Trial Outcomes & Findings for An Observational Study of NeoRecormon (Epoetin Beta) in Cancer Patients With Anemia (FAST) (NCT NCT01168349)

NCT ID: NCT01168349

Last Updated: 2015-10-02

Results Overview

Early treatment response was defined as an increase of Hemoglobin (Hb) concentration of at least 1 gram/deciliter (g/dL), 4 to 6 weeks after treatment initiation.

• Recruitment status: COMPLETED
• Target enrollment: 1060 participants
• Primary outcome timeframe: Day 28 to 42
• Results posted on: 2015-10-02

Participant Flow

Participant milestones

Measure	Anemic Cancer Participants (Total Participants) Anemic cancer participants on NeoRecormon® injection were observed until Week 24 to 28 or early withdrawal due to death, participants' will to end the study, lost to follow-up or other reasons. The dose and frequency of NeoRecormon® were at the discretion of treating physician.
Overall Study STARTED	1055
Overall Study COMPLETED	754
Overall Study NOT COMPLETED	301

Reasons for withdrawal

Measure	Anemic Cancer Participants (Total Participants) Anemic cancer participants on NeoRecormon® injection were observed until Week 24 to 28 or early withdrawal due to death, participants' will to end the study, lost to follow-up or other reasons. The dose and frequency of NeoRecormon® were at the discretion of treating physician.
Overall Study Death	157
Overall Study Lost to Follow-up	34
Overall Study Withdrawal by Subject	9
Overall Study Kidney transplantation	3
Overall Study Other	22
Overall Study Protocol Violation	76

Baseline Characteristics

An Observational Study of NeoRecormon (Epoetin Beta) in Cancer Patients With Anemia (FAST)

Baseline characteristics by cohort

Measure	Anemic Cancer Participants (Total Participants) n=979 Participants Anemic cancer participants on NeoRecormon® injection were observed until Week 24 to 28 or early withdrawal due to death, participants' will to end the study, lost to follow-up or other reasons. The dose and frequency of NeoRecormon® were at the discretion of treating physician.
Age, Continuous	65.4 years STANDARD_DEVIATION 12.5 • n=5 Participants
Sex: Female, Male Female	528 Participants n=5 Participants
Sex: Female, Male Male	451 Participants n=5 Participants

PRIMARY outcome

Timeframe: Day 28 to 42

Population: Efficacy population. Here "number of participants analyzed" included those participants who were evaluable for the outcome measure.

Early treatment response was defined as an increase of Hemoglobin (Hb) concentration of at least 1 gram/deciliter (g/dL), 4 to 6 weeks after treatment initiation.

Outcome measures

Measure	Solid Tumor Participants n=403 Participants Solid tumor (breast, colorectal, lung, and ovary) participants on NeoRecormon® injection were observed until Week 24 to 28 or early withdrawal due to death, participants' will to end the study, lost to follow-up or other reasons. The dose and frequency of NeoRecormon® were at the discretion of treating physician.	Hematological Malignancy Participants n=209 Participants Hematological malignancy (multiple myeloma, Chronic Lymphocytic Leukemia \[CLL\], and lymphoma) participants on NeoRecormon® injection were observed until Week 24 to 28 or early withdrawal due to death, participants' will to end the study, lost to follow-up or other reasons. The dose and frequency of NeoRecormon® were at the discretion of treating physician.	Anemic Cancer Participants (Total Participants) n=612 Participants Anemic cancer participants on NeoRecormon® injection were observed until Week 24 to 28 or early withdrawal due to death, participants' will to end the study, lost to follow-up or other reasons. The dose and frequency of NeoRecormon® were at the discretion of treating physician.	Ovary Cancer Participants Ovary cancer participants on NeoRecormon® injection were observed until Week 24 to 28 or early withdrawal due to death, participants' will to end the study, lost to follow-up or other reasons. The dose and frequency of NeoRecormon® were at the discretion of treating physician.	Multiple Myeloma Participants Multiple myeloma participants on NeoRecormon® injection were observed until Week 24 to 28 or early withdrawal due to death, participants' will to end the study, lost to follow-up or other reasons. The dose and frequency of NeoRecormon® were at the discretion of treating physician.	Non-Hodgkin's Lymphoma Participants Non-Hodgkin's lymphoma participants on NeoRecormon® injection were observed until Week 24 to 28 or early withdrawal due to death, participants' will to end the study, lost to follow-up or other reasons. The dose and frequency of NeoRecormon® were at the discretion of treating physician.	Hodgkin's Lymphoma Participants Hodgkin's lymphoma participants on NeoRecormon® injection were observed until Week 24 to 28 or early withdrawal due to death, participants' will to end the study, lost to follow-up or other reasons. The dose and frequency of NeoRecormon® were at the discretion of treating physician.	Chronic Lymphocytic Leukemia Participants Chronic lymphocytic leukemia participants on NeoRecormon® injection were observed until Week 24 to 28 or early withdrawal due to death, participants' will to end the study, lost to follow-up or other reasons. The dose and frequency of NeoRecormon® were at the discretion of treating physician.	Anemic Cancer Participants (Total Participants) Anemic cancer participants on NeoRecormon® injection were observed until Week 24 to 28 or early withdrawal due to death, participants' will to end the study, lost to follow-up or other reasons. The dose and frequency of NeoRecormon® were at the discretion of treating physician.
Percentage of Participants With Early Treatment Response: Day 28 to 42	52.4 percentage of participants Interval 47.48 to 57.23	56.5 percentage of participants Interval 49.74 to 63.18	53.8 percentage of participants Interval 49.81 to 57.71	—	—	—	—	—	—

PRIMARY outcome

Timeframe: Day 21 to 42

Population: Efficacy population. Here "number of participants analyzed" included those participants who were evaluable for the outcome measure.

Early treatment response was defined as an increase of Hb concentration of at least 1 g/dL, 3 to 6 weeks after treatment initiation.

Outcome measures

Measure	Solid Tumor Participants n=519 Participants Solid tumor (breast, colorectal, lung, and ovary) participants on NeoRecormon® injection were observed until Week 24 to 28 or early withdrawal due to death, participants' will to end the study, lost to follow-up or other reasons. The dose and frequency of NeoRecormon® were at the discretion of treating physician.	Hematological Malignancy Participants n=262 Participants Hematological malignancy (multiple myeloma, Chronic Lymphocytic Leukemia \[CLL\], and lymphoma) participants on NeoRecormon® injection were observed until Week 24 to 28 or early withdrawal due to death, participants' will to end the study, lost to follow-up or other reasons. The dose and frequency of NeoRecormon® were at the discretion of treating physician.	Anemic Cancer Participants (Total Participants) n=781 Participants Anemic cancer participants on NeoRecormon® injection were observed until Week 24 to 28 or early withdrawal due to death, participants' will to end the study, lost to follow-up or other reasons. The dose and frequency of NeoRecormon® were at the discretion of treating physician.	Ovary Cancer Participants Ovary cancer participants on NeoRecormon® injection were observed until Week 24 to 28 or early withdrawal due to death, participants' will to end the study, lost to follow-up or other reasons. The dose and frequency of NeoRecormon® were at the discretion of treating physician.	Multiple Myeloma Participants Multiple myeloma participants on NeoRecormon® injection were observed until Week 24 to 28 or early withdrawal due to death, participants' will to end the study, lost to follow-up or other reasons. The dose and frequency of NeoRecormon® were at the discretion of treating physician.	Non-Hodgkin's Lymphoma Participants Non-Hodgkin's lymphoma participants on NeoRecormon® injection were observed until Week 24 to 28 or early withdrawal due to death, participants' will to end the study, lost to follow-up or other reasons. The dose and frequency of NeoRecormon® were at the discretion of treating physician.	Hodgkin's Lymphoma Participants Hodgkin's lymphoma participants on NeoRecormon® injection were observed until Week 24 to 28 or early withdrawal due to death, participants' will to end the study, lost to follow-up or other reasons. The dose and frequency of NeoRecormon® were at the discretion of treating physician.	Chronic Lymphocytic Leukemia Participants Chronic lymphocytic leukemia participants on NeoRecormon® injection were observed until Week 24 to 28 or early withdrawal due to death, participants' will to end the study, lost to follow-up or other reasons. The dose and frequency of NeoRecormon® were at the discretion of treating physician.	Anemic Cancer Participants (Total Participants) Anemic cancer participants on NeoRecormon® injection were observed until Week 24 to 28 or early withdrawal due to death, participants' will to end the study, lost to follow-up or other reasons. The dose and frequency of NeoRecormon® were at the discretion of treating physician.
Percentage of Participants With Early Treatment Response: Day 21 to 42	52.4 percentage of participants Interval 48.11 to 56.71	55.7 percentage of participants Interval 49.71 to 61.74	53.5 percentage of participants Interval 50.02 to 57.02	—	—	—	—	—	—

PRIMARY outcome

Timeframe: Baseline up to Week 28

Population: Efficacy population. Here "number of participants analyzed" included those participants who were evaluable for the outcome measure.

Participants with at least 1 RBC transfusion was assessed based on the number of participants with early response or not at Day 21 to 42. Early treatment response was defined as an increase of Hb concentration of at least 1 g/dL, 3 to 6 weeks after treatment initiation.

Outcome measures

Measure	Solid Tumor Participants n=418 Participants Solid tumor (breast, colorectal, lung, and ovary) participants on NeoRecormon® injection were observed until Week 24 to 28 or early withdrawal due to death, participants' will to end the study, lost to follow-up or other reasons. The dose and frequency of NeoRecormon® were at the discretion of treating physician.	Hematological Malignancy Participants n=363 Participants Hematological malignancy (multiple myeloma, Chronic Lymphocytic Leukemia \[CLL\], and lymphoma) participants on NeoRecormon® injection were observed until Week 24 to 28 or early withdrawal due to death, participants' will to end the study, lost to follow-up or other reasons. The dose and frequency of NeoRecormon® were at the discretion of treating physician.	Anemic Cancer Participants (Total Participants) n=781 Participants Anemic cancer participants on NeoRecormon® injection were observed until Week 24 to 28 or early withdrawal due to death, participants' will to end the study, lost to follow-up or other reasons. The dose and frequency of NeoRecormon® were at the discretion of treating physician.	Ovary Cancer Participants Ovary cancer participants on NeoRecormon® injection were observed until Week 24 to 28 or early withdrawal due to death, participants' will to end the study, lost to follow-up or other reasons. The dose and frequency of NeoRecormon® were at the discretion of treating physician.	Multiple Myeloma Participants Multiple myeloma participants on NeoRecormon® injection were observed until Week 24 to 28 or early withdrawal due to death, participants' will to end the study, lost to follow-up or other reasons. The dose and frequency of NeoRecormon® were at the discretion of treating physician.	Non-Hodgkin's Lymphoma Participants Non-Hodgkin's lymphoma participants on NeoRecormon® injection were observed until Week 24 to 28 or early withdrawal due to death, participants' will to end the study, lost to follow-up or other reasons. The dose and frequency of NeoRecormon® were at the discretion of treating physician.	Hodgkin's Lymphoma Participants Hodgkin's lymphoma participants on NeoRecormon® injection were observed until Week 24 to 28 or early withdrawal due to death, participants' will to end the study, lost to follow-up or other reasons. The dose and frequency of NeoRecormon® were at the discretion of treating physician.	Chronic Lymphocytic Leukemia Participants Chronic lymphocytic leukemia participants on NeoRecormon® injection were observed until Week 24 to 28 or early withdrawal due to death, participants' will to end the study, lost to follow-up or other reasons. The dose and frequency of NeoRecormon® were at the discretion of treating physician.	Anemic Cancer Participants (Total Participants) Anemic cancer participants on NeoRecormon® injection were observed until Week 24 to 28 or early withdrawal due to death, participants' will to end the study, lost to follow-up or other reasons. The dose and frequency of NeoRecormon® were at the discretion of treating physician.
Percentage of Participants With At Least 1 Red Blood Cell (RBC) Transfusion	17.2 percentage of participants	31.4 percentage of participants	23.8 percentage of participants	—	—	—	—	—	—

PRIMARY outcome

Timeframe: Baseline up to Week 28

Population: Efficacy population. Here "number of participants analyzed" included those participants who were evaluable for the outcome measure without any missing data.

Mean number of transfusion was based on the number of participants with at least 1 RBC transfusion.

Outcome measures

Measure	Solid Tumor Participants n=67 Participants Solid tumor (breast, colorectal, lung, and ovary) participants on NeoRecormon® injection were observed until Week 24 to 28 or early withdrawal due to death, participants' will to end the study, lost to follow-up or other reasons. The dose and frequency of NeoRecormon® were at the discretion of treating physician.	Hematological Malignancy Participants n=111 Participants Hematological malignancy (multiple myeloma, Chronic Lymphocytic Leukemia \[CLL\], and lymphoma) participants on NeoRecormon® injection were observed until Week 24 to 28 or early withdrawal due to death, participants' will to end the study, lost to follow-up or other reasons. The dose and frequency of NeoRecormon® were at the discretion of treating physician.	Anemic Cancer Participants (Total Participants) n=178 Participants Anemic cancer participants on NeoRecormon® injection were observed until Week 24 to 28 or early withdrawal due to death, participants' will to end the study, lost to follow-up or other reasons. The dose and frequency of NeoRecormon® were at the discretion of treating physician.	Ovary Cancer Participants Ovary cancer participants on NeoRecormon® injection were observed until Week 24 to 28 or early withdrawal due to death, participants' will to end the study, lost to follow-up or other reasons. The dose and frequency of NeoRecormon® were at the discretion of treating physician.	Multiple Myeloma Participants Multiple myeloma participants on NeoRecormon® injection were observed until Week 24 to 28 or early withdrawal due to death, participants' will to end the study, lost to follow-up or other reasons. The dose and frequency of NeoRecormon® were at the discretion of treating physician.	Non-Hodgkin's Lymphoma Participants Non-Hodgkin's lymphoma participants on NeoRecormon® injection were observed until Week 24 to 28 or early withdrawal due to death, participants' will to end the study, lost to follow-up or other reasons. The dose and frequency of NeoRecormon® were at the discretion of treating physician.	Hodgkin's Lymphoma Participants Hodgkin's lymphoma participants on NeoRecormon® injection were observed until Week 24 to 28 or early withdrawal due to death, participants' will to end the study, lost to follow-up or other reasons. The dose and frequency of NeoRecormon® were at the discretion of treating physician.	Chronic Lymphocytic Leukemia Participants Chronic lymphocytic leukemia participants on NeoRecormon® injection were observed until Week 24 to 28 or early withdrawal due to death, participants' will to end the study, lost to follow-up or other reasons. The dose and frequency of NeoRecormon® were at the discretion of treating physician.	Anemic Cancer Participants (Total Participants) Anemic cancer participants on NeoRecormon® injection were observed until Week 24 to 28 or early withdrawal due to death, participants' will to end the study, lost to follow-up or other reasons. The dose and frequency of NeoRecormon® were at the discretion of treating physician.
Mean Number of RBC Transfusions	1.7 RBC transfusions Standard Deviation 1.4	2.1 RBC transfusions Standard Deviation 1.9	2.0 RBC transfusions Standard Deviation 1.8	—	—	—	—	—	—

PRIMARY outcome

Timeframe: Baseline up to Week 28

Population: Efficacy population. Here "number of participants analyzed" included those participants who were evaluable for the outcome measure without any missing data.

Mean number of units was based on the number of participants with at least 1 RBC transfusion.

Outcome measures

Measure	Solid Tumor Participants n=66 Participants Solid tumor (breast, colorectal, lung, and ovary) participants on NeoRecormon® injection were observed until Week 24 to 28 or early withdrawal due to death, participants' will to end the study, lost to follow-up or other reasons. The dose and frequency of NeoRecormon® were at the discretion of treating physician.	Hematological Malignancy Participants n=109 Participants Hematological malignancy (multiple myeloma, Chronic Lymphocytic Leukemia \[CLL\], and lymphoma) participants on NeoRecormon® injection were observed until Week 24 to 28 or early withdrawal due to death, participants' will to end the study, lost to follow-up or other reasons. The dose and frequency of NeoRecormon® were at the discretion of treating physician.	Anemic Cancer Participants (Total Participants) n=175 Participants Anemic cancer participants on NeoRecormon® injection were observed until Week 24 to 28 or early withdrawal due to death, participants' will to end the study, lost to follow-up or other reasons. The dose and frequency of NeoRecormon® were at the discretion of treating physician.	Ovary Cancer Participants Ovary cancer participants on NeoRecormon® injection were observed until Week 24 to 28 or early withdrawal due to death, participants' will to end the study, lost to follow-up or other reasons. The dose and frequency of NeoRecormon® were at the discretion of treating physician.	Multiple Myeloma Participants Multiple myeloma participants on NeoRecormon® injection were observed until Week 24 to 28 or early withdrawal due to death, participants' will to end the study, lost to follow-up or other reasons. The dose and frequency of NeoRecormon® were at the discretion of treating physician.	Non-Hodgkin's Lymphoma Participants Non-Hodgkin's lymphoma participants on NeoRecormon® injection were observed until Week 24 to 28 or early withdrawal due to death, participants' will to end the study, lost to follow-up or other reasons. The dose and frequency of NeoRecormon® were at the discretion of treating physician.	Hodgkin's Lymphoma Participants Hodgkin's lymphoma participants on NeoRecormon® injection were observed until Week 24 to 28 or early withdrawal due to death, participants' will to end the study, lost to follow-up or other reasons. The dose and frequency of NeoRecormon® were at the discretion of treating physician.	Chronic Lymphocytic Leukemia Participants Chronic lymphocytic leukemia participants on NeoRecormon® injection were observed until Week 24 to 28 or early withdrawal due to death, participants' will to end the study, lost to follow-up or other reasons. The dose and frequency of NeoRecormon® were at the discretion of treating physician.	Anemic Cancer Participants (Total Participants) Anemic cancer participants on NeoRecormon® injection were observed until Week 24 to 28 or early withdrawal due to death, participants' will to end the study, lost to follow-up or other reasons. The dose and frequency of NeoRecormon® were at the discretion of treating physician.
Mean Number of RBC Units	3.4 RBC units Standard Deviation 2.8	4.3 RBC units Standard Deviation 3.9	4.0 RBC units Standard Deviation 3.5	—	—	—	—	—	—

PRIMARY outcome

Timeframe: Baseline up to Week 28

Population: Efficacy population. Here "number of participants analyzed" included those participants who were evaluable for the outcome measure.

Time to first RBC transfusion was assessed based on the number of participants with early response or not at Day 21 to 42. Early treatment response was defined as an increase of Hb concentration of at least 1 g/dL, 3 to 6 weeks after treatment initiation. Kaplan-Meier estimate was used.

Outcome measures

Measure	Solid Tumor Participants n=418 Participants Solid tumor (breast, colorectal, lung, and ovary) participants on NeoRecormon® injection were observed until Week 24 to 28 or early withdrawal due to death, participants' will to end the study, lost to follow-up or other reasons. The dose and frequency of NeoRecormon® were at the discretion of treating physician.	Hematological Malignancy Participants n=363 Participants Hematological malignancy (multiple myeloma, Chronic Lymphocytic Leukemia \[CLL\], and lymphoma) participants on NeoRecormon® injection were observed until Week 24 to 28 or early withdrawal due to death, participants' will to end the study, lost to follow-up or other reasons. The dose and frequency of NeoRecormon® were at the discretion of treating physician.	Anemic Cancer Participants (Total Participants) Anemic cancer participants on NeoRecormon® injection were observed until Week 24 to 28 or early withdrawal due to death, participants' will to end the study, lost to follow-up or other reasons. The dose and frequency of NeoRecormon® were at the discretion of treating physician.	Ovary Cancer Participants Ovary cancer participants on NeoRecormon® injection were observed until Week 24 to 28 or early withdrawal due to death, participants' will to end the study, lost to follow-up or other reasons. The dose and frequency of NeoRecormon® were at the discretion of treating physician.	Multiple Myeloma Participants Multiple myeloma participants on NeoRecormon® injection were observed until Week 24 to 28 or early withdrawal due to death, participants' will to end the study, lost to follow-up or other reasons. The dose and frequency of NeoRecormon® were at the discretion of treating physician.	Non-Hodgkin's Lymphoma Participants Non-Hodgkin's lymphoma participants on NeoRecormon® injection were observed until Week 24 to 28 or early withdrawal due to death, participants' will to end the study, lost to follow-up or other reasons. The dose and frequency of NeoRecormon® were at the discretion of treating physician.	Hodgkin's Lymphoma Participants Hodgkin's lymphoma participants on NeoRecormon® injection were observed until Week 24 to 28 or early withdrawal due to death, participants' will to end the study, lost to follow-up or other reasons. The dose and frequency of NeoRecormon® were at the discretion of treating physician.	Chronic Lymphocytic Leukemia Participants Chronic lymphocytic leukemia participants on NeoRecormon® injection were observed until Week 24 to 28 or early withdrawal due to death, participants' will to end the study, lost to follow-up or other reasons. The dose and frequency of NeoRecormon® were at the discretion of treating physician.	Anemic Cancer Participants (Total Participants) Anemic cancer participants on NeoRecormon® injection were observed until Week 24 to 28 or early withdrawal due to death, participants' will to end the study, lost to follow-up or other reasons. The dose and frequency of NeoRecormon® were at the discretion of treating physician.
Time to First RBC Transfusions	NA weeks Median time was not reached since there were insufficient number of participants with at least 1 RBC transfusion.	NA weeks Median time was not reached since there were insufficient number of participants with at least 1 RBC transfusion.	—	—	—	—	—	—	—

PRIMARY outcome

Timeframe: Baseline

Population: Efficacy population. Here "number of participants analyzed" included those participants who were evaluable for the outcome measure.

