1534 lines
69 KiB
JSON
1534 lines
69 KiB
JSON
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{
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"protocolSection": {
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"identificationModule": {
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"nctId": "NCT01239745",
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"orgStudyIdInfo": {
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"id": "A5991094"
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},
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"organization": {
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"fullName": "Pfizer",
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"class": "INDUSTRY"
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},
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"briefTitle": "Aromasin\u00ae As Adjuvant Treatment In Postmenopausal Women With Invasive, Estrogen Receptor Positive Early Breast Cancer",
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"officialTitle": "A Non-Interventional Study With Aromasin\u00ae As Adjuvant Treatment In Postmenopausal Women With Invasive, Estrogen Receptor Positive Early Breast Cancer Who Are Disease-Free After 2-3 Years Of Initial Adjuvant Tamoxifen Therapy"
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},
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"statusModule": {
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"statusVerifiedDate": "2012-10",
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"overallStatus": "TERMINATED",
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"whyStopped": "See termination reason in detailed description.",
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"expandedAccessInfo": {
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"hasExpandedAccess": false
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},
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"startDateStruct": {
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"date": "2011-04"
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},
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"primaryCompletionDateStruct": {
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"date": "2011-10",
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"type": "ACTUAL"
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},
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"completionDateStruct": {
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"date": "2011-10",
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"type": "ACTUAL"
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},
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"studyFirstSubmitDate": "2010-11-03",
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"studyFirstSubmitQcDate": "2010-11-10",
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"studyFirstPostDateStruct": {
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"date": "2010-11-11",
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"type": "ESTIMATED"
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},
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"resultsFirstSubmitDate": "2012-10-11",
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"resultsFirstSubmitQcDate": "2012-10-11",
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"resultsFirstPostDateStruct": {
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"date": "2012-10-31",
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"type": "ESTIMATED"
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},
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"lastUpdateSubmitDate": "2012-10-11",
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"lastUpdatePostDateStruct": {
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"date": "2012-10-31",
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"type": "ESTIMATED"
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}
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},
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"sponsorCollaboratorsModule": {
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"responsibleParty": {
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"type": "SPONSOR"
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},
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"leadSponsor": {
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"name": "Pfizer",
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"class": "INDUSTRY"
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}
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},
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"oversightModule": {
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"oversightHasDmc": false
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},
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"descriptionModule": {
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"briefSummary": "This non-interventional study will be conducted in several Eastern European countries to assess the safety, tolerability and efficacy of Aromasin\u00ae when it is administered in real-word setting in postmenopausal women with invasive estrogen receptor positive early breast cancer , who are disease-free after completion of 2 to 3 years of tamoxifen and continue the treatment with Aromasin\u00ae until completion of 5 years of adjuvant hormonal therapy, to understand how Aromasin\u00ae is used in routine clinical practice, to assess adherence to prescribed Aromasin\u00ae treatment and to understand reasons for its early discontinuation.",
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"detailedDescription": "The study prematurely discontinued on October 11, 2011 due to slow enrollment. It should be noted that safety concerns have not been seen in this study and have not factored into this decision."
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},
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"conditionsModule": {
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"conditions": [
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"Breast Neoplasms"
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],
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"keywords": [
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"Hormone adjuvant treatment of early breast cancer with aromatase inhibitors following 2-3 years of tamoxifen"
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]
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},
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"designModule": {
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"studyType": "OBSERVATIONAL",
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"designInfo": {
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"observationalModel": "CASE_CONTROL",
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"timePerspective": "PROSPECTIVE"
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},
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"enrollmentInfo": {
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"count": 46,
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"type": "ACTUAL"
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}
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},
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"armsInterventionsModule": {
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"armGroups": [
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{
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"label": "1",
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"interventionNames": [
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"Drug: Aromasin"
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]
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}
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],
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"interventions": [
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{
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"type": "DRUG",
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"name": "Aromasin",
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"description": "Aromasin\u00ae one 25 mg tablet to be taken once daily",
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"armGroupLabels": [
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"1"
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],
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"otherNames": [
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"Exemestane"
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]
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}
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]
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},
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"outcomesModule": {
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"primaryOutcomes": [
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{
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"measure": "Number of Participants With Adverse Events (AEs)",
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"description": "Counts of participants who had treatment-emergent adverse events (TEAEs), defined as newly occurring or worsening after first dose. Relatedness (to study drug) was assessed by the investigator (Yes/No). Participants with multiple occurrences of an AE within a category were counted once within the category.",
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"timeFrame": "Baseline up to Month 36"
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}
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],
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"secondaryOutcomes": [
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{
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"measure": "Number of Participants With Concomitant Morbidities",
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"description": "Participants who had a concomitant morbidity during the study for any period of time; participants with more than one concomitant morbidity were counted for each of the concomitant morbidity classes applicable.",
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"timeFrame": "Baseline up to Month 36"
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},
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{
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"measure": "Number of Participants With Concomitant Medications",
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"description": "Concomitant medication (any medication other than, and in addition to, the study medication) taken for any period of time during the study and was coded by World Health Organization (WHO) medical dictionary.",
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"timeFrame": "Baseline up to Month 36"
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},
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{
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"measure": "Percentage of Participants Who Discontinued the Study Medication",
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"timeFrame": "Baseline up to Month 36"
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},
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{
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"measure": "Number of Participants With Reasons for Discontinuation From Study Medication",
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"timeFrame": "Baseline up to Month 36"
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},
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{
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"measure": "Time to Discontinuation",
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"timeFrame": "Baseline up to Month 36"
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},
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{
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"measure": "Recurrence-free Survival",
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"description": "Recurrence-free survival defined as the time from the initiation of study medication to the date of confirmation of any recurrence - as local or distant breast cancer recurrence; new primary breast cancer (ipsilateral or contralateral), death due to any cause.",
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"timeFrame": "Baseline up to Month 36"
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},
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{
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"measure": "Overall Survival",
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"description": "Time in months from the start of study treatment to date of death due to any cause. OS was calculated as (the death date minus the date of first dose of study medication plus 1) divided by 30.4. Death was determined from adverse event data (where outcome was death) or from follow-up contact data (where the participant current status was death).",
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"timeFrame": "Baseline until death (up to Month 36)"
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}
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]
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},
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"eligibilityModule": {
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"eligibilityCriteria": "Inclusion Criteria:\n\n* Postmenopausal females, defined as one from the next :\n\n 1. Natural menopause \u22651 year,\n 2. Surgical ovariectomy,\n 3. Chemotherapy-induced amenorrhoea \u2265 2 years.\n* Patients who have had surgical treatment for histologically confirmed breast cancer that was non-metastatic at the time of the initial diagnosis.\n* Patients who are disease-free after 2 to 3 years of adjuvant tamoxifen treatment.\n* Patients whose tumour was estrogen receptor positive (ER+).\n* 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.\n\nExclusion Criteria:\n\n* Patients for whom Aromasin\u00ae treatment is contraindicated (see SmPC).\n* Metastatic breast cancer or a contra lateral tumour.\n* Other concomitant adjuvant endocrine therapy.\n* Other concomitant antineoplastic treatment.\n* Participation in a clinical trial with an investigational drug during the 30 days prior to enrolment in the study.",
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"healthyVolunteers": false,
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"sex": "FEMALE",
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"stdAges": [
