Ignite Creation Date:
2025-12-24 @ 4:44 PM
Ignite Modification Date:
2026-02-13 @ 8:57 AM
Study NCT ID:
NCT03921866
Status:
COMPLETED
Last Update Posted:
2023-03-17
First Post:
2019-04-17
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
UK Ibrance Patient Program (IPP) Study
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001943', 'term': 'Breast Neoplasms'}], 'ancestors': [{'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D001941', 'term': 'Breast Diseases'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C500026', 'term': 'palbociclib'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ClinicalTrials.gov_Inquiries@pfizer.com', 'phone': '1-800-718-1021', 'title': 'Pfizer ClinicalTrials.gov Call Center', 'organization': 'Pfizer Inc.'}, 'certainAgreement': {'otherDetails': '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.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'From baseline up to maximum period of 3 years', 'description': "Same event may appear as both AE and SAE. But what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have both serious and non-serious event. AEs were reported as per participants' medical records. There was no specific medical dictionary. 6 participants had febrile neutropenia which was not recorded as SAE or non-SAE as associated grades were not collected as part of electronic case report form (eCRF).", 'eventGroups': [{'id': 'EG000', 'title': 'Palbociclib', 'description': "Participants with HR positive/HER2 negative MBC who received at least 1 dose of palbociclib as part of the IPP were observed during the study. Data was collected both retrospectively and prospectively, from participants' medical records for a maximum of 3 years following index date. Index date was defined as the palbociclib treatment initiation date.", 'otherNumAtRisk': 191, 'deathsNumAtRisk': 191, 'otherNumAffected': 116, 'seriousNumAtRisk': 191, 'deathsNumAffected': 3, 'seriousNumAffected': 54}], 'otherEvents': [{'term': 'Neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 191, 'numAffected': 90}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 191, 'numAffected': 22}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 191, 'numAffected': 13}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 191, 'numAffected': 24}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Other', 'stats': [{'groupId': 'EG000', 'numAtRisk': 191, 'numAffected': 18}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'Neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 191, 'numAffected': 53}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 191, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Other', 'stats': [{'groupId': 'EG000', 'numAtRisk': 191, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percentage of Participants According to Treatment Lines', 'denoms': [{'units': 'Participants', 'counts': [{'value': '191', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Palbociclib', 'description': "Participants with HR positive/HER2 negative MBC who received at least 1 dose of palbociclib as part of the IPP were observed during the study. Data was collected both retrospectively and prospectively, from participants' medical records for a maximum of 3 years following index date. Index date was defined as the palbociclib treatment initiation date."}], 'classes': [{'title': '1st Line', 'categories': [{'measurements': [{'value': '72', 'groupId': 'OG000'}]}]}, {'title': '1st Line palbociclib added to letrozole', 'categories': [{'measurements': [{'value': '16', 'groupId': 'OG000'}]}]}, {'title': '2nd Line', 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}]}]}, {'title': 'Unclassified', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'At baseline', 'description': 'Percentage of participants according to treatment lines during anytime between breast cancer (BC) diagnosis and index date were reported in this outcome measure. Treatment lines included: 1) 1st line where, palbociclib was prescribed as the first line treatment for MBC, 2) 1st line palbociclib added to letrozole where, palbociclib was prescribed as the first line treatment along with ongoing letrozole treatment which was prescribed more than 3 months prior to initiation of palbociclib, 3) 2nd line where palbociclib was prescribed as the second or later treatment line for MBC.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS comprised of medical records extracted for the purpose of the study from all eligible participants who were enrolled into the study.'}, {'type': 'PRIMARY', 'title': 'Time From Letrozole to Palbociclib Initiation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Palbociclib', 'description': "Participants with HR positive/HER2 negative MBC who received at least 1 dose of palbociclib as part of the IPP were observed during the study. Data was collected both retrospectively and prospectively, from participants' medical records for a maximum of 3 years following index date. Index date was defined as the palbociclib treatment initiation date."}], 'classes': [{'categories': [{'measurements': [{'value': '430.8', 'spread': '770.8', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'At baseline', 'description': 'Time from letrozole was defined as duration from the start date of letrozole which was ongoing at the time of palbociclib treatment initiation up to the index date.', 'unitOfMeasure': 'Days', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS comprised of medical records extracted for the purpose of the study from all eligible participants who were enrolled into the study. Here, "overall number of participants analyzed" signifies participants evaluable for this outcome measure.'}, {'type': 'PRIMARY', 'title': 'Number of Participants With Menopausal Status', 'denoms': [{'units': 'Participants', 'counts': [{'value': '191', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Palbociclib', 'description': "Participants with HR positive/HER2 negative MBC who received at least 1 dose of palbociclib as part of the IPP were observed during the study. Data was collected both retrospectively and prospectively, from participants' medical records for a maximum of 3 years following index date. Index date was defined as the palbociclib treatment initiation date."}], 'classes': [{'title': 'At initial diagnosis: Pre-menopausal', 'denoms': [{'units': 'Participants', 'counts': [{'value': '191', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '86', 'groupId': 'OG000'}]}]}, {'title': 'At initial diagnosis: Post-menopausal', 'denoms': [{'units': 'Participants', 'counts': [{'value': '191', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '94', 'groupId': 'OG000'}]}]}, {'title': 'At initial diagnosis: Peri-menopausal', 'denoms': [{'units': 'Participants', 'counts': [{'value': '191', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}]}]}, {'title': 'At initial diagnosis: NA', 'denoms': [{'units': 'Participants', 'counts': [{'value': '191', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'At initial diagnosis: Missing', 'denoms': [{'units': 'Participants', 'counts': [{'value': '191', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}]}]}, {'title': 'At recurrence of disease: Pre-menopausal', 'denoms': [{'units': 'Participants', 'counts': [{'value': '134', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '35', 'groupId': 'OG000'}]}]}, {'title': 'At recurrence of disease: Post-menopausal', 'denoms': [{'units': 'Participants', 'counts': [{'value': '134', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '94', 'groupId': 'OG000'}]}]}, {'title': 'At recurrence of disease: Peri-menopausal', 'denoms': [{'units': 'Participants', 'counts': [{'value': '134', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}]}]}, {'title': 'Metastatic setting: Pre-menopausal', 'denoms': [{'units': 'Participants', 'counts': [{'value': '191', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '55', 'groupId': 'OG000'}]}]}, {'title': 'Metastatic setting: Post-menopausal', 'denoms': [{'units': 'Participants', 'counts': [{'value': '191', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '127', 'groupId': 'OG000'}]}]}, {'title': 'Metastatic setting: Peri-menopausal', 'denoms': [{'units': 'Participants', 'counts': [{'value': '191', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}]}]}, {'title': 'Metastatic setting: NA', 'denoms': [{'units': 'Participants', 'counts': [{'value': '191', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'At baseline', 'description': 'Number of participants with menopausal status as pre-menopausal, peri-menopausal, post-menopausal and not applicable (NA), during anytime between initial BC disease diagnosis and index date were reported in this outcome measure.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS comprised of medical records extracted for the purpose of the study from all eligible participants who were enrolled into the study. Here "number analyzed" signifies number of participants evaluable for specified rows.'}, {'type': 'PRIMARY', 'title': 'Percentage of Participants According to Disease Free Interval at Palbociclib Initiation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '166', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Palbociclib', 'description': "Participants with HR positive/HER2 negative MBC who received at least 1 dose of palbociclib as part of the IPP were observed during the study. Data was collected both retrospectively and prospectively, from participants' medical records for a maximum of 3 years following index date. Index date was defined as the palbociclib treatment initiation date."}], 'classes': [{'title': 'More than 12 months', 'categories': [{'measurements': [{'value': '29', 'groupId': 'OG000'}]}]}, {'title': 'Less than or equal to (<=)12 months', 'categories': [{'measurements': [{'value': '37', 'groupId': 'OG000'}]}]}, {'title': 'De novo metastatic disease', 'categories': [{'measurements': [{'value': '34', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'At baseline', 'description': 'Disease free interval was defined as the time from the date of last known neo-adjuvant hormone therapy to the date of MBC diagnosis.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS comprised of medical records extracted for the purpose of the study from all eligible participants who were enrolled into the study. Here, "overall number of participants analyzed" signifies participants evaluable for this outcome measure.'}, {'type': 'PRIMARY', 'title': 'Percentage of Participants With Primary or Recurrent Metastatic Breast Cancer Diagnosis', 'denoms': [{'units': 'Participants', 'counts': [{'value': '191', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Palbociclib', 'description': "Participants with HR positive/HER2 negative MBC who received at least 1 dose of palbociclib as part of the IPP were observed during the study. Data was collected both retrospectively and prospectively, from participants' medical records for a maximum of 3 years following index date. Index date was defined as the palbociclib treatment initiation date."}], 'classes': [{'title': 'Participants with de novo metastatic disease', 'categories': [{'measurements': [{'value': '30', 'groupId': 'OG000'}]}]}, {'title': 'Participants with recurrent disease', 'categories': [{'measurements': [{'value': '70', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'At baseline', 'description': 'Percentage of participants with de novo and recurrent metastatic disease, during anytime between MBC disease diagnosis and index date were reported in this outcome measure.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS comprised of medical records extracted for the purpose of the study from all eligible participants who were enrolled into the study.'}, {'type': 'PRIMARY', 'title': 'Percentage of Participants With Lymph Nodes Involvement', 'denoms': [{'units': 'Participants', 'counts': [{'value': '188', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Palbociclib', 'description': "Participants with HR positive/HER2 negative MBC who received at least 1 dose of palbociclib as part of the IPP were observed during the study. Data was collected both retrospectively and prospectively, from participants' medical records for a maximum of 3 years following index date. Index date was defined as the palbociclib treatment initiation date."}], 'classes': [{'title': 'Initial diagnosis', 'denoms': [{'units': 'Participants', 'counts': [{'value': '188', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '58', 'groupId': 'OG000'}]}]}, {'title': 'De novo metastatic', 'denoms': [{'units': 'Participants', 'counts': [{'value': '55', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '58', 'groupId': 'OG000'}]}]}, {'title': 'Non de novo metastatic', 'denoms': [{'units': 'Participants', 'counts': [{'value': '133', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '58', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'At baseline', 'description': 'Percentage of participants with lymph nodes involvement during anytime between initial BC disease diagnosis and index date were reported in this outcome measure. Data for this outcome measure is also presented by de novo status.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS comprised of medical records extracted for the purpose of the study from all eligible participants who were enrolled into the study. Here, "overall number of participants analyzed" signifies participants evaluable for this outcome measure and "number analyzed" signifies number of participants evaluable for specified rows.'}, {'type': 'PRIMARY', 'title': 'Number of Lymph Nodes Involved', 'denoms': [{'units': 'Participants', 'counts': [{'value': '96', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Palbociclib', 'description': "Participants with HR positive/HER2 negative MBC who received at least 1 dose of palbociclib as part of the IPP were observed during the study. Data was collected both retrospectively and prospectively, from participants' medical records for a maximum of 3 years following index date. Index date was defined as the palbociclib treatment initiation date."}], 'classes': [{'title': 'Initial diagnosis', 'denoms': [{'units': 'Participants', 'counts': [{'value': '96', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '4.4', 'spread': '4.4', 'groupId': 'OG000'}]}]}, {'title': 'De novo metastatic', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '4.4', 'spread': '3', 'groupId': 'OG000'}]}]}, {'title': 'Non de novo metastatic', 'denoms': [{'units': 'Participants', 'counts': [{'value': '72', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '4.4', 'spread': '4.8', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'At baseline', 'description': 'Number of lymph nodes involved during anytime between initial BC disease diagnosis and index date were reported in this outcome measure. Data for this outcome measure is also presented by de novo status.', 'unitOfMeasure': 'Lymph nodes', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS comprised of medical records extracted for the purpose of the study from all eligible participants who were enrolled into the study. Here, "overall number of participants analyzed" signifies participants evaluable for this outcome measure and "number analyzed" signifies number of participants evaluable for specified rows.'}, {'type': 'PRIMARY', 'title': 'Number of Participants With Estrogen, Progesterone and Human Epidermal Growth Factor 2 (HER2) Receptor Status', 'denoms': [{'units': 'Participants', 'counts': [{'value': '191', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Palbociclib', 'description': "Participants with HR positive/HER2 negative MBC who received at least 1 dose of palbociclib as part of the IPP were observed during the study. Data was collected both retrospectively and prospectively, from participants' medical records for a maximum of 3 years following index date. Index date was defined as the palbociclib treatment initiation date."}], 'classes': [{'title': 'Estrogen receptor status at initial diagnosis: Positive', 'denoms': [{'units': 'Participants', 'counts': [{'value': '191', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '178', 'groupId': 'OG000'}]}]}, {'title': 'Estrogen receptor status at initial diagnosis: Negative', 'denoms': [{'units': 'Participants', 'counts': [{'value': '191', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}, {'title': 'Estrogen receptor status at initial diagnosis: Missing', 'denoms': [{'units': 'Participants', 'counts': [{'value': '191', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}]}]}, {'title': 'HER2 receptor status at initial diagnosis: Positive', 'denoms': [{'units': 'Participants', 'counts': [{'value': '191', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'HER2 receptor status at initial diagnosis: Negative', 'denoms': [{'units': 'Participants', 'counts': [{'value': '191', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '170', 'groupId': 'OG000'}]}]}, {'title': 'HER2 receptor status at initial diagnosis: Missing', 'denoms': [{'units': 'Participants', 'counts': [{'value': '191', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '20', 'groupId': 'OG000'}]}]}, {'title': 'Progesterone receptor status at initial diagnosis: Positive', 'denoms': [{'units': 'Participants', 'counts': [{'value': '191', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '38', 'groupId': 'OG000'}]}]}, {'title': 'Progesterone receptor status at initial diagnosis: Negative', 'denoms': [{'units': 'Participants', 'counts': [{'value': '191', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '25', 'groupId': 'OG000'}]}]}, {'title': 'Progesterone receptor status at initial diagnosis: Not known', 'denoms': [{'units': 'Participants', 'counts': [{'value': '191', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '14', 'groupId': 'OG000'}]}]}, {'title': 'Progesterone receptor status at initial diagnosis: Missing', 'denoms': [{'units': 'Participants', 'counts': [{'value': '191', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '114', 'groupId': 'OG000'}]}]}, {'title': 'Estrogen receptor status at recurrence of disease: Positive', 'denoms': [{'units': 'Participants', 'counts': [{'value': '77', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '73', 'groupId': 'OG000'}]}]}, {'title': 'Estrogen receptor status at recurrence of disease: Negative', 'denoms': [{'units': 'Participants', 'counts': [{'value': '77', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}, {'title': 'Estrogen receptor status at recurrence of disease: Missing', 'denoms': [{'units': 'Participants', 'counts': [{'value': '77', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}, {'title': 'HER2 receptor status at recurrence of disease: Negative', 'denoms': [{'units': 'Participants', 'counts': [{'value': '77', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '75', 'groupId': 'OG000'}]}]}, {'title': 'HER2 receptor status at recurrence of disease: Missing', 'denoms': [{'units': 'Participants', 'counts': [{'value': '77', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}, {'title': 'Progesterone receptor status at recurrence of disease: Positive', 'denoms': [{'units': 'Participants', 'counts': [{'value': '134', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '38', 'groupId': 'OG000'}]}]}, {'title': 'Progesterone receptor status at recurrence of disease: Negative', 'denoms': [{'units': 'Participants', 'counts': [{'value': '134', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '25', 'groupId': 'OG000'}]}]}, {'title': 'Progesterone receptor status at recurrence of disease: Not known', 'denoms': [{'units': 'Participants', 'counts': [{'value': '134', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '14', 'groupId': 'OG000'}]}]}, {'title': 'Progesterone receptor status at recurrence of disease: Missing', 'denoms': [{'units': 'Participants', 'counts': [{'value': '134', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '57', 'groupId': 'OG000'}]}]}, {'title': 'Estrogen receptor status at metastatic setting: Positive', 'denoms': [{'units': 'Participants', 'counts': [{'value': '191', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '130', 'groupId': 'OG000'}]}]}, {'title': 'Estrogen receptor status at metastatic setting: Negative', 'denoms': [{'units': 'Participants', 'counts': [{'value': '191', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}, {'title': 'Estrogen receptor status at metastatic setting: No rebiopsy in metastatic setting', 'denoms': [{'units': 'Participants', 'counts': [{'value': '191', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '50', 'groupId': 'OG000'}]}]}, {'title': 'Estrogen receptor status at metastatic setting: Missing', 'denoms': [{'units': 'Participants', 'counts': [{'value': '191', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}]}]}, {'title': 'HER2 receptor status at metastatic setting: Negative', 'denoms': [{'units': 'Participants', 'counts': [{'value': '191', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '131', 'groupId': 'OG000'}]}]}, {'title': 'HER2 receptor status at metastatic setting: No rebiopsy in metastatic setting', 'denoms': [{'units': 'Participants', 'counts': [{'value': '191', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '50', 'groupId': 'OG000'}]}]}, {'title': 'HER2 receptor status at metastatic setting: Missing', 'denoms': [{'units': 'Participants', 'counts': [{'value': '191', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}]}]}, {'title': 'Progesterone receptor status at metastatic setting: Positive', 'denoms': [{'units': 'Participants', 'counts': [{'value': '134', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '76', 'groupId': 'OG000'}]}]}, {'title': 'Progesterone receptor status at metastatic setting: Negative', 'denoms': [{'units': 'Participants', 'counts': [{'value': '134', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '35', 'groupId': 'OG000'}]}]}, {'title': 'Progesterone receptor status at metastatic setting: Not known', 'denoms': [{'units': 'Participants', 'counts': [{'value': '134', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '22', 'groupId': 'OG000'}]}]}, {'title': 'Progesterone receptor status at metastatic setting: Missing', 'denoms': [{'units': 'Participants', 'counts': [{'value': '134', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'At baseline', 'description': 'Number of participants with estrogen, progesterone and HER2 receptor status during anytime between initial BC disease diagnosis and index date were reported in this outcome measure.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS comprised of medical records extracted for the purpose of the study from all eligible participants who were enrolled into the study. Here, "number analyzed" signifies number of participants evaluable for specified rows.'}, {'type': 'PRIMARY', 'title': 'Percentage of Participants Who Had Rebiopsy After Metastatic Disease Diagnosis', 'denoms': [{'units': 'Participants', 'counts': [{'value': '127', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Palbociclib', 'description': "Participants with HR positive/HER2 negative MBC who received at least 1 dose of palbociclib as part of the IPP were observed during the study. Data was collected both retrospectively and prospectively, from participants' medical records for a maximum of 3 years following index date. Index date was defined as the palbociclib treatment initiation date."}], 'classes': [{'categories': [{'measurements': [{'value': '61', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'At baseline', 'description': 'Percentage of participants who had rebiopsy during anytime between MBC disease diagnosis and index date were reported in this outcome measure.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS comprised of medical records extracted for the purpose of the study from all eligible participants who were enrolled into the study. Here, "overall number of participants analyzed" signifies participants evaluable for this outcome measure.'}, {'type': 'PRIMARY', 'title': 'Percentage of Participants According to Tumor Stage', 'denoms': [{'units': 'Participants', 'counts': [{'value': '160', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Palbociclib', 'description': "Participants with HR positive/HER2 negative MBC who received at least 1 dose of palbociclib as part of the IPP were observed during the study. Data was collected both retrospectively and prospectively, from participants' medical records for a maximum of 3 years following index date. Index date was defined as the palbociclib treatment initiation date."}], 'classes': [{'title': 'At initial diagnosis: Stage 0', 'denoms': [{'units': 'Participants', 'counts': [{'value': '160', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}]}]}, {'title': 'At initial diagnosis: Stage 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '160', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '19', 'groupId': 'OG000'}]}]}, {'title': 'At initial diagnosis: Stage 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '160', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '51', 'groupId': 'OG000'}]}]}, {'title': 'At initial diagnosis: Stage 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '160', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '21', 'groupId': 'OG000'}]}]}, {'title': 'At initial diagnosis: Stage 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '160', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}]}]}, {'title': 'De novo metastatic: Stage 0', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000'}]}]}, {'title': 'De novo metastatic: Stage 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}]}]}, {'title': 'De novo metastatic: Stage 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '39', 'groupId': 'OG000'}]}]}, {'title': 'De novo metastatic: Stage 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '29', 'groupId': 'OG000'}]}]}, {'title': 'De novo metastatic: Stage 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000'}]}]}, {'title': 'Non de novo metastatic: Stage 0', 'denoms': [{'units': 'Participants', 'counts': [{'value': '111', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}, {'title': 'Non de novo metastatic: Stage 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '111', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '23', 'groupId': 'OG000'}]}]}, {'title': 'Non de novo metastatic: Stage 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '111', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '56', 'groupId': 'OG000'}]}]}, {'title': 'Non de novo metastatic: Stage 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '111', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '18', 'groupId': 'OG000'}]}]}, {'title': 'Non de novo metastatic: Stage 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '111', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'At baseline', 'description': 'Percentage of participants with tumor stages 0, 1, 2, 3 and 4, as per Tumor, Node, Metastasis (TNM) staging system, during anytime between initial BC disease diagnosis and index date were reported in this outcome measure. As per TNM staging system, tumor stage 0 indicates main tumor cannot be found; tumor stages 1, 2, 3 and 4 refers to the size and/or extent of the main tumor. The higher the number, the larger the tumor and/or the more it has spread into nearby tissues. Data for this outcome measure is also presented by de novo status.