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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.
Quality 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
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1: Darbepoetin alfa | Participants receiving systemic chemotherapy for solid tumors who also received darbepoetin alfa (Aranesp®) to treat symptomatic anemia according to routine institutional practice. | ||
| Cohort 2: Any ESA | 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. |
Not provided
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Receiving Darbepoetin Alfa With Improvement in Patient Perceived Fatigue (PPF) and Increase in Hemoglobin ≥ 1 g/dL | 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). | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants by Tumor Type With Improvement in Patient Perceived Fatigue (PPF) and Increase in Hemoglobin ≥ 1 g/dL | 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). |
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Inclusion Criteria:
Exclusion Criteria:
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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.
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| Name | Affiliation | Role |
|---|---|---|
| MD | Amgen | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Graz | 8042 | Austria | |||
| Research Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26855598 | Background | 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. |
| Label | URL |
|---|---|
| AmgenTrials clinical trials website | View source |
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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.
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.
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| ID | Title | Description |
|---|---|---|
| FG000 | Darbepoetin Alfa or Other ESA | 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. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Baseline to Week 9 |
| Mean Change From Baseline in FACT-F Score for Participants With a VAS Improvement of 5 ± 3 Points | 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). | Baseline and Week 9 |
| Time to First Increase in Hemoglobin | Time from Baseline to first increase in hemoglobin of ≥ 1 g/dL | From Baseline until Week 9 |
| Percentage of Participants With Improvement in Patient-perceived Fatigue (PPF) at Any Time | 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). | From Baseline to Week 13 |
| Percentage of Participants With Increase in Hemoglobin ≥ 1 g/dL at Any Time | 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). | From Baseline to Week 13 |
| Innsbruck |
| 6020 |
| Austria |
| Research Site | Sankt Pölten | 3100 | Austria |
| Research Site | Vienna | 1090 | Austria |
| Research Site | Vöcklabruck | 4840 | Austria |
| Research Site | Wels | 4600 | Austria |
| Research Site | Aalst | 9300 | Belgium |
| Research Site | Bonheiden | 2820 | Belgium |
| Research Site | Brasschaat | 2930 | Belgium |
| Research Site | Bruges | 8000 | Belgium |
| Research Site | Eupen | 4700 | Belgium |
| Research Site | Gilly | 6060 | Belgium |
| Research Site | Mechelen | 2800 | Belgium |
| Research Site | Namur | 5000 | Belgium |
| Research Site | Ostend | 8400 | Belgium |
| Research Site | Sint-Niklaas | 9100 | Belgium |
| Research Site | Verviers | 4800 | Belgium |
| Research Site | Aix-en-Provence | 13100 | France |
| Research Site | Aix-en-Provence | 13616 | France |
| Research Site | Amiens | 80000 | France |
| Research Site | Aubagne | 13675 | France |
| Research Site | Bayonne | 64100 | France |
| Research Site | Besançon | 25030 | France |
| Research Site | Bordeaux | 33077 | France |
| Research Site | Boulogne Sur Mer Cédex | 62321 | France |
| Research Site | Bourg-en-Bresse | 01012 | France |
| Research Site | Brive-la-Gaillarde | 19312 | France |
| Research Site | Carcassonne | 11890 | France |
| Research Site | Clermont-Ferrand | 63000 | France |
| Research Site | Clermont-Ferrand | 63011 | France |
| Research Site | Colmar | 68024 | France |
| Research Site | Dijon | 21034 | France |
| Research Site | Draguignan | 83007 | France |
| Research Site | La Seyne-sur-Mer | 83500 | France |
| Research Site | Le Mans | 72037 | France |
| Research Site | Longjumeau | 91161 | France |
| Research Site | Marseille | 13009 | France |
| Research Site | Marseille | 13331 | France |
| Research Site | Mont-de-Marsan | 40000 | France |
| Research Site | Montauban | 82013 | France |
