Anemia, Neoplasms
Conditions
Brief summary
This observational study will evaluate the clinical benefit of NeoRecormon (epoetin beta) in daily routine practice in cancer patients with anemia. Data will be collected from patients who are receiving chemotherapy for a solid tumor or hematological malignancy. Patients will be followed for 28 weeks.
Interventions
As prescribed by physician
Sponsors
Hoffmann-La Roche
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Adult patients, \>/=18 years of age * Patients receiving myelosuppressive chemotherapy for a solid tumor, a hematological malignancy or an autograft for hematological malignancy * Patients for whom treatment with epoetin beta is started at the inclusion visit * Life expectancy \>/=6 months according to the physician * Patients accepting and able to complete a French written questionnaire about his/her professional and social activities at each visit
Exclusion criteria
* Patients who received erythropoiesis-stimulating agents treatment, or red blood cell transfusion within 4 weeks before enrollment * Participation in a clinical trial in onco-hematology * Patients with myelodysplasia * Patients with more than one active malignancy at the time of enrollment
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Self-Reported Questionnaire: Change From Baseline on the Impact of Health on Regular Activities at Week 24 to 28 | Baseline, Week 24 to 28 | 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). |
| KPS: Week 4 to 6 | Week 4 to 6 | 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. |
| KPS: Week 12 to 16 | Week 12 to 16 | 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. |
| KPS: Week 24 to 28 | Week 24 to 28 | 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. |
| Percentage of Participants With Professional Activity: Baseline | Baseline | 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. |
| Percentage of Participants With At Least 1 Sick Leave | Week 4 Up to Week 28 | Sick leaves was described in active participants at inclusion (professional activity: active, in sick leave or unemployed participants). |
| Mean Number of Days of Sick Leave | Week 4 Up to Week 28 | Sick leaves was described in active participants at inclusion (professional activity: active, in sick leave or unemployed participants). |
| Self-Reported Questionnaire: Percentage of Participants With Current Employment at Baseline | Baseline | 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. |
| Self-Reported Questionnaire: Percentage of Participants With Current Employment at Week 4 to 6 | Week 4 to 6 | 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. |
| Self-Reported Questionnaire: Percentage of Participants With Current Employment at Week 12 to 16 | Week 12 to 16 | 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. |
| Self-Reported Questionnaire: Percentage of Participants With Current Employment at Week 24 to 28 | Week 24 to 28 | 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. |
| Self-Reported Questionnaire: Change From Baseline on the Impact of Health on Regular Activities at Week 4 to 6 | Baseline, Week 4 to 6 | 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). |
| Self-Reported Questionnaire: Change From Baseline on the Impact of Health on Regular Activities at Week 12 to 16 | Baseline, Week 12 to 16 | 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). |
| Percentage of Participants With Early Treatment Response: Day 28 to 42 | Day 28 to 42 | 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. |
| Percentage of Participants With Early Treatment Response: Day 21 to 42 | 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. |
| Percentage of Participants With At Least 1 Red Blood Cell (RBC) Transfusion | Baseline up to Week 28 | 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. |
| Mean Number of RBC Transfusions | Baseline up to Week 28 | Mean number of transfusion was based on the number of participants with at least 1 RBC transfusion. |
| Mean Number of RBC Units | Baseline up to Week 28 | Mean number of units was based on the number of participants with at least 1 RBC transfusion. |
| Time to First RBC Transfusions | Baseline up to Week 28 | 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. |
| Karnofsky Performance Status (KPS): Baseline | Baseline | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With Starting Dose Between 360 and 540 IU/kg/Weeks | Baseline | — |
| Percentage of Participants With Pre-specified Dose and Frequency of Injections | Baseline, Week 4 to 6, Week 12 to 16, Week 24 to 48 | 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. |
| Percentage of Participants With Subcutaneous (SC) Route of Administration | Baseline, Week 4 to 6, Week 12 to 16, Week 24 to 48 | — |
| Percentage of Participants With NeoRecormon® SC Injections at a Weekly Dose of 30000 IU | Baseline up to Week 28 | — |
| Percentage of Participants With Modifications of NeoRecormon® Regimen | Baseline up to Week 28 | 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. |
| Percentage of Participants With Temporary Discontinuation From NeoRecormon® Treatment | Baseline up to Week 28 | Percentage of participants with at least 1 temporary discontinuation was reported. |
| Percentage of Participants With Permanent Discontinuation From NeoRecormon® Treatment | Baseline up to Week 4 to 6, Week 12 to 16, Week 24 to 28 | — |
| Relative Percent Change in Hb Concentration From Baseline Over the Study Period | Baseline, Week 4 to 6, Week 12 to 16, Week 24 to 28 | — |
| Percentage of Participants With Hb Concentration Within the Range of 10 to 12 g/dL | Baseline up to Week 28 | — |
| Percentage of Participants With Adequate Iron Status | Baseline, Week 4 to 6, Week 12 to 16, Week 24 to 48 | Criteria for adequate iron status included serum ferritin greater than (\>) 100 micrograms/liter (µg/L) and transferrin saturation (TSAT)\> 20%. |
| Percentage of Participants With Vitamins Prescription | Week 4 to 6, Week 12 to 16, Week 24 to 48 | — |
| Mean Starting Dose of NeoRecormon® Injection | Baseline | Dose of NeoRecormon® injection was measured in international units/kilograms/weeks (IU/kg/weeks). |
Countries
France
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 979 |
| Total | 979 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Death | 157 |
| Overall Study | Kidney transplantation | 3 |
| Overall Study | Lost to Follow-up | 34 |
| Overall Study | Other | 22 |
| Overall Study | Protocol Violation | 76 |
| Overall Study | Withdrawal by Subject | 9 |
Baseline characteristics
| Characteristic | Anemic Cancer Participants (Total Participants) |
|---|---|
| Age, Continuous | 65.4 years STANDARD_DEVIATION 12.5 |
| Sex: Female, Male Female | 528 Participants |
| Sex: Female, Male Male | 451 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 63 / 735 | 31 / 319 | 94 / 1,054 |
| serious Total, serious adverse events | 6 / 735 | 4 / 319 | 10 / 1,054 |
Outcome results
Primary
Karnofsky Performance Status (KPS): Baseline
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.
