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To deterime the efficacy of 500 μg and 300 μg darbepoetin alfa administered subcutaneously (SC) on an every 3 weeks (Q3W) schedule, and the effect of intravenous (IV) iron supplementation in the treatment of anemia in patients with non-myeloid malignancies who were receiving multicycle chemotherapy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Darbepoetin alfa 300 μg plus IV Iron | Experimental | Darbepoetin alfa 300 μg subcutaneous injection plus intravenous (IV) iron 400 mg, every three weeks (Q3W), for up to 15 weeks (a total of 5 doses). |
|
| Darbepoetin alfa 300 μg | Experimental | Darbepoetin alfa 300 μg subcutaneous injection every three weeks (Q3W), for up to 15 weeks (a total of 5 doses). |
|
| Darbepoetin alfa 500 μg | Experimental | Darbepoetin alfa 500 μg subcutaneous injection every three weeks (Q3W), for up to 15 weeks (a total of 5 doses). |
|
| Darbepoetin alfa 500 μg plus IV Iron | Active Comparator | Darbepoetin alfa 500 μg subcutaneous injection plus intravenous (IV) iron 400 mg, every three weeks (Q3W), for up to 15 weeks (a total of 5 doses). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| darbepoetin alfa | Drug | Darbepoetin alfa administered by subcutaneous injection. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Who Achieved the Target Hemoglobin Level, by Darbepoetin Alfa Dose | Target hemoglobin was defined as ≥ 11 g/dL during the treatment period in the absence of a red blood cell (RBC) transfusion on the day of measurement or during the preceding 28 days. | From Week 1 to Week 16 |
| Number of Participants Who Achieved the Target Hemoglobin Levels, by IV Iron Usage | Target hemoglobin was defined as ≥ 11 g/dL during the treatment period in the absence of a red blood cell (RBC) transfusion on the day of measurement or during the preceding 28 days. | From Week 1 to Week 16 |
| Measure | Description | Time Frame |
|---|---|---|
| Time to Achieve Target Hemoglobin Level, by Darbepoetin Alfa Dose | The time to target hemoglobin is the interval in weeks between study day 1 and the first day that a hemoglobin value ≥ 11.0 g/dL is observed during the treatment period. If a participant did not achieve the target hemoglobin by the time of withdrawal or the end of the treatment period (EOTP), the time to target hemoglobin was censored on the day of the last hemoglobin measurement or the EOTP, whichever was earlier. Median was calculated using Kaplan-Meier estimates. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| MD | Amgen | Study Director |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20661916 | Result | Auerbach M, Silberstein PT, Webb RT, Averyanova S, Ciuleanu TE, Shao J, Bridges K. Darbepoetin alfa 300 or 500 mug once every 3 weeks with or without intravenous iron in patients with chemotherapy-induced anemia. Am J Hematol. 2010 Sep;85(9):655-63. doi: 10.1002/ajh.21779. |
| Label | URL |
|---|---|
| FDA-approved Drug Labeling | View source |
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A total of 243 patients were randomizd and 238 received study drug (4 participants in the Darbepoetin alfa 300 μg plus Iron group and 1 in the Darbepoetin alfa 500 μg plus Iron group were not treated)
Participants were enrolled from 18 December 2006 through 27 August 2007.
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| ID | Title | Description |
|---|---|---|
| FG000 | Darbepoetin Alfa 300 μg Plus Iron | Darbepoetin alfa 300 μg subcutaneous injection plus intravenous (IV) iron 400 mg, every three weeks (Q3W), for up to 15 weeks (a total of 5 doses). |
| FG001 | Darbepoetin Alfa 300 μg | Darbepoetin alfa 300 μg subcutaneous injection every three weeks (Q3W), for up to 15 weeks (a total of 5 doses). |
| FG002 | Darbepoetin Alfa 500 μg Plus Iron | Darbepoetin alfa 500 μg subcutaneous injection plus intravenous (IV) iron 400 mg, every three weeks (Q3W), for up to 15 weeks (a total of 5 doses). |
| FG003 | Darbepoetin Alfa 500 μg | Darbepoetin alfa 500 μg subcutaneous injection every three weeks (Q3W), for up to 15 weeks (a total of 5 doses). |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
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| ID | Title | Description |
|---|---|---|
| BG000 | Darbepoetin Alfa 300 μg Plus Iron | Darbepoetin alfa 300 μg subcutaneous injection plus intravenous (IV) iron 400 mg, every three weeks (Q3W), for up to 15 weeks (a total of 5 doses). |
| BG001 | Darbepoetin Alfa 300 μg |
| 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 | Number of Participants Who Achieved the Target Hemoglobin Level, by Darbepoetin Alfa Dose | Target hemoglobin was defined as ≥ 11 g/dL during the treatment period in the absence of a red blood cell (RBC) transfusion on the day of measurement or during the preceding 28 days. | Subset of Primary Analysis Set, composed of all randomized participants who received at least one dose of blinded study medication, who had baseline hemoglobin values < 11.0 g/dL. | Posted | Number | Participants | From Week 1 to Week 16 |
|
From first dose date to 3 weeks after the last dose of study drug or IV iron (Week 16).
