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See termination reason in detailed description.
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The IES study (A5991012) investigated 4742 patients treated for 2 to 3 years with tamoxifen, who either continued the same treatment or switched to Aromasin® for a total treatment period of 5 years. Only 65 Romanian patients were enrolled in the IES study. It would therefore appear to be essential to evaluate and confirm the tolerability of Aromasin® and the ways in which it is used on a broader sample of patients and under the standard conditions of use as stipulated in the MA. This Non-Interventional study was designed to address these issues.
This is a prospective, non-comparative, non interventional study (NIS) in four hundred (400) postmenopausal women hormone-receptor positive invasive with early breast cancer, following 2-3 years of initial adjuvant tamoxifen therapy conducted in 60 sites from Romania according to protocol A5991091.The selection of patients based on diagnosis, the attribution of medicinal products and the follow-up of the subjects fall within the current medical practice. A Non-Interventional study is primarily observational in nature. The present Non-interventional Study is performed by medical oncologist and medical oncologist /radiation oncologist who agree to take part in this project. n/a The study was prematurely terminated on August 31th 2012 due to unexpected high rate of patient withdrawal caused by Aromasin reimbursement policy change in Romania; There were no safety issues related to study termination.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Aromasin | All patients included in the study |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Aromasin | Drug | 25 mg daily continuously |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Treatment-Emergent Adverse Events (AEs) by Severity | An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Treatment-emergent are events between first dose of study drug and up to 28 days after last dose that were absent before treatment or that worsened relative to pretreatment state. AEs were graded using National Cancer Institute (NCI)/Cancer Therapy Evaluation Program (CTEP) Common Terminology Criteria for Adverse Events version 4.0 (CTCAE,v4.0) as Grade 1 (Mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated); Grade 2 (Moderate; minimal, local or noninvasive intervention; limiting age-appropriate instrumental activities of daily living [ADL]); Grade 3 (Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization; disabling; limiting self-care ADL); Grade 4 (Life-threatening; urgent intervention indicated) and Grade 5 (Death related to AE). | Baseline up to 28 days after last dose |
| Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs) by Relationship to Study Drug | An AE (all causalities) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to 28 days after last dose that were absent before treatment or that worsened relative to pretreatment state. Relatedness to exemestane was assessed by the investigator (Yes/No). Participants with multiple occurrences of an AE within a category were counted once within the category. | Baseline up to 28 days after last dose |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Missed Exemestane Doses | Week 25, 49, 73, 97, 121, 145 | |
| Number of Participants With Reasons for Discontinuing Exemestane Therapy | Baseline up to Year 3 | |
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Inclusion Criteria:
Postmenopausal females, defined as one from the next :
Patients who have had surgical treatment for histological confirmed breast cancer that was non-metastatic at the time of the initial diagnosis.
Patients who are disease-free after 2 or 3 years of adjuvant tamoxifen treatment.
Patients whose tumour was estrogen receptor positive (ER+).
Evidence of a personally signed and dated informed consent document indicating that the subject (or a legally acceptable representative) has been informed of all pertinent aspects of the study.
Exclusion Criteria:
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Postmenopausal women hormone-receptor positive invasive with early breast cancer, following 2-3 years of initial adjuvant tamoxifen therapy
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Policlinica Judeteana 1 Pitesti - Cabinet oncologie | Piteşti | Argeş | 110084 | Romania | ||
| Spitalul Judetean de Urgenta Bacau |
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| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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All participants were recruited from Romania.
