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| ID | Type | Description | Link |
|---|---|---|---|
| US oncology | Other Identifier | Alias Study Number |
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By leveraging a community-based, cancer-specific electronic healthcare record for this study, we aim to understand treatment patterns and clinical outcomes among patients with HR+/HER2- mBC who received care within the context of a large community oncology network in the United States.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PAL + FUL | Patients who initiated palbociclib-fulvestrant combination therapy as first-line or beyond therapy in the advanced or metastatic setting. |
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| Measure | Description | Time Frame |
|---|---|---|
| Time to Chemotherapy | Time to chemotherapy was defined as the interval (in weeks) between index treatment (palbociclib +fulvestrant) and start of chemotherapy as documented in the iKnowMed (iKM) EHR database. Participants with ongoing treatment at the study observation period were censored on the study end date or the last visit date available in the dataset, whichever occurred first. Kaplan-Meier method was used for analysis. | From start of index treatment until start of chemotherapy or censoring date, during study observation period maximum up to approximately 53 months (data was retrieved and observed during 2.5 years of this retrospective study) |
| Number of Participants According to Reasons for Treatment Discontinuation | The number of participants classified according to the reasons for treatment discontinuation were reported in this outcome measure. | From start of index treatment until stop of index treatment or censoring date, during study observation period maximum up to approximately 53 months (data was retrieved and observed during 2.5 years of this retrospective study) |
| Real-World Duration of Treatment (rwDOT) | Real-world duration of treatment (rwDOT) was defined as the interval between the start and stop index treatment as documented in the iKM EHR database. Participants with ongoing treatment at the study observation period were censored on the study end date or the last visit date available in the dataset, whichever occurred first. Kaplan-Meier method was used for analysis. | From start of index treatment until stop of index treatment or censoring date, during study observation period maximum up to approximately 53 months (data was retrieved and observed during 2.5 years of this retrospective study) |
| Time to Next Treatment (TTNT) From Index Treatment | Time to next treatment (TTNT) was defined as the interval between the start of the index treatment and the date of the next-line treatment as documented in the iKM EHR database. Participants who did not advance to the next treatment within the study observation period were censored on the study end date or the last visit date available in the dataset, whichever occurred first. Kaplan-Meier method was used for analysis. |
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| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants According to the Dosing Strength of Fulvestrant and Palbociclib as Their Index Treatment | The percentage of participants classified according to the dosing strength of Palbociclib and Fulvestrant as their index treatment were reported in this outcome measure. Index date was the date of initiation with palbociclib + fulvestrant during the study identification period. | At index, anytime between 01-February-2016 and 31-December-2019 (data was retrieved and observed during 2.5 years of this retrospective study) |
Inclusion Criteria:
Exclusion Criteria:
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Patients With Hormone Receptor-Positive/Human Epidermal Growth Factor Receptor 2-Negative Metastatic Breast Cancer (mBC) Receiving Palbociclib Combination Therapy, Endocrine Monotherapy Or Fulvestrant Monotherapy In The US Community Oncology Setting
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pfizer United States | New York | New York | 10017 | United States |
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| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.
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Data was retrieved from electronic healthcare record (EHR) and available data was evaluated over 2.5 years of this retrospective observational study.
Data for participants diagnosed with hormone receptor positive (HR+)/human epidermal growth factor receptor 2 negative (HER2-) metastatic breast cancer (MBC), who initiated first line treatment with palbociclib in combination with fulvestrant between 01-February-2016 to 31-December-2019 were observed retrospectively. To allow minimum follow-up period of 6 months, participants were followed until 30 June 2020, last participant record or date of death, whichever occurred first.
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| ID | Title | Description |
|---|---|---|
| FG000 | Palbociclib + Fulvestrant | Participants who initiated palbociclib in combination with fulvestrant as first line therapy for HR+/HER2- MBC during the period 01-February-2016 to 31-December-2019 were included in this retrospective observational study. Participants were followed up until 30-Jun-2020. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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Analysis population included all eligible participants whose data were retrieved and observed in this study.
