Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| epoetin beta [NeoRecormon] | Drug | As prescribed by physician |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Day 28 to 42 |
| 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. | Day 21 to 42 |
| 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. | Baseline up to Week 28 |
| Mean Number of RBC Transfusions | Mean number of transfusion was based on the number of participants with at least 1 RBC transfusion. | Baseline up to Week 28 |
| Mean Number of RBC Units | Mean number of units was based on the number of participants with at least 1 RBC transfusion. | Baseline up to Week 28 |
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Starting Dose of NeoRecormon® Injection | Dose of NeoRecormon® injection was measured in international units/kilograms/weeks (IU/kg/weeks). | Baseline |
| Percentage of Participants With Starting Dose Between 360 and 540 IU/kg/Weeks |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Anemic cancer patients receiving NeoRecormon (epoetin beta)
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Hoffmann-La Roche | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Neuilly-sur-Seine | 92521 | France |
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Efficacy population included participants who had received at least 1 dose of NeoRecormon® injection and without inclusion or exclusion criteria violation.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Efficacy population. Here "number of participants analyzed" included those participants who were evaluable for the outcome measure. | Posted | Number | 95% Confidence Interval | percentage of participants | Day 28 to 42 |
|
Baseline up to 28 day after last dose
Safety population included participants who had received at least 1 dose of NeoRecormon® injection.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Solid Tumor 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. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Death | General disorders | MedDRA (12.0) | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Asthenia | General disorders | MedDRA (12.0) | Non-systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Medical Communications | Hoffmann-La Roche | 800-821-8590 | genentech@druginfo.com |
Not provided
| ID | Term |
|---|---|
| D000740 | Anemia |
| D009369 | Neoplasms |
| ID | Term |
|---|---|
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C103998 | epoetin beta |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Baseline up to Week 28 |
| 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. | Baseline |
| 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. | Week 4 to 6 |
| 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. | Week 12 to 16 |
| 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. | Week 24 to 28 |
| 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. | Baseline |
| 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). | Week 4 Up to Week 28 |
| 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). | Week 4 Up to Week 28 |
| 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. | Baseline |
| 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. | Week 4 to 6 |
| 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. | Week 12 to 16 |
| 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. | Week 24 to 28 |
| 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). | Baseline, Week 4 to 6 |
| 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). | Baseline, Week 12 to 16 |
| 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). | Baseline, Week 24 to 28 |
| Baseline |
| 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. | Baseline, Week 4 to 6, Week 12 to 16, Week 24 to 48 |
| 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 | 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. | Baseline up to Week 28 |
| Percentage of Participants With Temporary Discontinuation From NeoRecormon® Treatment | Percentage of participants with at least 1 temporary discontinuation was reported. | Baseline up to Week 28 |
| 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 | Criteria for adequate iron status included serum ferritin greater than (>) 100 micrograms/liter (µg/L) and transferrin saturation (TSAT)> 20%. | Baseline, Week 4 to 6, Week 12 to 16, Week 24 to 48 |
| Percentage of Participants With Vitamins Prescription | Week 4 to 6, Week 12 to 16, Week 24 to 48 |
| Kidney transplantation |
|
| Other |
|
| Protocol Violation |
|
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| OG001 |
| Hematological Malignancy 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. |
| OG002 | 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. |
|
|
