adequate iron status is prerequisite to achieve and maintain target Hb levels. Mean change from Baseline (D 0) in transferrin to D1 of M2, 3, 4, 5, 6, 7, and 8 is reported.

Outcome measures

Measure	RO0503821 n=38 Participants Eligible participants were administered RO0503821 (methoxy polyethylene glycol-epoetin beta \[Mircera\]) subcutaneously (SC) every month for eight months (6 months of titration period \[TP\] and two months of evaluation period \[EP\] and 15-days following the final study visit (9 months post randomization). The first dose of Mircera (120, 200, or 360 mcg) was based upon the dose of epoetin alfa received 1 to 2 weeks prior to administration of study drug, while subsequent doses were adjusted to maintain haemoglobin (Hb) concentrations within target of \>=10.0 gram per decilitre (g/dL) and \<=12.0 g/dL. Participants who self-administered/visited to clinics for erythropoiesis stimulating agent (ESA) dosing prior to randomization continued to do so.	Epoetin Alfa n=40 Participants Eligible participants were administered epoetin alfa SC as per the standard of care for eight months (TP and EP), and were followed-up for 15 days following the final study visit. Participants who self-administered/visited to clinics for ESA dosing prior to randomization continued to do so.
Mean Change From Baseline in Transferrin Saturation M3 (n = 29, 29)	8.51 Percentage of Transferrin Saturation Standard Deviation 12.04	-2.44 Percentage of Transferrin Saturation Standard Deviation 13.33
Mean Change From Baseline in Transferrin Saturation M4 ( n = 22,24)	4.55 Percentage of Transferrin Saturation Standard Deviation 17.08	1.36 Percentage of Transferrin Saturation Standard Deviation 8.52
Mean Change From Baseline in Transferrin Saturation M2 (n = 33, 31)	7.10 Percentage of Transferrin Saturation Standard Deviation 15.32	4.08 Percentage of Transferrin Saturation Standard Deviation 10.39
Mean Change From Baseline in Transferrin Saturation M5 (n = 18, 17)	5.94 Percentage of Transferrin Saturation Standard Deviation 16.21	3.47 Percentage of Transferrin Saturation Standard Deviation 6.91
Mean Change From Baseline in Transferrin Saturation M6 (n = 13, 10)	7.07 Percentage of Transferrin Saturation Standard Deviation 18.10	0.39 Percentage of Transferrin Saturation Standard Deviation 10.79
Mean Change From Baseline in Transferrin Saturation M7 (n = 8, 6)	8.59 Percentage of Transferrin Saturation Standard Deviation 12.20	-1.80 Percentage of Transferrin Saturation Standard Deviation 10.90
Mean Change From Baseline in Transferrin Saturation M8 (n = 2, 3)	24.13 Percentage of Transferrin Saturation Standard Deviation 27.83	15.13 Percentage of Transferrin Saturation Standard Deviation 23.28

SECONDARY outcome

Timeframe: From Baseline (D 0) to M2, M3, M4, M5, M6, M7, M8

Population: Safety population included all participants who received at least one dose of the study drug and had at least one post-baseline safety assessment. Participants with available data at the time of evaluation were denoted as 'n'.

Adequate iron status is prerequisite to achieve and maintain target Hb levels. Mean change from Baseline (D 0) in serum transferrin to D1 of M2, 3, 4, 5, 6, 7, and 8 is reported.

Outcome measures

Measure	RO0503821 n=38 Participants Eligible participants were administered RO0503821 (methoxy polyethylene glycol-epoetin beta \[Mircera\]) subcutaneously (SC) every month for eight months (6 months of titration period \[TP\] and two months of evaluation period \[EP\] and 15-days following the final study visit (9 months post randomization). The first dose of Mircera (120, 200, or 360 mcg) was based upon the dose of epoetin alfa received 1 to 2 weeks prior to administration of study drug, while subsequent doses were adjusted to maintain haemoglobin (Hb) concentrations within target of \>=10.0 gram per decilitre (g/dL) and \<=12.0 g/dL. Participants who self-administered/visited to clinics for erythropoiesis stimulating agent (ESA) dosing prior to randomization continued to do so.	Epoetin Alfa n=40 Participants Eligible participants were administered epoetin alfa SC as per the standard of care for eight months (TP and EP), and were followed-up for 15 days following the final study visit. Participants who self-administered/visited to clinics for ESA dosing prior to randomization continued to do so.
Mean Change From Baseline in Serum Transferrin M2 (n = 15, 14)	-9.27 milligram (mg) per dL Standard Deviation 20.38	-5.00 milligram (mg) per dL Standard Deviation 16.06
Mean Change From Baseline in Serum Transferrin M3 (n = 12,15)	-0.25 milligram (mg) per dL Standard Deviation 24.68	-7.73 milligram (mg) per dL Standard Deviation 19.56
Mean Change From Baseline in Serum Transferrin M4 ( n = 8, 14)	7.25 milligram (mg) per dL Standard Deviation 16.02	-4.21 milligram (mg) per dL Standard Deviation 20.75
Mean Change From Baseline in Serum Transferrin M5 (n = 9, 11)	9.89 milligram (mg) per dL Standard Deviation 29.36	-6.64 milligram (mg) per dL Standard Deviation 23.68
Mean Change From Baseline in Serum Transferrin M6 (n = 6, 6)	10.50 milligram (mg) per dL Standard Deviation 27.19	1.50 milligram (mg) per dL Standard Deviation 16.84
Mean Change From Baseline in Serum Transferrin M7 (n = 4, 5)	2.50 milligram (mg) per dL Standard Deviation 24.06	-5.60 milligram (mg) per dL Standard Deviation 24.30
Mean Change From Baseline in Serum Transferrin M8 (n = 2, 2)	-15.50 milligram (mg) per dL Standard Deviation 9.19	-6.50 milligram (mg) per dL Standard Deviation 12.02

