Ignite Creation Date:
2025-12-24 @ 11:28 PM
Ignite Modification Date:
2025-12-30 @ 9:44 PM
Study NCT ID:
NCT01444456
Status:
COMPLETED
Last Update Posted:
2017-03-20
First Post:
2011-09-29
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Assessment of Quality of Life in Patients With Symptomatic Chemotherapy-induced Anaemia
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000740', 'term': 'Anemia'}, {'id': 'D001943', 'term': 'Breast Neoplasms'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D015179', 'term': 'Colorectal Neoplasms'}, {'id': 'D008175', 'term': 'Lung Neoplasms'}, {'id': 'D010051', 'term': 'Ovarian Neoplasms'}, {'id': 'D011471', 'term': 'Prostatic Neoplasms'}, {'id': 'D001749', 'term': 'Urinary Bladder Neoplasms'}, {'id': 'D016889', 'term': 'Endometrial Neoplasms'}, {'id': 'D007680', 'term': 'Kidney Neoplasms'}, {'id': 'D010190', 'term': 'Pancreatic Neoplasms'}, {'id': 'D004938', 'term': 'Esophageal Neoplasms'}, {'id': 'D013274', 'term': 'Stomach Neoplasms'}], 'ancestors': [{'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D001941', 'term': 'Breast Diseases'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D007414', 'term': 'Intestinal Neoplasms'}, {'id': 'D005770', 'term': 'Gastrointestinal Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D003108', 'term': 'Colonic Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D012002', 'term': 'Rectal Diseases'}, {'id': 'D012142', 'term': 'Respiratory Tract Neoplasms'}, {'id': 'D013899', 'term': 'Thoracic Neoplasms'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D004701', 'term': 'Endocrine Gland Neoplasms'}, {'id': 'D010049', 'term': 'Ovarian Diseases'}, {'id': 'D000291', 'term': 'Adnexal Diseases'}, {'id': 'D005831', 'term': 'Genital Diseases, Female'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D005833', 'term': 'Genital Neoplasms, Female'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D006058', 'term': 'Gonadal Disorders'}, {'id': 'D005834', 'term': 'Genital Neoplasms, Male'}, {'id': 'D005832', 'term': 'Genital Diseases, Male'}, {'id': 'D011469', 'term': 'Prostatic Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D014571', 'term': 'Urologic Neoplasms'}, {'id': 'D001745', 'term': 'Urinary Bladder Diseases'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D014594', 'term': 'Uterine Neoplasms'}, {'id': 'D014591', 'term': 'Uterine Diseases'}, {'id': 'D007674', 'term': 'Kidney Diseases'}, {'id': 'D010182', 'term': 'Pancreatic Diseases'}, {'id': 'D006258', 'term': 'Head and Neck Neoplasms'}, {'id': 'D004935', 'term': 'Esophageal Diseases'}, {'id': 'D013272', 'term': 'Stomach Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'phone': '866-572-6436', 'title': 'Study Director', 'organization': 'Amgen Inc.'}, 'certainAgreement': {'otherDetails': "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.", 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': "Up to 28 days after a participant's last dose date, capped at 17 weeks", 'description': 'Only adverse drug reactions to Amgen products were collected in this study. The table of Other Adverse Events summarizes non-serious occurrences of adverse drug reactions.', 'eventGroups': [{'id': 'EG000', 'title': 'Darbepoetin Alfa or Other ESA', 'description': 'Participants receiving systemic chemotherapy for solid tumors who also received darbepoetin alfa (Aranesp®) or another erythropoiesis-stimulating agent (ESA) to treat symptomatic anemia according to routine institutional practice.', 'otherNumAtRisk': 1158, 'otherNumAffected': 8, 'seriousNumAtRisk': 1158, 'seriousNumAffected': 2}], 'otherEvents': [{'term': 'Thrombocytosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1158, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Arrhythmia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1158, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Cystoid macular oedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1158, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1158, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Injection site pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1158, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Drug