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient who was randomized to the 300 μg without iron arm received commercial iron product and was counted in the 300 μg with iron arm.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Darbepoetin Alfa 300 µg (Without IV Iron) | Darbepoetin alfa 300 μg subcutaneous injection every three weeks (Q3W), for up to 15 weeks (a total of 5 doses). |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 10.0 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 10.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Director | Amgen Inc. | 866-572-6436 |
| ID | Term |
|---|---|
| D000740 | Anemia |
| D009369 | Neoplasms |
| ID | Term |
|---|---|
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
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| ID | Term |
|---|---|
| D000068256 | Darbepoetin alfa |
| D007505 | Iron-Dextran Complex |
| ID | Term |
|---|---|
| D004921 | Erythropoietin |
| D003115 | Colony-Stimulating Factors |
| D006023 | Glycoproteins |
| D006001 | Glycoconjugates |
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|
| IV iron dextran | Drug | Administered by intravenous (IV) injection. |
|
|
| From Week 1 to Week 16 |
| Time to Achieve the Target Hemoglobin Level, by IV Iron Usage | The time to target hemoglobin is the interval in weeks between study day 1 and the first day that a hemoglobin value ≥ 11.0 g/dL is observed during the treatment period. If a participant did not achieve the target hemoglobin by the time of withdrawal or the end of the treatment period (EOTP), the time to target hemoglobin was censored on the day of the last hemoglobin measurement or the EOTP, whichever was earlier. Median was calculated using Kaplan-Meier estimates. | From Week 1 to Week 16 |
| Change From Baseline in Hemoglobin Concentration, by Darbepoetin Alfa Dose | Change in hemoglobin concentration from Baseline to the end of the treatment period (Week 16). | Baseline and Week 16 |
| Change From Baseline in Hemoglobin Concentration, by IV Iron Usage | Change in hemoglobin concentration from Baseline to the end of the treatment period (Week 16). | Baseline and Week 16 |
| Number of Participants With ≥ 1 Red Blood Cell Transfusion From Week 1 to End of Study, by Darbepoetin Alfa Dose | The number of participants with ≥ 1 red blood cell (RBC) transfusion from week 1 to end of study (EOS). Participants with a hemoglobin value ≤ 8 g/dL but no RBC transfusion were counted as having had a transfusion. | From Week 1 to Week 16 |
| Number of Participants With ≥ 1 Red Blood Cell Transfusion From Week 1 to End of Study, by IV Iron Usage | The number of participants with ≥ 1 red blood cell (RBC) transfusion from week 1 to end of study (EOS). Participants with a hemoglobin value ≤ 8 g/dL but no RBC transfusion were counted as having had a transfusion. | From Week 1 to Week 16 |
| Number of Participants With ≥ 1 Red Blood Cell Transfusion From Week 5 to End of Study | Number of participants with ≥ 1 RBC transfusion from Week 5 to end of study (Week 16)). Participants with a hemoglobin value ≤ 8 g/dL but no RBC transfusion were counted as having had a transfusion. | From Week 5 to Week 16 |
| Number of Participants With a Hematopoietic Response, by Darbepoetin Alfa Dose | Number of participants with a hematopoietic response, defined as > 2 g/dL increase from baseline or hemoglobin ≥ 12 g/dL during the treatment period in the absence of a red blood cell transfusion within the prior 28 days. | From Week 1 to Week 16 |
| Number of Participants With a Hematopoietic Response, by IV Iron Usage | Number of participants with a hematopoietic response, defined as > 2 g/dL increase from baseline or hemoglobin ≥ 12 g/dL during the treatment period in the absence of a red blood cell transfusion within the prior 28 days. Assessing the effect of iron in a factorial experiment. | From Week 1 to Week 16 |
| Time to Hematopoietic Response, by Darbepoetin Alfa Dose | The time to hematopoietic response is the interval in weeks between study day 1 and the first day that a hematopoietic response is observed during the treatment period. Hematopoietic response is defined as an increase in hemoglobin concentration of ≥ 2.0 g/dL from baseline or a hemoglobin concentration ≥ 12.0 g/dL in the absence of RBC transfusions on the day of measurement and during the preceding 28 days of the treatment period. If a participant did not achieve a hematopoietic response by the time of withdrawal or the end of the treatment period (EOTP), the time to hematopoietic response was censored on the day of the last hemoglobin measurement or the EOTP, whichever was earlier. Median was calculated using using Kaplan-Meier estimates. | From Week 1 to Week 16 |