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"CHILD",
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"ADULT",
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"OLDER_ADULT"
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],
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"studyPopulation": "Estrogen receptor positive early breast cancer patients",
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"samplingMethod": "NON_PROBABILITY_SAMPLE"
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},
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"contactsLocationsModule": {
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"overallOfficials": [
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{
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"name": "Pfizer CT.gov Call Center",
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"affiliation": "Pfizer",
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"role": "STUDY_DIRECTOR"
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}
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],
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"locations": [
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{
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"facility": "General Hospital Karlovac",
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"city": "Karlovac",
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"zip": "47000",
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"country": "Croatia",
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"geoPoint": {
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"lat": 45.48941,
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"lon": 15.54887
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}
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},
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{
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"facility": "University Hospital Center Osijek",
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"city": "Osijek",
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"zip": "31000",
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"country": "Croatia",
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"geoPoint": {
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"lat": 45.55111,
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"lon": 18.69389
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}
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},
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{
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"facility": "General Hospital Pula",
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"city": "Pula",
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"zip": "52000",
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"country": "Croatia",
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"geoPoint": {
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"lat": 44.86833,
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"lon": 13.84806
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}
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},
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{
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"facility": "University Hospital Center Rijeka",
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"city": "Rijeka",
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"zip": "51000",
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"country": "Croatia",
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"geoPoint": {
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"lat": 45.32674,
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"lon": 14.44239
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}
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},
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{
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"facility": "University Hospital Center Split",
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"city": "Split",
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"zip": "21000",
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"country": "Croatia",
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"geoPoint": {
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"lat": 43.50891,
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"lon": 16.43915
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}
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},
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{
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"facility": "General Hospital Varazdin",
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"city": "Varazdin",
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"zip": "42000",
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"country": "Croatia",
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"geoPoint": {
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"lat": 46.30444,
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"lon": 16.33778
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}
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},
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{
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"facility": "Clinic for Tumors",
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"city": "Zagreb",
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"zip": "10000",
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"country": "Croatia",
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"geoPoint": {
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"lat": 45.81444,
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"lon": 15.97798
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||
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}
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},
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{
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"facility": "University Hospital Center \"Sestre milosrdnice\"",
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"city": "Zagreb",
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"zip": "10000",
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"country": "Croatia",
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"geoPoint": {
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||
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"lat": 45.81444,
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||
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"lon": 15.97798
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||
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}
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},
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{
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"facility": "North Estonia Medical Centre Foundation",
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"city": "Tallinn",
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"zip": "13419",
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"country": "Estonia",
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"geoPoint": {
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"lat": 59.43696,
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"lon": 24.75353
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}
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},
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{
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"facility": "Institute for Oncology and Radiology of Serbia",
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"city": "Belgrade",
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"zip": "11000",
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"country": "Serbia",
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"geoPoint": {
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"lat": 44.80401,
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"lon": 20.46513
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}
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},
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{
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"facility": "Oncology Clinic, Medical center, Bezanijska Kosa",
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"city": "Beograd",
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"zip": "11080",
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"country": "Serbia"
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}
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]
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},
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"referencesModule": {
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"seeAlsoLinks": [
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{
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"label": "To obtain contact information for a study center near you, click here.",
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||
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"url": "https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A5991094&StudyName=Aromasin%AE%20As%20Adjuvant%20Treatment%20In%20Postmenopausal%20Women%20With%20Invasive%2C%20Estrogen%20Receptor%20Positive%20Early%20Breast%20Cancer"
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}
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||
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]
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}
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},
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"resultsSection": {
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||
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"participantFlowModule": {
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||
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"groups": [
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{
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||
|
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"id": "FG000",
|
||
|
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"title": "Exemestane",
|
||
|
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"description": "Participants received exemestane (Aromasin) in accordance with Summary of Product Characteristics (SmPC) and adjusted according to medical and therapeutic necessity in a sequential adjuvant hormonal therapy (tamoxifen followed by Aromasin) up to 5 years or until tumor relapse occurred."
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||
|
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}
|
||
|
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],
|
||
|
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"periods": [
|
||
|
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{
|
||
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"title": "Overall Study",
|
||
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"milestones": [
|
||
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{
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||
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"type": "STARTED",
|
||
|
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"achievements": [
|
||
|
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{
|
||
|
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"groupId": "FG000",
|
||
|
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"numSubjects": "46"
|
||
|
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}
|
||
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]
|
||
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},
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||
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{
|
||
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"type": "COMPLETED",
|
||
|
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"achievements": [
|
||
|
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{
|
||
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"groupId": "FG000",
|
||
|
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"numSubjects": "0"
|
||
|
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}
|
||
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]
|
||
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},
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||
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{
|
||
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"type": "NOT COMPLETED",
|
||
|
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"achievements": [
|
||
|
|
{
|
||
|
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"groupId": "FG000",
|
||
|
|
"numSubjects": "46"
|
||
|
|
}
|
||
|
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]
|
||
|
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}
|
||
|
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],
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||
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"dropWithdraws": [
|
||
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{
|
||
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"type": "Study terminated by sponsor",
|
||
|
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"reasons": [
|
||
|
|
{
|
||
|
|
"groupId": "FG000",
|
||
|
|
"numSubjects": "45"
|
||
|
|
}
|
||
|
|
]
|
||
|
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},
|
||
|
|
{
|
||
|
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"type": "Adverse Event",
|
||
|
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"reasons": [
|
||
|
|
{
|
||
|
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"groupId": "FG000",
|
||
|
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"numSubjects": "1"
|
||
|
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}
|
||
|
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]
|
||
|
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}
|
||
|
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]
|
||
|
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}
|
||
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]
|
||
|
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},
|
||
|
|
"baselineCharacteristicsModule": {
|
||
|
|
"groups": [
|
||
|
|
{
|
||
|
|
"id": "BG000",
|
||
|
|
"title": "Exemestane",
|
||
|
|
"description": "Participants received exemestane (Aromasin) in accordance with Summary of Product Characteristics (SmPC) and adjusted according to medical and therapeutic necessity in a sequential adjuvant hormonal therapy (tamoxifen followed by Aromasin) up to 5 years or until tumor relapse occurred."
