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| ID | Type | Description | Link |
|---|---|---|---|
| POLARIS | Other Identifier | Alias Study Number |
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This Non-Interventional Study will describe and analyze the clinical use of palbociclib in routine clinical practice in the treatment of advanced breast cancer.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| non-interventional study | This prospective, observational study will be conducted according to each site's routine clinical practice. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| non-interventional | Other |
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| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants According to Real-World Tumor Response | Real world tumor response included complete response (CR), Partial response (PR), Stable disease (SD), Progressive Disease (PD), and was determined by physician based on imaging, biopsies, biomarkers, and/or clinical judgment. Response as assessed by Response Evaluation Criteria in Solid Tumors (RECIST) criteria may not be available for all participants. rwTR was derived as the best tumor response recorded from the palbociclib combination treatment start date until the first documentation of progressive disease. Only response assessments recorded on or before the start date of next subsequent line of treatment will be considered. | From start of palbociclib combination treatment until first documentation of progression (up to approximately 3 years) |
| Real-World Tumor Response Rate | Real world tumor response rate was defined as the percentage of participants with a best tumor response of complete response or partial response. Tumor response was determined by physician based on imaging, biopsies, biomarkers, and/or clinical judgment. RECIST criteria may not be available for all participants. | From start of palbociclib combination treatment until first documentation of progression (up to approximately 3 years) |
| Real World Progression Free Survival | Real world progression free survival was defined as time (months) from initiation of the palbociclib combination treatment to the earliest of clinician-documented progression or death due to any cause, whichever occurred first. Participants without documented disease progression or death were censored at the last date of response assessment. | From initiation of the palbociclib combination treatment to the earliest of clinician-documented progression or death due to any cause, whichever occurs first. (up to approximately 3 years) |
| Overall Survival | Overall survival was defined as time from initiation of the palbociclib combination treatment to date of death due to any cause. Participants without a documented death were censored at last available visit date known to be alive. |
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Inclusion Criteria
Exclusion Criteria:
Patients with a life expectancy of less than 3 months at the time of ABC diagnosis, per the investigator's judgment.
Patients participating in any interventional clinical trial that includes investigational or marketed products at the time of enrollment. (Patients participating in other investigator initiated research or NIS can be included as long as their standard of care is not altered by the study).
Patients on active treatment for malignancies other than ABC at the time of enrollment.
Patients who are unable to understand the nature of the study and are unwilling to sign an informed consent.
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HR+/HER2- ABC patients whose treatment decision with palbociclib has been made by their treating physician and who meet the eligibility criteria will be invited to participate in the study.
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Alabama Oncology | Alabaster | Alabama | 35007 | United States | ||
| Alabama Oncology |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 42017805 | Derived | Tripathy D, Blum JL, Karuturi MS, McCune S, Kurian S, Moezi MM, Anderson DM, Ji Y, Pluard TJ, Migas J, Lakhanpal S, Jepsen E, Wang Y, Montelongo MZ, Zhang Z, Cappelleri JC, Gauthier E, Rocque GB. Impact of Comorbidities on Clinical Outcomes and Quality of Life of Patients With Hormone Receptor-Positive/Human Epidermal Growth Factor Receptor 2-Negative (HR+/HER2-) Advanced Breast Cancer Treated With Palbociclib in the POLARIS Study. Cancer Med. 2026 Apr;15(4):e71788. doi: 10.1002/cam4.71788. | |
| 41140056 |
| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.
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A total of 1285 participants were enrolled in the study. However, only 1250 participants initiated treatment with palbociclib.
Participants with hormone receptor positive (HR+)/human epidermal growth factor receptor 2 negative (HER2-) advanced breast cancer (ABC) who were prescribed palbociclib in routine clinical practice across the United States and Canada were enrolled in this prospective observational study. Participants were followed up for approximately 3 years post end of treatment or until withdrawal from the study or death.
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| ID | Title | Description |
|---|---|---|
| FG000 | Palbociclib + Endocrine Therapy | Participants with HR+/HER2- advanced breast cancer who were prescribed palbociclib in combination with endocrine treatment (Palbociclib, Fulvestrant, and Other) by the treating physician in routine clinical practice were included. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Aug 2, 2017 | Sep 26, 2023 |
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blood
| From initiation of the palbociclib combination treatment to death due to any cause or censored, (up to approximately 3 years) |
| Absolute Eastern Co-Operative Oncology Group (ECOG) Performance Status Scores at Baseline: Participants More Than or Equal to 70 Years Only | ECOG performance status was a 6-level item used to assess the physical health of participants and ranged from 0 (fully active) to 5 (dead). | Baseline (last observed measurement prior to treatment start date) |
| ECOG Performance Status Scores at Month 1: Participants More Than or Equal to 70 Years Only | ECOG performance status was a 6-level item used to assess the physical health of participants and ranged from 0 (fully active) to 5 (dead). | Month 1 |
| ECOG Performance Status Scores at Month 2: Participants More Than or Equal to 70 Years Only | ECOG performance status was a 6-level item used to assess the physical health of participants and ranged from 0 (fully active) to 5 (dead). | Month 2 |
| ECOG Performance Status Scores at Month 3: Participants More Than or Equal to 70 Years Only | ECOG performance status was a 6-level item used to assess the physical health of participants and ranged from 0 (fully active) to 5 (dead). | Month 3 |
| ECOG Performance Status Scores at Month 6: Participants More Than or Equal to 70 Years Only | ECOG performance status was a 6-level item used to assess the physical health of participants and ranged from 0 (fully active) to 5 (dead). | Month 6 |
| ECOG Performance Status Scores at Month 9: Participants More Than or Equal to 70 Years Only | ECOG performance status was a 6-level item used to assess the physical health of participants and ranged from 0 (fully active) to 5 (dead). | Month 9 |
| ECOG Performance Status Scores at Month 12: Participants More Than or Equal to 70 Years Only | ECOG performance status was a 6-level item used to assess the physical health of participants and ranged from 0 (fully active) to 5 (dead). | Month 12 |
| ECOG Performance Status Scores at Month 15: Participants More Than or Equal to 70 Years Only | ECOG performance status was a 6-level item used to assess the physical health of participants and ranged from 0 (fully active) to 5 (dead). | Month 15 |
| ECOG Performance Status Scores at Month 18: Participants More Than or Equal to 70 Years Only | ECOG performance status was a 6-level item used to assess the physical health of participants and ranged from 0 (fully active) to 5 (dead). | Month 18 |
| ECOG Performance Status Scores at Month 21: Participants More Than or Equal to 70 Years Only | ECOG performance status was a 6-level item used to assess the physical health of participants and ranged from 0 (fully active) to 5 (dead). | Month 21 |
| ECOG Performance Status Scores at Month 24: Participants More Than or Equal to 70 Years Only | ECOG performance status was a 6-level item used to assess the physical health of participants and ranged from 0 (fully active) to 5 (dead). | Month 24 |
| ECOG Performance Status Scores in Month 27: Participants More Than or Equal to 70 Years Only | ECOG performance status was a 6-level item used to assess the physical health of participants and ranged from 0 (fully active) to 5 (dead). | Month 27 |
| ECOG Performance Status Scores at Month 30: Participants More Than or Equal to 70 Years Only | ECOG performance status was a 6-level item used to assess the physical health of participants and ranged from 0 (fully active) to 5 (dead). | Month 30 |
| ECOG Performance Status Scores at Month 33: Participants More Than or Equal to 70 Years Only | ECOG performance status was a 6-level item used to assess the physical health of participants and ranged from 0 (fully active) to 5 (dead). | Month 33 |
| ECOG Performance Status Scores in Month 36: Participants More Than or Equal to 70 Years Only | ECOG performance status was a 6-level item used to assess the physical health of participants and ranged from 0 (fully active) to 5 (dead). | Month 36 |
| ECOG Performance Status Scores at Month 39: Participants More Than or Equal to 70 Years Only | ECOG performance status was a 6-level item used to assess the physical health of participants and ranged from 0 (fully active) to 5 (dead). | Month 39 |
| ECOG Performance Status Scores at Month 42: Participants More Than or Equal to 70 Years Only | ECOG performance status was a 6-level item used to assess the physical health of participants and ranged from 0 (fully active) to 5 (dead). | Month 42 |
| Geriatric 8 Screening Tool Scores at Baseline: Participants More Than or Equal to 70 Years Only | The G8 Screening Tool consisted of 7 items based on the Mini-Nutritional Assessment and a single item covering the participants age. Specifically, the G8 assessed food intake, weight changes, mobility, neuropsychological problems, body mass index, prescription count, and health status compared to similarly aged participants. Points were associated to each item and index score was calculated by summing points. The index score ranged in value from 0 (heavily impaired) to 17 (not at all impaired). If any of the 8 items was missing, the total score was missing. | Baseline (last observed measurement prior to treatment start date) |
| Geriatric 8 Screening Tool Scores at Month 1: Participants More Than or Equal to 70 Years Only | The G8 Screening Tool consisted of 7 items based on the Mini-Nutritional Assessment and a single item covering the participants age. Specifically, the G8 assessed food intake, weight changes, mobility, neuropsychological problems, body mass index, prescription count, and health status compared to similarly aged participants. Points were associated to each item and index score was calculated by summing points. The index score ranged in value from 0 (heavily impaired) to 17 (not at all impaired). If any of the 8 items was missing, the total score was missing. | Month 1 |
| Geriatric 8 Screening Tool Scores at Month 2: Participants More Than or Equal to 70 Years Only | The G8 Screening Tool consisted of 7 items based on the Mini-Nutritional Assessment and a single item covering the participants age. Specifically, the G8 assessed food intake, weight changes, mobility, neuropsychological problems, body mass index, prescription count, and health status compared to similarly aged participants. Points were associated to each item and index score was calculated by summing points. The index score ranged in value from 0 (heavily impaired) to 17 (not at all impaired). If any of the 8 items was missing, the total score was missing. | Month 2 |
| Geriatric 8 Screening Tool Scores at Month 3: Participants More Than or Equal to 70 Years Only | The G8 Screening Tool consisted of 7 items based on the Mini-Nutritional Assessment and a single item covering the participants age. Specifically, the G8 assessed food intake, weight changes, mobility, neuropsychological problems, body mass index, prescription count, and health status compared to similarly aged participants. Points were associated to each item and index score was calculated by summing points. The index score ranged in value from 0 (heavily impaired) to 17 (not at all impaired). If any of the 8 items was missing, the total score was missing. | Month 3 |
| Geriatric 8 Screening Tool Scores at Month 6: Participants More Than or Equal to 70 Years Only | The G8 Screening Tool consisted of 7 items based on the Mini-Nutritional Assessment and a single item covering the participants age. Specifically, the G8 assessed food intake, weight changes, mobility, neuropsychological problems, body mass index, prescription count, and health status compared to similarly aged participants. Points were associated to each item and index score was calculated by summing points. The index score ranged in value from 0 (heavily impaired) to 17 (not at all impaired). If any of the 8 items was missing, the total score was missing. | Month 6 |
| Geriatric 8 Screening Tool Scores at Month 9: Participants More Than or Equal to 70 Years Only | The G8 Screening Tool consisted of 7 items based on the Mini-Nutritional Assessment and a single item covering the participants age. Specifically, the G8 assessed food intake, weight changes, mobility, neuropsychological problems, body mass index, prescription count, and health status compared to similarly aged participants. Points were associated to each item and index score was calculated by summing points. The index score ranged in value from 0 (heavily impaired) to 17 (not at all impaired). If any of the 8 items was missing, the total score was missing. | Month 9 |
| Geriatric 8 Screening Tool Scores at Month 12: Participants More Than or Equal to 70 Years Only | The G8 Screening Tool consisted of 7 items based on the Mini-Nutritional Assessment and a single item covering the participants age. Specifically, the G8 assessed food intake, weight changes, mobility, neuropsychological problems, body mass index, prescription count, and health status compared to similarly aged participants. Points were associated to each item and index score was calculated by summing points. The index score ranged in value from 0 (heavily impaired) to 17 (not at all impaired). If any of the 8 items was missing, the total score was missing. | Month 12 |
| Geriatric 8 Screening Tool Scores at Month 15: Participants More Than or Equal to 70 Years Only | The G8 Screening Tool consisted of 7 items based on the Mini-Nutritional Assessment and a single item covering the participants age. Specifically, the G8 assessed food intake, weight changes, mobility, neuropsychological problems, body mass index, prescription count, and health status compared to similarly aged participants. Points were associated to each item and index score was calculated by summing points. The index score ranged in value from 0 (heavily impaired) to 17 (not at all impaired). If any of the 8 items was missing, the total score was missing. | Month 15 |
| Geriatric 8 Screening Tool Scores at Month 18: Participants More Than or Equal to 70 Years Only | The G8 Screening Tool consisted of 7 items based on the Mini-Nutritional Assessment and a single item covering the participants age. Specifically, the G8 assessed food intake, weight changes, mobility, neuropsychological problems, body mass index, prescription count, and health status compared to similarly aged participants. Points were associated to each item and index score was calculated by summing points. The index score ranged in value from 0 (heavily impaired) to 17 (not at all impaired). If any of the 8 items was missing, the total score was missing. | Month 18 |
| Geriatric 8 Screening Tool Scores at Month 21: Participants More Than or Equal to 70 Years Only | The G8 Screening Tool consisted of 7 items based on the Mini-Nutritional Assessment and a single item covering the participants age. Specifically, the G8 assessed food intake, weight changes, mobility, neuropsychological problems, body mass index, prescription count, and health status compared to similarly aged participants. Points were associated to each item and index score was calculated by summing points. The index score ranged in value from 0 (heavily impaired) to 17 (not at all impaired). If any of the 8 items was missing, the total score was missing. | Month 21 |
| Geriatric 8 Screening Tool Scores at Month 24: Participants More Than or Equal to 70 Years Only | The G8 Screening Tool consisted of 7 items based on the Mini-Nutritional Assessment and a single item covering the participants age. Specifically, the G8 assessed food intake, weight changes, mobility, neuropsychological problems, body mass index, prescription count, and health status compared to similarly aged participants. Points were associated to each item and index score was calculated by summing points. The index score ranged in value from 0 (heavily impaired) to 17 (not at all impaired). If any of the 8 items was missing, the total score was missing. | Month 24 |
| Geriatric 8 Screening Tool Scores at Month 27: Participants More Than or Equal to 70 Years Only | The G8 Screening Tool consisted of 7 items based on the Mini-Nutritional Assessment and a single item covering the participants age. Specifically, the G8 assessed food intake, weight changes, mobility, neuropsychological problems, body mass index, prescription count, and health status compared to similarly aged participants. Points were associated to each item and index score was calculated by summing points. The index score ranged in value from 0 (heavily impaired) to 17 (not at all impaired). If any of the 8 items was missing, the total score was missing. | Month 27 |
| Geriatric 8 Screening Tool Scores at Month 30: Participants More Than or Equal to 70 Years Only | The G8 Screening Tool consisted of 7 items based on the Mini-Nutritional Assessment and a single item covering the participants age. Specifically, the G8 assessed food intake, weight changes, mobility, neuropsychological problems, body mass index, prescription count, and health status compared to similarly aged participants. Points were associated to each item and index score was calculated by summing points. The index score ranged in value from 0 (heavily impaired) to 17 (not at all impaired). If any of the 8 items was missing, the total score was missing. | Month 30 |
| Geriatric 8 Screening Tool Scores at Month 33: Participants More Than or Equal to 70 Years Only | The G8 Screening Tool consisted of 7 items based on the Mini-Nutritional Assessment and a single item covering the participants age. Specifically, the G8 assessed food intake, weight changes, mobility, neuropsychological problems, body mass index, prescription count, and health status compared to similarly aged participants. Points were associated to each item and index score was calculated by summing points. The index score ranged in value from 0 (heavily impaired) to 17 (not at all impaired). If any of the 8 items was missing, the total score was missing. | Month 33 |
