Raw JSON Patch
[
{
"op": "replace",
"path": "/protocolSection/statusModule/statusVerifiedDate",
"value": "2014-08"
},
{
"op": "replace",
"path": "/protocolSection/statusModule/completionDateStruct/date",
"value": "2015-01"
},
{
"op": "replace",
"path": "/protocolSection/statusModule/lastUpdateSubmitDate",
"value": "2014-08-29"
},
{
"op": "replace",
"path": "/protocolSection/statusModule/lastUpdatePostDateStruct/date",
"value": "2014-09-01"
},
{
"op": "replace",
"path": "/protocolSection/outcomesModule/primaryOutcomes/0/timeFrame",
"value": "RECIST(Response Evaluation Criteria in Solid Tumors ) tumour assessments carried out every 12 weeks (+/- 2 weeks) from randomisation for study duration (48 months)"
},
{
"op": "replace",
"path": "/protocolSection/outcomesModule/secondaryOutcomes/4/description",
"value": "Median time (in months) from randomisation until death (from any cause) (analysis at 50% deaths )"
},
{
"op": "replace",
"path": "/protocolSection/outcomesModule/secondaryOutcomes/5/measure",
"value": "Change From Randomisation in Trial Outcome Index (TOI) Over the Course of the Study"
},
{
"op": "replace",
"path": "/protocolSection/outcomesModule/secondaryOutcomes/5/description",
"value": "Mean (and standard deviation) change from randomisation until treatment discontinuation in TOI (defined as the first visit response of 'worsened' which is a decrease in TOI from baseline of 5 points or more) using the Kaplan-Meier method.\nIf a subject has not shown a reduction of 5 points or more at the time of analysis then the observation will be right censored using the last QOL assessment date.\nTrial Outcome Index (TOI) is derived from the FACT-B questionnaire (Cella et al, 1993) by adding together the scores from the following 3 subscales; Physical well-being (PWB), Functional well-being (FWB) and Breast cancer subscale (BCS).\nThe TOI score range is 0-92 with the higher scores representing the more favourable outcomes.\nData were collected from a subgroup of patients."
},
{
"op": "add",
"path": "/protocolSection/outcomesModule/secondaryOutcomes/6",
"value": {
"measure": "Overall Survival (OS) - Follow-up",
"timeFrame": "Median time (in months) from randomisation until death (from any cause),up to 80 months",
"description": "Overall Survival is equivalent to time to death.\nFor this endpoint, all deaths occurring during the study as a whole until the data cut-off for the survival extension (31st October 2011) are presented (analysis at 75% deaths)"
}
},
{
"op": "remove",
"path": "/protocolSection/eligibilityModule/stdAges/0"
},
{
"op": "add",
"path": "/protocolSection/eligibilityModule/minimumAge",
"value": "45 Years"
},
{
"op": "remove",
"path": "/protocolSection/contactsLocationsModule/locations/0"
},
{
"op": "remove",
"path": "/protocolSection/contactsLocationsModule/locations/0"
},
{
"op": "remove",
"path": "/protocolSection/contactsLocationsModule/locations/2"
},
{
"op": "add",
"path": "/protocolSection/contactsLocationsModule/locations/8",
"value": {
"city": "Greenville",
"state": "North Carolina",
"country": "United States",
"facility": "Research Site",
"geoPoint": {
"lat": 35.61266,
"lon": -77.36635
}
}
},
{
"op": "remove",
"path": "/protocolSection/contactsLocationsModule/locations/11/state"
},
{
"op": "replace",
"path": "/protocolSection/contactsLocationsModule/locations/12/city",
"value": "Brussels (Anderlecht)"
},
{
"op": "remove",
"path": "/protocolSection/contactsLocationsModule/locations/12/state"
},
{
"op": "replace",
"path": "/protocolSection/contactsLocationsModule/locations/13/city",
"value": "Brussels (Jette)"
},
{
"op": "remove",
"path": "/protocolSection/contactsLocationsModule/locations/13/state"
},
{
"op": "remove",
"path": "/protocolSection/contactsLocationsModule/locations/14/state"
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{
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"path": "/protocolSection/contactsLocationsModule/locations/15/state"