| 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. | Efficacy population. Here "number of participants analyzed" included those participants who were evaluable for the outcome measure. | Posted | Number | 95% Confidence Interval | percentage of participants | Day 21 to 42 |
|
|
|
| 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. | Efficacy population. Here "number of participants analyzed" included those participants who were evaluable for the outcome measure. | Posted | Number | percentage of participants | Baseline up to Week 28 |
|
|
|
|
| Primary | Mean Number of RBC Transfusions | Mean number of transfusion was based on the number of participants with at least 1 RBC transfusion. | Efficacy population. Here "number of participants analyzed" included those participants who were evaluable for the outcome measure without any missing data. | Posted | Mean | Standard Deviation | RBC transfusions | Baseline up to Week 28 |
|
|
|
| Primary | Mean Number of RBC Units | Mean number of units was based on the number of participants with at least 1 RBC transfusion. | Efficacy population. Here "number of participants analyzed" included those participants who were evaluable for the outcome measure without any missing data. | Posted | Mean | Standard Deviation | RBC units | Baseline up to Week 28 |
|
|
|
| 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. | Efficacy population. Here "number of participants analyzed" included those participants who were evaluable for the outcome measure. | Posted | Median | 95% Confidence Interval | weeks | Baseline up to Week 28 |
|
|
|
|
| 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. | Efficacy population. Here "number of participants analyzed" included those participants who were evaluable for the outcome measure. | Posted | Mean | Standard Deviation | units on a scale | Baseline |
|
|
|
| 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. | Efficacy population. Here "number of participants analyzed" included those participants who were evaluable for the outcome measure. | Posted | Mean | Standard Deviation | units on a scale | Week 4 to 6 |
|
|
|
| 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. | Efficacy population. Here "number of participants analyzed" included those participants who were evaluable for the outcome measure. | Posted | Mean | Standard Deviation | units on a scale | Week 12 to 16 |
|
|
|
| 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. | Efficacy population. Here "number of participants analyzed" included those participants who were evaluable for the outcome measure. | Posted | Mean | Standard Deviation | units on a scale | Week 24 to 28 |
|
|
|
| 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. | Efficacy population. Here "number of participants analyzed" included those participants who were evaluable for the outcome measure. | Posted | Number | percentage of participants | Baseline |
|
|
|
| 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). | Efficacy population. Here "number of participants analyzed" included those participants who were evaluable for the outcome measure. | Posted | Number | percentage of participants | Week 4 Up to Week 28 |
|
|
|
| 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). | Efficacy population. Here "number of participants analyzed" included those participants who had at least 1 sick leave without any missing data. | Posted | Mean | Standard Deviation | days | Week 4 Up to Week 28 |
|
|
|
| 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. | Efficacy population. Here "number of participants analyzed" included those participants who were evaluable for the outcome measure. | Posted | Number | percentage of participants | Baseline |
|
|
|
| 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. | Efficacy population. Here "number of participants analyzed" included those participants who were evaluable for the outcome measure. | Posted | Number | percentage of participants | Week 4 to 6 |
|
|
|
| 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. | Efficacy population. Here "number of participants analyzed" included those participants who were evaluable for the outcome measure. | Posted | Number | percentage of participants | Week 12 to 16 |
|
|
|
| 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. | Efficacy population. Here "number of participants analyzed" included those participants who were evaluable for the outcome measure. | Posted | Number | percentage of participants | Week 24 to 28 |
|
|
|
| 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). | Efficacy population. Here "number of participants analyzed" included those participants who were evaluable for the outcome measure. | Posted | Mean | Standard Deviation | units on a scale | Baseline, Week 4 to 6 |
|
|
|