SECONDARY outcome

Timeframe: From Baseline (D 0) to M2, M3, M4, M5, M6, M7, M8

Population: Safety population included all participants who received at least one dose of the study drug and had at least one post-baseline safety assessment. Participants with available data at the time of evaluation were denoted as 'n'.

Adequate iron status is prerequisite to achieve and maintain target Hb levels. Mean change from Baseline (D 0) in total Iron-binding Capacity to D1 of M2, 3, 4, 5, 6, 7, and 8 is reported.

Outcome measures

Measure	RO0503821 n=38 Participants Eligible participants were administered RO0503821 (methoxy polyethylene glycol-epoetin beta \[Mircera\]) subcutaneously (SC) every month for eight months (6 months of titration period \[TP\] and two months of evaluation period \[EP\] and 15-days following the final study visit (9 months post randomization). The first dose of Mircera (120, 200, or 360 mcg) was based upon the dose of epoetin alfa received 1 to 2 weeks prior to administration of study drug, while subsequent doses were adjusted to maintain haemoglobin (Hb) concentrations within target of \>=10.0 gram per decilitre (g/dL) and \<=12.0 g/dL. Participants who self-administered/visited to clinics for erythropoiesis stimulating agent (ESA) dosing prior to randomization continued to do so.	Epoetin Alfa n=40 Participants Eligible participants were administered epoetin alfa SC as per the standard of care for eight months (TP and EP), and were followed-up for 15 days following the final study visit. Participants who self-administered/visited to clinics for ESA dosing prior to randomization continued to do so.
Mean Change From Baseline in Total Iron-binding Capacity M2 (n = 18, 17)	20.94 mg per dL Standard Deviation 67.80	1.94 mg per dL Standard Deviation 29.47
Mean Change From Baseline in Total Iron-binding Capacity M3 (n = 17,14)	-3.29 mg per dL Standard Deviation 45.64	-9.57 mg per dL Standard Deviation 25.58
Mean Change From Baseline in Total Iron-binding Capacity M4 ( n = 12, 9)	15.17 mg per dL Standard Deviation 41.51	4.67 mg per dL Standard Deviation 19.25
Mean Change From Baseline in Total Iron-binding Capacity M5 (n = 9, 5)	19.67 mg per dL Standard Deviation 53.53	8.60 mg per dL Standard Deviation 7.89
Mean Change From Baseline in Total Iron-binding Capacity M6 (n = 7, 4)	9.29 mg per dL Standard Deviation 62.96	21.25 mg per dL Standard Deviation 48.34
Mean Change From Baseline in Total Iron-binding Capacity M7 (n = 4, 1)	3.25 mg per dL Standard Deviation 85.99	3.00 mg per dL Standard Deviation NA Data was available for only one participant; therefore, standard deviation cannot be calculated.
Mean Change From Baseline in Total Iron-binding Capacity M8 (n = 0, 1)	NA mg per dL Standard Deviation NA Data was not recorded at this visit.	-43.00 mg per dL Standard Deviation NA Data was available for only one participant; therefore, standard deviation cannot be calculated.

SECONDARY outcome

Timeframe: From Baseline (D 0) to D1 and D15 of M7, M8

Population: Safety population included all participants who received at least one dose of the study drug and had at least one post-baseline safety assessment. Participants with available data at the time of evaluation were denoted as 'n'.