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| ID | Title | Description |
|---|---|---|
| FG000 | Exemestane | Participants with 2 to 3 years of initial adjuvant tamoxifen therapy received exemestane (Aromasin) 25 milligram (mg) tablet orally once daily as per local standard of care to complete 5 years of adjuvant hormonal therapy. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Number of Participants Who Received Hormonal Therapy or Chemotherapy After Discontinuation of Exemestane Therapy |
| Baseline up to Year 3 |
| Percentage of Participants Who Discontinued the Exemestane Therapy | Baseline up to Year 3 |
| Recurrence-free Survival (RFS) | Recurrence-free survival defined as the time from study inclusion to the first date of documented recurrence, with events defined as: local recurrence, distant recurrence, new primary breast cancer (includes both ipsilateral and contralateral second primaries), or death due to any cause. New primary cancer at sites other than the breast were not considered as recurrence. | Baseline up to Year 3 |
| Time to Disease Progression (TTP) | Time to disease progression was defined as the time from inclusion to first local or distant recurrence at any site. | Baseline up to Year 3 |
| Bacau |
| Bacău |
| 600114 |
| Romania |
| CMDT MAPN Washington Ambulator oncologie | Bucharest | Bucharest | 011794 | Romania |
| Centru D.T. Titan Cabinet oncologie | Bucharest | Bucharest | 030442 | Romania |
| Spitalul Judetean de Urgenta Resita Sectia oncologie medicala | Reşiţa | Caraș-Severin County | 320076 | Romania |
| Institutul Oncologic "Prof. Dr. Ion Chiricuta" Cluj Napoca | Cluj-Napoca | Cluj | 400015 | Romania |
| Spitalul Clinic Judetean de Urgenta Cluj, Clinica de Oncologie Medicala si Radioterapie | Cluj-Napoca | Cluj | 40006 | Romania |
| Spitalul Judetean Covasna, Sectia Oncologie medicala | Sfantu Gheorghe | Covasna | 520064 | Romania |
| Spitalul Judetean de Urgenta Targoviste | Targoviste | Dâmbovița County | 130095 | Romania |
| Spitalulul Judetean de Urgenta Deva, Ambulator oncologie medicala | Hunedoara | Hunedoara County | 331021 | Romania |
| Spitalulul Clinic Judetean de Urgenta Sf. Spiridon, Ambulatoriu de specialitate adulti - Stationar o | Iași | Iaşi | 700106 | Romania |
| Spitalul Clinic Judetean de Urgenta "Sf. Spiridon" Iasi Clinica Oncologie Medicala | Iași | Iaşi | 700111 | Romania |
| Spital Clinic Judetean de Urgenta Oradea | Oradea | Jud. Bihor | 410167 | Romania |
| Spitalul Judeţean Brasov | Brasov | Jud. Brasov | 505200 | Romania |
| Spitalulul Judetean Clinic de Urgenta, Sf. Apostol Andrei | Galati | Jud. Galati | 800367 | Romania |
| Spitalul Judetean Bistrita Nasaud - Sectia Oncologie Medicala | Bistriţa | Jud. Nasaud | 420178 | Romania |
| Spitalul Clinic Judetean de Urgenta Sibiu - Sectia Oncologie Medicala | Sibiu | Jud. Sibiu | 550245 | Romania |
| Spitalul Judetean Drobeta Turnu Severin - Sectie oncologie | Drobeta-Turnu Severin | Mehedinți County | 220064 | Romania |
| Spitalul Judetean Targu Mures | Târgu Mureş | Mureș County | 540140 | Romania |
| Spitalulul Municipal de Urgenta Roman | Roman | Neamț County | 617385 | Romania |
| Spitalul Judetean de Urgenta Slatina, Sectie oncologie | Slatina | Olt | 230008 | Romania |
| Spitalul Municipal Campina Sectia oncologie | Câmpina | Prahova | 107425 | Romania |
| Spitalul Municipal Ploiesti Sectia oncologie | Ploieşti | Prahova | 100337 | Romania |
| Spitalul Municipal Medias Compartimentul Oncologie medicala | Mediaş | Sibiu County | 551026 | Romania |
| Spitalulul Clinic Judetean de Urgenta Sibiu- Sectia Oncologie medicala | Sibiu | Sibiu County | 550245 | Romania |
| Spitalulul Judetean de Urgenta, Sf. Ioan cel Nou | Suceava | Suceava | 720131 | Romania |
| Spitalul Clinic Municipal de Urgenta Timisoara Clinica Oncologie Medicala | Timișoara | Timiș County | 300223 | Romania |
| Spitalul Clinic Municipal Timisoara Sectia oncologie medicala | Timișoara | Timiș County | 300223 | Romania |
| Oncomed Srl | Timișoara | Timiș County | 300239 | Romania |
| Ambulator Spital Colentina, cabinet oncologie | Bucharest | 020142 | Romania |
| Cabinet Oncologie Medicala | Bucharest | 020947 | Romania |
| Ambulator Spital Sf. Pantelimon, cabinet oncolgie | Bucharest | 021659 | Romania |
| Institutul Oncologic "Prof. Dr. Al. Trestioreanu" | Bucharest | 022328 | Romania |
| Ambulator Spital Clinic Colţea, cabinet oncologie | Bucharest | 030171 | Romania |
| Policlinica Sf. Ioan Bucuresti, cabinet oncologie | Bucharest | 042121 | Romania |
| Policlinica Theodor Burghele, cabinet oncologie | Bucharest | 50659 | Romania |
| Ambulator Specialitate Cotroceni, cabinet oncolgie | Bucharest | 7000 | Romania |
| Str. Povernei 42, Sector 1 | Bucharest | 7000 | Romania |
| Spitalul Clinic de Urgenta | Oradea | 410032 | Romania |
| Spitalul Judetean de Urgenta Targu Jiu, Ambulator Spital - Oncologie medicala | Târgu Jiu | 210140 | Romania |
| COMPLETED |
|
| NOT COMPLETED |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Exemestane | Participants with 2 to 3 years of initial adjuvant tamoxifen therapy received exemestane (Aromasin) 25 milligram (mg) tablet orally once daily as per local standard of care to complete 5 years of adjuvant hormonal therapy. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| ||||||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| |||||||||||||||||||||||