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS comprised of medical records extracted for the purpose of the study from all eligible participants who were enrolled into the study. Here, "overall number of participants analyzed" signifies participants evaluable for this outcome measure and "number analyzed" signifies number of participants evaluable for specified rows.'}, {'type': 'PRIMARY', 'title': 'Percentage of Participants According to Nodal Status', 'denoms': [{'units': 'Participants', 'counts': [{'value': '157', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Palbociclib', 'description': "Participants with HR positive/HER2 negative MBC who received at least 1 dose of palbociclib as part of the IPP were observed during the study. Data was collected both retrospectively and prospectively, from participants' medical records for a maximum of 3 years following index date. Index date was defined as the palbociclib treatment initiation date."}], 'classes': [{'title': 'At initial diagnosis: Stage 0', 'denoms': [{'units': 'Participants', 'counts': [{'value': '157', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '39', 'groupId': 'OG000'}]}]}, {'title': 'At initial diagnosis: Stage 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '157', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '38', 'groupId': 'OG000'}]}]}, {'title': 'At initial diagnosis: Stage 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '157', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}]}]}, {'title': 'At initial diagnosis: Stage 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '157', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000'}]}]}, {'title': 'De novo metastatic: Stage 0', 'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '35', 'groupId': 'OG000'}]}]}, {'title': 'De novo metastatic: Stage 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '30', 'groupId': 'OG000'}]}]}, {'title': 'De novo metastatic: Stage 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '15', 'groupId': 'OG000'}]}]}, {'title': 'De novo metastatic: Stage 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '20', 'groupId': 'OG000'}]}]}, {'title': 'Non de novo metastatic: Stage 0', 'denoms': [{'units': 'Participants', 'counts': [{'value': '111', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '41', 'groupId': 'OG000'}]}]}, {'title': 'Non de novo metastatic: Stage 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '111', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '41', 'groupId': 'OG000'}]}]}, {'title': 'Non de novo metastatic: Stage 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '111', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}]}]}, {'title': 'Non de novo metastatic: Stage 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '111', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'At baseline', 'description': 'Percentage of participants with nodal stages 0, 1, 2 and 3, as per TNM staging system, during anytime between initial BC disease diagnosis and index date were reported in this outcome measure. As per TNM staging system, nodal stage 0 indicates no cancer in regional lymph nodes; nodal stages 1= cancer has spread to 1 to 3 lymph nodes; nodal stage 2= cancer has spread to 4 to 9 lymph nodes, nodal stage 3= indicates the cancer has spread to 10 or more lymph nodes. Data for this outcome measure is also presented by de novo status.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS comprised of medical records extracted for the purpose of the study from all eligible participants who were enrolled into the study. Here, "overall number of participants analyzed" signifies participants evaluable for this outcome measure and "number analyzed" signifies number of participants evaluable for specified rows.'}, {'type': 'PRIMARY', 'title': 'Percentage of Participants According to Metastasis', 'denoms': [{'units': 'Participants', 'counts': [{'value': '174', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Palbociclib', 'description': "Participants with HR positive/HER2 negative MBC who received at least 1 dose of palbociclib as part of the IPP were observed during the study. Data was collected both retrospectively and prospectively, from participants' medical records for a maximum of 3 years following index date. Index date was defined as the palbociclib treatment initiation date."}], 'classes': [{'title': 'At initial diagnosis: Stage 0', 'denoms': [{'units': 'Participants', 'counts': [{'value': '174', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '64', 'groupId': 'OG000'}]}]}, {'title': 'At initial diagnosis: Stage 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '174', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '36', 'groupId': 'OG000'}]}]}, {'title': 'De novo metastatic: Stage 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '57', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000'}]}]}, {'title': 'Non de novo metastatic: Stage 0', 'denoms': [{'units': 'Participants', 'counts': [{'value': '117', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '96', 'groupId': 'OG000'}]}]}, {'title': 'Non de novo metastatic: Stage 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '117', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'At baseline', 'description': 'Percentage of participants with metastasis stages 0 and 1, as per TNM staging system, during anytime between MBC disease diagnosis and index date were reported in this outcome measure. As per TNM staging system, metastasis stage 0 indicates cancer has not spread to other parts of the body; metastasis stage 1 indicates that the cancer has spread to distant parts of the body. Data for this outcome measure is also presented by de novo status.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS comprised of medical records extracted for the purpose of the study from all eligible participants who were enrolled into the study. Here, "overall number of participants analyzed" signifies participants evaluable for this outcome measure and "number analyzed" signifies number of participants evaluable for specified rows.'}, {'type': 'PRIMARY', 'title': 'Tumor Size at Palbociclib Initiation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '162', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Palbociclib', 'description': "Participants with HR positive/HER2 negative MBC who received at least 1 dose of palbociclib as part of the IPP were observed during the study. Data was collected both retrospectively and prospectively, from participants' medical records for a maximum of 3 years following index date. Index date was defined as the palbociclib treatment initiation date."}], 'classes': [{'title': 'At Initial diagnosis', 'denoms': [{'units': 'Participants', 'counts': [{'value': '162', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '35.4', 'spread': '27.5', 'groupId': 'OG000'}]}]}, {'title': 'De novo metastatic status', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '40.9', 'spread': '36', 'groupId': 'OG000'}]}]}, {'title': 'Non de novo metastatic status', 'denoms': [{'units': 'Participants', 'counts': [{'value': '114', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '33.1', 'spread': '22.9', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'At baseline', 'unitOfMeasure': 'Millimeters', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS comprised of medical records extracted for the purpose of the study from all eligible participants who were enrolled into the study. Here, "overall number of participants analyzed" signifies participants evaluable for this outcome measure and "number analyzed" signifies number of participants evaluable for specified rows.'}, {'type': 'PRIMARY', 'title': 'Percentage of Participants According to Tumor Grade', 'denoms': [{'units': 'Participants', 'counts': [{'value': '170', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Palbociclib', 'description': "Participants with HR positive/HER2 negative MBC who received at least 1 dose of palbociclib as part of the IPP were observed during the study. Data was collected both retrospectively and prospectively, from participants' medical records for a maximum of 3 years following index date. Index date was defined as the palbociclib treatment initiation date."}], 'classes': [{'title': 'At initial diagnosis: Grade 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '170', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}]}]}, {'title': 'At initial diagnosis: Grade 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '170', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '56', 'groupId': 'OG000'}]}]}, {'title': 'At initial diagnosis: Grade 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '170', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '34', 'groupId': 'OG000'}]}]}, {'title': 'De novo metastatic: Grade 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}]}]}, {'title': 'De novo metastatic: Grade 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '63', 'groupId': 'OG000'}]}]}, {'title': 'De novo metastatic: Grade 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '33', 'groupId': 'OG000'}]}]}, {'title': 'Non de novo metastatic: Grade 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '121', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000'}]}]}, {'title': 'Non de novo metastatic: Grade 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '121', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '53', 'groupId': 'OG000'}]}]}, {'title': 'Non de novo metastatic: Grade 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '121', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '35', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'At baseline', 'description': 'Percentage of participants with tumor grades, during anytime between initial BC disease diagnosis and index date were reported in this outcome measure. Grades of disease was classified as grades 1, 2 and 3. As per TNM system, grade 1= well differentiated cells, low grade; grade 2= moderately differentiated cells, intermediate grade and grade 3= poorly differentiated cells, high grade.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS comprised of medical records extracted for the purpose of the study from all eligible participants who were enrolled into the study. Here, "overall number of participants analyzed" signifies participants evaluable for this outcome measure and "number analyzed" signifies number of participants evaluable for specified rows.'}, {'type': 'PRIMARY', 'title': 'Percentage of Participants With Ki-67 Protein Proliferation Index Recorded', 'denoms': [{'units': 'Participants', 'counts': [{'value': '173', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Palbociclib', 'description': "Participants with HR positive/HER2 negative MBC who received at least 1 dose of palbociclib as part of the IPP were observed during the study. Data was collected both retrospectively and prospectively, from participants' medical records for a maximum of 3 years following index date. Index date was defined as the palbociclib treatment initiation date."}], 'classes': [{'categories': [{'measurements': [{'value': '14', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'At baseline', 'description': 'Percentage of participants with Ki-67 protein proliferation index during anytime between initial BC disease diagnosis and index date were reported in this outcome measure. The Ki-67 protein is a cellular marker for proliferation. Ki-67 is a protein in cells that increases as cells prepare to divide into new cells. A staining process can measure the percentage of tumor cells that are positive for Ki-67. More positive cells hasten in dividing and forming new cells. Proliferation index was measured by the percentage of cells staining for Ki-67.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS comprised of medical records extracted for the purpose of the study from all eligible participants who were enrolled into the study. Here, "overall number of participants analyzed" signifies participants evaluable for this outcome measure.'}, {'type': 'PRIMARY', 'title': 'Ki-67 Protein Proliferation Index', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Palbociclib', 'description': "Participants with HR positive/HER2 negative MBC who received at least 1 dose of palbociclib as part of the IPP were observed during the study. Data was collected both retrospectively and prospectively, from participants' medical records for a maximum of 3 years following index date. Index date was defined as the palbociclib treatment initiation date."}], 'classes': [{'categories': [{'measurements': [{'value': '30.8', 'spread': '23', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'At baseline', 'description': 'The Ki-67 protein is a cellular marker for proliferation. Ki-67 is a protein in cells that increases as cells prepare to divide into new cells. A staining process can measure the percentage of tumor cells that are positive for Ki-67. More positive cells hasten in dividing and forming new cells. Proliferation index was measured by the percentage of cells staining for Ki-67.', 'unitOfMeasure': 'Percentage of cells staining for Ki-67', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS comprised of medical records extracted for the purpose of the study from all eligible participants who were enrolled into the study. Here, "overall number of participants analyzed" signifies participants evaluable for this outcome measure.'}, {'type': 'PRIMARY', 'title': 'Percentage of Participants With Eastern Cooperative Oncology Group Performance Score (ECOG PS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '112', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Palbociclib', 'description': "Participants with HR positive/HER2 negative MBC who received at least 1 dose of palbociclib as part of the IPP were observed during the study. Data was collected both retrospectively and prospectively, from participants' medical records for a maximum of 3 years following index date. Index date was defined as the palbociclib treatment initiation date."}], 'classes': [{'title': 'At initial diagnosis: Score 0', 'denoms': [{'units': 'Participants', 'counts': [{'value': '93', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '68', 'groupId': 'OG000'}]}]}, {'title': 'At initial diagnosis: Score 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '93', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '25', 'groupId': 'OG000'}]}]}, {'title': 'At initial diagnosis: Score 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '93', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}]}]}, {'title': 'At recurrence of disease: Score 0', 'denoms': [{'units': 'Participants', 'counts': [{'value': '67', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '45', 'groupId': 'OG000'}]}]}, {'title': 'At recurrence of disease: Score1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '67', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '40', 'groupId': 'OG000'}]}]}, {'title': 'At recurrence of disease: Score 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '67', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '15', 'groupId': 'OG000'}]}]}, {'title': 'At metastatic diagnosis: Score 0', 'denoms': [{'units': 'Participants', 'counts': [{'value': '112', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '55', 'groupId': 'OG000'}]}]}, {'title': 'At metastatic diagnosis: Score1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '112', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '32', 'groupId': 'OG000'}]}]}, {'title': 'At metastatic diagnosis: Score 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '112', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'At baseline', 'description': 'ECOG PS measured quality of life of cancer participants on a 0 to 5 scale; 0= fully active, able to carry on all pre-disease performance without restriction; 1= restricted in physically strenuous activity, ambulatory, able to carry out light/sedentary work; 2= ambulatory, capable of all self-care, unable to carry out any work activity, up \\>50 % of waking hours; 3= capable of only limited self-care, confined to bed/ chair \\>50% of waking hours; 4= completely disabled, cannot carry on any self-care, totally confined to bed or chair; 5= dead. Higher scores indicated worsening of quality of life.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS comprised of medical records extracted for the purpose of the study from all eligible participants who were enrolled into the study. Here, "overall number of participants analyzed" signifies participants evaluable for this outcome measure and "number analyzed" signifies number of participants evaluable for specified rows.'}, {'type': 'PRIMARY', 'title': 'Percentage of Participants With Recurrence Type', 'denoms': [{'units': 'Participants', 'counts': [{'value': '127', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Palbociclib', 'description': "Participants with HR positive/HER2 negative MBC who received at least 1 dose of palbociclib as part of the IPP were observed during the study. Data was collected both retrospectively and prospectively, from participants' medical records for a maximum of 3 years following index date. Index date was defined as the palbociclib treatment initiation date."}], 'classes': [{'title': 'Distant', 'categories': [{'measurements': [{'value': '77', 'groupId': 'OG000'}]}]}, {'title': 'Locoregional', 'categories': [{'measurements': [{'value': '23', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'At baseline', 'description': 'Percentage of participants with recurrence type during anytime between initial BC disease diagnosis and index date were reported in this outcome measure.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS comprised of medical records extracted for the purpose of the study from all eligible participants who were enrolled into the study. Here, "overall number of participants analyzed" signifies participants evaluable for this outcome measure.'}, {'type': 'PRIMARY', 'title': 'Percentage of Participants According to Number of Metastatic Sites', 'denoms': [{'units': 'Participants', 'counts': [{'value': '146', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Palbociclib', 'description': "Participants with HR positive/HER2 negative MBC who received at least 1 dose of palbociclib as part of the IPP were observed during the study. Data was collected both retrospectively and prospectively, from participants' medical records for a maximum of 3 years following index date. Index date was defined as the palbociclib treatment initiation date."}], 'classes': [{'title': '1', 'categories': [{'measurements': [{'value': '45', 'groupId': 'OG000'}]}]}, {'title': '2', 'categories': [{'measurements': [{'value': '36', 'groupId': 'OG000'}]}]}, {'title': '3', 'categories': [{'measurements': [{'value': '14', 'groupId': 'OG000'}]}]}, {'title': '4 or more', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'At baseline', 'description': 'Percentage of participants according to number of metastatic sites during anytime between initial BC disease diagnosis and index date were reported in this outcome measure.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS comprised of medical records extracted for the purpose of the study from all eligible participants who were enrolled into the study. Here, "overall number of participants analyzed" signifies participants evaluable for this outcome measure.'}, {'type': 'PRIMARY', 'title': 'Percentage of Participants According to Location of Metastases', 'denoms': [{'units': 'Participants', 'counts': [{'value': '189', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Palbociclib', 'description': "Participants with HR positive/HER2 negative MBC who received at least 1 dose of palbociclib as part of the IPP were observed during the study. Data was collected both retrospectively and prospectively, from participants' medical records for a maximum of 3 years following index date. Index date was defined as the palbociclib treatment initiation date."}], 'classes': [{'title': 'Non-visceral', 'categories': [{'measurements': [{'value': '67', 'groupId': 'OG000'}]}]}, {'title': 'Visceral', 'categories': [{'measurements': [{'value': '33', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'At baseline', 'description': 'Percentage of participants according to location of metastases, during anytime between initial BC disease diagnosis and index date were reported in this outcome measure.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS comprised of medical records extracted for the purpose of the study from all eligible participants who were enrolled into the study. Here, "overall number of participants analyzed" signifies participants evaluable for this outcome measure.'}, {'type': 'PRIMARY', 'title': 'Percentage of Participants With Non-Visceral Location of Metastases', 'denoms': [{'units': 'Participants', 'counts': [{'value': '127', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Palbociclib', 'description': "Participants with HR positive/HER2 negative MBC who received at least 1 dose of palbociclib as part of the IPP were observed during the study. Data was collected both retrospectively and prospectively, from participants' medical records for a maximum of 3 years following index date. Index date was defined as the palbociclib treatment initiation date."}], 'classes': [{'title': 'Bone only metastases', 'categories': [{'measurements': [{'value': '67', 'groupId': 'OG000'}]}]}, {'title': 'Other non-visceral', 'categories': [{'measurements': [{'value': '33', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'At baseline', 'description': 'Percentage of participants with non-visceral location of metastases, during anytime between initial BC disease diagnosis and index date were reported in this outcome measure.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS comprised of medical records extracted for the purpose of the study from all eligible participants who were enrolled into the study. Here, "overall number of participants analyzed" signifies participants evaluable for this outcome measure.'}, {'type': 'PRIMARY', 'title': 'Number of Participants According to Metastatic Sites With Locoregional Recurrence', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Palbociclib', 'description': "Participants with HR positive/HER2 negative MBC who received at least 1 dose of palbociclib as part of the IPP were observed during the study. Data was collected both retrospectively and prospectively, from participants' medical records for a maximum of 3 years following index date. Index date was defined as the palbociclib treatment initiation date."}], 'classes': [{'title': 'Bone', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}]}]}, {'title': 'Breast', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}]}]}, {'title': 'Lung', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}, {'title': 'Pleural', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Regional lymph nodes', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}, {'title': 'Other sites', 'categories': [{'measurements': [{'value': '16', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'At baseline', 'description': 'Number of participants according to metastatic sites with locoregional recurrence, during anytime between initial BC disease diagnosis and index date were reported in this outcome measure. Metastatic sites with locoregional recurrence included bone, breast, lung, pleural, regional lymph nodes and other sites.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS comprised of medical records extracted for the purpose of the study from all eligible participants who were enrolled into the study. Here, "overall number of participants analyzed" signifies participants evaluable for this outcome measure.'}, {'type': 'PRIMARY', 'title': 'Duration of Disease at Initiation of Palbociclib', 'denoms': [{'units': 'Participants', 'counts': [{'value': '190', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Palbociclib', 'description': "Participants with HR positive/HER2 negative MBC who received at least 1 dose of palbociclib as part of the IPP were observed during the study. Data was collected both retrospectively and prospectively, from participants' medical records for a maximum of 3 years following index date. Index date was defined as the palbociclib treatment initiation date."}], 'classes': [{'categories': [{'measurements': [{'value': '225.9', 'groupId': 'OG000', 'lowerLimit': '1.9', 'upperLimit': '1722.4'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'At baseline', 'description': 'Duration of BC disease was the time duration between date of BC disease diagnosis to palbociclib treatment initiation date.', 'unitOfMeasure': 'Months', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS comprised of medical records extracted for the purpose of the study from all eligible participants who were enrolled into the study. Here, "overall number of participants analyzed" signifies participants evaluable for this outcome measure.'}, {'type': 'PRIMARY', 'title': 'Percentage of Participants Who Received Chemotherapy in Adjuvant or Neoadjuvant Setting', 'denoms': [{'units': 'Participants', 'counts': [{'value': '191', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Palbociclib', 'description': "Participants with HR positive/HER2 negative MBC who received at least 1 dose of palbociclib as part of the IPP were observed during the study. Data was collected both retrospectively and prospectively, from participants' medical records for a maximum of 3 years following index date. Index date was defined as the palbociclib treatment initiation date."