Time frame: Baseline
Population: Efficacy population. Here number of participants analyzed included those participants who were evaluable for the outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Solid Tumor Participants | Karnofsky Performance Status (KPS): Baseline | 78.5 units on a scale | Standard Deviation 13.1 |
| Hematological Malignancy Participants | Karnofsky Performance Status (KPS): Baseline | 78.6 units on a scale | Standard Deviation 12.3 |
| Anemic Cancer Participants (Total Participants) | Karnofsky Performance Status (KPS): Baseline | 78.6 units on a scale | Standard Deviation 12.7 |
Primary
KPS: Week 12 to 16
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.
Time frame: Week 12 to 16
Population: Efficacy population. Here number of participants analyzed included those participants who were evaluable for the outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Solid Tumor Participants | KPS: Week 12 to 16 | 78.4 units on a scale | Standard Deviation 22.6 |
| Hematological Malignancy Participants | KPS: Week 12 to 16 | 74.7 units on a scale | Standard Deviation 24.2 |
| Anemic Cancer Participants (Total Participants) | KPS: Week 12 to 16 | 76.7 units on a scale | Standard Deviation 23.4 |
Primary
KPS: Week 24 to 28
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.
Time frame: Week 24 to 28
Population: Efficacy population. Here number of participants analyzed included those participants who were evaluable for the outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Solid Tumor Participants | KPS: Week 24 to 28 | 79.7 units on a scale | Standard Deviation 22.1 |
| Hematological Malignancy Participants | KPS: Week 24 to 28 | 75.6 units on a scale | Standard Deviation 24.5 |
| Anemic Cancer Participants (Total Participants) | KPS: Week 24 to 28 | 77.8 units on a scale | Standard Deviation 23.3 |
Primary
KPS: Week 4 to 6
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.
Time frame: Week 4 to 6
Population: Efficacy population. Here number of participants analyzed included those participants who were evaluable for the outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Solid Tumor Participants | KPS: Week 4 to 6 | 81.2 units on a scale | Standard Deviation 14.1 |
| Hematological Malignancy Participants | KPS: Week 4 to 6 | 76.7 units on a scale | Standard Deviation 16.2 |
| Anemic Cancer Participants (Total Participants) | KPS: Week 4 to 6 | 79.2 units on a scale | Standard Deviation 15.3 |
Primary
Mean Number of Days of Sick Leave
Sick leaves was described in active participants at inclusion (professional activity: active, in sick leave or unemployed participants).
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Solid Tumor Participants | Mean Number of Days of Sick Leave | 89.4 days | Standard Deviation 62.2 |
| Hematological Malignancy Participants | Mean Number of Days of Sick Leave | 93.3 days | Standard Deviation 61.1 |
| Anemic Cancer Participants (Total Participants) | Mean Number of Days of Sick Leave | 91.5 days | Standard Deviation 61.4 |
Primary
Mean Number of RBC Transfusions
Mean number of transfusion was based on the number of participants with at least 1 RBC transfusion.
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Solid Tumor Participants | Mean Number of RBC Transfusions | 1.7 RBC transfusions | Standard Deviation 1.4 |
| Hematological Malignancy Participants | Mean Number of RBC Transfusions | 2.1 RBC transfusions | Standard Deviation 1.9 |
| Anemic Cancer Participants (Total Participants) | Mean Number of RBC Transfusions | 2.0 RBC transfusions | Standard Deviation 1.8 |
Primary
Mean Number of RBC Units
Mean number of units was based on the number of participants with at least 1 RBC transfusion.
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Solid Tumor Participants | Mean Number of RBC Units | 3.4 RBC units | Standard Deviation 2.8 |
| Hematological Malignancy Participants | Mean Number of RBC Units | 4.3 RBC units | Standard Deviation 3.9 |
| Anemic Cancer Participants (Total Participants) | Mean Number of RBC Units | 4.0 RBC units | Standard Deviation 3.5 |
Primary
Percentage of Participants With At Least 1 Red Blood Cell (RBC) Transfusion
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.
Time frame: Baseline up to Week 28
Population: Efficacy population. Here number of participants analyzed included those participants who were evaluable for the outcome measure.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Solid Tumor Participants | Percentage of Participants With At Least 1 Red Blood Cell (RBC) Transfusion | 17.2 percentage of participants |
| Hematological Malignancy Participants | Percentage of Participants With At Least 1 Red Blood Cell (RBC) Transfusion | 31.4 percentage of participants |
| Anemic Cancer Participants (Total Participants) | Percentage of Participants With At Least 1 Red Blood Cell (RBC) Transfusion | 23.8 percentage of participants |
95% CI: [0.42, 0.71]
Primary
Percentage of Participants With At Least 1 Sick Leave
Sick leaves was described in active participants at inclusion (professional activity: active, in sick leave or unemployed participants).
Time frame: Week 4 Up to Week 28
Population: Efficacy population. Here number of participants analyzed included those participants who were evaluable for the outcome measure.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Solid Tumor Participants | Percentage of Participants With At Least 1 Sick Leave | 59.2 percentage of participants |
| Hematological Malignancy Participants | Percentage of Participants With At Least 1 Sick Leave | 74.4 percentage of participants |
| Anemic Cancer Participants (Total Participants) | Percentage of Participants With At Least 1 Sick Leave | 66.3 percentage of participants |
Primary
Percentage of Participants With Early Treatment Response: 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.
Time frame: Day 21 to 42
Population: Efficacy population. Here number of participants analyzed included those participants who were evaluable for the outcome measure.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Solid Tumor Participants | Percentage of Participants With Early Treatment Response: Day 21 to 42 | 52.4 percentage of participants |
| Hematological Malignancy Participants | Percentage of Participants With Early Treatment Response: Day 21 to 42 | 55.7 percentage of participants |
| Anemic Cancer Participants (Total Participants) | Percentage of Participants With Early Treatment Response: Day 21 to 42 | 53.5 percentage of participants |
Primary
Percentage of Participants With Early Treatment Response: Day 28 to 42
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.