hypersensitivity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1158, 'numAffected': 1}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Hyperglycaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1158, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1158, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1158, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}], 'seriousEvents': [{'term': 'Cardiac arrest', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1158, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Cerebrovascular accident', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1158, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percentage of Participants Receiving Darbepoetin Alfa With Improvement in Patient Perceived Fatigue (PPF) and Increase in Hemoglobin ≥ 1 g/dL', 'denoms': [{'units': 'Participants', 'counts': [{'value': '510', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Darbepoetin Alfa', 'description': 'Participants receiving systemic chemotherapy for solid tumors who also received darbepoetin alfa (Aranesp®) to treat symptomatic anemia according to routine institutional practice.'}], 'classes': [{'categories': [{'measurements': [{'value': '31.8', 'groupId': 'OG000', 'lowerLimit': '27.7', 'upperLimit': '35.8'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline to Week 9 (Treatment Day 57). Due to the observational nature of the study and variation in ESA dosing schedules, assessments closest to day 57 and within Days 43 to 70 (inclusive) were used to calculate the Week 9 visit results.', 'description': 'Improvement in PPF was defined as improvement at Week 9 in Functional Assessment of Cancer Therapy-Fatigue (FACT-F) score of ≥ 3.5 points from Baseline (the minimally important difference \\[MID\\]), and an increase in hemoglobin was defined as ≥ 1 g/dL increase from Baseline. The FACT-F MID was determined by the mean FACT-F change score (between Baseline and Week 9) for participants who had an improvement in the fatigue visual analog scale (VAS) score of 5 ± 3 points. The FACT-F subscale consists of 13 fatigue-related items that are a subset of the Functional Assessment of Cancer Therapy - Anaemia (FACT-An) questionnaire. Participants indicate how they feel in response to 13 statements on a scale from 0 for "Not at all" to 4 for "Very much". Total scores for the FACT-F subscale range from 0 to 52; the higher the score the better the quality of life. The fatigue-VAS is a 100-point scale, where fatigue-levels are rated from 0 (least fatigue) to 100 (worst possible fatigue).', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The Primary analysis set consists of enrolled participants who received at least 1 dose of darbepoetin alfa, have baseline assessments for each of Hemoglobin, FACT-F subscale and VAS, and analyzable post-baseline assessments for each of Hemoglobin, FACT-F subscale, and VAS at Week 9.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants by Tumor Type With Improvement in Patient Perceived Fatigue (PPF) and Increase in Hemoglobin ≥ 1 g/dL', 'denoms': [{'units': 'Participants', 'counts': [{'value': '510', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Darbepoetin Alfa', 'description': 'Participants receiving systemic chemotherapy for solid tumors who also received darbepoetin alfa (Aranesp®) to treat symptomatic anemia according to routine institutional practice.'}], 'classes': [{'title': 'Breast cancer (N=152)', 'categories': [{'measurements': [{'value': '38.8', 'groupId': 'OG000', 'lowerLimit': '31.1', 'upperLimit': '46.6'}]}]}, {'title': 'Prostate cancer (N=39)', 'categories': [{'measurements': [{'value': '28.2', 'groupId': 'OG000', 'lowerLimit': '14.1', 'upperLimit': '42.3'}]}]}, {'title': 'Small cell lung cancer (N=12)', 'categories': [{'measurements': [{'value': '16.7', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '37.8'}]}]}, {'title': 'Non-small cell lung cancer (N=70)', 'categories': [{'measurements': [{'value': '28.6', 'groupId': 'OG000', 'lowerLimit': '18.0', 'upperLimit': '39.2'}]}]}, {'title': 'Colorectal cancer (N=71)', 'categories': [{'measurements': [{'value': '31.0', 