Trial · NCT01168349
Registered outcomes32
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 32
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | 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. |
| Primary | 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. |
| Primary | 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. |
| Primary | 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. |
| Primary | 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. |
| Primary | 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. |
| Primary | 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. |
| Primary | 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. |
| Primary | 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. |
| Primary | 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. |
| Primary | 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. |
| Primary | 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). |
| Primary | 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). |
| Primary | 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. |
| Primary | 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. |
| Primary | 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. |
| Primary | 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. |
| Primary | 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). |
| Primary | 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). |
| Primary | 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). |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
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