Time frame: Day 28 to 42
Population: Efficacy population. Here number of participants analyzed included those participants who were evaluable for the outcome measure.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Solid Tumor Participants | Percentage of Participants With Early Treatment Response: Day 28 to 42 | 52.4 percentage of participants |
| Hematological Malignancy Participants | Percentage of Participants With Early Treatment Response: Day 28 to 42 | 56.5 percentage of participants |
| Anemic Cancer Participants (Total Participants) | Percentage of Participants With Early Treatment Response: Day 28 to 42 | 53.8 percentage of participants |
Primary
Percentage of Participants With Professional Activity: Baseline
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.
Time frame: Baseline
Population: Efficacy population. Here number of participants analyzed included those participants who were evaluable for the outcome measure.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Solid Tumor Participants | Percentage of Participants With Professional Activity: Baseline | No occupation | 6.2 percentage of participants |
| Solid Tumor Participants | Percentage of Participants With Professional Activity: Baseline | Unemployment | 1.7 percentage of participants |
| Solid Tumor Participants | Percentage of Participants With Professional Activity: Baseline | Sick leave | 18.9 percentage of participants |
| Solid Tumor Participants | Percentage of Participants With Professional Activity: Baseline | Retired | 66.3 percentage of participants |
| Solid Tumor Participants | Percentage of Participants With Professional Activity: Baseline | Disability | 2.6 percentage of participants |
| Solid Tumor Participants | Percentage of Participants With Professional Activity: Baseline | Active | 4.1 percentage of participants |
| Solid Tumor Participants | Percentage of Participants With Professional Activity: Baseline | Student, training | 0.2 percentage of participants |
| Hematological Malignancy Participants | Percentage of Participants With Professional Activity: Baseline | Retired | 65 percentage of participants |
| Hematological Malignancy Participants | Percentage of Participants With Professional Activity: Baseline | Active | 3.0 percentage of participants |
| Hematological Malignancy Participants | Percentage of Participants With Professional Activity: Baseline | Disability | 3.3 percentage of participants |
| Hematological Malignancy Participants | Percentage of Participants With Professional Activity: Baseline | No occupation | 6.3 percentage of participants |
| Hematological Malignancy Participants | Percentage of Participants With Professional Activity: Baseline | Sick leave | 20.1 percentage of participants |
| Hematological Malignancy Participants | Percentage of Participants With Professional Activity: Baseline | Student, training | 0.6 percentage of participants |
| Hematological Malignancy Participants | Percentage of Participants With Professional Activity: Baseline | Unemployment | 1.7 percentage of participants |
| Anemic Cancer Participants (Total Participants) | Percentage of Participants With Professional Activity: Baseline | Sick leave | 19.5 percentage of participants |
| Anemic Cancer Participants (Total Participants) | Percentage of Participants With Professional Activity: Baseline | Disability | 2.9 percentage of participants |
| Anemic Cancer Participants (Total Participants) | Percentage of Participants With Professional Activity: Baseline | Unemployment | 1.7 percentage of participants |
| Anemic Cancer Participants (Total Participants) | Percentage of Participants With Professional Activity: Baseline | Student, training | 0.4 percentage of participants |
| Anemic Cancer Participants (Total Participants) | Percentage of Participants With Professional Activity: Baseline | Retired | 65.7 percentage of participants |
| Anemic Cancer Participants (Total Participants) | Percentage of Participants With Professional Activity: Baseline | No occupation | 6.3 percentage of participants |
| Anemic Cancer Participants (Total Participants) | Percentage of Participants With Professional Activity: Baseline | Active | 3.6 percentage of participants |
Primary
Self-Reported Questionnaire: Change From Baseline on the Impact of Health on Regular Activities at Week 12 to 16
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).
Time frame: Baseline, Week 12 to 16
Population: Efficacy population. Here number of participants analyzed included those participants who were evaluable for the outcome measure.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Solid Tumor Participants | 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 |
| Solid Tumor Participants | 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 |
| Hematological Malignancy Participants | Self-Reported Questionnaire: Change From Baseline on the Impact of Health on Regular Activities at Week 12 to 16 | Baseline | 5.9 units on a scale | Standard Deviation 2.3 |
| Hematological Malignancy Participants | 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 | -1.3 units on a scale | Standard Deviation 2.9 |
| Anemic Cancer Participants (Total Participants) | Self-Reported Questionnaire: Change From Baseline on the Impact of Health on Regular Activities at Week 12 to 16 | Baseline | 6.0 units on a scale | Standard Deviation 2.3 |
| Anemic Cancer Participants (Total Participants) | 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 | -1.4 units on a scale | Standard Deviation 2.9 |
Primary
Self-Reported Questionnaire: Change From Baseline on the Impact of Health on Regular Activities at Week 24 to 28
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).
Time frame: Baseline, Week 24 to 28
Population: Efficacy population. Here number of participants analyzed included those participants who were evaluable for the outcome measure.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Solid Tumor Participants | 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 |
| Solid Tumor Participants | 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 |
| Hematological Malignancy Participants | Self-Reported Questionnaire: Change From Baseline on the Impact of Health on Regular Activities at Week 24 to 28 | Baseline | 5.7 units on a scale | Standard Deviation 2.3 |
| Hematological Malignancy Participants | 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 | -1.4 units on a scale | Standard Deviation 3.1 |
| Anemic Cancer Participants (Total Participants) | Self-Reported Questionnaire: Change From Baseline on the Impact of Health on Regular Activities at Week 24 to 28 | Baseline | 5.8 units on a scale | Standard Deviation 2.2 |
| Anemic Cancer Participants (Total Participants) | 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 3.1 |
Primary
Self-Reported Questionnaire: Change From Baseline on the Impact of Health on Regular Activities at Week 4 to 6
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).