| Time to Hematopoietic Response, by IV Iron Usage | The time to hematopoietic response is the interval in weeks between study day 1 and the first day that a hematopoietic response is observed during the treatment period. Hematopoietic response is defined as an increase in hemoglobin concentration of ≥ 2.0 g/dL from baseline or a hemoglobin concentration ≥ 12.0 g/dL in the absence of RBC transfusions on the day of measurement and during the preceding 28 days of the treatment period. If a participant did not achieve a hematopoietic response by the time of withdrawal or the end of the treatment period (EOTP), the time to hematopoietic response was censored on the day of the last hemoglobin measurement or the EOTP, whichever was earlier. Median was calculated using using Kaplan-Meier estimates. | From Week 1 to Week 16 |
| Change From Baseline in Functional Assessment of Cancer Therapy (FACT) - Fatigue Score, by Darbepoetin Alfa Dose | Health related quality of life was measured using the Functional Assessment of Cancer Therapy (FACT) - Fatigue subscale. The FACT-F includes 13 fatigue items, with each item assessed on a 5-point scale (ie, response values of 0 to 4). The FACT-F subscale score ranges from 0 to 52, where a higher score represents less fatigue. | Baseline and Week 16 |
| Change From Baseline in Functional Assessment of Cancer Therapy (FACT) - Fatigue Score, by IV Iron Usage | Health related quality of life was measured using the Functional Assessment of Cancer Therapy (FACT) - Fatigue subscale. The FACT-F includes 13 fatigue items, with each item assessed on a 5-point scale (ie, response values of 0 to 4). The FACT-F subscale score ranges from 0 to 52, where a higher score represents less fatigue. | Baseline and Week 16 |
| AmgenTrials clinical trials website | View source |
| Death |
|
| Lost to Follow-up |
|
| Withdrawal by Subject |
|
| Physician Decision |
|
| Ineligibility determined |
|
| Disease progression |
|
| Other |
|
Darbepoetin alfa 300 μg subcutaneous injection every three weeks (Q3W), for up to 15 weeks (a total of 5 doses).
| BG002 | Darbepoetin Alfa 500 μg | Darbepoetin alfa 500 μg subcutaneous injection every three weeks (Q3W), for up to 15 weeks (a total of 5 doses). |
| BG003 | Darbepoetin Alfa 500 μg Plus Iron | Darbepoetin alfa 500 μg subcutaneous injection plus intravenous (IV) iron 400 mg, every three weeks (Q3W), for up to 15 weeks (a total of 5 doses). |
| BG004 | Total | Total of all reporting groups |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Number | Participants |
|
| FACT-Fatigue Score | Functional Assessment of Cancer Therapy (FACT) - Fatigue subscale score, ranging from 0 to 52, where 0 = worst outcome and higher scores represent less fatigue. | Mean | Standard Deviation | Units on a scale |
|
| Hemoglobin | Mean | Standard Deviation | g/dL |
|
Darbepoetin alfa 500 μg subcutaneous injection with or without intravenous (IV) iron 400 mg, every three weeks (Q3W), for up to 15 weeks (a total of 5 doses). |
|
|
|
| Primary | Number of Participants Who Achieved the Target Hemoglobin Levels, by IV Iron Usage | Target hemoglobin was defined as ≥ 11 g/dL during the treatment period in the absence of a red blood cell (RBC) transfusion on the day of measurement or during the preceding 28 days. | Subset of Primary Analysis Set, composed of all randomized participants who received at least one dose of blinded study medication, who had baseline hemoglobin values < 11.0 g/dL. | Posted | Number | Participants | From Week 1 to Week 16 |
|
|
|
|
| Secondary | Time to Achieve Target Hemoglobin Level, by Darbepoetin Alfa Dose | The time to target hemoglobin is the interval in weeks between study day 1 and the first day that a hemoglobin value ≥ 11.0 g/dL is observed during the treatment period. If a participant did not achieve the target hemoglobin by the time of withdrawal or the end of the treatment period (EOTP), the time to target hemoglobin was censored on the day of the last hemoglobin measurement or the EOTP, whichever was earlier. Median was calculated using Kaplan-Meier estimates. | Subset of Primary Analysis Set, composed of all randomized participants who received at least one dose of blinded study medication, who had baseline hemoglobin values < 11.0 g/dL. | Posted | Median | 95% Confidence Interval | Weeks | From Week 1 to Week 16 |
|
|
|