Outcome measures

Measure	RO0503821 n=38 Participants Eligible participants were administered RO0503821 (methoxy polyethylene glycol-epoetin beta \[Mircera\]) subcutaneously (SC) every month for eight months (6 months of titration period \[TP\] and two months of evaluation period \[EP\] and 15-days following the final study visit (9 months post randomization). The first dose of Mircera (120, 200, or 360 mcg) was based upon the dose of epoetin alfa received 1 to 2 weeks prior to administration of study drug, while subsequent doses were adjusted to maintain haemoglobin (Hb) concentrations within target of \>=10.0 gram per decilitre (g/dL) and \<=12.0 g/dL. Participants who self-administered/visited to clinics for erythropoiesis stimulating agent (ESA) dosing prior to randomization continued to do so.	Epoetin Alfa n=40 Participants Eligible participants were administered epoetin alfa SC as per the standard of care for eight months (TP and EP), and were followed-up for 15 days following the final study visit. Participants who self-administered/visited to clinics for ESA dosing prior to randomization continued to do so.
Mean Change From Baseline in Temperature M7 D1 (n = 9, 6)	-0.0 Degree Celsius Standard Deviation 0.43	-0.3 Degree Celsius Standard Deviation 1.03
Mean Change From Baseline in Temperature M7 D15 (n = 5, 3)	0.2 Degree Celsius Standard Deviation 0.54	-0.7 Degree Celsius Standard Deviation 1.44
Mean Change From Baseline in Temperature M8 D1 (n = 2, 3)	0.5 Degree Celsius Standard Deviation 0.14	-0.5 Degree Celsius Standard Deviation 0.95
Mean Change From Baseline in Temperature M8 D15 (n = 2, 2)	0.1 Degree Celsius Standard Deviation 0.21	-0.4 Degree Celsius Standard Deviation 0.07

SECONDARY outcome

Timeframe: From Baseline (D 0) to D1 and D15 of M7, M8

Population: Safety population included all participants who received at least one dose of the study drug and had at least one post-baseline safety assessment. Participants with available data at the time of evaluation were denoted as 'n'.

Outcome measures

Measure	RO0503821 n=38 Participants Eligible participants were administered RO0503821 (methoxy polyethylene glycol-epoetin beta \[Mircera\]) subcutaneously (SC) every month for eight months (6 months of titration period \[TP\] and two months of evaluation period \[EP\] and 15-days following the final study visit (9 months post randomization). The first dose of Mircera (120, 200, or 360 mcg) was based upon the dose of epoetin alfa received 1 to 2 weeks prior to administration of study drug, while subsequent doses were adjusted to maintain haemoglobin (Hb) concentrations within target of \>=10.0 gram per decilitre (g/dL) and \<=12.0 g/dL. Participants who self-administered/visited to clinics for erythropoiesis stimulating agent (ESA) dosing prior to randomization continued to do so.	Epoetin Alfa n=40 Participants Eligible participants were administered epoetin alfa SC as per the standard of care for eight months (TP and EP), and were followed-up for 15 days following the final study visit. Participants who self-administered/visited to clinics for ESA dosing prior to randomization continued to do so.
Mean Change From Baseline in Systolic Blood Pressure and Diastolic Blood Pressure DBP at M7 D1 (n = 9, 6)	3 millimeter of mercury Standard Deviation 10.2	2 millimeter of mercury Standard Deviation 6.9
Mean Change From Baseline in Systolic Blood Pressure and Diastolic Blood Pressure SBP at M7 D15 (n = 5, 3)	5 millimeter of mercury Standard Deviation 13.3	-7 millimeter of mercury Standard Deviation 14.2
Mean Change From Baseline in Systolic Blood Pressure and Diastolic Blood Pressure DBP at M8 D1 (n = 2, 3)	-5 millimeter of mercury Standard Deviation 2.1	-1 millimeter of mercury Standard Deviation 7.9
Mean Change From Baseline in Systolic Blood Pressure and Diastolic Blood Pressure SBP at M8 D15 (n = 2, 2)	6 millimeter of mercury Standard Deviation 2.8	-6 millimeter of mercury Standard Deviation 26.9
Mean Change From Baseline in Systolic Blood Pressure and Diastolic Blood Pressure DBP at M8 D15 (n = 2, 2)	-6 millimeter of mercury Standard Deviation 10.6	-5 millimeter of mercury Standard Deviation 10.6
Mean Change From Baseline in Systolic Blood Pressure and Diastolic Blood Pressure SBP at M7 D1 (n = 9, 6)	3 millimeter of mercury Standard Deviation 18.4	9 millimeter of mercury Standard Deviation 22.7
Mean Change From Baseline in Systolic Blood Pressure and Diastolic Blood Pressure DBP at M7 D15 (n = 5, 3)	1 millimeter of mercury Standard Deviation 10.7	-2 millimeter of mercury Standard Deviation 2.5
Mean Change From Baseline in Systolic Blood Pressure and Diastolic Blood Pressure SBP at M8 D1 (n = 2, 3)	7 millimeter of mercury Standard Deviation 12.7	5 millimeter of mercury Standard Deviation 19.3

SECONDARY outcome

Timeframe: From Baseline (D 0) to D1 and D15 of M7, M8

Population: Safety population included all participants who received at least one dose of the study drug and had at least one post-baseline safety assessment. Participants with available data at the time of evaluation were denoted as 'n'.