| Geriatric 8 Screening Tool Scores at Month 36: Participants More Than or Equal to 70 Years Only | The G8 Screening Tool consisted of 7 items based on the Mini-Nutritional Assessment and a single item covering the participants age. Specifically, the G8 assessed food intake, weight changes, mobility, neuropsychological problems, body mass index, prescription count, and health status compared to similarly aged participants. Points were associated to each item and index score was calculated by summing points. The index score ranged in value from 0 (heavily impaired) to 17 (not at all impaired). If any of the 8 items was missing, the total score was missing. | Month 36 |
| Geriatric 8 Screening Tool Scores at Month 39: Participants More Than 70 or Equal to Years Only | The G8 Screening Tool consisted of 7 items based on the Mini-Nutritional Assessment and a single item covering the participants age. Specifically, the G8 assessed food intake, weight changes, mobility, neuropsychological problems, body mass index, prescription count, and health status compared to similarly aged participants. Points were associated to each item and index score was calculated by summing points. The index score ranged in value from 0 (heavily impaired) to 17 (not at all impaired). If any of the 8 items was missing, the total score was missing. | Month 39 |
| Geriatric 8 Screening Tool Scores at Month 42: Participants More Than or Equal to 70 Years Only | The G8 Screening Tool consisted of 7 items based on the Mini-Nutritional Assessment and a single item covering the participants age. Specifically, the G8 assessed food intake, weight changes, mobility, neuropsychological problems, body mass index, prescription count, and health status compared to similarly aged participants. Points were associated to each item and index score was calculated by summing points. The index score ranged in value from 0 (heavily impaired) to 17 (not at all impaired). If any of the 8 items was missing, the total score was missing. | Month 42 |
| Change From Baseline to Month 6 in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Scores at Baseline | European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire 30: 30 item questionnaires composed of 5 functional subscales (physical, role, cognitive, emotional, and social); a global health/global quality of life scale; 3 symptom subscales (fatigue, pain and nausea/vomiting); and 6 single items that assessed additional symptoms (dyspnea, appetite loss, insomnia, constipation, diarrhea and financial difficulties). All scales and single item measures ranged in score from 0 to 100. Higher scores on functional and global quality of life scales represent better level of functioning. Higher scores on the symptom oriented scales represent more severe symptoms. | Baseline (last observed measurement prior to treatment start date) and Month 6 |
| Change From Baseline to Month 12 in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Scores at Baseline | EORTC QLQ-C30: 30 item questionnaire composed of 5 functional subscales (physical, role, cognitive, emotional, and social); a global health/global quality of life scale; 3 symptom subscales (fatigue, pain and nausea/vomiting); and 6 single items that assessed additional symptoms (dyspnea, appetite loss, insomnia, constipation, diarrhea and financial difficulties). All scales and single item measures ranged in score from 0 to 100. Higher scores on functional and global quality of life scales represent better level of functioning. Higher scores on the symptom oriented scales represent more severe symptoms. | Baseline (last observed measurement prior to treatment start date) and Month 12 |
| Change From Baseline to Month 18 in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Scores at Baseline | EORTC QLQ-C30: 30 item questionnaire composed of 5 functional subscales (physical, role, cognitive, emotional, and social); a global health/global quality of life scale; 3 symptom subscales (fatigue, pain and nausea/vomiting); and 6 single items that assessed additional symptoms (dyspnea, appetite loss, insomnia, constipation, diarrhea and financial difficulties). All scales and single item measures ranged in score from 0 to 100. Higher scores on functional and global quality of life scales represent better level of functioning. Higher scores on the symptom oriented scales represent more severe symptoms. | Baseline (last observed measurement prior to treatment start date) and Month 18 |
| Activities of Daily Living Scores at Baseline: Participants More Than or Equal to 70 Years Only | Activities of Daily Living is assessed using a six-item ADL limitations measure that inventoried whether participants had difficulty bathing, dressing, toileting, feeding, with transfer, and incontinence. Each item was rated on a 3-point Likert scale measuring independence in performing the activity and scores ranged from 1 to 3; where, 1=unable to do without assistance, 2=partial assistance needed and 3=no assistance. The total score was calculated as a sum of scores of individual items and ranged between 6 to 18, where a score of 6 indicated a very dependent participant and a score of 18 represented an independent participant. | Baseline (last observed measurement prior to treatment start date) |
| Activities of Daily Living Scores at Month 1: Participants More Than or Equal to 70 Years Only | Activities of Daily Living is assessed using a six-item ADL limitations measure that inventoried whether participants had difficulty bathing, dressing, toileting, feeding, with transfer, and incontinence. Each item was rated on a 3-point Likert scale measuring independence in performing the activity and scores ranged from 1 to 3; where, 1=unable to do without assistance, 2=partial assistance needed and 3=no assistance. The total score was calculated as a sum of scores of individual items and ranged between 6 to 18, where a score of 6 indicated a very dependent participant and a score of 18 represented an independent participants. | Month 1 |
| Activities of Daily Living Scores at Month 2: Participants More Than or Equal to 70 Years Only | Activities of Daily Living is assessed using a six-item ADL limitations measure that inventoried whether participants had difficulty bathing, dressing, toileting, feeding, with transfer, and incontinence. Each item was rated on a 3-point Likert scale measuring independence in performing the activity and scores ranged from 1 to 3; where, 1=unable to do without assistance, 2=partial assistance needed and 3=no assistance. The total score was calculated as a sum of scores of individual items and ranged between 6 to 18, where a score of 6 indicated a very dependent participant and a score of 18 represented an independent participants. | Month 2 |
| Activities of Daily Living Scores at Month 3: Participants More Than or Equal to 70 Years Only | Activities of Daily Living is assessed using a six-item ADL limitations measure that inventoried whether participants had difficulty bathing, dressing, toileting, feeding, with transfer, and incontinence. Each item was rated on a 3-point Likert scale measuring independence in performing the activity and scores ranged from 1 to 3; where, 1=unable to do without assistance, 2=partial assistance needed and 3=no assistance. The total score was calculated as a sum of scores of individual items and ranged between 6 to 18, where a score of 6 indicated a very dependent participant and a score of 18 represented an independent participants. | Month 3 |
| Activities of Daily Living Scores Month 6: Participants More Than or Equal to 70 Years Only | Activities of Daily Living is assessed using a six-item ADL limitations measure that inventoried whether participants had difficulty bathing, dressing, toileting, feeding, with transfer, and incontinence. Each item was rated on a 3-point Likert scale measuring independence in performing the activity and scores ranged from 1 to 3; where, 1=unable to do without assistance, 2=partial assistance needed and 3=no assistance. The total score was calculated as a sum of scores of individual items and ranged between 6 to 18, where a score of 6 indicated a very dependent participant and a score of 18 represented an independent participants. | Month 6 |
| Activities of Daily Living Scores at Month 9: Participants More Than or Equal to 70 Years Only | Activities of Daily Living is assessed using a six-item ADL limitations measure that inventoried whether participants had difficulty bathing, dressing, toileting, feeding, with transfer, and incontinence. Each item was rated on a 3-point Likert scale measuring independence in performing the activity and scores ranged from 1 to 3; where, 1=unable to do without assistance, 2=partial assistance needed and 3=no assistance. The total score was calculated as a sum of scores of individual items and ranged between 6 to 18, where a score of 6 indicated a very dependent participant and a score of 18 represented an independent participants. | Month 9 |
| Activities of Daily Living Scores at Month 12: Participants More Than or Equal to 70 Years Only | Activities of Daily Living is assessed using a six-item ADL limitations measure that inventoried whether participants had difficulty bathing, dressing, toileting, feeding, with transfer, and incontinence. Each item was rated on a 3-point Likert scale measuring independence in performing the activity and scores ranged from 1 to 3; where, 1=unable to do without assistance, 2=partial assistance needed and 3=no assistance. The total score was calculated as a sum of scores of individual items and ranged between 6 to 18, where a score of 6 indicated a very dependent participant and a score of 18 represented an independent participants. | Month 12 |
| Activities of Daily Living Scores at Month 15: Participants More Than or Equal to 70 Years Only | Activities of Daily Living is assessed using a six-item ADL limitations measure that inventoried whether participants had difficulty bathing, dressing, toileting, feeding, with transfer, and incontinence. Each item was rated on a 3-point Likert scale measuring independence in performing the activity and scores ranged from 1 to 3; where, 1=unable to do without assistance, 2=partial assistance needed and 3=no assistance. The total score was calculated as a sum of scores of individual items and ranged between 6 to 18, where a score of 6 indicated a very dependent participant and a score of 18 represented an independent participants. | Month 15 |
| Activities of Daily Living Scores at Month 18: Participants More Than or Equal to 70 Years Only | Activities of Daily Living is assessed using a six-item ADL limitations measure that inventoried whether participants had difficulty bathing, dressing, toileting, feeding, with transfer, and incontinence. Each item was rated on a 3-point Likert scale measuring independence in performing the activity and scores ranged from 1 to 3; where, 1=unable to do without assistance, 2=partial assistance needed and 3=no assistance. The total score was calculated as a sum of scores of individual items and ranged between 6 to 18, where a score of 6 indicated a very dependent participant and a score of 18 represented an independent participant. | Month 18 |
| Activities of Daily Living Scores at Month 21: Participants More Than or Equal to 70 Years Only | Activities of Daily Living is assessed using a six-item ADL limitations measure that inventoried whether participants had difficulty bathing, dressing, toileting, feeding, with transfer, and incontinence. Each item was rated on a 3-point Likert scale measuring independence in performing the activity and scores ranged from 1 to 3; where, 1=unable to do without assistance, 2=partial assistance needed and 3=no assistance. The total score was calculated as a sum of scores of individual items and ranged between 6 to 18, where a score of 6 indicated a very dependent participant and a score of 18 represented an independent participants. | Month 21 |
| Activities of Daily Living Scores at Month 24: Participants More Than or Equal to 70 Years Only | Activities of Daily Living is assessed using a six-item ADL limitations measure that inventoried whether participants had difficulty bathing, dressing, toileting, feeding, with transfer, and incontinence. Each item was rated on a 3-point Likert scale measuring independence in performing the activity and scores ranged from 1 to 3; where, 1=unable to do without assistance, 2=partial assistance needed and 3=no assistance. The total score was calculated as a sum of scores of individual items and ranged between 6 to 18, where a score of 6 indicated a very dependent participant and a score of 18 represented an independent participants. | Month 24 |
| Activities of Daily Living Scores at Month 27: Participants More Than or Equal to 70 Years Only | Activities of Daily Living is assessed using a six-item ADL limitations measure that inventoried whether participants had difficulty bathing, dressing, toileting, feeding, with transfer, and incontinence. Each item was rated on a 3-point Likert scale measuring independence in performing the activity and scores ranged from 1 to 3; where, 1=unable to do without assistance, 2=partial assistance needed and 3=no assistance. The total score was calculated as a sum of scores of individual items and ranged between 6 to 18, where a score of 6 indicated a very dependent participant and a score of 18 represented an independent participants. | Month 27 |
| Activities of Daily Living Scores at Month 30: Participants More Than or Equal to 70 Years Only | Activities of Daily Living is assessed using a six-item ADL limitations measure that inventoried whether participants had difficulty bathing, dressing, toileting, feeding, with transfer, and incontinence. Each item was rated on a 3-point Likert scale measuring independence in performing the activity and scores ranged from 1 to 3; where, 1=unable to do without assistance, 2=partial assistance needed and 3=no assistance. The total score was calculated as a sum of scores of individual items and ranged between 6 to 18, where a score of 6 indicated a very dependent participant and a score of 18 represented an independent participants. | Month 30 |
| Activities of Daily Living Scores at Month 33: Participants More Than or Equal to 70 Years Only | Activities of Daily Living is assessed using a six-item ADL limitations measure that inventoried whether participants had difficulty bathing, dressing, toileting, feeding, with transfer, and incontinence. Each item was rated on a 3-point Likert scale measuring independence in performing the activity and scores ranged from 1 to 3; where, 1=unable to do without assistance, 2=partial assistance needed and 3=no assistance. The total score was calculated as a sum of scores of individual items and ranged between 6 to 18, where a score of 6 indicated a very dependent participant and a score of 18 represented an independent participants. | Month 33 |
| Activities of Daily Living Scores at Month 36: Participants More Than or Equal to 70 Years Only | Activities of Daily Living is assessed using a six-item ADL limitations measure that inventoried whether participants had difficulty bathing, dressing, toileting, feeding, with transfer, and incontinence. Each item was rated on a 3-point Likert scale measuring independence in performing the activity and scores ranged from 1 to 3; where, 1=unable to do without assistance, 2=partial assistance needed and 3=no assistance. The total score was calculated as a sum of scores of individual items and ranged between 6 to 18, where a score of 6 indicated a very dependent participant and a score of 18 represented an independent participants. | Month 36 |
| Activities of Daily Living Scores at Month 39: Participants More Than or Equal to 70 Years Only | Activities of Daily Living is assessed using a six-item ADL limitations measure that inventoried whether participants had difficulty bathing, dressing, toileting, feeding, with transfer, and incontinence. Each item was rated on a 3-point Likert scale measuring independence in performing the activity and scores ranged from 1 to 3; where, 1=unable to do without assistance, 2=partial assistance needed and 3=no assistance. The total score was calculated as a sum of scores of individual items and ranged between 6 to 18, where a score of 6 indicated a very dependent participant and a score of 18 represented an independent participants. | Month 39 |
| Activities of Daily Living Scores at Month 42: Participants More Than or Equal to 70 Years Only | Activities of Daily Living is assessed using a six-item ADL limitations measure that inventoried whether participants had difficulty bathing, dressing, toileting, feeding, with transfer, and incontinence. Each item was rated on a 3-point Likert scale measuring independence in performing the activity and scores ranged from 1 to 3; where, 1=unable to do without assistance, 2=partial assistance needed and 3=no assistance. The total score was calculated as a sum of scores of individual items and ranged between 6 to 18, where a score of 6 indicated a very dependent participant and a score of 18 represented an independent participants. | Month 42 |
| Number of Participants With Adverse Events | An adverse event is any untoward medical occurrence in administered medicinal product. The event need not necessarily have a causal relationship with the product treatment or usage. | From start of palbociclib treatment or date of informed consent until 28 days after last dose of study treatment (up to approximately 3 years) |
| Number of Participants With Serious Adverse Events | A serious adverse event was any untoward medical occurrence in a participant administered a medicinal or nutritional product (including pediatric formulas) at any dose that: resulted in death; was life-threatening; required inpatient hospitalization or prolongation of hospitalization; resulted in persistent or significant disability/incapacity (substantial disruption of the ability to conduct normal life functions); resulted in congenital anomaly/birth defect. | From start of palbociclib treatment or date of informed consent until 28 days after last dose of study treatment (up to approximately 3 years). |
| Number of Participants With Any Clinical Laboratory Abnormalities | Following lab parameters were assessed Anemia, Hemoglobin increased, Lymphocyte count decreased, Lymphocyte count increased, Neutrophil count decreased, Platelet count decreased, Leukocyte count decreased, Leukocyte count increased, Number of participants with any lab abnormality was reported. | From start of palbociclib treatment or date of informed consent until 28 days after last dose of study treatment (up to approximately 3 years). |
| Bessemer |
| Alabama |
| 35022 |
| United States |
| Alabama Oncology | Birmingham | Alabama | 35205 | United States |
| Alabama Oncology | Birmingham | Alabama | 35209 | United States |
| Alabama Oncology | Birmingham | Alabama | 35211 | United States |
| Alabama Oncology | Birmingham | Alabama | 35235 | United States |
| Grandview Cancer Center, Alabama Oncology | Birmingham | Alabama | 35243 | United States |
| University of Alabama at Birmingham Comprehensive Cancer Center | Birmingham | Alabama | 35294-3300 | United States |
| The University of Alabama at Birmingham | Birmingham | Alabama | 35294 | United States |
| Central Arkansas Radiation Therapy Institute | Little Rock | Arkansas | 72205 | United States |