|
||
|
|
}
|
||
|
|
],
|
||
|
|
"denoms": [
|
||
|
|
{
|
||
|
|
"units": "Participants",
|
||
|
|
"counts": [
|
||
|
|
{
|
||
|
|
"groupId": "BG000",
|
||
|
|
"value": "46"
|
||
|
|
}
|
||
|
|
]
|
||
|
|
}
|
||
|
|
],
|
||
|
|
"measures": [
|
||
|
|
{
|
||
|
|
"title": "Age Continuous",
|
||
|
|
"paramType": "MEAN",
|
||
|
|
"dispersionType": "STANDARD_DEVIATION",
|
||
|
|
"unitOfMeasure": "years",
|
||
|
|
"classes": [
|
||
|
|
{
|
||
|
|
"categories": [
|
||
|
|
{
|
||
|
|
"measurements": [
|
||
|
|
{
|
||
|
|
"groupId": "BG000",
|
||
|
|
"value": "59.0",
|
||
|
|
"spread": "10.7"
|
||
|
|
}
|
||
|
|
]
|
||
|
|
}
|
||
|
|
]
|
||
|
|
}
|
||
|
|
]
|
||
|
|
},
|
||
|
|
{
|
||
|
|
"title": "Sex: Female, Male",
|
||
|
|
"paramType": "COUNT_OF_PARTICIPANTS",
|
||
|
|
"unitOfMeasure": "Participants",
|
||
|
|
"classes": [
|
||
|
|
{
|
||
|
|
"categories": [
|
||
|
|
{
|
||
|
|
"title": "Female",
|
||
|
|
"measurements": [
|
||
|
|
{
|
||
|
|
"groupId": "BG000",
|
||
|
|
"value": "46"
|
||
|
|
}
|
||
|
|
]
|
||
|
|
},
|
||
|
|
{
|
||
|
|
"title": "Male",
|
||
|
|
"measurements": [
|
||
|
|
{
|
||
|
|
"groupId": "BG000",
|
||
|
|
"value": "0"
|
||
|
|
}
|
||
|
|
]
|
||
|
|
}
|
||
|
|
]
|
||
|
|
}
|
||
|
|
]
|
||
|
|
},
|
||
|
|
{
|
||
|
|
"title": "Type of Tumor",
|
||
|
|
"description": "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.",
|
||
|
|
"paramType": "NUMBER",
|
||
|
|
"unitOfMeasure": "participants",
|
||
|
|
"classes": [
|
||
|
|
{
|
||
|
|
"title": "Invasive ductal carcinoma",
|
||
|
|
"categories": [
|
||
|
|
{
|
||
|
|
"measurements": [
|
||
|
|
{
|
||
|
|
"groupId": "BG000",
|
||
|
|
"value": "31"
|
||
|
|
}
|
||
|
|
]
|
||
|
|
}
|
||
|
|
]
|
||
|
|
},
|
||
|
|
{
|
||
|
|
"title": "Invasive lobular carcinoma",
|
||
|
|
"categories": [
|
||
|
|
{
|
||
|
|
"measurements": [
|
||
|
|
{
|
||
|
|
"groupId": "BG000",
|
||
|
|
"value": "7"
|
||
|
|
}
|
||
|
|
]
|
||
|
|
}
|
||
|
|
]
|
||
|
|
},
|
||
|
|
{
|
||
|
|
"title": "Papillary carcinoma",
|
||
|
|
"categories": [
|
||
|
|
{
|
||
|
|
"measurements": [
|
||
|
|
{
|
||
|
|
"groupId": "BG000",
|
||
|
|
"value": "0"
|
||
|
|
}
|
||
|
|
]
|
||
|
|
}
|
||
|
|
]
|
||
|
|
},
|
||
|
|
{
|
||
|
|
"title": "Medullary carcinoma",
|
||
|
|
"categories": [
|
||
|
|
{
|
||
|
|
"measurements": [
|
||
|
|
{
|
||
|
|
"groupId": "BG000",
|
||
|
|
"value": "1"
|
||
|
|
}
|
||
|
|
]
|
||
|
|
}
|
||
|
|
]
|
||
|
|
},
|
||
|
|
{
|
||
|
|
"title": "Mucinous (colloid) carcinoma",
|
||
|
|
"categories": [
|
||
|
|
{
|
||
|
|
"measurements": [
|
||
|
|
{
|
||
|
|
"groupId": "BG000",
|
||
|
|
"value": "2"
|
||
|
|
}
|
||
|
|
]
|
||
|
|
}
|
||
|
|
]
|
||
|
|
},
|
||
|
|
{
|
||
|
|
"title": "Other",
|
||
|
|
"categories": [
|
||
|
|
{
|
||
|
|
"measurements": [
|
||
|
|
{
|
||
|
|
"groupId": "BG000",
|
||
|
|
"value": "5"
|
||
|
|
}
|
||
|
|
]
|
||
|
|
}
|
||
|
|
]
|
||
|
|
}
|
||
|
|
]
|
||
|
|
},
|
||
|
|
{
|
||
|
|
"title": "Type of Surgery",
|
||
|
|
"description": "Number of participants who had undergone different type of surgeries which included mastectomy, axilla evacuation, breast quadrantectomy, dissectio axillae, radical mastectomy, axillary dissection, ablation of both breast, segmentectomy, lymphadenectomy, lumpectomy, core biopsy, sentinel lymph node biopsy, quadrantectomy, re-excision, tumorectomy.",
|
||
|
|
"paramType": "NUMBER",
|
||
|
|
"unitOfMeasure": "participants",
|
||
|
|
"classes": [
|
||
|
|
{
|
||
|
|
"categories": [
|
||
|
|
{
|
||
|
|
"measurements": [
|
||
|
|
{
|
||
|
|
"groupId": "BG000",
|
||
|
|
"value": "NA",
|
||
|
|
"comment": "Data for this pre-specified outcome measure was collected and reported in individual participant listings but not statistically summarized for analysis."
|
||
|
|
}
|
||
|
|
]
|
||
|
|
}
|
||
|
|
]
|
||
|
|
}
|
||
|
|
]
|
||
|
|
},
|
||
|
|
{
|
||
|
|
"title": "Hormone Receptor Status",
|
||
|
|
"description": "Number of participants with positive estrogen receptors.",
|
||
|
|
"paramType": "NUMBER",
|
||
|
|
"unitOfMeasure": "participants",
|
||
|
|
"classes": [
|
||
|
|
{
|
||
|
|
"categories": [
|
||
|
|
{
|
||
|
|
"measurements": [
|
||
|
|
{
|
||
|
|
"groupId": "BG000",
|
||
|
|
"value": "46"
|
||
|
|
}
|
||
|
|
]
|
||
|
|
}
|
||
|
|
]
|
||
|
|
}
|
||
|
|
]
|
||
|
|
},
|
||
|
|
{
|
||
|
|
"title": "Lymph Node Status",
|
||
|
|
"paramType": "NUMBER",
|
||
|
|
"unitOfMeasure": "participants",
|
||
|
|
"classes": [
|
||
|
|
{
|
||
|
|
"categories": [
|
||
|
|
{
|
||
|
|
"measurements": [
|
||
|
|
{
|
||
|
|
"groupId": "BG000",
|
||
|
|
"value": "NA",
|
||
|
|
"comment": "Data for this pre-specified outcome measure was collected and reported in individual participant listings but not statistically summarized for analysis."