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{
"op": "remove",
"path": "/protocolSection/contactsLocationsModule/locations/16/state"
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{
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"path": "/protocolSection/contactsLocationsModule/locations/17/state"
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{
"op": "remove",
"path": "/protocolSection/contactsLocationsModule/locations/18/state"
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{
"op": "remove",
"path": "/protocolSection/contactsLocationsModule/locations/19/state"
},
{
"op": "replace",
"path": "/protocolSection/contactsLocationsModule/locations/20/city",
"value": "Porto Alegre"
},
{
"op": "remove",
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{
"op": "replace",
"path": "/protocolSection/contactsLocationsModule/locations/20/geoPoint/lat",
"value": -30.03283
},
{
"op": "replace",
"path": "/protocolSection/contactsLocationsModule/locations/20/geoPoint/lon",
"value": -51.23019
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{
"op": "replace",
"path": "/protocolSection/contactsLocationsModule/locations/21/city",
"value": "Recife"
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{
"op": "remove",
"path": "/protocolSection/contactsLocationsModule/locations/21/state"
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{
"op": "replace",
"path": "/protocolSection/contactsLocationsModule/locations/21/geoPoint/lat",
"value": -8.05389
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{
"op": "replace",
"path": "/protocolSection/contactsLocationsModule/locations/21/geoPoint/lon",
"value": -34.88111
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{
"op": "replace",
"path": "/protocolSection/contactsLocationsModule/locations/22/city",
"value": "São Paulo"
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{
"op": "remove",
"path": "/protocolSection/contactsLocationsModule/locations/22/state"
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{
"op": "replace",
"path": "/protocolSection/contactsLocationsModule/locations/22/geoPoint/lat",
"value": -23.5475
},
{
"op": "replace",
"path": "/protocolSection/contactsLocationsModule/locations/22/geoPoint/lon",
"value": -46.63611
},
{
"op": "replace",
"path": "/protocolSection/contactsLocationsModule/locations/23/city",
"value": "Santiago"
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{
"op": "remove",
"path": "/protocolSection/contactsLocationsModule/locations/23/state"
},
{
"op": "replace",
"path": "/protocolSection/contactsLocationsModule/locations/23/country",
"value": "Chile"
},
{
"op": "replace",
"path": "/protocolSection/contactsLocationsModule/locations/23/geoPoint/lat",
"value": -33.45694
},
{
"op": "replace",
"path": "/protocolSection/contactsLocationsModule/locations/23/geoPoint/lon",
"value": -70.64827
},
{
"op": "replace",
"path": "/protocolSection/contactsLocationsModule/locations/24/city",
"value": "Bogotá"
},
{
"op": "replace",
"path": "/protocolSection/contactsLocationsModule/locations/24/country",
"value": "Colombia"
},
{
"op": "replace",
"path": "/protocolSection/contactsLocationsModule/locations/24/geoPoint/lat",
"value": 4.60971
},
{
"op": "replace",
"path": "/protocolSection/contactsLocationsModule/locations/24/geoPoint/lon",
"value": -74.08175
},
{
"op": "replace",
"path": "/protocolSection/contactsLocationsModule/locations/25/city",
"value": "Cali"
},
{
"op": "replace",
"path": "/protocolSection/contactsLocationsModule/locations/25/country",
"value": "Colombia"
},
{
"op": "replace",
"path": "/protocolSection/contactsLocationsModule/locations/25/geoPoint/lat",
"value": 3.43054
},
{
"op": "replace",
"path": "/protocolSection/contactsLocationsModule/locations/25/geoPoint/lon",
"value": -76.5199
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{
"op": "remove",
"path": "/protocolSection/contactsLocationsModule/locations/26"
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{
"op": "remove",