}], 'classes': [{'categories': [{'measurements': [{'value': '46', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'At baseline', 'description': 'Percentage of participants who received chemotherapy in adjuvant or neoadjuvant setting, during anytime between initial BC disease diagnosis and index date were reported in this outcome measure.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS comprised of medical records extracted for the purpose of the study from all eligible participants who were enrolled into the study.'}, {'type': 'PRIMARY', 'title': 'Percentage of Participants Who Received Chemotherapy in Advanced, Disease Modifying or Metastatic Setting', 'denoms': [{'units': 'Participants', 'counts': [{'value': '191', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Palbociclib', 'description': "Participants with HR positive/HER2 negative MBC who received at least 1 dose of palbociclib as part of the IPP were observed during the study. Data was collected both retrospectively and prospectively, from participants' medical records for a maximum of 3 years following index date. Index date was defined as the palbociclib treatment initiation date."}], 'classes': [{'categories': [{'measurements': [{'value': '15', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'At baseline', 'description': 'Percentage of participants who received chemotherapy in advanced, disease modifying or metastatic setting, during anytime between initial BC disease diagnosis and index date were reported in this outcome measure.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS comprised of medical records extracted for the purpose of the study from all eligible participants who were enrolled into the study.'}, {'type': 'PRIMARY', 'title': 'Number of Lines of Prior Chemotherapy for Metastatic Disease', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Palbociclib', 'description': "Participants with HR positive/HER2 negative MBC who received at least 1 dose of palbociclib as part of the IPP were observed during the study. Data was collected both retrospectively and prospectively, from participants' medical records for a maximum of 3 years following index date. Index date was defined as the palbociclib treatment initiation date."}], 'classes': [{'categories': [{'measurements': [{'value': '1.4', 'spread': '0.7', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'At baseline', 'description': 'Number of lines of prior chemotherapy for metastatic disease during anytime between MBC disease diagnosis and index date were reported in this outcome measure.', 'unitOfMeasure': 'Chemotherapy lines', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS comprised of medical records extracted for the purpose of the study from all eligible participants who were enrolled into the study. Here, "overall number of participants analyzed" signifies participants evaluable for this outcome measure.'}, {'type': 'PRIMARY', 'title': 'Percentage of Participants Who Received Luteinizing Hormone Releasing Hormone (LHRH) or Chemotherapy', 'denoms': [{'units': 'Participants', 'counts': [{'value': '53', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Palbociclib', 'description': "Participants with HR positive/HER2 negative MBC who received at least 1 dose of palbociclib as part of the IPP were observed during the study. Data was collected both retrospectively and prospectively, from participants' medical records for a maximum of 3 years following index date. Index date was defined as the palbociclib treatment initiation date."}], 'classes': [{'categories': [{'measurements': [{'value': '96', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'At baseline', 'description': 'Percentage of participants who received LHRH or chemotherapy, during anytime between initial BC disease diagnosis and index date were reported in this outcome measure.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS comprised of medical records extracted for the purpose of the study from all eligible participants who were enrolled into the study. Here, "overall number of participants analyzed" signifies participants evaluable for this outcome measure.'}, {'type': 'PRIMARY', 'title': 'Percentage of Participants Who Received Endocrine Therapy in Adjuvant or Neoadjuvant Setting', 'denoms': [{'units': 'Participants', 'counts': [{'value': '191', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Palbociclib', 'description': "Participants with HR positive/HER2 negative MBC who received at least 1 dose of palbociclib as part of the IPP were observed during the study. Data was collected both retrospectively and prospectively, from participants' medical records for a maximum of 3 years following index date. Index date was defined as the palbociclib treatment initiation date."}], 'classes': [{'categories': [{'measurements': [{'value': '61', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'At baseline', 'description': 'Percentage of participants who received endocrine therapy in adjuvant or neoadjuvant setting, during anytime between initial BC disease diagnosis and index date were reported in this outcome measure.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS comprised of medical records extracted for the purpose of the study from all eligible participants who were enrolled into the study.'}, {'type': 'PRIMARY', 'title': 'Number of Participants With Types of Endocrine Therapy in Adjuvant or Neoadjuvant Setting', 'denoms': [{'units': 'Participants', 'counts': [{'value': '137', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Palbociclib', 'description': "Participants with HR positive/HER2 negative MBC who received at least 1 dose of palbociclib as part of the IPP were observed during the study. Data was collected both retrospectively and prospectively, from participants' medical records for a maximum of 3 years following index date. Index date was defined as the palbociclib treatment initiation date."}], 'classes': [{'title': 'Adjuvant endocrine therapy: Anastrozole', 'denoms': [{'units': 'Participants', 'counts': [{'value': '137', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '19', 'groupId': 'OG000'}]}]}, {'title': 'Adjuvant endocrine therapy: Exemestane', 'denoms': [{'units': 'Participants', 'counts': [{'value': '137', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}]}]}, {'title': 'Adjuvant endocrine therapy: Letrozole', 'denoms': [{'units': 'Participants', 'counts': [{'value': '137', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '16', 'groupId': 'OG000'}]}]}, {'title': 'Adjuvant endocrine therapy: Tamoxifen', 'denoms': [{'units': 'Participants', 'counts': [{'value': '137', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '86', 'groupId': 'OG000'}]}]}, {'title': 'Adjuvant endocrine therapy: Other', 'denoms': [{'units': 'Participants', 'counts': [{'value': '137', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}]}]}, {'title': 'Neoadjuvant endocrine therapy: Anastrozole', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}, {'title': 'Neoadjuvant endocrine therapy: Letrozole', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}, {'title': 'Neoadjuvant endocrine therapy: Tamoxifen', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'At baseline', 'description': 'Number of participants with types of endocrine therapy in adjuvant or neoadjuvant setting, during anytime between initial BC disease diagnosis and index date were reported in this outcome measure.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS comprised of medical records extracted for the purpose of the study from all eligible participants who were enrolled into the study. Here, "overall number of participants analyzed" signifies participants evaluable for this outcome measure and "number analyzed" signifies number of participants evaluable for specified rows.'}, {'type': 'PRIMARY', 'title': 'Percentage of Participants Who Received Endocrine Therapy in Advanced, Disease Modifying or Metastatic Setting', 'denoms': [{'units': 'Participants', 'counts': [{'value': '191', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Palbociclib', 'description': "Participants with HR positive/HER2 negative MBC who received at least 1 dose of palbociclib as part of the IPP were observed during the study. Data was collected both retrospectively and prospectively, from participants' medical records for a maximum of 3 years following index date. Index date was defined as the palbociclib treatment initiation date."}], 'classes': [{'categories': [{'measurements': [{'value': '38', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'At baseline', 'description': 'Percentage of participants who received endocrine therapy in advanced, disease modifying or metastatic setting, during anytime between initial BC disease diagnosis and index date were reported in this outcome measure.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS comprised of medical records extracted for the purpose of the study from all eligible participants who were enrolled into the study.'}, {'type': 'PRIMARY', 'title': 'Percentage of Participants With Type of Endocrine Therapy in Advanced, Disease Modifying or Metastatic Setting', 'denoms': [{'units': 'Participants', 'counts': [{'value': '99', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Palbociclib', 'description': "Participants with HR positive/HER2 negative MBC who received at least 1 dose of palbociclib as part of the IPP were observed during the study. Data was collected both retrospectively and prospectively, from participants' medical records for a maximum of 3 years following index date. Index date was defined as the palbociclib treatment initiation date."}], 'classes': [{'title': 'Anastrozole', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}]}]}, {'title': 'Exemestane', 'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000'}]}]}, {'title': 'Fulvestrant', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}]}]}, {'title': 'Letrozole', 'categories': [{'measurements': [{'value': '54', 'groupId': 'OG000'}]}]}, {'title': 'Other', 'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000'}]}]}, {'title': 'Tamoxifen', 'categories': [{'measurements': [{'value': '14', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'At baseline', 'description': 'Percentage of participants with type of endocrine therapy in advanced, disease modifying or metastatic setting, during anytime between initial BC disease diagnosis and index date were reported in this outcome measure.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS comprised of medical records extracted for the purpose of the study from all eligible participants who were enrolled into the study. Here, "overall number of participants analyzed" signifies participants evaluable for this outcome measure.'}, {'type': 'PRIMARY', 'title': 'Number of Lines of Prior Endocrine Therapy for Metastatic Disease', 'denoms': [{'units': 'Participants', 'counts': [{'value': '73', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Palbociclib', 'description': "Participants with HR positive/HER2 negative MBC who received at least 1 dose of palbociclib as part of the IPP were observed during the study. Data was collected both retrospectively and prospectively, from participants' medical records for a maximum of 3 years following index date. Index date was defined as the palbociclib treatment initiation date."}], 'classes': [{'categories': [{'measurements': [{'value': '1.4', 'spread': '0.6', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'At baseline', 'description': 'Number of lines of prior endocrine therapy for metastatic disease during anytime between MBC disease diagnosis and index date were reported in this outcome measure.', 'unitOfMeasure': 'Endocrine therapy lines', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS comprised of medical records extracted for the purpose of the study from all eligible participants who were enrolled into the study. Here, "overall number of participants analyzed" signifies participants evaluable for this outcome measure.'}, {'type': 'PRIMARY', 'title': 'Number of Participants Who Received Radiotherapy in Advanced, Disease Modifying or Metastatic Setting', 'denoms': [{'units': 'Participants', 'counts': [{'value': '191', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Palbociclib', 'description': "Participants with HR positive/HER2 negative MBC who received at least 1 dose of palbociclib as part of the IPP were observed during the study. Data was collected both retrospectively and prospectively, from participants' medical records for a maximum of 3 years following index date. Index date was defined as the palbociclib treatment initiation date."}], 'classes': [{'categories': [{'measurements': [{'value': '53', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'At baseline', 'description': 'Number of participants who received radiotherapy in advanced, disease modifying or metastatic setting, during anytime between MBC disease diagnosis and index date were reported in this outcome measure.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS comprised of medical records extracted for the purpose of the study from all eligible participants who were enrolled into the study.'}, {'type': 'PRIMARY', 'title': 'Percentage of Participants Who Received Concomitant Medications', 'denoms': [{'units': 'Participants', 'counts': [{'value': '191', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Palbociclib', 'description': "Participants with HR positive/HER2 negative MBC who received at least 1 dose of palbociclib as part of the IPP were observed during the study. Data was collected both retrospectively and prospectively, from participants' medical records for a maximum of 3 years following index date. Index date was defined as the palbociclib treatment initiation date."}], 'classes': [{'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'At baseline', 'description': 'Percentage of participants who received concomitant medications, during anytime between initial BC disease diagnosis and index date were reported in this outcome measure.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS comprised of medical records extracted for the purpose of the study from all eligible participants who were enrolled into the study.'}, {'type': 'PRIMARY', 'title': 'Number of Participants With Concomitant Medications Prescribed Along With Goserelin', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Palbociclib', 'description': "Participants with HR positive/HER2 negative MBC who received at least 1 dose of palbociclib as part of the IPP were observed during the study. Data was collected both retrospectively and prospectively, from participants' medical records for a maximum of 3 years following index date. Index date was defined as the palbociclib treatment initiation date."}], 'classes': [{'title': 'Zoladex and Anastrozole', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Zoladex and Letrozole', 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}]}]}, {'title': 'Zoladex and Tamoxifen then Exemestane', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Zoladex only', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}]}]}, {'title': 'Zoladex, Exemestane, Letrozole and Tamoxifen', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'At baseline', 'description': 'Number of participants with concomitant medications prescribed along with goserelin, during anytime between initial BC disease diagnosis and index date were reported in this outcome measure. Goserelin is the generic drug with a brand name Zoladex.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS comprised of medical records extracted for the purpose of the study from all eligible participants who were enrolled into the study. Here, "overall number of participants analyzed" signifies participants evaluable for this outcome measure.'}, {'type': 'PRIMARY', 'title': 'Number of Participants According to Number of Prior Treatments in Metastatic Setting', 'denoms': [{'units': 'Participants', 'counts': [{'value': '191', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Palbociclib', 'description': "Participants with HR positive/HER2 negative MBC who received at least 1 dose of palbociclib as part of the IPP were observed during the study. Data was collected both retrospectively and prospectively, from participants' medical records for a maximum of 3 years following index date. Index date was defined as the palbociclib treatment initiation date."}], 'classes': [{'title': '0', 'categories': [{'measurements': [{'value': '83', 'groupId': 'OG000'}]}]}, {'title': '1', 'categories': [{'measurements': [{'value': '58', 'groupId': 'OG000'}]}]}, {'title': '2', 'categories': [{'measurements': [{'value': '24', 'groupId': 'OG000'}]}]}, {'title': '3', 'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000'}]}]}, {'title': '4', 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}]}]}, {'title': '5', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}]}]}, {'title': '6', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': '8', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': '10', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'At baseline', 'description': 'Number of participants according to number of prior treatments in metastatic setting, during anytime between MBC disease diagnosis and index date were reported in this outcome measure.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS comprised of medical records extracted for the purpose of the study from all eligible participants who were enrolled into the study.'}, {'type': 'PRIMARY', 'title': 'Number of Participants According to Number of Prior Chemotherapy and Hormone Therapy in Metastatic Setting', 'denoms': [{'units': 'Participants', 'counts': [{'value': '191', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Palbociclib', 'description': "Participants with HR positive/HER2 negative MBC who received at least 1 dose of palbociclib as part of the IPP were observed during the study. Data was collected both retrospectively and prospectively, from participants' medical records for a maximum of 3 years following index date. Index date was defined as the palbociclib treatment initiation date."}], 'classes': [{'title': '0', 'categories': [{'measurements': [{'value': '108', 'groupId': 'OG000'}]}]}, {'title': '1', 'categories': [{'measurements': [{'value': '46', 'groupId': 'OG000'}]}]}, {'title': '2', 'categories': [{'measurements': [{'value': '24', 'groupId': 'OG000'}]}]}, {'title': '3', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}]}]}, {'title': '4', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}]}]}, {'title': '5', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'At baseline', 'description': 'Number of participants according to number of prior chemotherapy and hormone therapy in metastatic setting, during anytime between MBC disease diagnosis and index date were reported in this outcome measure.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS comprised of medical records extracted for the purpose of the study from all eligible participants who were enrolled into the study.'}, {'type': 'PRIMARY', 'title': 'Number of Participants According to Number of Prior Chemotherapies in Metastatic Setting', 'denoms': [{'units': 'Participants', 'counts': [{'value': '191', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Palbociclib', 'description': "Participants with HR positive/HER2 negative MBC who received at least 1 dose of palbociclib as part of the IPP were observed during the study. Data was collected both retrospectively and prospectively, from participants' medical records for a maximum of 3 years following index date. Index date was defined as the palbociclib treatment initiation date."}], 'classes': [{'title': '0', 'categories': [{'measurements': [{'value': '162', 'groupId': 'OG000'}]}]}, {'title': '1', 'categories': [{'measurements': [{'value': '19', 'groupId': 'OG000'}]}]}, {'title': '2', 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}]}]}, {'title': '3', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'At baseline', 'description': 'Number of participants according to number of prior chemotherapies in metastatic setting, during anytime between MBC disease diagnosis and index date were reported in this outcome measure.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS comprised of medical records extracted for the purpose of the study from all eligible participants who were enrolled into the study.'}, {'type': 'PRIMARY', 'title': 'Number of Participants According to Number of Prior Hormone Therapies in Metastatic Setting', 'denoms': [{'units': 'Participants', 'counts': [{'value': '191', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Palbociclib', 'description': "Participants with HR positive/HER2 negative MBC who received at least 1 dose of palbociclib as part of the IPP were observed during the study. Data was collected both retrospectively and prospectively, from participants' medical records for a maximum of 3 years following index date. Index date was defined as the palbociclib treatment initiation date."}], 'classes': [{'title': '0', 'categories': [{'measurements': [{'value': '118', 'groupId': 'OG000'}]}]}, {'title': '1', 'categories': [{'measurements': [{'value': '52', 'groupId': 'OG000'}]}]}, {'title': '2', 'categories': [{'measurements': [{'value': '17', 'groupId': 'OG000'}]}]}, {'title': '3', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}]}]}, {'title': '4', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'At baseline', 'description': 'Number of participants according to number of prior hormone therapies in metastatic setting, during anytime between MBC disease diagnosis and index date were reported in this outcome measure.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS comprised of medical records extracted for the purpose of the study from all eligible participants who were enrolled into the study.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Their Starting Dose of Palbociclib', 'denoms': [{'units': 'Participants', 'counts': [{'value': '191', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Palbociclib', 'description': "Participants with HR positive/HER2 negative MBC who received at least 1 dose of palbociclib as part of the IPP were observed during the study. Data was collected both retrospectively and prospectively, from participants' medical records for a maximum of 3 years following index date. Index date was defined as the palbociclib treatment initiation date."}], 'classes': [{'title': '125 milligrams (mg)/day', 'categories': [{'measurements': [{'value': '97', 'groupId': 'OG000'}]}]}, {'title': '100 mg/day', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Data collected at index date (for a maximum period of 3 years)', 'description': 'Percentage of participants with their starting dose of palbociclib were reported.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS comprised of medical records extracted for the purpose of the study from all eligible participants who were enrolled into the study.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Who Received Endocrine Therapy Along With Palbociclib', 'denoms': [{'units': 'Participants', 'counts': [{'value': '190', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Palbociclib', 'description': "Participants with HR positive/HER2 negative MBC who received at least 1 dose of palbociclib as part of the IPP were observed during the study. Data was collected both retrospectively and prospectively, from participants' medical records for a maximum of 3 years following index date. Index date was defined as the palbociclib treatment initiation date."}], 'classes': [{'title': 'Anastrozole', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}]}]}, {'title': 'Exemestane', 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}]}]}, {'title': 'Fulvestrant', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Letrozole', 'categories': [{'measurements': [{'value': '89', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Data collected from index date until lost to follow up or end of follow up, whichever occurred first (for a maximum period of 3 years)', 'description': 'Percentage of participants who received endocrine therapy along with palbociclib were reported in this outcome measure. Endocrine therapy includes anastrozole, exemestane, fulvestrant and letrozole.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS comprised of medical records extracted for the purpose of the study from all eligible participants who were enrolled into the study. Here, "overall number of participants analyzed" signifies participants evaluable for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Dose Reductions and Treatment Discontinuation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '191', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Palbociclib', 'description': "Participants with HR positive/HER2 negative MBC who received at least 1 dose of palbociclib as part of the IPP were observed during the study. Data was collected both retrospectively and prospectively, from participants' medical records for a maximum of 3 years following index date. Index date was defined as the palbociclib treatment initiation date."}], 'classes': [{'title': 'Dose reduction', 'categories': [{'measurements': [{'value': '41', 'groupId': 'OG000'}]}]}, {'title': 'Treatment discontinuation', 'categories': [{'measurements': [{'value': '54', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Data collected from index date until lost to follow up or end of follow up, whichever occurred first (for a maximum period of 3 years)', 'description': 'Percentage of participants with dose reductions and treatment discontinuation were reported in this outcome measure.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS comprised of medical records extracted for the purpose of the study from all eligible participants who were enrolled into the study.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Reasons for Palbociclib Discontinuation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '103', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Palbociclib', 'description': "Participants with HR positive/HER2 negative MBC who received at least 1 dose of palbociclib as part of the IPP were observed during the study. Data was collected both retrospectively and prospectively, from participants' medical records for a maximum of 3 years following index date. Index date was defined as the palbociclib treatment initiation date."