| Central Arkansas Radiation Therapy Institute | Stuttgart | Arkansas | 72160 | United States |
| Sutter Auburn | Auburn | California | 95602 | United States |
| AIS Cancer Center at Adventist Health Bakersfield | Bakersfield | California | 93301 | United States |
| Beverly Hills Cancer Center | Beverly Hills | California | 90211 | United States |
| Providence Health and Services Southern California | Burbank | California | 91505 | United States |
| Enloe Regional Cancer Center | Chico | California | 95926 | United States |
| John Muir Clinical Research Center | Concord | California | 94520 | United States |
| John Muir Medical Center, Concord Campus | Concord | California | 94520 | United States |
| Mount Diablo Solano Oncology Group | Concord | California | 94520 | United States |
| Global Cancer Research Institute, Inc. | Gilroy | California | 95020 | United States |
| Breastlink Medical Group, Inc. | Laguna Hills | California | 92653 | United States |
| Breastlink Medical Group, Inc. | Newport Beach | California | 92660 | United States |
| Breastlink Medical Group, Inc. | Orange | California | 92868 | United States |
| St. Jude Hospital Yorba Linda DBA St. Joseph Heritage Healthcare | Petaluma | California | 94954 | United States |
| Diablo Valley Oncology Hematology Medical Group | Pleasant Hill | California | 94523 | United States |
| Epic Care | Pleasant Hill | California | 94523 | United States |
| Sutter Roseville Medical Center | Roseville | California | 95661 | United States |
| Sutter Institute for Medical Research | Sacramento | California | 95816 | United States |
| Salinas Valley Medical Clinic Cancer Care | Salinas | California | 93901 | United States |
| Salinas Valley Memorial Healthcare System | Salinas | California | 93901 | United States |
| Santa Clara Valley Medical Center | San Jose | California | 95128 | United States |
| Cancer Research Collaboration/Breastlink Medical Group, Inc. | Santa Ana | California | 92705 | United States |
| Ridley Tree Cancer Center | Santa Barbara | California | 93105 | United States |
| SANSUM Clinic | Santa Barbara | California | 93105 | United States |
| St. Jude Hospital Yorba Linda DBA St. Joseph Heritage Healthcare | Santa Rosa | California | 95403 | United States |
| Sansum Clinic | Solvang | California | 93463 | United States |
| St. Helena Hospital | St. Helena | California | 94574 | United States |
| St. Joseph's Medical Center | Stockton | California | 95204 | United States |
| Stockton Hematology Oncology Medical Group | Stockton | California | 95204 | United States |
| Cancer Treatment Center of Vacaville | Vacaville | California | 95687 | United States |
| Solano Hematology Oncology | Vallejo | California | 94589 | United States |
| Contra Costa Oncology | Walnut Creek | California | 94598 | United States |
| John Muir Medical Center, Walnut Creek Camous | Walnut Creek | California | 94598 | United States |
| Rocky Mountain Cancer Centers | Aurora | Colorado | 80012 | United States |
| Rocky Mountain Cancer Centers | Boulder | Colorado | 80303 | United States |
| Rocky Mountain Cancer Centers | Colorado Springs | Colorado | 80907 | United States |
| Rocky Mountain Cancer Centers | Denver | Colorado | 80218 | United States |
| Rocky Mountain Cancer Centers | Denver | Colorado | 80220 | United States |
| Colorado West Healthcare System, dba Community Hospital | Grand Junction | Colorado | 81505 | United States |
| Colorado West Healthcare System, dba Grand Valley Oncology | Grand Junction | Colorado | 81505 | United States |
| Rocky Mountain Cancer Centers | Lakewood | Colorado | 80228 | United States |
| Rocky Mountain Cancer Centers | Littleton | Colorado | 80120 | United States |
| Rocky Mountain Cancer Centers | Lone Tree | Colorado | 80124 | United States |
| Rocky Mountain Cancer Centers | Longmont | Colorado | 80501 | United States |
| Rocky Mountain Cancer Centers | Parker | Colorado | 80138 | United States |
| Rocky Mountain Cancer Centers | Pueblo | Colorado | 81008 | United States |
| Rocky Mountain Cancer Centers | Thornton | Colorado | 80260 | United States |
| Western Connecticut Health Network | Danbury | Connecticut | 06810 | United States |
| Western Connecticut Health Network | New Milford | Connecticut | 06776 | United States |
| Western Connecticut Health Network | Norwalk | Connecticut | 06856 | United States |
| MedStar Washington Hospital Center | Washington D.C. | District of Columbia | 20037 | United States |
| Florida Cancer Research Institute | Boca Raton | Florida | 33428 | United States |
| Boca Raton Regional Hospital/Lynn Cancer Institute | Boca Raton | Florida | 33486 | United States |
| Cancer Specialists of North Florida | Fleming Island | Florida | 32003 | United States |
| Southeast Florida Hematology-Oncology Group, PA | Fort Lauderdale | Florida | 33308 | United States |
| Cancer Specialists of North Florida | Jacksonville | Florida | 32204 | United States |
| Cancer Specialists of North Florida | Jacksonville | Florida | 32207 | United States |
| University of Florida Health | Jacksonville | Florida | 32209 | United States |
| Cancer Specialists of North Florida | Jacksonville | Florida | 32250 | United States |
| Cancer Specialists LLC | Jacksonville | Florida | 32256 | United States |
| Cancer Specialists of North Florida | Jacksonville | Florida | 32256 | United States |
| Cancer Specialists of North Florida | Jacksonville | Florida | 32258 | United States |
| Watson Clinic | Lakeland | Florida | 33805 | United States |
| Baptist Health Medical Group Oncology, LLC | Miami | Florida | 33176 | United States |
| Baptist Health Miami Cancer Institute | Miami | Florida | 33176 | United States |
| Miami Cancer Institute at Baptist Health, Inc. | Miami | Florida | 33176 | United States |
| Cancer Specialists of North Florida - St. Vincent's Clay | Middleburg | Florida | 32086 | United States |
| Millennium Oncology Research Clinic/Hematology and Oncology Private Practice | Pembroke | Florida | 33024 | United States |
| Baptist Health Miami Cancer Institute | Plantation | Florida | 33313 | United States |
| Florida Cancer Research Institute | Plantation | Florida | 33324 | United States |
| Cancer Specialists of North Florida | Saint Augustine | Florida | 32086 | United States |
| Baptist Health Urgent Care Sawgrass | Sunrise | Florida | 33323 | United States |
| Northwest Georgia Oncology Centers, PC | Austell | Georgia | 30106 | United States |
| Northwest Georgia Oncology Centers, PC | Carrollton | Georgia | 30117 | United States |
| Northwest Georgia Oncology Centers, PC | Cartersville | Georgia | 30121 | United States |
| Northwest Georgia Oncology Centers, PC | Douglasville | Georgia | 30134 | United States |
| Gwinnett Hospital System, Inc. The Center for Cancer Care | Duluth | Georgia | 30096 | United States |
| Gwinnett Hospital System, Inc. | Duluth | Georgia | 30096 | United States |
| Gwinnett Hospital System Inc. | Lawrenceville | Georgia | 30046 | United States |
| Gwinnett Hospital System, Inc. The Center for Cancer Care | Lawrenceville | Georgia | 30046 | United States |
| Northwest Georgia Oncology Centers, PC | Marietta | Georgia | 30060 | United States |
| Northwest Georgia Oncology Centers, PC | Roswell | Georgia | 30076 | United States |
| Candler Medical Oncology Practice (CMOP)/Summit Cancer Care | Savannah | Georgia | 31404 | United States |
| Summit Cancer Care Research | Savannah | Georgia | 31404 | United States |
| Candler Medical Oncology Practice (CMOP) | Savannah | Georgia | 31405 | United States |
| Gwinnett Hospital System, Inc. The Center for Cancer Care | Snellville | Georgia | 30078 | United States |
| Illinois Cancer Specialists | Arlington Heights | Illinois | 60005 | United States |
| Presence St. Mary's Cancer Center | Bourbonnais | Illinois | 60914 | United States |
| Presence Saint Joseph Hospital | Chicago | Illinois | 60657 | United States |
| North Shore Oncology Hematology Associates | Crystal Lake | Illinois | 60014 | United States |
| North Shore Oncology-Hematology Associates | Crystal Lake | Illinois | 60014 | United States |
| Presence Infusion Care - Evanston | Evanston | Illinois | 60202 | United States |
| Joliet Oncology-Hematology Associates, LTD | Joliet | Illinois | 60435 | United States |
| Advocate Condell Medical Center | Libertyville | Illinois | 60048 | United States |
| North Shore Oncology-Hematology Associates | Libertyville | Illinois | 60048 | United States |
| Joliet Oncology-Hematology Associates, LTD | Morris | Illinois | 60450 | United States |
| Joliet Oncology-Hematology Associates, LTD | New Lenox | Illinois | 60451 | United States |
| Mid Illinois Hematology And Oncology Associates, Limited | Normal | Illinois | 61761 | United States |
| Quincy Medical Group | Quincy | Illinois | 62301 | United States |
| Orchard Healthcare Research Inc. | Skokie | Illinois | 60077 | United States |
| Presence Infusion Care - Skokie | Skokie | Illinois | 60077 | United States |
| Oncology Hematology Associates of Southwest Indiana | Newburgh | Indiana | 47630 | United States |
| McFarland Clinic, P.C. | Ames | Iowa | 50010-3014 | United States |
| Oncology Associates at Mercy Medical Center | Cedar Rapids | Iowa | 52403 | United States |
| Stormont Vail Regional Health Center | Topeka | Kansas | 66604 | United States |
| Stormont Vail Cotton O'Neill Cancer Center | Topeka | Kansas | 66606 | United States |
| University of Kansas Cancer Center | Westwood | Kansas | 66205 | United States |
| Our Lady of the Lake Regional Medical Center | Baton Rouge | Louisiana | 70808 | United States |
| Mary Bird Perkins Cancer Center | Baton Rouge | Louisiana | 70809 | United States |
| Our Lady of the Lake Physician Group, Louisiana Hematology Oncology Associates | Baton Rouge | Louisiana | 70809 | United States |
| Our Lady of the Lake Regional Medical Center, Oncology 6 | Baton Rouge | Louisiana | 70809 | United States |
| Pontchartrain Cancer Center | Covington | Louisiana | 70433 | United States |
| Pontchartrain Cancer Center | Hammond | Louisiana | 70403 | United States |
| Cancer Center at West Jefferson Medical Center, New Orleans Physician Services, Inc. | Marrero | Louisiana | 70072 | United States |
| Crescent City Research Consortium, LLC | Marrero | Louisiana | 70072 | United States |
| East Jefferson General Hospital | Metairie | Louisiana | 70006 | United States |
| Touro Infirmary | New Orleans | Louisiana | 70115 | United States |
| Mercy Medical Center | Baltimore | Maryland | 21202 | United States |
| Greater Baltimore Medical Center | Baltimore | Maryland | 21204 | United States |
| Maryland Oncology and Hematology, PA | Bethesda | Maryland | 20817 | United States |
| The Office of Frederick P. Smith, MD | Chevy Chase | Maryland | 20815 | United States |
| Maryland Oncology Hematology, P.A. | Clinton | Maryland | 20735 | United States |
| Maryland Oncology Hematology, P.A. | Columbia | Maryland | 21044 | United States |
| Maryland Oncology Hematology, P.A. | Frederick | Maryland | 21702 | United States |
| Antietam Oncology and Hematology Group, PC | Haggerstown | Maryland | 21740 | United States |
| Maryland Oncology Hematology, P.A. | Rockville | Maryland | 20850 | United States |
| Maryland Oncology Hematology, P.A. | Silver Spring | Maryland | 20902 | United States |
| Maryland Oncology Hematology, P.A. | Silver Spring | Maryland | 20904 | United States |
| University of Maryland St. Joseph Medical Center | Towson | Maryland | 21204 | United States |
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | United States |
| New England Hematology Oncology/Massachusetts General Cancer Center at Newton Wellesley Hospital | Newton | Massachusetts | 02462 | United States |
| University of Massachusetts Memorial Medical Center | Worcester | Massachusetts | 01655 | United States |
| Great Lakes Cancer Management | Grosse Pointe Woods | Michigan | 48236 | United States |
| Munson Medical Center | Traverse City | Michigan | 49684 | United States |
| Great Lakes Cancer Management | Warren | Michigan | 48093 | United States |
| Fairview Ridges Hospital | Burnsville | Minnesota | 55337 | United States |
| Minnesota Oncology Hematology, PA | Coon Rapids | Minnesota | 55433 | United States |
| Fairview Southdale Hospital | Edina | Minnesota | 55435 | United States |
| Fairview Southdale Medical Oncology Clinic | Edina | Minnesota | 55435 | United States |
| University of Minnesota Health Maple Grove Clinics | Maple Grove | Minnesota | 55369 | United States |
| Minnesota Oncology Hematology, PA | Minneapolis | Minnesota | 55404 | United States |
| Metro-Minnesota Community Oncology Research Consortium | Saint Louis Park | Minnesota | 55416 | United States |
| Health Partners Institute | Saint Louis Park | Minnesota | 55426 | United States |
| Park Nicollet Frauenshuh Cancer Center | Saint Louis Park | Minnesota | 55426 | United States |
| Regions Hospital Cancer Care Center | Saint Paul | Minnesota | 55101 | United States |
| Regions Hospital | Saint Paul | Minnesota | 55101 | United States |
| Minnesota Oncology Hematology, PA | Saint Paul | Minnesota | 55102 | United States |
| Lakeview Hospital | Stillwater | Minnesota | 55082 | United States |
| Rice Memorial Hospital | Willmar | Minnesota | 56201 | United States |
| Minnesota Oncology Hematology, PA | Woodbury | Minnesota | 55125 | United States |
| North Mississippi Medical Center, Inc., Hematology and Oncology Research | Tupelo | Mississippi | 38801 | United States |
| Mercy Clinic St. Louis Cancer and Breast Institute | Ballwin | Missouri | 63011 | United States |
| St. Louis Cancer Care, LLP | Bridgeton | Missouri | 63044 | United States |
| St. Louis Cancer Care, LLP | Chesterfield | Missouri | 63017 | United States |
| Boone Hospital Center | Columbia | Missouri | 65201 | United States |
| Missouri Cancer Associates | Columbia | Missouri | 65201 | United States |
| St. Luke's Cancer Institute - East | Kansas City | Missouri | 64086 | United States |
| St. Luke's Cancer Institute | Kansas City | Missouri | 64111 | United States |
| St. Luke's Cancer Institute - Liberty | Liberty | Missouri | 64068 | United States |
| University of Kansas Cancer Center | North Kansas City | Missouri | 64116 | United States |
| Heartland Regional Medical Center/dba Cancer Care St. Joseph Mosaic Life Care | Saint Joseph | Missouri | 64507 | United States |
| Mercy Clinic St. Louis Cancer and Breast Institute | St Louis | Missouri | 63109 | United States |
| SSM Health St. Louis University Hospital | St Louis | Missouri | 63110 | United States |
| St. Louis University Cancer Center | St Louis | Missouri | 63110 | United States |
| St. Louis Cancer Care, LLP | St Louis | Missouri | 63128 | United States |
| Mercy Hospital St. Louis | St Louis | Missouri | 63141 | United States |
| Mercy Research - Mercy Heart Hospital St. Louis | St Louis | Missouri | 63141 | United States |
| Nebraska Hematology/Oncology, PC | Lincoln | Nebraska | 68506 | United States |
| Portsmouth Regional Hospital | Portsmouth | New Hampshire | 03801 | United States |
| Hackensack University Medical Center, John Theurer Cancer Center | Hackensack | New Jersey | 07601 | United States |
| The Valley Hospital | Paramus | New Jersey | 07652 | United States |
| St. Luke's University Heatlh Network - Warren Hospital | Phillipsburg | New Jersey | 08865 | United States |
| CareMount Medical | Brewster | New York | 10509 | United States |
| New York Cancer and Blood Specialists | East Setauket | New York | 11733 | United States |
| CareMount Medical | Mount Kisco | New York | 10549 | United States |
| Northern Westchester Hospital | Mount Kisco | New York | 10549 | United States |
| New York Cancer and Blood Specialists | Patchogue | New York | 11772 | United States |
| New York Cancer and Blood Specialists | Port Jefferson Station | New York | 11776 | United States |
| New York Cancer and Blood Specialists | Riverhead | New York | 11901 | United States |
| New York Cancer and Blood Specialists | Smithtown | New York | 11787 | United States |
| White Plains Hospital | White Plains | New York | 10601 | United States |
| Asheville Hematology and Oncology | Asheville | North Carolina | 28803 | United States |
| Johnston Health Services Corporation - Clayton | Clayton | North Carolina | 27520 | United States |
| Haywood Infusion Center | Clyde | North Carolina | 28721 | United States |
| Cape Fear Valley Health System | Fayetteville | North Carolina | 28304 | United States |
| Cape Fear Valley Health System | Fayetteville | North Carolina | 28311 | United States |
| East Carolina University Brody School of Medicine | Greenville | North Carolina | 27834 | United States |
| DLP Maria Parham Medical Center | Henderson | North Carolina | 27536 | United States |
| Advent Health - Hendersonville | Hendersonville | North Carolina | 28792 | United States |
| University of North Carolina Regional Physicians Hematology Oncology | High Point | North Carolina | 27262 | United States |
| Novant Health Oncology Specialists | Kernersville | North Carolina | 27284 | United States |
| Duke Cancer Network | Laurinburg | North Carolina | 28352 | United States |
| Southeastern Regional Medical Center | Lumberton | North Carolina | 27358 | United States |
| Novant Health Oncology Specialists | Mount Airy | North Carolina | 27030 | United States |
| Novant Health Oncology Specialists | North Wilkesboro | North Carolina | 28659 | United States |
| Johnston Health Services Corporation - Smithfield | Smithfield | North Carolina | 27577 | United States |
| Novant Health Oncology Specialists | Statesville | North Carolina | 28687 | United States |
| Novant Health Oncology Specialists | Thomasville | North Carolina | 27360 | United States |
| Novant Health Oncology Specialists | Winston-Salem | North Carolina | 27103 | United States |
| Hematology Oncology Associates, Inc. | Canton | Ohio | 44708 | United States |
| Mercy Medical Center | Canton | Ohio | 44708 | United States |
| Mid Ohio Oncology/Hematology, Inc. dba The Mark H. Zangmeister Center | Columbus | Ohio | 43219 | United States |
| Tri-County Hematology and Oncology Associates, Inc. | Dover | Ohio | 44622 | United States |
| Tri-County Hematology and Oncology Associates, Inc. | Massillon | Ohio | 44646 | United States |
| Mercy Health Perrysburg Cancer Center | Perrysburg | Ohio | 43551 | United States |
| Mercy Health St. Vincent Medical Center | Toledo | Ohio | 43608 | United States |
| Mercy Health Cancer Center | Toledo | Ohio | 46323 | United States |
| Mercy Health Youngstown dba St Joseph Warren Hospital | Warren | Ohio | 44484 | United States |
| Mercy Health Youngstown dba St. Elizabeth Youngstown Hospital | Youngstown | Ohio | 44501 | United States |
| Willamette Valley Cancer Institute and Research Center | Eugene | Oregon | 97401 | United States |
| Northwest Cancer Specialists, PC | Portland | Oregon | 97213 | United States |
| Northwest Cancer Specialists, PC | Portland | Oregon | 97225 | United States |
| Willamette Valley Cancer Institute and Research Center | Springfield | Oregon | 97477 | United States |
| St. Luke's University Health Network - Sacred Heart Hospital | Allentown | Pennsylvania | 18102 | United States |
| St. Luke's Hospital - Allentown Campus | Allentown | Pennsylvania | 18104 | United States |
| St. Luke's Hematology Oncology Specialists | Bethlehem | Pennsylvania | 18015 | United States |
| St. Luke's University Heatlh Network | Bethlehem | Pennsylvania | 18015 | United States |