| Secondary | Time to Achieve the Target Hemoglobin Level, by IV Iron Usage | The time to target hemoglobin is the interval in weeks between study day 1 and the first day that a hemoglobin value ≥ 11.0 g/dL is observed during the treatment period. If a participant did not achieve the target hemoglobin by the time of withdrawal or the end of the treatment period (EOTP), the time to target hemoglobin was censored on the day of the last hemoglobin measurement or the EOTP, whichever was earlier. Median was calculated using Kaplan-Meier estimates. | Subset of Primary Analysis Set, composed of all randomized participants who received at least one dose of blinded study medication, who had baseline hemoglobin values < 11.0 g/dL. | Posted | Median | 95% Confidence Interval | Weeks | From Week 1 to Week 16 |
|
|
|
| Secondary | Change From Baseline in Hemoglobin Concentration, by Darbepoetin Alfa Dose | Change in hemoglobin concentration from Baseline to the end of the treatment period (Week 16). | Primary Analysis Set, composed of all participants who were randomized, properly consented, and received at least one dose of blinded study drug. Imputation by last value carried forward (LVCF) was applied. | Posted | Mean | Standard Deviation | g/dL | Baseline and Week 16 |
|
|
|
| Secondary | Change From Baseline in Hemoglobin Concentration, by IV Iron Usage | Change in hemoglobin concentration from Baseline to the end of the treatment period (Week 16). | Primary Analysis Set, composed of all participants who were randomized, properly consented, and received at least one dose of blinded study drug. Imputation by last value carried forward (LVCF) was applied. | Posted | Mean | Standard Deviation | g/dL | Baseline and Week 16 |
|
|
|
| Secondary | Number of Participants With ≥ 1 Red Blood Cell Transfusion From Week 1 to End of Study, by Darbepoetin Alfa Dose | The number of participants with ≥ 1 red blood cell (RBC) transfusion from week 1 to end of study (EOS). Participants with a hemoglobin value ≤ 8 g/dL but no RBC transfusion were counted as having had a transfusion. | Primary Analysis Set, composed of all participants who were randomized, properly consented, and received at least one dose of blinded study drug. | Posted | Number | Participants | From Week 1 to Week 16 |
|
|
|
|
| Secondary | Number of Participants With ≥ 1 Red Blood Cell Transfusion From Week 1 to End of Study, by IV Iron Usage | The number of participants with ≥ 1 red blood cell (RBC) transfusion from week 1 to end of study (EOS). Participants with a hemoglobin value ≤ 8 g/dL but no RBC transfusion were counted as having had a transfusion. | Primary Analysis Set, composed of all participants who were randomized, properly consented, and received at least one dose of blinded study drug. | Posted | Number | Participants | From Week 1 to Week 16 |
|
|
|
|
| Secondary | Number of Participants With ≥ 1 Red Blood Cell Transfusion From Week 5 to End of Study | Number of participants with ≥ 1 RBC transfusion from Week 5 to end of study (Week 16)). Participants with a hemoglobin value ≤ 8 g/dL but no RBC transfusion were counted as having had a transfusion. | Subset of Primary Analysis Set, composed of all randomized participants who received at least one dose of blinded study medication, and who were eligible for an RBC transfusion at week 5. | Posted | Number | Participants | From Week 5 to Week 16 |
|
|
|
|
| Secondary | Number of Participants With a Hematopoietic Response, by Darbepoetin Alfa Dose | Number of participants with a hematopoietic response, defined as > 2 g/dL increase from baseline or hemoglobin ≥ 12 g/dL during the treatment period in the absence of a red blood cell transfusion within the prior 28 days. | Subset of Primary Analysis Set, composed of all participants who were randomized, properly consented, and received at least one dose of blinded study drug, who had a baseline hemoglobin value. | Posted | Number | Participants | From Week 1 to Week 16 |
|
|
|
|
| Secondary | Number of Participants With a Hematopoietic Response, by IV Iron Usage | Number of participants with a hematopoietic response, defined as > 2 g/dL increase from baseline or hemoglobin ≥ 12 g/dL during the treatment period in the absence of a red blood cell transfusion within the prior 28 days. Assessing the effect of iron in a factorial experiment. | Subset of Primary Analysis Set, composed of all participants who were randomized, properly consented, and received at least one dose of blinded study drug, who had a baseline hemoglobin value. | Posted | Number | Participants | From Week 1 to Week 16 |
|
|
|
|