| Research Site | Nancy | 54100 | France |
| Research Site | Orléans | 45000 | France |
| Research Site | Paris | 75020 | France |
| Research Site | Périgueux | 24004 | France |
| Research Site | Pontoise | 95301 | France |
| Research Site | Pringy | 74374 | France |
| Research Site | Reims | 51056 | France |
| Research Site | Reims | 51092 | France |
| Research Site | Reims | 51100 | France |
| Research Site | Rennes | 35033 | France |
| Research Site | Rouen | 76000 | France |
| Research Site | Saint-Grégoire | 35768 | France |
| Research Site | Saint-Quentin | 02321 | France |
| Research Site | Soissons | 02209 | France |
| Research Site | Soyaux | 16800 | France |
| Research Site | Strasbourg | 67000 | France |
| Research Site | Vichy | 03207 | France |
| Research Site | Villefranche-sur-Saône | 69400 | France |
| Research Site | Villejuif | 94804 | France |
| Research Site | Augsburg | 86150 | Germany |
| Research Site | Berlin | 10317 | Germany |
| Research Site | Berlin | 13055 | Germany |
| Research Site | Berlin | 13347 | Germany |
| Research Site | Bremerhaven | 27568 | Germany |
| Research Site | Cologne | 50677 | Germany |
| Research Site | Gelsenkirchen | 45899 | Germany |
| Research Site | Goslar | 38642 | Germany |
| Research Site | Halle | 06110 | Germany |
| Research Site | Mannheim | 68165 | Germany |
| Research Site | Neunkirchen | 66538 | Germany |
| Research Site | Rotenburg (Wümme) | 27356 | Germany |
| Research Site | Soest | 59494 | Germany |
| Research Site | Stralsund | 18435 | Germany |
| Research Site | Würselen | 52146 | Germany |
| Research Site | Athens | 11522 | Greece |
| Research Site | Athens | 18547 | Greece |
| Research Site | Chania | 73300 | Greece |
| Research Site | Marousi | 15121 | Greece |
| Research Site | Papagou | 11526 | Greece |
| Research Site | Cefalù PA | 90015 | Italy |
| Research Site | Naples | 80131 | Italy |
| Research Site | Padova | 35128 | Italy |
| Research Site | Roma | 00128 | Italy |
| Research Site | Torino | 10100 | Italy |
| Research Site | Amstelveen | 1186 AM | Netherlands |
| Research Site | Dordrecht | 3318 AT | Netherlands |
| Research Site | Enschede | 7513 ER | Netherlands |
| Research Site | Flushing | 4382 EE | Netherlands |
| Research Site | Leiderdorp | 2353 GA | Netherlands |
| Research Site | Purmerend | 1441 RN | Netherlands |
| Research Site | Roosendaal | 4708 AE | Netherlands |
| Research Site | Zutphen | 7207 AE | Netherlands |
| Research Site | Bialystok | 15-027 | Poland |
| Research Site | Gdansk | 80-402 | Poland |
| Research Site | Konin | 62-500 | Poland |
| Research Site | Koszalin | 75-581 | Poland |
| Research Site | Krakow | 31-531 | Poland |
| Research Site | Lubin | 59-300 | Poland |
| Research Site | Olsztyn | 10-228 | Poland |
| Research Site | Poznan | 61-878 | Poland |
| Research Site | Warsaw | 04-125 | Poland |
| Research Site | Wałbrzych | 58-309 | Poland |
| Research Site | Wroclaw | 50-981 | Poland |
| Research Site | Wroclaw | 51-124 | Poland |
| Research Site | Alba Iulia | 510077 | Romania |
| Research Site | Baia Mare | 430031 | Romania |
| Research Site | Brasov | 500366 | Romania |
| Research Site | Bucharest | 011171 | Romania |
| Research Site | Bucharest | 020947 | Romania |
| Research Site | Bucharest | 022328 | Romania |
| Research Site | Bucharest | 030442 | Romania |
| Research Site | Bucharest | 050659 | Romania |
| Research Site | Cluj-Napoca | 400058 | Romania |
| Research Site | Oradea | 410469 | Romania |
| Research Site | Râmnicu Vâlcea | 240156 | Romania |
| Research Site | Târgu Mureş | 540142 | Romania |
| Research Site | Timișoara | 300167 | Romania |
| Received Darbepoetin Alfa or Other ESA |
|
| Received Darbepoetin Alfa |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
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.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Darbepoetin Alfa or Other ESA | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||
| Fatigue-Visual Analog Scale (VAS) Score | 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. | Mean | Standard Deviation | units on a scale |
| ||||||||||||||||
| Functional Assessment of Cancer Therapy-Fatigue (FACT-F) score | 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. | Mean | Standard Deviation | units on a scale |
| ||||||||||||||||
| Hemoglobin level | Baseline hemoglobin levels were available for 1133 participants. | Mean | Standard Deviation | g/dL |
|