| St. Luke's Hematology Oncology Specialists | Bethlehem | Pennsylvania | 18104 | United States |
| St. Luke's University Heatlh Network | Easton | Pennsylvania | 18045 | United States |
| Pinnacle Health Cancer Center | Harrisburg | Pennsylvania | 17109 | United States |
| Pinnacle Health Cancer Institute | Harrisburg | Pennsylvania | 17109 | United States |
| Lancaster Cancer Center | Lancaster | Pennsylvania | 17605 | United States |
| Ortenzio Cancer Center at Pinnacle Health | Mechanicsburg | Pennsylvania | 17050 | United States |
| Charleston Cancer Center | Charleston | South Carolina | 29406 | United States |
| Greenville Health System | Easley | South Carolina | 29640 | United States |
| Tidelands Waccamaw Oncology/Georgrtown Hospital System | Georgetown | South Carolina | 29440 | United States |
| Greenville Health System | Greenville | South Carolina | 29605 | United States |
| Greenville Health System | Greenville | South Carolina | 29615 | United States |
| Greenville Health System | Greer | South Carolina | 29650 | United States |
| Carolina Blood and Cancer Care Associates, PA | Lancaster | South Carolina | 29720 | United States |
| Tidelands Waccamaw Oncology/Georgrtown Hospital System | Murrells Inlet | South Carolina | 29576 | United States |
| Tidelands Waccamaw Oncology/Georgrtown Hospital System | Myrtle Beach | South Carolina | 29577 | United States |
| Carolina Blood and Cancer Care Associates, PA | Rock Hill | South Carolina | 29732 | United States |
| Greenville Health System | Seneca | South Carolina | 29672 | United States |
| Spartanburg Regional Medical Center | Spartanburg | South Carolina | 29303 | United States |
| Greenville Health System | Spartanburg | South Carolina | 29307 | United States |
| M. Francisco Gonzalez, MD, PA | Sumter | South Carolina | 29150 | United States |
| Wellmont Bristol Regional Medical Center | Bristol | Tennessee | 37620 | United States |
| Wellmont Medical Associates Oncology and Hematology | Bristol | Tennessee | 37620 | United States |
| University of Tennessee/Erlanger Oncology and Hematology | Chattanooga | Tennessee | 37403 | United States |
| Wellmont Medical Associates Oncology and Hematology | Johnson City | Tennessee | 37601 | United States |
| Wellmont Cancer Institute | Kingsport | Tennessee | 37660 | United States |
| Wellmont Holston Valley Medical Center | Kingsport | Tennessee | 37660 | United States |
| Texas Oncology -Allen | Allen | Texas | 75013 | United States |
| Texas Oncology | Dallas | Texas | 75246 | United States |
| Texas Oncology-Denton South | Denton | Texas | 76210 | United States |
| Texas Oncology-El Paso Cancer Treatment Center | El Paso | Texas | 79902 | United States |
| Texas Oncology - Fort Worth Cancer Center | Fort Worth | Texas | 76104 | United States |
| Texas Oncology | Fort Worth | Texas | 76104 | United States |
| Texas Oncology - Southwest Fort Worth | Fort Worth | Texas | 76132 | United States |
| Texas Oncology | Houston | Texas | 77024 | United States |
| MD Anderson Cancer Center | Houston | Texas | 77030 | United States |
| University Medical Center Health System, Southwest Cancer Center | Lubbock | Texas | 79415 | United States |
| Texas Oncology | McAllen | Texas | 78503 | United States |
| Texas Oncology - McKinney | McKinney | Texas | 75071 | United States |
| Texas Oncology | Mesquite | Texas | 75150 | United States |
| Texas Oncology-Paris | Paris | Texas | 75460 | United States |
| Texas Oncology | Plano | Texas | 75075 | United States |
| Texas Oncology-San Antonio Downtown | San Antonio | Texas | 78212 | United States |
| Texas Oncology | San Antonio | Texas | 78217 | United States |
| Texas Oncology-San Antonio Stone Oak | San Antonio | Texas | 78258 | United States |
| Texas Oncology | Tyler | Texas | 75702 | United States |
| Virginia Cancer Specialists | Arlington | Virginia | 22205 | United States |
| Wellmont Medical Associates Oncology and Hematology | Bristol | Virginia | 24201 | United States |
| Cancer Specialists of Tidewater/Riverside Cancer Infusion Center | Chesapeake | Virginia | 23320 | United States |
| Virginia Cancer Specialists | Fairfax | Virginia | 22031 | United States |
| Augusta Health Cancer Center | Fishersville | Virginia | 22939 | United States |
| Virginia Cancer Specialists | Gainesville | Virginia | 20155 | United States |
| Peninsula Cancer Institute/Riverside Cancer Infusion Center | Gloucester | Virginia | 23061 | United States |
| Virginia Cancer Specialists | Leesburg | Virginia | 20176 | United States |
| Bon Secours Memorial Regional Medical Center, Inc. | Mechanicsville | Virginia | 23116 | United States |
| Bon Secours Richmond Community Hospital dba Oncology Associates at Memorial Regional Medical Center | Mechanicsville | Virginia | 23116 | United States |
| Bon Secours Cancer Institute @ St. Francis Medical Center | Midlothian | Virginia | 23114 | United States |
| Bon Secours Richmond Community Hospital dba Oncology Associates at St. Francis Medical Center | Midlothian | Virginia | 23114 | United States |
| Bon Secours St. Francis Medical Center, Inc. | Midlothian | Virginia | 23114 | United States |
| Riverside Shore Cancer Center | Nassawadox | Virginia | 23413 | United States |
| Peninsula Cancer Institute/Riverside Cancer Infusion Center | Newport News | Virginia | 23601 | United States |
| Southwest Virginia Regional Cancer Center | Norton | Virginia | 24273 | United States |
| Delta Hematology/Oncology Associates | Portsmouth | Virginia | 23704 | United States |
| Bon Secours Richmond Community Hospital dba Oncologists Associates at St. Mary's Hospital | Richmond | Virginia | 23226 | United States |
| Bon Secours St. Mary's Hospital, Inc. | Richmond | Virginia | 23226 | United States |
| Cancer Specialists of Tidewater/Riverside Cancer Infusion Center | Suffolk | Virginia | 23435 | United States |
| Cancer Specialists of Tidewater/Riverside Cancer Infusion Center | Virginia Beach | Virginia | 23454 | United States |
| Peninsula Cancer Institute/Riverside Cancer Infusion Center | Williamsburg | Virginia | 23185 | United States |
| Seattle Cancer Care Alliance | Seattle | Washington | 98109 | United States |
| Northwest Cancer Specialists, PC | Vancouver | Washington | 98684 | United States |
| West Virginia University Medicine - United Hospital Center | Bridgeport | West Virginia | 26330 | United States |
| Huntington Internal Medicine Group | Huntington | West Virginia | 25705 | United States |
| St. Mary's Medical Center | Huntington | West Virginia | 25705 | United States |
| West Virginia University, Mary Babb Randolph Cancer Center | Morgantown | West Virginia | 26506 | United States |
| Camden Clark Medical Center | Parkersburg | West Virginia | 26101 | United States |
| Burnaby Hospital Cancer Centre | Burnaby | British Columbia | V5G 2X6 | Canada |
| Trillium Health Partners | Mississauga | Ontario | L5M 2N1 | Canada |
| St. Michael's Hospital | Toronto | Ontario | M5B 1W8 | Canada |
| Integrated University Center for Health and Social Services (CIUSSS) of Saguenay-Lac Saint Jean | Chicoutimi | Quebec | G74 5H6 | Canada |
| Derived |
| Tripathy D, Blum JL, McCune S, Pluard T, Anderson D, Johnston A, Montelongo MZ, Zhang Z, Cappelleri JC, Gauthier E, Rocque GB. Real-world effectiveness of palbociclib plus hormone treatment and its impact on patient quality of life: a plain language summary of findings from POLARIS. Future Oncol. 2025 Nov;21(26):3359-3376. doi: 10.1080/14796694.2025.2570468. Epub 2025 Oct 27. |
| 40971858 | Derived | Rocque GB, Blum JL, Ji Y, Pluard T, Migas J, Lakhanpal S, Jepsen E, Gauthier E, Wang Y, Montelongo MZ, Cappelleri JC, Chen C, Karuturi MS, Tripathy D. Enhancing the interpretation of real-world quality of life in patients with hormone receptor-positive/human epidermal growth factor receptor 2-negative advanced breast cancer enrolled in the POLARIS study. Oncologist. 2025 Oct 1;30(10):oyaf281. doi: 10.1093/oncolo/oyaf281. |
| 40825169 | Derived | Tripathy D, Blum JL, Zhang H, Deng S, McCune SL, Patel K, Wang Y, Lakhanpal S, Karuturi MS, Zhang Z, Deshpande C, Montelongo MZ, Gauthier E, Liu Y, Rocque GB, Bardia A. Circulating Tumor DNA Genotyping of Intrinsic and Acquired Gene Alterations in Patients With Advanced Breast Cancer Receiving Palbociclib: Biomarker Results From POLARIS Study. JCO Precis Oncol. 2025 Aug;9:e2400810. doi: 10.1200/PO-24-00810. Epub 2025 Aug 18. |
| 40553419 | Derived | Rocque GB, Blum JL, Ji Y, Pluard T, Migas J, Lakhanpal S, Jepsen E, Wang Y, Montelongo MZ, Zhang Z, Gauthier E, Tripathy D. Relationship of Prior Anticancer Treatments with Palbociclib Clinical Outcomes in Patients with HR+/HER2- Advanced Breast Cancer in Real-World Settings. Target Oncol. 2025 Jul;20(4):679-692. doi: 10.1007/s11523-025-01158-0. Epub 2025 Jun 24. |
| 39581892 | Derived | Rocque GB, Blum JL, Ji Y, Pluard T, Migas J, Lakhanpal S, Jepsen E, Gauthier E, Wang Y, Montelongo MZ, Cappelleri JC, Karuturi MS, Tripathy D. Real-world quality-of-life of patients with HR+/HER2- advanced breast cancer treated with palbociclib plus endocrine therapy: EORTC QLQ-C30 results from POLARIS. Breast Cancer Res Treat. 2025 Feb;209(3):613-627. doi: 10.1007/s10549-024-07524-2. Epub 2024 Nov 25. |
| 39475418 | Derived | Tripathy D, Blum JL, Karuturi MS, McCune S, Kurian S, Moezi M, Anderson D, Gauthier E, Zhang Z, Montelongo MZ, Wang Y, Rocque GB. Real-world effectiveness of palbociclib plus endocrine therapy in HR+/HER2- advanced breast cancer: final results from the POLARIS trial. Oncologist. 2025 Jul 4;30(7):oyae291. doi: 10.1093/oncolo/oyae291. |
| 38061288 | Derived | Karuturi MS, Cappelleri JC, Blum JL, Patel K, Telivala B, McCune S, Cuevas JD, Lakhanpal S, Montelongo MZ, Wang Y, Tripathy D, Rocque GB. Measures of functional status in older patients treated with palbociclib for advanced breast cancer. J Geriatr Oncol. 2024 Jan;15(1):101670. doi: 10.1016/j.jgo.2023.101670. Epub 2023 Dec 6. |
| 37903899 | Derived | Blum JL, DiCristo C, Gordon D, Karuturi MS, Oubre D, Jepsen E, Cuevas J, Lakhanpal S, Montelongo MZ, Zhang Z, Cappelleri JC, Wang Y, Tripathy D. Outcomes of male patients with HR+/HER2- advanced breast cancer receiving palbociclib in the real-world POLARIS study. Breast Cancer Res Treat. 2024 Feb;203(3):463-475. doi: 10.1007/s10549-023-07145-1. Epub 2023 Oct 30. |
| 32787449 | Derived | Tripathy D, Blum JL, Rocque GB, Bardia A, Karuturi MS, Cappelleri JC, Liu Y, Zhang Z, Davis KL, Wang Y. POLARIS: a prospective, multicenter, noninterventional study assessing palbociclib in hormone receptor-positive advanced breast cancer. Future Oncol. 2020 Nov;16(31):2475-2485. doi: 10.2217/fon-2020-0573. Epub 2020 Aug 13. |
| COMPLETED |
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| NOT COMPLETED |
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Safety analysis set included all eligible participants enrolled in the study and received at least one dose of study medication.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Palbociclib + Endocrine Therapy | Participants with HR+/HER2- advanced breast cancer who were prescribed palbociclib in combination with endocrine treatment (Palbociclib, Fulvestrant, and Other) by the treating physician in routine clinical practice were included. |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
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| Age, Continuous | Mean | Standard Deviation | Years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| 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 | ||||||||||||||||||||||
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| Primary | Number of Participants According to Real-World Tumor Response | Real world tumor response included complete response (CR), Partial response (PR), Stable disease (SD), Progressive Disease (PD), and was determined by physician based on imaging, biopsies, biomarkers, and/or clinical judgment. Response as assessed by Response Evaluation Criteria in Solid Tumors (RECIST) criteria may not be available for all participants. rwTR was derived as the best tumor response recorded from the palbociclib combination treatment start date until the first documentation of progressive disease. Only response assessments recorded on or before the start date of next subsequent line of treatment will be considered. | Safety analysis set included all participants enrolled in the study and received at least one dose of study medication. Here, 'Number Analyzed' signifies participants evaluable for the specified rows. | Posted | Count of Participants | Participants | No | From start of palbociclib combination treatment until first documentation of progression (up to approximately 3 years) |
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| Primary | Real-World Tumor Response Rate | Real world tumor response rate was defined as the percentage of participants with a best tumor response of complete response or partial response. Tumor response was determined by physician based on imaging, biopsies, biomarkers, and/or clinical judgment. RECIST criteria may not be available for all participants. | Safety analysis set included all participants who were enrolled in the study and received at least one dose of study medication. Here, 'Number Analyzed' signifies participants evaluable for the specified rows. | Posted | Number | 95% Confidence Interval | Percentage of participants | From start of palbociclib combination treatment until first documentation of progression (up to approximately 3 years) |
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| Primary | Real World Progression Free Survival | Real world progression free survival was defined as time (months) from initiation of the palbociclib combination treatment to the earliest of clinician-documented progression or death due to any cause, whichever occurred first. Participants without documented disease progression or death were censored at the last date of response assessment. | Safety analysis set included all participants enrolled in the study and received at least one dose of study medication. Here, 'Number Analyzed' signifies participants evaluable for the specified rows. | Posted | Median | 95% Confidence Interval | Months | From initiation of the palbociclib combination treatment to the earliest of clinician-documented progression or death due to any cause, whichever occurs first. (up to approximately 3 years) |
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| Primary | Overall Survival | Overall survival was defined as time from initiation of the palbociclib combination treatment to date of death due to any cause. Participants without a documented death were censored at last available visit date known to be alive. | Safety analysis set included all participants who were enrolled in the study and received at least one dose of study medication. Here, 'Number Analyzed' signifies participants evaluable for the specified rows. | Posted | Median | 95% Confidence Interval | Months | From initiation of the palbociclib combination treatment to death due to any cause or censored, (up to approximately 3 years) |
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| Primary | Absolute Eastern Co-Operative Oncology Group (ECOG) Performance Status Scores at Baseline: Participants More Than or Equal to 70 Years Only | ECOG performance status was a 6-level item used to assess the physical health of participants and ranged from 0 (fully active) to 5 (dead). | Safety analysis set included all participants who were enrolled in the study and received at least one dose of study medication. Here, 'Overall Number of Participants Analyzed' signifies participants evaluable for the outcome measure. | Posted | Mean | Standard Deviation | Units on a scale | Baseline (last observed measurement prior to treatment start date) |
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| Primary | ECOG Performance Status Scores at Month 1: Participants More Than or Equal to 70 Years Only | ECOG performance status was a 6-level item used to assess the physical health of participants and ranged from 0 (fully active) to 5 (dead). | Safety analysis set included all participants who were enrolled in the study and received at least one dose of study medication, Here 'Overall Number of Participants Analyzed' signifies participants evaluable for the outcome measure. | Posted | Mean | Standard Deviation | Units on a scale | Month 1 |
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| Primary | ECOG Performance Status Scores at Month 2: Participants More Than or Equal to 70 Years Only | ECOG performance status was a 6-level item used to assess the physical health of participants and ranged from 0 (fully active) to 5 (dead). | Safety analysis set included all participants who were enrolled in the study and received at least one dose of study medication, Here 'Overall Number of Participants Analyzed' signifies participants evaluable for the outcome measure. | Posted | Mean | Standard Deviation | Units on a scale | Month 2 |
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| Primary | ECOG Performance Status Scores at Month 3: Participants More Than or Equal to 70 Years Only | ECOG performance status was a 6-level item used to assess the physical health of participants and ranged from 0 (fully active) to 5 (dead). | Safety analysis set included all participants who were enrolled in the study and received at least one dose of study medication. Here, 'Overall Number of Participants Analyzed' signifies participants evaluable for the outcome measure. | Posted | Mean | Standard Deviation | Units on a scale | Month 3 |
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| Primary | ECOG Performance Status Scores at Month 6: Participants More Than or Equal to 70 Years Only | ECOG performance status was a 6-level item used to assess the physical health of participants and ranged from 0 (fully active) to 5 (dead). | Safety analysis set included all participants who were enrolled in the study and received at least one dose of study medication. Here, 'Overall Number of Participants Analyzed' signifies participants evaluable for the outcome measure. | Posted | Mean | Standard Deviation | Units on a scale | Month 6 |
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| Primary | ECOG Performance Status Scores at Month 9: Participants More Than or Equal to 70 Years Only | ECOG performance status was a 6-level item used to assess the physical health of participants and ranged from 0 (fully active) to 5 (dead). | Safety analysis set included all participants who were enrolled in the study and received at least one dose of study medication. Here, 'Overall Number of Participants Analyzed' signifies participants evaluable for the outcome measure. | Posted | Mean | Standard Deviation | Units on a scale | Month 9 |
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| Primary | ECOG Performance Status Scores at Month 12: Participants More Than or Equal to 70 Years Only | ECOG performance status was a 6-level item used to assess the physical health of participants and ranged from 0 (fully active) to 5 (dead). | Safety analysis set included all participants who were enrolled in the study and received at least one dose of study medication. Here, 'Overall Number of Participants Analyzed' signifies participants evaluable for the outcome measure. | Posted | Mean | Standard Deviation | Units on a scale | Month 12 |
