Trial Outcomes & Findings for A Global Study to Compare the Effects of Fulvestrant and Arimidex in a Subset of Patients With Breast Cancer. (NCT NCT01602380)
NCT ID: NCT01602380
Last Updated: 2026-01-12
Results Overview
PFS was defined as the time from randomisation until objective disease progression according to Response Evaluation Criteria in Solid Tumours version 1.1 (RECIST 1.1), surgery or radiotherapy to manage worsening of disease or death by any cause (in the absence of progression). Outcome measure is reported as median time from randomisation to PFS, calculated using the Kaplan-Meier technique.
Recruitment status
ACTIVE_NOT_RECRUITING
Study phase
PHASE3
Target enrollment
462 participants
Primary outcome timeframe
Baseline RECIST 1.1 assessments (Day 0) and then every 12 weeks until the earliest of disease progression evident, patient dies or has surgery/radiotherapy for their disease (up to approximately 38 months)
Results posted on
2026-01-12
Participant Flow
First patient enrolled: 17 October 2012.
524 patients were enrolled (signed informed consent). Patients were assigned to treatment if they met all inclusion and none of the exclusion criteria. 62 patients were not randomised, mainly due to eligibility criteria not being fulfilled (44/62 patients) or patient decision (13/62 patients). 462 patients were randomised to receive treatment.
Participant milestones
| Measure |
Fulvestrant 500 mg
Patients received fulvestrant (Faslodex™) 500 milligrams (mg), administered as two 5 milliliters (mL) intramuscular injections, 1 in each buttock, at each visit on Days 0, 14 (±3), 28 (±3) and every 28 (±3) days thereafter. In order to support the double-blind, double-dummy design of the trial, each patient randomised to receive fulvestrant, also received placebo to match the anastrozole schedule (tablets, once daily).
|
Anastrozole 1 mg
Patients received anastrozole (Arimidex™), administered orally as a single tablet at a dose of 1 mg/day from randomisation on Day 0 and once daily thereafter. In order to support the double-blind, double-dummy design of the trial, each patient randomised to receive anastrozole also received placebo to match the fulvestrant schedule (injections on Days 0, 14 \[±3\], 28 \[±3\] and every 28 \[±3\] days thereafter).
|
|---|---|---|
|
Overall Study
STARTED
|
230
|
232
|
|
Overall Study
COMPLETED
|
25
|
31
|
|
Overall Study
NOT COMPLETED
|
205
|
201
|
Reasons for withdrawal
| Measure |
Fulvestrant 500 mg
Patients received fulvestrant (Faslodex™) 500 milligrams (mg), administered as two 5 milliliters (mL) intramuscular injections, 1 in each buttock, at each visit on Days 0, 14 (±3), 28 (±3) and every 28 (±3) days thereafter. In order to support the double-blind, double-dummy design of the trial, each patient randomised to receive fulvestrant, also received placebo to match the anastrozole schedule (tablets, once daily).
|
Anastrozole 1 mg
Patients received anastrozole (Arimidex™), administered orally as a single tablet at a dose of 1 mg/day from randomisation on Day 0 and once daily thereafter. In order to support the double-blind, double-dummy design of the trial, each patient randomised to receive anastrozole also received placebo to match the fulvestrant schedule (injections on Days 0, 14 \[±3\], 28 \[±3\] and every 28 \[±3\] days thereafter).
|
|---|---|---|
|
Overall Study
Death
|
147
|
145
|
|
Overall Study
Withdrawal by Subject
|
39
|
41
|
|
Overall Study
Lost to Follow-up
|
15
|
12
|
|
Overall Study
Eligibility criteria not fulfilled
|
2
|
3
|
|
Overall Study
Other
|
2
|
0
|
Baseline Characteristics
A Global Study to Compare the Effects of Fulvestrant and Arimidex in a Subset of Patients With Breast Cancer.
Baseline characteristics by cohort
| Measure |
Fulvestrant 500 mg
n=230 Participants
Patients received fulvestrant (Faslodex™) 500 mg, administered as two 5 mL intramuscular injections, 1 in each buttock, at each visit on Days 0, 14 (±3), 28 (±3) and every 28 (±3) days thereafter. In order to support the double-blind, double-dummy design of the trial, each patient randomised to receive fulvestrant, also received placebo to match the anastrozole schedule (tablets, once daily).
|
Anastrozole 1 mg
n=232 Participants
Patients received anastrozole (Arimidex™), administered orally as a single tablet at a dose of 1 mg/day from randomisation on Day 0 and once daily thereafter. In order to support the double-blind, double-dummy design of the trial, each patient randomised to receive anastrozole also received placebo to match the fulvestrant schedule (injections on Days 0, 14 \[±3\], 28 \[±3\] and every 28 \[±3\] days thereafter).