}], 'classes': [{'title': 'Adverse drug reaction', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}]}]}, {'title': 'Hematologic toxicity: Grade 3', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Non-hematologic: Grade 3', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Progression of disease', 'categories': [{'measurements': [{'value': '83', 'groupId': 'OG000'}]}]}, {'title': 'Other', 'categories': [{'measurements': [{'value': '15', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Data collected from index date until lost to follow up or end of follow up, whichever occurred first (for a maximum period of 3 years)', 'description': 'Number of participants with reasons for palbociclib discontinuation were reported in this outcome measure. Disease progression (PD) was defined as greater than or equal to (\\>=)20 percent (%) increase in sum of diameters of target lesions, taking as reference smallest sum on study, sum must demonstrate absolute increase of at least 5 millimeter (mm) or appearance of 1 or more new lesions. Adverse drug reactions (ADR) were defined as unintended, harmful events attributed to the use of drug. As per World Health Organisation (WHO) criteria for hematologic and nonhematologic toxicity grade 3 was defined as the severe/worst grade.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS comprised of medical records extracted for the purpose of the study from all eligible participants who were enrolled into the study. Here, "overall number of participants analyzed" signifies participants evaluable for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Temporary Discontinuation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '191', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Palbociclib', 'description': "Participants with HR positive/HER2 negative MBC who received at least 1 dose of palbociclib as part of the IPP were observed during the study. Data was collected both retrospectively and prospectively, from participants' medical records for a maximum of 3 years following index date. Index date was defined as the palbociclib treatment initiation date."}], 'classes': [{'categories': [{'measurements': [{'value': '40', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Data collected from index date until lost to follow up or end of follow up, whichever occurred first (for a maximum period of 3 years)', 'description': 'Percentage of participants with temporary discontinuation of palbociclib were reported in this outcome measure.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS comprised of medical records extracted for the purpose of the study from all eligible participants who were enrolled into the study.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants According to Time to Dose Reduction in First Line Therapy', 'denoms': [{'units': 'Participants', 'counts': [{'value': '137', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Palbociclib', 'description': "Participants with HR positive/HER2 negative MBC who received at least 1 dose of palbociclib as part of the IPP were observed during the study. Data was collected both retrospectively and prospectively, from participants' medical records for a maximum of 3 years following index date. Index date was defined as the palbociclib treatment initiation date."}], 'classes': [{'title': 'Within 3 months', 'categories': [{'measurements': [{'value': '19', 'groupId': 'OG000'}]}]}, {'title': 'Between 3 to 6 months', 'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}]}]}, {'title': 'Over 6 months', 'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Data collected from index date until lost to follow up or end of follow up, whichever occurred first (for a maximum period of 3 years)', 'description': 'Percentage of participants according to time to dose reduction after palbociclib initiation in 1st line therapy were reported in this outcome measure.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS comprised of medical records extracted for the purpose of the study from all eligible participants who were enrolled into the study. Here, "overall number of participants analyzed" signifies participants evaluable for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Time to Palbociclib Discontinuation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '103', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Palbociclib', 'description': "Participants with HR positive/HER2 negative MBC who received at least 1 dose of palbociclib as part of the IPP were observed during the study. Data was collected both retrospectively and prospectively, from participants' medical records for a maximum of 3 years following index date. Index date was defined as the palbociclib treatment initiation date."}], 'classes': [{'categories': [{'measurements': [{'value': '8.3', 'groupId': 'OG000', 'lowerLimit': '0.1', 'upperLimit': '24.0'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Data collected from index date until lost to follow up or end of follow up, whichever occurred first (for a maximum period of 3 years)', 'description': 'Time to palbociclib discontinuation were observed in participants who permanently discontinued palbociclib and were reported in this outcome measure.', 'unitOfMeasure': 'Months', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS comprised of medical records extracted for the purpose of the study from all eligible participants who were enrolled into the study. Here, "overall number of participants analyzed" signifies participants evaluable for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With First 3 Lines of Treatment After Progression', 'denoms': [{'units': 'Participants', 'counts': [{'value': '103', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Palbociclib', 'description': "Participants with HR positive/HER2 negative MBC who received at least 1 dose of palbociclib as part of the IPP were observed during the study. Data was collected both retrospectively and prospectively, from participants' medical records for a maximum of 3 years following index date. Index date was defined as the palbociclib treatment initiation date."}], 'classes': [{'title': '1st line treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '103', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '80', 'groupId': 'OG000'}]}]}, {'title': '2nd line treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '80', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '42', 'groupId': 'OG000'}]}]}, {'title': '3rd line treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '20', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Data collected from date of progression until lost to follow up or end of follow up period, whichever occurred first (for a maximum period of 3 years)', 'description': 'Number of participants according to lines of treatment after progression were reported in this outcome measure.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS comprised of medical records extracted for the purpose of the study from all eligible participants who were enrolled into the study. Here, "overall number of participants analyzed" signifies participants evaluable for this outcome measure and "number analyzed" signifies number of participants evaluable for specified rows. Participant can be included in more than 1 category.'}, {'type': 'SECONDARY', 'title': 'Doses Prescribed for First 3 Lines of Treatment After Progression', 'denoms': [{'units': 'Participants', 'counts': [{'value': '79', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Palbociclib', 'description': "Participants with HR positive/HER2 negative MBC who received at least 1 dose of palbociclib as part of the IPP were observed during the study. Data was collected both retrospectively and prospectively, from participants' medical records for a maximum of 3 years following index date. Index date was defined as the palbociclib treatment initiation date."}], 'classes': [{'title': '1st line - dose prescribed', 'denoms': [{'units': 'Participants', 'counts': [{'value': '79', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '909.4', 'spread': '1170.4', 'groupId': 'OG000'}]}]}, {'title': '2nd line - dose prescribed', 'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '560.6', 'spread': '1014.1', 'groupId': 'OG000'}]}]}, {'title': '3rd line - dose prescribed', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '362.4', 'spread': '531.0', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Data collected from date of progression until lost to follow up or end of follow up period, whichever occurred first (for a maximum period of 3 years)', 'description': 'Doses of drugs prescribed for first 3 lines of treatment after progression were reported in this outcome measure.', 'unitOfMeasure': 'Milligrams', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS comprised of medical records extracted for the purpose of the study from all eligible participants who were enrolled into the study. Here, "overall number of participants analyzed" signifies participants evaluable for this outcome measure and "number analyzed" signifies number of participants evaluable for specified rows.'}, {'type': 'SECONDARY', 'title': 'Duration of First 3 Lines of Treatment After Progression', 'denoms': [{'units': 'Participants', 'counts': [{'value': '59', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Palbociclib', 'description': "Participants with HR positive/HER2 negative MBC who received at least 1 dose of palbociclib as part of the IPP were observed during the study. Data was collected both retrospectively and prospectively, from participants' medical records for a maximum of 3 years following index date. Index date was defined as the palbociclib treatment initiation date."}], 'classes': [{'title': '1st line treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '59', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '77.0', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '592.0'}]}]}, {'title': '2nd line treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '67.0', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '304.0'}]}]}, {'title': '3rd line treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '42', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '91.0'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Data collected from date of progression until lost to follow up or end of follow up period, whichever occurred first (for a maximum period of 3 years)', 'description': 'Time duration of first 3 lines of treatment after progression up to lost to follow up or end of follow up period, whichever occurred first were reported in this outcome measure.', 'unitOfMeasure': 'Days', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS comprised of medical records extracted for the purpose of the study from all eligible participants who were enrolled into the study. Here, "overall number of participants analyzed" signifies participants evaluable for this outcome measure and "number analyzed" signifies participants evaluable for this outcome measure for specified rows.'}, {'type': 'SECONDARY', 'title': 'Number of Completed Cycles of Palbociclib', 'denoms': [{'units': 'Participants', 'counts': [{'value': '191', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Palbociclib', 'description': "Participants with HR positive/HER2 negative MBC who received at least 1 dose of palbociclib as part of the IPP were observed during the study. Data was collected both retrospectively and prospectively, from participants' medical records for a maximum of 3 years following index date. Index date was defined as the palbociclib treatment initiation date."}], 'classes': [{'categories': [{'measurements': [{'value': '15.0', 'spread': '8.8', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Data collected from index date until lost to follow up or end of follow up, whichever occurred first (for a maximum period of 3 years)', 'description': 'Number of 28-day cycles completed for palbociclib treatment were reported in this outcome measure.', 'unitOfMeasure': 'Cycles', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS comprised of medical records extracted for the purpose of the study from all eligible participants who were enrolled into the study.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Who Received Letrozole and Fulvestrant With Palbociclib', 'denoms': [{'units': 'Participants', 'counts': [{'value': '190', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Palbociclib', 'description': "Participants with HR positive/HER2 negative MBC who received at least 1 dose of palbociclib as part of the IPP were observed during the study. Data was collected both retrospectively and prospectively, from participants' medical records for a maximum of 3 years following index date. Index date was defined as the palbociclib treatment initiation date."}], 'classes': [{'title': 'Letrozole', 'categories': [{'measurements': [{'value': '89', 'groupId': 'OG000'}]}]}, {'title': 'Fulvestrant', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Data collected from index date until lost to follow up or end of follow up, whichever occurred first (for a maximum period of 3 years)', 'description': 'Percentage of participants who received letrozole and fulvestrant along with palbociclib were reported in this outcome measure.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS comprised of medical records extracted for the purpose of the study from all eligible participants who were enrolled into the study. Here, "overall number of participants analyzed" signifies participants evaluable for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Progression Free Survival Following Palbociclib Initiation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '191', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Palbociclib', 'description': "Participants with HR positive/HER2 negative MBC who received at least 1 dose of palbociclib as part of the IPP were observed during the study. Data was collected both retrospectively and prospectively, from participants' medical records for a maximum of 3 years following index date. Index date was defined as the palbociclib treatment initiation date."}], 'classes': [{'categories': [{'measurements': [{'value': '53', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Data collected from index date until lost to follow up or end of follow up, whichever occurred first (for a maximum period of 3 years)', 'description': 'Progression free survival (PFS) was defined as the time from the index date to the date of first documented disease progression (PD) or death. PD was defined as \\>=20% increase in sum of diameters of target lesions, taking as reference smallest sum on study, sum must demonstrate absolute increase of at least 5 mm or appearance of 1 or more new lesions. Percentage of participants with progression free survival after index date were reported in this outcome measure.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS comprised of medical records extracted for the purpose of the study from all eligible participants who were enrolled into the study.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Alive Following Palbociclib Initiation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '191', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Palbociclib', 'description': "Participants with HR positive/HER2 negative MBC who received at least 1 dose of palbociclib as part of the IPP were observed during the study. Data was collected both retrospectively and prospectively, from participants' medical records for a maximum of 3 years following index date. Index date was defined as the palbociclib treatment initiation date."}], 'classes': [{'categories': [{'measurements': [{'value': '71', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Data collected from index date until lost to follow up or end of follow up, whichever occurred first (for a maximum period of 3 years)', 'description': 'Percentage of participants who were alive after palbociclib initiation were reported in this outcome measure.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS comprised of medical records extracted for the purpose of the study from all eligible participants who were enrolled into the study.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Partial Response (PR) and Complete Response (CR) Following Palbociclib Initiation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '191', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Palbociclib', 'description': "Participants with HR positive/HER2 negative MBC who received at least 1 dose of palbociclib as part of the IPP were observed during the study. Data was collected both retrospectively and prospectively, from participants' medical records for a maximum of 3 years following index date. Index date was defined as the palbociclib treatment initiation date."}], 'classes': [{'title': 'Complete response', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}, {'title': 'Partial response', 'categories': [{'measurements': [{'value': '40', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Data collected from index date until lost to follow up or end of follow up, whichever occurred first (for a maximum period of 3 years)', 'description': 'CR was defined as disappearance of target, non-target lesions and normalization of tumor markers. Pathological lymph nodes had short axis measures less than (\\<)10 mm; PR was defined as \\>=30% decrease in sum of measures (longest diameter for tumor lesions, short axis measure for nodes) of target lesions, taking reference baseline sum of diameters. Non-target lesions must be non-PD; PD: \\>=20% increase in sum of diameters of target lesions, taking as reference smallest sum on study, sum must demonstrate absolute increase of at least 5 mm or appearance of 1 or more new lesions.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS comprised of medical records extracted for the purpose of the study from all eligible participants who were enrolled into the study.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Stable Disease (SD) Following Palbociclib Initiation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '191', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Palbociclib', 'description': "Participants with HR positive/HER2 negative MBC who received at least 1 dose of palbociclib as part of the IPP were observed during the study. Data was collected both retrospectively and prospectively, from participants' medical records for a maximum of 3 years following index date. Index date was defined as the palbociclib treatment initiation date."}], 'classes': [{'categories': [{'measurements': [{'value': '48', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Data collected from index date until lost to follow up or end of follow up, whichever occurred first (for a maximum period of 3 years)', 'description': 'SD was defined as neither shrinkage for CR or PR nor increase for PD taking as reference smallest sum of longest diameters since treatment start. Alive participants with no events were censored at date of last response assessment. CR: disappearance of target, non-target lesions and normalization of tumor markers. Pathological lymph nodes had short axis measures \\<10 mm; PR: \\>=30% decrease in sum of measures (longest diameter for tumor lesions, short axis measure for nodes) of target lesions, taking reference baseline sum of diameters. Non-target lesions must be non-PD; PD: \\>=20% increase in sum of diameters of target lesions, taking as reference smallest sum on study, sum must demonstrate absolute increase of at least 5 mm or appearance of 1 or more new lesions.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS comprised of medical records extracted for the purpose of the study from all eligible participants who were enrolled into the study.'}, {'type': 'SECONDARY', 'title': 'Progression Free Survival (PFS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '191', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Palbociclib', 'description': "Participants with HR positive/HER2 negative MBC who received at least 1 dose of palbociclib as part of the IPP were observed during the study. Data was collected both retrospectively and prospectively, from participants' medical records for a maximum of 3 years following index date. Index date was defined as the palbociclib treatment initiation date."}], 'classes': [{'categories': [{'measurements': [{'value': '19.5', 'comment': 'Upper limit of 95% confidence interval (CI) could not be calculated due to insufficient number of participants with events.', 'groupId': 'OG000', 'lowerLimit': '14.5', 'upperLimit': 'NA'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'From index date to PD or death whichever occurred first (for a maximum period of 3 years)', 'description': 'PFS was defined as the time from the index date to the date of first documented PD or death. PD was defined as at least a 20% increase in sum of diameters of target lesions, taking as reference the smallest sum on study. In addition to relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions was also considered progression.', 'unitOfMeasure': 'Months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS comprised of medical records extracted for the purpose of the study from all eligible participants who were enrolled into the study.'}, {'type': 'SECONDARY', 'title': 'Overall Survival (OS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '190', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Palbociclib', 'description': "Participants with HR positive/HER2 negative MBC who received at least 1 dose of palbociclib as part of the IPP were observed during the study. Data was collected both retrospectively and prospectively, from participants' medical records for a maximum of 3 years following index date. Index date was defined as the palbociclib treatment initiation date."}], 'classes': [{'categories': [{'measurements': [{'value': 'NA', 'comment': 'Median and 95% CI could not be calculated due to less number of participants with event.', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'From index date until date of death or date of censoring (for a maximum period of 3 years)', 'description': 'OS was defined as the time between the index date and the date of death from any cause. Participants who were still alive at the last date of data collection were censored.', 'unitOfMeasure': 'Months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS comprised of medical records extracted for the purpose of the study from all eligible participants who were enrolled into the study. Here, "overall number of participants analyzed" signifies participants evaluable for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Time to Achieving Best Overall Response (BOR)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '185', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Palbociclib', 'description': "Participants with HR positive/HER2 negative MBC who received at least 1 dose of palbociclib as part of the IPP were observed during the study. Data was collected both retrospectively and prospectively, from participants' medical records for a maximum of 3 years following index date. Index date was defined as the palbociclib treatment initiation date."}], 'classes': [{'categories': [{'measurements': [{'value': '3.5', 'groupId': 'OG000', 'lowerLimit': '0.1', 'upperLimit': '23.8'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'From index date till date of BOR or date of censoring (for a maximum period of 3 years)', 'description': 'Time to achieving BOR: time from index date until achievement of BOR: CR or PR, if CR was not achieved during follow-up. CR: disappearance of target, non-target lesions and normalization of tumor markers. Pathological lymph nodes had short axis measures \\<10 mm; PR: \\>=30% decrease in sum of measures (longest diameter for tumor lesions, short axis measure for nodes) of target lesions, taking reference baseline sum of diameters. Non-target lesions must be non-PD; PD: \\>=20% increase in sum of diameters of target lesions, taking as reference smallest sum on study, sum must demonstrate absolute increase of at least 5 mm. Appearance of 1 or more new lesions; Alive participants with no events were censored at date of last response assessment.', 'unitOfMeasure': 'Months', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS comprised of medical records extracted for the purpose of the study from all eligible participants who were enrolled into the study. Here, "overall number of participants analyzed" signifies participants evaluable for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Duration of Follow-up Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '190', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Palbociclib', 'description': "Participants with HR positive/HER2 negative MBC who received at least 1 dose of palbociclib as part of the IPP were observed during the study. Data was collected both retrospectively and prospectively, from participants' medical records for a maximum of 3 years following index date. Index date was defined as the palbociclib treatment initiation date."}], 'classes': [{'categories': [{'measurements': [{'value': '20.8', 'spread': '6', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Data collected from index date until lost to follow up or end of follow up, whichever occurred first (for a maximum period of 3 years)', 'description': 'Duration of follow-up period defined as the duration from index date until lost to follow up or end of follow up period, whichever occurred first, were reported in this outcome measure.', 'unitOfMeasure': 'Months', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS comprised of medical records extracted for the purpose of the study from all eligible participants who were enrolled into the study. Here, "overall number of participants analyzed" signifies participants evaluable for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Best Response (BR), Progressive Disease (PD) and Stable Disease (SD) to Palbociclib', 'denoms': [{'units': 'Participants', 'counts': [{'value': '191', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Palbociclib', 'description': "Participants with HR positive/HER2 negative MBC who received at least 1 dose of palbociclib as part of the IPP were observed during the study. Data was collected both retrospectively and prospectively, from participants' medical records for a maximum of 3 years following index date. Index date was defined as the palbociclib treatment initiation date."