KPS was used to quantify participant's general well-being and activities of daily life and participants were classified based on their functional impairment. An 11-level score, KPS score ranged between 0 (death) to 100 (no evidence of disease). Higher score means higher ability to perform daily tasks. KPS was based on the number of participants with early response.

Outcome measures

Measure	Solid Tumor Participants n=411 Participants Solid tumor (breast, colorectal, lung, and ovary) participants on NeoRecormon® injection were observed until Week 24 to 28 or early withdrawal due to death, participants' will to end the study, lost to follow-up or other reasons. The dose and frequency of NeoRecormon® were at the discretion of treating physician.	Hematological Malignancy Participants n=359 Participants Hematological malignancy (multiple myeloma, Chronic Lymphocytic Leukemia \[CLL\], and lymphoma) participants on NeoRecormon® injection were observed until Week 24 to 28 or early withdrawal due to death, participants' will to end the study, lost to follow-up or other reasons. The dose and frequency of NeoRecormon® were at the discretion of treating physician.	Anemic Cancer Participants (Total Participants) n=770 Participants Anemic cancer participants on NeoRecormon® injection were observed until Week 24 to 28 or early withdrawal due to death, participants' will to end the study, lost to follow-up or other reasons. The dose and frequency of NeoRecormon® were at the discretion of treating physician.	Ovary Cancer Participants Ovary cancer participants on NeoRecormon® injection were observed until Week 24 to 28 or early withdrawal due to death, participants' will to end the study, lost to follow-up or other reasons. The dose and frequency of NeoRecormon® were at the discretion of treating physician.	Multiple Myeloma Participants Multiple myeloma participants on NeoRecormon® injection were observed until Week 24 to 28 or early withdrawal due to death, participants' will to end the study, lost to follow-up or other reasons. The dose and frequency of NeoRecormon® were at the discretion of treating physician.	Non-Hodgkin's Lymphoma Participants Non-Hodgkin's lymphoma participants on NeoRecormon® injection were observed until Week 24 to 28 or early withdrawal due to death, participants' will to end the study, lost to follow-up or other reasons. The dose and frequency of NeoRecormon® were at the discretion of treating physician.	Hodgkin's Lymphoma Participants Hodgkin's lymphoma participants on NeoRecormon® injection were observed until Week 24 to 28 or early withdrawal due to death, participants' will to end the study, lost to follow-up or other reasons. The dose and frequency of NeoRecormon® were at the discretion of treating physician.	Chronic Lymphocytic Leukemia Participants Chronic lymphocytic leukemia participants on NeoRecormon® injection were observed until Week 24 to 28 or early withdrawal due to death, participants' will to end the study, lost to follow-up or other reasons. The dose and frequency of NeoRecormon® were at the discretion of treating physician.	Anemic Cancer Participants (Total Participants) Anemic cancer participants on NeoRecormon® injection were observed until Week 24 to 28 or early withdrawal due to death, participants' will to end the study, lost to follow-up or other reasons. The dose and frequency of NeoRecormon® were at the discretion of treating physician.
Karnofsky Performance Status (KPS): Baseline	78.5 units on a scale Standard Deviation 13.1	78.6 units on a scale Standard Deviation 12.3	78.6 units on a scale Standard Deviation 12.7	—	—	—	—	—	—

PRIMARY outcome

Timeframe: Week 4 to 6

Population: Efficacy population. Here "number of participants analyzed" included those participants who were evaluable for the outcome measure.

KPS was used to quantify participant's general well-being and activities of daily life and participants were classified based on their functional impairment. An 11-level score, KPS score ranged between 0 (death) to 100 (no evidence of disease). Higher score means higher ability to perform daily tasks. KPS was based on the number of participants with early response.

Outcome measures

Measure	Solid Tumor Participants n=380 Participants Solid tumor (breast, colorectal, lung, and ovary) participants on NeoRecormon® injection were observed until Week 24 to 28 or early withdrawal due to death, participants' will to end the study, lost to follow-up or other reasons. The dose and frequency of NeoRecormon® were at the discretion of treating physician.	Hematological Malignancy Participants n=321 Participants Hematological malignancy (multiple myeloma, Chronic Lymphocytic Leukemia \[CLL\], and lymphoma) participants on NeoRecormon® injection were observed until Week 24 to 28 or early withdrawal due to death, participants' will to end the study, lost to follow-up or other reasons. The dose and frequency of NeoRecormon® were at the discretion of treating physician.	Anemic Cancer Participants (Total Participants) n=701 Participants Anemic cancer participants on NeoRecormon® injection were observed until Week 24 to 28 or early withdrawal due to death, participants' will to end the study, lost to follow-up or other reasons. The dose and frequency of NeoRecormon® were at the discretion of treating physician.	Ovary Cancer Participants Ovary cancer participants on NeoRecormon® injection were observed until Week 24 to 28 or early withdrawal due to death, participants' will to end the study, lost to follow-up or other reasons. The dose and frequency of NeoRecormon® were at the discretion of treating physician.	Multiple Myeloma Participants Multiple myeloma participants on NeoRecormon® injection were observed until Week 24 to 28 or early withdrawal due to death, participants' will to end the study, lost to follow-up or other reasons. The dose and frequency of NeoRecormon® were at the discretion of treating physician.	Non-Hodgkin's Lymphoma Participants Non-Hodgkin's lymphoma participants on NeoRecormon® injection were observed until Week 24 to 28 or early withdrawal due to death, participants' will to end the study, lost to follow-up or other reasons. The dose and frequency of NeoRecormon® were at the discretion of treating physician.	Hodgkin's Lymphoma Participants Hodgkin's lymphoma participants on NeoRecormon® injection were observed until Week 24 to 28 or early withdrawal due to death, participants' will to end the study, lost to follow-up or other reasons. The dose and frequency of NeoRecormon® were at the discretion of treating physician.	Chronic Lymphocytic Leukemia Participants Chronic lymphocytic leukemia participants on NeoRecormon® injection were observed until Week 24 to 28 or early withdrawal due to death, participants' will to end the study, lost to follow-up or other reasons. The dose and frequency of NeoRecormon® were at the discretion of treating physician.	Anemic Cancer Participants (Total Participants) Anemic cancer participants on NeoRecormon® injection were observed until Week 24 to 28 or early withdrawal due to death, participants' will to end the study, lost to follow-up or other reasons. The dose and frequency of NeoRecormon® were at the discretion of treating physician.
KPS: Week 4 to 6	81.2 units on a scale Standard Deviation 14.1	76.7 units on a scale Standard Deviation 16.2	79.2 units on a scale Standard Deviation 15.3	—	—	—	—	—	—

PRIMARY outcome

Timeframe: Week 12 to 16

Population: Efficacy population. Here "number of participants analyzed" included those participants who were evaluable for the outcome measure.

KPS was used to quantify participant's general well-being and activities of daily life and participants were classified based on their functional impairment. An 11-level score, KPS score ranged between 0 (death) to 100 (no evidence of disease). Higher score means higher ability to perform daily tasks. KPS was based on the number of participants with early response.

Outcome measures

Measure	Solid Tumor Participants n=375 Participants Solid tumor (breast, colorectal, lung, and ovary) participants on NeoRecormon® injection were observed until Week 24 to 28 or early withdrawal due to death, participants' will to end the study, lost to follow-up or other reasons. The dose and frequency of NeoRecormon® were at the discretion of treating physician.	Hematological Malignancy Participants n=314 Participants Hematological malignancy (multiple myeloma, Chronic Lymphocytic Leukemia \[CLL\], and lymphoma) participants on NeoRecormon® injection were observed until Week 24 to 28 or early withdrawal due to death, participants' will to end the study, lost to follow-up or other reasons. The dose and frequency of NeoRecormon® were at the discretion of treating physician.	Anemic Cancer Participants (Total Participants) n=689 Participants Anemic cancer participants on NeoRecormon® injection were observed until Week 24 to 28 or early withdrawal due to death, participants' will to end the study, lost to follow-up or other reasons. The dose and frequency of NeoRecormon® were at the discretion of treating physician.	Ovary Cancer Participants Ovary cancer participants on NeoRecormon® injection were observed until Week 24 to 28 or early withdrawal due to death, participants' will to end the study, lost to follow-up or other reasons. The dose and frequency of NeoRecormon® were at the discretion of treating physician.	Multiple Myeloma Participants Multiple myeloma participants on NeoRecormon® injection were observed until Week 24 to 28 or early withdrawal due to death, participants' will to end the study, lost to follow-up or other reasons. The dose and frequency of NeoRecormon® were at the discretion of treating physician.	Non-Hodgkin's Lymphoma Participants Non-Hodgkin's lymphoma participants on NeoRecormon® injection were observed until Week 24 to 28 or early withdrawal due to death, participants' will to end the study, lost to follow-up or other reasons. The dose and frequency of NeoRecormon® were at the discretion of treating physician.	Hodgkin's Lymphoma Participants Hodgkin's lymphoma participants on NeoRecormon® injection were observed until Week 24 to 28 or early withdrawal due to death, participants' will to end the study, lost to follow-up or other reasons. The dose and frequency of NeoRecormon® were at the discretion of treating physician.	Chronic Lymphocytic Leukemia Participants Chronic lymphocytic leukemia participants on NeoRecormon® injection were observed until Week 24 to 28 or early withdrawal due to death, participants' will to end the study, lost to follow-up or other reasons. The dose and frequency of NeoRecormon® were at the discretion of treating physician.	Anemic Cancer Participants (Total Participants) Anemic cancer participants on NeoRecormon® injection were observed until Week 24 to 28 or early withdrawal due to death, participants' will to end the study, lost to follow-up or other reasons. The dose and frequency of NeoRecormon® were at the discretion of treating physician.
KPS: Week 12 to 16	78.4 units on a scale Standard Deviation 22.6	74.7 units on a scale Standard Deviation 24.2	76.7 units on a scale Standard Deviation 23.4	—	—	—	—	—	—

PRIMARY outcome

Timeframe: Week 24 to 28

Population: Efficacy population. Here "number of participants analyzed" included those participants who were evaluable for the outcome measure.

KPS was used to quantify participant's general well-being and activities of daily life and participants were classified based on their functional impairment. An 11-level score, KPS score ranged between 0 (death) to 100 (no evidence of disease). Higher score means higher ability to perform daily tasks. KPS was based on the number of participants with early response.

Outcome measures

Measure	Solid Tumor Participants n=301 Participants Solid tumor (breast, colorectal, lung, and ovary) participants on NeoRecormon® injection were observed until Week 24 to 28 or early withdrawal due to death, participants' will to end the study, lost to follow-up or other reasons. The dose and frequency of NeoRecormon® were at the discretion of treating physician.	Hematological Malignancy Participants n=260 Participants Hematological malignancy (multiple myeloma, Chronic Lymphocytic Leukemia \[CLL\], and lymphoma) participants on NeoRecormon® injection were observed until Week 24 to 28 or early withdrawal due to death, participants' will to end the study, lost to follow-up or other reasons. The dose and frequency of NeoRecormon® were at the discretion of treating physician.	Anemic Cancer Participants (Total Participants) n=561 Participants Anemic cancer participants on NeoRecormon® injection were observed until Week 24 to 28 or early withdrawal due to death, participants' will to end the study, lost to follow-up or other reasons. The dose and frequency of NeoRecormon® were at the discretion of treating physician.	Ovary Cancer Participants Ovary cancer participants on NeoRecormon® injection were observed until Week 24 to 28 or early withdrawal due to death, participants' will to end the study, lost to follow-up or other reasons. The dose and frequency of NeoRecormon® were at the discretion of treating physician.	Multiple Myeloma Participants Multiple myeloma participants on NeoRecormon® injection were observed until Week 24 to 28 or early withdrawal due to death, participants' will to end the study, lost to follow-up or other reasons. The dose and frequency of NeoRecormon® were at the discretion of treating physician.	Non-Hodgkin's Lymphoma Participants Non-Hodgkin's lymphoma participants on NeoRecormon® injection were observed until Week 24 to 28 or early withdrawal due to death, participants' will to end the study, lost to follow-up or other reasons. The dose and frequency of NeoRecormon® were at the discretion of treating physician.	Hodgkin's Lymphoma Participants Hodgkin's lymphoma participants on NeoRecormon® injection were observed until Week 24 to 28 or early withdrawal due to death, participants' will to end the study, lost to follow-up or other reasons. The dose and frequency of NeoRecormon® were at the discretion of treating physician.	Chronic Lymphocytic Leukemia Participants Chronic lymphocytic leukemia participants on NeoRecormon® injection were observed until Week 24 to 28 or early withdrawal due to death, participants' will to end the study, lost to follow-up or other reasons. The dose and frequency of NeoRecormon® were at the discretion of treating physician.	Anemic Cancer Participants (Total Participants) Anemic cancer participants on NeoRecormon® injection were observed until Week 24 to 28 or early withdrawal due to death, participants' will to end the study, lost to follow-up or other reasons. The dose and frequency of NeoRecormon® were at the discretion of treating physician.
KPS: Week 24 to 28	79.7 units on a scale Standard Deviation 22.1	75.6 units on a scale Standard Deviation 24.5	77.8 units on a scale Standard Deviation 23.3	—	—	—	—	—	—

PRIMARY outcome

Timeframe: Baseline

Population: Efficacy population. Here "number of participants analyzed" included those participants who were evaluable for the outcome measure.

Percentage of participants with professional activity was assessed based on the number of participants with early response or not at Day 21 to 42. Professional activity was categorized as active; disability; no occupation; retired; sick leave; student, training; and unemployment.

Outcome measures

Measure	Solid Tumor Participants n=418 Participants Solid tumor (breast, colorectal, lung, and ovary) participants on NeoRecormon® injection were observed until Week 24 to 28 or early withdrawal due to death, participants' will to end the study, lost to follow-up or other reasons. The dose and frequency of NeoRecormon® were at the discretion of treating physician.	Hematological Malignancy Participants n=363 Participants Hematological malignancy (multiple myeloma, Chronic Lymphocytic Leukemia \[CLL\], and lymphoma) participants on NeoRecormon® injection were observed until Week 24 to 28 or early withdrawal due to death, participants' will to end the study, lost to follow-up or other reasons. The dose and frequency of NeoRecormon® were at the discretion of treating physician.	Anemic Cancer Participants (Total Participants) n=781 Participants Anemic cancer participants on NeoRecormon® injection were observed until Week 24 to 28 or early withdrawal due to death, participants' will to end the study, lost to follow-up or other reasons. The dose and frequency of NeoRecormon® were at the discretion of treating physician.	Ovary Cancer Participants Ovary cancer participants on NeoRecormon® injection were observed until Week 24 to 28 or early withdrawal due to death, participants' will to end the study, lost to follow-up or other reasons. The dose and frequency of NeoRecormon® were at the discretion of treating physician.	Multiple Myeloma Participants Multiple myeloma participants on NeoRecormon® injection were observed until Week 24 to 28 or early withdrawal due to death, participants' will to end the study, lost to follow-up or other reasons. The dose and frequency of NeoRecormon® were at the discretion of treating physician.	Non-Hodgkin's Lymphoma Participants Non-Hodgkin's lymphoma participants on NeoRecormon® injection were observed until Week 24 to 28 or early withdrawal due to death, participants' will to end the study, lost to follow-up or other reasons. The dose and frequency of NeoRecormon® were at the discretion of treating physician.	Hodgkin's Lymphoma Participants Hodgkin's lymphoma participants on NeoRecormon® injection were observed until Week 24 to 28 or early withdrawal due to death, participants' will to end the study, lost to follow-up or other reasons. The dose and frequency of NeoRecormon® were at the discretion of treating physician.	Chronic Lymphocytic Leukemia Participants Chronic lymphocytic leukemia participants on NeoRecormon® injection were observed until Week 24 to 28 or early withdrawal due to death, participants' will to end the study, lost to follow-up or other reasons. The dose and frequency of NeoRecormon® were at the discretion of treating physician.	Anemic Cancer Participants (Total Participants) Anemic cancer participants on NeoRecormon® injection were observed until Week 24 to 28 or early withdrawal due to death, participants' will to end the study, lost to follow-up or other reasons. The dose and frequency of NeoRecormon® were at the discretion of treating physician.
Percentage of Participants With Professional Activity: Baseline Unemployment	1.7 percentage of participants	1.7 percentage of participants	1.7 percentage of participants	—	—	—	—	—	—
Percentage of Participants With Professional Activity: Baseline Active	4.1 percentage of participants	3.0 percentage of participants	3.6 percentage of participants	—	—	—	—	—	—
Percentage of Participants With Professional Activity: Baseline Disability	2.6 percentage of participants	3.3 percentage of participants	2.9 percentage of participants	—	—	—	—	—	—
Percentage of Participants With Professional Activity: Baseline No occupation	6.2 percentage of participants	6.3 percentage of participants	6.3 percentage of participants	—	—	—	—	—	—
Percentage of Participants With Professional Activity: Baseline Retired	66.3 percentage of participants	65 percentage of participants	65.7 percentage of participants	—	—	—	—	—	—
Percentage of Participants With Professional Activity: Baseline Sick leave	18.9 percentage of participants	20.1 percentage of participants	19.5 percentage of participants	—	—	—	—	—	—
Percentage of Participants With Professional Activity: Baseline Student, training	0.2 percentage of participants	0.6 percentage of participants	0.4 percentage of participants	—	—	—	—	—	—

PRIMARY outcome

Timeframe: Week 4 Up to Week 28

Population: Efficacy population. Here "number of participants analyzed" included those participants who were evaluable for the outcome measure.

Sick leaves was described in active participants at inclusion (professional activity: active, in sick leave or unemployed participants).

Outcome measures

Measure	Solid Tumor Participants n=103 Participants Solid tumor (breast, colorectal, lung, and ovary) participants on NeoRecormon® injection were observed until Week 24 to 28 or early withdrawal due to death, participants' will to end the study, lost to follow-up or other reasons. The dose and frequency of NeoRecormon® were at the discretion of treating physician.	Hematological Malignancy Participants n=90 Participants Hematological malignancy (multiple myeloma, Chronic Lymphocytic Leukemia \[CLL\], and lymphoma) participants on NeoRecormon® injection were observed until Week 24 to 28 or early withdrawal due to death, participants' will to end the study, lost to follow-up or other reasons. The dose and frequency of NeoRecormon® were at the discretion of treating physician.	Anemic Cancer Participants (Total Participants) n=193 Participants Anemic cancer participants on NeoRecormon® injection were observed until Week 24 to 28 or early withdrawal due to death, participants' will to end the study, lost to follow-up or other reasons. The dose and frequency of NeoRecormon® were at the discretion of treating physician.	Ovary Cancer Participants Ovary cancer participants on NeoRecormon® injection were observed until Week 24 to 28 or early withdrawal due to death, participants' will to end the study, lost to follow-up or other reasons. The dose and frequency of NeoRecormon® were at the discretion of treating physician.	Multiple Myeloma Participants Multiple myeloma participants on NeoRecormon® injection were observed until Week 24 to 28 or early withdrawal due to death, participants' will to end the study, lost to follow-up or other reasons. The dose and frequency of NeoRecormon® were at the discretion of treating physician.	Non-Hodgkin's Lymphoma Participants Non-Hodgkin's lymphoma participants on NeoRecormon® injection were observed until Week 24 to 28 or early withdrawal due to death, participants' will to end the study, lost to follow-up or other reasons. The dose and frequency of NeoRecormon® were at the discretion of treating physician.	Hodgkin's Lymphoma Participants Hodgkin's lymphoma participants on NeoRecormon® injection were observed until Week 24 to 28 or early withdrawal due to death, participants' will to end the study, lost to follow-up or other reasons. The dose and frequency of NeoRecormon® were at the discretion of treating physician.	Chronic Lymphocytic Leukemia Participants Chronic lymphocytic leukemia participants on NeoRecormon® injection were observed until Week 24 to 28 or early withdrawal due to death, participants' will to end the study, lost to follow-up or other reasons. The dose and frequency of NeoRecormon® were at the discretion of treating physician.	Anemic Cancer Participants (Total Participants) Anemic cancer participants on NeoRecormon® injection were observed until Week 24 to 28 or early withdrawal due to death, participants' will to end the study, lost to follow-up or other reasons. The dose and frequency of NeoRecormon® were at the discretion of treating physician.
Percentage of Participants With At Least 1 Sick Leave	59.2 percentage of participants	74.4 percentage of participants	66.3 percentage of participants	—	—	—	—	—	—

PRIMARY outcome

Timeframe: Week 4 Up to Week 28

Population: Efficacy population. Here "number of participants analyzed" included those participants who had at least 1 sick leave without any missing data.