Outcome measures

Measure	RO0503821 n=38 Participants Eligible participants were administered RO0503821 (methoxy polyethylene glycol-epoetin beta \[Mircera\]) subcutaneously (SC) every month for eight months (6 months of titration period \[TP\] and two months of evaluation period \[EP\] and 15-days following the final study visit (9 months post randomization). The first dose of Mircera (120, 200, or 360 mcg) was based upon the dose of epoetin alfa received 1 to 2 weeks prior to administration of study drug, while subsequent doses were adjusted to maintain haemoglobin (Hb) concentrations within target of \>=10.0 gram per decilitre (g/dL) and \<=12.0 g/dL. Participants who self-administered/visited to clinics for erythropoiesis stimulating agent (ESA) dosing prior to randomization continued to do so.	Epoetin Alfa n=40 Participants Eligible participants were administered epoetin alfa SC as per the standard of care for eight months (TP and EP), and were followed-up for 15 days following the final study visit. Participants who self-administered/visited to clinics for ESA dosing prior to randomization continued to do so.
Mean Change From Baseline in Pulse Rate M7 D1 (n = 9, 6)	-2 Beats per minute Standard Deviation 11.0	-2 Beats per minute Standard Deviation 10.6
Mean Change From Baseline in Pulse Rate M7 D15 (n = 5, 3)	1 Beats per minute Standard Deviation 13.3	3 Beats per minute Standard Deviation 3.1
Mean Change From Baseline in Pulse Rate M8 D1 (n = 2, 3)	-7 Beats per minute Standard Deviation 0.0	2 Beats per minute Standard Deviation 4.4
Mean Change From Baseline in Pulse Rate M8 D15 (n = 2, 2)	-4 Beats per minute Standard Deviation 3.5	7 Beats per minute Standard Deviation 6.4

SECONDARY outcome

Timeframe: From Baseline (D 0) to D1 and D15 of M7, M8

Population: Safety population included all participants who received at least one dose of the study drug and had at least one post-baseline safety assessment. Participants with available data at the time of evaluation were denoted as 'n'.

Outcome measures

Measure	RO0503821 n=38 Participants Eligible participants were administered RO0503821 (methoxy polyethylene glycol-epoetin beta \[Mircera\]) subcutaneously (SC) every month for eight months (6 months of titration period \[TP\] and two months of evaluation period \[EP\] and 15-days following the final study visit (9 months post randomization). The first dose of Mircera (120, 200, or 360 mcg) was based upon the dose of epoetin alfa received 1 to 2 weeks prior to administration of study drug, while subsequent doses were adjusted to maintain haemoglobin (Hb) concentrations within target of \>=10.0 gram per decilitre (g/dL) and \<=12.0 g/dL. Participants who self-administered/visited to clinics for erythropoiesis stimulating agent (ESA) dosing prior to randomization continued to do so.	Epoetin Alfa n=40 Participants Eligible participants were administered epoetin alfa SC as per the standard of care for eight months (TP and EP), and were followed-up for 15 days following the final study visit. Participants who self-administered/visited to clinics for ESA dosing prior to randomization continued to do so.
Mean Change From Baseline in Weight M7 D1 (n = 9, 6)	0.5 kilogram Standard Deviation 3.56	3.2 kilogram Standard Deviation 3.46
Mean Change From Baseline in Weight M7 D15 (n = 5, 3)	1.2 kilogram Standard Deviation 2.93	1.1 kilogram Standard Deviation 2.14
Mean Change From Baseline in Weight M8 D1 (n = 2, 3)	3.0 kilogram Standard Deviation 4.74	1.9 kilogram Standard Deviation 1.57
Mean Change From Baseline in Weight M8 D15 (n = 2, 2)	1.5 kilogram Standard Deviation 3.04	2.5 kilogram Standard Deviation 2.33

SECONDARY outcome

Timeframe: Up to Month 9

Population: Safety population included all participants who received at least one dose of the study drug and had at least one post-baseline safety assessment.

Erythropoietin is human protein which helps to make more RBCs and is used for the treatment of anemia of chronic kidney disease. However, during treatment with erythropoietin, anti-erythropoietin antibody (Anti-EPO) may develop in human serum. These antibodies have been shown to cross-react with all ESAs and leads to failure to respond to treatment. Number of participants with anti-EPO antibody that are quantifiable and those that were "below the limit of quantification (BLQ)" at Baseline (Day 0) and Visit 17 (Month 9 [M 9]) or final visit/early termination in human serum samples are reported.