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| Primary | ECOG Performance Status Scores at Month 15: Participants More Than or Equal to 70 Years Only | ECOG performance status was a 6-level item used to assess the physical health of participants and ranged from 0 (fully active) to 5 (dead). | Safety analysis set included all participants who were enrolled in the study and received at least one dose of study medication. Here, 'Overall Number of Participants Analyzed' signifies participants evaluable for the outcome measure. | Posted | Mean | Standard Deviation | Units on a scale | Month 15 |
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| Primary | ECOG Performance Status Scores at Month 18: Participants More Than or Equal to 70 Years Only | ECOG performance status was a 6-level item used to assess the physical health of participants and ranged from 0 (fully active) to 5 (dead). | Safety analysis set included all participants who were enrolled in the study and received at least one dose of study medication. Here, 'Overall Number of Participants Analyzed' signifies participants evaluable for the outcome measure. | Posted | Mean | Standard Deviation | Units on a scale | Month 18 |
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| Primary | ECOG Performance Status Scores at Month 21: Participants More Than or Equal to 70 Years Only | ECOG performance status was a 6-level item used to assess the physical health of participants and ranged from 0 (fully active) to 5 (dead). | Safety analysis set included all participants who were enrolled in the study and received at least one dose of study medication. Here, 'Overall Number of Participants Analyzed' signifies participants evaluable for the outcome measure. | Posted | Mean | Standard Deviation | Units on a scale | Month 21 |
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| Primary | ECOG Performance Status Scores at Month 24: Participants More Than or Equal to 70 Years Only | ECOG performance status was a 6-level item used to assess the physical health of participants and ranged from 0 (fully active) to 5 (dead). | Safety analysis set included all participants who were enrolled in the study and received at least one dose of study medication. Here, 'Overall Number of Participants Analyzed' signifies participants evaluable for the outcome measure. | Posted | Mean | Standard Deviation | Units on a scale | Month 24 |
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| Primary | ECOG Performance Status Scores in Month 27: Participants More Than or Equal to 70 Years Only | ECOG performance status was a 6-level item used to assess the physical health of participants and ranged from 0 (fully active) to 5 (dead). | Safety analysis set included all participants who were enrolled in the study and received at least one dose of study medication. | Posted | Mean | Standard Deviation | Units on a scale | Month 27 |
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| Primary | ECOG Performance Status Scores at Month 30: Participants More Than or Equal to 70 Years Only | ECOG performance status was a 6-level item used to assess the physical health of participants and ranged from 0 (fully active) to 5 (dead). | Safety analysis set included all participants who were enrolled in the study and received at least one dose of study medication. Here, 'Overall Number of Participants Analyzed' signifies participants evaluable for the outcome measure. | Posted | Mean | Standard Deviation | Units on a scale | Month 30 |
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| Primary | ECOG Performance Status Scores at Month 33: Participants More Than or Equal to 70 Years Only | ECOG performance status was a 6-level item used to assess the physical health of participants and ranged from 0 (fully active) to 5 (dead). | Safety analysis set included all participants who were enrolled in the study and received at least one dose of study medication. Here, 'Overall Number of Participants Analyzed' signifies participants evaluable for the outcome measure. | Posted | Mean | Standard Deviation | Units on a scale | Month 33 |
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| Primary | ECOG Performance Status Scores in Month 36: Participants More Than or Equal to 70 Years Only | ECOG performance status was a 6-level item used to assess the physical health of participants and ranged from 0 (fully active) to 5 (dead). | Safety analysis set included all participants who were enrolled in the study and received at least one dose of study medication. Here, 'Overall Number of Participants Analyzed' signifies participants evaluable for the outcome measure. | Posted | Mean | Standard Deviation | Units on a scale | Month 36 |
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| Primary | ECOG Performance Status Scores at Month 39: Participants More Than or Equal to 70 Years Only | ECOG performance status was a 6-level item used to assess the physical health of participants and ranged from 0 (fully active) to 5 (dead). | Safety analysis set included all participants who were enrolled in the study and received at least one dose of study medication. Here, 'Overall Number of Participants Analyzed' signifies participants evaluable for the outcome measure. | Posted | Mean | Standard Deviation | Units on a scale | Month 39 |
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| Primary | ECOG Performance Status Scores at Month 42: Participants More Than or Equal to 70 Years Only | ECOG performance status was a 6-level item used to assess the physical health of participants and ranged from 0 (fully active) to 5 (dead). | Safety analysis set included all participants who were enrolled in the study and received at least one dose of study medication. Here, 'Overall Number of Participants Analyzed' signifies participants evaluable for the outcome measure. | Posted | Mean | Standard Deviation | Units on a scale | Month 42 |
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| Primary | Geriatric 8 Screening Tool Scores at Baseline: Participants More Than or Equal to 70 Years Only | The G8 Screening Tool consisted of 7 items based on the Mini-Nutritional Assessment and a single item covering the participants age. Specifically, the G8 assessed food intake, weight changes, mobility, neuropsychological problems, body mass index, prescription count, and health status compared to similarly aged participants. Points were associated to each item and index score was calculated by summing points. The index score ranged in value from 0 (heavily impaired) to 17 (not at all impaired). If any of the 8 items was missing, the total score was missing. | Safety analysis set included all participants who were enrolled in the study and received at least one dose of study medication. Here, 'Overall Number of Participants Analyzed' signifies participants evaluable for the outcome measure. | Posted | Mean | Standard Deviation | Units on a scale | Baseline (last observed measurement prior to treatment start date) |
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| Primary | Geriatric 8 Screening Tool Scores at Month 1: Participants More Than or Equal to 70 Years Only | The G8 Screening Tool consisted of 7 items based on the Mini-Nutritional Assessment and a single item covering the participants age. Specifically, the G8 assessed food intake, weight changes, mobility, neuropsychological problems, body mass index, prescription count, and health status compared to similarly aged participants. Points were associated to each item and index score was calculated by summing points. The index score ranged in value from 0 (heavily impaired) to 17 (not at all impaired). If any of the 8 items was missing, the total score was missing. | Safety analysis set included all participants who were enrolled in the study and received at least one dose of study medication. Here, 'Overall Number of Participants Analyzed' signifies participants evaluable for the outcome measure. | Posted | Mean | Standard Deviation | Units on a scale | Month 1 |
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| Primary | Geriatric 8 Screening Tool Scores at Month 2: Participants More Than or Equal to 70 Years Only | The G8 Screening Tool consisted of 7 items based on the Mini-Nutritional Assessment and a single item covering the participants age. Specifically, the G8 assessed food intake, weight changes, mobility, neuropsychological problems, body mass index, prescription count, and health status compared to similarly aged participants. Points were associated to each item and index score was calculated by summing points. The index score ranged in value from 0 (heavily impaired) to 17 (not at all impaired). If any of the 8 items was missing, the total score was missing. | Safety analysis set included all participants who were enrolled in the study and received at least one dose of study medication. Here, 'Overall Number of Participants Analyzed' signifies participants evaluable for the outcome measure. | Posted | Mean | Standard Deviation | Units on a scale | Month 2 |
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| Primary | Geriatric 8 Screening Tool Scores at Month 3: Participants More Than or Equal to 70 Years Only | The G8 Screening Tool consisted of 7 items based on the Mini-Nutritional Assessment and a single item covering the participants age. Specifically, the G8 assessed food intake, weight changes, mobility, neuropsychological problems, body mass index, prescription count, and health status compared to similarly aged participants. Points were associated to each item and index score was calculated by summing points. The index score ranged in value from 0 (heavily impaired) to 17 (not at all impaired). If any of the 8 items was missing, the total score was missing. | Safety analysis set included all participants who were enrolled in the study and received at least one dose of study medication. Here, 'Overall Number of Participants Analyzed' signifies participants evaluable for the outcome measure. | Posted | Mean | Standard Deviation | Units on a scale | Month 3 |
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| Primary | Geriatric 8 Screening Tool Scores at Month 6: Participants More Than or Equal to 70 Years Only | The G8 Screening Tool consisted of 7 items based on the Mini-Nutritional Assessment and a single item covering the participants age. Specifically, the G8 assessed food intake, weight changes, mobility, neuropsychological problems, body mass index, prescription count, and health status compared to similarly aged participants. Points were associated to each item and index score was calculated by summing points. The index score ranged in value from 0 (heavily impaired) to 17 (not at all impaired). If any of the 8 items was missing, the total score was missing. | Safety analysis set included all participants who were enrolled in the study and received at least one dose of study medication. Here, 'Overall Number of Participants Analyzed' signifies participants evaluable for the outcome measure. | Posted | Mean | Standard Deviation | Units on a scale | Month 6 |
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| Primary | Geriatric 8 Screening Tool Scores at Month 9: Participants More Than or Equal to 70 Years Only | The G8 Screening Tool consisted of 7 items based on the Mini-Nutritional Assessment and a single item covering the participants age. Specifically, the G8 assessed food intake, weight changes, mobility, neuropsychological problems, body mass index, prescription count, and health status compared to similarly aged participants. Points were associated to each item and index score was calculated by summing points. The index score ranged in value from 0 (heavily impaired) to 17 (not at all impaired). If any of the 8 items was missing, the total score was missing. | Safety analysis set included all participants who were enrolled in the study and received at least one dose of study medication. Here, 'Overall Number of Participants Analyzed' signifies participants evaluable for the outcome measure. | Posted | Mean | Standard Deviation | Units on a scale | Month 9 |
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| Primary | Geriatric 8 Screening Tool Scores at Month 12: Participants More Than or Equal to 70 Years Only | The G8 Screening Tool consisted of 7 items based on the Mini-Nutritional Assessment and a single item covering the participants age. Specifically, the G8 assessed food intake, weight changes, mobility, neuropsychological problems, body mass index, prescription count, and health status compared to similarly aged participants. Points were associated to each item and index score was calculated by summing points. The index score ranged in value from 0 (heavily impaired) to 17 (not at all impaired). If any of the 8 items was missing, the total score was missing. | Safety analysis set included all participants who were enrolled in the study and received at least one dose of study medication. Here, 'Overall Number of Participants Analyzed' signifies participants evaluable for the outcome measure. | Posted | Mean | Standard Deviation | Units on a scale | Month 12 |
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| Primary | Geriatric 8 Screening Tool Scores at Month 15: Participants More Than or Equal to 70 Years Only | The G8 Screening Tool consisted of 7 items based on the Mini-Nutritional Assessment and a single item covering the participants age. Specifically, the G8 assessed food intake, weight changes, mobility, neuropsychological problems, body mass index, prescription count, and health status compared to similarly aged participants. Points were associated to each item and index score was calculated by summing points. The index score ranged in value from 0 (heavily impaired) to 17 (not at all impaired). If any of the 8 items was missing, the total score was missing. | Safety analysis set included all participants who were enrolled in the study and received at least one dose of study medication. Here, 'Overall Number of Participants Analyzed' signifies participants evaluable for the outcome measure. | Posted | Mean | Standard Deviation | Units on a scale | Month 15 |
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| Primary | Geriatric 8 Screening Tool Scores at Month 18: Participants More Than or Equal to 70 Years Only | The G8 Screening Tool consisted of 7 items based on the Mini-Nutritional Assessment and a single item covering the participants age. Specifically, the G8 assessed food intake, weight changes, mobility, neuropsychological problems, body mass index, prescription count, and health status compared to similarly aged participants. Points were associated to each item and index score was calculated by summing points. The index score ranged in value from 0 (heavily impaired) to 17 (not at all impaired). If any of the 8 items was missing, the total score was missing. | Safety analysis set included all participants who were enrolled in the study and received at least one dose of study medication. Here, 'Overall Number of Participants Analyzed' signifies participants evaluable for the outcome measure. | Posted | Mean | Standard Deviation | Units on a scale | Month 18 |
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| Primary | Geriatric 8 Screening Tool Scores at Month 21: Participants More Than or Equal to 70 Years Only | The G8 Screening Tool consisted of 7 items based on the Mini-Nutritional Assessment and a single item covering the participants age. Specifically, the G8 assessed food intake, weight changes, mobility, neuropsychological problems, body mass index, prescription count, and health status compared to similarly aged participants. Points were associated to each item and index score was calculated by summing points. The index score ranged in value from 0 (heavily impaired) to 17 (not at all impaired). If any of the 8 items was missing, the total score was missing. | Safety analysis set included all participants who were enrolled in the study and received at least one dose of study medication. Here, 'Overall Number of Participants Analyzed' signifies participants evaluable for the outcome measure. | Posted | Mean | Standard Deviation | Units on a scale | Month 21 |
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| Primary | Geriatric 8 Screening Tool Scores at Month 24: Participants More Than or Equal to 70 Years Only | The G8 Screening Tool consisted of 7 items based on the Mini-Nutritional Assessment and a single item covering the participants age. Specifically, the G8 assessed food intake, weight changes, mobility, neuropsychological problems, body mass index, prescription count, and health status compared to similarly aged participants. Points were associated to each item and index score was calculated by summing points. The index score ranged in value from 0 (heavily impaired) to 17 (not at all impaired). If any of the 8 items was missing, the total score was missing. | Safety analysis set included all participants who were enrolled in the study and received at least one dose of study medication. Here, 'Overall Number of Participants Analyzed' signifies participants evaluable for the outcome measure. | Posted | Mean | Standard Deviation | Units on a scale | Month 24 |
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| Primary | Geriatric 8 Screening Tool Scores at Month 27: Participants More Than or Equal to 70 Years Only | The G8 Screening Tool consisted of 7 items based on the Mini-Nutritional Assessment and a single item covering the participants age. Specifically, the G8 assessed food intake, weight changes, mobility, neuropsychological problems, body mass index, prescription count, and health status compared to similarly aged participants. Points were associated to each item and index score was calculated by summing points. The index score ranged in value from 0 (heavily impaired) to 17 (not at all impaired). If any of the 8 items was missing, the total score was missing. | Safety analysis set included all participants who were enrolled in the study and received at least one dose of study medication. Here, 'Overall Number of Participants Analyzed' signifies participants evaluable for the outcome measure. | Posted | Mean | Standard Deviation | Units on a scale | Month 27 |
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| Primary | Geriatric 8 Screening Tool Scores at Month 30: Participants More Than or Equal to 70 Years Only | The G8 Screening Tool consisted of 7 items based on the Mini-Nutritional Assessment and a single item covering the participants age. Specifically, the G8 assessed food intake, weight changes, mobility, neuropsychological problems, body mass index, prescription count, and health status compared to similarly aged participants. Points were associated to each item and index score was calculated by summing points. The index score ranged in value from 0 (heavily impaired) to 17 (not at all impaired). If any of the 8 items was missing, the total score was missing. | Safety analysis set included all participants who were enrolled in the study and received at least one dose of study medication. Here, 'Overall Number of Participants Analyzed' signifies participants evaluable for the outcome measure. | Posted | Mean | Standard Deviation | Units on a scale | Month 30 |