| 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). | Efficacy population. Here "number of participants analyzed" included those participants who were evaluable for the outcome measure. | Posted | Mean | Standard Deviation | units on a scale | Baseline, Week 12 to 16 |
|
|
|
| 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). | Efficacy population. Here "number of participants analyzed" included those participants who were evaluable for the outcome measure. | Posted | Mean | Standard Deviation | units on a scale | Baseline, Week 24 to 28 |
|
|
|
| Secondary | Mean Starting Dose of NeoRecormon® Injection | Dose of NeoRecormon® injection was measured in international units/kilograms/weeks (IU/kg/weeks). | Efficacy population. Here "number of participants analyzed" included those participants who were evaluable for the outcome measure. | Posted | Mean | Standard Deviation | IU/kg/weeks | Baseline |
|
|
|
| Secondary | Percentage of Participants With Starting Dose Between 360 and 540 IU/kg/Weeks | Efficacy population. Here "number of participants analyzed" included those participants who were evaluable for the outcome measure. | Posted | Number | percentage of participants | Baseline |
|
|
|
| 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. | 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. | Posted | Number | percentage of participants | Baseline, Week 4 to 6, Week 12 to 16, Week 24 to 48 |
|
|
|
| Secondary | Percentage of Participants With Subcutaneous (SC) Route of Administration | 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. | Posted | Number | percentage of participants | Baseline, Week 4 to 6, Week 12 to 16, Week 24 to 48 |
|
|
|
| Secondary | Percentage of Participants With NeoRecormon® SC Injections at a Weekly Dose of 30000 IU | Efficacy population. Here "number of participants analyzed" included those participants who were evaluable for the outcome measure. | Posted | Number | percentage of participants | Baseline up to Week 28 |
|
|
|
| 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. | Efficacy population. Here "number of participants analyzed" included those participants who were evaluable for the outcome measure. | Posted | Number | percentage of participants | Baseline up to Week 28 |
|
|
|
| Secondary | Percentage of Participants With Temporary Discontinuation From NeoRecormon® Treatment | Percentage of participants with at least 1 temporary discontinuation was reported. | Efficacy population. Here "number of participants analyzed" included those participants who were evaluable for the outcome measure. | Posted | Number | percentage of participants | Baseline up to Week 28 |
|
|
|
| Secondary | Percentage of Participants With Permanent Discontinuation From NeoRecormon® Treatment | 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. | Posted | Number | percentage of participants | Baseline up to Week 4 to 6, Week 12 to 16, Week 24 to 28 |
|
|
|
| Secondary | Relative Percent Change in Hb Concentration From Baseline Over the Study Period | 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. | Posted | Mean | Standard Deviation | percent change | Baseline, Week 4 to 6, Week 12 to 16, Week 24 to 28 |
|
|
|
| Secondary | Percentage of Participants With Hb Concentration Within the Range of 10 to 12 g/dL | Efficacy population. Here "number of participants analyzed" included those participants who were evaluable for the outcome measure. | Posted | Number | percentage of participants | Baseline up to Week 28 |
|
|
|
| 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%. | 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. | Posted | Number | percentage of participants | Baseline, Week 4 to 6, Week 12 to 16, Week 24 to 48 |
|
|
|
| Secondary | Percentage of Participants With Vitamins Prescription | 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. | Posted | Number | percentage of participants | Week 4 to 6, Week 12 to 16, Week 24 to 48 |
|
|
|
| 6 |
| 735 |
| 63 |
| 735 |
| EG001 | Hematological Malignancy Participants | 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. | 4 | 319 | 31 | 319 |
| EG002 | 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. | 10 | 1,054 | 94 | 1,054 |
| Pain | General disorders | MedDRA (12.0) | Non-systematic Assessment |
|
| Sepsis | Infections and infestations | MedDRA (12.0) | Non-systematic Assessment |
|
| Septic shock | Infections and infestations | MedDRA (12.0) | Non-systematic Assessment |
|
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA (12.0) | Non-systematic Assessment |
|
| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA (12.0) | Non-systematic Assessment |
|
| Fistula | Musculoskeletal and connective tissue disorders | MedDRA (12.0) | Non-systematic Assessment |
|
| Phlebitis | Vascular disorders | MedDRA (12.0) | Non-systematic Assessment |
|