Outcome measures

Measure	RO0503821 n=38 Participants Eligible participants were administered RO0503821 (methoxy polyethylene glycol-epoetin beta \[Mircera\]) subcutaneously (SC) every month for eight months (6 months of titration period \[TP\] and two months of evaluation period \[EP\] and 15-days following the final study visit (9 months post randomization). The first dose of Mircera (120, 200, or 360 mcg) was based upon the dose of epoetin alfa received 1 to 2 weeks prior to administration of study drug, while subsequent doses were adjusted to maintain haemoglobin (Hb) concentrations within target of \>=10.0 gram per decilitre (g/dL) and \<=12.0 g/dL. Participants who self-administered/visited to clinics for erythropoiesis stimulating agent (ESA) dosing prior to randomization continued to do so.	Epoetin Alfa n=40 Participants Eligible participants were administered epoetin alfa SC as per the standard of care for eight months (TP and EP), and were followed-up for 15 days following the final study visit. Participants who self-administered/visited to clinics for ESA dosing prior to randomization continued to do so.
Number of Participants With Anti-erythropoietin Antibody in Human Serum Quantifiable at M 9 final visit/early termination	1 Participants	4 Participants
Number of Participants With Anti-erythropoietin Antibody in Human Serum BLQ at M 9 final visit/early termination	29 Participants	34 Participants
Number of Participants With Anti-erythropoietin Antibody in Human Serum Quantifiable at Baseline	2 Participants	1 Participants
Number of Participants With Anti-erythropoietin Antibody in Human Serum BLQ at Baseline	33 Participants	37 Participants

SECONDARY outcome

Timeframe: Up to Month 9

Population: Safety population included all participants who received at least one dose of the study drug and had at least one post-baseline safety assessment.

RO0503821 is a chemically modified erythropoietin which helps to make more RBCs and is used for the treatment of anemia of chronic kidney disease. However, during treatment with RO0503821, anti-RO0503821 antibody may develop in human serum. These antibodies have been shown to cross-react with all ESAs and leads to failure to respond. Number of participants with anti- RO0503821 antibody that are quantifiable and those that were "BLQ" at Baseline (Day 0) and Visit 17 (M 9) or final visit/early termination in human serum samples are reported.

Outcome measures

Measure	RO0503821 n=36 Participants Eligible participants were administered RO0503821 (methoxy polyethylene glycol-epoetin beta \[Mircera\]) subcutaneously (SC) every month for eight months (6 months of titration period \[TP\] and two months of evaluation period \[EP\] and 15-days following the final study visit (9 months post randomization). The first dose of Mircera (120, 200, or 360 mcg) was based upon the dose of epoetin alfa received 1 to 2 weeks prior to administration of study drug, while subsequent doses were adjusted to maintain haemoglobin (Hb) concentrations within target of \>=10.0 gram per decilitre (g/dL) and \<=12.0 g/dL. Participants who self-administered/visited to clinics for erythropoiesis stimulating agent (ESA) dosing prior to randomization continued to do so.	Epoetin Alfa Eligible participants were administered epoetin alfa SC as per the standard of care for eight months (TP and EP), and were followed-up for 15 days following the final study visit. Participants who self-administered/visited to clinics for ESA dosing prior to randomization continued to do so.
Number of Participants With Anti-RO0503821 Antibody in Human Serum Quantifiable at M 9 final visit/early termination	0 Participants	—
Number of Participants With Anti-RO0503821 Antibody in Human Serum Quantifiable at Baseline	0 Participants	—
Number of Participants With Anti-RO0503821 Antibody in Human Serum BLQ at Baseline	35 Participants	—
Number of Participants With Anti-RO0503821 Antibody in Human Serum BLQ at M 9 final visit/early termination	29 Participants	—

SECONDARY outcome

Timeframe: Up to 9 months

Population: Safety population included all participants who received at least one dose of the study drug and had at least one post-baseline safety assessment.

An AE is untoward medical occurrence in a participant who received the study drug without regard to possibility of causal relationship. A serious adverse event (SAE) is with any of the following outcomes: Death, initial or prolonged inpatient hospitalisation, life-threatening experience, persistent or significant disability/incapacity; congenital anomaly.