}], 'classes': [{'title': 'Overall: CR', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}, {'title': 'Overall: PR', 'categories': [{'measurements': [{'value': '40', 'groupId': 'OG000'}]}]}, {'title': 'Overall: PD', 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}]}]}, {'title': 'Overall: SD', 'categories': [{'measurements': [{'value': '48', 'groupId': 'OG000'}]}]}, {'title': 'De novo status: CR', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}, {'title': 'De novo status: PR', 'categories': [{'measurements': [{'value': '40', 'groupId': 'OG000'}]}]}, {'title': 'De novo status: PD', 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}]}]}, {'title': 'De novo status: SD', 'categories': [{'measurements': [{'value': '48', 'groupId': 'OG000'}]}]}, {'title': 'Relapse status: CR', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}, {'title': 'Relapse status: PR', 'categories': [{'measurements': [{'value': '40', 'groupId': 'OG000'}]}]}, {'title': 'Relapse status: PD', 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}]}]}, {'title': 'Relapse status: SD', 'categories': [{'measurements': [{'value': '48', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From index date till BR (CR or PR, whichever occurred first), SD, PD or date of censoring (for a maximum period of 3 years)', 'description': 'Percentage of participants with BR, PD and SD to palbociclib were reported in this outcome measure. BR was recorded for CR or PR. CR: disappearance of target, non-target lesions and normalization of tumor markers. Pathological lymph nodes had short axis measures \\<10 mm; PR: \\>=30% decrease in sum of measures (longest diameter for tumor lesions, short axis measure for nodes) of target lesions, taking reference baseline sum of diameters. Non-target lesions must be non-PD; PD: \\>=20% increase in sum of diameters of target lesions, taking as reference smallest sum on study, sum must demonstrate absolute increase of at least 5 mm or appearance of 1 or more new lesions. SD: neither shrinkage for CR/PR nor increase for PD taking as reference smallest sum of longest diameters since treatment start. Alive participants with no events were censored at date of last response assessment.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS comprised of medical records extracted for the purpose of the study from all eligible participants who were enrolled into the study.'}, {'type': 'SECONDARY', 'title': 'Time to Best Response (BR)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '185', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Palbociclib', 'description': "Participants with HR positive/HER2 negative MBC who received at least 1 dose of palbociclib as part of the IPP were observed during the study. Data was collected both retrospectively and prospectively, from participants' medical records for a maximum of 3 years following index date. Index date was defined as the palbociclib treatment initiation date."}], 'classes': [{'title': 'Overall', 'denoms': [{'units': 'Participants', 'counts': [{'value': '185', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '3.5', 'groupId': 'OG000', 'lowerLimit': '0.1', 'upperLimit': '23.8'}]}]}, {'title': 'De novo status: Metastatic disease', 'denoms': [{'units': 'Participants', 'counts': [{'value': '55', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '3.4', 'groupId': 'OG000', 'lowerLimit': '0.1', 'upperLimit': '19.7'}]}]}, {'title': 'De novo status: Recurrent disease', 'denoms': [{'units': 'Participants', 'counts': [{'value': '130', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '3.6', 'groupId': 'OG000', 'lowerLimit': '0.2', 'upperLimit': '23.8'}]}]}, {'title': 'Relapse status: More than 12 months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '3.9', 'groupId': 'OG000', 'lowerLimit': '1.0', 'upperLimit': '23.2'}]}]}, {'title': 'Relapse status: De novo metastatic disease', 'denoms': [{'units': 'Participants', 'counts': [{'value': '55', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '3.4', 'groupId': 'OG000', 'lowerLimit': '0.1', 'upperLimit': '19.7'}]}]}, {'title': 'Relapse status: <=12 months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '59', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '3.8', 'groupId': 'OG000', 'lowerLimit': '0.2', 'upperLimit': '23.8'}]}]}, {'title': 'Relapse status: Missing', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '3.4', 'groupId': 'OG000', 'lowerLimit': '0.3', 'upperLimit': '11.0'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'From index date till BR or date of censoring (for a maximum period of 3 years)', 'description': 'Time to BR: time from index date until achievement of BR:CR or PR, if CR not achieved during follow-up. CR: disappearance of target, non-target lesions and normalization of tumor markers. Pathological lymph nodes had short axis measures \\<10 mm; PR: \\>=30% decrease in sum of measures (longest diameter for tumor lesions, short axis measure for nodes) of target lesions, taking reference baseline sum of diameters. Non-target lesions must be non-PD; PD: \\>=20% increase in sum of diameters of target lesions, taking as reference smallest sum on study, sum must demonstrate absolute increase of at least 5 mm or appearance of 1 or more new lesions. Alive participants with no events were censored at date of last response assessment. Data is also presented by de novo status and relapse status.', 'unitOfMeasure': 'Months', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS comprised of medical records extracted for the purpose of the study from all eligible participants who were enrolled into the study. Here, "overall number of participants analyzed" signifies participants evaluable for this outcome measure and "number analyzed" signifies number of participants evaluable for specified rows.'}, {'type': 'SECONDARY', 'title': 'Time to First Response', 'denoms': [{'units': 'Participants', 'counts': [{'value': '80', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Palbociclib', 'description': "Participants with HR positive/HER2 negative MBC who received at least 1 dose of palbociclib as part of the IPP were observed during the study. Data was collected both retrospectively and prospectively, from participants' medical records for a maximum of 3 years following index date. Index date was defined as the palbociclib treatment initiation date."}], 'classes': [{'title': 'Overall', 'denoms': [{'units': 'Participants', 'counts': [{'value': '80', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '115.5', 'groupId': 'OG000', 'lowerLimit': '4.0', 'upperLimit': '724.0'}]}]}, {'title': 'De novo status: Metastatic disease', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '93.0', 'groupId': 'OG000', 'lowerLimit': '4.0', 'upperLimit': '599.0'}]}]}, {'title': 'De novo status: Recurrent disease', 'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '127.5', 'groupId': 'OG000', 'lowerLimit': '53.0', 'upperLimit': '724.0'}]}]}, {'title': 'Relapse status: More than 12 months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '105.0', 'groupId': 'OG000', 'lowerLimit': '63.0', 'upperLimit': '706.0'}]}]}, {'title': 'Relapse status: De novo metastatic disease', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '93.0', 'groupId': 'OG000', 'lowerLimit': '4.0', 'upperLimit': '599.0'}]}]}, {'title': 'Relapse status: <=12 months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '166.0', 'groupId': 'OG000', 'lowerLimit': '76.0', 'upperLimit': '724.0'}]}]}, {'title': 'Relapse status: Missing', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '116.0', 'groupId': 'OG000', 'lowerLimit': '53.0', 'upperLimit': '258.0'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'From index date till first documented CR or PR or date of censoring (for a maximum period of 3 years)', 'description': 'Time to first response: time from index date until achievement of first response of CR or PR, if CR not achieved during follow-up. CR: disappearance of target, non-target lesions and normalization of tumor markers. Pathological lymph nodes had short axis measures \\<10 mm; PR: \\>=30% decrease in sum of measures (longest diameter for tumor lesions, short axis measure for nodes) of target lesions, taking reference baseline sum of diameters. Non-target lesions must be non-PD; PD: \\>=20% increase in sum of diameters of target lesions, taking as reference smallest sum on study, sum must demonstrate absolute increase of at least 5 mm or appearance of 1 or more new lesions. Alive participants with no events were censored at date of last response assessment. Data is also presented by de novo status and relapse status.', 'unitOfMeasure': 'Days', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS comprised of medical records extracted for the purpose of the study from all eligible participants who were enrolled into the study. Here, "overall number of participants analyzed" signifies participants evaluable for this outcome measure and "number analyzed" signifies number of participants evaluable for specified rows.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Neutropenia Post-Palbociclib Initiation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '191', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Palbociclib', 'description': "Participants with HR positive/HER2 negative MBC who received at least 1 dose of palbociclib as part of the IPP were observed during the study. Data was collected both retrospectively and prospectively, from participants' medical records for a maximum of 3 years following index date. Index date was defined as the palbociclib treatment initiation date."}], 'classes': [{'title': 'All grades', 'categories': [{'measurements': [{'value': '88', 'groupId': 'OG000'}]}]}, {'title': 'Grade 3', 'categories': [{'measurements': [{'value': '40', 'groupId': 'OG000'}]}]}, {'title': 'Grade 4', 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Data collected from index date up to 6 months post-palbociclib initiation (for a maximum period of 3 years)', 'description': 'Neutropenia is an abnormally low level of neutrophils with count \\<1500 neutrophils per microliter (mcL) in blood and was classified as per Common Toxicity Criteria (CTC) version 2.0 criteria: grade 1 (mild) with an absolute neutrophil count (ANC) of \\>=1500 to \\<2000 cells per mcL, grade 2 (moderate) with an ANC of \\>=1000 to \\<1500 cells per mcL, grade 3 (severe) with an ANC of \\>=500 to \\<1000 cells per mcL or grade 4 (severe) with an ANC lower than 500 cells per mcL. Percentage of participants with all grades, grade 3 and grade 4 were reported in this outcome measure. All grades category included grades 1 to grade 4.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS comprised of medical records extracted for the purpose of the study from all eligible participants who were enrolled into the study.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Neutropenia Post-Palbociclib Initiation as Recorded and Inferred From Clinical Notes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '190', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Palbociclib', 'description': "Participants with HR positive/HER2 negative MBC who received at least 1 dose of palbociclib as part of the IPP were observed during the study. Data was collected both retrospectively and prospectively, from participants' medical records for a maximum of 3 years following index date. Index date was defined as the palbociclib treatment initiation date."}], 'classes': [{'title': 'Grade 1', 'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}]}]}, {'title': 'Grade 2', 'categories': [{'measurements': [{'value': '14', 'groupId': 'OG000'}]}]}, {'title': 'Grade 3', 'categories': [{'measurements': [{'value': '25', 'groupId': 'OG000'}]}]}, {'title': 'Grade 4', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Data collected from index date up to 6 months post-palbociclib initiation (for a maximum period of 3 years)', 'description': 'Neutropenia is an abnormally low level of neutrophils with count \\<1500 neutrophils per mcL in blood and was classified as per CTC version 2.0 criteria: grade 1 (mild) with an ANC of \\>=1500 to \\<2000 cells per mcL, grade 2 (moderate) with an ANC of \\>=1000 to \\<1500 cells per mcL, grade 3 (severe) with an ANC of \\>=500 to \\<1000 cells per mcL or grade 4 (severe) with an ANC lower than 500 cells per mcL.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS comprised of medical records extracted for the purpose of the study from all eligible participants who were enrolled into the study. Here, "overall number of participants analyzed" signifies participants evaluable for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Neutropenia Post-Palbociclib Initiation as Recorded and Inferred From ANC Measurements', 'denoms': [{'units': 'Participants', 'counts': [{'value': '191', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Palbociclib', 'description': "Participants with HR positive/HER2 negative MBC who received at least 1 dose of palbociclib as part of the IPP were observed during the study. Data was collected both retrospectively and prospectively, from participants' medical records for a maximum of 3 years following index date. Index date was defined as the palbociclib treatment initiation date."}], 'classes': [{'title': 'Grade 1', 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}]}]}, {'title': 'Grade 2', 'categories': [{'measurements': [{'value': '31', 'groupId': 'OG000'}]}]}, {'title': 'Grade 3', 'categories': [{'measurements': [{'value': '40', 'groupId': 'OG000'}]}]}, {'title': 'Grade 4', 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Data collected from index date up to 6 months post-palbociclib initiation (for a maximum period of 3 years)', 'description': 'Neutropenia is an abnormally low level of neutrophils with count \\<1500 neutrophils per mcL in blood and was classified as per CTC version 2.0 criteria: grade 1 (mild) with an ANC of \\>=1500 to \\<2000 cells per mcL, grade 2 (moderate) with an ANC of \\>=1000 to \\<1500 cells per mcL, grade 3 (severe) with an ANC of \\>=500 to \\<1000 cells per mcL or grade 4 (severe) with an ANC lower than 500 cells per mcL.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS comprised of medical records extracted for the purpose of the study from all eligible participants who were enrolled into the study.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants According to the Severe Grade of Neutropenia', 'denoms': [{'units': 'Participants', 'counts': [{'value': '191', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Palbociclib', 'description': "Participants with HR positive/HER2 negative MBC who received at least 1 dose of palbociclib as part of the IPP were observed during the study. Data was collected both retrospectively and prospectively, from participants' medical records for a maximum of 3 years following index date. Index date was defined as the palbociclib treatment initiation date."}], 'classes': [{'title': 'Grade 3', 'categories': [{'measurements': [{'value': '37', 'groupId': 'OG000'}]}]}, {'title': 'Grade 4', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Data collected from index date up to 3 months post-palbociclib initiation (for a maximum period of 3 years)', 'description': 'Neutropenia is an abnormally low level of neutrophils with count \\<1500 neutrophils per mcL in blood and was classified as per CTC version 2.0 criteria: grade 1 (mild) with an ANC of \\>=1500 to \\<2000 cells per mcL, grade 2 (moderate) with an ANC of \\>=1000 to \\<1500 cells per mcL, grade 3 (severe) with an ANC of \\>=500 to \\<1000 cells per mcL or grade 4 (severe) with an ANC lower than 500 cells per mcL. Percentage of participants with grade 3 and 4 were reported in this outcome measure.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS comprised of medical records extracted for the purpose of the study from all eligible participants who were enrolled into the study.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Febrile Neutropenia Post-Palbociclib Initiation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '191', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Palbociclib', 'description': "Participants with HR positive/HER2 negative MBC who received at least 1 dose of palbociclib as part of the IPP were observed during the study. Data was collected both retrospectively and prospectively, from participants' medical records for a maximum of 3 years following index date. Index date was defined as the palbociclib treatment initiation date."}], 'classes': [{'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Data collected from index date up to 3 months post-palbociclib initiation (for a maximum period of 3 years)', 'description': 'Febrile neutropenia (FN) was defined as an ANC of \\< 1.0 x 10\\^9 cells/L predicted to fall below 0.5 x 10\\^9 cells/L within 48 hours with fever or clinical signs of sepsis; fever and ANC were measured the same day or within ± 1 calendar day.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS comprised of medical records extracted for the purpose of the study from all eligible participants who were enrolled into the study.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Gastro-Intestinal Toxicities Post-Palbociclib Initiation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '191', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Palbociclib', 'description': "Participants with HR positive/HER2 negative MBC who received at least 1 dose of palbociclib as part of the IPP were observed during the study. Data was collected both retrospectively and prospectively, from participants' medical records for a maximum of 3 years following index date. Index date was defined as the palbociclib treatment initiation date."}], 'classes': [{'title': 'Diarrhea: All grades', 'categories': [{'measurements': [{'value': '16', 'groupId': 'OG000'}]}]}, {'title': 'Diarrhea: Grade 3', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Diarrhea: Grade not available', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}]}]}, {'title': 'Nausea: All grades', 'categories': [{'measurements': [{'value': '18', 'groupId': 'OG000'}]}]}, {'title': 'Nausea: Grade 1', 'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000'}]}]}, {'title': 'Nausea: Grade 2', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Nausea: Grade not available', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}]}]}, {'title': 'Vomiting: All grades', 'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}]}]}, {'title': 'Vomiting: Grade 1', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}]}]}, {'title': 'Vomiting: Grade 2', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Vomiting: Grade not available', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Data collected from index date up to 1-year of follow up period (for a maximum period of 3 years)', 'description': 'Percentage of participants with gastro-intestinal toxicities as diarrhea, nausea and vomiting after index date were reported in this outcome measure. As per CTC version 2.0 criteria, for diarrhea: grade 1 (mild)- less than 4 stools per day, grade 2 (moderate)- 4 to 6 stools per day, grade 3 (severe)- \\>=7 stools per day and grade 4 (life-threatening)- physiologic consequences requiring intensive care; Vomiting: grade 1 (mild)- 1 episode per day , grade 2 (moderate)- 2 to 5 episodes per day, grade 3 (severe)- \\>=6 episodes per day and grade 4 (life-threatening)- physiologic consequences requiring intensive care; Nausea: grade 1 (mild)- able to eat, grade 2 (moderate)- oral intake significantly reduced, grade 3 (severe)- no significant intake and requiring intravenous fluids.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS comprised of medical records extracted for the purpose of the study from all eligible participants who were enrolled into the study.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Adverse Events During Follow-up', 'denoms': [{'units': 'Participants', 'counts': [{'value': '191', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Palbociclib', 'description': "Participants with HR positive/HER2 negative MBC who received at least 1 dose of palbociclib as part of the IPP were observed during the study. Data was collected both retrospectively and prospectively, from participants' medical records for a maximum of 3 years following index date. Index date was defined as the palbociclib treatment initiation date."}], 'classes': [{'categories': [{'measurements': [{'value': '72', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Data collected from index date up to 1-year of follow up period (for a maximum period of 3 years)', 'description': 'Percentage of participants with at least one of the adverse events (neutropenia, diarrhea, nausea, and vomiting) after index date were reported in this outcome measure.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS comprised of medical records extracted for the purpose of the study from all eligible participants who were enrolled into the study.'}, {'type': 'SECONDARY', 'title': 'Absolute Values for Hematology Parameter in First 6 Months Following Palbociclib Initiation: Hemoglobin', 'denoms': [{'units': 'Participants', 'counts': [{'value': '183', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Palbociclib', 'description': "Participants with HR positive/HER2 negative MBC who received at least 1 dose of palbociclib as part of the IPP were observed during the study. Data was collected both retrospectively and prospectively, from participants' medical records for a maximum of 3 years following index date. Index date was defined as the palbociclib treatment initiation date."}], 'classes': [{'categories': [{'measurements': [{'value': '120.5', 'spread': '10', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'From index date up to 6 months after palbociclib initiation (for a maximum period of 3 years)', 'description': 'Absolute values for hematology parameter- hemoglobin, were reported in this outcome measure.', 'unitOfMeasure': 'Grams per liter', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS comprised of medical records extracted for the purpose of the study from all eligible participants who were enrolled into the study. Here, "overall number of participants analyzed" signifies participants evaluable for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Absolute Values for Hematology Parameters in First 6 Months Following Palbociclib Initiation: White Blood Cell, Absolute Neutrophil Counts and Platelet Counts', 'denoms': [{'units': 'Participants', 'counts': [{'value': '183', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Palbociclib', 'description': "Participants with HR positive/HER2 negative MBC who received at least 1 dose of palbociclib as part of the IPP were observed during the study. Data was collected both retrospectively and prospectively, from participants' medical records for a maximum of 3 years following index date. Index date was defined as the palbociclib treatment initiation date."}], 'classes': [{'title': 'WBC', 'denoms': [{'units': 'Participants', 'counts': [{'value': '183', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '4', 'spread': '1.5', 'groupId': 'OG000'}]}]}, {'title': 'ANC', 'denoms': [{'units': 'Participants', 'counts': [{'value': '176', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '2', 'spread': '1.2', 'groupId': 'OG000'}]}]}, {'title': 'PLT', 'denoms': [{'units': 'Participants', 'counts': [{'value': '183', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '233.6', 'spread': '63.8', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Data collected from index date up to 6 months after palbociclib initiation (for a maximum period of 3 years)', 'description': 'Absolute values for hematology parameters- white blood cell (WBC) counts, absolute neutrophil counts (ANC) and platelet counts (PLT), were reported in this outcome measure.', 'unitOfMeasure': '10^9 cells per liter', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS comprised of medical records extracted for the purpose of the study from all eligible participants who were enrolled into the study. Here, "overall number of participants analyzed" signifies participants evaluable for this outcome measure and "number analyzed" signifies number of participants evaluable for specified rows.'}, {'type': 'SECONDARY', 'title': 'Absolute Values for Liver Function Parameters in First 6 Months Following Palbociclib Initiation: Aspartate Aminotransferase, Alanine Aminotransferase and Alkaline Phosphatase', 'denoms': [{'units': 'Participants', 'counts': [{'value': '174', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Palbociclib', 'description': "Participants with HR positive/HER2 negative MBC who received at least 1 dose of palbociclib as part of the IPP were observed during the study. Data was collected both retrospectively and prospectively, from participants' medical records for a maximum of 3 years following index date. Index date was defined as the palbociclib treatment initiation date."}], 'classes': [{'title': 'AST', 'denoms': [{'units': 'Participants', 'counts': [{'value': '112', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '26.9', 'spread': '17.9', 'groupId': 'OG000'}]}]}, {'title': 'ALT', 'denoms': [{'units': 'Participants', 'counts': [{'value': '138', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '24.5', 'spread': '19.4', 'groupId': 'OG000'}]}]}, {'title': 'ALP', 'denoms': [{'units': 'Participants', 'counts': [{'value': '174', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '100.8', 'spread': '69.3', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Data collected from index date up to 6 months after palbociclib initiation (for a maximum period of 3 years)', 'description': 'Absolute values for liver function parameters- Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT) and Alkaline Phosphatase (ALP), were reported in this outcome measure.', 'unitOfMeasure': 'International units per liter', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS comprised of medical records extracted for the purpose of the study from all eligible participants who were enrolled into the study. Here, "overall number of participants analyzed" signifies participants evaluable for this outcome measure and "number analyzed" signifies number of participants evaluable for specified rows.'