'groupId': 'OG000', 'lowerLimit': '20.2', 'upperLimit': '41.7'}]}]}, {'title': 'Ovarian cancer (N=79)', 'categories': [{'measurements': [{'value': '38.0', 'groupId': 'OG000', 'lowerLimit': '27.3', 'upperLimit': '48.7'}]}]}, {'title': 'Bladder cancer (N=16)', 'categories': [{'measurements': [{'value': '0.0', 'comment': 'Confidence interval could not be calculated since there were no participants with both PPF improvement and hemoglobin increase.', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}, {'title': 'Endometrial cancer (N=12)', 'categories': [{'measurements': [{'value': '8.3', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '24.0'}]}]}, {'title': 'Renal cancer (N=10)', 'categories': [{'measurements': [{'value': '10.0', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '28.6'}]}]}, {'title': 'Pancreatic cancer (N=31)', 'categories': [{'measurements': [{'value': '35.5', 'groupId': 'OG000', 'lowerLimit': '18.6', 'upperLimit': '52.3'}]}]}, {'title': 'Esophogeal cancer (N=3)', 'categories': [{'measurements': [{'value': '33.3', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '86.7'}]}]}, {'title': 'Gastric cancer (N=15)', 'categories': [{'measurements': [{'value': '26.7', 'groupId': 'OG000', 'lowerLimit': '4.3', 'upperLimit': '49.0'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline to Week 9', 'description': 'Improvement in PPF was defined as improvement at week 9 in Functional Assessment of Cancer Therapy-Fatigue (FACT-F) score of ≥ 3.5 points from Baseline (the minimally important difference \\[MID\\]), and an increase in hemoglobin was defined as ≥ 1 g/dL increase from Baseline. The FACT-F MID was determined by the mean FACT-F change score (between Baseline and Week 9) for participants who had an improvement in the fatigue visual analog scale (VAS) score of 5 ± 3 points. The FACT-F subscale consists of 13 fatigue-related items that are a subset of the Functional Assessment of Cancer Therapy - Anaemia (FACT-An) questionnaire. Participants indicate how they feel in response to 13 statements on a scale from 0 for "Not at all" to 4 for "Very much". Total scores for the FACT-F subscale range from 0 to 52; the higher the score the better the quality of life. The fatigue-VAS is a 100-point scale, where fatigue-levels are rated from 0 (least fatigue) to 100 (worst possible fatigue).', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Primary analysis set'}, {'type': 'SECONDARY', 'title': 'Mean Change From Baseline in FACT-F Score for Participants With a VAS Improvement of 5 ± 3 Points', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Darbepoetin Alfa', 'description': 'Participants receiving systemic chemotherapy for solid tumors who also received darbepoetin alfa (Aranesp®) to treat symptomatic anemia according to routine institutional practice.'}], 'classes': [{'categories': [{'measurements': [{'value': '3.5', 'spread': '5.5', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and Week 9', 'description': 'The FACT-F subscale consists of 13 fatigue-related items (statements) that are a subset of the Functional Assessment of Cancer Therapy - Anaemia (FACT-An) questionnaire. Participants are asked to indicate how they feel in response to each of the 13 statements on a scale from 0 for "Not at all" to 4 for "Very much". Total scores for the FACT-F subscale can range from 0 to 52; the higher the score the better the quality of life. A positive change (\\>0) from baseline score constitutes an improvement in fatigue between Baseline and Week 9. The fatigue-visual analog scale (VAS) is a 100-point scale where fatigue-levels are rated from 0 (least fatigue) to 100 (worst possible fatigue).', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Primary analysis set participants with a fatigue VAS score improvement at Week 9 of 5 ± 3 points from Baseline'}, {'type': 'SECONDARY', 'title': 'Time to First Increase in Hemoglobin', 'denoms': [{'units': 'Participants', 'counts': [{'value': '510', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Darbepoetin Alfa', 'description': 'Participants receiving systemic chemotherapy for solid tumors who also received darbepoetin alfa (Aranesp®) to treat symptomatic anemia according to routine institutional practice.'