Outcome measures

Measure	RO0503821 n=38 Participants Eligible participants were administered RO0503821 (methoxy polyethylene glycol-epoetin beta \[Mircera\]) subcutaneously (SC) every month for eight months (6 months of titration period \[TP\] and two months of evaluation period \[EP\] and 15-days following the final study visit (9 months post randomization). The first dose of Mircera (120, 200, or 360 mcg) was based upon the dose of epoetin alfa received 1 to 2 weeks prior to administration of study drug, while subsequent doses were adjusted to maintain haemoglobin (Hb) concentrations within target of \>=10.0 gram per decilitre (g/dL) and \<=12.0 g/dL. Participants who self-administered/visited to clinics for erythropoiesis stimulating agent (ESA) dosing prior to randomization continued to do so.	Epoetin Alfa n=40 Participants Eligible participants were administered epoetin alfa SC as per the standard of care for eight months (TP and EP), and were followed-up for 15 days following the final study visit. Participants who self-administered/visited to clinics for ESA dosing prior to randomization continued to do so.
Number of Participants With Any AEs, Any Serious Adverse Events and Death Any AEs	24 Participants	23 Participants
Number of Participants With Any AEs, Any Serious Adverse Events and Death Death	1 Participants	0 Participants
Number of Participants With Any AEs, Any Serious Adverse Events and Death Any SAEs	11 Participants	2 Participants