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| ID | Title | Description |
|---|---|---|
| BG000 | Palbociclib + Fulvestrant | Participants who initiated palbociclib in combination with fulvestrant as first line therapy for HR+/HER2- MBC during the period 01-February-2016 to 31-December-2019 were included in this retrospective observational study. Participants were followed up until 30-Jun-2020. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Time to Chemotherapy | Time to chemotherapy was defined as the interval (in weeks) between index treatment (palbociclib +fulvestrant) and start of chemotherapy as documented in the iKnowMed (iKM) EHR database. Participants with ongoing treatment at the study observation period were censored on the study end date or the last visit date available in the dataset, whichever occurred first. Kaplan-Meier method was used for analysis. | Analysis population included all eligible participants whose data were retrieved and observed in this study. | Posted | Median | 95% Confidence Interval | Weeks | From start of index treatment until start of chemotherapy or censoring date, during study observation period maximum up to approximately 53 months (data was retrieved and observed during 2.5 years of this retrospective study) |
|
For adverse events, not applicable as adverse events were not collected during the study. For all-cause mortality, from start of index treatment until end of study observation period maximum up to approximately 53 months (data was retrieved and observed during 2.5 years of this retrospective study).
This observational retrospective study retrieved data from medical records and the data existed as unstructured data. In these data sources, individual participant data were not retrieved or validated, and it was not possible to link a particular product and medical event for any individual. Thus, the minimum criteria (identifiable participant, identifiable reporter, a suspect product, and event) for reporting an adverse event could not be met, hence safety data were not collected and reported.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Palbociclib + Fulvestrant | Participants who initiated palbociclib in combination with fulvestrant as first line therapy for HR+/HER2- MBC during the period 01-February-2016 to 31-December-2019 were included in this retrospective observational study. Participants were followed up until 30-Jun-2020. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pfizer ClinicalTrials.gov Call Center | Pfizer Inc. | 1-800-718-1021 | ClinicalTrials.gov_Inquiries@pfizer.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Aug 30, 2021 | Mar 30, 2023 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Sep 1, 2021 | Mar 30, 2023 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| From start of index treatment to date of next line treatment or censoring date, during study observation period maximum up to approximately 53 months (data was retrieved and observed during 2.5 years of this retrospective study) |
| Percentage of Participants With Provider Documented Disease Progression | Percentage of participants with provider documented progression (documented as disease has progressed or worsening of disease) is reported in this outcome measure. | From start of treatment until documented disease progression, during study observation period maximum up to approximately 53 months (data was retrieved and observed during 2.5 years of this retrospective study) |
| Real-World Time to Tumor Progression (rwTTP) | The rwTTP was measured from the initiation of index treatment to the date of provider-documented progression (documented by provider as disease has progressed or worsening of disease), censoring participants without evidence of provider-documented progression at the last visit date. Kaplan-Meier method was used for analysis. | From initiation of the index treatment to the date of progression or censoring date, during study observation period maximum up to approximately 53 months (data was retrieved and observed during 2.5 years of this retrospective study) |
| Real-World Progression-Free Survival (rwPFS) | The rwPFS was measured from the initiation of the index treatment to the date of progression (documented by provider as disease has progressed or worsening of disease) or date of death due to any cause, censoring participants who were still alive at the end of the study observation period and did not progress at the last visit date. Kaplan-Meier method was used for analysis. | From initiation of index treatment to date of progression or death due to any cause or censoring date, during study observation period maximum up to approximately 53 months (data was retrieved and observed during 2.5 years of this retrospective study) |
| Overall Survival (OS) | Overall survival (OS) was defined as the interval between index treatment and the date of death (any cause) as documented in the Limited Access Death Master File (LADMF), National Death Index (NDI) and the iKM EHR database. Participants who did not die within the study observation period were censored on the study end date or the last visit date available in the dataset, whichever occurred first. Kaplan-Meier method was used for analysis. | From start of index treatment until date of death or censoring date, during study observation period maximum up to approximately 53 months (data was retrieved and observed during 2.5 years of this retrospective study) |