|
||
|
|
}
|
||
|
|
]
|
||
|
|
}
|
||
|
|
]
|
||
|
|
}
|
||
|
|
]
|
||
|
|
},
|
||
|
|
{
|
||
|
|
"title": "Tumor Node Metastasis (TNM) Stage",
|
||
|
|
"description": "TNM:based on tumor size, if cancer cells had spread to nearby lymph nodes (LN), or distant (other parts of body) metastasis. 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 IIIb( T4 anyNM0, any TN3M0),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, 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.",
|
||
|
|
"paramType": "NUMBER",
|
||
|
|
"unitOfMeasure": "participants",
|
||
|
|
"classes": [
|
||
|
|
{
|
||
|
|
"title": "Stage I",
|
||
|
|
"categories": [
|
||
|
|
{
|
||
|
|
"measurements": [
|
||
|
|
{
|
||
|
|
"groupId": "BG000",
|
||
|
|
"value": "18"
|
||
|
|
}
|
||
|
|
]
|
||
|
|
}
|
||
|
|
]
|
||
|
|
},
|
||
|
|
{
|
||
|
|
"title": "Stage IIA",
|
||
|
|
"categories": [
|
||
|
|
{
|
||
|
|
"measurements": [
|
||
|
|
{
|
||
|
|
"groupId": "BG000",
|
||
|
|
"value": "14"
|
||
|
|
}
|
||
|
|
]
|
||
|
|
}
|
||
|
|
]
|
||
|
|
},
|
||
|
|
{
|
||
|
|
"title": "Stage IIB",
|
||
|
|
"categories": [
|
||
|
|
{
|
||
|
|
"measurements": [
|
||
|
|
{
|
||
|
|
"groupId": "BG000",
|
||
|
|
"value": "5"
|
||
|
|
}
|
||
|
|
]
|
||
|
|
}
|
||
|
|
]
|
||
|
|
},
|
||
|
|
{
|
||
|
|
"title": "Stage IIIB",
|
||
|
|
"categories": [
|
||
|
|
{
|
||
|
|
"measurements": [
|
||
|
|
{
|
||
|
|
"groupId": "BG000",
|
||
|
|
"value": "4"
|
||
|
|
}
|
||
|
|
]
|
||
|
|
}
|
||
|
|
]
|
||
|
|
},
|
||
|
|
{
|
||
|
|
"title": "Stage IV",
|
||
|
|
"categories": [
|
||
|
|
{
|
||
|
|
"measurements": [
|
||
|
|
{
|
||
|
|
"groupId": "BG000",
|
||
|
|
"value": "0"
|
||
|
|
}
|
||
|
|
]
|
||
|
|
}
|
||
|
|
]
|
||
|
|
},
|
||
|
|
{
|
||
|
|
"title": "Stage IIIA",
|
||
|
|
"categories": [
|
||
|
|
{
|
||
|
|
"measurements": [
|
||
|
|
{
|
||
|
|
"groupId": "BG000",
|
||
|
|
"value": "4"
|
||
|
|
}
|
||
|
|
]
|
||
|
|
}
|
||
|
|
]
|
||
|
|
},
|
||
|
|
{
|
||
|
|
"title": "Stage IIIC",
|
||
|
|
"categories": [
|
||
|
|
{
|
||
|
|
"measurements": [
|
||
|
|
{
|
||
|
|
"groupId": "BG000",
|
||
|
|
"value": "0"
|
||
|
|
}
|
||
|
|
]
|
||
|
|
}
|
||
|
|
]
|
||
|
|
},
|
||
|
|
{
|
||
|
|
"title": "Other",
|
||
|
|
"categories": [
|
||
|
|
{
|
||
|
|
"measurements": [
|
||
|
|
{
|
||
|
|
"groupId": "BG000",
|
||
|
|
"value": "1"
|
||
|
|
}
|
||
|
|
]
|
||
|
|
}
|
||
|
|
]
|
||
|
|
}
|
||
|
|
]
|
||
|
|
},
|
||
|
|
{
|
||
|
|
"title": "Histopathological Grade",
|
||
|
|
"description": "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).",
|
||
|
|
"paramType": "NUMBER",
|
||
|
|
"unitOfMeasure": "participants",
|
||
|
|
"classes": [
|
||
|
|
{
|
||
|
|
"title": "Grade 1",
|
||
|
|
"categories": [
|
||
|
|
{
|
||
|
|
"measurements": [
|
||
|
|
{
|
||
|
|
"groupId": "BG000",
|
||
|
|
"value": "10"
|
||
|
|
}
|
||
|
|
]
|
||
|
|
}
|
||
|
|
]
|
||
|
|
},
|
||
|
|
{
|
||
|
|
"title": "Grade 2",
|
||
|
|
"categories": [
|
||
|
|
{
|
||
|
|
"measurements": [
|
||
|
|
{
|
||
|
|
"groupId": "BG000",
|
||
|
|
"value": "19"
|
||
|
|
}
|
||
|
|
]
|
||
|
|
}
|
||
|
|
]
|
||
|
|
},
|
||
|
|
{
|
||
|
|
"title": "Grade 3",
|
||
|
|
"categories": [
|
||
|
|
{
|
||
|
|
"measurements": [
|
||
|
|
{
|
||
|
|
"groupId": "BG000",
|
||
|
|
"value": "7"
|
||
|
|
}
|
||
|
|
]
|
||
|
|
}
|
||
|
|
]
|
||
|
|
},
|
||
|
|
{
|
||
|
|
"title": "Unknown",
|
||
|
|
"categories": [
|
||
|
|
{
|
||
|
|
"measurements": [
|
||
|
|
{
|
||
|
|
"groupId": "BG000",
|
||
|
|
"value": "10"
|
||
|
|
}
|
||
|
|
]
|
||
|
|
}
|
||
|
|
]
|
||
|
|
}
|
||
|
|
]
|
||
|
|
},
|
||
|
|
{
|
||
|
|
"title": "Number of participants on chemotherapy",
|
||
|
|
"description": "Number of participants who received chemotherapy. Chemotherapeutic drugs included doxorubicin, cyclophosphamide, docetaxel, fluorouracil, methotrexate , 5-fluorouracil, epirubicin, endoxan, farmorubicin, adriamycin, cytoxan, trastuzumab.",
|
||
|
|
"paramType": "NUMBER",
|
||
|
|
"unitOfMeasure": "participants",
|
||
|
|
"classes": [
|
||
|
|
{
|
||
|
|
"categories": [
|
||
|
|
{
|
||
|
|
"measurements": [
|
||
|
|
{
|
||
|
|
"groupId": "BG000",
|
||
|
|
"value": "NA",
|
||
|
|
"comment": "Data for this pre-specified outcome measure was collected and reported in individual participant listings but not statistically summarized for analysis."
|
||
|
|
}
|
||
|
|
]
|
||
|
|
}
|
||
|
|
]
|
||
|
|
}
|
||
|
|
]
|
||
|
|
},
|
||
|
|
{
|
||
|
|
"title": "Number of participants on radiotherapy",
|
||
|
|
"description": "Number of participants who received radiotherapy as measured in radiations per centigray (Rads/cGy).",
|
||
|
|
"paramType": "NUMBER",
|
||
|
|
"unitOfMeasure": "participants",
|
||
|
|
"classes": [
|
||
|
|
{
|
||
|
|
"categories": [
|
||
|
|
{
|
||
|
|
"measurements": [
|
||
|
|
{
|
||
|
|
"groupId": "BG000",
|
||
|
|
"value": "NA",
|
||
|
|
"comment": "Data for this pre-specified outcome measure was collected and reported in individual participant listings but not statistically summarized for analysis."