}, {'type': 'SECONDARY', 'title': 'Absolute Values for Liver Function Parameter in First 6 Months Following Palbociclib Initiation: Albumin', 'denoms': [{'units': 'Participants', 'counts': [{'value': '178', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Palbociclib', 'description': "Participants with HR positive/HER2 negative MBC who received at least 1 dose of palbociclib as part of the IPP were observed during the study. Data was collected both retrospectively and prospectively, from participants' medical records for a maximum of 3 years following index date. Index date was defined as the palbociclib treatment initiation date."}], 'classes': [{'categories': [{'measurements': [{'value': '42.8', 'spread': '4.7', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Data collected from index date up to 6 months after palbociclib initiation (for a maximum period of 3 years)', 'description': 'Absolute values for liver function parameter- albumin, were reported in this outcome measure.', 'unitOfMeasure': 'Grams per deciliter', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS comprised of medical records extracted for the purpose of the study from all eligible participants who were enrolled into the study. Here, "overall number of participants analyzed" signifies participants evaluable for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Absolute Values for Liver Function Parameter in First 6 Months Following Palbociclib Initiation: Bilirubin', 'denoms': [{'units': 'Participants', 'counts': [{'value': '175', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Palbociclib', 'description': "Participants with HR positive/HER2 negative MBC who received at least 1 dose of palbociclib as part of the IPP were observed during the study. Data was collected both retrospectively and prospectively, from participants' medical records for a maximum of 3 years following index date. Index date was defined as the palbociclib treatment initiation date."}], 'classes': [{'categories': [{'measurements': [{'value': '6.9', 'spread': '3.6', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Data collected from index date up to 6 months after palbociclib initiation (for a maximum period of 3 years)', 'description': 'Absolute values for liver function parameter- bilirubin, were reported in this outcome measure.', 'unitOfMeasure': 'Milligrams per deciliter', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS comprised of medical records extracted for the purpose of the study from all eligible participants who were enrolled into the study. Here, "overall number of participants analyzed" signifies participants evaluable for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Absolute Values for Bone Profile Parameters in First 6 Months Following Palbociclib Initiation: Calcium and Phosphate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '167', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Palbociclib', 'description': "Participants with HR positive/HER2 negative MBC who received at least 1 dose of palbociclib as part of the IPP were observed during the study. Data was collected both retrospectively and prospectively, from participants' medical records for a maximum of 3 years following index date. Index date was defined as the palbociclib treatment initiation date."}], 'classes': [{'title': 'Calcium', 'denoms': [{'units': 'Participants', 'counts': [{'value': '167', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '2.3', 'spread': '0.1', 'groupId': 'OG000'}]}]}, {'title': 'Phosphate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '156', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1.1', 'spread': '0.2', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Data collected from index date up to 6 months after palbociclib initiation (for a maximum period of 3 years)', 'description': 'Absolute values for bone profile parameters- calcium and phosphate were reported in this outcome measure.', 'unitOfMeasure': 'Millimoles per liter', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS comprised of medical records extracted for the purpose of the study from all eligible participants who were enrolled into the study. Here, "overall number of participants analyzed" signifies participants evaluable for this outcome measure and "number analyzed" signifies number of participants evaluable for specified rows.'}, {'type': 'SECONDARY', 'title': 'Absolute Values for Clinical Chemistry Parameters in First 6 Months Following Palbociclib Initiation: Potassium, Sodium and Urea', 'denoms': [{'units': 'Participants', 'counts': [{'value': '168', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Palbociclib', 'description': "Participants with HR positive/HER2 negative MBC who received at least 1 dose of palbociclib as part of the IPP were observed during the study. Data was collected both retrospectively and prospectively, from participants' medical records for a maximum of 3 years following index date. Index date was defined as the palbociclib treatment initiation date."}], 'classes': [{'title': 'Potassium', 'denoms': [{'units': 'Participants', 'counts': [{'value': '168', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '4.3', 'spread': '0.4', 'groupId': 'OG000'}]}]}, {'title': 'Sodium', 'denoms': [{'units': 'Participants', 'counts': [{'value': '168', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '139.4', 'spread': '10.6', 'groupId': 'OG000'}]}]}, {'title': 'Urea', 'denoms': [{'units': 'Participants', 'counts': [{'value': '152', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '5.8', 'spread': '11.2', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Data collected from index date up to 6 months after palbociclib initiation (for a maximum period of 3 years)', 'description': 'Absolute values for clinical chemistry parameters- potassium, sodium and urea were reported in this outcome measure.', 'unitOfMeasure': 'Millimoles per liter', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS comprised of medical records extracted for the purpose of the study from all eligible participants who were enrolled into the study. Here, "overall number of participants analyzed" signifies participants evaluable for this outcome measure and "number analyzed" signifies number of participants evaluable for specified rows.'}, {'type': 'SECONDARY', 'title': 'Absolute Values for Clinical Chemistry Parameter in First 6 Months Following Palbociclib Initiation: Creatinine', 'denoms': [{'units': 'Participants', 'counts': [{'value': '168', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Palbociclib', 'description': "Participants with HR positive/HER2 negative MBC who received at least 1 dose of palbociclib as part of the IPP were observed during the study. Data was collected both retrospectively and prospectively, from participants' medical records for a maximum of 3 years following index date. Index date was defined as the palbociclib treatment initiation date."}], 'classes': [{'categories': [{'measurements': [{'value': '70.6', 'spread': '16.1', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Data collected from index date up to 6 months after palbociclib initiation (for a maximum period of 3 years)', 'description': 'Absolute values for clinical chemistry parameter- creatinine, were reported in this outcome measure.', 'unitOfMeasure': 'Micromoles per liter', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS comprised of medical records extracted for the purpose of the study from all eligible participants who were enrolled into the study. Here, "overall number of participants analyzed" signifies participants evaluable for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Inpatient Admissions and Outpatient Visits', 'denoms': [{'units': 'Participants', 'counts': [{'value': '191', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Palbociclib', 'description': "Participants with HR positive/HER2 negative MBC who received at least 1 dose of palbociclib as part of the IPP were observed during the study. Data was collected both retrospectively and prospectively, from participants' medical records for a maximum of 3 years following index date. Index date was defined as the palbociclib treatment initiation date."}], 'classes': [{'title': 'Inpatient Admissions', 'categories': [{'measurements': [{'value': '28', 'groupId': 'OG000'}]}]}, {'title': 'Outpatient Visits', 'categories': [{'measurements': [{'value': '77', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Data collected from index date up to 1-year of follow up period (for a maximum period of 3 years)', 'description': 'Percentage of participants with inpatient admissions and outpatient visits were reported in this outcome measure.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS comprised of medical records extracted for the purpose of the study from all eligible participants who were enrolled into the study.'}, {'type': 'SECONDARY', 'title': 'Number of Inpatient Admissions Per Participant', 'denoms': [{'units': 'Participants', 'counts': [{'value': '53', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Palbociclib', 'description': "Participants with HR positive/HER2 negative MBC who received at least 1 dose of palbociclib as part of the IPP were observed during the study. Data was collected both retrospectively and prospectively, from participants' medical records for a maximum of 3 years following index date. Index date was defined as the palbociclib treatment initiation date."}], 'classes': [{'categories': [{'measurements': [{'value': '1.4', 'spread': '0.7', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Data collected from index date up to 1-year of follow up period (for a maximum period of 3 years)', 'unitOfMeasure': 'Admissions per participant', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS comprised of medical records extracted for the purpose of the study from all eligible participants who were enrolled into the study. Here, "overall number of participants analyzed" signifies participants evaluable for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Number of Outpatient Visits Per Participant', 'denoms': [{'units': 'Participants', 'counts': [{'value': '147', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Palbociclib', 'description': "Participants with HR positive/HER2 negative MBC who received at least 1 dose of palbociclib as part of the IPP were observed during the study. Data was collected both retrospectively and prospectively, from participants' medical records for a maximum of 3 years following index date. Index date was defined as the palbociclib treatment initiation date."}], 'classes': [{'categories': [{'measurements': [{'value': '9.5', 'spread': '7.5', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Data collected from index date up to 1-year of follow up period (for a maximum period of 3 years)', 'unitOfMeasure': 'Visits per participant', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS comprised of medical records extracted for the purpose of the study from all eligible participants who were enrolled into the study. Here, "overall number of participants analyzed" signifies participants evaluable for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Type of Hospital Admission', 'denoms': [{'units': 'Participants', 'counts': [{'value': '73', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Palbociclib', 'description': "Participants with HR positive/HER2 negative MBC who received at least 1 dose of palbociclib as part of the IPP were observed during the study. Data was collected both retrospectively and prospectively, from participants' medical records for a maximum of 3 years following index date. Index date was defined as the palbociclib treatment initiation date."}], 'classes': [{'title': 'Accident and emergency', 'categories': [{'measurements': [{'value': '86', 'groupId': 'OG000'}]}]}, {'title': 'Planned', 'categories': [{'measurements': [{'value': '14', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Data collected from index date up to 1-year of follow up period (for a maximum period of 3 years)', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS comprised of medical records extracted for the purpose of the study from all eligible participants who were enrolled into the study. Here, "overall number of participants analyzed" signifies participants evaluable for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Reasons for Hospital Admission', 'denoms': [{'units': 'Participants', 'counts': [{'value': '73', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Palbociclib', 'description': "Participants with HR positive/HER2 negative MBC who received at least 1 dose of palbociclib as part of the IPP were observed during the study. Data was collected both retrospectively and prospectively, from participants' medical records for a maximum of 3 years following index date. Index date was defined as the palbociclib treatment initiation date."}], 'classes': [{'title': 'Blood tests', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}]}]}, {'title': 'Breathlessness', 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}]}]}, {'title': 'Collapse and transfer to the ward', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Hypocalcemia', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Hypoxia', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Incidental deep vein thrombosis (DVT)', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Palliative Mastectomy', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Pleural Effusion', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Pyrexia', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Sepsis', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Shortness of breath and clinically progressive disease', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Small bowel obstruction: no clear cause', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Surgery: appendicectomy', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Swollen/Painful left arm seen by general practitioner (GP)/DVT/cellulitis', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Temperature', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Transfusion', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Unwell', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Urgent review', 'categories': [{'measurements': [{'value': '66', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Data collected from index date up to 1-year of follow up period (for a maximum period of 3 years)', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS comprised of medical records extracted for the purpose of the study from all eligible participants who were enrolled into the study. Here, "overall number of participants analyzed" signifies participants evaluable for this outcome measure. One participant could have more than 1 reason for hospital admission.'}, {'type': 'SECONDARY', 'title': 'Duration of Inpatient Hospital Stay', 'denoms': [{'units': 'Participants', 'counts': [{'value': '67', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Palbociclib', 'description': "Participants with HR positive/HER2 negative MBC who received at least 1 dose of palbociclib as part of the IPP were observed during the study. Data was collected both retrospectively and prospectively, from participants' medical records for a maximum of 3 years following index date. Index date was defined as the palbociclib treatment initiation date."}], 'classes': [{'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000', 'lowerLimit': '1.0', 'upperLimit': '54.0'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Data collected from index date up to 1-year of follow up period (for a maximum period of 3 years)', 'description': 'Duration of hospital stay was the time from the date of hospital entry to date of hospital discharge.', 'unitOfMeasure': 'Days', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS comprised of medical records extracted for the purpose of the study from all eligible participants who were enrolled into the study. Here, "overall number of participants analyzed" signifies participants evaluable for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Reasons of Outpatient Visit', 'denoms': [{'units': 'Participants', 'counts': [{'value': '191', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Palbociclib', 'description': "Participants with HR positive/HER2 negative MBC who received at least 1 dose of palbociclib as part of the IPP were observed during the study. Data was collected both retrospectively and prospectively, from participants' medical records for a maximum of 3 years following index date. Index date was defined as the palbociclib treatment initiation date."}], 'classes': [{'title': 'Bloods', 'categories': [{'measurements': [{'value': '40', 'groupId': 'OG000'}]}]}, {'title': 'Bloods, Zoladex and Denosumab', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}]}]}, {'title': 'Capecitabine pick up', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Chemotherapy', 'categories': [{'measurements': [{'value': '44', 'groupId': 'OG000'}]}]}, {'title': 'Dalteparin administration', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Denosumab', 'categories': [{'measurements': [{'value': '27', 'groupId': 'OG000'}]}]}, {'title': 'Denosumab + bloods', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}, {'title': 'Denosumab + Palbociclib handout', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Discontinuation of palbociclib discussed', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Follow-up', 'categories': [{'measurements': [{'value': '1041', 'groupId': 'OG000'}]}]}, {'title': 'Genetics testing', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}, {'title': 'Given treatment', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}]}]}, {'title': 'Goserelin + Denosumab', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Goserelin treatment', 'categories': [{'measurements': [{'value': '21', 'groupId': 'OG000'}]}]}, {'title': 'Home visit from palliative care', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}]}]}, {'title': 'Information about disease/treatment', 'categories': [{'measurements': [{'value': '123', 'groupId': 'OG000'}]}]}, {'title': 'Insertion of central venous access device', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Lymphoedema review', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}, {'title': 'Medical concerns', 'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000'}]}]}, {'title': 'Oral chemotherapy clinic', 'categories': [{'measurements': [{'value': '22', 'groupId': 'OG000'}]}]}, {'title': 'Palbociclib pick up, Zoladex and Denosumab', 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}]}]}, {'title': 'Palbociclib Initiation', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}, {'title': 'Palliative care appointment', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}]}]}, {'title': 'Peripherally inserted central catheter (PICC) line insertion', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}, {'title': 'Pick up Cyclophosphamide /Methotrexate', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}, {'title': 'Pick up palbociclib', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}]}]}, {'title': 'Radiotherapy appointment', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Review before discharge', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Treatment initiation', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Trial initiation (1st dose & consent)', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Zoledronic acid', 'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Data collected from index date up to 1-year of follow up period (for a maximum period of 3 years)', 'unitOfMeasure': 'Events', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS comprised of medical records extracted for the purpose of the study from all eligible participants who were enrolled into the study. Here, one participant could have more than one event.'}, {'type': 'SECONDARY', 'title': 'Type of Health Care Professional Consultations During Outpatient Visit', 'denoms': [{'units': 'Participants', 'counts': [{'value': '191', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Palbociclib', 'description': "Participants with HR positive/HER2 negative MBC who received at least 1 dose of palbociclib as part of the IPP were observed during the study. Data was collected both retrospectively and prospectively, from participants' medical records for a maximum of 3 years following index date. Index date was defined as the palbociclib treatment initiation date."}], 'classes': [{'title': 'Advanced nurse practitioner (ANP)', 'categories': [{'measurements': [{'value': '47', 'groupId': 'OG000'}]}]}, {'title': 'Consultant', 'categories': [{'measurements': [{'value': '772', 'groupId': 'OG000'}]}]}, {'title': 'Nurse', 'categories': [{'measurements': [{'value': '284', 'groupId': 'OG000'}]}]}, {'title': 'Pharmacist', 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}]}]}, {'title': 'Specialist registrar (SpR)', 'categories': [{'measurements': [{'value': '209', 'groupId': 'OG000'}]}]}, {'title': 'Other', 'categories': [{'measurements': [{'value': '45', 'groupId': 'OG000'}]}]}, {'title': 'Not known', 'categories': [{'measurements': [{'value': '30', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Data collected from index date up to 1-year of follow up period (for a maximum period of 3 years)', 'unitOfMeasure': 'Consultations', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS comprised of medical records extracted for the purpose of the study from all eligible participants who were enrolled into the study. Here, one participant could consult more than one health care professional.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Contacted Cancer National Service (CNS) and Acute Oncology Service (AOS) During First Year After Palbociclib Initiation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '191', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Palbociclib', 'description': "Participants with HR positive/HER2 negative MBC who received at least 1 dose of palbociclib as part of the IPP were observed during the study. Data was collected both retrospectively and prospectively, from participants' medical records for a maximum of 3 years following index date. Index date was defined as the palbociclib treatment initiation date."}], 'classes': [{'title': 'CNS', 'categories': [{'measurements': [{'value': '36', 'groupId': 'OG000'}]}]}, {'title': 'AOS', 'categories': [{'measurements': [{'value': '19', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Data collected from index date up to 1-year of follow up period (for a maximum period of 3 years)', 'description': 'Percentage of participants who contacted CNS by phone calls and AOS either by phone calls or visits were reported in this outcome measure.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS comprised of medical records extracted for the purpose of the study from all eligible participants who were enrolled into the study.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants According to Number of CNS Interactions', 'denoms': [{'units': 'Participants', 'counts': [{'value': '69', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Palbociclib', 'description': "Participants with HR positive/HER2 negative MBC who received at least 1 dose of palbociclib as part of the IPP were observed during the study. Data was collected both retrospectively and prospectively, from participants' medical records for a maximum of 3 years following index date. Index date was defined as the palbociclib treatment initiation date."}], 'classes': [{'title': '1', 'categories': [{'measurements': [{'value': '17', 'groupId': 'OG000'}]}]}, {'title': '2', 'categories': [{'measurements': [{'value': '26', 'groupId': 'OG000'}]}]}, {'title': '3', 'categories': [{'measurements': [{'value': '19', 'groupId': 'OG000'}]}]}, {'title': '4', 'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000'}]}]}, {'title': '5', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': '6', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}]}]}, {'title': '7', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': '8', 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}]}]}, {'title': '9', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}]}]}, {'title': '10', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}]}]}, {'title': '11', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': '14', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Data collected from index date up to 1-year of follow up period (for a maximum period of 3 years)', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS comprised of medical records extracted for the purpose of the study from all eligible participants who were enrolled into the study. Here, "overall number of participants analyzed" signifies participants evaluable for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Number of AOS Interactions Per Participant', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Palbociclib', 'description': "Participants with HR positive/HER2 negative MBC who received at least 1 dose of palbociclib as part of the IPP were observed during the study. Data was collected both retrospectively and prospectively, from participants' medical records for a maximum of 3 years following index date. Index date was defined as the palbociclib treatment initiation date."}], 'classes': [{'categories': [{'measurements': [{'value': '2.1', 'spread': '1.2', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Data collected from index date up to 1-year of follow up period (for a maximum period of 3 years)', 'unitOfMeasure': 'Interactions per participant', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS comprised of medical records extracted for the purpose of the study from all eligible participants who were enrolled into the study. Here, "overall number of participants analyzed" signifies participants evaluable for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Type of CNS and AOS Interactions', 'denoms': [{'units': 'Participants', 'counts': [{'value': '191', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Palbociclib', 'description': "Participants with HR positive/HER2 negative MBC who received at least 1 dose of palbociclib as part of the IPP were observed during the study. Data was collected both retrospectively and prospectively, from participants' medical records for a maximum of 3 years following index date. Index date was defined as the palbociclib treatment initiation date."