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| Primary | Geriatric 8 Screening Tool Scores at Month 33: Participants More Than or Equal to 70 Years Only | The G8 Screening Tool consisted of 7 items based on the Mini-Nutritional Assessment and a single item covering the participants age. Specifically, the G8 assessed food intake, weight changes, mobility, neuropsychological problems, body mass index, prescription count, and health status compared to similarly aged participants. Points were associated to each item and index score was calculated by summing points. The index score ranged in value from 0 (heavily impaired) to 17 (not at all impaired). If any of the 8 items was missing, the total score was missing. | Safety analysis set included all participants who were enrolled in the study and received at least one dose of study medication. Here, 'Overall Number of Participants Analyzed' signifies participants evaluable for the outcome measure. | Posted | Mean | Standard Deviation | Units on a scale | Month 33 |
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| Primary | Geriatric 8 Screening Tool Scores at Month 36: Participants More Than or Equal to 70 Years Only | The G8 Screening Tool consisted of 7 items based on the Mini-Nutritional Assessment and a single item covering the participants age. Specifically, the G8 assessed food intake, weight changes, mobility, neuropsychological problems, body mass index, prescription count, and health status compared to similarly aged participants. Points were associated to each item and index score was calculated by summing points. The index score ranged in value from 0 (heavily impaired) to 17 (not at all impaired). If any of the 8 items was missing, the total score was missing. | Safety analysis set included all participants who were enrolled in the study and received at least one dose of study medication. Here, 'Overall Number of Participants Analyzed' signifies participants evaluable for the outcome measure. | Posted | Mean | Standard Deviation | Units on a scale | Month 36 |
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| Primary | Geriatric 8 Screening Tool Scores at Month 39: Participants More Than 70 or Equal to Years Only | The G8 Screening Tool consisted of 7 items based on the Mini-Nutritional Assessment and a single item covering the participants age. Specifically, the G8 assessed food intake, weight changes, mobility, neuropsychological problems, body mass index, prescription count, and health status compared to similarly aged participants. Points were associated to each item and index score was calculated by summing points. The index score ranged in value from 0 (heavily impaired) to 17 (not at all impaired). If any of the 8 items was missing, the total score was missing. | Safety analysis set included all participants who were enrolled in the study and received at least one dose of study medication. Here, 'Overall Number of Participants Analyzed' signifies participants evaluable for the outcome measure | Posted | Mean | Standard Deviation | Units on a scale | Month 39 |
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| Primary | Geriatric 8 Screening Tool Scores at Month 42: Participants More Than or Equal to 70 Years Only | The G8 Screening Tool consisted of 7 items based on the Mini-Nutritional Assessment and a single item covering the participants age. Specifically, the G8 assessed food intake, weight changes, mobility, neuropsychological problems, body mass index, prescription count, and health status compared to similarly aged participants. Points were associated to each item and index score was calculated by summing points. The index score ranged in value from 0 (heavily impaired) to 17 (not at all impaired). If any of the 8 items was missing, the total score was missing. | Safety analysis set included all participants who were enrolled in the study and received at least one dose of study medication. Here, 'Overall Number of Participants Analyzed' signifies participants evaluable for the outcome measure. | Posted | Mean | Standard Deviation | Units on a scale | Month 42 |
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| Primary | Change From Baseline to Month 6 in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Scores at Baseline | European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire 30: 30 item questionnaires composed of 5 functional subscales (physical, role, cognitive, emotional, and social); a global health/global quality of life scale; 3 symptom subscales (fatigue, pain and nausea/vomiting); and 6 single items that assessed additional symptoms (dyspnea, appetite loss, insomnia, constipation, diarrhea and financial difficulties). All scales and single item measures ranged in score from 0 to 100. Higher scores on functional and global quality of life scales represent better level of functioning. Higher scores on the symptom oriented scales represent more severe symptoms. | Safety analysis set included all participants who were enrolled in the study and received at least one dose of study medication. All participants reported under 'Number of Participants Analyzed' contributed data to the table; however, may not have evaluable data for every row. Here 'Number Analyzed' signifies number of participants who provided an answer on the QoL Questionnaire for the specific item listed on each row. | Posted | Mean | Standard Deviation | Units on a scale | Baseline (last observed measurement prior to treatment start date) and Month 6 |
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| Primary | Change From Baseline to Month 12 in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Scores at Baseline | EORTC QLQ-C30: 30 item questionnaire composed of 5 functional subscales (physical, role, cognitive, emotional, and social); a global health/global quality of life scale; 3 symptom subscales (fatigue, pain and nausea/vomiting); and 6 single items that assessed additional symptoms (dyspnea, appetite loss, insomnia, constipation, diarrhea and financial difficulties). All scales and single item measures ranged in score from 0 to 100. Higher scores on functional and global quality of life scales represent better level of functioning. Higher scores on the symptom oriented scales represent more severe symptoms. | Safety analysis set included all participants who were enrolled in the study and received at least one dose of study medication. All participants reported under 'Number of Participants Analyzed' contributed data to the table; however, may not have evaluable data for every row. Here 'Number Analyzed' signifies number of participants who provided an answer on the QoL Questionnaire for the specific item listed on each row. | Posted | Mean | Standard Deviation | Units on a scale | Baseline (last observed measurement prior to treatment start date) and Month 12 |
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| Primary | Change From Baseline to Month 18 in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Scores at Baseline | EORTC QLQ-C30: 30 item questionnaire composed of 5 functional subscales (physical, role, cognitive, emotional, and social); a global health/global quality of life scale; 3 symptom subscales (fatigue, pain and nausea/vomiting); and 6 single items that assessed additional symptoms (dyspnea, appetite loss, insomnia, constipation, diarrhea and financial difficulties). All scales and single item measures ranged in score from 0 to 100. Higher scores on functional and global quality of life scales represent better level of functioning. Higher scores on the symptom oriented scales represent more severe symptoms. | Safety analysis set included all participants who were enrolled in the study and received at least one dose of study medication. All participants reported under 'Number of Participants Analyzed' contributed data to the table; however, may not have evaluable data for every row. Here 'Number Analyzed' signifies number of participants who provided an answer on the QoL Questionnaire for the specific item listed on each row. | Posted | Mean | Standard Deviation | Units on a scale | Baseline (last observed measurement prior to treatment start date) and Month 18 |
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| Primary | Activities of Daily Living Scores at Baseline: Participants More Than or Equal to 70 Years Only | Activities of Daily Living is assessed using a six-item ADL limitations measure that inventoried whether participants had difficulty bathing, dressing, toileting, feeding, with transfer, and incontinence. Each item was rated on a 3-point Likert scale measuring independence in performing the activity and scores ranged from 1 to 3; where, 1=unable to do without assistance, 2=partial assistance needed and 3=no assistance. The total score was calculated as a sum of scores of individual items and ranged between 6 to 18, where a score of 6 indicated a very dependent participant and a score of 18 represented an independent participant. | Safety analysis set included all participants who were enrolled in the study and received at least one dose of study medication. Here, 'Overall Number of Participants Analyzed' signifies participants evaluable for the outcome measure. | Posted | Mean | Standard Deviation | Units on a scale | Baseline (last observed measurement prior to treatment start date) |
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| Primary | Activities of Daily Living Scores at Month 1: Participants More Than or Equal to 70 Years Only | Activities of Daily Living is assessed using a six-item ADL limitations measure that inventoried whether participants had difficulty bathing, dressing, toileting, feeding, with transfer, and incontinence. Each item was rated on a 3-point Likert scale measuring independence in performing the activity and scores ranged from 1 to 3; where, 1=unable to do without assistance, 2=partial assistance needed and 3=no assistance. The total score was calculated as a sum of scores of individual items and ranged between 6 to 18, where a score of 6 indicated a very dependent participant and a score of 18 represented an independent participants. | Safety analysis set included all participants who were enrolled in the study and received at least one dose of study medication. Here, 'Overall Number of Participants Analyzed' signifies participants evaluable for the outcome measure. | Posted | Mean | Standard Deviation | Units on a scale | Month 1 |
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| Primary | Activities of Daily Living Scores at Month 2: Participants More Than or Equal to 70 Years Only | Activities of Daily Living is assessed using a six-item ADL limitations measure that inventoried whether participants had difficulty bathing, dressing, toileting, feeding, with transfer, and incontinence. Each item was rated on a 3-point Likert scale measuring independence in performing the activity and scores ranged from 1 to 3; where, 1=unable to do without assistance, 2=partial assistance needed and 3=no assistance. The total score was calculated as a sum of scores of individual items and ranged between 6 to 18, where a score of 6 indicated a very dependent participant and a score of 18 represented an independent participants. | Safety analysis set included all participants who were enrolled in the study and received at least one dose of study medication, 'Overall Number of Participants Analyzed' signifies participants evaluable for the outcome measure. | Posted | Mean | Standard Deviation | Units on a scale | Month 2 |
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| Primary | Activities of Daily Living Scores at Month 3: Participants More Than or Equal to 70 Years Only | Activities of Daily Living is assessed using a six-item ADL limitations measure that inventoried whether participants had difficulty bathing, dressing, toileting, feeding, with transfer, and incontinence. Each item was rated on a 3-point Likert scale measuring independence in performing the activity and scores ranged from 1 to 3; where, 1=unable to do without assistance, 2=partial assistance needed and 3=no assistance. The total score was calculated as a sum of scores of individual items and ranged between 6 to 18, where a score of 6 indicated a very dependent participant and a score of 18 represented an independent participants. | Safety analysis set included all participants who were enrolled in the study and received at least one dose of study medication, 'Overall Number of Participants Analyzed' signifies participants evaluable for the outcome measure. | Posted | Mean | Standard Deviation | Units on a scale | Month 3 |
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| Primary | Activities of Daily Living Scores Month 6: Participants More Than or Equal to 70 Years Only | Activities of Daily Living is assessed using a six-item ADL limitations measure that inventoried whether participants had difficulty bathing, dressing, toileting, feeding, with transfer, and incontinence. Each item was rated on a 3-point Likert scale measuring independence in performing the activity and scores ranged from 1 to 3; where, 1=unable to do without assistance, 2=partial assistance needed and 3=no assistance. The total score was calculated as a sum of scores of individual items and ranged between 6 to 18, where a score of 6 indicated a very dependent participant and a score of 18 represented an independent participants. | Safety analysis set included all participants who were enrolled in the study and received at least one dose of study medication, 'Overall Number of Participants Analyzed' signifies participants evaluable for the outcome measure. | Posted | Mean | Standard Deviation | Units on a scale | Month 6 |
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| Primary | Activities of Daily Living Scores at Month 9: Participants More Than or Equal to 70 Years Only | Activities of Daily Living is assessed using a six-item ADL limitations measure that inventoried whether participants had difficulty bathing, dressing, toileting, feeding, with transfer, and incontinence. Each item was rated on a 3-point Likert scale measuring independence in performing the activity and scores ranged from 1 to 3; where, 1=unable to do without assistance, 2=partial assistance needed and 3=no assistance. The total score was calculated as a sum of scores of individual items and ranged between 6 to 18, where a score of 6 indicated a very dependent participant and a score of 18 represented an independent participants. | Safety analysis set included all participants who were enrolled in the study and received at least one dose of study medication, 'Overall Number of Participants Analyzed' signifies participants evaluable for the outcome measure. | Posted | Mean | Standard Deviation | Units on a scale | Month 9 |
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| Primary | Activities of Daily Living Scores at Month 12: Participants More Than or Equal to 70 Years Only | Activities of Daily Living is assessed using a six-item ADL limitations measure that inventoried whether participants had difficulty bathing, dressing, toileting, feeding, with transfer, and incontinence. Each item was rated on a 3-point Likert scale measuring independence in performing the activity and scores ranged from 1 to 3; where, 1=unable to do without assistance, 2=partial assistance needed and 3=no assistance. The total score was calculated as a sum of scores of individual items and ranged between 6 to 18, where a score of 6 indicated a very dependent participant and a score of 18 represented an independent participants. | Safety analysis set included all participants who were enrolled in the study and received at least one dose of study medication, 'Overall Number of Participants Analyzed' signifies participants evaluable for the outcome measure. | Posted | Mean | Standard Deviation | Units on a scale | Month 12 |
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| Primary | Activities of Daily Living Scores at Month 15: Participants More Than or Equal to 70 Years Only | Activities of Daily Living is assessed using a six-item ADL limitations measure that inventoried whether participants had difficulty bathing, dressing, toileting, feeding, with transfer, and incontinence. Each item was rated on a 3-point Likert scale measuring independence in performing the activity and scores ranged from 1 to 3; where, 1=unable to do without assistance, 2=partial assistance needed and 3=no assistance. The total score was calculated as a sum of scores of individual items and ranged between 6 to 18, where a score of 6 indicated a very dependent participant and a score of 18 represented an independent participants. | Safety analysis set included all participants who were enrolled in the study and received at least one dose of study medication, 'Overall Number of Participants Analyzed' signifies participants evaluable for the outcome measure. | Posted | Mean | Standard Deviation | Units on a scale | Month 15 |
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| Primary | Activities of Daily Living Scores at Month 18: Participants More Than or Equal to 70 Years Only | Activities of Daily Living is assessed using a six-item ADL limitations measure that inventoried whether participants had difficulty bathing, dressing, toileting, feeding, with transfer, and incontinence. Each item was rated on a 3-point Likert scale measuring independence in performing the activity and scores ranged from 1 to 3; where, 1=unable to do without assistance, 2=partial assistance needed and 3=no assistance. The total score was calculated as a sum of scores of individual items and ranged between 6 to 18, where a score of 6 indicated a very dependent participant and a score of 18 represented an independent participant. | Safety analysis set included all participants who were enrolled in the study and received at least one dose of study medication, 'Overall Number of Participants Analyzed' signifies participants evaluable for the outcome measure. | Posted | Mean | Standard Deviation | Units on a scale | Month 18 |
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| Primary | Activities of Daily Living Scores at Month 21: Participants More Than or Equal to 70 Years Only | Activities of Daily Living is assessed using a six-item ADL limitations measure that inventoried whether participants had difficulty bathing, dressing, toileting, feeding, with transfer, and incontinence. Each item was rated on a 3-point Likert scale measuring independence in performing the activity and scores ranged from 1 to 3; where, 1=unable to do without assistance, 2=partial assistance needed and 3=no assistance. The total score was calculated as a sum of scores of individual items and ranged between 6 to 18, where a score of 6 indicated a very dependent participant and a score of 18 represented an independent participants. | Safety analysis set included all participants who were enrolled in the study and received at least one dose of study medication, 'Overall Number of Participants Analyzed' signifies participants evaluable for the outcome measure. | Posted | Mean | Standard Deviation | Units on a scale | Month 21 |
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| Primary | Activities of Daily Living Scores at Month 24: Participants More Than or Equal to 70 Years Only | Activities of Daily Living is assessed using a six-item ADL limitations measure that inventoried whether participants had difficulty bathing, dressing, toileting, feeding, with transfer, and incontinence. Each item was rated on a 3-point Likert scale measuring independence in performing the activity and scores ranged from 1 to 3; where, 1=unable to do without assistance, 2=partial assistance needed and 3=no assistance. The total score was calculated as a sum of scores of individual items and ranged between 6 to 18, where a score of 6 indicated a very dependent participant and a score of 18 represented an independent participants. | Safety analysis set included all participants who were enrolled in the study and received at least one dose of study medication.'Overall Number of Participants Analyzed' signifies participants evaluable for the outcome measure. | Posted | Mean | Standard Deviation | Units on a scale | Month 24 |