| Number of Participants With Type of Tumor | Number of participants with different types of tumor such as; ductal carcinoma, lobular carcinoma, invasive ductal carcinoma, invasive lobular carcinoma, papillary carcinoma, medullary carcinoma, mucinous (colloid) carcinoma and others. | Number | participants |
| ||||||||||||||||||||||
| Number of Participants With Type of Surgery | Number of participants who had undergone different type of surgeries which included appendicectomy, breast lump removal, cataract operation, cholecystectomy, hysterectomy, intervertebral disc operation, malignant tumor excision, salpingo-oophorectomy bilateral, and splenectomy. | Number | participants |
| ||||||||||||||||||||||
| Number of Participants With Estrogen Receptor Positive | Participants whose tumor was estrogen receptor positive are reported. | Number | participants |
| ||||||||||||||||||||||
| Number of Participants With Lymph Node Involvement | Number | participants |
| |||||||||||||||||||||||
| Number of Participants With Tumor Node Metastasis (TNM) Stage | TNM was based on size of tumor, if cancer cells had spread to nearby lymph nodes (LN), or distant (to other parts of the body) metastasis had occurred. Stages included: stage 0(no evidence of cancer cells), stage 1(T1N0M0), stage IIA(T0N1M0, T1N1M0, T2N0M0), stage IIB(T2N1M0, T3N0M0), stage IIIA(T0N2M0, T1N2M0, T2N3M0, T3N1orN2M0), stage IIIC(any TN3M0), stage IV(anyT anyNM1), where T0=early form of tumor, T1= <2 centimeter(cm), T2=2-5 cm, T3= >2 cm, T4=large sized tumor, 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. | Number | participants |
| ||||||||||||||||||||||
| Number of Participants With Histopathological Grade | The grade of a cancer depends on what the cells look like and the growth-rate. Lower grade indicates a slower-growing cancer and a higher grade indicates a faster-growing one. Grade 1 (resemble normal cells, not growing rapidly), Grade 2 (grow faster than normal cells), Grade 3 and 4 (abnormal cells, grow and spread aggressively). | Number | participants |
| ||||||||||||||||||||||
| Number of Participants With Prior Chemotherapy | Number | participants |
| |||||||||||||||||||||||
| Number of Participants With Prior Radiation Therapy | A total 271 participants were evaluable for this measure. | Number | participants |
|
| 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 | Number of Participants With Treatment-Emergent Adverse Events (AEs) by Severity | An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Treatment-emergent are events between first dose of study drug and up to 28 days after last dose that were absent before treatment or that worsened relative to pretreatment state. AEs were graded using National Cancer Institute (NCI)/Cancer Therapy Evaluation Program (CTEP) Common Terminology Criteria for Adverse Events version 4.0 (CTCAE,v4.0) as Grade 1 (Mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated); Grade 2 (Moderate; minimal, local or noninvasive intervention; limiting age-appropriate instrumental activities of daily living [ADL]); Grade 3 (Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization; disabling; limiting self-care ADL); Grade 4 (Life-threatening; urgent intervention indicated) and Grade 5 (Death related to AE). | Safety analysis set included all participants who had received at least 1 dose of exemestane during the observation period. | Posted | Number | participants | Baseline up to 28 days after last dose |
|
|
| ||||||||||||||||||||||||||||||||||||
| Primary | Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs) by Relationship to Study Drug | An AE (all causalities) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to 28 days after last dose that were absent before treatment or that worsened relative to pretreatment state. Relatedness to exemestane was assessed by the investigator (Yes/No). Participants with multiple occurrences of an AE within a category were counted once within the category. | Safety analysis set included all participants who had received at least 1 dose of exemestane during the observation period. | Posted | Number | participants | Baseline up to 28 days after last dose |
|
| |||||||||||||||||||||||||||||||||||||
| Secondary | Number of Missed Exemestane Doses | Full analysis set (FAS) included all participants who had received at least 1 dose of exemestane during the observation period. 'N' (number of participants analyzed)=participants evaluable for this measure. n=number of participants evaluable at specified time points. None of the participants were evaluable at Week 145 and hence data not reported. | Posted | Mean | Standard Deviation | missed doses | Week 25, 49, 73, 97, 121, 145 |
|
| |||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Reasons for Discontinuing Exemestane Therapy | Safety analysis set included all participants who had received at least 1 dose of exemestane during the observation period. | Posted | Number | participants | Baseline up to Year 3 |
|
| ||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants Who Received Hormonal Therapy or Chemotherapy After Discontinuation of Exemestane Therapy | FAS included all participants who had received at least 1 dose of exemestane during the observation period. | Posted | Number | participants | Baseline up to Year 3 |