}], 'classes': [{'categories': [{'measurements': [{'value': '36.5', 'groupId': 'OG000', 'lowerLimit': '30.0', 'upperLimit': '43.0'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'From Baseline until Week 9', 'description': 'Time from Baseline to first increase in hemoglobin of ≥ 1 g/dL', 'unitOfMeasure': 'days', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Primary analysis set'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Improvement in Patient-perceived Fatigue (PPF) at Any Time', 'denoms': [{'units': 'Participants', 'counts': [{'value': '510', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Darbepoetin Alfa', 'description': 'Participants receiving systemic chemotherapy for solid tumors who also received darbepoetin alfa (Aranesp®) to treat symptomatic anemia according to routine institutional practice.'}], 'classes': [{'categories': [{'measurements': [{'value': '70.0', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From Baseline to Week 13', 'description': 'The percentage of participants with iimprovement in PPF at any time from Day 2 until the end-of-study assessment (Week 13). Improvement in PPF was defined as improvement in Functional Assessment of Cancer Therapy-Fatigue (FACT-F) score of ≥ 3.5 points from Baseline (the minimally important difference \\[MID\\]). The FACT-F MID was determined by the mean FACT-F change score (between Baseline and Week 9) for participants who had an improvement in the fatigue visual analog scale (VAS) score of 5 ± 3 points. The FACT-F subscale consists of 13 fatigue-related items that are a subset of the FACT-An questionnaire. Participants indicate how they feel in response to 13 statements on a scale from 0 for "Not at all" to 4 for "Very much". Total scores for the FACT-F subscale range from 0 to 52; the higher the score the better the quality of life. The fatigue-VAS is a 100-point scale, where fatigue-levels are rated from 0 (least fatigue) to 100 (worst possible fatigue).', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Primary analysis set'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Increase in Hemoglobin ≥ 1 g/dL at Any Time', 'denoms': [{'units': 'Participants', 'counts': [{'value': '510', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Darbepoetin Alfa', 'description': 'Participants receiving systemic chemotherapy for solid tumors who also received darbepoetin alfa (Aranesp®) to treat symptomatic anemia according to routine institutional practice.'}], 'classes': [{'categories': [{'measurements': [{'value': '75.7', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From Baseline to Week 13', 'description': 'The percentage of participants with increase in hemoglobin (≥ 1 g/dL) at any time from Day 2 until the end-of-study assessment (Week 13).', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Primary analysis set'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Darbepoetin Alfa or Other ESA', 'description': 'Participants receiving systemic chemotherapy for solid tumors who also received darbepoetin alfa (Aranesp®) or another erythropoiesis-stimulating agent (ESA) to treat symptomatic anemia according to routine institutional practice.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1262'}]}, {'type': 'Received Darbepoetin Alfa or Other ESA', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1158'}]}, {'type': 'Received Darbepoetin Alfa', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1134'}]}, {'type': 'COMPLETED', 'achievements': [{'comment': 'Defined as 4 weeks after last dose of ESA or chemotherapy or 13 weeks after enrolment', 'groupId': 'FG000', 'numSubjects': '977'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '285'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '21'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '9'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '37'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '73'}]}, {'type': 'Ineligibility determined', 'reasons': [{'groupId': 'FG000', 'numSubjects': '23'}]}, {'type': 'Other', 'reasons': [{'groupId': 