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| Primary | Activities of Daily Living Scores at Month 27: Participants More Than or Equal to 70 Years Only | Activities of Daily Living is assessed using a six-item ADL limitations measure that inventoried whether participants had difficulty bathing, dressing, toileting, feeding, with transfer, and incontinence. Each item was rated on a 3-point Likert scale measuring independence in performing the activity and scores ranged from 1 to 3; where, 1=unable to do without assistance, 2=partial assistance needed and 3=no assistance. The total score was calculated as a sum of scores of individual items and ranged between 6 to 18, where a score of 6 indicated a very dependent participant and a score of 18 represented an independent participants. | Safety analysis set included all participants who were enrolled in the study and received at least one dose of study medication, 'Overall Number of Participants Analyzed' signifies participants evaluable for the outcome measure. | Posted | Mean | Standard Deviation | Units on a scale | Month 27 |
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| Primary | Activities of Daily Living Scores at Month 30: Participants More Than or Equal to 70 Years Only | Activities of Daily Living is assessed using a six-item ADL limitations measure that inventoried whether participants had difficulty bathing, dressing, toileting, feeding, with transfer, and incontinence. Each item was rated on a 3-point Likert scale measuring independence in performing the activity and scores ranged from 1 to 3; where, 1=unable to do without assistance, 2=partial assistance needed and 3=no assistance. The total score was calculated as a sum of scores of individual items and ranged between 6 to 18, where a score of 6 indicated a very dependent participant and a score of 18 represented an independent participants. | Safety analysis set included all participants who were enrolled in the study and received at least one dose of study medication, 'Overall Number of Participants Analyzed' signifies participants evaluable for the outcome measure. | Posted | Mean | Standard Deviation | Units on a scale | Month 30 |
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| Primary | Activities of Daily Living Scores at Month 33: Participants More Than or Equal to 70 Years Only | Activities of Daily Living is assessed using a six-item ADL limitations measure that inventoried whether participants had difficulty bathing, dressing, toileting, feeding, with transfer, and incontinence. Each item was rated on a 3-point Likert scale measuring independence in performing the activity and scores ranged from 1 to 3; where, 1=unable to do without assistance, 2=partial assistance needed and 3=no assistance. The total score was calculated as a sum of scores of individual items and ranged between 6 to 18, where a score of 6 indicated a very dependent participant and a score of 18 represented an independent participants. | Safety analysis set included all participants who were enrolled in the study and received at least one dose of study medication, 'Overall Number of Participants Analyzed' signifies participants evaluable for the outcome measure. | Posted | Mean | Standard Deviation | Units on a scale | Month 33 |
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| Primary | Activities of Daily Living Scores at Month 36: Participants More Than or Equal to 70 Years Only | Activities of Daily Living is assessed using a six-item ADL limitations measure that inventoried whether participants had difficulty bathing, dressing, toileting, feeding, with transfer, and incontinence. Each item was rated on a 3-point Likert scale measuring independence in performing the activity and scores ranged from 1 to 3; where, 1=unable to do without assistance, 2=partial assistance needed and 3=no assistance. The total score was calculated as a sum of scores of individual items and ranged between 6 to 18, where a score of 6 indicated a very dependent participant and a score of 18 represented an independent participants. | Safety analysis set included all participants who were enrolled in the study and received at least one dose of study medication, 'Overall Number of Participants Analyzed' signifies participants evaluable for the outcome measure. | Posted | Mean | Standard Deviation | Units on a scale | Month 36 |
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| Primary | Activities of Daily Living Scores at Month 39: Participants More Than or Equal to 70 Years Only | Activities of Daily Living is assessed using a six-item ADL limitations measure that inventoried whether participants had difficulty bathing, dressing, toileting, feeding, with transfer, and incontinence. Each item was rated on a 3-point Likert scale measuring independence in performing the activity and scores ranged from 1 to 3; where, 1=unable to do without assistance, 2=partial assistance needed and 3=no assistance. The total score was calculated as a sum of scores of individual items and ranged between 6 to 18, where a score of 6 indicated a very dependent participant and a score of 18 represented an independent participants. | Safety analysis set included all participants who were enrolled in the study and received at least one dose of study medication, 'Overall Number of Participants Analyzed' signifies participants evaluable for the outcome measure. | Posted | Mean | Standard Deviation | Units on a scale | Month 39 |
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| Primary | Activities of Daily Living Scores at Month 42: Participants More Than or Equal to 70 Years Only | Activities of Daily Living is assessed using a six-item ADL limitations measure that inventoried whether participants had difficulty bathing, dressing, toileting, feeding, with transfer, and incontinence. Each item was rated on a 3-point Likert scale measuring independence in performing the activity and scores ranged from 1 to 3; where, 1=unable to do without assistance, 2=partial assistance needed and 3=no assistance. The total score was calculated as a sum of scores of individual items and ranged between 6 to 18, where a score of 6 indicated a very dependent participant and a score of 18 represented an independent participants. | Safety analysis set included all participants who were enrolled in the study and received at least one dose of study medication, 'Overall Number of Participants Analyzed' signifies participants evaluable for the outcome measure. | Posted | Mean | Standard Deviation | Units on a scale | Month 42 |
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| Primary | Number of Participants With Adverse Events | An adverse event is any untoward medical occurrence in administered medicinal product. The event need not necessarily have a causal relationship with the product treatment or usage. | Safety analysis set included all participants who were enrolled in the study and received at least one dose of study medication. | Posted | Count of Participants | Participants | From start of palbociclib treatment or date of informed consent until 28 days after last dose of study treatment (up to approximately 3 years) |
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| Primary | Number of Participants With Serious Adverse Events | A serious adverse event was any untoward medical occurrence in a participant administered a medicinal or nutritional product (including pediatric formulas) at any dose that: resulted in death; was life-threatening; required inpatient hospitalization or prolongation of hospitalization; resulted in persistent or significant disability/incapacity (substantial disruption of the ability to conduct normal life functions); resulted in congenital anomaly/birth defect. | Safety analysis set included all participants who were enrolled in the study and received at least one dose of study medication. | Posted | Count of Participants | Participants | From start of palbociclib treatment or date of informed consent until 28 days after last dose of study treatment (up to approximately 3 years). |
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| Primary | Number of Participants With Any Clinical Laboratory Abnormalities | Following lab parameters were assessed Anemia, Hemoglobin increased, Lymphocyte count decreased, Lymphocyte count increased, Neutrophil count decreased, Platelet count decreased, Leukocyte count decreased, Leukocyte count increased, Number of participants with any lab abnormality was reported. | Safety analysis set included all participants who were enrolled in the study and received at least one dose of study medication. | Posted | Count of Participants | Participants | From start of palbociclib treatment or date of informed consent until 28 days after last dose of study treatment (up to approximately 3 years). |
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From start of palbociclib treatment or date of informed consent until 28 days after last dose of study treatment (up to approximately 3 years)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants enrolled in the study and received at least one dose of study medication.
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 | Palbociclib + Endocrine Therapy | Participants with HR+/HER2- advanced breast cancer who were prescribed palbociclib in combination with endocrine treatment (Palbociclib, Fulvestrant, and Other) by the treating physician in routine clinical practice were included. | 505 | 1,250 | 403 | 1,250 | 1,035 | 1,250 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Neutropenia | Blood and lymphatic system disorders | MedDRA 19.1 | Non-systematic Assessment |
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| Anaemia | Blood and lymphatic system disorders | MedDRA 19.1 | Non-systematic Assessment |
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| Leukopenia | Blood and lymphatic system disorders | MedDRA 19.1 | Non-systematic Assessment |
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| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 19.1 | Non-systematic Assessment |
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| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA 19.1 | Non-systematic Assessment |
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| Pancytopenia | Blood and lymphatic system disorders | MedDRA 19.1 | Non-systematic Assessment |
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| Leukocytosis | Blood and lymphatic system disorders | MedDRA 19.1 | Non-systematic Assessment |
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| Neutrophil count decreased | Investigations | MedDRA 19.1 | Non-systematic Assessment |
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| White blood cell count decreased | Investigations | MedDRA 19.1 | Non-systematic Assessment |
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| Platelet count decreased | Investigations | MedDRA 19.1 | Non-systematic Assessment |
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| Transaminases increased | Investigations | MedDRA 19.1 | Non-systematic Assessment |
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| Blood creatinine increased | Investigations | MedDRA 19.1 | Non-systematic Assessment |
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| Blood creatine increased | Investigations | MedDRA 19.1 | Non-systematic Assessment |
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| Blood lactate dehydrogenase increased | Investigations | MedDRA 19.1 | Non-systematic Assessment |
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| Respiratory syncytial virus test positive | Investigations | MedDRA 19.1 | Non-systematic Assessment |
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| Weight decreased | Investigations | MedDRA 19.1 | Non-systematic Assessment |
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| Sepsis | Infections and infestations | MedDRA 19.1 | Non-systematic Assessment |
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| Pneumonia | Infections and infestations | MedDRA 19.1 | Non-systematic Assessment |
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| Urinary tract infection | Infections and infestations | MedDRA 19.1 | Non-systematic Assessment |
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| Cellulitis | Infections and infestations | MedDRA 19.1 | Non-systematic Assessment |
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| Septic shock | Infections and infestations | MedDRA 19.1 | Non-systematic Assessment |
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| Appendicitis | Infections and infestations | MedDRA 19.1 | Non-systematic Assessment |
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| Influenza | Infections and infestations | MedDRA 19.1 | Non-systematic Assessment |
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| Bronchitis | Infections and infestations | MedDRA 19.1 | Non-systematic Assessment |
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| Diverticulitis | Infections and infestations | MedDRA 19.1 | Non-systematic Assessment |
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| Kidney infection | Infections and infestations | MedDRA 19.1 | Non-systematic Assessment |
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| Wound infection | Infections and infestations | MedDRA 19.1 | Non-systematic Assessment |
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| Abscess | Infections and infestations | MedDRA 19.1 | Non-systematic Assessment |
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| Bacteraemia | Infections and infestations | MedDRA 19.1 | Non-systematic Assessment |
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| Clostridium difficile colitis | Infections and infestations | MedDRA 19.1 | Non-systematic Assessment |
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| Empyema | Infections and infestations | MedDRA 19.1 | Non-systematic Assessment |
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| Postoperative wound infection | Infections and infestations | MedDRA 19.1 | Non-systematic Assessment |
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| Pyelonephritis | Infections and infestations | MedDRA 19.1 | Non-systematic Assessment |
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| Urosepsis | Infections and infestations | MedDRA 19.1 | Non-systematic Assessment |
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| Beta haemolytic streptococcal infection | Infections and infestations | MedDRA 19.1 | Non-systematic Assessment |
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| Breast cellulitis | Infections and infestations | MedDRA 19.1 | Non-systematic Assessment |
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| Corona virus infection | Infections and infestations | MedDRA 19.1 | Non-systematic Assessment |
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| Gastroenteritis | Infections and infestations | MedDRA 19.1 | Non-systematic Assessment |
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| Infection | Infections and infestations | MedDRA 19.1 | Non-systematic Assessment |
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| Liver abscess | Infections and infestations | MedDRA 19.1 | Non-systematic Assessment |
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| Lung infection | Infections and infestations | MedDRA 19.1 | Non-systematic Assessment |
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| Neutropenic sepsis | Infections and infestations | MedDRA 19.1 | Non-systematic Assessment |
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| Osteomyelitis | Infections and infestations | MedDRA 19.1 | Non-systematic Assessment |
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| Pneumonia viral | Infections and infestations | MedDRA 19.1 | Non-systematic Assessment |
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| Post procedural infection | Infections and infestations | MedDRA 19.1 | Non-systematic Assessment |
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| Pyelonephritis acute | Infections and infestations | MedDRA 19.1 | Non-systematic Assessment |
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| Staphylococcal bacteraemia | Infections and infestations | MedDRA 19.1 | Non-systematic Assessment |
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| Subcutaneous abscess | Infections and infestations | MedDRA 19.1 | Non-systematic Assessment |
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| Tooth infection | Infections and infestations | MedDRA 19.1 | Non-systematic Assessment |
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| Upper respiratory tract infection | Infections and infestations | MedDRA 19.1 | Non-systematic Assessment |
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| Disease progression | General disorders | MedDRA 19.1 | Non-systematic Assessment |
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| Fatigue | General disorders | MedDRA 19.1 | Non-systematic Assessment |
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| Asthenia | General disorders | MedDRA 19.1 | Non-systematic Assessment |
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| Death | General disorders | MedDRA 19.1 | Non-systematic Assessment |
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| Pain | General disorders | MedDRA 19.1 | Non-systematic Assessment |
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| Chest pain | General disorders | MedDRA 19.1 | Non-systematic Assessment |
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| Pyrexia | General disorders | MedDRA 19.1 | Non-systematic Assessment |
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| Oedema peripheral | General disorders | MedDRA 19.1 | Non-systematic Assessment |
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| Non-cardiac chest pain | General disorders | MedDRA 19.1 | Non-systematic Assessment |
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| Hernia obstructive | General disorders | MedDRA 19.1 | Non-systematic Assessment |
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| Systemic inflammatory response syndrome | General disorders | MedDRA 19.1 | Non-systematic Assessment |
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| Dyspnea | Respiratory, thoracic and mediastinal disorders | MedDRA 19.1 | Non-systematic Assessment |
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| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 19.1 | Non-systematic Assessment |
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| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA 19.1 | Non-systematic Assessment |
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| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA 19.1 | Non-systematic Assessment |
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| Hypoxia | Respiratory, thoracic and mediastinal disorders | MedDRA 19.1 | Non-systematic Assessment |
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| Acute respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 19.1 | Non-systematic Assessment |