| Secondary | Time to Hematopoietic Response, by Darbepoetin Alfa Dose | The time to hematopoietic response is the interval in weeks between study day 1 and the first day that a hematopoietic response is observed during the treatment period. Hematopoietic response is defined as an increase in hemoglobin concentration of ≥ 2.0 g/dL from baseline or a hemoglobin concentration ≥ 12.0 g/dL in the absence of RBC transfusions on the day of measurement and during the preceding 28 days of the treatment period. If a participant did not achieve a hematopoietic response by the time of withdrawal or the end of the treatment period (EOTP), the time to hematopoietic response was censored on the day of the last hemoglobin measurement or the EOTP, whichever was earlier. Median was calculated using using Kaplan-Meier estimates. | Subset of Primary Analysis Set, composed of all participants who were randomized, properly consented, and received at least one dose of blinded study drug, who had a baseline hemoglobin value. | Posted | Median | 95% Confidence Interval | Weeks | From Week 1 to Week 16 |
|
|
|
| Secondary | Time to Hematopoietic Response, by IV Iron Usage | The time to hematopoietic response is the interval in weeks between study day 1 and the first day that a hematopoietic response is observed during the treatment period. Hematopoietic response is defined as an increase in hemoglobin concentration of ≥ 2.0 g/dL from baseline or a hemoglobin concentration ≥ 12.0 g/dL in the absence of RBC transfusions on the day of measurement and during the preceding 28 days of the treatment period. If a participant did not achieve a hematopoietic response by the time of withdrawal or the end of the treatment period (EOTP), the time to hematopoietic response was censored on the day of the last hemoglobin measurement or the EOTP, whichever was earlier. Median was calculated using using Kaplan-Meier estimates. | Subset of Primary Analysis Set, composed of all participants who were randomized, properly consented, and received at least one dose of blinded study drug, who had a baseline hemoglobin value. | Posted | Median | 95% Confidence Interval | Weeks | From Week 1 to Week 16 |
|
|
|
| Secondary | Change From Baseline in Functional Assessment of Cancer Therapy (FACT) - Fatigue Score, by Darbepoetin Alfa Dose | Health related quality of life was measured using the Functional Assessment of Cancer Therapy (FACT) - Fatigue subscale. The FACT-F includes 13 fatigue items, with each item assessed on a 5-point scale (ie, response values of 0 to 4). The FACT-F subscale score ranges from 0 to 52, where a higher score represents less fatigue. | Patient-Reported Outcomes (PRO) Analysis Set, composed of all participants who were randomized, properly consented, and received at least one dose of blinded study drug, and who completed at least one baseline and one post-baseline PRO assessment. | Posted | Mean | Standard Deviation | Units on a scale | Baseline and Week 16 |
|
|
|
| Secondary | Change From Baseline in Functional Assessment of Cancer Therapy (FACT) - Fatigue Score, by IV Iron Usage | Health related quality of life was measured using the Functional Assessment of Cancer Therapy (FACT) - Fatigue subscale. The FACT-F includes 13 fatigue items, with each item assessed on a 5-point scale (ie, response values of 0 to 4). The FACT-F subscale score ranges from 0 to 52, where a higher score represents less fatigue. | Patient-Reported Outcomes (PRO) Analysis Set, composed of all participants who were randomized, properly consented, and received at least one dose of blinded study drug, and who completed at least one baseline and one post-baseline PRO assessment. | Posted | Mean | Standard Deviation | Units on a scale | Baseline and Week 16 |
|
|
|
| 26 |
| 61 |
| 48 |
| 61 |
| EG001 | Darbepoetin Alfa 300 µg Plus Iron | Darbepoetin alfa 300 μg subcutaneous injection plus intravenous (IV) iron 400 mg, every three weeks (Q3W), for up to 15 weeks (a total of 5 doses). | 18 | 57 | 46 | 57 |
| EG002 | Darbepoetin Alfa 500 µg (Without Iron) | Darbepoetin alfa 500 μg subcutaneous injection every three weeks (Q3W), for up to 15 weeks (a total of 5 doses). | 19 | 60 | 51 | 60 |
| EG003 | Darbepoetin Alfa 500 µg Plus Iron | Darbepoetin alfa 500 μg subcutaneous injection plus intravenous (IV) iron 400 mg, every three weeks (Q3W), for up to 15 weeks (a total of 5 doses). | 23 | 60 | 48 | 60 |
| Bone marrow failure | Blood and lymphatic system disorders | MedDRA 10.0 | Systematic Assessment |
|
| Coagulopathy | Blood and lymphatic system disorders | MedDRA 10.0 | Systematic Assessment |
|
| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA 10.0 | Systematic Assessment |
|
| Neutropenia | Blood and lymphatic system disorders | MedDRA 10.0 | Systematic Assessment |
|
| Pancytopenia | Blood and lymphatic system disorders | MedDRA 10.0 | Systematic Assessment |