Sick leaves was described in active participants at inclusion (professional activity: active, in sick leave or unemployed participants).

Outcome measures

Measure	Solid Tumor Participants n=53 Participants Solid tumor (breast, colorectal, lung, and ovary) participants on NeoRecormon® injection were observed until Week 24 to 28 or early withdrawal due to death, participants' will to end the study, lost to follow-up or other reasons. The dose and frequency of NeoRecormon® were at the discretion of treating physician.	Hematological Malignancy Participants n=62 Participants Hematological malignancy (multiple myeloma, Chronic Lymphocytic Leukemia \[CLL\], and lymphoma) participants on NeoRecormon® injection were observed until Week 24 to 28 or early withdrawal due to death, participants' will to end the study, lost to follow-up or other reasons. The dose and frequency of NeoRecormon® were at the discretion of treating physician.	Anemic Cancer Participants (Total Participants) n=115 Participants Anemic cancer participants on NeoRecormon® injection were observed until Week 24 to 28 or early withdrawal due to death, participants' will to end the study, lost to follow-up or other reasons. The dose and frequency of NeoRecormon® were at the discretion of treating physician.	Ovary Cancer Participants Ovary cancer participants on NeoRecormon® injection were observed until Week 24 to 28 or early withdrawal due to death, participants' will to end the study, lost to follow-up or other reasons. The dose and frequency of NeoRecormon® were at the discretion of treating physician.	Multiple Myeloma Participants Multiple myeloma participants on NeoRecormon® injection were observed until Week 24 to 28 or early withdrawal due to death, participants' will to end the study, lost to follow-up or other reasons. The dose and frequency of NeoRecormon® were at the discretion of treating physician.	Non-Hodgkin's Lymphoma Participants Non-Hodgkin's lymphoma participants on NeoRecormon® injection were observed until Week 24 to 28 or early withdrawal due to death, participants' will to end the study, lost to follow-up or other reasons. The dose and frequency of NeoRecormon® were at the discretion of treating physician.	Hodgkin's Lymphoma Participants Hodgkin's lymphoma participants on NeoRecormon® injection were observed until Week 24 to 28 or early withdrawal due to death, participants' will to end the study, lost to follow-up or other reasons. The dose and frequency of NeoRecormon® were at the discretion of treating physician.	Chronic Lymphocytic Leukemia Participants Chronic lymphocytic leukemia participants on NeoRecormon® injection were observed until Week 24 to 28 or early withdrawal due to death, participants' will to end the study, lost to follow-up or other reasons. The dose and frequency of NeoRecormon® were at the discretion of treating physician.	Anemic Cancer Participants (Total Participants) Anemic cancer participants on NeoRecormon® injection were observed until Week 24 to 28 or early withdrawal due to death, participants' will to end the study, lost to follow-up or other reasons. The dose and frequency of NeoRecormon® were at the discretion of treating physician.
Mean Number of Days of Sick Leave	89.4 days Standard Deviation 62.2	93.3 days Standard Deviation 61.1	91.5 days Standard Deviation 61.4	—	—	—	—	—	—

PRIMARY outcome

Timeframe: Baseline

Population: Efficacy population. Here "number of participants analyzed" included those participants who were evaluable for the outcome measure.

Self-administered questionnaire, work productivity and activity impairment (WPAI) questionnaire was used to assess work and activity impairment due to anemia in cancer participants in the last 7 days. The self-administered questionnaire consisted of 6 questions. It assessed amount of absenteeism, presenteeism and daily activity impairment attributable to anemia in cancer participants. Question 1 asked participants to indicate if they were currently employed or working for pay (Yes or No). Data reported for the outcome included those who were employed.

Outcome measures

Measure	Solid Tumor Participants n=311 Participants Solid tumor (breast, colorectal, lung, and ovary) participants on NeoRecormon® injection were observed until Week 24 to 28 or early withdrawal due to death, participants' will to end the study, lost to follow-up or other reasons. The dose and frequency of NeoRecormon® were at the discretion of treating physician.	Hematological Malignancy Participants n=270 Participants Hematological malignancy (multiple myeloma, Chronic Lymphocytic Leukemia \[CLL\], and lymphoma) participants on NeoRecormon® injection were observed until Week 24 to 28 or early withdrawal due to death, participants' will to end the study, lost to follow-up or other reasons. The dose and frequency of NeoRecormon® were at the discretion of treating physician.	Anemic Cancer Participants (Total Participants) n=581 Participants Anemic cancer participants on NeoRecormon® injection were observed until Week 24 to 28 or early withdrawal due to death, participants' will to end the study, lost to follow-up or other reasons. The dose and frequency of NeoRecormon® were at the discretion of treating physician.	Ovary Cancer Participants Ovary cancer participants on NeoRecormon® injection were observed until Week 24 to 28 or early withdrawal due to death, participants' will to end the study, lost to follow-up or other reasons. The dose and frequency of NeoRecormon® were at the discretion of treating physician.	Multiple Myeloma Participants Multiple myeloma participants on NeoRecormon® injection were observed until Week 24 to 28 or early withdrawal due to death, participants' will to end the study, lost to follow-up or other reasons. The dose and frequency of NeoRecormon® were at the discretion of treating physician.	Non-Hodgkin's Lymphoma Participants Non-Hodgkin's lymphoma participants on NeoRecormon® injection were observed until Week 24 to 28 or early withdrawal due to death, participants' will to end the study, lost to follow-up or other reasons. The dose and frequency of NeoRecormon® were at the discretion of treating physician.	Hodgkin's Lymphoma Participants Hodgkin's lymphoma participants on NeoRecormon® injection were observed until Week 24 to 28 or early withdrawal due to death, participants' will to end the study, lost to follow-up or other reasons. The dose and frequency of NeoRecormon® were at the discretion of treating physician.	Chronic Lymphocytic Leukemia Participants Chronic lymphocytic leukemia participants on NeoRecormon® injection were observed until Week 24 to 28 or early withdrawal due to death, participants' will to end the study, lost to follow-up or other reasons. The dose and frequency of NeoRecormon® were at the discretion of treating physician.	Anemic Cancer Participants (Total Participants) Anemic cancer participants on NeoRecormon® injection were observed until Week 24 to 28 or early withdrawal due to death, participants' will to end the study, lost to follow-up or other reasons. The dose and frequency of NeoRecormon® were at the discretion of treating physician.
Self-Reported Questionnaire: Percentage of Participants With Current Employment at Baseline	6.8 percentage of participants	8.1 percentage of participants	7.4 percentage of participants	—	—	—	—	—	—

PRIMARY outcome

Timeframe: Week 4 to 6

Population: Efficacy population. Here "number of participants analyzed" included those participants who were evaluable for the outcome measure.

Self-administered questionnaire, WPAI questionnaire was used to assess work and activity impairment due to anemia in cancer participants in the last 7 days. The self-administered questionnaire consisted of 6 questions. It assessed amount of absenteeism, presenteeism and daily activity impairment attributable to anemia in cancer participants. Question 1 asked participants to indicate if they were currently employed or working for pay (Yes or No). Data reported for the outcome included those who were employed.

Outcome measures

Measure	Solid Tumor Participants n=258 Participants Solid tumor (breast, colorectal, lung, and ovary) participants on NeoRecormon® injection were observed until Week 24 to 28 or early withdrawal due to death, participants' will to end the study, lost to follow-up or other reasons. The dose and frequency of NeoRecormon® were at the discretion of treating physician.	Hematological Malignancy Participants n=226 Participants Hematological malignancy (multiple myeloma, Chronic Lymphocytic Leukemia \[CLL\], and lymphoma) participants on NeoRecormon® injection were observed until Week 24 to 28 or early withdrawal due to death, participants' will to end the study, lost to follow-up or other reasons. The dose and frequency of NeoRecormon® were at the discretion of treating physician.	Anemic Cancer Participants (Total Participants) n=484 Participants Anemic cancer participants on NeoRecormon® injection were observed until Week 24 to 28 or early withdrawal due to death, participants' will to end the study, lost to follow-up or other reasons. The dose and frequency of NeoRecormon® were at the discretion of treating physician.	Ovary Cancer Participants Ovary cancer participants on NeoRecormon® injection were observed until Week 24 to 28 or early withdrawal due to death, participants' will to end the study, lost to follow-up or other reasons. The dose and frequency of NeoRecormon® were at the discretion of treating physician.	Multiple Myeloma Participants Multiple myeloma participants on NeoRecormon® injection were observed until Week 24 to 28 or early withdrawal due to death, participants' will to end the study, lost to follow-up or other reasons. The dose and frequency of NeoRecormon® were at the discretion of treating physician.	Non-Hodgkin's Lymphoma Participants Non-Hodgkin's lymphoma participants on NeoRecormon® injection were observed until Week 24 to 28 or early withdrawal due to death, participants' will to end the study, lost to follow-up or other reasons. The dose and frequency of NeoRecormon® were at the discretion of treating physician.	Hodgkin's Lymphoma Participants Hodgkin's lymphoma participants on NeoRecormon® injection were observed until Week 24 to 28 or early withdrawal due to death, participants' will to end the study, lost to follow-up or other reasons. The dose and frequency of NeoRecormon® were at the discretion of treating physician.	Chronic Lymphocytic Leukemia Participants Chronic lymphocytic leukemia participants on NeoRecormon® injection were observed until Week 24 to 28 or early withdrawal due to death, participants' will to end the study, lost to follow-up or other reasons. The dose and frequency of NeoRecormon® were at the discretion of treating physician.	Anemic Cancer Participants (Total Participants) Anemic cancer participants on NeoRecormon® injection were observed until Week 24 to 28 or early withdrawal due to death, participants' will to end the study, lost to follow-up or other reasons. The dose and frequency of NeoRecormon® were at the discretion of treating physician.
Self-Reported Questionnaire: Percentage of Participants With Current Employment at Week 4 to 6	5.8 percentage of participants	6.2 percentage of participants	6.0 percentage of participants	—	—	—	—	—	—

PRIMARY outcome

Timeframe: Week 12 to 16

Population: Efficacy population. Here "number of participants analyzed" included those participants who were evaluable for the outcome measure.

Self-administered questionnaire, WPAI questionnaire was used to assess work and activity impairment due to anemia in cancer participants in the last 7 days. The self-administered questionnaire consisted of 6 questions. It assessed amount of absenteeism, presenteeism and daily activity impairment attributable to anemia in cancer participants. Question 1 asked participants to indicate if they were currently employed or working for pay (Yes or No). Data reported for the outcome included those who were employed.

Outcome measures

Measure	Solid Tumor Participants n=235 Participants Solid tumor (breast, colorectal, lung, and ovary) participants on NeoRecormon® injection were observed until Week 24 to 28 or early withdrawal due to death, participants' will to end the study, lost to follow-up or other reasons. The dose and frequency of NeoRecormon® were at the discretion of treating physician.	Hematological Malignancy Participants n=209 Participants Hematological malignancy (multiple myeloma, Chronic Lymphocytic Leukemia \[CLL\], and lymphoma) participants on NeoRecormon® injection were observed until Week 24 to 28 or early withdrawal due to death, participants' will to end the study, lost to follow-up or other reasons. The dose and frequency of NeoRecormon® were at the discretion of treating physician.	Anemic Cancer Participants (Total Participants) n=444 Participants Anemic cancer participants on NeoRecormon® injection were observed until Week 24 to 28 or early withdrawal due to death, participants' will to end the study, lost to follow-up or other reasons. The dose and frequency of NeoRecormon® were at the discretion of treating physician.	Ovary Cancer Participants Ovary cancer participants on NeoRecormon® injection were observed until Week 24 to 28 or early withdrawal due to death, participants' will to end the study, lost to follow-up or other reasons. The dose and frequency of NeoRecormon® were at the discretion of treating physician.	Multiple Myeloma Participants Multiple myeloma participants on NeoRecormon® injection were observed until Week 24 to 28 or early withdrawal due to death, participants' will to end the study, lost to follow-up or other reasons. The dose and frequency of NeoRecormon® were at the discretion of treating physician.	Non-Hodgkin's Lymphoma Participants Non-Hodgkin's lymphoma participants on NeoRecormon® injection were observed until Week 24 to 28 or early withdrawal due to death, participants' will to end the study, lost to follow-up or other reasons. The dose and frequency of NeoRecormon® were at the discretion of treating physician.	Hodgkin's Lymphoma Participants Hodgkin's lymphoma participants on NeoRecormon® injection were observed until Week 24 to 28 or early withdrawal due to death, participants' will to end the study, lost to follow-up or other reasons. The dose and frequency of NeoRecormon® were at the discretion of treating physician.	Chronic Lymphocytic Leukemia Participants Chronic lymphocytic leukemia participants on NeoRecormon® injection were observed until Week 24 to 28 or early withdrawal due to death, participants' will to end the study, lost to follow-up or other reasons. The dose and frequency of NeoRecormon® were at the discretion of treating physician.	Anemic Cancer Participants (Total Participants) Anemic cancer participants on NeoRecormon® injection were observed until Week 24 to 28 or early withdrawal due to death, participants' will to end the study, lost to follow-up or other reasons. The dose and frequency of NeoRecormon® were at the discretion of treating physician.
Self-Reported Questionnaire: Percentage of Participants With Current Employment at Week 12 to 16	4.3 percentage of participants	4.3 percentage of participants	4.3 percentage of participants	—	—	—	—	—	—

PRIMARY outcome

Timeframe: Week 24 to 28

Population: Efficacy population. Here "number of participants analyzed" included those participants who were evaluable for the outcome measure.

Self-administered questionnaire, WPAI questionnaire was used to assess work and activity impairment due to anemia in cancer participants in the last 7 days. The self-administered questionnaire consisted of 6 questions. It assessed amount of absenteeism, presenteeism and daily activity impairment attributable to anemia in cancer participants. Question 1 asked participants to indicate if they were currently employed or working for pay (Yes or No). Data reported for the outcome included those who were employed.

Outcome measures

Measure	Solid Tumor Participants n=163 Participants Solid tumor (breast, colorectal, lung, and ovary) participants on NeoRecormon® injection were observed until Week 24 to 28 or early withdrawal due to death, participants' will to end the study, lost to follow-up or other reasons. The dose and frequency of NeoRecormon® were at the discretion of treating physician.	Hematological Malignancy Participants n=147 Participants Hematological malignancy (multiple myeloma, Chronic Lymphocytic Leukemia \[CLL\], and lymphoma) participants on NeoRecormon® injection were observed until Week 24 to 28 or early withdrawal due to death, participants' will to end the study, lost to follow-up or other reasons. The dose and frequency of NeoRecormon® were at the discretion of treating physician.	Anemic Cancer Participants (Total Participants) n=310 Participants Anemic cancer participants on NeoRecormon® injection were observed until Week 24 to 28 or early withdrawal due to death, participants' will to end the study, lost to follow-up or other reasons. The dose and frequency of NeoRecormon® were at the discretion of treating physician.	Ovary Cancer Participants Ovary cancer participants on NeoRecormon® injection were observed until Week 24 to 28 or early withdrawal due to death, participants' will to end the study, lost to follow-up or other reasons. The dose and frequency of NeoRecormon® were at the discretion of treating physician.	Multiple Myeloma Participants Multiple myeloma participants on NeoRecormon® injection were observed until Week 24 to 28 or early withdrawal due to death, participants' will to end the study, lost to follow-up or other reasons. The dose and frequency of NeoRecormon® were at the discretion of treating physician.	Non-Hodgkin's Lymphoma Participants Non-Hodgkin's lymphoma participants on NeoRecormon® injection were observed until Week 24 to 28 or early withdrawal due to death, participants' will to end the study, lost to follow-up or other reasons. The dose and frequency of NeoRecormon® were at the discretion of treating physician.	Hodgkin's Lymphoma Participants Hodgkin's lymphoma participants on NeoRecormon® injection were observed until Week 24 to 28 or early withdrawal due to death, participants' will to end the study, lost to follow-up or other reasons. The dose and frequency of NeoRecormon® were at the discretion of treating physician.	Chronic Lymphocytic Leukemia Participants Chronic lymphocytic leukemia participants on NeoRecormon® injection were observed until Week 24 to 28 or early withdrawal due to death, participants' will to end the study, lost to follow-up or other reasons. The dose and frequency of NeoRecormon® were at the discretion of treating physician.	Anemic Cancer Participants (Total Participants) Anemic cancer participants on NeoRecormon® injection were observed until Week 24 to 28 or early withdrawal due to death, participants' will to end the study, lost to follow-up or other reasons. The dose and frequency of NeoRecormon® were at the discretion of treating physician.
Self-Reported Questionnaire: Percentage of Participants With Current Employment at Week 24 to 28	4.9 percentage of participants	4.1 percentage of participants	4.5 percentage of participants	—	—	—	—	—	—

PRIMARY outcome

Timeframe: Baseline, Week 4 to 6

Population: Efficacy population. Here "number of participants analyzed" included those participants who were evaluable for the outcome measure.

Self-administered questionnaire, WPAI questionnaire was used to assess work and activity impairment due to anemia in cancer participants in the last 7 days. The self-administered questionnaire consisted of 6 questions. It assessed amount of absenteeism, presenteeism and daily activity impairment attributable to anemia in cancer participants. Question 6 asked participants to indicate how much their anemia affected their ability to do their regular daily activities such as housework, childcare, exercising, shopping, studying and so on, in the past 7 days on a scale from 0 (no effect) to 10 (completely prevented from doing daily activities).

Outcome measures

Measure	Solid Tumor Participants n=207 Participants Solid tumor (breast, colorectal, lung, and ovary) participants on NeoRecormon® injection were observed until Week 24 to 28 or early withdrawal due to death, participants' will to end the study, lost to follow-up or other reasons. The dose and frequency of NeoRecormon® were at the discretion of treating physician.	Hematological Malignancy Participants n=190 Participants Hematological malignancy (multiple myeloma, Chronic Lymphocytic Leukemia \[CLL\], and lymphoma) participants on NeoRecormon® injection were observed until Week 24 to 28 or early withdrawal due to death, participants' will to end the study, lost to follow-up or other reasons. The dose and frequency of NeoRecormon® were at the discretion of treating physician.	Anemic Cancer Participants (Total Participants) n=397 Participants Anemic cancer participants on NeoRecormon® injection were observed until Week 24 to 28 or early withdrawal due to death, participants' will to end the study, lost to follow-up or other reasons. The dose and frequency of NeoRecormon® were at the discretion of treating physician.	Ovary Cancer Participants Ovary cancer participants on NeoRecormon® injection were observed until Week 24 to 28 or early withdrawal due to death, participants' will to end the study, lost to follow-up or other reasons. The dose and frequency of NeoRecormon® were at the discretion of treating physician.	Multiple Myeloma Participants Multiple myeloma participants on NeoRecormon® injection were observed until Week 24 to 28 or early withdrawal due to death, participants' will to end the study, lost to follow-up or other reasons. The dose and frequency of NeoRecormon® were at the discretion of treating physician.	Non-Hodgkin's Lymphoma Participants Non-Hodgkin's lymphoma participants on NeoRecormon® injection were observed until Week 24 to 28 or early withdrawal due to death, participants' will to end the study, lost to follow-up or other reasons. The dose and frequency of NeoRecormon® were at the discretion of treating physician.	Hodgkin's Lymphoma Participants Hodgkin's lymphoma participants on NeoRecormon® injection were observed until Week 24 to 28 or early withdrawal due to death, participants' will to end the study, lost to follow-up or other reasons. The dose and frequency of NeoRecormon® were at the discretion of treating physician.	Chronic Lymphocytic Leukemia Participants Chronic lymphocytic leukemia participants on NeoRecormon® injection were observed until Week 24 to 28 or early withdrawal due to death, participants' will to end the study, lost to follow-up or other reasons. The dose and frequency of NeoRecormon® were at the discretion of treating physician.	Anemic Cancer Participants (Total Participants) Anemic cancer participants on NeoRecormon® injection were observed until Week 24 to 28 or early withdrawal due to death, participants' will to end the study, lost to follow-up or other reasons. The dose and frequency of NeoRecormon® were at the discretion of treating physician.
Self-Reported Questionnaire: Change From Baseline on the Impact of Health on Regular Activities at Week 4 to 6 Baseline	6.2 units on a scale Standard Deviation 2.4	6.2 units on a scale Standard Deviation 2.3	6.2 units on a scale Standard Deviation 2.4	—	—	—	—	—	—
Self-Reported Questionnaire: Change From Baseline on the Impact of Health on Regular Activities at Week 4 to 6 Change at Week 4 to 6	-1.1 units on a scale Standard Deviation 2.7	-0.8 units on a scale Standard Deviation 2.5	-0.9 units on a scale Standard Deviation 2.6	—	—	—	—	—	—

PRIMARY outcome

Timeframe: Baseline, Week 12 to 16

Population: Efficacy population. Here "number of participants analyzed" included those participants who were evaluable for the outcome measure.