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| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA 19.1 | Non-systematic Assessment |
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| Pneumonitis | Respiratory, thoracic and mediastinal disorders | MedDRA 19.1 | Non-systematic Assessment |
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| Pneumothorax | Respiratory, thoracic and mediastinal disorders | MedDRA 19.1 | Non-systematic Assessment |
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| Acute respiratory distress syndrome | Respiratory, thoracic and mediastinal disorders | MedDRA 19.1 | Non-systematic Assessment |
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| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA 19.1 | Non-systematic Assessment |
| |
| Pneumonia aspiration | Respiratory, thoracic and mediastinal disorders | MedDRA 19.1 | Non-systematic Assessment |
| |
| Respiratory arrest | Respiratory, thoracic and mediastinal disorders | MedDRA 19.1 | Non-systematic Assessment |
| |
| Respiratory distress | Respiratory, thoracic and mediastinal disorders | MedDRA 19.1 | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 19.1 | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 19.1 | Non-systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 19.1 | Non-systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 19.1 | Non-systematic Assessment |
| |
| Small intestinal obstruction | Gastrointestinal disorders | MedDRA 19.1 | Non-systematic Assessment |
| |
| Ascites | Gastrointestinal disorders | MedDRA 19.1 | Non-systematic Assessment |
| |
| Dysphagia | Gastrointestinal disorders | MedDRA 19.1 | Non-systematic Assessment |
| |
| Intestinal obstruction | Gastrointestinal disorders | MedDRA 19.1 | Non-systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 19.1 | Non-systematic Assessment |
| |
| Colitis | Gastrointestinal disorders | MedDRA 19.1 | Non-systematic Assessment |
| |
| Gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA 19.1 | Non-systematic Assessment |
| |
| Obstruction gastric | Gastrointestinal disorders | MedDRA 19.1 | Non-systematic Assessment |
| |
| Oesophagitis | Gastrointestinal disorders | MedDRA 19.1 | Non-systematic Assessment |
| |
| Toothache | Gastrointestinal disorders | MedDRA 19.1 | Non-systematic Assessment |
| |
| Upper gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA 19.1 | Non-systematic Assessment |
| |
| Abdominal distension | Gastrointestinal disorders | MedDRA 19.1 | Non-systematic Assessment |
| |
| Abdominal hernia | Gastrointestinal disorders | MedDRA 19.1 | Non-systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 19.1 | Non-systematic Assessment |
| |
| Enteritis | Gastrointestinal disorders | MedDRA 19.1 | Non-systematic Assessment |
| |
| Enterocolitis | Gastrointestinal disorders | MedDRA 19.1 | Non-systematic Assessment |
| |
| Gastric antral vascular ectasia | Gastrointestinal disorders | MedDRA 19.1 | Non-systematic Assessment |
| |
| Gastric haemorrhage | Gastrointestinal disorders | MedDRA 19.1 | Non-systematic Assessment |
| |
| Gastrointestinal perforation | Gastrointestinal disorders | MedDRA 19.1 | Non-systematic Assessment |
| |
| Ileus | Gastrointestinal disorders | MedDRA 19.1 | Non-systematic Assessment |
| |
| Intestinal perforation | Gastrointestinal disorders | MedDRA 19.1 | Non-systematic Assessment |
| |
| Intra-abdominal haemorrhage | Gastrointestinal disorders | MedDRA 19.1 | Non-systematic Assessment |
| |
| Large intestinal obstruction | Gastrointestinal disorders | MedDRA 19.1 | Non-systematic Assessment |
| |
| Peptic ulcer | Gastrointestinal disorders | MedDRA 19.1 | Non-systematic Assessment |
| |
| Proctitis | Gastrointestinal disorders | MedDRA 19.1 | Non-systematic Assessment |
| |
| Rectal haemorrhage | Gastrointestinal disorders | MedDRA 19.1 | Non-systematic Assessment |
| |
| Breast cancer metastatic | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 19.1 | Non-systematic Assessment |
| |
| Breast cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 19.1 | Non-systematic Assessment |
| |
| Cancer pain | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 19.1 | Non-systematic Assessment |
| |
| Metastases to bone | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 19.1 | Non-systematic Assessment |
| |
| Metastases to central nervous system | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 19.1 | Non-systematic Assessment |
| |
| Metastases to liver | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 19.1 | Non-systematic Assessment |
| |
| Metastases to meninges | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 19.1 | Non-systematic Assessment |
| |
| Neoplasm malignant | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 19.1 | Non-systematic Assessment |
| |
| Acute myeloid leukaemia | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 19.1 | Non-systematic Assessment |
| |
| Acute myeloid leukaemia recurrent | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 19.1 | Non-systematic Assessment |
| |
| Endometrial cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 19.1 | Non-systematic Assessment |
| |
| Inflammatory carcinoma of the breast | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 19.1 | Non-systematic Assessment |
| |
| Lung adenocarcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 19.1 | Non-systematic Assessment |
| |
| Lung adenocarcinoma metastatic | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 19.1 | Non-systematic Assessment |
| |
| Lung neoplasm malignant | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 19.1 | Non-systematic Assessment |
| |
| Malignant peritoneal neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 19.1 | Non-systematic Assessment |
| |
| Myelodysplastic syndrome | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 19.1 | Non-systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA 19.1 | Non-systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA 19.1 | Non-systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA 19.1 | Non-systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA 19.1 | Non-systematic Assessment |
| |
| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA 19.1 | Non-systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 19.1 | Non-systematic Assessment |
| |
| Hypercalcaemia | Metabolism and nutrition disorders | MedDRA 19.1 | Non-systematic Assessment |
| |
| Hyperphosphataemia | Metabolism and nutrition disorders | MedDRA 19.1 | Non-systematic Assessment |
| |
| Diabetic ketoacidosis | Metabolism and nutrition disorders | MedDRA 19.1 | Non-systematic Assessment |
| |
| Failure to thrive | Metabolism and nutrition disorders | MedDRA 19.1 | Non-systematic Assessment |
| |
| Metabolic acidosis | Metabolism and nutrition disorders | MedDRA 19.1 | Non-systematic Assessment |
| |
| Hypovolaemia | Metabolism and nutrition disorders | MedDRA 19.1 | Non-systematic Assessment |
| |
| Lactic acidosis | Metabolism and nutrition disorders | MedDRA 19.1 | Non-systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA 19.1 | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 19.1 | Non-systematic Assessment |
| |
| Cerebrovascular accident | Nervous system disorders | MedDRA 19.1 | Non-systematic Assessment |
| |
| Ischaemic stroke | Nervous system disorders | MedDRA 19.1 | Non-systematic Assessment |
| |
| Metabolic encephalopathy | Nervous system disorders | MedDRA 19.1 | Non-systematic Assessment |
| |
| Aphasia | Nervous system disorders | MedDRA 19.1 | Non-systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 19.1 | Non-systematic Assessment |
| |
| Encephalopathy | Nervous system disorders | MedDRA 19.1 | Non-systematic Assessment |
| |
| Brain oedema | Nervous system disorders | MedDRA 19.1 | Non-systematic Assessment |
| |
| Cerebral artery occlusion | Nervous system disorders | MedDRA 19.1 | Non-systematic Assessment |
| |
| Cerebral haemorrhage | Nervous system disorders | MedDRA 19.1 | Non-systematic Assessment |
| |
| Cerebral infarction | Nervous system disorders | MedDRA 19.1 | Non-systematic Assessment |
| |
| Cerebrovascular disorder | Nervous system disorders | MedDRA 19.1 | Non-systematic Assessment |
| |
| Cognitive disorder | Nervous system disorders | MedDRA 19.1 | Non-systematic Assessment |
| |
| Dementia | Nervous system disorders | MedDRA 19.1 | Non-systematic Assessment |
| |
| Presyncope | Nervous system disorders | MedDRA 19.1 | Non-systematic Assessment |
| |
| Seizure | Nervous system disorders | MedDRA 19.1 | Non-systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 19.1 | Non-systematic Assessment |
| |
| Muscular weakness | Musculoskeletal and connective tissue disorders | MedDRA 19.1 | Non-systematic Assessment |
| |
| Pain in jaw | Musculoskeletal and connective tissue disorders | MedDRA 19.1 | Non-systematic Assessment |
| |
| Cardiac arrest | Cardiac disorders | MedDRA 19.1 | Non-systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MedDRA 19.1 | Non-systematic Assessment |
| |
| Cardiac failure congestive | Cardiac disorders | MedDRA 19.1 | Non-systematic Assessment |
| |
| Acute myocardial infarction | Cardiac disorders | MedDRA 19.1 | Non-systematic Assessment |
| |
| Pericardial effusion | Cardiac disorders | MedDRA 19.1 | Non-systematic Assessment |
| |
| Angina pectoris | Cardiac disorders | MedDRA 19.1 | Non-systematic Assessment |
| |
| Cardiomyopathy | Cardiac disorders | MedDRA 19.1 | Non-systematic Assessment |
| |
| Arrhythmia | Cardiac disorders | MedDRA 19.1 | Non-systematic Assessment |
| |
| Atrial flutter | Cardiac disorders | MedDRA 19.1 | Non-systematic Assessment |
| |
| Atrioventricular block complete | Cardiac disorders | MedDRA 19.1 | Non-systematic Assessment |
| |
| Cardiac failure chronic | Cardiac disorders | MedDRA 19.1 | Non-systematic Assessment |
| |
| Cardio-respiratory arrest | Cardiac disorders | MedDRA 19.1 | Non-systematic Assessment |
| |
| Cardiogenic shock | Cardiac disorders | MedDRA 19.1 | Non-systematic Assessment |
| |
| Chronic left ventricular failure | Cardiac disorders | MedDRA 19.1 | Non-systematic Assessment |
| |
| Left ventricular failure | Cardiac disorders | MedDRA 19.1 | Non-systematic Assessment |
| |
| Supraventricular tachycardia | Cardiac disorders | MedDRA 19.1 | Non-systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA 19.1 | Non-systematic Assessment |
| |
| Hip fracture | Injury, poisoning and procedural complications | MedDRA 19.1 | Non-systematic Assessment |
| |
| Femur fracture | Injury, poisoning and procedural complications | MedDRA 19.1 | Non-systematic Assessment |
| |
| Humerus fracture | Injury, poisoning and procedural complications | MedDRA 19.1 | Non-systematic Assessment |
| |
| fracture | Injury, poisoning and procedural complications | MedDRA 19.1 | Non-systematic Assessment |
| |
| Subarachnoid haemorrhage | Injury, poisoning and procedural complications | MedDRA 19.1 | Non-systematic Assessment |
| |
| Cervical vertebral fracture | Injury, poisoning and procedural complications | MedDRA 19.1 | Non-systematic Assessment |
| |
| Compression fracture | Injury, poisoning and procedural complications | MedDRA 19.1 | Non-systematic Assessment |
| |
| Craniocerebral injury | Injury, poisoning and procedural complications | MedDRA 19.1 | Non-systematic Assessment |
| |
| Hand fracture | Injury, poisoning and procedural complications | MedDRA 19.1 | Non-systematic Assessment |
| |
| Joint dislocation | Injury, poisoning and procedural complications | MedDRA 19.1 | Non-systematic Assessment |
| |
| Overdose | Injury, poisoning and procedural complications | MedDRA 19.1 | Non-systematic Assessment |
| |
| Radiation oesophagitis | Injury, poisoning and procedural complications | MedDRA 19.1 | Non-systematic Assessment |
| |
| Traumatic intracranial haemorrhage | Injury, poisoning and procedural complications | MedDRA 19.1 | Non-systematic Assessment |
| |
| Alcohol poisoning | Injury, poisoning and procedural complications | MedDRA 19.1 | Non-systematic Assessment |
| |
| Vascular access complication | Injury, poisoning and procedural complications | MedDRA 19.1 | Non-systematic Assessment |
| |
| Wound dehiscence | Injury, poisoning and procedural complications | MedDRA 19.1 | Non-systematic Assessment |
| |
| Acute kidney injury | Renal and urinary disorders | MedDRA 19.1 | Non-systematic Assessment |
| |
| Hydronephrosis | Renal and urinary disorders | MedDRA 19.1 | Non-systematic Assessment |
| |
| Nephrolithiasis | Renal and urinary disorders | MedDRA 19.1 | Non-systematic Assessment |
| |
| Haematuria | Renal and urinary disorders | MedDRA 19.1 | Non-systematic Assessment |
| |
| Renal failure | Renal and urinary disorders | MedDRA 19.1 | Non-systematic Assessment |
| |
| Renal tubular necrosis | Renal and urinary disorders | MedDRA 19.1 | Non-systematic Assessment |
| |
| Urinary tract obstruction | Renal and urinary disorders | MedDRA 19.1 | Non-systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA 19.1 | Non-systematic Assessment |
| |
| Confusional state | Psychiatric disorders | MedDRA 19.1 | Non-systematic Assessment |
| |
| Mental status changes | Psychiatric disorders | MedDRA 19.1 | Non-systematic Assessment |
| |
| Hallucination | Psychiatric disorders | MedDRA 19.1 | Non-systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA 19.1 | Non-systematic Assessment |
| |
| Psychotic disorder | Psychiatric disorders | MedDRA 19.1 | Non-systematic Assessment |
| |
| Substance abuse | Psychiatric disorders | MedDRA 19.1 | Non-systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA 19.1 | Non-systematic Assessment |
| |
| Deep vein thrombosis | Vascular disorders | MedDRA 19.1 | Non-systematic Assessment |
| |
| Lymphoedema | Vascular disorders | MedDRA 19.1 | Non-systematic Assessment |
| |
| Thrombophlebitis | Vascular disorders | MedDRA 19.1 | Non-systematic Assessment |
| |
| Hypovolaemic shock | Vascular disorders | MedDRA 19.1 | Non-systematic Assessment |
| |
| Thrombophlebitis superficial | Vascular disorders | MedDRA 19.1 | Non-systematic Assessment |
| |
| Vena cava thrombosis | Vascular disorders | MedDRA 19.1 | Non-systematic Assessment |
| |
| Hepatic failure | Hepatobiliary disorders | MedDRA 19.1 | Non-systematic Assessment |
| |
| Acute hepatic failure | Hepatobiliary disorders | MedDRA 19.1 | Non-systematic Assessment |
| |
| Bile duct stone | Hepatobiliary disorders | MedDRA 19.1 | Non-systematic Assessment |
| |
| Portal vein thrombosis | Hepatobiliary disorders | MedDRA 19.1 | Non-systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 19.1 | Non-systematic Assessment |
| |
| Diplopia | Eye disorders | MedDRA 19.1 | Non-systematic Assessment |
| |
| Exophthalmos | Eye disorders | MedDRA 19.1 | Non-systematic Assessment |
| |
| Vertigo | Ear and labyrinth disorders | MedDRA 19.1 | Non-systematic Assessment |
| |
| Anaphylactic reaction | Immune system disorders | MedDRA 19.1 | Non-systematic Assessment |
| |
| Vaginal haemorrhage | Reproductive system and breast disorders | MedDRA 19.1 | Non-systematic Assessment |
| |
| Left ventricular dysfunction | Cardiac disorders | MedDRA 19.1 | Non-systematic Assessment |
| |
| Bradycardia | Cardiac disorders | MedDRA 19.1 | Non-systematic Assessment |
| |
| Palpitations | Cardiac disorders | MedDRA 19.1 | Non-systematic Assessment |
| |
| Sinus arrest | Cardiac disorders | MedDRA 19.1 | Non-systematic Assessment |
| |
| Tachycardia | Cardiac disorders | MedDRA 19.1 | Non-systematic Assessment |
| |
| Chest discomfort | General disorders | MedDRA 19.1 | Non-systematic Assessment |
| |
| Medical device site joint infection | Infections and infestations | MedDRA 19.1 | Non-systematic Assessment |
| |
| Respiratory tract infection | Infections and infestations | MedDRA 19.1 | Non-systematic Assessment |
| |
| Occult blood positive | Investigations | MedDRA 19.1 | Non-systematic Assessment |
| |
| Haemorrhage intracranial | Nervous system disorders | MedDRA 19.1 | Non-systematic Assessment |
| |
| Hypoaesthesia | Nervous system disorders | MedDRA 19.1 | Non-systematic Assessment |
| |
| Lacunar infarction | Nervous system disorders | MedDRA 19.1 | Non-systematic Assessment |
| |
| Paraesthesia | Nervous system disorders | MedDRA 19.1 | Non-systematic Assessment |
| |
| Pulmonary hypertension | Respiratory, thoracic and mediastinal disorders | MedDRA 19.1 | Non-systematic Assessment |
| |
| Pulmonary oedema | Respiratory, thoracic and mediastinal disorders | MedDRA 19.1 | Non-systematic Assessment |
| |
| Respiratory alkalosis | Respiratory, thoracic and mediastinal disorders | MedDRA 19.1 | Non-systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA 19.1 | Non-systematic Assessment |
| |
| Cardiac Failure | Cardiac disorders | MedDRA 19.1 | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Neutropenia | Blood and lymphatic system disorders | MedDRA 19.1 | Non-systematic Assessment |
| |
| Anaemia | Blood and lymphatic system disorders | MedDRA 19.1 | Non-systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 19.1 | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 19.1 | Non-systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 19.1 | Non-systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 19.1 | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 19.1 | Non-systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | MedDRA 19.1 | Non-systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 19.1 | Non-systematic Assessment |
| |
| White blood cell count decreased | Investigations | MedDRA 19.1 | Non-systematic Assessment |
| |
| Neutrophil count decreased | Investigations | MedDRA 19.1 | Non-systematic Assessment |
| |
| Platelet count decreased | Investigations | MedDRA 19.1 | Non-systematic Assessment |
| |
| Lymphocyte count decreased | Investigations | MedDRA 19.1 | Non-systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 19.1 | Non-systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 19.1 | Non-systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 19.1 | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 19.1 | Non-systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 19.1 | Non-systematic Assessment |
| |
| Neuropathy peripheral | Nervous system disorders | MedDRA 19.1 | Non-systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 19.1 | Non-systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 19.1 | Non-systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA 19.1 | Non-systematic Assessment |
| |
| Hot flush | Vascular disorders | MedDRA 19.1 | Non-systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 19.1 | Non-systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA 19.1 | Non-systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 19.1 | Non-systematic Assessment |
| |
| Leukopenia | Blood and lymphatic system disorders | MedDRA 19.1 | Non-systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA 19.1 | Non-systematic Assessment |
|
Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pfizer ClinicalTrials.gov Call Center | Pfizer Inc. | 1-800-718-1021 | ClinicalTrials.gov_Inquiries@pfizer.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jan 25, 2022 | Sep 26, 2023 | SAP_001.pdf |
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
Not provided
Not provided
| Unknown or Not Reported |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| Stable disease |
|
| Progressive disease |
|
| Indeterminate |
|
| 1 Line of treatment |
|
|
| 2 or more lines of treatment |
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