| Duration of Treatment for Advanced Metastatic Breast Cancer | The duration of treatment for advanced metastatic breast cancer was reported in this outcome measure. | From start of index treatment until stop of index treatment, during study observation period maximum up to approximately 53 months (data was retrieved and observed during 2.5 years of this retrospective study) |
| Percentage of Participants With Prior Adjuvant Hormonal Treatment for Advanced Metastatic Breast Cancer | Percentage of participants with prior adjuvant hormonal treatment for breast cancer were reported in this outcome measure. Index date was the date of initiation with palbociclib + fulvestrant during the study identification period. | Prior to index date (the date of initiation with Palbociclib-Fulvestrant during the study identification period) (data was retrieved and observed during 2.5 years of this retrospective study) |
| Number of Participants According to Year of Treatment Initiation for Advanced Metastatic Breast Cancer | Number of participants were classified according to the year of treatment initiation for advanced metastatic breast cancer in this outcome measure. | Quarter(Q)1 2015,Q2 2015,Q3 2015,Q4 2015,Q1 2016,Q2 2016,Q3 2016,Q4 2016,Q1 2017,Q2 2017,Q3 2017,Q4 2017,Q1 2018,Q2 2018,Q3 2018,Q4 2018,Q1 2019,Q2 2019,Q3 2019,Q4 2019(data was retrieved and observed during 2.5 years of this retrospective study) |
| Percentage of Participants With Change in Dose | The percentage of participants with dose change for index treatment were reported in this outcome measure. | From index treatment until follow up period of 6 months (data was retrieved and observed during 2.5 years of this retrospective study) |
| Years |
|
| Age, Customized | Count of Participants | Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Body Mass Index (BMI) at Index Date | Mean | Standard Deviation | Kilogram per square meter |
|
| Number of Participants According to Smoking history | Number of participants classified according to smoking history were reported. | Count of Participants | Participants |
|
| Number of Participants According to Family History of Cancer | Number of participants classified according to family history of cancer were reported. | Count of Participants | Participants |
|
| Number of Participants According to Menopausal Status | Number of participants classified according to menopausal status were reported. | Count of Participants | Participants |
|
| Time Since Initial BC Diagnosis | The duration of time, in weeks, between the date of BC diagnosis and presentation of metastatic disease were reported. | Here, 'Number Analyzed' signifies number of participants evaluable for the specified rows. | Mean | Standard Deviation | Weeks |
|
| Time Since MBC Diagnosis | The duration of time, in weeks, between the index date and presentation of metastatic disease were reported. Index date was defined as the date of the first administration of either drug (palbociclib or fulvestrant). | Mean | Standard Deviation | Weeks |
|
| Number of Participants According to Distant Metastatic Sites | Number of participants classified according to the distant metastatic sites were reported. No information signifies that metastases were not documented in the chart, not necessarily that participants did not have metastases. One participant may have more than 1 sites of metastasis. | Count of Participants | Participants |
|
| Number of Participants According to Disease-Free Interval | Disease-free interval was defined as the duration between discontinuation of adjuvant therapy and the start of treatment for metastatic disease. | Here, 'Number Analyzed' signifies number of participants evaluable for the specified rows. | Count of Participants | Participants |
|
| Number of Participants According to Visceral/non-Visceral Status | Number of participants classified according to visceral or non-visceral status were reported. | Count of Participants | Participants |
|
| Number of Participants According to Count of Metastatic Sites | Number of participants classified according to the count of metastatic sites were reported. | Count of Participants | Participants |
|
| Number of Participants According to Stage at Diagnosis | Tumor Node Metastasis(TNM): based on tumor size, metastasis to nearby lymph nodes(LN),or distant metastasis. Stages were: stage 0(no evidence of cancer cells),stage 1(T1N0M0),stage IA(T1N0M0),stage IB(T0 or T1N1M0),stage IIA(T0N1M0,T1N1M0,T2N0M0),stage IIB(T2N1M0,T3N0M0),stage IIIA(T0N2M0,T1N2M0,T2N3M0,T3N1 or N2M0),stage IIIB(T4 any NM0,any TN3M0),stage IIIC(any TN3M0),stage IV(any T any NM1),where T0=early form of tumor,T1= <2 centimeter(cm),T2=2-5 cm,T3= >2 cm,T4=large sized,N0=not spread to LN,N1=spread to 1 to 3,N2=spread to 4 to 9,N3=spread >10 axillary LN,M0=no metastasis,M1=metastasis. | Count of Participants | Participants |
|
| Number of Participants According to Eastern Cooperative Oncology Group (ECOG) Performance Status | The ECOG performance status score is a rating of a participant's disease status, daily living activities and quality of life, where 0 indicates fully active,1 indicates restricted in physically strenuous activity, 2 indicates ambulatory and capable of self-care but unable to work, 3 indicates capable only of limited self-care, 4 indicates completely disabled and 5 indicates dead. Higher scores indicated more severe disease, difficulty in performing daily activity and poor quality of life. Number of participants classified according to ECOG performance status. | Count of Participants | Participants |