|
| ||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants Who Discontinued the Exemestane Therapy | Safety analysis set included all participants who had received at least 1 dose of exemestane during the observation period. | Posted | Number | percentage of participants | Baseline up to Year 3 |
|
| ||||||||||||||||||||||||||||||||||||||
| Secondary | Recurrence-free Survival (RFS) | Recurrence-free survival defined as the time from study inclusion to the first date of documented recurrence, with events defined as: local recurrence, distant recurrence, new primary breast cancer (includes both ipsilateral and contralateral second primaries), or death due to any cause. New primary cancer at sites other than the breast were not considered as recurrence. | A subgroup of participants from FAS who had documented recurrence was evaluable for this measure. | Posted | Median | Full Range | weeks | Baseline up to Year 3 |
|
| ||||||||||||||||||||||||||||||||||||
| Secondary | Time to Disease Progression (TTP) | Time to disease progression was defined as the time from inclusion to first local or distant recurrence at any site. | Time to disease progression was considered complementary to RFS and hence, was not analyzed. | Posted | Baseline up to Year 3 |
|
|
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The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
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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 | Exemestane | Participants with 2 to 3 years of initial adjuvant tamoxifen therapy received exemestane (Aromasin) 25 milligram (mg) tablet orally once daily as per local standard of care to complete 5 years of adjuvant hormonal therapy. | 5 | 378 | 5 | 378 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Atrial fibrillation | Cardiac disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Cataract | Eye disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Visual acuity reduced | Eye disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Intestinal obstruction | Gastrointestinal disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Cholelithiasis | Hepatobiliary disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Pyelonephritis acute | Infections and infestations | MedDRA 16.0 | Non-systematic Assessment |
| |
| Colorectal cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 16.0 | Non-systematic Assessment |
| |
| Meningioma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 16.0 | Non-systematic Assessment |
| |
| Cerebrovascular accident | Nervous system disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Asthmatic crisis | Respiratory, thoracic and mediastinal disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Hypertensive crisis | Vascular disorders | MedDRA 16.0 | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 16.0 | Non-systematic Assessment |
|
The study was prematurely terminated on 31 August 2012 due to unexpected high rate of participant withdrawal caused by Aromasin reimbursement policy change in Romania. There were no safety issues related to study termination.
Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pfizer ClinicalTrials.gov Call Center | Pfizer, Inc. | 1-800-718-1021 | ClinicalTrials.gov_Inquiries@pfizer.com |
| ID | Term |
|---|---|
| C056516 | exemestane |
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| Invasive Ductal Carcinoma |
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| Invasive Lobular Carcinoma |
|
| Papillary Carcinoma |
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| Medullary Carcinoma |
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| Mucinous (Colloid) Carcinoma |
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| Other |
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| Missing/No Response |
|
| Cataract operation |
|
| Cholecystectomy |
|
| Hysterectomy |
|
| Intervertebral disc operation |
|
| Malignant tumor excision |
|
| Salpingo-oophorectomy bilateral |
|
| Splenectomy |
|
| Title | Measurements |
|---|---|
|
| Stage IIB |
|
| Stage IIIA |
|
| Stage IIIB |
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| Stage IIIC |
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| Other |
|
| Missing/No Response |
|
| Grade 3 |
|
| Unknown |
|
| Missing/No Response |
|
| Title | Measurements |
|---|
|
| Grade 4 |
|
| Grade 5 |
|
| Missing or Unknown |
|
| Participants |
|
|
|
| Title | Denominators | Categories | ||||
|---|---|---|---|---|---|---|
| Adverse event |
| |||||
| Insufficient clinical response |
| |||||
| Did not meet entrance criteria |
| |||||
| Lost to follow-up |
| |||||
| No longer willing to participate in study |
| |||||
| Other unspecified |
| |||||
| Protocol violation |
| |||||
| Study terminated by sponsor |
| |||||
| Withdrawn due to pregnancy |
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| Title | Denominators | Categories | ||||
|---|---|---|---|---|---|---|
| Received hormonal therapy |
| |||||
| Received chemotherapy |
| |||||
| Received both hormonal and chemotherapy |
| |||||
| No hormonal or chemotherapy received |
| |||||
| Missing or no response |
|
| Title | Denominators | Categories | ||||
|---|---|---|---|---|---|---|
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|