}], 'classes': [{'title': 'CNS interactions: Phone call', 'categories': [{'measurements': [{'value': '124', 'groupId': 'OG000'}]}]}, {'title': 'CNS interactions: Visit', 'categories': [{'measurements': [{'value': '133', 'groupId': 'OG000'}]}]}, {'title': 'CNS interactions: Other', 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}]}]}, {'title': 'AOS interactions: Phone call', 'categories': [{'measurements': [{'value': '49', 'groupId': 'OG000'}]}]}, {'title': 'AOS interactions: Visit', 'categories': [{'measurements': [{'value': '25', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Data collected from index date up to 1-year of follow up period (for a maximum period of 3 years)', 'unitOfMeasure': 'Interactions', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS comprised of medical records extracted for the purpose of the study from all eligible participants who were enrolled into the study. Here, one participant could have more than one interaction.'}, {'type': 'SECONDARY', 'title': 'Reasons for CNS and AOS Interaction', 'denoms': [{'units': 'Participants', 'counts': [{'value': '191', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Palbociclib', 'description': "Participants with HR positive/HER2 negative MBC who received at least 1 dose of palbociclib as part of the IPP were observed during the study. Data was collected both retrospectively and prospectively, from participants' medical records for a maximum of 3 years following index date. Index date was defined as the palbociclib treatment initiation date."}], 'classes': [{'title': 'CNS interactions: Follow-up', 'categories': [{'measurements': [{'value': '157', 'groupId': 'OG000'}]}]}, {'title': 'CNS interactions: General health and wellbeing check', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}, {'title': 'CNS interactions: Information about scans/appointments', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}, {'title': 'CNS interactions: Information about disease/treatment', 'categories': [{'measurements': [{'value': '44', 'groupId': 'OG000'}]}]}, {'title': 'CNS interactions: Medical concerns', 'categories': [{'measurements': [{'value': '44', 'groupId': 'OG000'}]}]}, {'title': 'CNS interactions: Psychological support', 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}]}]}, {'title': 'CNS interactions: Admin issue', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'CNS interactions: Clinical letter query', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'CNS interactions: Computed tomographic of chest, abdomen and pelvis (CT CAP) query', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'CNS interactions: Discussion about further dental work and denosumab injection', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'CNS interactions: Not known', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'CNS interactions: Pain issues', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'CNS interactions: Scan/blood test', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'CNS interactions: Treatment schedule', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'AOS interactions: Follow-up', 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}]}]}, {'title': 'AOS interactions: Information about disease/treatment', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}]}]}, {'title': 'AOS interactions: Inpatient admission', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'AOS interactions: Medical concerns', 'categories': [{'measurements': [{'value': '60', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Data collected from index date up to 1-year of follow up period (for a maximum period of 3 years)', 'unitOfMeasure': 'Events', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS comprised of medical records extracted for the purpose of the study from all eligible participants who were enrolled into the study. Here, one participant could have more than one event.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Palbociclib', 'description': "Participants with HR positive/HER2 negative MBC who received at least 1 dose of palbociclib as part of the IPP were observed during the study. Data was collected both retrospectively and prospectively, from participants' medical records for a maximum of 3 years following index date. Index date was defined as the palbociclib treatment initiation date."}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '191'}]}, {'type': 'COMPLETED', 'achievements': [{'comment': 'Out of these 191 participants, 3 participants died. But data available before censoring date for these 3 participants were observed and included in results.', 'groupId': 'FG000', 'numSubjects': '191'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Participants who had hormone receptor (HR) positive, human epidermal growth factor 2 (HER2) negative metastatic breast cancer (MBC) and were treated with palbociclib in the United Kingdom Ibrance Patient Program (IPP), in between 2018 to 2021 were observed in this study. Data collected from hospital medical records were observed both retrospectively and prospectively for approximately 3 years in this study.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '191', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Palbociclib', 'description': "Participants with HR positive/HER2 negative MBC who received at least 1 dose of palbociclib as part of the IPP were observed during the study. Data was collected both retrospectively and prospectively, from participants' medical records for a maximum of 3 years following index date. Index date was defined as the palbociclib treatment initiation date."}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '57.6', 'spread': '12.8', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': 'NA', 'comment': 'Due to low enrollment in one category, providing data would risk re-identification of participants.', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': 'NA', 'comment': 'Due to low enrollment in one category, providing data would risk re-identification of participants.', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'categories': [{'title': 'White', 'measurements': [{'value': '169', 'groupId': 'BG000'}]}, {'title': 'Black', 'measurements': [{'value': '8', 'groupId': 'BG000'}]}, {'title': 'Asian', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': 'Other', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': 'Missing', 'measurements': [{'value': '12', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'The full analysis set (FAS) comprised of medical records extracted for the purpose of the study from all eligible participants who were enrolled into the study.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2018-11-12', 'size': 867020, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2022-06-03T12:37', 'hasProtocol': True}, {'date': '2022-01-17', 'size': 627973, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2022-06-03T12:37', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 191}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-03-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-06', 'completionDateStruct': {'date': '2021-03-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-06-03', 'studyFirstSubmitDate': '2019-04-17', 'resultsFirstSubmitDate': '2022-03-03', 'studyFirstSubmitQcDate': '2019-04-17', 'lastUpdatePostDateStruct': {'date': '2023-03-17', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2022-06-03', 'studyFirstPostDateStruct': {'date': '2019-04-19', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2023-03-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-03-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of Participants According to Treatment Lines', 'timeFrame': 'At baseline', 'description': 'Percentage of participants according to treatment lines during anytime between breast cancer (BC) diagnosis and index date were reported in this outcome measure. Treatment lines included: 1) 1st line where, palbociclib was prescribed as the first line treatment for MBC, 2) 1st line palbociclib added to letrozole where, palbociclib was prescribed as the first line treatment along with ongoing letrozole treatment which was prescribed more than 3 months prior to initiation of palbociclib, 3) 2nd line where palbociclib was prescribed as the second or later treatment line for MBC.'}, {'measure': 'Time From Letrozole to Palbociclib Initiation', 'timeFrame': 'At baseline', 'description': 'Time from letrozole was defined as duration from the start date of letrozole which was ongoing at the time of palbociclib treatment initiation up to the index date.'}, {'measure': 'Number of Participants With Menopausal Status', 'timeFrame': 'At baseline', 'description': 'Number of participants with menopausal status as pre-menopausal, peri-menopausal, post-menopausal and not applicable (NA), during anytime between initial BC disease diagnosis and index date were reported in this outcome measure.'}, {'measure': 'Percentage of Participants According to Disease Free Interval at Palbociclib Initiation', 'timeFrame': 'At baseline', 'description': 'Disease free interval was defined as the time from the date of last known neo-adjuvant hormone therapy to the date of MBC diagnosis.'}, {'measure': 'Percentage of Participants With Primary or Recurrent Metastatic Breast Cancer Diagnosis', 'timeFrame': 'At baseline', 'description': 'Percentage of participants with de novo and recurrent metastatic disease, during anytime between MBC disease diagnosis and index date were reported in this outcome measure.'}, {'measure': 'Percentage of Participants With Lymph Nodes Involvement', 'timeFrame': 'At baseline', 'description': 'Percentage of participants with lymph nodes involvement during anytime between initial BC disease diagnosis and index date were reported in this outcome measure. Data for this outcome measure is also presented by de novo status.'}, {'measure': 'Number of Lymph Nodes Involved', 'timeFrame': 'At baseline', 'description': 'Number of lymph nodes involved during anytime between initial BC disease diagnosis and index date were reported in this outcome measure. Data for this outcome measure is also presented by de novo status.'}, {'measure': 'Number of Participants With Estrogen, Progesterone and Human Epidermal Growth Factor 2 (HER2) Receptor Status', 'timeFrame': 'At baseline', 'description': 'Number of participants with estrogen, progesterone and HER2 receptor status during anytime between initial BC disease diagnosis and index date were reported in this outcome measure.'}, {'measure': 'Percentage of Participants Who Had Rebiopsy After Metastatic Disease Diagnosis', 'timeFrame': 'At baseline', 'description': 'Percentage of participants who had rebiopsy during anytime between MBC disease diagnosis and index date were reported in this outcome measure.'}, {'measure': 'Percentage of Participants According to Tumor Stage', 'timeFrame': 'At baseline', 'description': 'Percentage of participants with tumor stages 0, 1, 2, 3 and 4, as per Tumor, Node, Metastasis (TNM) staging system, during anytime between initial BC disease diagnosis and index date were reported in this outcome measure. As per TNM staging system, tumor stage 0 indicates main tumor cannot be found; tumor stages 1, 2, 3 and 4 refers to the size and/or extent of the main tumor. The higher the number, the larger the tumor and/or the more it has spread into nearby tissues. Data for this outcome measure is also presented by de novo status.'}, {'measure': 'Percentage of Participants According to Nodal Status', 'timeFrame': 'At baseline', 'description': 'Percentage of participants with nodal stages 0, 1, 2 and 3, as per TNM staging system, during anytime between initial BC disease diagnosis and index date were reported in this outcome measure. As per TNM staging system, nodal stage 0 indicates no cancer in regional lymph nodes; nodal stages 1= cancer has spread to 1 to 3 lymph nodes; nodal stage 2= cancer has spread to 4 to 9 lymph nodes, nodal stage 3= indicates the cancer has spread to 10 or more lymph nodes. Data for this outcome measure is also presented by de novo status.'}, {'measure': 'Percentage of Participants According to Metastasis', 'timeFrame': 'At baseline', 'description': 'Percentage of participants with metastasis stages 0 and 1, as per TNM staging system, during anytime between MBC disease diagnosis and index date were reported in this outcome measure. As per TNM staging system, metastasis stage 0 indicates cancer has not spread to other parts of the body; metastasis stage 1 indicates that the cancer has spread to distant parts of the body. Data for this outcome measure is also presented by de novo status.'}, {'measure': 'Tumor Size at Palbociclib Initiation', 'timeFrame': 'At baseline'}, {'measure': 'Percentage of Participants According to Tumor Grade', 'timeFrame': 'At baseline', 'description': 'Percentage of participants with tumor grades, during anytime between initial BC disease diagnosis and index date were reported in this outcome measure. Grades of disease was classified as grades 1, 2 and 3. As per TNM system, grade 1= well differentiated cells, low grade; grade 2= moderately differentiated cells, intermediate grade and grade 3= poorly differentiated cells, high grade.'}, {'measure': 'Percentage of Participants With Ki-67 Protein Proliferation Index Recorded', 'timeFrame': 'At baseline', 'description': 'Percentage of participants with Ki-67 protein proliferation index during anytime between initial BC disease diagnosis and index date were reported in this outcome measure. The Ki-67 protein is a cellular marker for proliferation. Ki-67 is a protein in cells that increases as cells prepare to divide into new cells. A staining process can measure the percentage of tumor cells that are positive for Ki-67. More positive cells hasten in dividing and forming new cells. Proliferation index was measured by the percentage of cells staining for Ki-67.'}, {'measure': 'Ki-67 Protein Proliferation Index', 'timeFrame': 'At baseline', 'description': 'The Ki-67 protein is a cellular marker for proliferation. Ki-67 is a protein in cells that increases as cells prepare to divide into new cells. A staining process can measure the percentage of tumor cells that are positive for Ki-67. More positive cells hasten in dividing and forming new cells. Proliferation index was measured by the percentage of cells staining for Ki-67.'}, {'measure': 'Percentage of Participants With Eastern Cooperative Oncology Group Performance Score (ECOG PS)', 'timeFrame': 'At baseline', 'description': 'ECOG PS measured quality of life of cancer participants on a 0 to 5 scale; 0= fully active, able to carry on all pre-disease performance without restriction; 1= restricted in physically strenuous activity, ambulatory, able to carry out light/sedentary work; 2= ambulatory, capable of all self-care, unable to carry out any work activity, up \\>50 % of waking hours; 3= capable of only limited self-care, confined to bed/ chair \\>50% of waking hours; 4= completely disabled, cannot carry on any self-care, totally confined to bed or chair; 5= dead. Higher scores indicated worsening of quality of life.'}, {'measure': 'Percentage of Participants With Recurrence Type', 'timeFrame': 'At baseline', 'description': 'Percentage of participants with recurrence type during anytime between initial BC disease diagnosis and index date were reported in this outcome measure.'}, {'measure': 'Percentage of Participants According to Number of Metastatic Sites', 'timeFrame': 'At baseline', 'description': 'Percentage of participants according to number of metastatic sites during anytime between initial BC disease diagnosis and index date were reported in this outcome measure.'}, {'measure': 'Percentage of Participants According to Location of Metastases', 'timeFrame': 'At baseline', 'description': 'Percentage of participants according to location of metastases, during anytime between initial BC disease diagnosis and index date were reported in this outcome measure.'}, {'measure': 'Percentage of Participants With Non-Visceral Location of Metastases', 'timeFrame': 'At baseline', 'description': 'Percentage of participants with non-visceral location of metastases, during anytime between initial BC disease diagnosis and index date were reported in this outcome measure.'}, {'measure': 'Number of Participants According to Metastatic Sites With Locoregional Recurrence', 'timeFrame': 'At baseline', 'description': 'Number of participants according to metastatic sites with locoregional recurrence, during anytime between initial BC disease diagnosis and index date were reported in this outcome measure. Metastatic sites with locoregional recurrence included bone, breast, lung, pleural, regional lymph nodes and other sites.'}, {'measure': 'Duration of Disease at Initiation of Palbociclib', 'timeFrame': 'At baseline', 'description': 'Duration of BC disease was the time duration between date of BC disease diagnosis to palbociclib treatment initiation date.'}, {'measure': 'Percentage of Participants Who Received Chemotherapy in Adjuvant or Neoadjuvant Setting', 'timeFrame': 'At baseline', 'description': 'Percentage of participants who received chemotherapy in adjuvant or neoadjuvant setting, during anytime between initial BC disease diagnosis and index date were reported in this outcome measure.'}, {'measure': 'Percentage of Participants Who Received Chemotherapy in Advanced, Disease Modifying or Metastatic Setting', 'timeFrame': 'At baseline', 'description': 'Percentage of participants who received chemotherapy in advanced, disease modifying or metastatic setting, during anytime between initial BC disease diagnosis and index date were reported in this outcome measure.'}, {'measure': 'Number of Lines of Prior Chemotherapy for Metastatic Disease', 'timeFrame': 'At baseline', 'description': 'Number of lines of prior chemotherapy for metastatic disease during anytime between MBC disease diagnosis and index date were reported in this outcome measure.'}, {'measure': 'Percentage of Participants Who Received Luteinizing Hormone Releasing Hormone (LHRH) or Chemotherapy', 'timeFrame': 'At baseline', 'description': 'Percentage of participants who received LHRH or chemotherapy, during anytime between initial BC disease diagnosis and index date were reported in this outcome measure.'}, {'measure': 'Percentage of Participants Who Received Endocrine Therapy in Adjuvant or Neoadjuvant Setting', 'timeFrame': 'At baseline', 'description': 'Percentage of participants who received endocrine therapy in adjuvant or neoadjuvant setting, during anytime between initial BC disease diagnosis and index date were reported in this outcome measure.'}, {'measure': 'Number of Participants With Types of Endocrine Therapy in Adjuvant or Neoadjuvant Setting', 'timeFrame': 'At baseline', 'description': 'Number of participants with types of endocrine therapy in adjuvant or neoadjuvant setting, during anytime between initial BC disease diagnosis and index date were reported in this outcome measure.'}, {'measure': 'Percentage of Participants Who Received Endocrine Therapy in Advanced, Disease Modifying or Metastatic Setting', 'timeFrame': 'At baseline', 'description': 'Percentage of participants who received endocrine therapy in advanced, disease modifying or metastatic setting, during anytime between initial BC disease diagnosis and index date were reported in this outcome measure.'}, {'measure': 'Percentage of Participants With Type of Endocrine Therapy in Advanced, Disease Modifying or Metastatic Setting', 'timeFrame': 'At baseline', 'description': 'Percentage of participants with type of endocrine therapy in advanced, disease modifying or metastatic setting, during anytime between initial BC disease diagnosis and index date were reported in this outcome measure.'}, {'measure': 'Number of Lines of Prior Endocrine Therapy for Metastatic Disease', 'timeFrame': 'At baseline', 'description': 'Number of lines of prior endocrine therapy for metastatic disease during anytime between MBC disease diagnosis and index date were reported in this outcome measure.'}, {'measure': 'Number of Participants Who Received Radiotherapy in Advanced, Disease Modifying or Metastatic Setting', 'timeFrame': 'At baseline', 'description': 'Number of participants who received radiotherapy in advanced, disease modifying or metastatic setting, during anytime between MBC disease diagnosis and index date were reported in this outcome measure.'}, {'measure': 'Percentage of Participants Who Received Concomitant Medications', 'timeFrame': 'At baseline', 'description': 'Percentage of participants who received concomitant medications, during anytime between initial BC disease diagnosis and index date were reported in this outcome measure.'}, {'measure': 'Number of Participants With Concomitant Medications Prescribed Along With Goserelin', 'timeFrame': 'At baseline', 'description': 'Number of participants with concomitant medications prescribed along with goserelin, during anytime between initial BC disease diagnosis and index date were reported in this outcome measure. Goserelin is the generic drug with a brand name Zoladex.'}, {'measure': 'Number of Participants According to Number of Prior Treatments in Metastatic Setting', 'timeFrame': 'At baseline', 'description': 'Number of participants according to number of prior treatments in metastatic setting, during anytime between MBC disease diagnosis and index date were reported in this outcome measure.'}, {'measure': 'Number of Participants According to Number of Prior Chemotherapy and Hormone Therapy in Metastatic Setting', 'timeFrame': 'At baseline', 'description': 'Number of participants according to number of prior chemotherapy and hormone therapy in metastatic setting, during anytime between MBC disease diagnosis and index date were reported in this outcome measure.'}, {'measure': 'Number of Participants According to Number of Prior Chemotherapies in Metastatic Setting', 'timeFrame': 'At baseline', 'description': 'Number of participants according to number of prior chemotherapies in metastatic setting, during anytime between MBC disease diagnosis and index date were reported in this outcome measure.'}, {'measure': 'Number of Participants According to Number of Prior Hormone Therapies in Metastatic Setting', 'timeFrame': 'At baseline', 'description': 'Number of participants according to number of prior hormone therapies in metastatic setting, during anytime between MBC disease diagnosis and index date were reported in this outcome measure.'}], 'secondaryOutcomes': [{'measure': 'Percentage of Participants With Their Starting Dose of Palbociclib', 'timeFrame': 'Data collected at index date (for a maximum period of 3 years)', 'description': 'Percentage of participants with their starting dose of palbociclib were reported.'}, {'measure': 'Percentage of Participants Who Received Endocrine Therapy Along With Palbociclib', 'timeFrame': 'Data collected from index date until lost to follow up or end of follow up, whichever occurred first (for a maximum period of 3 years)', 'description': 'Percentage of participants who received endocrine therapy along with palbociclib were reported in this outcome measure. Endocrine therapy includes anastrozole, exemestane, fulvestrant and letrozole.'}, {'measure': 'Percentage of Participants With Dose Reductions and Treatment Discontinuation', 'timeFrame': 'Data collected from index date until lost to follow up or end of follow up, whichever occurred first (for a maximum period of 3 years)', 'description': 'Percentage of participants with dose reductions and treatment discontinuation were reported in this outcome measure.'}, {'measure': 'Number of Participants With Reasons for Palbociclib Discontinuation', 'timeFrame': 'Data collected from index date until lost to follow up or end of follow up, whichever occurred first (for a maximum period of 3 years)', 'description': 'Number of participants with reasons for palbociclib discontinuation were reported in this outcome measure. Disease progression (PD) was defined as greater than or equal to (\\>=)20 percent (%) increase in sum of diameters of target lesions, taking as reference smallest sum on study, sum must demonstrate absolute increase of at least 5 millimeter (mm) or appearance of 1 or more new lesions. Adverse drug reactions (ADR) were defined as unintended, harmful events attributed to the use of drug. As per World Health Organisation (WHO) criteria for hematologic and nonhematologic toxicity grade 3 was defined as the severe/worst grade.'}, {'measure': 'Percentage of Participants With Temporary Discontinuation', 'timeFrame': 'Data collected from index date until lost to follow up or end of follow up, whichever occurred first (for a maximum period of 3 years)', 'description': 'Percentage of participants with temporary discontinuation of palbociclib were reported in this outcome measure.'}, {'measure': 'Percentage of Participants According to Time to Dose Reduction in First Line Therapy', 'timeFrame': 'Data collected from index date until lost to follow up or end of follow up, whichever occurred first (for a maximum period of 3 years)', 'description': 'Percentage of participants according to time to dose reduction after palbociclib initiation in 1st line therapy were reported in this outcome measure.'}, {'measure': 'Time to Palbociclib Discontinuation', 'timeFrame': 'Data collected from index date until lost to follow up or end of follow up, whichever occurred first (for a maximum period of 3 years)', 'description': 'Time to palbociclib discontinuation were observed in participants who permanently discontinued palbociclib and were reported in this outcome measure.'}, {'measure': 'Number of Participants With First 3 Lines of Treatment After Progression', 'timeFrame': 'Data collected from date of progression until lost to follow up or end of follow up period, whichever occurred first (for a maximum period of 3 years)', 'description': 'Number of participants according to lines of treatment after progression were reported in this outcome measure.'}, {'measure': 'Doses Prescribed for First 3 Lines of Treatment After Progression', 'timeFrame': 'Data collected from date of progression until lost to follow up or end of follow up period, whichever occurred first (for a maximum period of 3 years)', 'description': 'Doses of drugs prescribed for first 3 lines of treatment after progression were reported in this outcome measure.'