'FG000', 'numSubjects': '18'}]}, {'type': 'Not treated', 'reasons': [{'groupId': 'FG000', 'numSubjects': '104'}]}]}], 'recruitmentDetails': 'Open to patients receiving systemic chemotherapy for solid tumors who also received darbepoetin alfa or another erythropoiesis-stimulating agent (ESA) to treat symptomatic anemia. First patient enrolled 10 october 2011; last patient enrolled 28 May 2013.', 'preAssignmentDetails': 'Before enrolling participants, each country was assigned to either cohort 1 (patients receiving only darbepoetin alfa) or cohort 2 (patients receiving any ESA). Cohort 2 was assigned only to those countries in which local regulations did not permit observational study participation by participants receiving a specific agent in a drug class.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '1158', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Darbepoetin Alfa or Other ESA', 'description': 'Participants receiving systemic chemotherapy for solid tumors who also received darbepoetin alfa (Aranesp®) or another erythropoiesis-stimulating agent (ESA) to treat symptomatic anemia according to routine institutional practice.'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '63.9', 'spread': '11.1', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '691', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '467', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Fatigue-Visual Analog Scale (VAS) Score', 'classes': [{'categories': [{'measurements': [{'value': '51.2', 'spread': '22.6', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'description': 'The fatigue VAS is a 100-point scale where fatigue-levels are rated from 0 (least fatigue) to 100 (worst possible fatigue). Baseline VAS data were available for 1109 participants.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Functional Assessment of Cancer Therapy-Fatigue (FACT-F) score', 'classes': [{'categories': [{'measurements': [{'value': '28.4', 'spread': '10.5', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'description': 'The FACT-F subscale consists of 13 fatigue-related items that are a subset of the Functional Assessment of Cancer Therapy - Anaemia (FACT-An) questionnaire. Participants indicate how they feel in response to 13 statements on a scale from 0 for "Not at all" to 4 for "Very much". Total scores for the FACT-F subscale range from 0 to 52; the higher the score the better the quality of life. Baseline data were available for 1109 participants.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Hemoglobin level', 'classes': [{'categories': [{'measurements': [{'value': '9.3', 'spread': '0.6', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'description': 'Baseline hemoglobin levels were available for 1133 participants.', 'unitOfMeasure': 'g/dL', 'dispersionType': 'STANDARD_DEVIATION'}], 'populationDescription': 'Full analysis set, defined as enrolled participants who received at least 1 dose of darbepoetin alfa or any other erythropoiesis-stimulating agent (ESA) before the end of study.'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1262}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-02', 'lastUpdateSubmitDate': '2017-02-07', 'studyFirstSubmitDate': '2011-09-29', 'resultsFirstSubmitDate': '2014-07-24', 'studyFirstSubmitQcDate': '2011-09-29', 'lastUpdatePostDateStruct': {'date': '2017-03-20', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2014-07-24', 'studyFirstPostDateStruct': {'date': '2011-09-30', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2014-08-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of Participants Receiving Darbepoetin Alfa With Improvement in Patient Perceived Fatigue (PPF) and Increase in Hemoglobin ≥ 1 g/dL', 'timeFrame': 'Baseline to Week 9 (Treatment Day 57). Due to the observational nature of the study and variation in ESA dosing schedules, assessments closest to day 57 and within Days 43 to 70 (inclusive) were used to calculate the Week 9 visit results.', 'description': 'Improvement in PPF was defined as improvement at Week 9 in Functional Assessment of Cancer Therapy-Fatigue (FACT-F) score of ≥ 3.5 points from Baseline (the minimally important difference \\[MID\\]), and an increase in hemoglobin was defined as ≥ 1 g/dL increase from Baseline. The FACT-F MID was determined by the mean FACT-F change score (between Baseline and Week 9) for participants who had an improvement in the fatigue visual analog scale (VAS) score of 5 ± 3 points. The FACT-F subscale consists of 13 fatigue-related items that are a subset of the Functional Assessment of Cancer Therapy - Anaemia (FACT-An) questionnaire. Participants indicate how they feel in response to 13 statements on a scale from 0 for "Not at all" to 4 for "Very much". Total scores for the FACT-F subscale range from 0 to 52; the higher the score the better the quality of life. The fatigue-VAS is a 100-point scale, where fatigue-levels are rated from 0 (least fatigue) to 100 (worst possible fatigue).'}], 'secondaryOutcomes': [{'measure': 'Percentage of Participants by Tumor Type With Improvement in Patient Perceived Fatigue (PPF) and Increase in Hemoglobin ≥ 1 g/dL', 'timeFrame': 'Baseline to Week 9', 'description': 'Improvement in PPF was defined as improvement at week 9 in Functional Assessment of Cancer Therapy-Fatigue (FACT-F) score of ≥ 3.5 points from Baseline (the minimally important difference \\[MID\\]), and an increase in hemoglobin was defined as ≥ 1 g/dL increase from Baseline. The FACT-F MID was determined by the mean FACT-F change score (between Baseline and Week 9) for participants who had an improvement in the fatigue visual analog scale (VAS) score of 5 ± 3 points. The FACT-F subscale consists of 13 fatigue-related items that are a subset of the Functional Assessment of Cancer Therapy - Anaemia (FACT-An) questionnaire. Participants indicate how they feel in response to 13 statements on a scale from 0 for "Not at all" to 4 for "Very much". Total scores for the FACT-F subscale range from 0 to 52; the higher the score the better the quality of life. The fatigue-VAS is a 100-point scale, where fatigue-levels are rated from 0 (least fatigue) to 100 (worst possible fatigue).'}, {'measure': 'Mean Change From Baseline in FACT-F Score for Participants With a VAS Improvement of 5 ± 3 Points', 'timeFrame': 'Baseline and Week 9', 'description': 'The FACT-F subscale consists of 13 fatigue-related items (statements) that are a subset of the Functional Assessment of Cancer Therapy - Anaemia (FACT-An) questionnaire. Participants are asked to indicate how they feel in response to each of the 13 statements on a scale from 0 for "Not at all" to 4 for "Very much". Total scores for the FACT-F subscale can range from 0 to 52; the higher the score the better the quality of life. A positive change (\\>0) from baseline score constitutes an improvement in fatigue between Baseline and Week 9. The fatigue-visual analog scale (VAS) is a 100-point scale where fatigue-levels are rated from 0 (least fatigue) to 100 (worst possible fatigue).'}, {'measure': 'Time to First Increase in Hemoglobin', 'timeFrame': 'From Baseline until Week 9', 'description': 'Time from Baseline to first increase in hemoglobin of ≥ 1 g/dL'}, {'measure': 'Percentage of Participants With Improvement in Patient-perceived Fatigue (PPF) at Any Time', 'timeFrame': 'From Baseline to Week 13', 'description': 'The percentage of participants with iimprovement in PPF at any time from Day 2 until the end-of-study assessment (Week 13). Improvement in PPF was defined as improvement in Functional Assessment of Cancer Therapy-Fatigue (FACT-F) score of ≥ 3.5 points from Baseline (the minimally important difference \\[MID\\]). The FACT-F MID was determined by the mean FACT-F change score (between Baseline and Week 9) for participants who had an improvement in the fatigue visual analog scale (VAS) score of 5 ± 3 points. The FACT-F subscale consists of 13 fatigue-related items that are a subset of the FACT-An questionnaire. Participants indicate how they feel in response to 13 statements on a scale from 0 for "Not at all" to 4 for "Very much". Total scores for the FACT-F subscale range from 0 to 52; the higher the score the better the quality of life. The fatigue-VAS is a 100-point scale, where fatigue-levels are rated from 0 (least fatigue) to 100 (worst possible fatigue).'