| 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 Receiving Darbepoetin Alfa With Improvement in Patient Perceived Fatigue (PPF) and Increase in Hemoglobin ≥ 1 g/dL | 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). | 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. | Posted | Number | 95% Confidence Interval | percentage of participants | 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. |
|
|
| |||||||||||||||||||||||||
| Secondary | Percentage of Participants by Tumor Type With Improvement in Patient Perceived Fatigue (PPF) and Increase in Hemoglobin ≥ 1 g/dL | 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). | Primary analysis set | Posted | Number | 95% Confidence Interval | percentage of participants | Baseline to Week 9 |
|
| ||||||||||||||||||||||||||
| Secondary | Mean Change From Baseline in FACT-F Score for Participants With a VAS Improvement of 5 ± 3 Points | 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). | Primary analysis set participants with a fatigue VAS score improvement at Week 9 of 5 ± 3 points from Baseline | Posted | Mean | Standard Deviation | units on a scale | Baseline and Week 9 |
|
| ||||||||||||||||||||||||||
| Secondary | Time to First Increase in Hemoglobin | Time from Baseline to first increase in hemoglobin of ≥ 1 g/dL | Primary analysis set | Posted | Median | 95% Confidence Interval | days | From Baseline until Week 9 |
|
| ||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Improvement in Patient-perceived Fatigue (PPF) at Any Time | 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). | Primary analysis set | Posted | Number | percentage of participants | From Baseline to Week 13 |
|
| |||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Increase in Hemoglobin ≥ 1 g/dL at Any Time | 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). | Primary analysis set | Posted | Number | percentage of participants | From Baseline to Week 13 |
|
|
Up to 28 days after a participant's last dose date, capped at 17 weeks
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.
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 | Darbepoetin Alfa or Other ESA | 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. | 2 | 1,158 | 8 | 1,158 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cardiac arrest | Cardiac disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Cerebrovascular accident | Nervous system disorders | MedDRA 15.1 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Thrombocytosis | Blood and lymphatic system disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Arrhythmia | Cardiac disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Cystoid macular oedema | Eye disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Injection site pain | General disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Drug hypersensitivity | Immune system disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA 15.1 | 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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Director | Amgen Inc. | 866-572-6436 |
| ID | Term |
|---|---|
| D000740 | Anemia |
| D001943 | Breast Neoplasms |
| D009369 | Neoplasms |
| D015179 | Colorectal Neoplasms |
| D008175 | Lung Neoplasms |
| D010051 | Ovarian Neoplasms |
| D011471 | Prostatic Neoplasms |
| D001749 | Urinary Bladder Neoplasms |
| D016889 | Endometrial Neoplasms |
| D007680 | Kidney Neoplasms |
| D010190 | Pancreatic Neoplasms |
| D004938 | Esophageal Neoplasms |
| D013274 | Stomach Neoplasms |
| ID | Term |
|---|---|
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D009371 | Neoplasms by Site |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D004701 | Endocrine Gland Neoplasms |
| D010049 | Ovarian Diseases |
| D000291 | Adnexal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D000091662 | Genital Diseases |
| D004700 | Endocrine System Diseases |
| D006058 | Gonadal Disorders |
| D005834 | Genital Neoplasms, Male |
| D005832 | Genital Diseases, Male |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
| D014571 | Urologic Neoplasms |
| D001745 | Urinary Bladder Diseases |
| D014570 | Urologic Diseases |
| D014594 | Uterine Neoplasms |
| D014591 | Uterine Diseases |
| D007674 | Kidney Diseases |
| D010182 | Pancreatic Diseases |
| D006258 | Head and Neck Neoplasms |
| D004935 | Esophageal Diseases |
| D013272 | Stomach Diseases |
Not provided
Not provided
| Counts |
|---|
| Participants |
|
|
|
| Title | Denominators | Categories | ||||
|---|---|---|---|---|---|---|
|
| Participants |
|
|
|