|
||
|
|
}
|
||
|
|
]
|
||
|
|
}
|
||
|
|
]
|
||
|
|
}
|
||
|
|
]
|
||
|
|
},
|
||
|
|
{
|
||
|
|
"title": "Concomitant morbidities in the past",
|
||
|
|
"description": "Participants who had a concomitant morbidity in the past; participants with more than one concomitant morbidity were counted for each of the concomitant morbidity classes applicable.",
|
||
|
|
"paramType": "NUMBER",
|
||
|
|
"unitOfMeasure": "participants",
|
||
|
|
"classes": [
|
||
|
|
{
|
||
|
|
"title": "Cholelithiasis",
|
||
|
|
"categories": [
|
||
|
|
{
|
||
|
|
"measurements": [
|
||
|
|
{
|
||
|
|
"groupId": "BG000",
|
||
|
|
"value": "1"
|
||
|
|
}
|
||
|
|
]
|
||
|
|
}
|
||
|
|
]
|
||
|
|
},
|
||
|
|
{
|
||
|
|
"title": "Intracranial aneurysm",
|
||
|
|
"categories": [
|
||
|
|
{
|
||
|
|
"measurements": [
|
||
|
|
{
|
||
|
|
"groupId": "BG000",
|
||
|
|
"value": "1"
|
||
|
|
}
|
||
|
|
]
|
||
|
|
}
|
||
|
|
]
|
||
|
|
},
|
||
|
|
{
|
||
|
|
"title": "Cystitis noninfective",
|
||
|
|
"categories": [
|
||
|
|
{
|
||
|
|
"measurements": [
|
||
|
|
{
|
||
|
|
"groupId": "BG000",
|
||
|
|
"value": "1"
|
||
|
|
}
|
||
|
|
]
|
||
|
|
}
|
||
|
|
]
|
||
|
|
},
|
||
|
|
{
|
||
|
|
"title": "Reproductive tract disorder",
|
||
|
|
"categories": [
|
||
|
|
{
|
||
|
|
"measurements": [
|
||
|
|
{
|
||
|
|
"groupId": "BG000",
|
||
|
|
"value": "3"
|
||
|
|
}
|
||
|
|
]
|
||
|
|
}
|
||
|
|
]
|
||
|
|
},
|
||
|
|
{
|
||
|
|
"title": "Hypertension",
|
||
|
|
"categories": [
|
||
|
|
{
|
||
|
|
"measurements": [
|
||
|
|
{
|
||
|
|
"groupId": "BG000",
|
||
|
|
"value": "3"
|
||
|
|
}
|
||
|
|
]
|
||
|
|
}
|
||
|
|
]
|
||
|
|
}
|
||
|
|
]
|
||
|
|
}
|
||
|
|
]
|
||
|
|
},
|
||
|
|
"outcomeMeasuresModule": {
|
||
|
|
"outcomeMeasures": [
|
||
|
|
{
|
||
|
|
"type": "PRIMARY",
|
||
|
|
"title": "Number of Participants With Adverse Events (AEs)",
|
||
|
|
"description": "Counts of participants who had treatment-emergent adverse events (TEAEs), defined as newly occurring or worsening after first dose. Relatedness (to study drug) was assessed by the investigator (Yes/No). Participants with multiple occurrences of an AE within a category were counted once within the category.",
|
||
|
|
"populationDescription": "Safety analysis set included participants who received at least one dose of the study medication during the observation period.",
|
||
|
|
"reportingStatus": "POSTED",
|
||
|
|
"paramType": "NUMBER",
|
||
|
|
"unitOfMeasure": "participants",
|
||
|
|
"timeFrame": "Baseline up to Month 36",
|
||
|
|
"groups": [
|
||
|
|
{
|
||
|
|
"id": "OG000",
|
||
|
|
"title": "Exemestane",
|
||
|
|
"description": "Participants received exemestane (Aromasin) in accordance with Summary of Product Characteristics (SmPC) and adjusted according to medical and therapeutic necessity in a sequential adjuvant hormonal therapy (tamoxifen followed by Aromasin) up to 5 years or until tumor relapse occurred."
|
||
|
|
}
|
||
|
|
],
|
||
|
|
"denoms": [
|
||
|
|
{
|
||
|
|
"units": "Participants",
|
||
|
|
"counts": [
|
||
|
|
{
|
||
|
|
"groupId": "OG000",
|
||
|
|
"value": "46"
|
||
|
|
}
|
||
|
|
]
|
||
|
|
}
|
||
|
|
],
|
||
|
|
"classes": [
|
||
|
|
{
|
||
|
|
"categories": [
|
||
|
|
{
|
||
|
|
"measurements": [
|
||
|
|
{
|
||
|
|
"groupId": "OG000",
|
||
|
|
"value": "2"
|
||
|
|
}
|
||
|
|
]
|
||
|
|
}
|
||
|
|
]
|
||
|
|
}
|
||
|
|
]
|
||
|
|
},
|
||
|
|
{
|
||
|
|
"type": "SECONDARY",
|
||
|
|
"title": "Number of Participants With Concomitant Morbidities",
|
||
|
|
"description": "Participants who had a concomitant morbidity during the study for any period of time; participants with more than one concomitant morbidity were counted for each of the concomitant morbidity classes applicable.",
|
||
|
|
"populationDescription": "Safety analysis set included participants who received at least one dose of the study medication during the observation period.",
|
||
|
|
"reportingStatus": "POSTED",
|
||
|
|
"paramType": "NUMBER",
|
||
|
|
"unitOfMeasure": "participants",
|
||
|
|
"timeFrame": "Baseline up to Month 36",
|
||
|
|
"groups": [
|
||
|
|
{
|
||
|
|
"id": "OG000",
|
||
|
|
"title": "Exemestane",
|
||
|
|
"description": "Participants received exemestane (Aromasin) in accordance with Summary of Product Characteristics (SmPC) and adjusted according to medical and therapeutic necessity in a sequential adjuvant hormonal therapy (tamoxifen followed by Aromasin) up to 5 years or until tumor relapse occurred."