}, {'measure': 'Percentage of Participants With Increase in Hemoglobin ≥ 1 g/dL at Any Time', 'timeFrame': 'From Baseline to Week 13', 'description': 'The percentage of participants with increase in hemoglobin (≥ 1 g/dL) at any time from Day 2 until the end-of-study assessment (Week 13).'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Breast Cancer', 'Lung Cancer', 'Ovarian Cancer', 'Prostate Cancer', 'Colorectal Cancer', 'Aranesp', 'Chemotherapy induced anaemia', 'Chemotherapy', 'Bladder Cancer', 'Endometrial Cancer', 'Renal Cancer', 'Pancreatic Cancer', 'Esophageal Cancer', 'Gastric Cancer'], 'conditions': ['Anemia', 'Breast Cancer', 'Cancer', 'Colorectal Cancer', 'Lung Cancer', 'Ovarian Cancer', 'Prostate Cancer', 'Solid Tumors', 'Bladder Cancer', 'Endometrial Cancer', 'Renal Cancer', 'Pancreatic Cancer', 'Esophageal Cancer', 'Gastric Cancer']}, 'referencesModule': {'references': [{'pmid': '26855598', 'type': 'BACKGROUND', 'citation': 'Mouysset JL, Freier B, van den Bosch J, Levache CB, Bols A, Tessen HW, Belton L, Bohac GC, Terwey JH, Tonini G. Hemoglobin levels and quality of life in patients with symptomatic chemotherapy-induced anemia: the eAQUA study. Cancer Manag Res. 2016 Jan 21;8:1-10. doi: 10.2147/CMAR.S88110. eCollection 2016.'}], 'seeAlsoLinks': [{'url': 'http://www.amgentrials.com', 'label': 'AmgenTrials clinical trials website'}]}, 'descriptionModule': {'briefSummary': 'This is a multicenter, international, prospective, observational study of patients who are receiving systemic chemotherapy for solid tumour cancers (breast, colorectal, ovarian, prostate, lung, bladder, endometrial, renal, pancreatic, esophageal or gastric) and who are receiving darbepoetin alfa (Aranesp®) or other erythropoiesis-stimulating agent (ESA) to treat symptomatic anaemia.\n\nQuality of Life will be assessed electronically with the aim of estimating improvement in quality of life for those patients receiving darbepoetin alfa (Aranesp®) who also have an increase in haemoglobin (Hb) of ≥1 g/dL', 'detailedDescription': 'Before enrolling participants, each country was assigned to either cohort 1 (patients receiving only darbepoetin alfa) or cohort 2 (patients receiving any ESA). Cohort 2 was assigned only to those countries in which local regulations did not permit observational study participation by patients receiving a specific agent in a drug class.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Adults with either breast, colorectal, ovarian, prostate, lung, bladder, endometrial, renal, pancreatic, esophageal or gastric cancer who will receive darbepoetin alfa (Aranesp®) or other erythropoiesis-stimulating agent (ESA) for the treatment of symptomatic chemotherapy-induced anaemia (CIA) in routine clinical practice.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosed with breast, colorectal, ovarian, prostate, lung, bladder, endometrial, renal, pancreatic, esophageal or gastric cancer\n* Expected to receive at least 8 additional weeks of a given regimen of myelosuppressive chemotherapy after enrolment\n* Starting treatment with either darbepoetin alfa (in Cohort 1 countries) or any ESA (in Cohort 2 countries) as per European Summary of Product Characteristics (SPC) for symptomatic anaemia.\n\nExclusion Criteria:\n\n* Received any ESA treatment or Red Blood Cell (RBC) transfusion within 28 days prior to enrolment\n* Known primary benign or malignant haematologic disorder which can cause anaemia\n* Known hypersensitivity to ESAs'}, 'identificationModule': {'nctId': 'NCT01444456', 'briefTitle': 'Assessment of Quality of Life in Patients With Symptomatic Chemotherapy-induced Anaemia', 'organization': {'class': 'INDUSTRY', 'fullName': 'Amgen'}, 'officialTitle': 'Electronic Assessment of Quality of Life in Patients With Symptomatic Chemotherapy-induced Anaemia: An International Prospective Observational Study (eAQUA)', 'orgStudyIdInfo': {'id': '20101123'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Cohort 1: Darbepoetin alfa', 'description': 'Participants receiving systemic 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