Adverse Events

RO0503821

Serious events: 11 serious events

Other events: 18 other events

Deaths: 0 deaths

Epoetin Alfa

Serious events: 2 serious events

Other events: 15 other events

Deaths: 0 deaths

Serious adverse events

Measure	RO0503821 n=38 participants at risk Eligible participants were administered RO0503821 (methoxy polyethylene glycol-epoetin beta \[Mircera\]) subcutaneously (SC) every month for eight months (6 months of titration period \[TP\] and two months of evaluation period \[EP\] and 15-days following the final study visit (9 months post randomization). The first dose of Mircera (120, 200, or 360 mcg) was based upon the dose of epoetin alfa received 1 to 2 weeks prior to administration of study drug, while subsequent doses were adjusted to maintain haemoglobin (Hb) concentrations within target of \>=10.0 gram per decilitre (g/dL) and \<=12.0 g/dL. Participants who self-administered/visited to clinics for erythropoiesis stimulating agent (ESA) dosing prior to randomization continued to do so.	Epoetin Alfa n=40 participants at risk Eligible participants were administered epoetin alfa SC as per the standard of care for eight months (TP and EP), and were followed-up for 15 days following the final study visit. Participants who self-administered/visited to clinics for ESA dosing prior to randomization continued to do so.
Gastrointestinal disorders Abdominal pain	2.6% 1/38 • Up to 9 months Safety population included all participants who received at least one dose of the study drug and had at least one post-baseline safety assessment.	0.00% 0/40 • Up to 9 months Safety population included all participants who received at least one dose of the study drug and had at least one post-baseline safety assessment.
Gastrointestinal disorders Ileus	2.6% 1/38 • Up to 9 months Safety population included all participants who received at least one dose of the study drug and had at least one post-baseline safety assessment.	0.00% 0/40 • Up to 9 months Safety population included all participants who received at least one dose of the study drug and had at least one post-baseline safety assessment.
Gastrointestinal disorders Pancreatitis	2.6% 1/38 • Up to 9 months Safety population included all participants who received at least one dose of the study drug and had at least one post-baseline safety assessment.	0.00% 0/40 • Up to 9 months Safety population included all participants who received at least one dose of the study drug and had at least one post-baseline safety assessment.
Gastrointestinal disorders Upper gastrointestinal haemorrhage	2.6% 1/38 • Up to 9 months Safety population included all participants who received at least one dose of the study drug and had at least one post-baseline safety assessment.	0.00% 0/40 • Up to 9 months Safety population included all participants who received at least one dose of the study drug and had at least one post-baseline safety assessment.
Gastrointestinal disorders Peritonitis	0.00% 0/38 • Up to 9 months Safety population included all participants who received at least one dose of the study drug and had at least one post-baseline safety assessment.	5.0% 2/40 • Up to 9 months Safety population included all participants who received at least one dose of the study drug and had at least one post-baseline safety assessment.
Cardiac disorders Angina unstable	2.6% 1/38 • Up to 9 months Safety population included all participants who received at least one dose of the study drug and had at least one post-baseline safety assessment.	0.00% 0/40 • Up to 9 months Safety population included all participants who received at least one dose of the study drug and had at least one post-baseline safety assessment.
Cardiac disorders Cardiac arrest	2.6% 1/38 • Up to 9 months Safety population included all participants who received at least one dose of the study drug and had at least one post-baseline safety assessment.	0.00% 0/40 • Up to 9 months Safety population included all participants who received at least one dose of the study drug and had at least one post-baseline safety assessment.
Cardiac disorders Myocardial infarction	2.6% 1/38 • Up to 9 months Safety population included all participants who received at least one dose of the study drug and had at least one post-baseline safety assessment.	0.00% 0/40 • Up to 9 months Safety population included all participants who received at least one dose of the study drug and had at least one post-baseline safety assessment.
Infections and infestations Gastroenteritis	2.6% 1/38 • Up to 9 months Safety population included all participants who received at least one dose of the study drug and had at least one post-baseline safety assessment.	0.00% 0/40 • Up to 9 months Safety population included all participants who received at least one dose of the study drug and had at least one post-baseline safety assessment.
Infections and infestations Pneumonia	2.6% 1/38 • Up to 9 months Safety population included all participants who received at least one dose of the study drug and had at least one post-baseline safety assessment.	0.00% 0/40 • Up to 9 months Safety population included all participants who received at least one dose of the study drug and had at least one post-baseline safety assessment.
Infections and infestations Subdiaphragmatic abscess	0.00% 0/38 • Up to 9 months Safety population included all participants who received at least one dose of the study drug and had at least one post-baseline safety assessment.	2.5% 1/40 • Up to 9 months Safety population included all participants who received at least one dose of the study drug and had at least one post-baseline safety assessment.
Metabolism and nutrition disorders Dehydration	2.6% 1/38 • Up to 9 months Safety population included all participants who received at least one dose of the study drug and had at least one post-baseline safety assessment.	0.00% 0/40 • Up to 9 months Safety population included all participants who received at least one dose of the study drug and had at least one post-baseline safety assessment.
Metabolism and nutrition disorders Hypocalcaemia	2.6% 1/38 • Up to 9 months Safety population included all participants who received at least one dose of the study drug and had at least one post-baseline safety assessment.	0.00% 0/40 • Up to 9 months Safety population included all participants who received at least one dose of the study drug and had at least one post-baseline safety assessment.
Endocrine disorders Hyperparathyroidism secondary	2.6% 1/38 • Up to 9 months Safety population included all participants who received at least one dose of the study drug and had at least one post-baseline safety assessment.	0.00% 0/40 • Up to 9 months Safety population included all participants who received at least one dose of the study drug and had at least one post-baseline safety assessment.
Injury, poisoning and procedural complications Fall	2.6% 1/38 • Up to 9 months Safety population included all participants who received at least one dose of the study drug and had at least one post-baseline safety assessment.	0.00% 0/40 • Up to 9 months Safety population included all participants who received at least one dose of the study drug and had at least one post-baseline safety assessment.
Nervous system disorders Syncope	2.6% 1/38 • Up to 9 months Safety population included all participants who received at least one dose of the study drug and had at least one post-baseline safety assessment.	0.00% 0/40 • Up to 9 months Safety population included all participants who received at least one dose of the study drug and had at least one post-baseline safety assessment.
Psychiatric disorders Mental status changes	2.6% 1/38 • Up to 9 months Safety population included all participants who received at least one dose of the study drug and had at least one post-baseline safety assessment.	0.00% 0/40 • Up to 9 months Safety population included all participants who received at least one dose of the study drug and had at least one post-baseline safety assessment.
Respiratory, thoracic and mediastinal disorders Respiratory failure	2.6% 1/38 • Up to 9 months Safety population included all participants who received at least one dose of the study drug and had at least one post-baseline safety assessment.	0.00% 0/40 • Up to 9 months Safety population included all participants who received at least one dose of the study drug and had at least one post-baseline safety assessment.
Vascular disorders Orthostatic hypotension	2.6% 1/38 • Up to 9 months Safety population included all participants who received at least one dose of the study drug and had at least one post-baseline safety assessment.	0.00% 0/40 • Up to 9 months Safety population included all participants who received at least one dose of the study drug and had at least one post-baseline safety assessment.