"path": "/protocolSection/contactsLocationsModule/locations/26"
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{
"op": "remove",
"path": "/protocolSection/contactsLocationsModule/locations/26"
},
{
"op": "replace",
"path": "/protocolSection/contactsLocationsModule/locations/31/city",
"value": "V Uvalu 84"
},
{
"op": "replace",
"path": "/protocolSection/contactsLocationsModule/locations/31/country",
"value": "Czechia"
},
{
"op": "remove",
"path": "/protocolSection/contactsLocationsModule/locations/31/geoPoint"
},
{
"op": "remove",
"path": "/protocolSection/contactsLocationsModule/locations/32"
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{
"op": "remove",
"path": "/protocolSection/contactsLocationsModule/locations/33/state"
},
{
"op": "replace",
"path": "/protocolSection/contactsLocationsModule/locations/34/city",
"value": "Jaipur"
},
{
"op": "remove",
"path": "/protocolSection/contactsLocationsModule/locations/34/state"
},
{
"op": "replace",
"path": "/protocolSection/contactsLocationsModule/locations/34/geoPoint/lat",
"value": 26.91962
},
{
"op": "replace",
"path": "/protocolSection/contactsLocationsModule/locations/34/geoPoint/lon",
"value": 75.78781
},
{
"op": "replace",
"path": "/protocolSection/contactsLocationsModule/locations/35/city",
"value": "Kolkata"
},
{
"op": "remove",
"path": "/protocolSection/contactsLocationsModule/locations/35/state"
},
{
"op": "replace",
"path": "/protocolSection/contactsLocationsModule/locations/35/geoPoint/lat",
"value": 22.56263
},
{
"op": "replace",
"path": "/protocolSection/contactsLocationsModule/locations/35/geoPoint/lon",
"value": 88.36304
},
{
"op": "replace",
"path": "/protocolSection/contactsLocationsModule/locations/36/city",
"value": "Marg Jaipur"
},
{
"op": "remove",
"path": "/protocolSection/contactsLocationsModule/locations/36/state"
},
{
"op": "remove",
"path": "/protocolSection/contactsLocationsModule/locations/36/geoPoint"
},
{
"op": "remove",
"path": "/protocolSection/contactsLocationsModule/locations/37/state"
},
{
"op": "remove",
"path": "/protocolSection/contactsLocationsModule/locations/38"
},
{
"op": "remove",
"path": "/protocolSection/contactsLocationsModule/locations/38"
},
{
"op": "remove",
"path": "/protocolSection/contactsLocationsModule/locations/38"
},
{
"op": "remove",
"path": "/protocolSection/contactsLocationsModule/locations/38"
},
{
"op": "remove",
"path": "/protocolSection/contactsLocationsModule/locations/38"
},
{
"op": "replace",
"path": "/protocolSection/contactsLocationsModule/locations/39/city",
"value": "Vellore"
},
{
"op": "remove",
"path": "/protocolSection/contactsLocationsModule/locations/39/state"
},
{
"op": "replace",
"path": "/protocolSection/contactsLocationsModule/locations/39/country",
"value": "India"
},
{
"op": "replace",
"path": "/protocolSection/contactsLocationsModule/locations/39/geoPoint/lat",
"value": 12.9184
},
{
"op": "replace",
"path": "/protocolSection/contactsLocationsModule/locations/39/geoPoint/lon",
"value": 79.13255
},
{
"op": "replace",
"path": "/protocolSection/contactsLocationsModule/locations/40/city",
"value": "Aviano"
},
{
"op": "remove",
"path": "/protocolSection/contactsLocationsModule/locations/40/state"
},
{
"op": "replace",
"path": "/protocolSection/contactsLocationsModule/locations/40/geoPoint/lat",
"value": 46.07056
},
{
"op": "replace",
"path": "/protocolSection/contactsLocationsModule/locations/40/geoPoint/lon",
"value": 12.59472
},
{
"op": "replace",
"path": "/protocolSection/contactsLocationsModule/locations/41/city",
"value": "Bergamo"
},
{
"op": "remove",
"path": "/protocolSection/contactsLocationsModule/locations/41/state"
},
{
"op": "replace",
"path": "/protocolSection/contactsLocationsModule/locations/41/geoPoint/lat",
"value": 45.69601
},
{
"op": "replace",
"path": "/protocolSection/contactsLocationsModule/locations/41/geoPoint/lon",
"value": 9.66721
},
{
"op": "replace",
"path": "/protocolSection/contactsLocationsModule/locations/42/city",
"value": "Carpi"
},
{