Time frame: Baseline, Week 4 to 6
Population: Efficacy population. Here number of participants analyzed included those participants who were evaluable for the outcome measure.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Solid Tumor Participants | 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 |
| Solid Tumor Participants | 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 |
| Hematological Malignancy Participants | 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 2.3 |
| Hematological Malignancy Participants | 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 | -0.8 units on a scale | Standard Deviation 2.5 |
| Anemic Cancer Participants (Total Participants) | 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 |
| Anemic Cancer Participants (Total Participants) | 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 | -0.9 units on a scale | Standard Deviation 2.6 |
Primary
Self-Reported Questionnaire: Percentage of Participants With Current Employment at Baseline
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.
Time frame: Baseline
Population: Efficacy population. Here number of participants analyzed included those participants who were evaluable for the outcome measure.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Solid Tumor Participants | Self-Reported Questionnaire: Percentage of Participants With Current Employment at Baseline | 6.8 percentage of participants |
| Hematological Malignancy Participants | Self-Reported Questionnaire: Percentage of Participants With Current Employment at Baseline | 8.1 percentage of participants |
| Anemic Cancer Participants (Total Participants) | Self-Reported Questionnaire: Percentage of Participants With Current Employment at Baseline | 7.4 percentage of participants |
Primary
Self-Reported Questionnaire: Percentage of Participants With Current Employment at Week 12 to 16
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.
Time frame: Week 12 to 16
Population: Efficacy population. Here number of participants analyzed included those participants who were evaluable for the outcome measure.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Solid Tumor Participants | Self-Reported Questionnaire: Percentage of Participants With Current Employment at Week 12 to 16 | 4.3 percentage of participants |
| Hematological Malignancy Participants | Self-Reported Questionnaire: Percentage of Participants With Current Employment at Week 12 to 16 | 4.3 percentage of participants |
| Anemic Cancer Participants (Total Participants) | Self-Reported Questionnaire: Percentage of Participants With Current Employment at Week 12 to 16 | 4.3 percentage of participants |
Primary
Self-Reported Questionnaire: Percentage of Participants With Current Employment at Week 24 to 28
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.
Time frame: Week 24 to 28
Population: Efficacy population. Here number of participants analyzed included those participants who were evaluable for the outcome measure.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Solid Tumor Participants | Self-Reported Questionnaire: Percentage of Participants With Current Employment at Week 24 to 28 | 4.9 percentage of participants |
| Hematological Malignancy Participants | Self-Reported Questionnaire: Percentage of Participants With Current Employment at Week 24 to 28 | 4.1 percentage of participants |
| Anemic Cancer Participants (Total Participants) | Self-Reported Questionnaire: Percentage of Participants With Current Employment at Week 24 to 28 | 4.5 percentage of participants |
Primary
Self-Reported Questionnaire: Percentage of Participants With Current Employment at Week 4 to 6
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.
Time frame: Week 4 to 6
Population: Efficacy population. Here number of participants analyzed included those participants who were evaluable for the outcome measure.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Solid Tumor Participants | Self-Reported Questionnaire: Percentage of Participants With Current Employment at Week 4 to 6 | 5.8 percentage of participants |
| Hematological Malignancy Participants | Self-Reported Questionnaire: Percentage of Participants With Current Employment at Week 4 to 6 | 6.2 percentage of participants |
| Anemic Cancer Participants (Total Participants) | Self-Reported Questionnaire: Percentage of Participants With Current Employment at Week 4 to 6 | 6.0 percentage of participants |
Primary
Time to First RBC Transfusions
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.
Time frame: Baseline up to Week 28
Population: Efficacy population. Here number of participants analyzed included those participants who were evaluable for the outcome measure.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Solid Tumor Participants | Time to First RBC Transfusions | NA weeks |
| Hematological Malignancy Participants | Time to First RBC Transfusions | NA weeks |
p-value: <0.0001Log Rank
Secondary
Mean Starting Dose of NeoRecormon® Injection
Dose of NeoRecormon® injection was measured in international units/kilograms/weeks (IU/kg/weeks).
Time frame: Baseline
Population: Efficacy population. Here number of participants analyzed included those participants who were evaluable for the outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Solid Tumor Participants | Mean Starting Dose of NeoRecormon® Injection | 471.2 IU/kg/weeks | Standard Deviation 91.2 |
| Hematological Malignancy Participants | Mean Starting Dose of NeoRecormon® Injection | 447.3 IU/kg/weeks | Standard Deviation 95.9 |
| Anemic Cancer Participants (Total Participants) | Mean Starting Dose of NeoRecormon® Injection | 463.9 IU/kg/weeks | Standard Deviation 93.3 |
Secondary
Percentage of Participants With Adequate Iron Status
Criteria for adequate iron status included serum ferritin greater than (\>) 100 micrograms/liter (µg/L) and transferrin saturation (TSAT)\> 20%.