|
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 10.0 | Systematic Assessment |
|
| Acute myocardial infarction | Cardiac disorders | MedDRA 10.0 | Systematic Assessment |
|
| Angina pectoris | Cardiac disorders | MedDRA 10.0 | Systematic Assessment |
|
| Atrial fibrillation | Cardiac disorders | MedDRA 10.0 | Systematic Assessment |
|
| Atrial flutter | Cardiac disorders | MedDRA 10.0 | Systematic Assessment |
|
| Atrioventricular block complete | Cardiac disorders | MedDRA 10.0 | Systematic Assessment |
|
| Cardiac arrest | Cardiac disorders | MedDRA 10.0 | Systematic Assessment |
|
| Cardiac failure congestive | Cardiac disorders | MedDRA 10.0 | Systematic Assessment |
|
| Cardio-respiratory arrest | Cardiac disorders | MedDRA 10.0 | Systematic Assessment |
|
| Cardiogenic shock | Cardiac disorders | MedDRA 10.0 | Systematic Assessment |
|
| Myocardial infarction | Cardiac disorders | MedDRA 10.0 | Systematic Assessment |
|
| Tachycardia | Cardiac disorders | MedDRA 10.0 | Systematic Assessment |
|
| Ventricular arrhythmia | Cardiac disorders | MedDRA 10.0 | Systematic Assessment |
|
| Ventricular fibrillation | Cardiac disorders | MedDRA 10.0 | Systematic Assessment |
|
| Abdominal adhesions | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
|
| Abdominal discomfort | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
|
| Ascites | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
|
| Dysphagia | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
|
| Enlarged uvula | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
|
| Gastric haemorrhage | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
|
| Gastritis | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
|
| Gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
|
| Haematemesis | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
|
| Intestinal obstruction | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
|
| Intestinal stenosis | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
|
| Lip swelling | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
|
| Oesophageal stenosis | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
|
| Asthenia | General disorders | MedDRA 10.0 | Systematic Assessment |
|
| Chest pain | General disorders | MedDRA 10.0 | Systematic Assessment |
|
| Chills | General disorders | MedDRA 10.0 | Systematic Assessment |
|
| Disease progression | General disorders | MedDRA 10.0 | Systematic Assessment |
|
| Fatigue | General disorders | MedDRA 10.0 | Systematic Assessment |
|
| Malaise | General disorders | MedDRA 10.0 | Systematic Assessment |
|
| Non-cardiac chest pain | General disorders | MedDRA 10.0 | Systematic Assessment |
|
| Oedema peripheral | General disorders | MedDRA 10.0 | Systematic Assessment |
|
| Pain | General disorders | MedDRA 10.0 | Systematic Assessment |
|
| Pyrexia | General disorders | MedDRA 10.0 | Systematic Assessment |
|
| Cholecystitis acute | Hepatobiliary disorders | MedDRA 10.0 | Systematic Assessment |
|
| Hyperbilirubinaemia | Hepatobiliary disorders | MedDRA 10.0 | Systematic Assessment |
|
| Anaphylactic reaction | Immune system disorders | MedDRA 10.0 | Systematic Assessment |
|
| Bacteraemia | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
|
| Bronchitis | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
|
| Catheter related infection | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
|
| Clostridium difficile colitis | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
|
| Gastroenteritis | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
|
| Infection | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
|
| Intervertebral discitis | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
|
| Lobar pneumonia | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
|
| Sepsis | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
|
| Urinary tract infection | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
|
| Urosepsis | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
|
| Drug toxicity | Injury, poisoning and procedural complications | MedDRA 10.0 | Systematic Assessment |
|
| Gastrointestinal stoma complication | Injury, poisoning and procedural complications | MedDRA 10.0 | Systematic Assessment |
|
| Traumatic haematoma | Injury, poisoning and procedural complications | MedDRA 10.0 | Systematic Assessment |
|
| Blood potassium decreased | Investigations | MedDRA 10.0 | Systematic Assessment |
|
| Dehydration | Metabolism and nutrition disorders | MedDRA 10.0 | Systematic Assessment |
|
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA 10.0 | Systematic Assessment |
|