| Disease progression | General disorders | MedDRA (12.0) | Non-systematic Assessment |
|
| General physical health deterioration | General disorders | MedDRA (12.0) | Non-systematic Assessment |
|
| Pyrexia | General disorders | MedDRA (12.0) | Non-systematic Assessment |
|
| Hyperthermia | General disorders | MedDRA (12.0) | Non-systematic Assessment |
|
| Malaise | General disorders | MedDRA (12.0) | Non-systematic Assessment |
|
| Oedema peripheral | General disorders | MedDRA (12.0) | Non-systematic Assessment |
|
| Catheter thrombosis | General disorders | MedDRA (12.0) | Non-systematic Assessment |
|
| Facial pain | General disorders | MedDRA (12.0) | Non-systematic Assessment |
|
| Fatigue | General disorders | MedDRA (12.0) | Non-systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA (12.0) | Non-systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA (12.0) | Non-systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA (12.0) | Non-systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | MedDRA (12.0) | Non-systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA (12.0) | Non-systematic Assessment |
|
| Anorectal discomfort | Gastrointestinal disorders | MedDRA (12.0) | Non-systematic Assessment |
|
| Aphthous stomatitis | Gastrointestinal disorders | MedDRA (12.0) | Non-systematic Assessment |
|
| Dry mouth | Gastrointestinal disorders | MedDRA (12.0) | Non-systematic Assessment |
|
| Gastrointestinal disorder | Gastrointestinal disorders | MedDRA (12.0) | Non-systematic Assessment |
|
| Gastrointestinal motility disorder | Gastrointestinal disorders | MedDRA (12.0) | Non-systematic Assessment |
|
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA (12.0) | Non-systematic Assessment |
|
| Haemorrhoids | Gastrointestinal disorders | MedDRA (12.0) | Non-systematic Assessment |
|
| Oesophagitis | Gastrointestinal disorders | MedDRA (12.0) | Non-systematic Assessment |
|
| Stomatitis | Gastrointestinal disorders | MedDRA (12.0) | Non-systematic Assessment |
|
| Neutropenia | Blood and lymphatic system disorders | MedDRA (12.0) | Non-systematic Assessment |
|
| Anaemia | Blood and lymphatic system disorders | MedDRA (12.0) | Non-systematic Assessment |
|
| Febrile bone marrow aplasia | Blood and lymphatic system disorders | MedDRA (12.0) | Non-systematic Assessment |
|
| Pancytopenia | Blood and lymphatic system disorders | MedDRA (12.0) | Non-systematic Assessment |
|
| Thrombocythaemia | Blood and lymphatic system disorders | MedDRA (12.0) | Non-systematic Assessment |
|
| Lymphopenia | Blood and lymphatic system disorders | MedDRA (12.0) | Non-systematic Assessment |
|
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA (12.0) | Non-systematic Assessment |
|
| Urinary tract infection | Infections and infestations | MedDRA (12.0) | Non-systematic Assessment |
|
| Bronchitis | Infections and infestations | MedDRA (12.0) | Non-systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA (12.0) | Non-systematic Assessment |
|
| Candidiasis | Infections and infestations | MedDRA (12.0) | Non-systematic Assessment |
|
| Ear infection | Infections and infestations | MedDRA (12.0) | Non-systematic Assessment |
|
| Erysipelas | Infections and infestations | MedDRA (12.0) | Non-systematic Assessment |
|
| Escherichia infection | Infections and infestations | MedDRA (12.0) | Non-systematic Assessment |
|
| Folliculitis | Infections and infestations | MedDRA (12.0) | Non-systematic Assessment |
|
| HIV infection | Infections and infestations | MedDRA (12.0) | Non-systematic Assessment |
|
| Oral fungal infection | Infections and infestations | MedDRA (12.0) | Non-systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA (12.0) | Non-systematic Assessment |
|
| Sinusitis | Infections and infestations | MedDRA (12.0) | Non-systematic Assessment |
|
| Tonsilitis | Infections and infestations | MedDRA (12.0) | Non-systematic Assessment |
|
| Dysaesthesia | Nervous system disorders | MedDRA (12.0) | Non-systematic Assessment |
|
| Neuropathy peripheral | Nervous system disorders | MedDRA (12.0) | Non-systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA (12.0) | Non-systematic Assessment |
|
| Ageusia | Nervous system disorders | MedDRA (12.0) | Non-systematic Assessment |
|
| Cerebral ischaemia | Nervous system disorders | MedDRA (12.0) | Non-systematic Assessment |
|
| Transient ischaemic attack | Nervous system disorders | MedDRA (12.0) | Non-systematic Assessment |
|
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA (12.0) | Non-systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (12.0) | Non-systematic Assessment |
|
| Lung disorder | Respiratory, thoracic and mediastinal disorders | MedDRA (12.0) | Non-systematic Assessment |
|
| Dyspnoea exertional | Respiratory, thoracic and mediastinal disorders | MedDRA (12.0) | Non-systematic Assessment |