"op": "remove",
"path": "/protocolSection/contactsLocationsModule/locations/42/state"
},
{
"op": "replace",
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"value": 44.78237
},
{
"op": "replace",
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"value": 10.8777
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{
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{
"op": "remove",
"path": "/protocolSection/contactsLocationsModule/locations/44/state"
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{
"op": "remove",
"path": "/protocolSection/contactsLocationsModule/locations/45/state"
},
{
"op": "add",
"path": "/protocolSection/contactsLocationsModule/locations/47",
"value": {
"city": "Mexico City",
"country": "Mexico",
"facility": "Research Site",
"geoPoint": {
"lat": 19.42847,
"lon": -99.12766
}
}
},
{
"op": "add",
"path": "/protocolSection/contactsLocationsModule/locations/48",
"value": {
"city": "México",
"country": "Mexico",
"facility": "Research Site",
"geoPoint": {
"lat": 31.00435,
"lon": -108.15213
}
}
},
{
"op": "remove",
"path": "/protocolSection/contactsLocationsModule/locations/52"
},
{
"op": "remove",
"path": "/protocolSection/contactsLocationsModule/locations/52"
},
{
"op": "add",
"path": "/protocolSection/contactsLocationsModule/locations/57",
"value": {
"city": "Obninsk",
"country": "Russia",
"facility": "Research Site",
"geoPoint": {
"lat": 55.10993,
"lon": 36.61238
}
}
},
{
"op": "add",
"path": "/protocolSection/contactsLocationsModule/locations/60",
"value": {
"city": "Yaroslavl",
"country": "Russia",
"facility": "Research Site",
"geoPoint": {
"lat": 57.62987,
"lon": 39.87368
}
}
},
{
"op": "replace",
"path": "/protocolSection/contactsLocationsModule/locations/62/city",
"value": "Madrid"
},
{
"op": "replace",
"path": "/protocolSection/contactsLocationsModule/locations/62/country",
"value": "Spain"
},
{
"op": "replace",
"path": "/protocolSection/contactsLocationsModule/locations/62/geoPoint/lat",
"value": 40.4165
},
{
"op": "replace",
"path": "/protocolSection/contactsLocationsModule/locations/62/geoPoint/lon",
"value": -3.70256
},
{
"op": "remove",
"path": "/protocolSection/contactsLocationsModule/locations/63/state"
},
{
"op": "replace",
"path": "/protocolSection/contactsLocationsModule/locations/64/city",
"value": "Oviedo"
},
{
"op": "remove",
"path": "/protocolSection/contactsLocationsModule/locations/64/state"
},
{
"op": "replace",
"path": "/protocolSection/contactsLocationsModule/locations/64/geoPoint/lat",
"value": 43.36029
},
{
"op": "replace",
"path": "/protocolSection/contactsLocationsModule/locations/64/geoPoint/lon",
"value": -5.84476
},
{
"op": "remove",
"path": "/protocolSection/contactsLocationsModule/locations/65/state"
},
{
"op": "replace",
"path": "/protocolSection/contactsLocationsModule/locations/65/geoPoint/lat",
"value": 40.42972
},
{
"op": "replace",
"path": "/protocolSection/contactsLocationsModule/locations/65/geoPoint/lon",
"value": -3.67975
},
{
"op": "replace",
"path": "/protocolSection/contactsLocationsModule/locations/66/city",
"value": "Seville"
},
{
"op": "remove",
"path": "/protocolSection/contactsLocationsModule/locations/66/state"
},
{
"op": "add",
"path": "/protocolSection/contactsLocationsModule/locations/66/geoPoint",
"value": {
"lat": 37.38283,
"lon": -5.97317
}
},
{
"op": "remove",
"path": "/protocolSection/contactsLocationsModule/locations/67"
},
{
"op": "remove",
"path": "/protocolSection/contactsLocationsModule/locations/67"
},
{
"op": "remove",
"path": "/protocolSection/contactsLocationsModule/locations/73"
},
{
"op": "add",
"path": "/protocolSection/contactsLocationsModule/locations/74",
"value": {
"city": "Caracas",
"country": "Venezuela",
"facility": "Research Site",
"geoPoint": {
"lat": 10.48801,
"lon": -66.87919
}
}
},
{
"op": "add",
"path": "/protocolSection/referencesModule/seeAlsoLinks",
"value": [
{
"url": "http://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_MED_6111&studyid=589&filename=CSP-D6997C00002.PDF",