Self-administered questionnaire, WPAI questionnaire was used to assess work and activity impairment due to anemia in cancer participants in the last 7 days. The self-administered questionnaire consisted of 6 questions. It assessed amount of absenteeism, presenteeism and daily activity impairment attributable to anemia in cancer participants. Question 6 asked participants to indicate how much their anemia affected their ability to do their regular daily activities such as housework, childcare, exercising, shopping, studying and so on, in the past 7 days on a scale from 0 (no effect) to 10 (completely prevented from doing daily activities).

Outcome measures

Measure	Solid Tumor Participants n=195 Participants Solid tumor (breast, colorectal, lung, and ovary) participants on NeoRecormon® injection were observed until Week 24 to 28 or early withdrawal due to death, participants' will to end the study, lost to follow-up or other reasons. The dose and frequency of NeoRecormon® were at the discretion of treating physician.	Hematological Malignancy Participants n=175 Participants Hematological malignancy (multiple myeloma, Chronic Lymphocytic Leukemia \[CLL\], and lymphoma) participants on NeoRecormon® injection were observed until Week 24 to 28 or early withdrawal due to death, participants' will to end the study, lost to follow-up or other reasons. The dose and frequency of NeoRecormon® were at the discretion of treating physician.	Anemic Cancer Participants (Total Participants) n=370 Participants Anemic cancer participants on NeoRecormon® injection were observed until Week 24 to 28 or early withdrawal due to death, participants' will to end the study, lost to follow-up or other reasons. The dose and frequency of NeoRecormon® were at the discretion of treating physician.	Ovary Cancer Participants Ovary cancer participants on NeoRecormon® injection were observed until Week 24 to 28 or early withdrawal due to death, participants' will to end the study, lost to follow-up or other reasons. The dose and frequency of NeoRecormon® were at the discretion of treating physician.	Multiple Myeloma Participants Multiple myeloma participants on NeoRecormon® injection were observed until Week 24 to 28 or early withdrawal due to death, participants' will to end the study, lost to follow-up or other reasons. The dose and frequency of NeoRecormon® were at the discretion of treating physician.	Non-Hodgkin's Lymphoma Participants Non-Hodgkin's lymphoma participants on NeoRecormon® injection were observed until Week 24 to 28 or early withdrawal due to death, participants' will to end the study, lost to follow-up or other reasons. The dose and frequency of NeoRecormon® were at the discretion of treating physician.	Hodgkin's Lymphoma Participants Hodgkin's lymphoma participants on NeoRecormon® injection were observed until Week 24 to 28 or early withdrawal due to death, participants' will to end the study, lost to follow-up or other reasons. The dose and frequency of NeoRecormon® were at the discretion of treating physician.	Chronic Lymphocytic Leukemia Participants Chronic lymphocytic leukemia participants on NeoRecormon® injection were observed until Week 24 to 28 or early withdrawal due to death, participants' will to end the study, lost to follow-up or other reasons. The dose and frequency of NeoRecormon® were at the discretion of treating physician.	Anemic Cancer Participants (Total Participants) Anemic cancer participants on NeoRecormon® injection were observed until Week 24 to 28 or early withdrawal due to death, participants' will to end the study, lost to follow-up or other reasons. The dose and frequency of NeoRecormon® were at the discretion of treating physician.
Self-Reported Questionnaire: Change From Baseline on the Impact of Health on Regular Activities at Week 12 to 16 Baseline	6.1 units on a scale Standard Deviation 2.3	5.9 units on a scale Standard Deviation 2.3	6.0 units on a scale Standard Deviation 2.3	—	—	—	—	—	—
Self-Reported Questionnaire: Change From Baseline on the Impact of Health on Regular Activities at Week 12 to 16 Change at Week 12 to 16	-1.5 units on a scale Standard Deviation 2.8	-1.3 units on a scale Standard Deviation 2.9	-1.4 units on a scale Standard Deviation 2.9	—	—	—	—	—	—

PRIMARY outcome

Timeframe: Baseline, Week 24 to 28

Population: Efficacy population. Here "number of participants analyzed" included those participants who were evaluable for the outcome measure.

Self-administered questionnaire, WPAI questionnaire was used to assess work and activity impairment due to anemia in cancer participants in the last 7 days. The self-administered questionnaire consisted of 6 questions. It assessed amount of absenteeism, presenteeism and daily activity impairment attributable to anemia in cancer participants. Question 6 asked participants to indicate how much their anemia affected their ability to do their regular daily activities such as housework, childcare, exercising, shopping, studying and so on, in the past 7 days on a scale from 0 (no effect) to 10 (completely prevented from doing daily activities).

Outcome measures

Measure	Solid Tumor Participants n=125 Participants Solid tumor (breast, colorectal, lung, and ovary) participants on NeoRecormon® injection were observed until Week 24 to 28 or early withdrawal due to death, participants' will to end the study, lost to follow-up or other reasons. The dose and frequency of NeoRecormon® were at the discretion of treating physician.	Hematological Malignancy Participants n=115 Participants Hematological malignancy (multiple myeloma, Chronic Lymphocytic Leukemia \[CLL\], and lymphoma) participants on NeoRecormon® injection were observed until Week 24 to 28 or early withdrawal due to death, participants' will to end the study, lost to follow-up or other reasons. The dose and frequency of NeoRecormon® were at the discretion of treating physician.	Anemic Cancer Participants (Total Participants) n=240 Participants Anemic cancer participants on NeoRecormon® injection were observed until Week 24 to 28 or early withdrawal due to death, participants' will to end the study, lost to follow-up or other reasons. The dose and frequency of NeoRecormon® were at the discretion of treating physician.	Ovary Cancer Participants Ovary cancer participants on NeoRecormon® injection were observed until Week 24 to 28 or early withdrawal due to death, participants' will to end the study, lost to follow-up or other reasons. The dose and frequency of NeoRecormon® were at the discretion of treating physician.	Multiple Myeloma Participants Multiple myeloma participants on NeoRecormon® injection were observed until Week 24 to 28 or early withdrawal due to death, participants' will to end the study, lost to follow-up or other reasons. The dose and frequency of NeoRecormon® were at the discretion of treating physician.	Non-Hodgkin's Lymphoma Participants Non-Hodgkin's lymphoma participants on NeoRecormon® injection were observed until Week 24 to 28 or early withdrawal due to death, participants' will to end the study, lost to follow-up or other reasons. The dose and frequency of NeoRecormon® were at the discretion of treating physician.	Hodgkin's Lymphoma Participants Hodgkin's lymphoma participants on NeoRecormon® injection were observed until Week 24 to 28 or early withdrawal due to death, participants' will to end the study, lost to follow-up or other reasons. The dose and frequency of NeoRecormon® were at the discretion of treating physician.	Chronic Lymphocytic Leukemia Participants Chronic lymphocytic leukemia participants on NeoRecormon® injection were observed until Week 24 to 28 or early withdrawal due to death, participants' will to end the study, lost to follow-up or other reasons. The dose and frequency of NeoRecormon® were at the discretion of treating physician.	Anemic Cancer Participants (Total Participants) Anemic cancer participants on NeoRecormon® injection were observed until Week 24 to 28 or early withdrawal due to death, participants' will to end the study, lost to follow-up or other reasons. The dose and frequency of NeoRecormon® were at the discretion of treating physician.
Self-Reported Questionnaire: Change From Baseline on the Impact of Health on Regular Activities at Week 24 to 28 Baseline	5.9 units on a scale Standard Deviation 2.2	5.7 units on a scale Standard Deviation 2.3	5.8 units on a scale Standard Deviation 2.2	—	—	—	—	—	—
Self-Reported Questionnaire: Change From Baseline on the Impact of Health on Regular Activities at Week 24 to 28 Change at Week 24 to 28	-1.5 units on a scale Standard Deviation 3.0	-1.4 units on a scale Standard Deviation 3.1	-1.5 units on a scale Standard Deviation 3.1	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Baseline

Population: Efficacy population. Here "number of participants analyzed" included those participants who were evaluable for the outcome measure.

Dose of NeoRecormon® injection was measured in international units/kilograms/weeks (IU/kg/weeks).

Outcome measures

Measure	Solid Tumor Participants n=665 Participants Solid tumor (breast, colorectal, lung, and ovary) participants on NeoRecormon® injection were observed until Week 24 to 28 or early withdrawal due to death, participants' will to end the study, lost to follow-up or other reasons. The dose and frequency of NeoRecormon® were at the discretion of treating physician.	Hematological Malignancy Participants n=296 Participants Hematological malignancy (multiple myeloma, Chronic Lymphocytic Leukemia \[CLL\], and lymphoma) participants on NeoRecormon® injection were observed until Week 24 to 28 or early withdrawal due to death, participants' will to end the study, lost to follow-up or other reasons. The dose and frequency of NeoRecormon® were at the discretion of treating physician.	Anemic Cancer Participants (Total Participants) n=961 Participants Anemic cancer participants on NeoRecormon® injection were observed until Week 24 to 28 or early withdrawal due to death, participants' will to end the study, lost to follow-up or other reasons. The dose and frequency of NeoRecormon® were at the discretion of treating physician.	Ovary Cancer Participants Ovary cancer participants on NeoRecormon® injection were observed until Week 24 to 28 or early withdrawal due to death, participants' will to end the study, lost to follow-up or other reasons. The dose and frequency of NeoRecormon® were at the discretion of treating physician.	Multiple Myeloma Participants Multiple myeloma participants on NeoRecormon® injection were observed until Week 24 to 28 or early withdrawal due to death, participants' will to end the study, lost to follow-up or other reasons. The dose and frequency of NeoRecormon® were at the discretion of treating physician.	Non-Hodgkin's Lymphoma Participants Non-Hodgkin's lymphoma participants on NeoRecormon® injection were observed until Week 24 to 28 or early withdrawal due to death, participants' will to end the study, lost to follow-up or other reasons. The dose and frequency of NeoRecormon® were at the discretion of treating physician.	Hodgkin's Lymphoma Participants Hodgkin's lymphoma participants on NeoRecormon® injection were observed until Week 24 to 28 or early withdrawal due to death, participants' will to end the study, lost to follow-up or other reasons. The dose and frequency of NeoRecormon® were at the discretion of treating physician.	Chronic Lymphocytic Leukemia Participants Chronic lymphocytic leukemia participants on NeoRecormon® injection were observed until Week 24 to 28 or early withdrawal due to death, participants' will to end the study, lost to follow-up or other reasons. The dose and frequency of NeoRecormon® were at the discretion of treating physician.	Anemic Cancer Participants (Total Participants) Anemic cancer participants on NeoRecormon® injection were observed until Week 24 to 28 or early withdrawal due to death, participants' will to end the study, lost to follow-up or other reasons. The dose and frequency of NeoRecormon® were at the discretion of treating physician.
Mean Starting Dose of NeoRecormon® Injection	471.2 IU/kg/weeks Standard Deviation 91.2	447.3 IU/kg/weeks Standard Deviation 95.9	463.9 IU/kg/weeks Standard Deviation 93.3	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Baseline

Population: Efficacy population. Here "number of participants analyzed" included those participants who were evaluable for the outcome measure.

Outcome measures

Measure	Solid Tumor Participants n=665 Participants Solid tumor (breast, colorectal, lung, and ovary) participants on NeoRecormon® injection were observed until Week 24 to 28 or early withdrawal due to death, participants' will to end the study, lost to follow-up or other reasons. The dose and frequency of NeoRecormon® were at the discretion of treating physician.	Hematological Malignancy Participants n=296 Participants Hematological malignancy (multiple myeloma, Chronic Lymphocytic Leukemia \[CLL\], and lymphoma) participants on NeoRecormon® injection were observed until Week 24 to 28 or early withdrawal due to death, participants' will to end the study, lost to follow-up or other reasons. The dose and frequency of NeoRecormon® were at the discretion of treating physician.	Anemic Cancer Participants (Total Participants) n=961 Participants Anemic cancer participants on NeoRecormon® injection were observed until Week 24 to 28 or early withdrawal due to death, participants' will to end the study, lost to follow-up or other reasons. The dose and frequency of NeoRecormon® were at the discretion of treating physician.	Ovary Cancer Participants Ovary cancer participants on NeoRecormon® injection were observed until Week 24 to 28 or early withdrawal due to death, participants' will to end the study, lost to follow-up or other reasons. The dose and frequency of NeoRecormon® were at the discretion of treating physician.	Multiple Myeloma Participants Multiple myeloma participants on NeoRecormon® injection were observed until Week 24 to 28 or early withdrawal due to death, participants' will to end the study, lost to follow-up or other reasons. The dose and frequency of NeoRecormon® were at the discretion of treating physician.	Non-Hodgkin's Lymphoma Participants Non-Hodgkin's lymphoma participants on NeoRecormon® injection were observed until Week 24 to 28 or early withdrawal due to death, participants' will to end the study, lost to follow-up or other reasons. The dose and frequency of NeoRecormon® were at the discretion of treating physician.	Hodgkin's Lymphoma Participants Hodgkin's lymphoma participants on NeoRecormon® injection were observed until Week 24 to 28 or early withdrawal due to death, participants' will to end the study, lost to follow-up or other reasons. The dose and frequency of NeoRecormon® were at the discretion of treating physician.	Chronic Lymphocytic Leukemia Participants Chronic lymphocytic leukemia participants on NeoRecormon® injection were observed until Week 24 to 28 or early withdrawal due to death, participants' will to end the study, lost to follow-up or other reasons. The dose and frequency of NeoRecormon® were at the discretion of treating physician.	Anemic Cancer Participants (Total Participants) Anemic cancer participants on NeoRecormon® injection were observed until Week 24 to 28 or early withdrawal due to death, participants' will to end the study, lost to follow-up or other reasons. The dose and frequency of NeoRecormon® were at the discretion of treating physician.
Percentage of Participants With Starting Dose Between 360 and 540 IU/kg/Weeks	69.9 percentage of participants	67.6 percentage of participants	69.2 percentage of participants	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Baseline, Week 4 to 6, Week 12 to 16, Week 24 to 48

Population: Efficacy population. Here "number of participants analyzed" included those participants who were evaluable for the outcome measure and "n" included participants who were evaluable at specified time point for each arm, respectively.

Pre-specified doses and frequency included; 20000 IU/week - Once a week (qw), 30000 IU/week -qw, 30000 IU/week - Twice a week (tw), 30000 IU/week - Once every 2 weeks (q2w), 40000 IU/week - qw, 60000 IU/week - qw, and other. Missing data were not reported.

Outcome measures

Measure	Solid Tumor Participants n=669 Participants Solid tumor (breast, colorectal, lung, and ovary) participants on NeoRecormon® injection were observed until Week 24 to 28 or early withdrawal due to death, participants' will to end the study, lost to follow-up or other reasons. The dose and frequency of NeoRecormon® were at the discretion of treating physician.	Hematological Malignancy Participants n=300 Participants Hematological malignancy (multiple myeloma, Chronic Lymphocytic Leukemia \[CLL\], and lymphoma) participants on NeoRecormon® injection were observed until Week 24 to 28 or early withdrawal due to death, participants' will to end the study, lost to follow-up or other reasons. The dose and frequency of NeoRecormon® were at the discretion of treating physician.	Anemic Cancer Participants (Total Participants) n=969 Participants Anemic cancer participants on NeoRecormon® injection were observed until Week 24 to 28 or early withdrawal due to death, participants' will to end the study, lost to follow-up or other reasons. The dose and frequency of NeoRecormon® were at the discretion of treating physician.	Ovary Cancer Participants Ovary cancer participants on NeoRecormon® injection were observed until Week 24 to 28 or early withdrawal due to death, participants' will to end the study, lost to follow-up or other reasons. The dose and frequency of NeoRecormon® were at the discretion of treating physician.	Multiple Myeloma Participants Multiple myeloma participants on NeoRecormon® injection were observed until Week 24 to 28 or early withdrawal due to death, participants' will to end the study, lost to follow-up or other reasons. The dose and frequency of NeoRecormon® were at the discretion of treating physician.	Non-Hodgkin's Lymphoma Participants Non-Hodgkin's lymphoma participants on NeoRecormon® injection were observed until Week 24 to 28 or early withdrawal due to death, participants' will to end the study, lost to follow-up or other reasons. The dose and frequency of NeoRecormon® were at the discretion of treating physician.	Hodgkin's Lymphoma Participants Hodgkin's lymphoma participants on NeoRecormon® injection were observed until Week 24 to 28 or early withdrawal due to death, participants' will to end the study, lost to follow-up or other reasons. The dose and frequency of NeoRecormon® were at the discretion of treating physician.	Chronic Lymphocytic Leukemia Participants Chronic lymphocytic leukemia participants on NeoRecormon® injection were observed until Week 24 to 28 or early withdrawal due to death, participants' will to end the study, lost to follow-up or other reasons. The dose and frequency of NeoRecormon® were at the discretion of treating physician.	Anemic Cancer Participants (Total Participants) Anemic cancer participants on NeoRecormon® injection were observed until Week 24 to 28 or early withdrawal due to death, participants' will to end the study, lost to follow-up or other reasons. The dose and frequency of NeoRecormon® were at the discretion of treating physician.
Percentage of Participants With Pre-specified Dose and Frequency of Injections Baseline: Other (n=669,300,969)	0.4 percentage of participants	0.3 percentage of participants	0.4 percentage of participants	—	—	—	—	—	—
Percentage of Participants With Pre-specified Dose and Frequency of Injections Week 4-6: 20000 IU/weeks-qw (n=494,262,756)	1.0 percentage of participants	3.1 percentage of participants	1.7 percentage of participants	—	—	—	—	—	—
Percentage of Participants With Pre-specified Dose and Frequency of Injections Week 12-16: 30000 IU/weeks-qw (n=244,163,407)	91.4 percentage of participants	84.7 percentage of participants	88.7 percentage of participants	—	—	—	—	—	—
Percentage of Participants With Pre-specified Dose and Frequency of Injections Week 12-16: 20000 IU/weeks-qw (n=244,163,407)	2.5 percentage of participants	2.5 percentage of participants	2.5 percentage of participants	—	—	—	—	—	—
Percentage of Participants With Pre-specified Dose and Frequency of Injections Week 12-16: 30000 IU/weeks-tw (n=244,163,407)	0.0 percentage of participants	3.7 percentage of participants	1.5 percentage of participants	—	—	—	—	—	—
Percentage of Participants With Pre-specified Dose and Frequency of Injections Week 12-16: 60000 IU/weeks-qw (n=244,163,407)	1.2 percentage of participants	1.2 percentage of participants	1.2 percentage of participants	—	—	—	—	—	—
Percentage of Participants With Pre-specified Dose and Frequency of Injections Week 12-16: 30000 IU/weeks-q2w (n=244,163,407)	2.5 percentage of participants	3.1 percentage of participants	2.7 percentage of participants	—	—	—	—	—	—
Percentage of Participants With Pre-specified Dose and Frequency of Injections Week 12-16: Other (n=244,163,407)	2.5 percentage of participants	4.9 percentage of participants	3.4 percentage of participants	—	—	—	—	—	—
Percentage of Participants With Pre-specified Dose and Frequency of Injections Week 24-28: 30000 IU/weeks-qw (n=119,76,195)	89.9 percentage of participants	89.5 percentage of participants	89.7 percentage of participants	—	—	—	—	—	—
Percentage of Participants With Pre-specified Dose and Frequency of Injections Week 24-28: 20000 IU/weeks-qw (n=119,76,195)	2.5 percentage of participants	1.3 percentage of participants	2.1 percentage of participants	—	—	—	—	—	—
Percentage of Participants With Pre-specified Dose and Frequency of Injections Week 24-28: 60000 IU/weeks-qw (n=119,76,195)	1.7 percentage of participants	2.6 percentage of participants	2.1 percentage of participants	—	—	—	—	—	—
Percentage of Participants With Pre-specified Dose and Frequency of Injections Baseline: 30000 IU/weeks-qw (n=669,300,969)	97.8 percentage of participants	93.7 percentage of participants	96.5 percentage of participants	—	—	—	—	—	—
Percentage of Participants With Pre-specified Dose and Frequency of Injections Baseline: 20000 IU/weeks-qw (n=669,300,969)	1.2 percentage of participants	3.7 percentage of participants	2.0 percentage of participants	—	—	—	—	—	—
Percentage of Participants With Pre-specified Dose and Frequency of Injections Baseline: 40000 IU/weeks-qw (n=669,300,969)	0.6 percentage of participants	2.3 percentage of participants	1.1 percentage of participants	—	—	—	—	—	—
Percentage of Participants With Pre-specified Dose and Frequency of Injections Week 4-6: 30000 IU/weeks-qw (n=494,262,756)	94.9 percentage of participants	89.7 percentage of participants	93.1 percentage of participants	—	—	—	—	—	—
Percentage of Participants With Pre-specified Dose and Frequency of Injections Week 4-6: 30000 IU/weeks-tw (n=494,262,756)	1.0 percentage of participants	1.5 percentage of participants	1.2 percentage of participants	—	—	—	—	—	—
Percentage of Participants With Pre-specified Dose and Frequency of Injections Week 4-6: 60000 IU/weeks-qw (n=494,262,756)	1.0 percentage of participants	0.8 percentage of participants	0.9 percentage of participants	—	—	—	—	—	—
Percentage of Participants With Pre-specified Dose and Frequency of Injections Week 4-6: 30000 IU/weeks-q2w (n=494,262,756)	0.8 percentage of participants	1.5 percentage of participants	1.1 percentage of participants	—	—	—	—	—	—
Percentage of Participants With Pre-specified Dose and Frequency of Injections Week 4-6: 40000 IU/weeks-qw (n=494,262,756)	0.4 percentage of participants	2.7 percentage of participants	1.2 percentage of participants	—	—	—	—	—	—
Percentage of Participants With Pre-specified Dose and Frequency of Injections Week 4-6: Other (n=494,262,756)	0.8 percentage of participants	0.8 percentage of participants	0.8 percentage of participants	—	—	—	—	—	—
Percentage of Participants With Pre-specified Dose and Frequency of Injections Week 24-28: 40000 IU/weeks-qw (n=119,76,195)	0.8 percentage of participants	3.9 percentage of participants	2.1 percentage of participants	—	—	—	—	—	—
Percentage of Participants With Pre-specified Dose and Frequency of Injections Week 24-28: Other (n=119,76,195)	5.0 percentage of participants	2.6 percentage of participants	4.1 percentage of participants	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Baseline, Week 4 to 6, Week 12 to 16, Week 24 to 48

Population: Efficacy population. Here "number of participants analyzed" included those participants who were evaluable for the outcome measure and "n" included participants who were evaluable at specified time point for each arm, respectively.