|
Total
n=462 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Race/Ethnicity, Customized
Other
|
14 Participants
n=210 Participants
|
15 Participants
n=19 Participants
|
29 Participants
n=8 Participants
|
|
Age, Continuous
|
63.8 years
STANDARD_DEVIATION 9.86 • n=210 Participants
|
63.3 years
STANDARD_DEVIATION 10.38 • n=19 Participants
|
63.5 years
STANDARD_DEVIATION 10.12 • n=8 Participants
|
|
Sex: Female, Male
Female
|
230 Participants
n=210 Participants
|
232 Participants
n=19 Participants
|
462 Participants
n=8 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=210 Participants
|
0 Participants
n=19 Participants
|
0 Participants
n=8 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
1 Participants
n=210 Participants
|
5 Participants
n=19 Participants
|
6 Participants
n=8 Participants
|
|
Race/Ethnicity, Customized
Asian
|
36 Participants
n=210 Participants
|
34 Participants
n=19 Participants
|
70 Participants
n=8 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
4 Participants
n=210 Participants
|
4 Participants
n=19 Participants
|
8 Participants
n=8 Participants
|
|
Race/Ethnicity, Customized
White
|
175 Participants
n=210 Participants
|
174 Participants
n=19 Participants
|
349 Participants
n=8 Participants
|
PRIMARY outcome
Timeframe: Baseline RECIST 1.1 assessments (Day 0) and then every 12 weeks until the earliest of disease progression evident, patient dies or has surgery/radiotherapy for their disease (up to approximately 38 months)Population: The ITT analysis set included all randomised patients.
PFS was defined as the time from randomisation until objective disease progression according to Response Evaluation Criteria in Solid Tumours version 1.1 (RECIST 1.1), surgery or radiotherapy to manage worsening of disease or death by any cause (in the absence of progression). Outcome measure is reported as median time from randomisation to PFS, calculated using the Kaplan-Meier technique.
Outcome measures
| Measure |
Fulvestrant 500 mg
n=230 Participants
Patients received fulvestrant (Faslodex™) 500 mg, administered as two 5 mL intramuscular injections, 1 in each buttock, at each visit on Days 0, 14 (±3), 28 (±3) and every 28 (±3) days thereafter. In order to support the double-blind, double-dummy design of the trial, each patient randomised to receive fulvestrant, also received placebo to match the anastrozole schedule (tablets, once daily).
|
Anastrozole 1 mg
n=232 Participants
Patients received anastrozole (Arimidex™), administered orally as a single tablet at a dose of 1 mg/day from randomisation on Day 0 and once daily thereafter. In order to support the double-blind, double-dummy design of the trial, each patient randomised to receive anastrozole also received placebo to match the fulvestrant schedule (injections on Days 0, 14 \[±3\], 28 \[±3\] and every 28 \[±3\] days thereafter).
|
|---|---|---|
|
Comparison of Progression-Free Survival (PFS) in Patients Treated With Fulvestrant With Those Treated With Anastrozole
|
16.6 Months
Interval 13.83 to 20.99
|
13.8 Months
Interval 11.99 to 16.59
|
SECONDARY outcome
Timeframe: Baseline (Day 0) up to data cut-off for final analysis (up to approximately 116 months). Following disease progression, patients were to be contacted at 12 weekly intervals to determine survival statusPopulation: The ITT analysis set included all randomised patients. Date of death of 2 participants were unknown in the Anastrozole 1mg arm, hence they were censored for OS analysis.
OS was defined as the time from randomisation until death by any cause. The current OS data correspond to that of the final analysis and the outcome measure is reported as percentage of patients with events.
Outcome measures
| Measure |
Fulvestrant 500 mg
n=230 Participants
Patients received fulvestrant (Faslodex™) 500 mg, administered as two 5 mL intramuscular injections, 1 in each buttock, at each visit on Days 0, 14 (±3), 28 (±3) and every 28 (±3) days thereafter. In order to support the double-blind, double-dummy design of the trial, each patient randomised to receive fulvestrant, also received placebo to match the anastrozole schedule (tablets, once daily).
|
Anastrozole 1 mg
n=232 Participants
Patients received anastrozole (Arimidex™), administered orally as a single tablet at a dose of 1 mg/day from randomisation on Day 0 and once daily thereafter. In order to support the double-blind, double-dummy design of the trial, each patient randomised to receive anastrozole also received placebo to match the fulvestrant schedule (injections on Days 0, 14 \[±3\], 28 \[±3\] and every 28 \[±3\] days thereafter).
|
|---|---|---|
|
Comparison of Overall Survival (OS) in Patients Treated With Fulvestrant With Those Treated With Anastrozole; Percentage of Patients With Events
|
68.3 Percentage of patients
|
67.7 Percentage of patients
|
SECONDARY outcome
Timeframe: Baseline RECIST 1.1 assessments (Day 0) and then every 12 weeks until disease progression or treatment discontinuation (up to approximately 38 months)Population: Percentages for ORR were calculated based on the number of patients in the ITT analysis set (which included all randomised patients) who had measurable disease at baseline (n=193 for Fulvestrant arm and n=196 for Anastrozole arm).