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA 10.0 | Systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 10.0 | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 10.0 | Systematic Assessment |
|
| Musculoskeletal chest pain | Musculoskeletal and connective tissue disorders | MedDRA 10.0 | Systematic Assessment |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 10.0 | Systematic Assessment |
|
| Cervix carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 10.0 | Systematic Assessment |
|
| Gastric cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 10.0 | Systematic Assessment |
|
| Lung neoplasm malignant | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 10.0 | Systematic Assessment |
|
| Malignant neoplasm progression | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 10.0 | Systematic Assessment |
|
| Metastatic neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 10.0 | Systematic Assessment |
|
| Oesophageal carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 10.0 | Systematic Assessment |
|
| Pancreatic carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 10.0 | Systematic Assessment |
|
| Prostate cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 10.0 | Systematic Assessment |
|
| Small cell lung cancer metastatic | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 10.0 | Systematic Assessment |
|
| Altered state of consciousness | Nervous system disorders | MedDRA 10.0 | Systematic Assessment |
|
| Cerebral ischaemia | Nervous system disorders | MedDRA 10.0 | Systematic Assessment |
|
| Convulsion | Nervous system disorders | MedDRA 10.0 | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 10.0 | Systematic Assessment |
|
| Syncope | Nervous system disorders | MedDRA 10.0 | Systematic Assessment |
|
| Mental status changes | Psychiatric disorders | MedDRA 10.0 | Systematic Assessment |
|
| Haematuria | Renal and urinary disorders | MedDRA 10.0 | Systematic Assessment |
|
| Hydronephrosis | Renal and urinary disorders | MedDRA 10.0 | Systematic Assessment |
|
| Nephropathy | Renal and urinary disorders | MedDRA 10.0 | Systematic Assessment |
|
| Renal failure | Renal and urinary disorders | MedDRA 10.0 | Systematic Assessment |
|
| Renal failure acute | Renal and urinary disorders | MedDRA 10.0 | Systematic Assessment |
|
| Ureteric obstruction | Renal and urinary disorders | MedDRA 10.0 | Systematic Assessment |
|
| Uterine enlargement | Reproductive system and breast disorders | MedDRA 10.0 | Systematic Assessment |
|
| Bronchial obstruction | Respiratory, thoracic and mediastinal disorders | MedDRA 10.0 | Systematic Assessment |
|
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA 10.0 | Systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 10.0 | Systematic Assessment |
|
| Haemoptysis | Respiratory, thoracic and mediastinal disorders | MedDRA 10.0 | Systematic Assessment |
|
| Increased upper airway secretion | Respiratory, thoracic and mediastinal disorders | MedDRA 10.0 | Systematic Assessment |
|
| Pharyngolaryngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 10.0 | Systematic Assessment |
|
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA 10.0 | Systematic Assessment |
|
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA 10.0 | Systematic Assessment |
|
| Pulmonary hypertension | Respiratory, thoracic and mediastinal disorders | MedDRA 10.0 | Systematic Assessment |
|
| Respiratory distress | Respiratory, thoracic and mediastinal disorders | MedDRA 10.0 | Systematic Assessment |
|
| Decubitus ulcer | Skin and subcutaneous tissue disorders | MedDRA 10.0 | Systematic Assessment |
|
| Deep vein thrombosis | Vascular disorders | MedDRA 10.0 | Systematic Assessment |
|
| Femoral arterial stenosis | Vascular disorders | MedDRA 10.0 | Systematic Assessment |
|
| Hypertension | Vascular disorders | MedDRA 10.0 | Systematic Assessment |
|
| Hypotension | Vascular disorders | MedDRA 10.0 | Systematic Assessment |
|
| Leukopenia | Blood and lymphatic system disorders | MedDRA 10.0 | Systematic Assessment |
|
| Neutropenia | Blood and lymphatic system disorders | MedDRA 10.0 | Systematic Assessment |
|
| Pancytopenia | Blood and lymphatic system disorders | MedDRA 10.0 | Systematic Assessment |
|
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 10.0 | Systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
|
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
|
| Dry mouth | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
|
| Dyspepsia | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
|
| Dysphagia | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
|