Outcome measures

Measure	Solid Tumor Participants n=668 Participants Solid tumor (breast, colorectal, lung, and ovary) participants on NeoRecormon® injection were observed until Week 24 to 28 or early withdrawal due to death, participants' will to end the study, lost to follow-up or other reasons. The dose and frequency of NeoRecormon® were at the discretion of treating physician.	Hematological Malignancy Participants n=300 Participants Hematological malignancy (multiple myeloma, Chronic Lymphocytic Leukemia \[CLL\], and lymphoma) participants on NeoRecormon® injection were observed until Week 24 to 28 or early withdrawal due to death, participants' will to end the study, lost to follow-up or other reasons. The dose and frequency of NeoRecormon® were at the discretion of treating physician.	Anemic Cancer Participants (Total Participants) n=968 Participants Anemic cancer participants on NeoRecormon® injection were observed until Week 24 to 28 or early withdrawal due to death, participants' will to end the study, lost to follow-up or other reasons. The dose and frequency of NeoRecormon® were at the discretion of treating physician.	Ovary Cancer Participants Ovary cancer participants on NeoRecormon® injection were observed until Week 24 to 28 or early withdrawal due to death, participants' will to end the study, lost to follow-up or other reasons. The dose and frequency of NeoRecormon® were at the discretion of treating physician.	Multiple Myeloma Participants Multiple myeloma participants on NeoRecormon® injection were observed until Week 24 to 28 or early withdrawal due to death, participants' will to end the study, lost to follow-up or other reasons. The dose and frequency of NeoRecormon® were at the discretion of treating physician.	Non-Hodgkin's Lymphoma Participants Non-Hodgkin's lymphoma participants on NeoRecormon® injection were observed until Week 24 to 28 or early withdrawal due to death, participants' will to end the study, lost to follow-up or other reasons. The dose and frequency of NeoRecormon® were at the discretion of treating physician.	Hodgkin's Lymphoma Participants Hodgkin's lymphoma participants on NeoRecormon® injection were observed until Week 24 to 28 or early withdrawal due to death, participants' will to end the study, lost to follow-up or other reasons. The dose and frequency of NeoRecormon® were at the discretion of treating physician.	Chronic Lymphocytic Leukemia Participants Chronic lymphocytic leukemia participants on NeoRecormon® injection were observed until Week 24 to 28 or early withdrawal due to death, participants' will to end the study, lost to follow-up or other reasons. The dose and frequency of NeoRecormon® were at the discretion of treating physician.	Anemic Cancer Participants (Total Participants) Anemic cancer participants on NeoRecormon® injection were observed until Week 24 to 28 or early withdrawal due to death, participants' will to end the study, lost to follow-up or other reasons. The dose and frequency of NeoRecormon® were at the discretion of treating physician.
Percentage of Participants With Subcutaneous (SC) Route of Administration Baseline (n=668,300,968)	98.7 percentage of participants	100.0 percentage of participants	99.1 percentage of participants	—	—	—	—	—	—
Percentage of Participants With Subcutaneous (SC) Route of Administration Week 4-6 (n=494,262,756)	98.8 percentage of participants	100.0 percentage of participants	99.2 percentage of participants	—	—	—	—	—	—
Percentage of Participants With Subcutaneous (SC) Route of Administration Week 12-16 (n=238,163,401)	98.3 percentage of participants	100.0 percentage of participants	99.0 percentage of participants	—	—	—	—	—	—
Percentage of Participants With Subcutaneous (SC) Route of Administration Week 24-28 (n=116,76,192)	98.3 percentage of participants	100.0 percentage of participants	99.0 percentage of participants	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Baseline up to Week 28

Population: Efficacy population. Here "number of participants analyzed" included those participants who were evaluable for the outcome measure.

Outcome measures

Measure	Solid Tumor Participants n=667 Participants Solid tumor (breast, colorectal, lung, and ovary) participants on NeoRecormon® injection were observed until Week 24 to 28 or early withdrawal due to death, participants' will to end the study, lost to follow-up or other reasons. The dose and frequency of NeoRecormon® were at the discretion of treating physician.	Hematological Malignancy Participants n=300 Participants Hematological malignancy (multiple myeloma, Chronic Lymphocytic Leukemia \[CLL\], and lymphoma) participants on NeoRecormon® injection were observed until Week 24 to 28 or early withdrawal due to death, participants' will to end the study, lost to follow-up or other reasons. The dose and frequency of NeoRecormon® were at the discretion of treating physician.	Anemic Cancer Participants (Total Participants) n=967 Participants Anemic cancer participants on NeoRecormon® injection were observed until Week 24 to 28 or early withdrawal due to death, participants' will to end the study, lost to follow-up or other reasons. The dose and frequency of NeoRecormon® were at the discretion of treating physician.	Ovary Cancer Participants Ovary cancer participants on NeoRecormon® injection were observed until Week 24 to 28 or early withdrawal due to death, participants' will to end the study, lost to follow-up or other reasons. The dose and frequency of NeoRecormon® were at the discretion of treating physician.	Multiple Myeloma Participants Multiple myeloma participants on NeoRecormon® injection were observed until Week 24 to 28 or early withdrawal due to death, participants' will to end the study, lost to follow-up or other reasons. The dose and frequency of NeoRecormon® were at the discretion of treating physician.	Non-Hodgkin's Lymphoma Participants Non-Hodgkin's lymphoma participants on NeoRecormon® injection were observed until Week 24 to 28 or early withdrawal due to death, participants' will to end the study, lost to follow-up or other reasons. The dose and frequency of NeoRecormon® were at the discretion of treating physician.	Hodgkin's Lymphoma Participants Hodgkin's lymphoma participants on NeoRecormon® injection were observed until Week 24 to 28 or early withdrawal due to death, participants' will to end the study, lost to follow-up or other reasons. The dose and frequency of NeoRecormon® were at the discretion of treating physician.	Chronic Lymphocytic Leukemia Participants Chronic lymphocytic leukemia participants on NeoRecormon® injection were observed until Week 24 to 28 or early withdrawal due to death, participants' will to end the study, lost to follow-up or other reasons. The dose and frequency of NeoRecormon® were at the discretion of treating physician.	Anemic Cancer Participants (Total Participants) Anemic cancer participants on NeoRecormon® injection were observed until Week 24 to 28 or early withdrawal due to death, participants' will to end the study, lost to follow-up or other reasons. The dose and frequency of NeoRecormon® were at the discretion of treating physician.
Percentage of Participants With NeoRecormon® SC Injections at a Weekly Dose of 30000 IU	86.2 percentage of participants	82.7 percentage of participants	85.1 percentage of participants	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Baseline up to Week 28

Population: Efficacy population. Here "number of participants analyzed" included those participants who were evaluable for the outcome measure.

All modifications were based on the change in frequency, route of administration or dose depending on the need for treatment adjustments according to Hb concentration. Percentage of participants with at least 1 modification in NeoRecormon® regimen was reported.

Outcome measures

Measure	Solid Tumor Participants n=670 Participants Solid tumor (breast, colorectal, lung, and ovary) participants on NeoRecormon® injection were observed until Week 24 to 28 or early withdrawal due to death, participants' will to end the study, lost to follow-up or other reasons. The dose and frequency of NeoRecormon® were at the discretion of treating physician.	Hematological Malignancy Participants n=300 Participants Hematological malignancy (multiple myeloma, Chronic Lymphocytic Leukemia \[CLL\], and lymphoma) participants on NeoRecormon® injection were observed until Week 24 to 28 or early withdrawal due to death, participants' will to end the study, lost to follow-up or other reasons. The dose and frequency of NeoRecormon® were at the discretion of treating physician.	Anemic Cancer Participants (Total Participants) n=970 Participants Anemic cancer participants on NeoRecormon® injection were observed until Week 24 to 28 or early withdrawal due to death, participants' will to end the study, lost to follow-up or other reasons. The dose and frequency of NeoRecormon® were at the discretion of treating physician.	Ovary Cancer Participants Ovary cancer participants on NeoRecormon® injection were observed until Week 24 to 28 or early withdrawal due to death, participants' will to end the study, lost to follow-up or other reasons. The dose and frequency of NeoRecormon® were at the discretion of treating physician.	Multiple Myeloma Participants Multiple myeloma participants on NeoRecormon® injection were observed until Week 24 to 28 or early withdrawal due to death, participants' will to end the study, lost to follow-up or other reasons. The dose and frequency of NeoRecormon® were at the discretion of treating physician.	Non-Hodgkin's Lymphoma Participants Non-Hodgkin's lymphoma participants on NeoRecormon® injection were observed until Week 24 to 28 or early withdrawal due to death, participants' will to end the study, lost to follow-up or other reasons. The dose and frequency of NeoRecormon® were at the discretion of treating physician.	Hodgkin's Lymphoma Participants Hodgkin's lymphoma participants on NeoRecormon® injection were observed until Week 24 to 28 or early withdrawal due to death, participants' will to end the study, lost to follow-up or other reasons. The dose and frequency of NeoRecormon® were at the discretion of treating physician.	Chronic Lymphocytic Leukemia Participants Chronic lymphocytic leukemia participants on NeoRecormon® injection were observed until Week 24 to 28 or early withdrawal due to death, participants' will to end the study, lost to follow-up or other reasons. The dose and frequency of NeoRecormon® were at the discretion of treating physician.	Anemic Cancer Participants (Total Participants) Anemic cancer participants on NeoRecormon® injection were observed until Week 24 to 28 or early withdrawal due to death, participants' will to end the study, lost to follow-up or other reasons. The dose and frequency of NeoRecormon® were at the discretion of treating physician.
Percentage of Participants With Modifications of NeoRecormon® Regimen	7.2 percentage of participants	12.0 percentage of participants	8.7 percentage of participants	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Baseline up to Week 28

Population: Efficacy population. Here "number of participants analyzed" included those participants who were evaluable for the outcome measure.

Percentage of participants with at least 1 temporary discontinuation was reported.

Outcome measures

Measure	Solid Tumor Participants n=670 Participants Solid tumor (breast, colorectal, lung, and ovary) participants on NeoRecormon® injection were observed until Week 24 to 28 or early withdrawal due to death, participants' will to end the study, lost to follow-up or other reasons. The dose and frequency of NeoRecormon® were at the discretion of treating physician.	Hematological Malignancy Participants n=300 Participants Hematological malignancy (multiple myeloma, Chronic Lymphocytic Leukemia \[CLL\], and lymphoma) participants on NeoRecormon® injection were observed until Week 24 to 28 or early withdrawal due to death, participants' will to end the study, lost to follow-up or other reasons. The dose and frequency of NeoRecormon® were at the discretion of treating physician.	Anemic Cancer Participants (Total Participants) n=970 Participants Anemic cancer participants on NeoRecormon® injection were observed until Week 24 to 28 or early withdrawal due to death, participants' will to end the study, lost to follow-up or other reasons. The dose and frequency of NeoRecormon® were at the discretion of treating physician.	Ovary Cancer Participants Ovary cancer participants on NeoRecormon® injection were observed until Week 24 to 28 or early withdrawal due to death, participants' will to end the study, lost to follow-up or other reasons. The dose and frequency of NeoRecormon® were at the discretion of treating physician.	Multiple Myeloma Participants Multiple myeloma participants on NeoRecormon® injection were observed until Week 24 to 28 or early withdrawal due to death, participants' will to end the study, lost to follow-up or other reasons. The dose and frequency of NeoRecormon® were at the discretion of treating physician.	Non-Hodgkin's Lymphoma Participants Non-Hodgkin's lymphoma participants on NeoRecormon® injection were observed until Week 24 to 28 or early withdrawal due to death, participants' will to end the study, lost to follow-up or other reasons. The dose and frequency of NeoRecormon® were at the discretion of treating physician.	Hodgkin's Lymphoma Participants Hodgkin's lymphoma participants on NeoRecormon® injection were observed until Week 24 to 28 or early withdrawal due to death, participants' will to end the study, lost to follow-up or other reasons. The dose and frequency of NeoRecormon® were at the discretion of treating physician.	Chronic Lymphocytic Leukemia Participants Chronic lymphocytic leukemia participants on NeoRecormon® injection were observed until Week 24 to 28 or early withdrawal due to death, participants' will to end the study, lost to follow-up or other reasons. The dose and frequency of NeoRecormon® were at the discretion of treating physician.	Anemic Cancer Participants (Total Participants) Anemic cancer participants on NeoRecormon® injection were observed until Week 24 to 28 or early withdrawal due to death, participants' will to end the study, lost to follow-up or other reasons. The dose and frequency of NeoRecormon® were at the discretion of treating physician.
Percentage of Participants With Temporary Discontinuation From NeoRecormon® Treatment	8.1 percentage of participants	10.3 percentage of participants	8.8 percentage of participants	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Baseline up to Week 4 to 6, Week 12 to 16, Week 24 to 28

Population: Efficacy population. Here "number of participants analyzed" included those participants who were evaluable for the outcome measure and "n" included participants who were evaluable at specified time point for each arm, respectively.

Outcome measures

Measure	Solid Tumor Participants n=639 Participants Solid tumor (breast, colorectal, lung, and ovary) participants on NeoRecormon® injection were observed until Week 24 to 28 or early withdrawal due to death, participants' will to end the study, lost to follow-up or other reasons. The dose and frequency of NeoRecormon® were at the discretion of treating physician.	Hematological Malignancy Participants n=294 Participants Hematological malignancy (multiple myeloma, Chronic Lymphocytic Leukemia \[CLL\], and lymphoma) participants on NeoRecormon® injection were observed until Week 24 to 28 or early withdrawal due to death, participants' will to end the study, lost to follow-up or other reasons. The dose and frequency of NeoRecormon® were at the discretion of treating physician.	Anemic Cancer Participants (Total Participants) n=933 Participants Anemic cancer participants on NeoRecormon® injection were observed until Week 24 to 28 or early withdrawal due to death, participants' will to end the study, lost to follow-up or other reasons. The dose and frequency of NeoRecormon® were at the discretion of treating physician.	Ovary Cancer Participants Ovary cancer participants on NeoRecormon® injection were observed until Week 24 to 28 or early withdrawal due to death, participants' will to end the study, lost to follow-up or other reasons. The dose and frequency of NeoRecormon® were at the discretion of treating physician.	Multiple Myeloma Participants Multiple myeloma participants on NeoRecormon® injection were observed until Week 24 to 28 or early withdrawal due to death, participants' will to end the study, lost to follow-up or other reasons. The dose and frequency of NeoRecormon® were at the discretion of treating physician.	Non-Hodgkin's Lymphoma Participants Non-Hodgkin's lymphoma participants on NeoRecormon® injection were observed until Week 24 to 28 or early withdrawal due to death, participants' will to end the study, lost to follow-up or other reasons. The dose and frequency of NeoRecormon® were at the discretion of treating physician.	Hodgkin's Lymphoma Participants Hodgkin's lymphoma participants on NeoRecormon® injection were observed until Week 24 to 28 or early withdrawal due to death, participants' will to end the study, lost to follow-up or other reasons. The dose and frequency of NeoRecormon® were at the discretion of treating physician.	Chronic Lymphocytic Leukemia Participants Chronic lymphocytic leukemia participants on NeoRecormon® injection were observed until Week 24 to 28 or early withdrawal due to death, participants' will to end the study, lost to follow-up or other reasons. The dose and frequency of NeoRecormon® were at the discretion of treating physician.	Anemic Cancer Participants (Total Participants) Anemic cancer participants on NeoRecormon® injection were observed until Week 24 to 28 or early withdrawal due to death, participants' will to end the study, lost to follow-up or other reasons. The dose and frequency of NeoRecormon® were at the discretion of treating physician.
Percentage of Participants With Permanent Discontinuation From NeoRecormon® Treatment Baseline up to Week 4-6 (n=639,294,933)	19.9 percentage of participants	8.5 percentage of participants	16.3 percentage of participants	—	—	—	—	—	—
Percentage of Participants With Permanent Discontinuation From NeoRecormon® Treatment Baseline up to Week 12-16 (n=582,275,857)	54.6 percentage of participants	37.1 percentage of participants	49.0 percentage of participants	—	—	—	—	—	—
Percentage of Participants With Permanent Discontinuation From NeoRecormon® Treatment Baseline up to Week 24-28 (n=457,227,684)	74.2 percentage of participants	65.6 percentage of participants	71.3 percentage of participants	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Baseline, Week 4 to 6, Week 12 to 16, Week 24 to 28

Population: Efficacy population. Here "number of participants analyzed" included those participants who were evaluable for the outcome measure and "n" included participants who were evaluable at specified time point for each arm, respectively.