Time frame: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Solid Tumor Participants | Percentage of Participants With Adequate Iron Status | Week 24-28 (n=13,17,30) | 53.8 percentage of participants |
| Solid Tumor Participants | Percentage of Participants With Adequate Iron Status | Week 12-16 (n=24,18,42) | 25.0 percentage of participants |
| Solid Tumor Participants | Percentage of Participants With Adequate Iron Status | Week 4-6 (n=31,18,49) | 22.6 percentage of participants |
| Solid Tumor Participants | Percentage of Participants With Adequate Iron Status | Baseline (n=58,65,123) | 37.9 percentage of participants |
| Hematological Malignancy Participants | Percentage of Participants With Adequate Iron Status | Baseline (n=58,65,123) | 47.7 percentage of participants |
| Hematological Malignancy Participants | Percentage of Participants With Adequate Iron Status | Week 4-6 (n=31,18,49) | 16.7 percentage of participants |
| Hematological Malignancy Participants | Percentage of Participants With Adequate Iron Status | Week 12-16 (n=24,18,42) | 38.9 percentage of participants |
| Hematological Malignancy Participants | Percentage of Participants With Adequate Iron Status | Week 24-28 (n=13,17,30) | 70.6 percentage of participants |
| Anemic Cancer Participants (Total Participants) | Percentage of Participants With Adequate Iron Status | Week 12-16 (n=24,18,42) | 31.0 percentage of participants |
| Anemic Cancer Participants (Total Participants) | Percentage of Participants With Adequate Iron Status | Baseline (n=58,65,123) | 43.1 percentage of participants |
| Anemic Cancer Participants (Total Participants) | Percentage of Participants With Adequate Iron Status | Week 4-6 (n=31,18,49) | 20.4 percentage of participants |
| Anemic Cancer Participants (Total Participants) | Percentage of Participants With Adequate Iron Status | Week 24-28 (n=13,17,30) | 63.3 percentage of participants |
Secondary
Percentage of Participants With Hb Concentration Within the Range of 10 to 12 g/dL
Time frame: Baseline up to Week 28
Population: Efficacy population. Here number of participants analyzed included those participants who were evaluable for the outcome measure.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Solid Tumor Participants | Percentage of Participants With Hb Concentration Within the Range of 10 to 12 g/dL | 36.0 percentage of participants |
| Hematological Malignancy Participants | Percentage of Participants With Hb Concentration Within the Range of 10 to 12 g/dL | 18.5 percentage of participants |
| Anemic Cancer Participants (Total Participants) | Percentage of Participants With Hb Concentration Within the Range of 10 to 12 g/dL | 30.3 percentage of participants |
Secondary
Percentage of Participants With Modifications of NeoRecormon® Regimen
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.
Time frame: Baseline up to Week 28
Population: Efficacy population. Here number of participants analyzed included those participants who were evaluable for the outcome measure.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Solid Tumor Participants | Percentage of Participants With Modifications of NeoRecormon® Regimen | 7.2 percentage of participants |
| Hematological Malignancy Participants | Percentage of Participants With Modifications of NeoRecormon® Regimen | 12.0 percentage of participants |
| Anemic Cancer Participants (Total Participants) | Percentage of Participants With Modifications of NeoRecormon® Regimen | 8.7 percentage of participants |
Secondary
Percentage of Participants With NeoRecormon® SC Injections at a Weekly Dose of 30000 IU
Time frame: Baseline up to Week 28
Population: Efficacy population. Here number of participants analyzed included those participants who were evaluable for the outcome measure.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Solid Tumor Participants | Percentage of Participants With NeoRecormon® SC Injections at a Weekly Dose of 30000 IU | 86.2 percentage of participants |
| Hematological Malignancy Participants | Percentage of Participants With NeoRecormon® SC Injections at a Weekly Dose of 30000 IU | 82.7 percentage of participants |
| Anemic Cancer Participants (Total Participants) | Percentage of Participants With NeoRecormon® SC Injections at a Weekly Dose of 30000 IU | 85.1 percentage of participants |
Secondary
Percentage of Participants With Permanent Discontinuation From NeoRecormon® Treatment
Time frame: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Solid Tumor 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 |
| Solid Tumor Participants | Percentage of Participants With Permanent Discontinuation From NeoRecormon® Treatment | Baseline up to Week 4-6 (n=639,294,933) | 19.9 percentage of participants |
| Solid Tumor 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 |
| Hematological Malignancy Participants | Percentage of Participants With Permanent Discontinuation From NeoRecormon® Treatment | Baseline up to Week 12-16 (n=582,275,857) | 37.1 percentage of participants |
| Hematological Malignancy Participants | Percentage of Participants With Permanent Discontinuation From NeoRecormon® Treatment | Baseline up to Week 4-6 (n=639,294,933) | 8.5 percentage of participants |
| Hematological Malignancy Participants | Percentage of Participants With Permanent Discontinuation From NeoRecormon® Treatment | Baseline up to Week 24-28 (n=457,227,684) | 65.6 percentage of participants |
| Anemic Cancer Participants (Total Participants) | Percentage of Participants With Permanent Discontinuation From NeoRecormon® Treatment | Baseline up to Week 4-6 (n=639,294,933) | 16.3 percentage of participants |
| Anemic Cancer Participants (Total Participants) | Percentage of Participants With Permanent Discontinuation From NeoRecormon® Treatment | Baseline up to Week 24-28 (n=457,227,684) | 71.3 percentage of participants |
| Anemic Cancer Participants (Total Participants) | Percentage of Participants With Permanent Discontinuation From NeoRecormon® Treatment | Baseline up to Week 12-16 (n=582,275,857) | 49.0 percentage of participants |
Secondary
Percentage of Participants With Pre-specified Dose and Frequency of Injections
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.