}, {'measure': 'Duration of First 3 Lines of Treatment After Progression', 'timeFrame': 'Data collected from date of progression until lost to follow up or end of follow up period, whichever occurred first (for a maximum period of 3 years)', 'description': 'Time duration of first 3 lines of treatment after progression up to lost to follow up or end of follow up period, whichever occurred first were reported in this outcome measure.'}, {'measure': 'Number of Completed Cycles of Palbociclib', 'timeFrame': 'Data collected from index date until lost to follow up or end of follow up, whichever occurred first (for a maximum period of 3 years)', 'description': 'Number of 28-day cycles completed for palbociclib treatment were reported in this outcome measure.'}, {'measure': 'Percentage of Participants Who Received Letrozole and Fulvestrant With Palbociclib', 'timeFrame': 'Data collected from index date until lost to follow up or end of follow up, whichever occurred first (for a maximum period of 3 years)', 'description': 'Percentage of participants who received letrozole and fulvestrant along with palbociclib were reported in this outcome measure.'}, {'measure': 'Percentage of Participants With Progression Free Survival Following Palbociclib Initiation', 'timeFrame': 'Data collected from index date until lost to follow up or end of follow up, whichever occurred first (for a maximum period of 3 years)', 'description': 'Progression free survival (PFS) was defined as the time from the index date to the date of first documented disease progression (PD) or death. PD was defined as \\>=20% increase in sum of diameters of target lesions, taking as reference smallest sum on study, sum must demonstrate absolute increase of at least 5 mm or appearance of 1 or more new lesions. Percentage of participants with progression free survival after index date were reported in this outcome measure.'}, {'measure': 'Percentage of Participants Alive Following Palbociclib Initiation', 'timeFrame': 'Data collected from index date until lost to follow up or end of follow up, whichever occurred first (for a maximum period of 3 years)', 'description': 'Percentage of participants who were alive after palbociclib initiation were reported in this outcome measure.'}, {'measure': 'Percentage of Participants With Partial Response (PR) and Complete Response (CR) Following Palbociclib Initiation', 'timeFrame': 'Data collected from index date until lost to follow up or end of follow up, whichever occurred first (for a maximum period of 3 years)', 'description': 'CR was defined as disappearance of target, non-target lesions and normalization of tumor markers. Pathological lymph nodes had short axis measures less than (\\<)10 mm; PR was defined as \\>=30% decrease in sum of measures (longest diameter for tumor lesions, short axis measure for nodes) of target lesions, taking reference baseline sum of diameters. Non-target lesions must be non-PD; PD: \\>=20% increase in sum of diameters of target lesions, taking as reference smallest sum on study, sum must demonstrate absolute increase of at least 5 mm or appearance of 1 or more new lesions.'}, {'measure': 'Percentage of Participants With Stable Disease (SD) Following Palbociclib Initiation', 'timeFrame': 'Data collected from index date until lost to follow up or end of follow up, whichever occurred first (for a maximum period of 3 years)', 'description': 'SD was defined as neither shrinkage for CR or PR nor increase for PD taking as reference smallest sum of longest diameters since treatment start. Alive participants with no events were censored at date of last response assessment. CR: disappearance of target, non-target lesions and normalization of tumor markers. Pathological lymph nodes had short axis measures \\<10 mm; PR: \\>=30% decrease in sum of measures (longest diameter for tumor lesions, short axis measure for nodes) of target lesions, taking reference baseline sum of diameters. Non-target lesions must be non-PD; PD: \\>=20% increase in sum of diameters of target lesions, taking as reference smallest sum on study, sum must demonstrate absolute increase of at least 5 mm or appearance of 1 or more new lesions.'}, {'measure': 'Progression Free Survival (PFS)', 'timeFrame': 'From index date to PD or death whichever occurred first (for a maximum period of 3 years)', 'description': 'PFS was defined as the time from the index date to the date of first documented PD or death. PD was defined as at least a 20% increase in sum of diameters of target lesions, taking as reference the smallest sum on study. In addition to relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions was also considered progression.'}, {'measure': 'Overall Survival (OS)', 'timeFrame': 'From index date until date of death or date of censoring (for a maximum period of 3 years)', 'description': 'OS was defined as the time between the index date and the date of death from any cause. Participants who were still alive at the last date of data collection were censored.'}, {'measure': 'Time to Achieving Best Overall Response (BOR)', 'timeFrame': 'From index date till date of BOR or date of censoring (for a maximum period of 3 years)', 'description': 'Time to achieving BOR: time from index date until achievement of BOR: CR or PR, if CR was not achieved during follow-up. CR: disappearance of target, non-target lesions and normalization of tumor markers. Pathological lymph nodes had short axis measures \\<10 mm; PR: \\>=30% decrease in sum of measures (longest diameter for tumor lesions, short axis measure for nodes) of target lesions, taking reference baseline sum of diameters. Non-target lesions must be non-PD; PD: \\>=20% increase in sum of diameters of target lesions, taking as reference smallest sum on study, sum must demonstrate absolute increase of at least 5 mm. Appearance of 1 or more new lesions; Alive participants with no events were censored at date of last response assessment.'}, {'measure': 'Duration of Follow-up Period', 'timeFrame': 'Data collected from index date until lost to follow up or end of follow up, whichever occurred first (for a maximum period of 3 years)', 'description': 'Duration of follow-up period defined as the duration from index date until lost to follow up or end of follow up period, whichever occurred first, were reported in this outcome measure.'}, {'measure': 'Percentage of Participants With Best Response (BR), Progressive Disease (PD) and Stable Disease (SD) to Palbociclib', 'timeFrame': 'From index date till BR (CR or PR, whichever occurred first), SD, PD or date of censoring (for a maximum period of 3 years)', 'description': 'Percentage of participants with BR, PD and SD to palbociclib were reported in this outcome measure. BR was recorded for CR or PR. CR: disappearance of target, non-target lesions and normalization of tumor markers. Pathological lymph nodes had short axis measures \\<10 mm; PR: \\>=30% decrease in sum of measures (longest diameter for tumor lesions, short axis measure for nodes) of target lesions, taking reference baseline sum of diameters. Non-target lesions must be non-PD; PD: \\>=20% increase in sum of diameters of target lesions, taking as reference smallest sum on study, sum must demonstrate absolute increase of at least 5 mm or appearance of 1 or more new lesions. SD: neither shrinkage for CR/PR nor increase for PD taking as reference smallest sum of longest diameters since treatment start. Alive participants with no events were censored at date of last response assessment.'}, {'measure': 'Time to Best Response (BR)', 'timeFrame': 'From index date till BR or date of censoring (for a maximum period of 3 years)', 'description': 'Time to BR: time from index date until achievement of BR:CR or PR, if CR not achieved during follow-up. CR: disappearance of target, non-target lesions and normalization of tumor markers. Pathological lymph nodes had short axis measures \\<10 mm; PR: \\>=30% decrease in sum of measures (longest diameter for tumor lesions, short axis measure for nodes) of target lesions, taking reference baseline sum of diameters. Non-target lesions must be non-PD; PD: \\>=20% increase in sum of diameters of target lesions, taking as reference smallest sum on study, sum must demonstrate absolute increase of at least 5 mm or appearance of 1 or more new lesions. Alive participants with no events were censored at date of last response assessment. Data is also presented by de novo status and relapse status.'}, {'measure': 'Time to First Response', 'timeFrame': 'From index date till first documented CR or PR or date of censoring (for a maximum period of 3 years)', 'description': 'Time to first response: time from index date until achievement of first response of CR or PR, if CR not achieved during follow-up. CR: disappearance of target, non-target lesions and normalization of tumor markers. Pathological lymph nodes had short axis measures \\<10 mm; PR: \\>=30% decrease in sum of measures (longest diameter for tumor lesions, short axis measure for nodes) of target lesions, taking reference baseline sum of diameters. Non-target lesions must be non-PD; PD: \\>=20% increase in sum of diameters of target lesions, taking as reference smallest sum on study, sum must demonstrate absolute increase of at least 5 mm or appearance of 1 or more new lesions. Alive participants with no events were censored at date of last response assessment. Data is also presented by de novo status and relapse status.'}, {'measure': 'Percentage of Participants With Neutropenia Post-Palbociclib Initiation', 'timeFrame': 'Data collected from index date up to 6 months post-palbociclib initiation (for a maximum period of 3 years)', 'description': 'Neutropenia is an abnormally low level of neutrophils with count \\<1500 neutrophils per microliter (mcL) in blood and was classified as per Common Toxicity Criteria (CTC) version 2.0 criteria: grade 1 (mild) with an absolute neutrophil count (ANC) of \\>=1500 to \\<2000 cells per mcL, grade 2 (moderate) with an ANC of \\>=1000 to \\<1500 cells per mcL, grade 3 (severe) with an ANC of \\>=500 to \\<1000 cells per mcL or grade 4 (severe) with an ANC lower than 500 cells per mcL. Percentage of participants with all grades, grade 3 and grade 4 were reported in this outcome measure. All grades category included grades 1 to grade 4.'}, {'measure': 'Percentage of Participants With Neutropenia Post-Palbociclib Initiation as Recorded and Inferred From Clinical Notes', 'timeFrame': 'Data collected from index date up to 6 months post-palbociclib initiation (for a maximum period of 3 years)', 'description': 'Neutropenia is an abnormally low level of neutrophils with count \\<1500 neutrophils per mcL in blood and was classified as per CTC version 2.0 criteria: grade 1 (mild) with an ANC of \\>=1500 to \\<2000 cells per mcL, grade 2 (moderate) with an ANC of \\>=1000 to \\<1500 cells per mcL, grade 3 (severe) with an ANC of \\>=500 to \\<1000 cells per mcL or grade 4 (severe) with an ANC lower than 500 cells per mcL.'}, {'measure': 'Percentage of Participants With Neutropenia Post-Palbociclib Initiation as Recorded and Inferred From ANC Measurements', 'timeFrame': 'Data collected from index date up to 6 months post-palbociclib initiation (for a maximum period of 3 years)', 'description': 'Neutropenia is an abnormally low level of neutrophils with count \\<1500 neutrophils per mcL in blood and was classified as per CTC version 2.0 criteria: grade 1 (mild) with an ANC of \\>=1500 to \\<2000 cells per mcL, grade 2 (moderate) with an ANC of \\>=1000 to \\<1500 cells per mcL, grade 3 (severe) with an ANC of \\>=500 to \\<1000 cells per mcL or grade 4 (severe) with an ANC lower than 500 cells per mcL.'}, {'measure': 'Percentage of Participants According to the Severe Grade of Neutropenia', 'timeFrame': 'Data collected from index date up to 3 months post-palbociclib initiation (for a maximum period of 3 years)', 'description': 'Neutropenia is an abnormally low level of neutrophils with count \\<1500 neutrophils per mcL in blood and was classified as per CTC version 2.0 criteria: grade 1 (mild) with an ANC of \\>=1500 to \\<2000 cells per mcL, grade 2 (moderate) with an ANC of \\>=1000 to \\<1500 cells per mcL, grade 3 (severe) with an ANC of \\>=500 to \\<1000 cells per mcL or grade 4 (severe) with an ANC lower than 500 cells per mcL. Percentage of participants with grade 3 and 4 were reported in this outcome measure.'}, {'measure': 'Percentage of Participants With Febrile Neutropenia Post-Palbociclib Initiation', 'timeFrame': 'Data collected from index date up to 3 months post-palbociclib initiation (for a maximum period of 3 years)', 'description': 'Febrile neutropenia (FN) was defined as an ANC of \\< 1.0 x 10\\^9 cells/L predicted to fall below 0.5 x 10\\^9 cells/L within 48 hours with fever or clinical signs of sepsis; fever and ANC were measured the same day or within ± 1 calendar day.'}, {'measure': 'Percentage of Participants With Gastro-Intestinal Toxicities Post-Palbociclib Initiation', 'timeFrame': 'Data collected from index date up to 1-year of follow up period (for a maximum period of 3 years)', 'description': 'Percentage of participants with gastro-intestinal toxicities as diarrhea, nausea and vomiting after index date were reported in this outcome measure. As per CTC version 2.0 criteria, for diarrhea: grade 1 (mild)- less than 4 stools per day, grade 2 (moderate)- 4 to 6 stools per day, grade 3 (severe)- \\>=7 stools per day and grade 4 (life-threatening)- physiologic consequences requiring intensive care; Vomiting: grade 1 (mild)- 1 episode per day , grade 2 (moderate)- 2 to 5 episodes per day, grade 3 (severe)- \\>=6 episodes per day and grade 4 (life-threatening)- physiologic consequences requiring intensive care; Nausea: grade 1 (mild)- able to eat, grade 2 (moderate)- oral intake significantly reduced, grade 3 (severe)- no significant intake and requiring intravenous fluids.'}, {'measure': 'Percentage of Participants With Adverse Events During Follow-up', 'timeFrame': 'Data collected from index date up to 1-year of follow up period (for a maximum period of 3 years)', 'description': 'Percentage of participants with at least one of the adverse events (neutropenia, diarrhea, nausea, and vomiting) after index date were reported in this outcome measure.'}, {'measure': 'Absolute Values for Hematology Parameter in First 6 Months Following Palbociclib Initiation: Hemoglobin', 'timeFrame': 'From index date up to 6 months after palbociclib initiation (for a maximum period of 3 years)', 'description': 'Absolute values for hematology parameter- hemoglobin, were reported in this outcome measure.'}, {'measure': 'Absolute Values for Hematology Parameters in First 6 Months Following Palbociclib Initiation: White Blood Cell, Absolute Neutrophil Counts and Platelet Counts', 'timeFrame': 'Data collected from index date up to 6 months after palbociclib initiation (for a maximum period of 3 years)', 'description': 'Absolute values for hematology parameters- white blood cell (WBC) counts, absolute neutrophil counts (ANC) and platelet counts (PLT), were reported in this outcome measure.'}, {'measure': 'Absolute Values for Liver Function Parameters in First 6 Months Following Palbociclib Initiation: Aspartate Aminotransferase, Alanine Aminotransferase and Alkaline Phosphatase', 'timeFrame': 'Data collected from index date up to 6 months after palbociclib initiation (for a maximum period of 3 years)', 'description': 'Absolute values for liver function parameters- Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT) and Alkaline Phosphatase (ALP), were reported in this outcome measure.'}, {'measure': 'Absolute Values for Liver Function Parameter in First 6 Months Following Palbociclib Initiation: Albumin', 'timeFrame': 'Data collected from index date up to 6 months after palbociclib initiation (for a maximum period of 3 years)', 'description': 'Absolute values for liver function parameter- albumin, were reported in this outcome measure.'}, {'measure': 'Absolute Values for Liver Function Parameter in First 6 Months Following Palbociclib Initiation: Bilirubin', 'timeFrame': 'Data collected from index date up to 6 months after palbociclib initiation (for a maximum period of 3 years)', 'description': 'Absolute values for liver function parameter- bilirubin, were reported in this outcome measure.'}, {'measure': 'Absolute Values for Bone Profile Parameters in First 6 Months Following Palbociclib Initiation: Calcium and Phosphate', 'timeFrame': 'Data collected from index date up to 6 months after palbociclib initiation (for a maximum period of 3 years)', 'description': 'Absolute values for bone profile parameters- calcium and phosphate were reported in this outcome measure.'}, {'measure': 'Absolute Values for Clinical Chemistry Parameters in First 6 Months Following Palbociclib Initiation: Potassium, Sodium and Urea', 'timeFrame': 'Data collected from index date up to 6 months after palbociclib initiation (for a maximum period of 3 years)', 'description': 'Absolute values for clinical chemistry parameters- potassium, sodium and urea were reported in this outcome measure.'}, {'measure': 'Absolute Values for Clinical Chemistry Parameter in First 6 Months Following Palbociclib Initiation: Creatinine', 'timeFrame': 'Data collected from index date up to 6 months after palbociclib initiation (for a maximum period of 3 years)', 'description': 'Absolute values for clinical chemistry parameter- creatinine, were reported in this outcome measure.'}, {'measure': 'Percentage of Participants With Inpatient Admissions and Outpatient Visits', 'timeFrame': 'Data collected from index date up to 1-year of follow up period (for a maximum period of 3 years)', 'description': 'Percentage of participants with inpatient admissions and outpatient visits were reported in this outcome measure.'}, {'measure': 'Number of Inpatient Admissions Per Participant', 'timeFrame': 'Data collected from index date up to 1-year of follow up period (for a maximum period of 3 years)'}, {'measure': 'Number of Outpatient Visits Per Participant', 'timeFrame': 'Data collected from index date up to 1-year of follow up period (for a maximum period of 3 years)'}, {'measure': 'Percentage of Participants With Type of Hospital Admission', 'timeFrame': 'Data collected from index date up to 1-year of follow up period (for a maximum period of 3 years)'}, {'measure': 'Percentage of Participants With Reasons for Hospital Admission', 'timeFrame': 'Data collected from index date up to 1-year of follow up period (for a maximum period of 3 years)'}, {'measure': 'Duration of Inpatient Hospital Stay', 'timeFrame': 'Data collected from index date up to 1-year of follow up period (for a maximum period of 3 years)', 'description': 'Duration of hospital stay was the time from the date of hospital entry to date of hospital discharge.'}, {'measure': 'Reasons of Outpatient Visit', 'timeFrame': 'Data collected from index date up to 1-year of follow up period (for a maximum period of 3 years)'}, {'measure': 'Type of Health Care Professional Consultations During Outpatient Visit', 'timeFrame': 'Data collected from index date up to 1-year of follow up period (for a maximum period of 3 years)'}, {'measure': 'Percentage of Participants Contacted Cancer National Service (CNS) and Acute Oncology Service (AOS) During First Year After Palbociclib Initiation', 'timeFrame': 'Data collected from index date up to 1-year of follow up period (for a maximum period of 3 years)', 'description': 'Percentage of participants who contacted CNS by phone calls and AOS either by phone calls or visits were reported in this outcome measure.'}, {'measure': 'Percentage of Participants According to Number of CNS Interactions', 'timeFrame': 'Data collected from index date up to 1-year of follow up period (for a maximum period of 3 years)'}, {'measure': 'Number of AOS Interactions Per Participant', 'timeFrame': 'Data collected from index date up to 1-year of follow up period (for a maximum period of 3 years)'}, {'measure': 'Type of CNS and AOS Interactions', 'timeFrame': 'Data collected from index date up to 1-year of follow up period (for a maximum period of 3 years)'}, {'measure': 'Reasons for CNS and AOS Interaction', 'timeFrame': 'Data collected from index date up to 1-year of follow up period (for a maximum period of 3 years)'}]}, 'conditionsModule': {'conditions': ['HR+/HER2- Locally Advanced, Metastatic Breast Cancer']}, 'referencesModule': {'references': [{'pmid': '37468569', 'type': 'DERIVED', 'citation': 'Palmieri C, Musson A, Harper-Wynne C, Wheatley D, Bertelli G, Macpherson IR, Nathan M, McDowall E, Bhojwani A, Verrill M, Eva J, Doody C, Chowdhury R. A real-world study of the first use of palbociclib for the treatment of advanced breast cancer within the UK National Health Service as part of the novel Ibrance(R) Patient Program. Br J Cancer. 2023 Sep;129(5):852-860. doi: 10.1038/s41416-023-02352-5. Epub 2023 Jul 19.'}], 'seeAlsoLinks': [{'url': 'https://pmiform.com/clinical-trial-info-request?StudyID=X9001194', 'label': 'To obtain contact information for a study center near you, click here.'}]}, 'descriptionModule': {'briefSummary': "What are the real-world treatment patterns, patients' characteristics, clinical outcomes and healthcare resource utilisation associated with palbociclib treatment in the 3 years following initiation in United Kingdom patients with hormone receptor-positive, human epidermal growth factor 2-negative metastatic breast cancer treated as part of the IPP?", 'detailedDescription': "Hormone receptor positive (HR+) breast cancer (BC) represents the largest therapeutic subtype of the disease, accounting for 60 to 65% of all malignant neoplasms of the breast. Palbociclib (Ibrance®) is a small-molecule inhibitor of cyclin-dependent kinases 4 and 6 (CDK4/6) which in clinical trial settings has been shown to increase progression-free survival (PFS) for patients with HR+, human epidermal growth factor 2-negative (HER2-) metastatic breast cancer (MBC). Palbociclib first received a European Union (EU) marketing authorisation in September 2016, to be commercialised as Ibrance® by Pfizer. Palbociclib was recommended for use with an aromatase inhibitor in patients with HR+/HER2- locally advanced and MBC in the National Health Service (NHS) in England by the National Institute for Health and Care Excellence (NICE) in November 2017 and by the Scottish Medicines Consortium (SMC) in December 2017. In order to provide access to palbociclib in the United Kingdom (UK) during the NICE/SMC appraisal period, the Ibrance® Patient Program (IPP) was initiated and run by Pfizer between April 2017 until a positive NICE/SMC appraisal in November 2017 (for England and Wales) or December 2017 (for Scotland).\n\nPfizer are interested in the opportunity to collect data from patients who received palbociclib as part of the UK IPP, to better understand patients' characteristics in a routine care setting, treatment persistence and dose management, clinical outcomes, and healthcare resource utilisation. This study will provide real-world evidence on patients' clinical progression and experience of treatment with palbociclib in routine clinical settings in a UK context.\n\nResearch question:\n\nWhat are the real-world treatment patterns, patients' characteristics, clinical outcomes and healthcare resource utilisation associated with palbociclib treatment in the 3 years following initiation in United Kingdom patients with HR+/HER2- MBC treated as part of the IPP?"}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'genderBased': True, 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Women over the age of 18 who entered into the UK IPP', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion criteria:\n\nAll patients meeting the following eligibility criteria will be included in the study:\n\n* Patients enrolled into the IPP at one of the selected hospitals (see Annex 1 for IPP enrolment letter).\n* Patients who received ≥1 dose of palbociclib as part of the IPP at one of the selected sites.\n* For sites where data collection is performed by pH Associates, written informed consent will be required from living patients to access their medical records.\n* Patient aged ≥18 years old at enrollment into the IPP'}, 'identificationModule': {'nctId': 'NCT03921866', 'acronym': 'ROIS', 'briefTitle': 'UK Ibrance Patient Program (IPP) Study', 'organization': {'class': 'INDUSTRY', 'fullName': 'Pfizer'}, 'officialTitle': 'Observational Cohort Study of Patients With Hormone Receptor-positive Metastatic Breast Cancer Treated With Palbociclib (Ibrance(Registered)) as Part of the United Kingdom Ibrance (Registered) Patient Program (IPP); the Real Outcomes Ibrance (Registered) Study (ROIS)', 'orgStudyIdInfo': {'id': 'X9001194'}, 'secondaryIdInfos': [{'id': 'ROIS', 'type': 'OTHER', 'domain': 'Alias Study Number'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'Palbociclib', 'type': 'DRUG', 'description': 'Palbociclib'}]}, 'contactsLocationsModule': {'locations': [{'zip': 'TR1 3LQ', 'city': 'Truro', 'state': 'Cornwall', 'country': 'United Kingdom', 'facility': 'Royal Cornwall Hospital', 'geoPoint': {'lat': 50.26526, 'lon': -5.05436}}, {'zip': 'BN2 5BB', 'city': 'Brighton', 'country': 'United Kingdom', 'facility': 'Brighton Sussex Cancer Centre', 'geoPoint': {'lat': 50.82838, 'lon': -0.13947}}, {'zip': 'G12 0YN', 'city': 'Glasgow', 'country': 'United Kingdom', 'facility': 'Beatson West of Scotland Cancer Centre', 'geoPoint': {'lat': 55.86515, 'lon': -4.25763}}, {'zip': 'SE1 9RT', 'city': 'London', 'country': 'United Kingdom', 'facility': "Guys and St Thomas' NHS Trust", 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}, {'zip': 'ME16 9QQ', 'city': 'Maidstone', 'country': 'United Kingdom', 'facility': 'Maidstone Hospital', 'geoPoint': {'lat': 51.26667, 'lon': 0.51667}}, {'zip': 'M20 4BX', 'city': 'Manchester', 'country': 'United Kingdom', 'facility': 'The Christie NHS Foundation Trust', 'geoPoint': {'lat': 53.48095, 'lon': -2.23743}}, {'zip': 'CH63 4JY', 'city': 'Metropolitan Borough of Wirral', 'country': 'United Kingdom', 'facility': 'Clatterbridge', 'geoPoint': {'lat': 53.37616, 'lon': -3.10501}}, {'zip': 'NE7 7DN', 'city': 'Newcastle upon Tyne', 'country': 'United Kingdom', 'facility': 'Newcastle Freeman Hospital', 'geoPoint': {'lat': 54.97328, 'lon': -1.61396}}], 'overallOfficials': [{'name': 'Pfizer CT.gov Call Center', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Pfizer'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': "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."}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Pfizer', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}