|
||
|
|
}
|
||
|
|
],
|
||
|
|
"denoms": [
|
||
|
|
{
|
||
|
|
"units": "Participants",
|
||
|
|
"counts": [
|
||
|
|
{
|
||
|
|
"groupId": "OG000",
|
||
|
|
"value": "46"
|
||
|
|
}
|
||
|
|
]
|
||
|
|
}
|
||
|
|
],
|
||
|
|
"classes": [
|
||
|
|
{
|
||
|
|
"title": "Coronary artery disease",
|
||
|
|
"categories": [
|
||
|
|
{
|
||
|
|
"measurements": [
|
||
|
|
{
|
||
|
|
"groupId": "OG000",
|
||
|
|
"value": "1"
|
||
|
|
}
|
||
|
|
]
|
||
|
|
}
|
||
|
|
]
|
||
|
|
},
|
||
|
|
{
|
||
|
|
"title": "Glaucoma",
|
||
|
|
"categories": [
|
||
|
|
{
|
||
|
|
"measurements": [
|
||
|
|
{
|
||
|
|
"groupId": "OG000",
|
||
|
|
"value": "1"
|
||
|
|
}
|
||
|
|
]
|
||
|
|
}
|
||
|
|
]
|
||
|
|
},
|
||
|
|
{
|
||
|
|
"title": "Scotoma",
|
||
|
|
"categories": [
|
||
|
|
{
|
||
|
|
"measurements": [
|
||
|
|
{
|
||
|
|
"groupId": "OG000",
|
||
|
|
"value": "1"
|
||
|
|
}
|
||
|
|
]
|
||
|
|
}
|
||
|
|
]
|
||
|
|
},
|
||
|
|
{
|
||
|
|
"title": "Crohn's disease",
|
||
|
|
"categories": [
|
||
|
|
{
|
||
|
|
"measurements": [
|
||
|
|
{
|
||
|
|
"groupId": "OG000",
|
||
|
|
"value": "1"
|
||
|
|
}
|
||
|
|
]
|
||
|
|
}
|
||
|
|
]
|
||
|
|
},
|
||
|
|
{
|
||
|
|
"title": "Fatigue",
|
||
|
|
"categories": [
|
||
|
|
{
|
||
|
|
"measurements": [
|
||
|
|
{
|
||
|
|
"groupId": "OG000",
|
||
|
|
"value": "1"
|
||
|
|
}
|
||
|
|
]
|
||
|
|
}
|
||
|
|
]
|
||
|
|
},
|
||
|
|
{
|
||
|
|
"title": "Multiple allergies",
|
||
|
|
"categories": [
|
||
|
|
{
|
||
|
|
"measurements": [
|
||
|
|
{
|
||
|
|
"groupId": "OG000",
|
||
|
|
"value": "1"
|
||
|
|
}
|
||
|
|
]
|
||
|
|
}
|
||
|
|
]
|
||
|
|
},
|
||
|
|
{
|
||
|
|
"title": "Skin infection",
|
||
|
|
"categories": [
|
||
|
|
{
|
||
|
|
"measurements": [
|
||
|
|
{
|
||
|
|
"groupId": "OG000",
|
||
|
|
"value": "1"
|
||
|
|
}
|
||
|
|
]
|
||
|
|
}
|
||
|
|
]
|
||
|
|
},
|
||
|
|
{
|
||
|
|
"title": "Diabetes mellitus",
|
||
|
|
"categories": [
|
||
|
|
{
|
||
|
|
"measurements": [
|
||
|
|
{
|
||
|
|
"groupId": "OG000",
|
||
|
|
"value": "1"
|
||
|
|
}
|
||
|
|
]
|
||
|
|
}
|
||
|
|
]
|
||
|
|
},
|
||
|
|
{
|
||
|
|
"title": "Arthralgia",
|
||
|
|
"categories": [
|
||
|
|
{
|
||
|
|
"measurements": [
|
||
|
|
{
|
||
|
|
"groupId": "OG000",
|
||
|
|
"value": "2"
|
||
|
|
}
|
||
|
|
]
|
||
|
|
}
|
||
|
|
]
|
||
|
|
},
|
||
|
|
{
|
||
|
|
"title": "Collagen disorder",
|
||
|
|
"categories": [
|
||
|
|
{
|
||
|
|
"measurements": [
|
||
|
|
{
|
||
|
|
"groupId": "OG000",
|
||
|
|
"value": "1"
|
||
|
|
}
|
||
|
|
]
|
||
|
|
}
|
||
|
|
]
|
||
|
|
},
|
||
|
|
{
|
||
|
|
"title": "Intervertebral disc protrusion",
|
||
|
|
"categories": [
|
||
|
|
{
|
||
|
|
"measurements": [
|
||
|
|
{
|
||
|
|
"groupId": "OG000",
|
||
|
|
"value": "1"
|
||
|
|
}
|
||
|
|
]
|
||
|
|
}
|
||
|
|
]
|
||
|
|
},
|
||
|
|
{
|
||
|
|
"title": "Osteoporosis",
|
||
|
|
"categories": [
|
||
|
|
{
|
||
|
|
"measurements": [
|
||
|
|
{
|
||
|
|
"groupId": "OG000",
|
||
|
|
"value": "3"
|
||
|
|
}
|
||
|
|
]
|
||
|
|
}
|
||
|
|
]
|
||
|
|
},
|
||
|
|
{
|
||
|
|
"title": "Headache",
|
||
|
|
"categories": [
|
||
|
|
{
|
||
|
|
"measurements": [
|
||
|
|
{
|
||
|
|
"groupId": "OG000",
|
||
|
|
"value": "1"
|
||
|
|
}
|
||
|
|
]
|
||
|
|
}
|
||
|
|
]
|
||
|
|
},
|
||
|
|
{
|
||
|
|
"title": "Depression",
|
||
|
|
"categories": [
|
||
|
|
{
|
||
|
|
"measurements": [
|
||
|
|
{
|
||
|
|
"groupId": "OG000",
|
||
|
|
"value": "1"
|
||
|
|
}
|
||
|
|
]
|
||
|
|
}
|
||
|
|
]
|
||
|
|
},
|
||
|
|
{
|
||
|
|
"title": "Hypertension",
|
||
|
|
"categories": [
|
||
|
|
{
|
||
|
|
"measurements": [
|
||
|
|
{
|
||
|
|
"groupId": "OG000",
|
||
|
|
"value": "8"
|
||
|
|
}
|
||
|
|
]
|
||
|
|
}
|
||
|
|
]
|
||
|
|
}
|
||
|
|
]
|
||
|
|
},
|
||
|
|
{
|
||
|
|
"type": "SECONDARY",
|
||
|
|
"title": "Number of Participants With Concomitant Medications",
|
||
|
|
"description": "Concomitant medication (any medication other than, and in addition to, the study medication) taken for any period of time during the study and was coded by World Health Organization (WHO) medical dictionary.",
|
||
|
|
"populationDescription": "Safety analysis set included participants who received at least one dose of the study medication during the observation period.",
|
||
|
|
"reportingStatus": "POSTED",
|
||
|
|
"paramType": "NUMBER",
|
||
|
|
"unitOfMeasure": "participants",
|
||
|
|
"timeFrame": "Baseline up to Month 36",
|
||
|
|
"groups": [
|
||
|
|
{
|
||
|
|
"id": "OG000",
|
||
|
|
"title": "Exemestane",
|
||
|
|
"description": "Participants received exemestane (Aromasin) in accordance with Summary of Product Characteristics (SmPC) and adjusted according to medical and therapeutic necessity in a sequential adjuvant hormonal therapy (tamoxifen followed by Aromasin) up to 5 years or until tumor relapse occurred."
|
||
|
|
}
|
||
|
|
],
|
||
|
|
"denoms": [
|
||
|
|
{
|
||
|
|
"units": "Participants",
|
||
|
|
"counts": [
|
||
|
|
{
|
||
|
|
"groupId": "OG000",
|
||
|
|
"value": "46"
|
||
|
|
}
|
||
|
|
]
|
||
|
|
}
|
||
|
|
],
|
||
|
|
"classes": [
|
||
|
|
{
|
||
|
|
"categories": [
|
||
|
|
{
|
||
|
|
"measurements": [
|
||
|
|
{
|
||
|
|
"groupId": "OG000",
|
||
|
|
"value": "0"
|
||
|
|
}
|
||
|
|
]
|
||
|
|
}
|
||
|
|
]
|
||
|
|
}
|
||
|
|
]
|
||
|
|
},
|
||
|
|
{
|
||
|
|
"type": "SECONDARY",
|
||
|
|
"title": "Percentage of Participants Who Discontinued the Study Medication",
|
||
|
|
"populationDescription": "Data was not analyzed as the study was terminated due to insufficient number of participants enrolled in the study.",
|
||
|
|
"reportingStatus": "POSTED",
|
||
|
|
"timeFrame": "Baseline up to Month 36",
|
||
|
|
"groups": [
|
||
|
|
{
|
||
|
|
"id": "OG000",
|
||
|
|
"title": "Exemestane",
|
||
|
|
"description": "Participants received exemestane (Aromasin) in accordance with Summary of Product Characteristics (SmPC) and adjusted according to medical and therapeutic necessity in a sequential adjuvant hormonal therapy (tamoxifen followed by Aromasin) up to 5 years or until tumor relapse occurred."