"label": "CSP-D6997C00002.PDF"
},
{
"url": "http://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_MED_6111&studyid=589&filename=CSR-D6997C00002.pdf",
"label": "D6997C00002 Study Report Synopsis"
}
]
},
{
"op": "replace",
"path": "/resultsSection/participantFlowModule/periods/0/milestones/1/achievements/0/comment",
"value": "ongoing study treatment at survival follow-up data cut-off"
},
{
"op": "replace",
"path": "/resultsSection/participantFlowModule/periods/0/milestones/1/achievements/0/numSubjects",
"value": "8"
},
{
"op": "replace",
"path": "/resultsSection/participantFlowModule/periods/0/milestones/1/achievements/1/comment",
"value": "ongoing study treatment at survival follow-up data cut-off"
},
{
"op": "replace",
"path": "/resultsSection/participantFlowModule/periods/0/milestones/1/achievements/1/numSubjects",
"value": "13"
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{
"op": "replace",
"path": "/resultsSection/participantFlowModule/periods/0/milestones/2/achievements/0/numSubjects",
"value": "366"
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{
"op": "replace",
"path": "/resultsSection/participantFlowModule/periods/0/milestones/2/achievements/1/numSubjects",
"value": "349"
},
{
"op": "replace",
"path": "/resultsSection/participantFlowModule/periods/0/dropWithdraws/0/type",
"value": "Lost to Follow-up"
},
{
"op": "replace",
"path": "/resultsSection/participantFlowModule/periods/0/dropWithdraws/0/reasons/0/numSubjects",
"value": "30"
},
{
"op": "replace",
"path": "/resultsSection/participantFlowModule/periods/0/dropWithdraws/0/reasons/1/numSubjects",
"value": "33"
},
{
"op": "replace",
"path": "/resultsSection/participantFlowModule/periods/0/dropWithdraws/1/type",
"value": "Death"
},
{
"op": "replace",
"path": "/resultsSection/participantFlowModule/periods/0/dropWithdraws/1/reasons/0/numSubjects",
"value": "293"
},
{
"op": "replace",
"path": "/resultsSection/participantFlowModule/periods/0/dropWithdraws/1/reasons/1/numSubjects",
"value": "261"
},
{
"op": "replace",
"path": "/resultsSection/participantFlowModule/periods/0/dropWithdraws/2/type",
"value": "Withdrawal by Subject"
},
{
"op": "replace",
"path": "/resultsSection/participantFlowModule/periods/0/dropWithdraws/2/reasons/0/numSubjects",
"value": "6"
},
{
"op": "replace",
"path": "/resultsSection/participantFlowModule/periods/0/dropWithdraws/2/reasons/1/numSubjects",
"value": "10"
},
{
"op": "replace",
"path": "/resultsSection/participantFlowModule/periods/0/dropWithdraws/3/type",
"value": "Ongoing in FU but not on treatment"
},
{
"op": "replace",
"path": "/resultsSection/participantFlowModule/periods/0/dropWithdraws/3/reasons/0/numSubjects",
"value": "37"
},
{
"op": "replace",
"path": "/resultsSection/participantFlowModule/periods/0/dropWithdraws/3/reasons/1/numSubjects",
"value": "45"
},
{
"op": "remove",
"path": "/resultsSection/participantFlowModule/periods/0/dropWithdraws/4"
},
{
"op": "remove",
"path": "/resultsSection/participantFlowModule/periods/0/dropWithdraws/4"
},
{
"op": "remove",
"path": "/resultsSection/participantFlowModule/periods/0/dropWithdraws/4"
},
{
"op": "remove",
"path": "/resultsSection/participantFlowModule/periods/0/dropWithdraws/4"
},
{
"op": "replace",
"path": "/resultsSection/baselineCharacteristicsModule/measures/0/title",
"value": "Age, Continuous"
},
{
"op": "replace",
"path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/0/timeFrame",
"value": "RECIST(Response Evaluation Criteria in Solid Tumors ) tumour assessments carried out every 12 weeks (+/- 2 weeks) from randomisation for study duration (48 months)"
},
{
"op": "replace",
"path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/0/classes/0/categories/0/measurements/0/upperLimit",
"value": "NA"
},
{
"op": "add",
"path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/0/classes/0/categories/0/measurements/0/comment",
"value": "Not Applicable - not all participants had an event at time of analysis, max time censored"