Other adverse events

Measure	RO0503821 n=38 participants at risk Eligible participants were administered RO0503821 (methoxy polyethylene glycol-epoetin beta \[Mircera\]) subcutaneously (SC) every month for eight months (6 months of titration period \[TP\] and two months of evaluation period \[EP\] and 15-days following the final study visit (9 months post randomization). The first dose of Mircera (120, 200, or 360 mcg) was based upon the dose of epoetin alfa received 1 to 2 weeks prior to administration of study drug, while subsequent doses were adjusted to maintain haemoglobin (Hb) concentrations within target of \>=10.0 gram per decilitre (g/dL) and \<=12.0 g/dL. Participants who self-administered/visited to clinics for erythropoiesis stimulating agent (ESA) dosing prior to randomization continued to do so.	Epoetin Alfa n=40 participants at risk Eligible participants were administered epoetin alfa SC as per the standard of care for eight months (TP and EP), and were followed-up for 15 days following the final study visit. Participants who self-administered/visited to clinics for ESA dosing prior to randomization continued to do so.
Gastrointestinal disorders Abdominal pain	2.6% 1/38 • Up to 9 months Safety population included all participants who received at least one dose of the study drug and had at least one post-baseline safety assessment.	5.0% 2/40 • Up to 9 months Safety population included all participants who received at least one dose of the study drug and had at least one post-baseline safety assessment.
Gastrointestinal disorders Diarrhoea	5.3% 2/38 • Up to 9 months Safety population included all participants who received at least one dose of the study drug and had at least one post-baseline safety assessment.	0.00% 0/40 • Up to 9 months Safety population included all participants who received at least one dose of the study drug and had at least one post-baseline safety assessment.
Gastrointestinal disorders Peritonitis	5.3% 2/38 • Up to 9 months Safety population included all participants who received at least one dose of the study drug and had at least one post-baseline safety assessment.	5.0% 2/40 • Up to 9 months Safety population included all participants who received at least one dose of the study drug and had at least one post-baseline safety assessment.
General disorders Asthenia	5.3% 2/38 • Up to 9 months Safety population included all participants who received at least one dose of the study drug and had at least one post-baseline safety assessment.	0.00% 0/40 • Up to 9 months Safety population included all participants who received at least one dose of the study drug and had at least one post-baseline safety assessment.
General disorders Fatigue	13.2% 5/38 • Up to 9 months Safety population included all participants who received at least one dose of the study drug and had at least one post-baseline safety assessment.	0.00% 0/40 • Up to 9 months Safety population included all participants who received at least one dose of the study drug and had at least one post-baseline safety assessment.
Infections and infestations Bronchitis	5.3% 2/38 • Up to 9 months Safety population included all participants who received at least one dose of the study drug and had at least one post-baseline safety assessment.	2.5% 1/40 • Up to 9 months Safety population included all participants who received at least one dose of the study drug and had at least one post-baseline safety assessment.
Infections and infestations Catheter site infection	0.00% 0/38 • Up to 9 months Safety population included all participants who received at least one dose of the study drug and had at least one post-baseline safety assessment.	7.5% 3/40 • Up to 9 months Safety population included all participants who received at least one dose of the study drug and had at least one post-baseline safety assessment.
Infections and infestations Nasopharyngitis	0.00% 0/38 • Up to 9 months Safety population included all participants who received at least one dose of the study drug and had at least one post-baseline safety assessment.	5.0% 2/40 • Up to 9 months Safety population included all participants who received at least one dose of the study drug and had at least one post-baseline safety assessment.
Infections and infestations Postoperative wound infection	0.00% 0/38 • Up to 9 months Safety population included all participants who received at least one dose of the study drug and had at least one post-baseline safety assessment.	5.0% 2/40 • Up to 9 months Safety population included all participants who received at least one dose of the study drug and had at least one post-baseline safety assessment.
Injury, poisoning and procedural complications Fall	5.3% 2/38 • Up to 9 months Safety population included all participants who received at least one dose of the study drug and had at least one post-baseline safety assessment.	0.00% 0/40 • Up to 9 months Safety population included all participants who received at least one dose of the study drug and had at least one post-baseline safety assessment.
Nervous system disorders Dizziness	5.3% 2/38 • Up to 9 months Safety population included all participants who received at least one dose of the study drug and had at least one post-baseline safety assessment.	2.5% 1/40 • Up to 9 months Safety population included all participants who received at least one dose of the study drug and had at least one post-baseline safety assessment.
Respiratory, thoracic and mediastinal disorders Cough	0.00% 0/38 • Up to 9 months Safety population included all participants who received at least one dose of the study drug and had at least one post-baseline safety assessment.	5.0% 2/40 • Up to 9 months Safety population included all participants who received at least one dose of the study drug and had at least one post-baseline safety assessment.
Respiratory, thoracic and mediastinal disorders Dyspnoea	5.3% 2/38 • Up to 9 months Safety population included all participants who received at least one dose of the study drug and had at least one post-baseline safety assessment.	2.5% 1/40 • Up to 9 months Safety population included all participants who received at least one dose of the study drug and had at least one post-baseline safety assessment.
Vascular disorders Hypertension	0.00% 0/38 • Up to 9 months Safety population included all participants who received at least one dose of the study drug and had at least one post-baseline safety assessment.	5.0% 2/40 • Up to 9 months Safety population included all participants who received at least one dose of the study drug and had at least one post-baseline safety assessment.

Additional Information

Roche Trial Information Hotline

F. Hoffmann-La Roche AG

Phone: +41 616878333

Email: global.trial_information@roche.com

Results disclosure agreements

• Principal investigator is a sponsor employee The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.
• Publication restrictions are in place

Restriction type: OTHER