|
||
|
|
}
|
||
|
|
],
|
||
|
|
"denoms": [
|
||
|
|
{
|
||
|
|
"units": "Participants",
|
||
|
|
"counts": [
|
||
|
|
{
|
||
|
|
"groupId": "OG000",
|
||
|
|
"value": "0"
|
||
|
|
}
|
||
|
|
]
|
||
|
|
}
|
||
|
|
]
|
||
|
|
},
|
||
|
|
{
|
||
|
|
"type": "SECONDARY",
|
||
|
|
"title": "Number of Participants With Reasons for Discontinuation From Study Medication",
|
||
|
|
"populationDescription": "Data was not analyzed as the study was terminated due to insufficient number of participants enrolled in the study.",
|
||
|
|
"reportingStatus": "POSTED",
|
||
|
|
"timeFrame": "Baseline up to Month 36",
|
||
|
|
"groups": [
|
||
|
|
{
|
||
|
|
"id": "OG000",
|
||
|
|
"title": "Exemestane",
|
||
|
|
"description": "Participants received exemestane (Aromasin) in accordance with Summary of Product Characteristics (SmPC) and adjusted according to medical and therapeutic necessity in a sequential adjuvant hormonal therapy (tamoxifen followed by Aromasin) up to 5 years or until tumor relapse occurred."
|
||
|
|
}
|
||
|
|
],
|
||
|
|
"denoms": [
|
||
|
|
{
|
||
|
|
"units": "Participants",
|
||
|
|
"counts": [
|
||
|
|
{
|
||
|
|
"groupId": "OG000",
|
||
|
|
"value": "0"
|
||
|
|
}
|
||
|
|
]
|
||
|
|
}
|
||
|
|
]
|
||
|
|
},
|
||
|
|
{
|
||
|
|
"type": "SECONDARY",
|
||
|
|
"title": "Time to Discontinuation",
|
||
|
|
"populationDescription": "Data was not analyzed as the study was terminated due to insufficient number of participants enrolled in the study.",
|
||
|
|
"reportingStatus": "POSTED",
|
||
|
|
"timeFrame": "Baseline up to Month 36",
|
||
|
|
"groups": [
|
||
|
|
{
|
||
|
|
"id": "OG000",
|
||
|
|
"title": "Exemestane",
|
||
|
|
"description": "Participants received exemestane (Aromasin) in accordance with Summary of Product Characteristics (SmPC) and adjusted according to medical and therapeutic necessity in a sequential adjuvant hormonal therapy (tamoxifen followed by Aromasin) up to 5 years or until tumor relapse occurred."
|
||
|
|
}
|
||
|
|
],
|
||
|
|
"denoms": [
|
||
|
|
{
|
||
|
|
"units": "Participants",
|
||
|
|
"counts": [
|
||
|
|
{
|
||
|
|
"groupId": "OG000",
|
||
|
|
"value": "0"
|
||
|
|
}
|
||
|
|
]
|
||
|
|
}
|
||
|
|
]
|
||
|
|
},
|
||
|
|
{
|
||
|
|
"type": "SECONDARY",
|
||
|
|
"title": "Recurrence-free Survival",
|
||
|
|
"description": "Recurrence-free survival defined as the time from the initiation of study medication to the date of confirmation of any recurrence - as local or distant breast cancer recurrence; new primary breast cancer (ipsilateral or contralateral), death due to any cause.",
|
||
|
|
"populationDescription": "Data was not analyzed as the study was terminated due to insufficient number of participants enrolled in the study.",
|
||
|
|
"reportingStatus": "POSTED",
|
||
|
|
"timeFrame": "Baseline up to Month 36",
|
||
|
|
"groups": [
|
||
|
|
{
|
||
|
|
"id": "OG000",
|
||
|
|
"title": "Exemestane",
|
||
|
|
"description": "Participants received exemestane (Aromasin) in accordance with Summary of Product Characteristics (SmPC) and adjusted according to medical and therapeutic necessity in a sequential adjuvant hormonal therapy (tamoxifen followed by Aromasin) up to 5 years or until tumor relapse occurred."
|
||
|
|
}
|
||
|
|
],
|
||
|
|
"denoms": [
|
||
|
|
{
|
||
|
|
"units": "Participants",
|
||
|
|
"counts": [
|
||
|
|
{
|
||
|
|
"groupId": "OG000",
|
||
|
|
"value": "0"
|
||
|
|
}
|
||
|
|
]
|
||
|
|
}
|
||
|
|
]
|
||
|
|
},
|
||
|
|
{
|
||
|
|
"type": "SECONDARY",
|
||
|
|
"title": "Overall Survival",
|
||
|
|
"description": "Time in months from the start of study treatment to date of death due to any cause. OS was calculated as (the death date minus the date of first dose of study medication plus 1) divided by 30.4. Death was determined from adverse event data (where outcome was death) or from follow-up contact data (where the participant current status was death).",
|
||
|
|
"populationDescription": "Data was not analyzed as the study was terminated due to insufficient number of participants enrolled in the study.",
|
||
|
|
"reportingStatus": "POSTED",
|
||
|
|
"timeFrame": "Baseline until death (up to Month 36)",
|
||
|
|
"groups": [
|
||
|
|
{
|
||
|
|
"id": "OG000",
|
||
|
|
"title": "Exemestane",
|
||
|
|
"description": "Participants received exemestane (Aromasin) in accordance with Summary of Product Characteristics (SmPC) and adjusted according to medical and therapeutic necessity in a sequential adjuvant hormonal therapy (tamoxifen followed by Aromasin) up to 5 years or until tumor relapse occurred."
|
||
|
|
}
|
||
|
|
],
|
||
|
|
"denoms": [
|
||
|
|
{
|
||
|
|
"units": "Participants",
|
||
|
|
"counts": [
|
||
|
|
{
|
||
|
|
"groupId": "OG000",
|
||
|
|
"value": "0"
|
||
|
|
}
|
||
|
|
]
|
||
|
|
}
|
||
|
|
]
|
||
|
|
}
|
||
|
|
]
|
||
|
|
},
|
||
|
|
"adverseEventsModule": {
|
||
|
|
"frequencyThreshold": "0",
|
||
|
|
"description": "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.",
|
||
|
|
"eventGroups": [
|
||
|
|
{
|
||
|
|
"id": "EG000",
|
||
|
|
"title": "Exemestane",
|
||
|
|
"description": "Participants received exemestane (Aromasin) in accordance with Summary of Product Characteristics (SmPC) and adjusted according to medical and therapeutic necessity in a sequential adjuvant hormonal therapy (tamoxifen followed by Aromasin) up to 5 years or until tumor relapse occurred.",
|
||
|
|
"seriousNumAffected": 0,
|
||
|
|
"seriousNumAtRisk": 46,
|
||
|
|
"otherNumAffected": 2,
|
||
|
|
"otherNumAtRisk": 46
|
||
|
|
}
|
||
|
|
],
|
||
|
|
"otherEvents": [
|
||
|
|
{
|
||
|
|
"term": "Musculoskeletal pain",
|
||
|
|
"organSystem": "Musculoskeletal and connective tissue disorders",
|
||
|
|
"sourceVocabulary": "MedDRA (14.1)",
|
||
|
|
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
|
||
|
|
"stats": [
|
||
|
|
{
|
||
|
|
"groupId": "EG000",
|
||
|
|
"numAffected": 1,
|
||
|
|
"numAtRisk": 46
|
||
|
|
}
|
||
|
|
]
|
||
|
|
},
|
||
|
|
{
|
||
|
|
"term": "Hot flush",
|
||
|
|
"organSystem": "Vascular disorders",
|
||
|
|
"sourceVocabulary": "MedDRA (14.1)",
|
||
|
|
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
|
||
|
|
"stats": [
|
||
|
|
{
|
||
|
|
"groupId": "EG000",
|
||
|
|
"numAffected": 1,
|
||
|
|
"numAtRisk": 46
|
||
|
|
}
|
||
|
|
]
|
||
|
|
}
|
||
|
|
]
|
||
|
|
},
|
||
|
|
"moreInfoModule": {
|
||
|
|
"limitationsAndCaveats": {
|
||
|
|
"description": "The study was prematurely discontinued, therefore not all data was analyzed."