},
{
"op": "replace",
"path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/0/classes/0/categories/0/measurements/1/upperLimit",
"value": "NA"
},
{
"op": "add",
"path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/0/classes/0/categories/0/measurements/1/comment",
"value": "Not Applicable - not all participants had an event at time of analysis, max time censored"
},
{
"op": "replace",
"path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/3/classes/0/categories/0/measurements/0/upperLimit",
"value": "NA"
},
{
"op": "add",
"path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/3/classes/0/categories/0/measurements/0/comment",
"value": "Not Applicable - not all participants had an event at time of analysis, max time censored"
},
{
"op": "replace",
"path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/3/classes/0/categories/0/measurements/1/upperLimit",
"value": "NA"
},
{
"op": "add",
"path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/3/classes/0/categories/0/measurements/1/comment",
"value": "Not Applicable - not all participants had an event at time of analysis, max time censored"
},
{
"op": "replace",
"path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/4/classes/0/categories/0/measurements/0/upperLimit",
"value": "NA"
},
{
"op": "add",
"path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/4/classes/0/categories/0/measurements/0/comment",
"value": "Not Applicable - not all participants had an event at time of analysis, max time censored"
},
{
"op": "replace",
"path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/4/classes/0/categories/0/measurements/1/upperLimit",
"value": "NA"
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{
"op": "add",
"path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/4/classes/0/categories/0/measurements/1/comment",
"value": "Not Applicable - not all participants had an event at time of analysis, max time censored"
},
{
"op": "replace",
"path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/5/description",
"value": "Median time (in months) from randomisation until death (from any cause) (analysis at 50% deaths )"
},
{
"op": "replace",
"path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/5/classes/0/categories/0/measurements/0/upperLimit",
"value": "NA"
},
{
"op": "add",
"path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/5/classes/0/categories/0/measurements/0/comment",
"value": "Not Applicable - not all participants had an event at time of analysis, max time censored"
},
{
"op": "replace",
"path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/5/classes/0/categories/0/measurements/1/upperLimit",
"value": "NA"
},
{
"op": "add",
"path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/5/classes/0/categories/0/measurements/1/comment",
"value": "Not Applicable - not all participants had an event at time of analysis, max time censored"
},
{
"op": "replace",
"path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/6/title",
"value": "Change From Randomisation in Trial Outcome Index (TOI) Over the Course of the Study"
},
{
"op": "replace",
"path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/6/description",
"value": "Mean (and standard deviation) change from randomisation until treatment discontinuation in TOI (defined as the first visit response of 'worsened' which is a decrease in TOI from baseline of 5 points or more) using the Kaplan-Meier method.\nIf a subject has not shown a reduction of 5 points or more at the time of analysis then the observation will be right censored using the last QOL assessment date.\nTrial Outcome Index (TOI) is derived from the FACT-B questionnaire (Cella et al, 1993) by adding together the scores from the following 3 subscales; Physical well-being (PWB), Functional well-being (FWB) and Breast cancer subscale (BCS).\nThe TOI score range is 0-92 with the higher scores representing the more favourable outcomes.\nData were collected from a subgroup of patients."