|
| Number of Participants According to Comorbidities | Number of participants classified according to comorbidities documented within 6 months prior to or on index date were reported. Index date was defined as the date of the first administration of either drug (palbociclib or fulvestrant). | Here, 'Number Analyzed' signifies number of participants evaluable for the specified rows. | Count of Participants | Participants |
|
| Number of Participants According to Disease Histology | Number of participants classified according to disease histology were reported. | Count of Participants | Participants |
|
| Number of Participants According to Breast Cancer Gene (BRCA) 1/2 Status | Number of participants classified according to Breast cancer gene (BRCA) 1/2 status were reported. | Count of Participants | Participants |
|
| Number of Participants According to Estrogen Receptor 1 Gene (ESR1) Status | Number of participants classified according to Estrogen receptor 1 gene (ESR1) status were reported. | Count of Participants | Participants |
|
| Number of Participants According to Next Generation Sequencing (NGS) Status | Number of participants classified according to Next generation sequencing (NGS) status were reported. | Count of Participants | Participants |
|
|
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| Primary | Number of Participants According to Reasons for Treatment Discontinuation | The number of participants classified according to the reasons for treatment discontinuation were reported in this outcome measure. | Analysis population included all eligible participants whose data were retrieved and observed in this study. Here, 'Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure. | Posted | Count of Participants | Participants | From start of index treatment until stop of index treatment or censoring date, during study observation period maximum up to approximately 53 months (data was retrieved and observed during 2.5 years of this retrospective study) |
|
|
|
| Primary | Real-World Duration of Treatment (rwDOT) | Real-world duration of treatment (rwDOT) was defined as the interval between the start and stop index treatment as documented in the iKM EHR database. Participants with ongoing treatment at the study observation period were censored on the study end date or the last visit date available in the dataset, whichever occurred first. Kaplan-Meier method was used for analysis. | Analysis population included all eligible participants whose data were retrieved and observed in this study. | Posted | Median | 95% Confidence Interval | Weeks | From start of index treatment until stop of index treatment or censoring date, during study observation period maximum up to approximately 53 months (data was retrieved and observed during 2.5 years of this retrospective study) |
|
|
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| Primary | Time to Next Treatment (TTNT) From Index Treatment | Time to next treatment (TTNT) was defined as the interval between the start of the index treatment and the date of the next-line treatment as documented in the iKM EHR database. Participants who did not advance to the next treatment within the study observation period were censored on the study end date or the last visit date available in the dataset, whichever occurred first. Kaplan-Meier method was used for analysis. | Analysis population included all eligible participants whose data were retrieved and observed in this study. | Posted | Median | 95% Confidence Interval | Weeks | From start of index treatment to date of next line treatment or censoring date, during study observation period maximum up to approximately 53 months (data was retrieved and observed during 2.5 years of this retrospective study) |
|
|
|
| Primary | Percentage of Participants With Provider Documented Disease Progression | Percentage of participants with provider documented progression (documented as disease has progressed or worsening of disease) is reported in this outcome measure. | Analysis population included all eligible participants whose data were retrieved and observed in this study. | Posted | Number | Percentage of participants | From start of treatment until documented disease progression, during study observation period maximum up to approximately 53 months (data was retrieved and observed during 2.5 years of this retrospective study) |
|
|
|
| Primary | Real-World Time to Tumor Progression (rwTTP) | The rwTTP was measured from the initiation of index treatment to the date of provider-documented progression (documented by provider as disease has progressed or worsening of disease), censoring participants without evidence of provider-documented progression at the last visit date. Kaplan-Meier method was used for analysis. | Analysis population included all eligible participants whose data were retrieved and observed in this study. | Posted | Median | 95% Confidence Interval | Weeks | From initiation of the index treatment to the date of progression or censoring date, during study observation period maximum up to approximately 53 months (data was retrieved and observed during 2.5 years of this retrospective study) |
|
|
|