|
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA (12.0) | Non-systematic Assessment |
|
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA (12.0) | Non-systematic Assessment |
|
| Phlebitis superficial | Vascular disorders | MedDRA (12.0) | Non-systematic Assessment |
|
| Deep vein thrombosis | Vascular disorders | MedDRA (12.0) | Non-systematic Assessment |
|
| Phlebitis | Vascular disorders | MedDRA (12.0) | Non-systematic Assessment |
|
| Hypertension | Vascular disorders | MedDRA (12.0) | Non-systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (12.0) | Non-systematic Assessment |
|
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA (12.0) | Non-systematic Assessment |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA (12.0) | Non-systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (12.0) | Non-systematic Assessment |
|
| Arthritis | Musculoskeletal and connective tissue disorders | MedDRA (12.0) | Non-systematic Assessment |
|
| Bone pain | Musculoskeletal and connective tissue disorders | MedDRA (12.0) | Non-systematic Assessment |
|
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA (12.0) | Non-systematic Assessment |
|
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA (12.0) | Non-systematic Assessment |
|
| Dermititis bullous | Skin and subcutaneous tissue disorders | MedDRA (12.0) | Non-systematic Assessment |
|
| Erythema | Skin and subcutaneous tissue disorders | MedDRA (12.0) | Non-systematic Assessment |
|
| Lividity | Skin and subcutaneous tissue disorders | MedDRA (12.0) | Non-systematic Assessment |
|
| Nail disorder | Skin and subcutaneous tissue disorders | MedDRA (12.0) | Non-systematic Assessment |
|
| Palmar-plantar erythrodysaesthesia syndrome | Skin and subcutaneous tissue disorders | MedDRA (12.0) | Non-systematic Assessment |
|
| Pigmentation disorder | Skin and subcutaneous tissue disorders | MedDRA (12.0) | Non-systematic Assessment |
|
| Hypersensitivity | Immune system disorders | MedDRA (12.0) | Non-systematic Assessment |
|
| Drug hypersensitivity | Immune system disorders | MedDRA (12.0) | Non-systematic Assessment |
|
| Confusional state | Psychiatric disorders | MedDRA (12.0) | Non-systematic Assessment |
|
| Initial insomnia | Psychiatric disorders | MedDRA (12.0) | Non-systematic Assessment |
|
| Sleep disorder | Psychiatric disorders | MedDRA (12.0) | Non-systematic Assessment |
|
| Dysuria | Renal and urinary disorders | MedDRA (12.0) | Non-systematic Assessment |
|
| Renal failure | Renal and urinary disorders | MedDRA (12.0) | Non-systematic Assessment |
|
| Vesical fistula | Renal and urinary disorders | MedDRA (12.0) | Non-systematic Assessment |
|
| Post procedural haemorrhage | Injury, poisoning and procedural complications | MedDRA (12.0) | Non-systematic Assessment |
|
| Subdural haematoma | Injury, poisoning and procedural complications | MedDRA (12.0) | Non-systematic Assessment |
|
| Anorexia | Metabolism and nutrition disorders | MedDRA (12.0) | Non-systematic Assessment |
|
| Infected neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (12.0) | Non-systematic Assessment |
|
| Renal cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (12.0) | Non-systematic Assessment |
|
| Cholestatis | Hepatobiliary disorders | MedDRA (12.0) | Non-systematic Assessment |
|
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.
| Title | Measurements |
|---|---|
|
| No occupation |
|
| Retired |
|
| Sick leave |
|
| Student, training |
|
| Unemployment |
|
|
|
|
|
| Baseline: 40000 IU/weeks-qw (n=669,300,969) |
|
| Baseline: Other (n=669,300,969) |
|
| Week 4-6: 30000 IU/weeks-qw (n=494,262,756) |
|
| Week 4-6: 20000 IU/weeks-qw (n=494,262,756) |
|
| Week 4-6: 30000 IU/weeks-tw (n=494,262,756) |
|
| Week 4-6: 60000 IU/weeks-qw (n=494,262,756) |
|
| Week 4-6: 30000 IU/weeks-q2w (n=494,262,756) |
|
| Week 4-6: 40000 IU/weeks-qw (n=494,262,756) |
|
| Week 4-6: Other (n=494,262,756) |
|
| Week 12-16: 30000 IU/weeks-qw (n=244,163,407) |
|
| Week 12-16: 20000 IU/weeks-qw (n=244,163,407) |
|
| Week 12-16: 30000 IU/weeks-tw (n=244,163,407) |
|
| Week 12-16: 60000 IU/weeks-qw (n=244,163,407) |
|
| Week 12-16: 30000 IU/weeks-q2w (n=244,163,407) |
|
| Week 12-16: Other (n=244,163,407) |
|
| Week 24-28: 30000 IU/weeks-qw (n=119,76,195) |
|
| Week 24-28: 20000 IU/weeks-qw (n=119,76,195) |
|
| Week 24-28: 60000 IU/weeks-qw (n=119,76,195) |
|
| Week 24-28: 40000 IU/weeks-qw (n=119,76,195) |
|
| Week 24-28: Other (n=119,76,195) |
|
|
| Week 12-16 (n=238,163,401) |
|
| Week 24-28 (n=116,76,192) |
|
|
| Baseline up to Week 24-28 (n=457,227,684) |
|
|
| Change at Week 24-28 (n=357,195,552) |
|
|
| Week 12-16 (n=24,18,42) |
|
| Week 24-28 (n=13,17,30) |
|
| Week 12-16 (n=230,132,153,86,72,158,23,30,884) |
|
| Week 24-28 (n=165,114,111,72,57,127,17,21,684) |
|