Time frame: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Solid Tumor 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 |
| Solid Tumor 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 |
| Solid Tumor 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 |
| Solid Tumor 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 |
| Solid Tumor 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 |
| Solid Tumor 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 |
| Solid Tumor 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 |
| Solid Tumor Participants | Percentage of Participants With Pre-specified Dose and Frequency of Injections | Baseline: Other (n=669,300,969) | 0.4 percentage of participants |
| Solid Tumor 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 |
| Solid Tumor 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 |
| Solid Tumor 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 |
| Solid Tumor 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 |
| Solid Tumor 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 |
| Solid Tumor 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 |
| Solid Tumor 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 |
| Solid Tumor 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 |
| Solid Tumor 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 |
| Solid Tumor 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 |
| Solid Tumor 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 |
| Solid Tumor 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 |
| Solid Tumor 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 |
| Solid Tumor 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 |
| Hematological Malignancy Participants | Percentage of Participants With Pre-specified Dose and Frequency of Injections | Week 12-16: 30000 IU/weeks-tw (n=244,163,407) | 3.7 percentage of participants |
| Hematological Malignancy Participants | Percentage of Participants With Pre-specified Dose and Frequency of Injections | Baseline: 30000 IU/weeks-qw (n=669,300,969) | 93.7 percentage of participants |
| Hematological Malignancy Participants | Percentage of Participants With Pre-specified Dose and Frequency of Injections | Baseline: 20000 IU/weeks-qw (n=669,300,969) | 3.7 percentage of participants |
| Hematological Malignancy Participants | Percentage of Participants With Pre-specified Dose and Frequency of Injections | Baseline: 40000 IU/weeks-qw (n=669,300,969) | 2.3 percentage of participants |
| Hematological Malignancy Participants | Percentage of Participants With Pre-specified Dose and Frequency of Injections | Baseline: Other (n=669,300,969) | 0.3 percentage of participants |
| Hematological Malignancy Participants | Percentage of Participants With Pre-specified Dose and Frequency of Injections | Week 4-6: 30000 IU/weeks-qw (n=494,262,756) | 89.7 percentage of participants |
| Hematological Malignancy Participants | Percentage of Participants With Pre-specified Dose and Frequency of Injections | Week 4-6: 20000 IU/weeks-qw (n=494,262,756) | 3.1 percentage of participants |
| Hematological Malignancy Participants | Percentage of Participants With Pre-specified Dose and Frequency of Injections | Week 4-6: 30000 IU/weeks-tw (n=494,262,756) | 1.5 percentage of participants |
| Hematological Malignancy Participants | Percentage of Participants With Pre-specified Dose and Frequency of Injections | Week 4-6: 60000 IU/weeks-qw (n=494,262,756) | 0.8 percentage of participants |
| Hematological Malignancy Participants | Percentage of Participants With Pre-specified Dose and Frequency of Injections | Week 4-6: 30000 IU/weeks-q2w (n=494,262,756) | 1.5 percentage of participants |
| Hematological Malignancy Participants | Percentage of Participants With Pre-specified Dose and Frequency of Injections | Week 4-6: 40000 IU/weeks-qw (n=494,262,756) | 2.7 percentage of participants |
| Hematological Malignancy 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 |
| Hematological Malignancy Participants | Percentage of Participants With Pre-specified Dose and Frequency of Injections | Week 12-16: 30000 IU/weeks-qw (n=244,163,407) | 84.7 percentage of participants |
| Hematological Malignancy 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 |
| Hematological Malignancy 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 |
| Hematological Malignancy Participants | Percentage of Participants With Pre-specified Dose and Frequency of Injections | Week 12-16: 30000 IU/weeks-q2w (n=244,163,407) | 3.1 percentage of participants |
| Hematological Malignancy Participants | Percentage of Participants With Pre-specified Dose and Frequency of Injections | Week 12-16: Other (n=244,163,407) | 4.9 percentage of participants |
| Hematological Malignancy Participants | Percentage of Participants With Pre-specified Dose and Frequency of Injections | Week 24-28: 30000 IU/weeks-qw (n=119,76,195) | 89.5 percentage of participants |
| Hematological Malignancy Participants | Percentage of Participants With Pre-specified Dose and Frequency of Injections | Week 24-28: 20000 IU/weeks-qw (n=119,76,195) | 1.3 percentage of participants |
| Hematological Malignancy Participants | Percentage of Participants With Pre-specified Dose and Frequency of Injections | Week 24-28: 60000 IU/weeks-qw (n=119,76,195) | 2.6 percentage of participants |
| Hematological Malignancy Participants | Percentage of Participants With Pre-specified Dose and Frequency of Injections | Week 24-28: 40000 IU/weeks-qw (n=119,76,195) | 3.9 percentage of participants |
| Hematological Malignancy Participants | Percentage of Participants With Pre-specified Dose and Frequency of Injections | Week 24-28: Other (n=119,76,195) | 2.6 percentage of participants |
| Anemic Cancer Participants (Total Participants) | Percentage of Participants With Pre-specified Dose and Frequency of Injections | Baseline: 30000 IU/weeks-qw (n=669,300,969) | 96.5 percentage of participants |
| Anemic Cancer Participants (Total 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 |
| Anemic Cancer Participants (Total Participants) | Percentage of Participants With Pre-specified Dose and Frequency of Injections | Week 4-6: 20000 IU/weeks-qw (n=494,262,756) | 1.7 percentage of participants |
| Anemic Cancer Participants (Total Participants) | Percentage of Participants With Pre-specified Dose and Frequency of Injections | Week 24-28: 60000 IU/weeks-qw (n=119,76,195) | 2.1 percentage of participants |
| Anemic Cancer Participants (Total Participants) | Percentage of Participants With Pre-specified Dose and Frequency of Injections | Week 12-16: 30000 IU/weeks-q2w (n=244,163,407) | 2.7 percentage of participants |