| Primary | Real-World Progression-Free Survival (rwPFS) | The rwPFS was measured from the initiation of the index treatment to the date of progression (documented by provider as disease has progressed or worsening of disease) or date of death due to any cause, censoring participants who were still alive at the end of the study observation period and did not progress at the last visit date. Kaplan-Meier method was used for analysis. | Analysis population included all eligible participants whose data were retrieved and observed in this study. | Posted | Median | 95% Confidence Interval | Weeks | From initiation of index treatment to date of progression or death due to any cause or censoring date, during study observation period maximum up to approximately 53 months (data was retrieved and observed during 2.5 years of this retrospective study) |
|
|
|
| Primary | Overall Survival (OS) | Overall survival (OS) was defined as the interval between index treatment and the date of death (any cause) as documented in the Limited Access Death Master File (LADMF), National Death Index (NDI) and the iKM EHR database. Participants who did not die within the study observation period were censored on the study end date or the last visit date available in the dataset, whichever occurred first. Kaplan-Meier method was used for analysis. | Analysis population included all eligible participants whose data were retrieved and observed in this study. | Posted | Median | 95% Confidence Interval | Weeks | From start of index treatment until date of death or censoring date, during study observation period maximum up to approximately 53 months (data was retrieved and observed during 2.5 years of this retrospective study) |
|
|
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| Other Pre-specified | Percentage of Participants According to the Dosing Strength of Fulvestrant and Palbociclib as Their Index Treatment | The percentage of participants classified according to the dosing strength of Palbociclib and Fulvestrant as their index treatment were reported in this outcome measure. Index date was the date of initiation with palbociclib + fulvestrant during the study identification period. | Analysis population included all eligible participants whose data were retrieved and observed in this study. | Posted | Number | Percentage of participants | At index, anytime between 01-February-2016 and 31-December-2019 (data was retrieved and observed during 2.5 years of this retrospective study) |
|
|
|
| Other Pre-specified | Duration of Treatment for Advanced Metastatic Breast Cancer | The duration of treatment for advanced metastatic breast cancer was reported in this outcome measure. | Analysis population included all eligible participants whose data were retrieved and observed in this study. | Posted | Median | Full Range | Weeks | From start of index treatment until stop of index treatment, during study observation period maximum up to approximately 53 months (data was retrieved and observed during 2.5 years of this retrospective study) |
|
|
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| Other Pre-specified | Percentage of Participants With Prior Adjuvant Hormonal Treatment for Advanced Metastatic Breast Cancer | Percentage of participants with prior adjuvant hormonal treatment for breast cancer were reported in this outcome measure. Index date was the date of initiation with palbociclib + fulvestrant during the study identification period. | Analysis population included all eligible participants whose data were retrieved and observed in this study. Here, 'Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure. | Posted | Number | Percentage of participants | Prior to index date (the date of initiation with Palbociclib-Fulvestrant during the study identification period) (data was retrieved and observed during 2.5 years of this retrospective study) |
|
|
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| Other Pre-specified | Number of Participants According to Year of Treatment Initiation for Advanced Metastatic Breast Cancer | Number of participants were classified according to the year of treatment initiation for advanced metastatic breast cancer in this outcome measure. | Analysis population included all eligible participants whose data were retrieved and observed in this study. | Posted | Count of Participants | Participants | Quarter(Q)1 2015,Q2 2015,Q3 2015,Q4 2015,Q1 2016,Q2 2016,Q3 2016,Q4 2016,Q1 2017,Q2 2017,Q3 2017,Q4 2017,Q1 2018,Q2 2018,Q3 2018,Q4 2018,Q1 2019,Q2 2019,Q3 2019,Q4 2019(data was retrieved and observed during 2.5 years of this retrospective study) |
|
|
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| Other Pre-specified | Percentage of Participants With Change in Dose | The percentage of participants with dose change for index treatment were reported in this outcome measure. | Analysis population included all eligible participants whose data were retrieved and observed in this study. | Posted | Number | Percentage of participants | From index treatment until follow up period of 6 months (data was retrieved and observed during 2.5 years of this retrospective study) |
|
|
|
| 92 |
| 317 |
| 0 |
| 0 |
| 0 |
| 0 |
Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publication 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.
| D017437 |
| Skin and Connective Tissue Diseases |
| Title | Measurements |
|---|---|
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| Patient preference |
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| Toxicity |
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| Other |
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| No information |
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| Title | Measurements |
|---|---|
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