|
||
|
|
},
|
||
|
|
"certainAgreement": {
|
||
|
|
"piSponsorEmployee": false,
|
||
|
|
"restrictionType": "OTHER",
|
||
|
|
"restrictiveAgreement": true,
|
||
|
|
"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."
|
||
|
|
},
|
||
|
|
"pointOfContact": {
|
||
|
|
"title": "Pfizer ClinicalTrials.gov Call Center",
|
||
|
|
"organization": "Pfizer, Inc.",
|
||
|
|
"email": "ClinicalTrials.gov_Inquiries@pfizer.com",
|
||
|
|
"phone": "1-800-718-1021"
|
||
|
|
}
|
||
|
|
}
|
||
|
|
},
|
||
|
|
"derivedSection": {
|
||
|
|
"miscInfoModule": {
|
||
|
|
"versionHolder": "2025-05-21"
|
||
|
|
},
|
||
|
|
"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"
|
||
|
|
}
|
||
|
|
],
|
||
|
|
"browseLeaves": [
|
||
|
|
{
|
||
|
|
"id": "M5220",
|
||
|
|
"name": "Breast Neoplasms",
|
||
|
|
"asFound": "Breast Neoplasms",
|
||
|
|
"relevance": "HIGH"
|
||
|
|
},
|
||
|
|
{
|
||
|
|
"id": "M5218",
|
||
|
|
"name": "Breast Diseases",
|
||
|
|
"relevance": "LOW"
|
||
|
|
},
|
||
|
|
{
|
||
|
|
"id": "M15674",
|
||
|
|
"name": "Skin Diseases",
|
||
|
|
"relevance": "LOW"
|
||
|
|
}
|
||
|
|
],
|
||
|
|
"browseBranches": [
|
||
|
|
{
|
||
|
|
"abbrev": "BC04",
|
||
|
|
"name": "Neoplasms"
|
||
|
|
},
|
||
|
|
{
|
||
|
|
"abbrev": "BC17",
|
||
|
|
"name": "Skin and Connective Tissue Diseases"
|
||
|
|
},
|
||
|
|
{
|
||
|
|
"abbrev": "All",
|
||
|
|
"name": "All Conditions"
|
||
|
|
}
|
||
|
|
]
|
||
|
|
},
|
||
|
|
"interventionBrowseModule": {
|
||
|
|
"meshes": [
|
||
|
|
{
|
||
|
|
"id": "C056516",
|
||
|
|
"term": "Exemestane"
|
||
|
|
}
|
||
|
|
],
|
||
|
|
"ancestors": [
|
||
|
|
{
|
||
|
|
"id": "D000970",
|
||
|
|
"term": "Antineoplastic Agents"
|
||
|
|
},
|
||
|
|
{
|
||
|
|
"id": "D047072",
|
||
|
|
"term": "Aromatase Inhibitors"
|
||
|
|
},
|
||
|
|
{
|
||
|
|
"id": "D065088",
|
||
|
|
"term": "Steroid Synthesis Inhibitors"
|
||
|
|
},
|
||
|
|
{
|
||
|
|
"id": "D004791",
|
||
|
|
"term": "Enzyme Inhibitors"
|
||
|
|
},
|
||
|
|
{
|
||
|
|
"id": "D045504",
|
||
|
|
"term": "Molecular Mechanisms of Pharmacological Action"
|
||
|
|
},
|
||
|
|
{
|
||
|
|
"id": "D004965",
|
||
|
|
"term": "Estrogen Antagonists"
|
||
|
|
},
|
||
|
|
{
|
||
|
|
"id": "D006727",
|
||
|
|
"term": "Hormone Antagonists"
|
||
|
|
},
|
||
|
|
{
|
||
|
|
"id": "D006730",
|
||
|
|
"term": "Hormones, Hormone Substitutes, and Hormone Antagonists"
|
||
|
|
},
|
||
|
|
{
|
||
|
|
"id": "D045505",
|
||
|
|
"term": "Physiological Effects of Drugs"
|
||
|
|
}
|
||
|
|
],
|
||
|
|
"browseLeaves": [
|
||
|
|
{
|
||
|
|
"id": "M16403",
|
||
|
|
"name": "Tamoxifen",
|
||
|
|
"relevance": "LOW"
|
||
|
|
},
|
||
|
|
{
|
||
|
|
"id": "M247237",
|
||
|
|
"name": "Exemestane",
|
||
|
|
"asFound": "Rectal Cancer",
|
||
|
|
"relevance": "HIGH"
|
||
|
|
},
|
||
|
|
{
|
||
|
|
"id": "M25769",
|
||
|
|
"name": "Aromatase Inhibitors",
|
||
|
|
"relevance": "LOW"
|
||
|
|
},
|
||
|
|
{
|
||
|
|
"id": "M9789",
|
||
|
|
"name": "Hormones",
|
||
|
|
"relevance": "LOW"
|
||
|
|
},
|
||
|
|
{
|
||
|
|
"id": "M8116",
|
||
|
|
"name": "Estrogens",
|
||
|
|
"relevance": "LOW"
|
||
|
|
},
|
||
|
|
{
|
||
|
|
"id": "M7951",
|
||
|
|
"name": "Enzyme Inhibitors",
|
||
|
|
"relevance": "LOW"
|
||
|
|
},
|
||
|
|
{
|
||
|
|
"id": "M8114",
|
||
|
|
"name": "Estrogen Antagonists",
|
||
|
|
"relevance": "LOW"
|
||
|
|
},
|
||
|
|
{
|
||
|
|
"id": "M30483",
|
||
|
|
"name": "Estrogen Receptor Antagonists",
|
||
|
|
"relevance": "LOW"
|
||
|
|
},
|
||
|
|
{
|
||
|
|
"id": "M9788",
|
||
|
|
"name": "Hormone Antagonists",
|
||
|
|
"relevance": "LOW"
|
||
|
|
}
|
||
|
|
],
|
||
|
|
"browseBranches": [
|
||
|
|
{
|
||
|
|
"abbrev": "BDCA",
|
||
|
|
"name": "Bone Density Conservation Agents"
|
||
|
|
},
|
||
|
|
{
|
||
|
|
"abbrev": "ANeo",
|
||
|
|
"name": "Antineoplastic Agents"
|
||
|
|
},
|
||
|
|
{
|
||
|
|
"abbrev": "All",
|
||
|
|
"name": "All Drugs and Chemicals"
|
||
|
|
}
|
||
|
|
]
|
||
|
|
}
|
||
|
|
},
|
||
|
|
"hasResults": true
|
||
|
|
}
|