Outcome measures

Measure	Solid Tumor Participants n=519 Participants Solid tumor (breast, colorectal, lung, and ovary) participants on NeoRecormon® injection were observed until Week 24 to 28 or early withdrawal due to death, participants' will to end the study, lost to follow-up or other reasons. The dose and frequency of NeoRecormon® were at the discretion of treating physician.	Hematological Malignancy Participants n=262 Participants Hematological malignancy (multiple myeloma, Chronic Lymphocytic Leukemia \[CLL\], and lymphoma) participants on NeoRecormon® injection were observed until Week 24 to 28 or early withdrawal due to death, participants' will to end the study, lost to follow-up or other reasons. The dose and frequency of NeoRecormon® were at the discretion of treating physician.	Anemic Cancer Participants (Total Participants) n=781 Participants Anemic cancer participants on NeoRecormon® injection were observed until Week 24 to 28 or early withdrawal due to death, participants' will to end the study, lost to follow-up or other reasons. The dose and frequency of NeoRecormon® were at the discretion of treating physician.	Ovary Cancer Participants Ovary cancer participants on NeoRecormon® injection were observed until Week 24 to 28 or early withdrawal due to death, participants' will to end the study, lost to follow-up or other reasons. The dose and frequency of NeoRecormon® were at the discretion of treating physician.	Multiple Myeloma Participants Multiple myeloma participants on NeoRecormon® injection were observed until Week 24 to 28 or early withdrawal due to death, participants' will to end the study, lost to follow-up or other reasons. The dose and frequency of NeoRecormon® were at the discretion of treating physician.	Non-Hodgkin's Lymphoma Participants Non-Hodgkin's lymphoma participants on NeoRecormon® injection were observed until Week 24 to 28 or early withdrawal due to death, participants' will to end the study, lost to follow-up or other reasons. The dose and frequency of NeoRecormon® were at the discretion of treating physician.	Hodgkin's Lymphoma Participants Hodgkin's lymphoma participants on NeoRecormon® injection were observed until Week 24 to 28 or early withdrawal due to death, participants' will to end the study, lost to follow-up or other reasons. The dose and frequency of NeoRecormon® were at the discretion of treating physician.	Chronic Lymphocytic Leukemia Participants Chronic lymphocytic leukemia participants on NeoRecormon® injection were observed until Week 24 to 28 or early withdrawal due to death, participants' will to end the study, lost to follow-up or other reasons. The dose and frequency of NeoRecormon® were at the discretion of treating physician.	Anemic Cancer Participants (Total Participants) Anemic cancer participants on NeoRecormon® injection were observed until Week 24 to 28 or early withdrawal due to death, participants' will to end the study, lost to follow-up or other reasons. The dose and frequency of NeoRecormon® were at the discretion of treating physician.
Relative Percent Change in Hb Concentration From Baseline Over the Study Period Change at Week 4-6 (n=519,262,781)	11.3 percent change Standard Deviation 15.9	13.0 percent change Standard Deviation 16.0	11.9 percent change Standard Deviation 15.9	—	—	—	—	—	—
Relative Percent Change in Hb Concentration From Baseline Over the Study Period Change at Week 12-16 (n=501,257,758)	15.6 percent change Standard Deviation 19.5	18.6 percent change Standard Deviation 20.0	16.6 percent change Standard Deviation 19.7	—	—	—	—	—	—
Relative Percent Change in Hb Concentration From Baseline Over the Study Period Change at Week 24-28 (n=357,195,552)	16.6 percent change Standard Deviation 20.2	24.7 percent change Standard Deviation 23.4	19.5 percent change Standard Deviation 21.7	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Baseline up to Week 28

Population: Efficacy population. Here "number of participants analyzed" included those participants who were evaluable for the outcome measure.

Outcome measures

Measure	Solid Tumor Participants n=609 Participants Solid tumor (breast, colorectal, lung, and ovary) participants on NeoRecormon® injection were observed until Week 24 to 28 or early withdrawal due to death, participants' will to end the study, lost to follow-up or other reasons. The dose and frequency of NeoRecormon® were at the discretion of treating physician.	Hematological Malignancy Participants n=292 Participants Hematological malignancy (multiple myeloma, Chronic Lymphocytic Leukemia \[CLL\], and lymphoma) participants on NeoRecormon® injection were observed until Week 24 to 28 or early withdrawal due to death, participants' will to end the study, lost to follow-up or other reasons. The dose and frequency of NeoRecormon® were at the discretion of treating physician.	Anemic Cancer Participants (Total Participants) n=901 Participants Anemic cancer participants on NeoRecormon® injection were observed until Week 24 to 28 or early withdrawal due to death, participants' will to end the study, lost to follow-up or other reasons. The dose and frequency of NeoRecormon® were at the discretion of treating physician.	Ovary Cancer Participants Ovary cancer participants on NeoRecormon® injection were observed until Week 24 to 28 or early withdrawal due to death, participants' will to end the study, lost to follow-up or other reasons. The dose and frequency of NeoRecormon® were at the discretion of treating physician.	Multiple Myeloma Participants Multiple myeloma participants on NeoRecormon® injection were observed until Week 24 to 28 or early withdrawal due to death, participants' will to end the study, lost to follow-up or other reasons. The dose and frequency of NeoRecormon® were at the discretion of treating physician.	Non-Hodgkin's Lymphoma Participants Non-Hodgkin's lymphoma participants on NeoRecormon® injection were observed until Week 24 to 28 or early withdrawal due to death, participants' will to end the study, lost to follow-up or other reasons. The dose and frequency of NeoRecormon® were at the discretion of treating physician.	Hodgkin's Lymphoma Participants Hodgkin's lymphoma participants on NeoRecormon® injection were observed until Week 24 to 28 or early withdrawal due to death, participants' will to end the study, lost to follow-up or other reasons. The dose and frequency of NeoRecormon® were at the discretion of treating physician.	Chronic Lymphocytic Leukemia Participants Chronic lymphocytic leukemia participants on NeoRecormon® injection were observed until Week 24 to 28 or early withdrawal due to death, participants' will to end the study, lost to follow-up or other reasons. The dose and frequency of NeoRecormon® were at the discretion of treating physician.	Anemic Cancer Participants (Total Participants) Anemic cancer participants on NeoRecormon® injection were observed until Week 24 to 28 or early withdrawal due to death, participants' will to end the study, lost to follow-up or other reasons. The dose and frequency of NeoRecormon® were at the discretion of treating physician.
Percentage of Participants With Hb Concentration Within the Range of 10 to 12 g/dL	36.0 percentage of participants	18.5 percentage of participants	30.3 percentage of participants	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Baseline, Week 4 to 6, Week 12 to 16, Week 24 to 48

Population: Efficacy population. Here "number of participants analyzed" included those participants who were evaluable for the outcome measure and "n" included participants who were evaluable at specified time point for each arm, respectively.

Criteria for adequate iron status included serum ferritin greater than (>) 100 micrograms/liter (µg/L) and transferrin saturation (TSAT)> 20%.

Outcome measures

Measure	Solid Tumor Participants n=58 Participants Solid tumor (breast, colorectal, lung, and ovary) participants on NeoRecormon® injection were observed until Week 24 to 28 or early withdrawal due to death, participants' will to end the study, lost to follow-up or other reasons. The dose and frequency of NeoRecormon® were at the discretion of treating physician.	Hematological Malignancy Participants n=65 Participants Hematological malignancy (multiple myeloma, Chronic Lymphocytic Leukemia \[CLL\], and lymphoma) participants on NeoRecormon® injection were observed until Week 24 to 28 or early withdrawal due to death, participants' will to end the study, lost to follow-up or other reasons. The dose and frequency of NeoRecormon® were at the discretion of treating physician.	Anemic Cancer Participants (Total Participants) n=123 Participants Anemic cancer participants on NeoRecormon® injection were observed until Week 24 to 28 or early withdrawal due to death, participants' will to end the study, lost to follow-up or other reasons. The dose and frequency of NeoRecormon® were at the discretion of treating physician.	Ovary Cancer Participants Ovary cancer participants on NeoRecormon® injection were observed until Week 24 to 28 or early withdrawal due to death, participants' will to end the study, lost to follow-up or other reasons. The dose and frequency of NeoRecormon® were at the discretion of treating physician.	Multiple Myeloma Participants Multiple myeloma participants on NeoRecormon® injection were observed until Week 24 to 28 or early withdrawal due to death, participants' will to end the study, lost to follow-up or other reasons. The dose and frequency of NeoRecormon® were at the discretion of treating physician.	Non-Hodgkin's Lymphoma Participants Non-Hodgkin's lymphoma participants on NeoRecormon® injection were observed until Week 24 to 28 or early withdrawal due to death, participants' will to end the study, lost to follow-up or other reasons. The dose and frequency of NeoRecormon® were at the discretion of treating physician.	Hodgkin's Lymphoma Participants Hodgkin's lymphoma participants on NeoRecormon® injection were observed until Week 24 to 28 or early withdrawal due to death, participants' will to end the study, lost to follow-up or other reasons. The dose and frequency of NeoRecormon® were at the discretion of treating physician.	Chronic Lymphocytic Leukemia Participants Chronic lymphocytic leukemia participants on NeoRecormon® injection were observed until Week 24 to 28 or early withdrawal due to death, participants' will to end the study, lost to follow-up or other reasons. The dose and frequency of NeoRecormon® were at the discretion of treating physician.	Anemic Cancer Participants (Total Participants) Anemic cancer participants on NeoRecormon® injection were observed until Week 24 to 28 or early withdrawal due to death, participants' will to end the study, lost to follow-up or other reasons. The dose and frequency of NeoRecormon® were at the discretion of treating physician.
Percentage of Participants With Adequate Iron Status Baseline (n=58,65,123)	37.9 percentage of participants	47.7 percentage of participants	43.1 percentage of participants	—	—	—	—	—	—
Percentage of Participants With Adequate Iron Status Week 4-6 (n=31,18,49)	22.6 percentage of participants	16.7 percentage of participants	20.4 percentage of participants	—	—	—	—	—	—
Percentage of Participants With Adequate Iron Status Week 12-16 (n=24,18,42)	25.0 percentage of participants	38.9 percentage of participants	31.0 percentage of participants	—	—	—	—	—	—
Percentage of Participants With Adequate Iron Status Week 24-28 (n=13,17,30)	53.8 percentage of participants	70.6 percentage of participants	63.3 percentage of participants	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Week 4 to 6, Week 12 to 16, Week 24 to 48

Population: Efficacy population. Here "number of participants analyzed" included those participants who were evaluable for the outcome measure and "n" included participants who were evaluable at specified time point for each arm, respectively.

Outcome measures

Measure	Solid Tumor Participants n=230 Participants Solid tumor (breast, colorectal, lung, and ovary) participants on NeoRecormon® injection were observed until Week 24 to 28 or early withdrawal due to death, participants' will to end the study, lost to follow-up or other reasons. The dose and frequency of NeoRecormon® were at the discretion of treating physician.	Hematological Malignancy Participants n=132 Participants Hematological malignancy (multiple myeloma, Chronic Lymphocytic Leukemia \[CLL\], and lymphoma) participants on NeoRecormon® injection were observed until Week 24 to 28 or early withdrawal due to death, participants' will to end the study, lost to follow-up or other reasons. The dose and frequency of NeoRecormon® were at the discretion of treating physician.	Anemic Cancer Participants (Total Participants) n=153 Participants Anemic cancer participants on NeoRecormon® injection were observed until Week 24 to 28 or early withdrawal due to death, participants' will to end the study, lost to follow-up or other reasons. The dose and frequency of NeoRecormon® were at the discretion of treating physician.	Ovary Cancer Participants n=86 Participants Ovary cancer participants on NeoRecormon® injection were observed until Week 24 to 28 or early withdrawal due to death, participants' will to end the study, lost to follow-up or other reasons. The dose and frequency of NeoRecormon® were at the discretion of treating physician.	Multiple Myeloma Participants n=72 Participants Multiple myeloma participants on NeoRecormon® injection were observed until Week 24 to 28 or early withdrawal due to death, participants' will to end the study, lost to follow-up or other reasons. The dose and frequency of NeoRecormon® were at the discretion of treating physician.	Non-Hodgkin's Lymphoma Participants n=158 Participants Non-Hodgkin's lymphoma participants on NeoRecormon® injection were observed until Week 24 to 28 or early withdrawal due to death, participants' will to end the study, lost to follow-up or other reasons. The dose and frequency of NeoRecormon® were at the discretion of treating physician.	Hodgkin's Lymphoma Participants n=23 Participants Hodgkin's lymphoma participants on NeoRecormon® injection were observed until Week 24 to 28 or early withdrawal due to death, participants' will to end the study, lost to follow-up or other reasons. The dose and frequency of NeoRecormon® were at the discretion of treating physician.	Chronic Lymphocytic Leukemia Participants n=30 Participants Chronic lymphocytic leukemia participants on NeoRecormon® injection were observed until Week 24 to 28 or early withdrawal due to death, participants' will to end the study, lost to follow-up or other reasons. The dose and frequency of NeoRecormon® were at the discretion of treating physician.	Anemic Cancer Participants (Total Participants) n=884 Participants Anemic cancer participants on NeoRecormon® injection were observed until Week 24 to 28 or early withdrawal due to death, participants' will to end the study, lost to follow-up or other reasons. The dose and frequency of NeoRecormon® were at the discretion of treating physician.
Percentage of Participants With Vitamins Prescription Week 24-28 (n=165,114,111,72,57,127,17,21,684)	6.1 percentage of participants	0.9 percentage of participants	1.8 percentage of participants	2.8 percentage of participants	0.0 percentage of participants	3.9 percentage of participants	5.9 percentage of participants	9.5 percentage of participants	3.4 percentage of participants
Percentage of Participants With Vitamins Prescription Week 4-6 (n=217,129,142,74,63,143,23,29,820)	12.4 percentage of participants	1.6 percentage of participants	0.7 percentage of participants	4.1 percentage of participants	3.2 percentage of participants	9.8 percentage of participants	17.4 percentage of participants	10.3 percentage of participants	6.8 percentage of participants
Percentage of Participants With Vitamins Prescription Week 12-16 (n=230,132,153,86,72,158,23,30,884)	6.5 percentage of participants	0.8 percentage of participants	3.9 percentage of participants	3.5 percentage of participants	4.2 percentage of participants	8.2 percentage of participants	17.4 percentage of participants	10.0 percentage of participants	5.4 percentage of participants

Adverse Events

Solid Tumor Participants

Serious events: 6 serious events

Other events: 63 other events

Deaths: 0 deaths

Hematological Malignancy Participants

Serious events: 4 serious events

Other events: 31 other events

Deaths: 0 deaths

Anemic Cancer Participants (Total Participants)

Serious events: 10 serious events

Other events: 94 other events

Deaths: 0 deaths

Serious adverse events

Measure	Solid Tumor Participants n=735 participants at risk Solid tumor (breast, colorectal, lung, and ovary) participants on NeoRecormon® injection were observed until Week 24 to 28 or early withdrawal due to death, participants' will to end the study, lost to follow-up or other reasons. The dose and frequency of NeoRecormon® were at the discretion of treating physician.	Hematological Malignancy Participants n=319 participants at risk Hematological malignancy (multiple myeloma, CLL, and lymphoma) participants on NeoRecormon® injection were observed until Week 24 to 28 or early withdrawal due to death, participants' will to end the study, lost to follow-up or other reasons. The dose and frequency of NeoRecormon® were at the discretion of treating physician.	Anemic Cancer Participants (Total Participants) n=1054 participants at risk Anemic cancer participants on NeoRecormon® injection were observed until Week 24 to 28 or early withdrawal due to death, participants' will to end the study, lost to follow-up or other reasons. The dose and frequency of NeoRecormon® were at the discretion of treating physician.
General disorders Death	0.14% 1/735 • Number of events 1 • Baseline up to 28 day after last dose Safety population included participants who had received at least 1 dose of NeoRecormon® injection.	0.63% 2/319 • Number of events 2 • Baseline up to 28 day after last dose Safety population included participants who had received at least 1 dose of NeoRecormon® injection.	0.28% 3/1054 • Number of events 3 • Baseline up to 28 day after last dose Safety population included participants who had received at least 1 dose of NeoRecormon® injection.
General disorders Pain	0.14% 1/735 • Number of events 1 • Baseline up to 28 day after last dose Safety population included participants who had received at least 1 dose of NeoRecormon® injection.	0.00% 0/319 • Baseline up to 28 day after last dose Safety population included participants who had received at least 1 dose of NeoRecormon® injection.	0.09% 1/1054 • Number of events 1 • Baseline up to 28 day after last dose Safety population included participants who had received at least 1 dose of NeoRecormon® injection.
Infections and infestations Sepsis	0.00% 0/735 • Baseline up to 28 day after last dose Safety population included participants who had received at least 1 dose of NeoRecormon® injection.	0.31% 1/319 • Number of events 1 • Baseline up to 28 day after last dose Safety population included participants who had received at least 1 dose of NeoRecormon® injection.	0.09% 1/1054 • Number of events 1 • Baseline up to 28 day after last dose Safety population included participants who had received at least 1 dose of NeoRecormon® injection.
Infections and infestations Septic shock	0.00% 0/735 • Baseline up to 28 day after last dose Safety population included participants who had received at least 1 dose of NeoRecormon® injection.	0.31% 1/319 • Number of events 1 • Baseline up to 28 day after last dose Safety population included participants who had received at least 1 dose of NeoRecormon® injection.	0.09% 1/1054 • Number of events 1 • Baseline up to 28 day after last dose Safety population included participants who had received at least 1 dose of NeoRecormon® injection.
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	0.27% 2/735 • Number of events 2 • Baseline up to 28 day after last dose Safety population included participants who had received at least 1 dose of NeoRecormon® injection.	0.00% 0/319 • Baseline up to 28 day after last dose Safety population included participants who had received at least 1 dose of NeoRecormon® injection.	0.19% 2/1054 • Number of events 2 • Baseline up to 28 day after last dose Safety population included participants who had received at least 1 dose of NeoRecormon® injection.
Blood and lymphatic system disorders Febrile neutropenia	0.00% 0/735 • Baseline up to 28 day after last dose Safety population included participants who had received at least 1 dose of NeoRecormon® injection.	0.31% 1/319 • Number of events 1 • Baseline up to 28 day after last dose Safety population included participants who had received at least 1 dose of NeoRecormon® injection.	0.09% 1/1054 • Number of events 1 • Baseline up to 28 day after last dose Safety population included participants who had received at least 1 dose of NeoRecormon® injection.
Musculoskeletal and connective tissue disorders Fistula	0.14% 1/735 • Number of events 1 • Baseline up to 28 day after last dose Safety population included participants who had received at least 1 dose of NeoRecormon® injection.	0.00% 0/319 • Baseline up to 28 day after last dose Safety population included participants who had received at least 1 dose of NeoRecormon® injection.	0.09% 1/1054 • Number of events 1 • Baseline up to 28 day after last dose Safety population included participants who had received at least 1 dose of NeoRecormon® injection.
Vascular disorders Phlebitis	0.14% 1/735 • Number of events 1 • Baseline up to 28 day after last dose Safety population included participants who had received at least 1 dose of NeoRecormon® injection.	0.00% 0/319 • Baseline up to 28 day after last dose Safety population included participants who had received at least 1 dose of NeoRecormon® injection.	0.09% 1/1054 • Number of events 1 • Baseline up to 28 day after last dose Safety population included participants who had received at least 1 dose of NeoRecormon® injection.