| Anemic Cancer Participants (Total Participants) | Percentage of Participants With Pre-specified Dose and Frequency of Injections | Week 4-6: 30000 IU/weeks-qw (n=494,262,756) | 93.1 percentage of participants |
| Anemic Cancer Participants (Total Participants) | Percentage of Participants With Pre-specified Dose and Frequency of Injections | Baseline: 20000 IU/weeks-qw (n=669,300,969) | 2.0 percentage of participants |
| Anemic Cancer Participants (Total Participants) | Percentage of Participants With Pre-specified Dose and Frequency of Injections | Week 12-16: Other (n=244,163,407) | 3.4 percentage of participants |
| Anemic Cancer Participants (Total Participants) | Percentage of Participants With Pre-specified Dose and Frequency of Injections | Baseline: Other (n=669,300,969) | 0.4 percentage of participants |
| Anemic Cancer Participants (Total Participants) | Percentage of Participants With Pre-specified Dose and Frequency of Injections | Week 24-28: Other (n=119,76,195) | 4.1 percentage of participants |
| Anemic Cancer Participants (Total Participants) | Percentage of Participants With Pre-specified Dose and Frequency of Injections | Week 24-28: 30000 IU/weeks-qw (n=119,76,195) | 89.7 percentage of participants |
| Anemic Cancer Participants (Total Participants) | Percentage of Participants With Pre-specified Dose and Frequency of Injections | Baseline: 40000 IU/weeks-qw (n=669,300,969) | 1.1 percentage of participants |
| Anemic Cancer Participants (Total 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 |
| Anemic Cancer Participants (Total Participants) | Percentage of Participants With Pre-specified Dose and Frequency of Injections | Week 24-28: 40000 IU/weeks-qw (n=119,76,195) | 2.1 percentage of participants |
| Anemic Cancer Participants (Total Participants) | Percentage of Participants With Pre-specified Dose and Frequency of Injections | Week 12-16: 30000 IU/weeks-qw (n=244,163,407) | 88.7 percentage of participants |
| Anemic Cancer Participants (Total Participants) | Percentage of Participants With Pre-specified Dose and Frequency of Injections | Week 4-6: 40000 IU/weeks-qw (n=494,262,756) | 1.2 percentage of participants |
| Anemic Cancer Participants (Total Participants) | Percentage of Participants With Pre-specified Dose and Frequency of Injections | Week 24-28: 20000 IU/weeks-qw (n=119,76,195) | 2.1 percentage of participants |
| Anemic Cancer Participants (Total 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 |
| Anemic Cancer Participants (Total Participants) | Percentage of Participants With Pre-specified Dose and Frequency of Injections | Week 4-6: 30000 IU/weeks-q2w (n=494,262,756) | 1.1 percentage of participants |
| Anemic Cancer Participants (Total Participants) | Percentage of Participants With Pre-specified Dose and Frequency of Injections | Week 4-6: 60000 IU/weeks-qw (n=494,262,756) | 0.9 percentage of participants |
| Anemic Cancer Participants (Total Participants) | Percentage of Participants With Pre-specified Dose and Frequency of Injections | Week 12-16: 30000 IU/weeks-tw (n=244,163,407) | 1.5 percentage of participants |
| Anemic Cancer Participants (Total Participants) | Percentage of Participants With Pre-specified Dose and Frequency of Injections | Week 4-6: 30000 IU/weeks-tw (n=494,262,756) | 1.2 percentage of participants |
Secondary
Percentage of Participants With Starting Dose Between 360 and 540 IU/kg/Weeks
Time frame: Baseline
Population: Efficacy population. Here number of participants analyzed included those participants who were evaluable for the outcome measure.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Solid Tumor Participants | Percentage of Participants With Starting Dose Between 360 and 540 IU/kg/Weeks | 69.9 percentage of participants |
| Hematological Malignancy Participants | Percentage of Participants With Starting Dose Between 360 and 540 IU/kg/Weeks | 67.6 percentage of participants |
| Anemic Cancer Participants (Total Participants) | Percentage of Participants With Starting Dose Between 360 and 540 IU/kg/Weeks | 69.2 percentage of participants |
Secondary
Percentage of Participants With Subcutaneous (SC) Route of Administration
Time frame: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Solid Tumor Participants | Percentage of Participants With Subcutaneous (SC) Route of Administration | Baseline (n=668,300,968) | 98.7 percentage of participants |
| Solid Tumor Participants | Percentage of Participants With Subcutaneous (SC) Route of Administration | Week 4-6 (n=494,262,756) | 98.8 percentage of participants |
| Solid Tumor Participants | Percentage of Participants With Subcutaneous (SC) Route of Administration | Week 12-16 (n=238,163,401) | 98.3 percentage of participants |
| Solid Tumor Participants | Percentage of Participants With Subcutaneous (SC) Route of Administration | Week 24-28 (n=116,76,192) | 98.3 percentage of participants |
| Hematological Malignancy Participants | Percentage of Participants With Subcutaneous (SC) Route of Administration | Week 24-28 (n=116,76,192) | 100.0 percentage of participants |
| Hematological Malignancy Participants | Percentage of Participants With Subcutaneous (SC) Route of Administration | Baseline (n=668,300,968) | 100.0 percentage of participants |
| Hematological Malignancy Participants | Percentage of Participants With Subcutaneous (SC) Route of Administration | Week 12-16 (n=238,163,401) | 100.0 percentage of participants |
| Hematological Malignancy Participants | Percentage of Participants With Subcutaneous (SC) Route of Administration | Week 4-6 (n=494,262,756) | 100.0 percentage of participants |
| Anemic Cancer Participants (Total Participants) | Percentage of Participants With Subcutaneous (SC) Route of Administration | Week 24-28 (n=116,76,192) | 99.0 percentage of participants |
| Anemic Cancer Participants (Total Participants) | Percentage of Participants With Subcutaneous (SC) Route of Administration | Week 4-6 (n=494,262,756) | 99.2 percentage of participants |
| Anemic Cancer Participants (Total Participants) | Percentage of Participants With Subcutaneous (SC) Route of Administration | Week 12-16 (n=238,163,401) | 99.0 percentage of participants |
| Anemic Cancer Participants (Total Participants) | Percentage of Participants With Subcutaneous (SC) Route of Administration | Baseline (n=668,300,968) | 99.1 percentage of participants |
Secondary
Percentage of Participants With Temporary Discontinuation From NeoRecormon® Treatment
Percentage of participants with at least 1 temporary discontinuation was reported.