},
{
"op": "replace",
"path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/6/reportingStatus",
"value": "POSTED"
},
{
"op": "add",
"path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/6/paramType",
"value": "MEAN"
},
{
"op": "add",
"path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/6/dispersionType",
"value": "Standard Deviation"
},
{
"op": "add",
"path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/6/unitOfMeasure",
"value": "Scores on a scale"
},
{
"op": "add",
"path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/6/groups",
"value": [
{
"id": "OG000",
"title": "Fulvestrant 250 mg",
"description": "Fulvestrant 250 mg Intramuscular Injection every 28 days"
},
{
"id": "OG001",
"title": "Fulvestrant 500 mg",
"description": "Fulvestrant 500 mg Intramuscular Injection every 28 days plus 500 mg on day 14"
}
]
},
{
"op": "add",
"path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/6/denoms",
"value": [
{
"units": "Participants",
"counts": [
{
"value": "35",
"groupId": "OG000"
},
{
"value": "34",
"groupId": "OG001"
}
]
}
]
},
{
"op": "add",
"path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/6/classes",
"value": [
{
"categories": [
{
"measurements": [
{
"value": "-5.9",
"spread": "9.89",
"groupId": "OG000"
},
{
"value": "-7.5",
"spread": "13.72",
"groupId": "OG001"
}
]
}
]
}
]
},
{
"op": "add",
"path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/7",
"value": {
"type": "SECONDARY",
"title": "Overall Survival (OS) - Follow-up",
"denoms": [
{
"units": "Participants",
"counts": [
{
"value": "374",
"groupId": "OG000"
},
{
"value": "362",
"groupId": "OG001"
}
]
}
],
"groups": [
{
"id": "OG000",
"title": "Fulvestrant 250 mg",
"description": "Fulvestrant 250 mg Intramuscular Injection every 28 days"
},
{
"id": "OG001",
"title": "Fulvestrant 500 mg",
"description": "Fulvestrant 500 mg Intramuscular Injection every 28 days plus 500 mg on day 14"
}
],
"classes": [
{
"categories": [
{
"measurements": [
{
"value": "22.3",
"comment": "Not Applicable - not all participants had an event at time of analysis, max time censored",
"groupId": "OG000",
"lowerLimit": "0.2",
"upperLimit": "NA"
},
{
"value": "26.4",
"comment": "Not Applicable - not all participants had an event at time of analysis, max time censored",
"groupId": "OG001",
"lowerLimit": "0.1",
"upperLimit": "NA"
}
]
}
]
}
],
"paramType": "MEDIAN",
"timeFrame": "Median time (in months) from randomisation until death (from any cause),up to 80 months",
"description": "Overall Survival is equivalent to time to death.\nFor this endpoint, all deaths occurring during the study as a whole until the data cut-off for the survival extension (31st October 2011) are presented (analysis at 75% deaths)",
"unitOfMeasure": "months",
"dispersionType": "Full Range",
"reportingStatus": "POSTED",
"populationDescription": "All randomised patients"
}
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/description",
"value": "1 participant was randomised to fulvestrant 500 mg but did not receive any treatment.\nAEs have been collected up to primary data cut off.\nSAEs have been collected up to follow-up phase data cut-off."
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/eventGroups/0/seriousNumAffected",
"value": 27
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/eventGroups/1/seriousNumAffected",
"value": 35
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/0/stats/1/numAffected",
"value": 3
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/5/stats/0/numAffected",
"value": 2
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/20/stats/1/numAffected",
"value": 2
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/26/stats/0/numAffected",
"value": 2
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/31/stats/1/numAffected",
"value": 2
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/61",
"value": {
"term": "ATRIAL FIBRILLATION",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 374,
"numAffected": 0
},
{
"groupId": "EG001",
"numAtRisk": 361,
"numAffected": 1
}
],
"organSystem": "Cardiac disorders",
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "MedDRA 11.1"
}
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/62",
"value": {
"term": "ASTHENIA",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 374,
"numAffected": 0
},
{
"groupId": "EG001",
"numAtRisk": 361,
"numAffected": 1
}
],
"organSystem": "General disorders",
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "MedDRA 11.1"
}
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/63",
"value": {
"term": "INFECTIOUS PERITONITIS",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 374,
"numAffected": 0
},
{
"groupId": "EG001",
"numAtRisk": 361,
"numAffected": 1
}
],
"organSystem": "Infections and infestations",
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "MedDRA 11.1"
}
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/64",
"value": {
"term": "FALL",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 374,
"numAffected": 1
},
{
"groupId": "EG001",
"numAtRisk": 361,
"numAffected": 0
}
],
"organSystem": "Injury, poisoning and procedural complications",
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "MedDRA 11.1"
}
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/65",
"value": {
"term": "BONE PAIN",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 374,
"numAffected": 0
},
{
"groupId": "EG001",
"numAtRisk": 361,
"numAffected": 1
}
],
"organSystem": "Musculoskeletal and connective tissue disorders",
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "MedDRA 11.1"
}
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/seriousEvents/66",
"value": {
"term": "HAEMOTHORAX",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 374,
"numAffected": 0
},
{
"groupId": "EG001",
"numAtRisk": 361,
"numAffected": 1
}
],
"organSystem": "Respiratory, thoracic and mediastinal disorders",
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "MedDRA 11.1"
}
},
{
"op": "add",
"path": "/resultsSection/adverseEventsModule/timeFrame",
"value": "SAE- From baseline up to October 31st 2011; AE- From baseline up to 28th February 2009"
}
]