Other adverse events

Measure	Solid Tumor Participants n=735 participants at risk Solid tumor (breast, colorectal, lung, and ovary) participants on NeoRecormon® injection were observed until Week 24 to 28 or early withdrawal due to death, participants' will to end the study, lost to follow-up or other reasons. The dose and frequency of NeoRecormon® were at the discretion of treating physician.	Hematological Malignancy Participants n=319 participants at risk Hematological malignancy (multiple myeloma, CLL, and lymphoma) participants on NeoRecormon® injection were observed until Week 24 to 28 or early withdrawal due to death, participants' will to end the study, lost to follow-up or other reasons. The dose and frequency of NeoRecormon® were at the discretion of treating physician.	Anemic Cancer Participants (Total Participants) n=1054 participants at risk Anemic cancer participants on NeoRecormon® injection were observed until Week 24 to 28 or early withdrawal due to death, participants' will to end the study, lost to follow-up or other reasons. The dose and frequency of NeoRecormon® were at the discretion of treating physician.
General disorders Asthenia	100.0% 8/8 • Number of events 9 • Baseline up to 28 day after last dose Safety population included participants who had received at least 1 dose of NeoRecormon® injection.	0.94% 3/319 • Number of events 3 • Baseline up to 28 day after last dose Safety population included participants who had received at least 1 dose of NeoRecormon® injection.	1.0% 11/1054 • Number of events 12 • Baseline up to 28 day after last dose Safety population included participants who had received at least 1 dose of NeoRecormon® injection.
General disorders Disease progression	1.2% 9/735 • Number of events 9 • Baseline up to 28 day after last dose Safety population included participants who had received at least 1 dose of NeoRecormon® injection.	0.31% 1/319 • Number of events 1 • Baseline up to 28 day after last dose Safety population included participants who had received at least 1 dose of NeoRecormon® injection.	0.95% 10/1054 • Number of events 10 • Baseline up to 28 day after last dose Safety population included participants who had received at least 1 dose of NeoRecormon® injection.
General disorders General physical health deterioration	0.68% 5/735 • Number of events 5 • Baseline up to 28 day after last dose Safety population included participants who had received at least 1 dose of NeoRecormon® injection.	0.31% 1/319 • Number of events 1 • Baseline up to 28 day after last dose Safety population included participants who had received at least 1 dose of NeoRecormon® injection.	0.57% 6/1054 • Number of events 6 • Baseline up to 28 day after last dose Safety population included participants who had received at least 1 dose of NeoRecormon® injection.
General disorders Pyrexia	0.27% 2/735 • Number of events 2 • Baseline up to 28 day after last dose Safety population included participants who had received at least 1 dose of NeoRecormon® injection.	0.63% 2/319 • Number of events 2 • Baseline up to 28 day after last dose Safety population included participants who had received at least 1 dose of NeoRecormon® injection.	0.38% 4/1054 • Number of events 4 • Baseline up to 28 day after last dose Safety population included participants who had received at least 1 dose of NeoRecormon® injection.
General disorders Hyperthermia	0.14% 1/735 • Number of events 1 • Baseline up to 28 day after last dose Safety population included participants who had received at least 1 dose of NeoRecormon® injection.	0.63% 2/319 • Number of events 3 • Baseline up to 28 day after last dose Safety population included participants who had received at least 1 dose of NeoRecormon® injection.	0.28% 3/1054 • Number of events 4 • Baseline up to 28 day after last dose Safety population included participants who had received at least 1 dose of NeoRecormon® injection.
General disorders Malaise	0.14% 1/735 • Number of events 1 • Baseline up to 28 day after last dose Safety population included participants who had received at least 1 dose of NeoRecormon® injection.	0.31% 1/319 • Number of events 1 • Baseline up to 28 day after last dose Safety population included participants who had received at least 1 dose of NeoRecormon® injection.	0.19% 2/1054 • Number of events 2 • Baseline up to 28 day after last dose Safety population included participants who had received at least 1 dose of NeoRecormon® injection.
General disorders Oedema peripheral	0.00% 0/735 • Baseline up to 28 day after last dose Safety population included participants who had received at least 1 dose of NeoRecormon® injection.	0.63% 2/319 • Number of events 2 • Baseline up to 28 day after last dose Safety population included participants who had received at least 1 dose of NeoRecormon® injection.	0.19% 2/1054 • Number of events 2 • Baseline up to 28 day after last dose Safety population included participants who had received at least 1 dose of NeoRecormon® injection.
General disorders Catheter thrombosis	0.14% 1/735 • Number of events 1 • Baseline up to 28 day after last dose Safety population included participants who had received at least 1 dose of NeoRecormon® injection.	0.00% 0/319 • Baseline up to 28 day after last dose Safety population included participants who had received at least 1 dose of NeoRecormon® injection.	0.09% 1/1054 • Number of events 1 • Baseline up to 28 day after last dose Safety population included participants who had received at least 1 dose of NeoRecormon® injection.
General disorders Facial pain	0.00% 0/735 • Baseline up to 28 day after last dose Safety population included participants who had received at least 1 dose of NeoRecormon® injection.	0.31% 1/319 • Number of events 1 • Baseline up to 28 day after last dose Safety population included participants who had received at least 1 dose of NeoRecormon® injection.	0.09% 1/1054 • Number of events 1 • Baseline up to 28 day after last dose Safety population included participants who had received at least 1 dose of NeoRecormon® injection.
General disorders Fatigue	0.14% 1/735 • Number of events 1 • Baseline up to 28 day after last dose Safety population included participants who had received at least 1 dose of NeoRecormon® injection.	0.00% 0/319 • Baseline up to 28 day after last dose Safety population included participants who had received at least 1 dose of NeoRecormon® injection.	0.09% 1/1054 • Number of events 1 • Baseline up to 28 day after last dose Safety population included participants who had received at least 1 dose of NeoRecormon® injection.
Gastrointestinal disorders Nausea	0.95% 7/735 • Number of events 7 • Baseline up to 28 day after last dose Safety population included participants who had received at least 1 dose of NeoRecormon® injection.	0.94% 3/319 • Number of events 3 • Baseline up to 28 day after last dose Safety population included participants who had received at least 1 dose of NeoRecormon® injection.	0.95% 10/1054 • Number of events 10 • Baseline up to 28 day after last dose Safety population included participants who had received at least 1 dose of NeoRecormon® injection.
Gastrointestinal disorders Diarrhoea	0.82% 6/735 • Number of events 6 • Baseline up to 28 day after last dose Safety population included participants who had received at least 1 dose of NeoRecormon® injection.	0.94% 3/319 • Number of events 4 • Baseline up to 28 day after last dose Safety population included participants who had received at least 1 dose of NeoRecormon® injection.	0.85% 9/1054 • Number of events 10 • Baseline up to 28 day after last dose Safety population included participants who had received at least 1 dose of NeoRecormon® injection.
Gastrointestinal disorders Vomiting	0.54% 4/735 • Number of events 4 • Baseline up to 28 day after last dose Safety population included participants who had received at least 1 dose of NeoRecormon® injection.	0.31% 1/319 • Number of events 1 • Baseline up to 28 day after last dose Safety population included participants who had received at least 1 dose of NeoRecormon® injection.	0.47% 5/1054 • Number of events 5 • Baseline up to 28 day after last dose Safety population included participants who had received at least 1 dose of NeoRecormon® injection.
Gastrointestinal disorders Abdominal pain	0.27% 2/735 • Number of events 2 • Baseline up to 28 day after last dose Safety population included participants who had received at least 1 dose of NeoRecormon® injection.	0.00% 0/319 • Baseline up to 28 day after last dose Safety population included participants who had received at least 1 dose of NeoRecormon® injection.	0.19% 2/1054 • Number of events 2 • Baseline up to 28 day after last dose Safety population included participants who had received at least 1 dose of NeoRecormon® injection.
Gastrointestinal disorders Constipation	0.27% 2/735 • Number of events 2 • Baseline up to 28 day after last dose Safety population included participants who had received at least 1 dose of NeoRecormon® injection.	0.00% 0/319 • Baseline up to 28 day after last dose Safety population included participants who had received at least 1 dose of NeoRecormon® injection.	0.19% 2/1054 • Number of events 2 • Baseline up to 28 day after last dose Safety population included participants who had received at least 1 dose of NeoRecormon® injection.
Gastrointestinal disorders Anorectal discomfort	0.14% 1/735 • Number of events 1 • Baseline up to 28 day after last dose Safety population included participants who had received at least 1 dose of NeoRecormon® injection.	0.00% 0/319 • Baseline up to 28 day after last dose Safety population included participants who had received at least 1 dose of NeoRecormon® injection.	0.09% 1/1054 • Number of events 1 • Baseline up to 28 day after last dose Safety population included participants who had received at least 1 dose of NeoRecormon® injection.
Gastrointestinal disorders Aphthous stomatitis	0.00% 0/735 • Baseline up to 28 day after last dose Safety population included participants who had received at least 1 dose of NeoRecormon® injection.	0.31% 1/319 • Number of events 1 • Baseline up to 28 day after last dose Safety population included participants who had received at least 1 dose of NeoRecormon® injection.	0.09% 1/1054 • Number of events 1 • Baseline up to 28 day after last dose Safety population included participants who had received at least 1 dose of NeoRecormon® injection.
Gastrointestinal disorders Dry mouth	0.00% 0/735 • Baseline up to 28 day after last dose Safety population included participants who had received at least 1 dose of NeoRecormon® injection.	0.31% 1/319 • Number of events 1 • Baseline up to 28 day after last dose Safety population included participants who had received at least 1 dose of NeoRecormon® injection.	0.09% 1/1054 • Number of events 1 • Baseline up to 28 day after last dose Safety population included participants who had received at least 1 dose of NeoRecormon® injection.
Gastrointestinal disorders Gastrointestinal disorder	0.14% 1/735 • Number of events 1 • Baseline up to 28 day after last dose Safety population included participants who had received at least 1 dose of NeoRecormon® injection.	0.00% 0/319 • Baseline up to 28 day after last dose Safety population included participants who had received at least 1 dose of NeoRecormon® injection.	0.09% 1/1054 • Number of events 1 • Baseline up to 28 day after last dose Safety population included participants who had received at least 1 dose of NeoRecormon® injection.
Gastrointestinal disorders Gastrointestinal motility disorder	0.00% 0/735 • Baseline up to 28 day after last dose Safety population included participants who had received at least 1 dose of NeoRecormon® injection.	0.31% 1/319 • Number of events 1 • Baseline up to 28 day after last dose Safety population included participants who had received at least 1 dose of NeoRecormon® injection.	0.09% 1/1054 • Number of events 1 • Baseline up to 28 day after last dose Safety population included participants who had received at least 1 dose of NeoRecormon® injection.
Gastrointestinal disorders Gastrooesophageal reflux disease	0.00% 0/735 • Baseline up to 28 day after last dose Safety population included participants who had received at least 1 dose of NeoRecormon® injection.	0.31% 1/319 • Number of events 1 • Baseline up to 28 day after last dose Safety population included participants who had received at least 1 dose of NeoRecormon® injection.	0.09% 1/1054 • Number of events 1 • Baseline up to 28 day after last dose Safety population included participants who had received at least 1 dose of NeoRecormon® injection.
Gastrointestinal disorders Haemorrhoids	0.00% 0/735 • Baseline up to 28 day after last dose Safety population included participants who had received at least 1 dose of NeoRecormon® injection.	0.31% 1/319 • Number of events 1 • Baseline up to 28 day after last dose Safety population included participants who had received at least 1 dose of NeoRecormon® injection.	0.09% 1/1054 • Number of events 1 • Baseline up to 28 day after last dose Safety population included participants who had received at least 1 dose of NeoRecormon® injection.
Gastrointestinal disorders Oesophagitis	0.14% 1/735 • Number of events 1 • Baseline up to 28 day after last dose Safety population included participants who had received at least 1 dose of NeoRecormon® injection.	0.00% 0/319 • Baseline up to 28 day after last dose Safety population included participants who had received at least 1 dose of NeoRecormon® injection.	0.09% 1/1054 • Number of events 1 • Baseline up to 28 day after last dose Safety population included participants who had received at least 1 dose of NeoRecormon® injection.
Gastrointestinal disorders Stomatitis	0.14% 1/735 • Number of events 1 • Baseline up to 28 day after last dose Safety population included participants who had received at least 1 dose of NeoRecormon® injection.	0.00% 0/319 • Baseline up to 28 day after last dose Safety population included participants who had received at least 1 dose of NeoRecormon® injection.	0.09% 1/1054 • Number of events 1 • Baseline up to 28 day after last dose Safety population included participants who had received at least 1 dose of NeoRecormon® injection.
Blood and lymphatic system disorders Neutropenia	0.68% 5/735 • Number of events 6 • Baseline up to 28 day after last dose Safety population included participants who had received at least 1 dose of NeoRecormon® injection.	0.31% 1/319 • Number of events 1 • Baseline up to 28 day after last dose Safety population included participants who had received at least 1 dose of NeoRecormon® injection.	0.57% 6/1054 • Number of events 7 • Baseline up to 28 day after last dose Safety population included participants who had received at least 1 dose of NeoRecormon® injection.
Blood and lymphatic system disorders Anaemia	0.41% 3/735 • Number of events 4 • Baseline up to 28 day after last dose Safety population included participants who had received at least 1 dose of NeoRecormon® injection.	0.31% 1/319 • Number of events 1 • Baseline up to 28 day after last dose Safety population included participants who had received at least 1 dose of NeoRecormon® injection.	0.38% 4/1054 • Number of events 5 • Baseline up to 28 day after last dose Safety population included participants who had received at least 1 dose of NeoRecormon® injection.
Blood and lymphatic system disorders Febrile bone marrow aplasia	0.27% 2/735 • Number of events 2 • Baseline up to 28 day after last dose Safety population included participants who had received at least 1 dose of NeoRecormon® injection.	0.31% 1/319 • Number of events 2 • Baseline up to 28 day after last dose Safety population included participants who had received at least 1 dose of NeoRecormon® injection.	0.28% 3/1054 • Number of events 4 • Baseline up to 28 day after last dose Safety population included participants who had received at least 1 dose of NeoRecormon® injection.
Blood and lymphatic system disorders Pancytopenia	0.14% 1/735 • Number of events 1 • Baseline up to 28 day after last dose Safety population included participants who had received at least 1 dose of NeoRecormon® injection.	0.31% 1/319 • Number of events 1 • Baseline up to 28 day after last dose Safety population included participants who had received at least 1 dose of NeoRecormon® injection.	0.19% 2/1054 • Number of events 2 • Baseline up to 28 day after last dose Safety population included participants who had received at least 1 dose of NeoRecormon® injection.
Blood and lymphatic system disorders Thrombocythaemia	0.27% 2/735 • Number of events 2 • Baseline up to 28 day after last dose Safety population included participants who had received at least 1 dose of NeoRecormon® injection.	0.00% 0/319 • Baseline up to 28 day after last dose Safety population included participants who had received at least 1 dose of NeoRecormon® injection.	0.19% 2/1054 • Number of events 2 • Baseline up to 28 day after last dose Safety population included participants who had received at least 1 dose of NeoRecormon® injection.
Blood and lymphatic system disorders Lymphopenia	0.14% 1/735 • Number of events 1 • Baseline up to 28 day after last dose Safety population included participants who had received at least 1 dose of NeoRecormon® injection.	0.00% 0/319 • Baseline up to 28 day after last dose Safety population included participants who had received at least 1 dose of NeoRecormon® injection.	0.09% 1/1054 • Number of events 1 • Baseline up to 28 day after last dose Safety population included participants who had received at least 1 dose of NeoRecormon® injection.
Blood and lymphatic system disorders Thrombocytopenia	0.14% 1/735 • Number of events 1 • Baseline up to 28 day after last dose Safety population included participants who had received at least 1 dose of NeoRecormon® injection.	0.00% 0/319 • Baseline up to 28 day after last dose Safety population included participants who had received at least 1 dose of NeoRecormon® injection.	0.09% 1/1054 • Number of events 1 • Baseline up to 28 day after last dose Safety population included participants who had received at least 1 dose of NeoRecormon® injection.
Infections and infestations Urinary tract infection	0.27% 2/735 • Number of events 2 • Baseline up to 28 day after last dose Safety population included participants who had received at least 1 dose of NeoRecormon® injection.	0.31% 1/319 • Number of events 1 • Baseline up to 28 day after last dose Safety population included participants who had received at least 1 dose of NeoRecormon® injection.	0.28% 3/1054 • Number of events 3 • Baseline up to 28 day after last dose Safety population included participants who had received at least 1 dose of NeoRecormon® injection.
Infections and infestations Bronchitis	0.14% 1/735 • Number of events 1 • Baseline up to 28 day after last dose Safety population included participants who had received at least 1 dose of NeoRecormon® injection.	0.31% 1/319 • Number of events 1 • Baseline up to 28 day after last dose Safety population included participants who had received at least 1 dose of NeoRecormon® injection.	0.19% 2/1054 • Number of events 2 • Baseline up to 28 day after last dose Safety population included participants who had received at least 1 dose of NeoRecormon® injection.
Infections and infestations Nasopharyngitis	0.00% 0/735 • Baseline up to 28 day after last dose Safety population included participants who had received at least 1 dose of NeoRecormon® injection.	0.63% 2/319 • Number of events 2 • Baseline up to 28 day after last dose Safety population included participants who had received at least 1 dose of NeoRecormon® injection.	0.19% 2/1054 • Number of events 2 • Baseline up to 28 day after last dose Safety population included participants who had received at least 1 dose of NeoRecormon® injection.
Infections and infestations Candidiasis	0.14% 1/735 • Number of events 1 • Baseline up to 28 day after last dose Safety population included participants who had received at least 1 dose of NeoRecormon® injection.	0.00% 0/319 • Baseline up to 28 day after last dose Safety population included participants who had received at least 1 dose of NeoRecormon® injection.	0.09% 1/1054 • Number of events 1 • Baseline up to 28 day after last dose Safety population included participants who had received at least 1 dose of NeoRecormon® injection.
Infections and infestations Ear infection	0.00% 0/735 • Baseline up to 28 day after last dose Safety population included participants who had received at least 1 dose of NeoRecormon® injection.	0.31% 1/319 • Number of events 1 • Baseline up to 28 day after last dose Safety population included participants who had received at least 1 dose of NeoRecormon® injection.	0.09% 1/1054 • Number of events 1 • Baseline up to 28 day after last dose Safety population included participants who had received at least 1 dose of NeoRecormon® injection.
Infections and infestations Erysipelas	0.00% 0/735 • Baseline up to 28 day after last dose Safety population included participants who had received at least 1 dose of NeoRecormon® injection.	0.31% 1/319 • Number of events 1 • Baseline up to 28 day after last dose Safety population included participants who had received at least 1 dose of NeoRecormon® injection.	0.09% 1/1054 • Number of events 1 • Baseline up to 28 day after last dose Safety population included participants who had received at least 1 dose of NeoRecormon® injection.
Infections and infestations Escherichia infection	0.00% 0/735 • Baseline up to 28 day after last dose Safety population included participants who had received at least 1 dose of NeoRecormon® injection.	0.31% 1/319 • Number of events 1 • Baseline up to 28 day after last dose Safety population included participants who had received at least 1 dose of NeoRecormon® injection.	0.09% 1/1054 • Number of events 1 • Baseline up to 28 day after last dose Safety population included participants who had received at least 1 dose of NeoRecormon® injection.
Infections and infestations Folliculitis	0.14% 1/735 • Number of events 1 • Baseline up to 28 day after last dose Safety population included participants who had received at least 1 dose of NeoRecormon® injection.	0.00% 0/319 • Baseline up to 28 day after last dose Safety population included participants who had received at least 1 dose of NeoRecormon® injection.	0.09% 1/1054 • Number of events 1 • Baseline up to 28 day after last dose Safety population included participants who had received at least 1 dose of NeoRecormon® injection.
Infections and infestations HIV infection	0.00% 0/735 • Baseline up to 28 day after last dose Safety population included participants who had received at least 1 dose of NeoRecormon® injection.	0.31% 1/319 • Number of events 1 • Baseline up to 28 day after last dose Safety population included participants who had received at least 1 dose of NeoRecormon® injection.	0.09% 1/1054 • Number of events 1 • Baseline up to 28 day after last dose Safety population included participants who had received at least 1 dose of NeoRecormon® injection.
Infections and infestations Oral fungal infection	0.00% 0/735 • Baseline up to 28 day after last dose Safety population included participants who had received at least 1 dose of NeoRecormon® injection.	0.31% 1/319 • Number of events 1 • Baseline up to 28 day after last dose Safety population included participants who had received at least 1 dose of NeoRecormon® injection.	0.09% 1/1054 • Number of events 1 • Baseline up to 28 day after last dose Safety population included participants who had received at least 1 dose of NeoRecormon® injection.
Infections and infestations Pneumonia	0.00% 0/735 • Baseline up to 28 day after last dose Safety population included participants who had received at least 1 dose of NeoRecormon® injection.	0.31% 1/319 • Number of events 1 • Baseline up to 28 day after last dose Safety population included participants who had received at least 1 dose of NeoRecormon® injection.	0.09% 1/1054 • Number of events 1 • Baseline up to 28 day after last dose Safety population included participants who had received at least 1 dose of NeoRecormon® injection.
Infections and infestations Sinusitis	0.14% 1/735 • Number of events 1 • Baseline up to 28 day after last dose Safety population included participants who had received at least 1 dose of NeoRecormon® injection.	0.00% 0/319 • Baseline up to 28 day after last dose Safety population included participants who had received at least 1 dose of NeoRecormon® injection.	0.09% 1/1054 • Number of events 1 • Baseline up to 28 day after last dose Safety population included participants who had received at least 1 dose of NeoRecormon® injection.