| Asthenia | General disorders | MedDRA 10.0 | Systematic Assessment |
|
| Disease progression | General disorders | MedDRA 10.0 | Systematic Assessment |
|
| Fatigue | General disorders | MedDRA 10.0 | Systematic Assessment |
|
| Mucosal inflammation | General disorders | MedDRA 10.0 | Systematic Assessment |
|
| Oedema peripheral | General disorders | MedDRA 10.0 | Systematic Assessment |
|
| Pain | General disorders | MedDRA 10.0 | Systematic Assessment |
|
| Pyrexia | General disorders | MedDRA 10.0 | Systematic Assessment |
|
| Urinary tract infection | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
|
| Weight decreased | Investigations | MedDRA 10.0 | Systematic Assessment |
|
| Anorexia | Metabolism and nutrition disorders | MedDRA 10.0 | Systematic Assessment |
|
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 10.0 | Systematic Assessment |
|
| Dehydration | Metabolism and nutrition disorders | MedDRA 10.0 | Systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 10.0 | Systematic Assessment |
|
| Bone pain | Musculoskeletal and connective tissue disorders | MedDRA 10.0 | Systematic Assessment |
|
| Muscular weakness | Musculoskeletal and connective tissue disorders | MedDRA 10.0 | Systematic Assessment |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 10.0 | Systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA 10.0 | Systematic Assessment |
|
| Neuropathy | Nervous system disorders | MedDRA 10.0 | Systematic Assessment |
|
| Insomnia | Psychiatric disorders | MedDRA 10.0 | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 10.0 | Systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 10.0 | Systematic Assessment |
|
| Pharyngolaryngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 10.0 | Systematic Assessment |
|
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA 10.0 | Systematic Assessment |
|
| Wheezing | Respiratory, thoracic and mediastinal disorders | MedDRA 10.0 | Systematic Assessment |
|
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA 10.0 | Systematic Assessment |
|
| Dry skin | Skin and subcutaneous tissue disorders | MedDRA 10.0 | Systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA 10.0 | Systematic Assessment |
|
| Hypotension | Vascular disorders | MedDRA 10.0 | Systematic Assessment |
|
The Clinical Trial Agreement generally does not restrict an investigator's discussion of trial results aftercompletion. The Agreement permits Amgen a limited period of time to review material discussing trial results (typically up to 45 days and possible extension). Amgen may remove confidential information, but authors have final control and approval of publication content. For multicenter studies, the investigator agrees not to publish any results before the first multi-center publication.
| D002241 |
| Carbohydrates |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D056831 | Coordination Complexes |
| D009930 | Organic Chemicals |
| D003911 | Dextrans |
| D005936 | Glucans |
| D011134 | Polysaccharides |
| Percentage of participants |
| 62 |
| 95 |
| 54 |
| 71 |
Binomial proportion with confidence limit calculation using the normal approximation, and converted to percentages. |
| No |
| Superiority or Other |
| Percentage of participants |
| 38 |
| 95 |
| 29 |
| 47 |
Binomial proportion with confidence limit calculation using the normal approximation, and converted to percentages. |
| No |
| Superiority or Other |
| Percentage of participants |
| 39 |
| 95 |
| 30 |
| 47 |
Binomial proportion with confidence limit calculation using the normal approximation, and converted to percentages. |
| No |
| Superiority or Other |
| Percentage of participants |
| 31 |
| 95 |
| 19 |
| 42 |
Binomial proportion with confidence limit calculation using the normal approximation, and converted to percentages. |
| No |
| Superiority or Other |
| Percentage of participants | 28 | 95 | 17 | 40 | Binomial proportion with confidence limit calculation using the normal approximation, and converted to percentages. | No | Superiority or Other |
| Percentage of participants | 25 | 95 | 14 | 36 | Binomial proportion with confidence limit calculation using the normal approximation, and converted to percentages. | No | Superiority or Other |
| Percentage of participants |
| 59 |
| 95 |
| 50 |
| 68 |
Binomial proportion with confidence limit calculation using the normal approximation, and converted to percentages. |
| No |
| Superiority or Other |
| Percentage of participants |
| 74 |
| 95 |
| 66 |
| 82 |
Binomial proportion with confidence limit calculation using the normal approximation, and converted to percentages. |
| No |
| Superiority or Other |