Time frame: Baseline up to Week 28
Population: Efficacy population. Here number of participants analyzed included those participants who were evaluable for the outcome measure.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Solid Tumor Participants | Percentage of Participants With Temporary Discontinuation From NeoRecormon® Treatment | 8.1 percentage of participants |
| Hematological Malignancy Participants | Percentage of Participants With Temporary Discontinuation From NeoRecormon® Treatment | 10.3 percentage of participants |
| Anemic Cancer Participants (Total Participants) | Percentage of Participants With Temporary Discontinuation From NeoRecormon® Treatment | 8.8 percentage of participants |
Secondary
Percentage of Participants With Vitamins Prescription
Time frame: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Solid Tumor 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 |
| Solid Tumor Participants | Percentage of Participants With Vitamins Prescription | Week 24-28 (n=165,114,111,72,57,127,17,21,684) | 6.1 percentage of participants |
| Solid Tumor 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 |
| Hematological Malignancy Participants | Percentage of Participants With Vitamins Prescription | Week 24-28 (n=165,114,111,72,57,127,17,21,684) | 0.9 percentage of participants |
| Hematological Malignancy Participants | Percentage of Participants With Vitamins Prescription | Week 12-16 (n=230,132,153,86,72,158,23,30,884) | 0.8 percentage of participants |
| Hematological Malignancy Participants | Percentage of Participants With Vitamins Prescription | Week 4-6 (n=217,129,142,74,63,143,23,29,820) | 1.6 percentage of participants |
| Anemic Cancer Participants (Total Participants) | Percentage of Participants With Vitamins Prescription | Week 12-16 (n=230,132,153,86,72,158,23,30,884) | 3.9 percentage of participants |
| Anemic Cancer Participants (Total Participants) | Percentage of Participants With Vitamins Prescription | Week 4-6 (n=217,129,142,74,63,143,23,29,820) | 0.7 percentage of participants |
| Anemic Cancer Participants (Total Participants) | Percentage of Participants With Vitamins Prescription | Week 24-28 (n=165,114,111,72,57,127,17,21,684) | 1.8 percentage of participants |
| Ovary Cancer Participants | Percentage of Participants With Vitamins Prescription | Week 12-16 (n=230,132,153,86,72,158,23,30,884) | 3.5 percentage of participants |
| Ovary Cancer Participants | Percentage of Participants With Vitamins Prescription | Week 4-6 (n=217,129,142,74,63,143,23,29,820) | 4.1 percentage of participants |
| Ovary Cancer Participants | Percentage of Participants With Vitamins Prescription | Week 24-28 (n=165,114,111,72,57,127,17,21,684) | 2.8 percentage of participants |
| Multiple Myeloma Participants | Percentage of Participants With Vitamins Prescription | Week 4-6 (n=217,129,142,74,63,143,23,29,820) | 3.2 percentage of participants |
| Multiple Myeloma Participants | Percentage of Participants With Vitamins Prescription | Week 24-28 (n=165,114,111,72,57,127,17,21,684) | 0.0 percentage of participants |
| Multiple Myeloma Participants | Percentage of Participants With Vitamins Prescription | Week 12-16 (n=230,132,153,86,72,158,23,30,884) | 4.2 percentage of participants |
| Non-Hodgkin's Lymphoma Participants | Percentage of Participants With Vitamins Prescription | Week 12-16 (n=230,132,153,86,72,158,23,30,884) | 8.2 percentage of participants |
| Non-Hodgkin's Lymphoma Participants | Percentage of Participants With Vitamins Prescription | Week 24-28 (n=165,114,111,72,57,127,17,21,684) | 3.9 percentage of participants |
| Non-Hodgkin's Lymphoma Participants | Percentage of Participants With Vitamins Prescription | Week 4-6 (n=217,129,142,74,63,143,23,29,820) | 9.8 percentage of participants |
| Hodgkin's Lymphoma Participants | Percentage of Participants With Vitamins Prescription | Week 12-16 (n=230,132,153,86,72,158,23,30,884) | 17.4 percentage of participants |
| Hodgkin's Lymphoma Participants | Percentage of Participants With Vitamins Prescription | Week 24-28 (n=165,114,111,72,57,127,17,21,684) | 5.9 percentage of participants |
| Hodgkin's Lymphoma Participants | Percentage of Participants With Vitamins Prescription | Week 4-6 (n=217,129,142,74,63,143,23,29,820) | 17.4 percentage of participants |
| Chronic Lymphocytic Leukemia Participants | Percentage of Participants With Vitamins Prescription | Week 24-28 (n=165,114,111,72,57,127,17,21,684) | 9.5 percentage of participants |
| Chronic Lymphocytic Leukemia Participants | Percentage of Participants With Vitamins Prescription | Week 4-6 (n=217,129,142,74,63,143,23,29,820) | 10.3 percentage of participants |
| Chronic Lymphocytic Leukemia Participants | Percentage of Participants With Vitamins Prescription | Week 12-16 (n=230,132,153,86,72,158,23,30,884) | 10.0 percentage of participants |
| Anemic Cancer Participants (Total Participants) | Percentage of Participants With Vitamins Prescription | Week 12-16 (n=230,132,153,86,72,158,23,30,884) | 5.4 percentage of participants |
| Anemic Cancer Participants (Total Participants) | Percentage of Participants With Vitamins Prescription | Week 4-6 (n=217,129,142,74,63,143,23,29,820) | 6.8 percentage of participants |
| Anemic Cancer Participants (Total Participants) | Percentage of Participants With Vitamins Prescription | Week 24-28 (n=165,114,111,72,57,127,17,21,684) | 3.4 percentage of participants |
Secondary
Relative Percent Change in Hb Concentration From Baseline Over the Study Period
Time frame: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Solid Tumor Participants | 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 |
| Solid Tumor Participants | 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 |
| Solid Tumor Participants | 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 |
| Hematological Malignancy Participants | Relative Percent Change in Hb Concentration From Baseline Over the Study Period | Change at Week 12-16 (n=501,257,758) | 18.6 percent change | Standard Deviation 20 |
| Hematological Malignancy Participants | Relative Percent Change in Hb Concentration From Baseline Over the Study Period | Change at Week 4-6 (n=519,262,781) | 13.0 percent change | Standard Deviation 16 |
| Hematological Malignancy Participants | Relative Percent Change in Hb Concentration From Baseline Over the Study Period | Change at Week 24-28 (n=357,195,552) | 24.7 percent change | Standard Deviation 23.4 |
| Anemic Cancer Participants (Total Participants) | Relative Percent Change in Hb Concentration From Baseline Over the Study Period | Change at Week 4-6 (n=519,262,781) | 11.9 percent change | Standard Deviation 15.9 |
| Anemic Cancer Participants (Total Participants) | Relative Percent Change in Hb Concentration From Baseline Over the Study Period | Change at Week 24-28 (n=357,195,552) | 19.5 percent change | Standard Deviation 21.7 |
| Anemic Cancer Participants (Total Participants) | Relative Percent Change in Hb Concentration From Baseline Over the Study Period | Change at Week 12-16 (n=501,257,758) | 16.6 percent change | Standard Deviation 19.7 |