Infections and infestations Tonsilitis	0.00% 0/735 • Baseline up to 28 day after last dose Safety population included participants who had received at least 1 dose of NeoRecormon® injection.	0.31% 1/319 • Number of events 1 • Baseline up to 28 day after last dose Safety population included participants who had received at least 1 dose of NeoRecormon® injection.	0.09% 1/1054 • Number of events 1 • Baseline up to 28 day after last dose Safety population included participants who had received at least 1 dose of NeoRecormon® injection.
Nervous system disorders Dysaesthesia	0.14% 1/735 • Number of events 1 • Baseline up to 28 day after last dose Safety population included participants who had received at least 1 dose of NeoRecormon® injection.	0.63% 2/319 • Number of events 2 • Baseline up to 28 day after last dose Safety population included participants who had received at least 1 dose of NeoRecormon® injection.	0.28% 3/1054 • Number of events 3 • Baseline up to 28 day after last dose Safety population included participants who had received at least 1 dose of NeoRecormon® injection.
Nervous system disorders Neuropathy peripheral	0.14% 1/735 • Number of events 1 • Baseline up to 28 day after last dose Safety population included participants who had received at least 1 dose of NeoRecormon® injection.	0.63% 2/319 • Number of events 2 • Baseline up to 28 day after last dose Safety population included participants who had received at least 1 dose of NeoRecormon® injection.	0.28% 3/1054 • Number of events 3 • Baseline up to 28 day after last dose Safety population included participants who had received at least 1 dose of NeoRecormon® injection.
Nervous system disorders Headache	0.00% 0/735 • Baseline up to 28 day after last dose Safety population included participants who had received at least 1 dose of NeoRecormon® injection.	0.63% 2/319 • Number of events 2 • Baseline up to 28 day after last dose Safety population included participants who had received at least 1 dose of NeoRecormon® injection.	0.19% 2/1054 • Number of events 2 • Baseline up to 28 day after last dose Safety population included participants who had received at least 1 dose of NeoRecormon® injection.
Nervous system disorders Ageusia	0.00% 0/735 • Baseline up to 28 day after last dose Safety population included participants who had received at least 1 dose of NeoRecormon® injection.	0.31% 1/319 • Number of events 1 • Baseline up to 28 day after last dose Safety population included participants who had received at least 1 dose of NeoRecormon® injection.	0.09% 1/1054 • Number of events 1 • Baseline up to 28 day after last dose Safety population included participants who had received at least 1 dose of NeoRecormon® injection.
Nervous system disorders Cerebral ischaemia	0.00% 0/735 • Baseline up to 28 day after last dose Safety population included participants who had received at least 1 dose of NeoRecormon® injection.	0.31% 1/319 • Number of events 1 • Baseline up to 28 day after last dose Safety population included participants who had received at least 1 dose of NeoRecormon® injection.	0.09% 1/1054 • Number of events 1 • Baseline up to 28 day after last dose Safety population included participants who had received at least 1 dose of NeoRecormon® injection.
Nervous system disorders Transient ischaemic attack	0.14% 1/735 • Number of events 1 • Baseline up to 28 day after last dose Safety population included participants who had received at least 1 dose of NeoRecormon® injection.	0.00% 0/319 • Baseline up to 28 day after last dose Safety population included participants who had received at least 1 dose of NeoRecormon® injection.	0.09% 1/1054 • Number of events 1 • Baseline up to 28 day after last dose Safety population included participants who had received at least 1 dose of NeoRecormon® injection.
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	0.27% 2/735 • Number of events 2 • Baseline up to 28 day after last dose Safety population included participants who had received at least 1 dose of NeoRecormon® injection.	0.31% 1/319 • Number of events 1 • Baseline up to 28 day after last dose Safety population included participants who had received at least 1 dose of NeoRecormon® injection.	0.28% 3/1054 • Number of events 3 • Baseline up to 28 day after last dose Safety population included participants who had received at least 1 dose of NeoRecormon® injection.
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.00% 0/735 • Baseline up to 28 day after last dose Safety population included participants who had received at least 1 dose of NeoRecormon® injection.	0.63% 2/319 • Number of events 2 • Baseline up to 28 day after last dose Safety population included participants who had received at least 1 dose of NeoRecormon® injection.	0.19% 2/1054 • Number of events 2 • Baseline up to 28 day after last dose Safety population included participants who had received at least 1 dose of NeoRecormon® injection.
Respiratory, thoracic and mediastinal disorders Lung disorder	0.27% 2/735 • Number of events 2 • Baseline up to 28 day after last dose Safety population included participants who had received at least 1 dose of NeoRecormon® injection.	0.00% 0/319 • Baseline up to 28 day after last dose Safety population included participants who had received at least 1 dose of NeoRecormon® injection.	0.19% 2/1054 • Number of events 2 • Baseline up to 28 day after last dose Safety population included participants who had received at least 1 dose of NeoRecormon® injection.
Respiratory, thoracic and mediastinal disorders Dyspnoea exertional	0.00% 0/735 • Baseline up to 28 day after last dose Safety population included participants who had received at least 1 dose of NeoRecormon® injection.	0.31% 1/319 • Number of events 1 • Baseline up to 28 day after last dose Safety population included participants who had received at least 1 dose of NeoRecormon® injection.	0.09% 1/1054 • Number of events 1 • Baseline up to 28 day after last dose Safety population included participants who had received at least 1 dose of NeoRecormon® injection.
Respiratory, thoracic and mediastinal disorders Epistaxis	0.14% 1/735 • Number of events 1 • Baseline up to 28 day after last dose Safety population included participants who had received at least 1 dose of NeoRecormon® injection.	0.00% 0/319 • Baseline up to 28 day after last dose Safety population included participants who had received at least 1 dose of NeoRecormon® injection.	0.09% 1/1054 • Number of events 1 • Baseline up to 28 day after last dose Safety population included participants who had received at least 1 dose of NeoRecormon® injection.
Respiratory, thoracic and mediastinal disorders Rhinorrhoea	0.00% 0/735 • Baseline up to 28 day after last dose Safety population included participants who had received at least 1 dose of NeoRecormon® injection.	0.31% 1/319 • Number of events 1 • Baseline up to 28 day after last dose Safety population included participants who had received at least 1 dose of NeoRecormon® injection.	0.09% 1/1054 • Number of events 1 • Baseline up to 28 day after last dose Safety population included participants who had received at least 1 dose of NeoRecormon® injection.
Vascular disorders Phlebitis superficial	0.14% 1/735 • Number of events 1 • Baseline up to 28 day after last dose Safety population included participants who had received at least 1 dose of NeoRecormon® injection.	0.63% 2/319 • Number of events 2 • Baseline up to 28 day after last dose Safety population included participants who had received at least 1 dose of NeoRecormon® injection.	0.28% 3/1054 • Number of events 3 • Baseline up to 28 day after last dose Safety population included participants who had received at least 1 dose of NeoRecormon® injection.
Vascular disorders Deep vein thrombosis	0.41% 3/735 • Number of events 3 • Baseline up to 28 day after last dose Safety population included participants who had received at least 1 dose of NeoRecormon® injection.	0.00% 0/319 • Baseline up to 28 day after last dose Safety population included participants who had received at least 1 dose of NeoRecormon® injection.	0.28% 3/1054 • Number of events 3 • Baseline up to 28 day after last dose Safety population included participants who had received at least 1 dose of NeoRecormon® injection.
Vascular disorders Phlebitis	0.27% 2/735 • Number of events 2 • Baseline up to 28 day after last dose Safety population included participants who had received at least 1 dose of NeoRecormon® injection.	0.00% 0/319 • Baseline up to 28 day after last dose Safety population included participants who had received at least 1 dose of NeoRecormon® injection.	0.19% 2/1054 • Number of events 2 • Baseline up to 28 day after last dose Safety population included participants who had received at least 1 dose of NeoRecormon® injection.
Vascular disorders Hypertension	0.14% 1/735 • Number of events 1 • Baseline up to 28 day after last dose Safety population included participants who had received at least 1 dose of NeoRecormon® injection.	0.00% 0/319 • Baseline up to 28 day after last dose Safety population included participants who had received at least 1 dose of NeoRecormon® injection.	0.09% 1/1054 • Number of events 1 • Baseline up to 28 day after last dose Safety population included participants who had received at least 1 dose of NeoRecormon® injection.
Musculoskeletal and connective tissue disorders Back pain	0.27% 2/735 • Number of events 2 • Baseline up to 28 day after last dose Safety population included participants who had received at least 1 dose of NeoRecormon® injection.	0.00% 0/319 • Baseline up to 28 day after last dose Safety population included participants who had received at least 1 dose of NeoRecormon® injection.	0.19% 2/1054 • Number of events 2 • Baseline up to 28 day after last dose Safety population included participants who had received at least 1 dose of NeoRecormon® injection.
Musculoskeletal and connective tissue disorders Myalgia	0.27% 2/735 • Number of events 2 • Baseline up to 28 day after last dose Safety population included participants who had received at least 1 dose of NeoRecormon® injection.	0.00% 0/319 • Baseline up to 28 day after last dose Safety population included participants who had received at least 1 dose of NeoRecormon® injection.	0.19% 2/1054 • Number of events 2 • Baseline up to 28 day after last dose Safety population included participants who had received at least 1 dose of NeoRecormon® injection.
Musculoskeletal and connective tissue disorders Pain in extremity	0.27% 2/735 • Number of events 2 • Baseline up to 28 day after last dose Safety population included participants who had received at least 1 dose of NeoRecormon® injection.	0.00% 0/319 • Baseline up to 28 day after last dose Safety population included participants who had received at least 1 dose of NeoRecormon® injection.	0.19% 2/1054 • Number of events 2 • Baseline up to 28 day after last dose Safety population included participants who had received at least 1 dose of NeoRecormon® injection.
Musculoskeletal and connective tissue disorders Arthralgia	0.00% 0/735 • Baseline up to 28 day after last dose Safety population included participants who had received at least 1 dose of NeoRecormon® injection.	0.31% 1/319 • Number of events 1 • Baseline up to 28 day after last dose Safety population included participants who had received at least 1 dose of NeoRecormon® injection.	0.09% 1/1054 • Number of events 1 • Baseline up to 28 day after last dose Safety population included participants who had received at least 1 dose of NeoRecormon® injection.
Musculoskeletal and connective tissue disorders Arthritis	0.14% 1/735 • Number of events 1 • Baseline up to 28 day after last dose Safety population included participants who had received at least 1 dose of NeoRecormon® injection.	0.00% 0/319 • Baseline up to 28 day after last dose Safety population included participants who had received at least 1 dose of NeoRecormon® injection.	0.09% 1/1054 • Number of events 1 • Baseline up to 28 day after last dose Safety population included participants who had received at least 1 dose of NeoRecormon® injection.
Musculoskeletal and connective tissue disorders Bone pain	0.00% 0/735 • Baseline up to 28 day after last dose Safety population included participants who had received at least 1 dose of NeoRecormon® injection.	0.31% 1/319 • Number of events 1 • Baseline up to 28 day after last dose Safety population included participants who had received at least 1 dose of NeoRecormon® injection.	0.09% 1/1054 • Number of events 1 • Baseline up to 28 day after last dose Safety population included participants who had received at least 1 dose of NeoRecormon® injection.
Musculoskeletal and connective tissue disorders Muscle spasms	0.00% 0/735 • Baseline up to 28 day after last dose Safety population included participants who had received at least 1 dose of NeoRecormon® injection.	0.31% 1/319 • Number of events 1 • Baseline up to 28 day after last dose Safety population included participants who had received at least 1 dose of NeoRecormon® injection.	0.09% 1/1054 • Number of events 1 • Baseline up to 28 day after last dose Safety population included participants who had received at least 1 dose of NeoRecormon® injection.
Skin and subcutaneous tissue disorders Alopecia	0.27% 2/735 • Number of events 2 • Baseline up to 28 day after last dose Safety population included participants who had received at least 1 dose of NeoRecormon® injection.	0.00% 0/319 • Baseline up to 28 day after last dose Safety population included participants who had received at least 1 dose of NeoRecormon® injection.	0.19% 2/1054 • Number of events 2 • Baseline up to 28 day after last dose Safety population included participants who had received at least 1 dose of NeoRecormon® injection.
Skin and subcutaneous tissue disorders Dermititis bullous	0.14% 1/735 • Number of events 1 • Baseline up to 28 day after last dose Safety population included participants who had received at least 1 dose of NeoRecormon® injection.	0.00% 0/319 • Baseline up to 28 day after last dose Safety population included participants who had received at least 1 dose of NeoRecormon® injection.	0.09% 1/1054 • Number of events 1 • Baseline up to 28 day after last dose Safety population included participants who had received at least 1 dose of NeoRecormon® injection.
Skin and subcutaneous tissue disorders Erythema	0.14% 1/735 • Number of events 1 • Baseline up to 28 day after last dose Safety population included participants who had received at least 1 dose of NeoRecormon® injection.	0.00% 0/319 • Baseline up to 28 day after last dose Safety population included participants who had received at least 1 dose of NeoRecormon® injection.	0.09% 1/1054 • Number of events 1 • Baseline up to 28 day after last dose Safety population included participants who had received at least 1 dose of NeoRecormon® injection.
Skin and subcutaneous tissue disorders Lividity	0.14% 1/735 • Number of events 1 • Baseline up to 28 day after last dose Safety population included participants who had received at least 1 dose of NeoRecormon® injection.	0.00% 0/319 • Baseline up to 28 day after last dose Safety population included participants who had received at least 1 dose of NeoRecormon® injection.	0.09% 1/1054 • Number of events 1 • Baseline up to 28 day after last dose Safety population included participants who had received at least 1 dose of NeoRecormon® injection.
Skin and subcutaneous tissue disorders Nail disorder	0.14% 1/735 • Number of events 1 • Baseline up to 28 day after last dose Safety population included participants who had received at least 1 dose of NeoRecormon® injection.	0.00% 0/319 • Baseline up to 28 day after last dose Safety population included participants who had received at least 1 dose of NeoRecormon® injection.	0.09% 1/1054 • Number of events 1 • Baseline up to 28 day after last dose Safety population included participants who had received at least 1 dose of NeoRecormon® injection.
Skin and subcutaneous tissue disorders Palmar-plantar erythrodysaesthesia syndrome	0.14% 1/735 • Number of events 1 • Baseline up to 28 day after last dose Safety population included participants who had received at least 1 dose of NeoRecormon® injection.	0.00% 0/319 • Baseline up to 28 day after last dose Safety population included participants who had received at least 1 dose of NeoRecormon® injection.	0.09% 1/1054 • Number of events 1 • Baseline up to 28 day after last dose Safety population included participants who had received at least 1 dose of NeoRecormon® injection.
Skin and subcutaneous tissue disorders Pigmentation disorder	0.14% 1/735 • Number of events 1 • Baseline up to 28 day after last dose Safety population included participants who had received at least 1 dose of NeoRecormon® injection.	0.00% 0/319 • Baseline up to 28 day after last dose Safety population included participants who had received at least 1 dose of NeoRecormon® injection.	0.09% 1/1054 • Number of events 1 • Baseline up to 28 day after last dose Safety population included participants who had received at least 1 dose of NeoRecormon® injection.
Immune system disorders Hypersensitivity	0.27% 2/735 • Number of events 2 • Baseline up to 28 day after last dose Safety population included participants who had received at least 1 dose of NeoRecormon® injection.	0.00% 0/319 • Baseline up to 28 day after last dose Safety population included participants who had received at least 1 dose of NeoRecormon® injection.	0.19% 2/1054 • Number of events 2 • Baseline up to 28 day after last dose Safety population included participants who had received at least 1 dose of NeoRecormon® injection.
Immune system disorders Drug hypersensitivity	0.14% 1/735 • Number of events 1 • Baseline up to 28 day after last dose Safety population included participants who had received at least 1 dose of NeoRecormon® injection.	0.00% 0/319 • Baseline up to 28 day after last dose Safety population included participants who had received at least 1 dose of NeoRecormon® injection.	0.09% 1/1054 • Number of events 1 • Baseline up to 28 day after last dose Safety population included participants who had received at least 1 dose of NeoRecormon® injection.
Psychiatric disorders Confusional state	0.00% 0/735 • Baseline up to 28 day after last dose Safety population included participants who had received at least 1 dose of NeoRecormon® injection.	0.31% 1/319 • Number of events 1 • Baseline up to 28 day after last dose Safety population included participants who had received at least 1 dose of NeoRecormon® injection.	0.09% 1/1054 • Number of events 1 • Baseline up to 28 day after last dose Safety population included participants who had received at least 1 dose of NeoRecormon® injection.
Psychiatric disorders Initial insomnia	0.14% 1/735 • Number of events 1 • Baseline up to 28 day after last dose Safety population included participants who had received at least 1 dose of NeoRecormon® injection.	0.00% 0/319 • Baseline up to 28 day after last dose Safety population included participants who had received at least 1 dose of NeoRecormon® injection.	0.09% 1/1054 • Number of events 1 • Baseline up to 28 day after last dose Safety population included participants who had received at least 1 dose of NeoRecormon® injection.
Psychiatric disorders Sleep disorder	0.14% 1/735 • Number of events 1 • Baseline up to 28 day after last dose Safety population included participants who had received at least 1 dose of NeoRecormon® injection.	0.00% 0/319 • Baseline up to 28 day after last dose Safety population included participants who had received at least 1 dose of NeoRecormon® injection.	0.09% 1/1054 • Number of events 1 • Baseline up to 28 day after last dose Safety population included participants who had received at least 1 dose of NeoRecormon® injection.
Renal and urinary disorders Dysuria	0.00% 0/735 • Baseline up to 28 day after last dose Safety population included participants who had received at least 1 dose of NeoRecormon® injection.	0.31% 1/319 • Number of events 1 • Baseline up to 28 day after last dose Safety population included participants who had received at least 1 dose of NeoRecormon® injection.	0.09% 1/1054 • Number of events 1 • Baseline up to 28 day after last dose Safety population included participants who had received at least 1 dose of NeoRecormon® injection.
Renal and urinary disorders Renal failure	0.00% 0/735 • Baseline up to 28 day after last dose Safety population included participants who had received at least 1 dose of NeoRecormon® injection.	0.31% 1/319 • Number of events 1 • Baseline up to 28 day after last dose Safety population included participants who had received at least 1 dose of NeoRecormon® injection.	0.09% 1/1054 • Number of events 1 • Baseline up to 28 day after last dose Safety population included participants who had received at least 1 dose of NeoRecormon® injection.
Renal and urinary disorders Vesical fistula	0.14% 1/735 • Number of events 1 • Baseline up to 28 day after last dose Safety population included participants who had received at least 1 dose of NeoRecormon® injection.	0.00% 0/319 • Baseline up to 28 day after last dose Safety population included participants who had received at least 1 dose of NeoRecormon® injection.	0.09% 1/1054 • Number of events 1 • Baseline up to 28 day after last dose Safety population included participants who had received at least 1 dose of NeoRecormon® injection.
Injury, poisoning and procedural complications Post procedural haemorrhage	0.00% 0/735 • Baseline up to 28 day after last dose Safety population included participants who had received at least 1 dose of NeoRecormon® injection.	0.31% 1/319 • Number of events 1 • Baseline up to 28 day after last dose Safety population included participants who had received at least 1 dose of NeoRecormon® injection.	0.09% 1/1054 • Number of events 1 • Baseline up to 28 day after last dose Safety population included participants who had received at least 1 dose of NeoRecormon® injection.
Injury, poisoning and procedural complications Subdural haematoma	0.14% 1/735 • Number of events 1 • Baseline up to 28 day after last dose Safety population included participants who had received at least 1 dose of NeoRecormon® injection.	0.00% 0/319 • Baseline up to 28 day after last dose Safety population included participants who had received at least 1 dose of NeoRecormon® injection.	0.09% 1/1054 • Number of events 1 • Baseline up to 28 day after last dose Safety population included participants who had received at least 1 dose of NeoRecormon® injection.
Metabolism and nutrition disorders Anorexia	0.27% 2/735 • Number of events 2 • Baseline up to 28 day after last dose Safety population included participants who had received at least 1 dose of NeoRecormon® injection.	0.00% 0/319 • Baseline up to 28 day after last dose Safety population included participants who had received at least 1 dose of NeoRecormon® injection.	0.19% 2/1054 • Number of events 2 • Baseline up to 28 day after last dose Safety population included participants who had received at least 1 dose of NeoRecormon® injection.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Infected neoplasm	0.14% 1/735 • Number of events 1 • Baseline up to 28 day after last dose Safety population included participants who had received at least 1 dose of NeoRecormon® injection.	0.00% 0/319 • Baseline up to 28 day after last dose Safety population included participants who had received at least 1 dose of NeoRecormon® injection.	0.09% 1/1054 • Number of events 1 • Baseline up to 28 day after last dose Safety population included participants who had received at least 1 dose of NeoRecormon® injection.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Renal cancer	0.14% 1/735 • Number of events 1 • Baseline up to 28 day after last dose Safety population included participants who had received at least 1 dose of NeoRecormon® injection.	0.00% 0/319 • Baseline up to 28 day after last dose Safety population included participants who had received at least 1 dose of NeoRecormon® injection.	0.09% 1/1054 • Number of events 1 • Baseline up to 28 day after last dose Safety population included participants who had received at least 1 dose of NeoRecormon® injection.
Hepatobiliary disorders Cholestatis	0.14% 1/735 • Number of events 1 • Baseline up to 28 day after last dose Safety population included participants who had received at least 1 dose of NeoRecormon® injection.	0.00% 0/319 • Baseline up to 28 day after last dose Safety population included participants who had received at least 1 dose of NeoRecormon® injection.	0.09% 1/1054 • Number of events 1 • Baseline up to 28 day after last dose Safety population included participants who had received at least 1 dose of NeoRecormon® injection.

Additional Information

Medical Communications

Hoffmann-La Roche

Phone: 800-821-8590

Email: genentech@druginfo.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