ORR was defined as the percentage patients with an objective response (i.e. those recording a partial response \[PR\] or complete response \[CR\]) at some point during the study, prior to disease progression. ORR was assessed in patients with measurable disease at baseline only. The determination of measurable disease at baseline was done using baseline RECIST data. CR was disappearance of all target lesions since baseline; was any pathological lymph nodes selected as target lesions (TL) to have a reduction in short axis to \<10 millimeter. PR was at least a 30% decrease in the sum of the diameters of TL, taking as reference the baseline sum of diameters.
Outcome measures
| Measure |
Fulvestrant 500 mg
n=193 Participants
Patients received fulvestrant (Faslodex™) 500 mg, administered as two 5 mL intramuscular injections, 1 in each buttock, at each visit on Days 0, 14 (±3), 28 (±3) and every 28 (±3) days thereafter. In order to support the double-blind, double-dummy design of the trial, each patient randomised to receive fulvestrant, also received placebo to match the anastrozole schedule (tablets, once daily).
|
Anastrozole 1 mg
n=196 Participants
Patients received anastrozole (Arimidex™), administered orally as a single tablet at a dose of 1 mg/day from randomisation on Day 0 and once daily thereafter. In order to support the double-blind, double-dummy design of the trial, each patient randomised to receive anastrozole also received placebo to match the fulvestrant schedule (injections on Days 0, 14 \[±3\], 28 \[±3\] and every 28 \[±3\] days thereafter).
|
|---|---|---|
|
Objective Response Rate (ORR) for Fulvestrant Treatment Versus Anastrozole Treatment
|
46.1 Percentage of participants
|
44.9 Percentage of participants
|
SECONDARY outcome
Timeframe: Baseline RECIST 1.1 assessments (Day 0) and then every 12 weeks until disease progression or treatment discontinuation (up to approximately 38 months)Population: Only patients in the ITT analysis set (which included all randomised patients), who also had an objective response and had measurable disease at baseline were included in the DoR analysis (n=89 for Fulvestrant arm and n=88 for Anastrozole arm).
DoR was defined only for patients who had an objective response, as the time in days from date of first documentation of response (CR/PR) until date of disease progression. CR was disappearance of all target lesions since baseline; any pathological lymph nodes selected as TL to have a reduction in short axis to \<10 mm. At least a 30% decrease in the sum of the diameters of TL, taking as reference the baseline sum of diameters.
Outcome measures
| Measure |
Fulvestrant 500 mg
n=89 Participants
Patients received fulvestrant (Faslodex™) 500 mg, administered as two 5 mL intramuscular injections, 1 in each buttock, at each visit on Days 0, 14 (±3), 28 (±3) and every 28 (±3) days thereafter. In order to support the double-blind, double-dummy design of the trial, each patient randomised to receive fulvestrant, also received placebo to match the anastrozole schedule (tablets, once daily).
|
Anastrozole 1 mg
n=88 Participants
Patients received anastrozole (Arimidex™), administered orally as a single tablet at a dose of 1 mg/day from randomisation on Day 0 and once daily thereafter. In order to support the double-blind, double-dummy design of the trial, each patient randomised to receive anastrozole also received placebo to match the fulvestrant schedule (injections on Days 0, 14 \[±3\], 28 \[±3\] and every 28 \[±3\] days thereafter).
|
|---|---|---|
|
Duration of Response (DoR) for Fulvestrant Treatment Versus Anastrozole Treatment
|
20.0 Months
Interval 10.6 to
NA = Not Available. 75th percentile value not calculable due to insufficient data.
|
13.2 Months
Interval 8.3 to 24.7
|
SECONDARY outcome
Timeframe: Baseline RECIST 1.1 assessments and then every 12 weeks until disease progression or treatment discontinuation (up to approximately 38 months)Population: EDoR analysis was based on the number of patients in the ITT analysis set (which included all randomised patients) who had measurable disease at baseline (n=193 for Fulvestrant arm and n=196 for Anastrozole arm).
EDoR was estimated using the formula EDoR = p Efp(x), where x = DoR, p = proportion of responders, and Efp(x) = mean duration of response for responders. The estimation was completed by using the maximum likelihood estimates of p and Efp(x), as described by Ellis (Ellis S et al. Analysis of duration of response in oncology trials, Contemp Clin Trials 2008; 29:456-65).
Outcome measures
| Measure |
Fulvestrant 500 mg
n=193 Participants
Patients received fulvestrant (Faslodex™) 500 mg, administered as two 5 mL intramuscular injections, 1 in each buttock, at each visit on Days 0, 14 (±3), 28 (±3) and every 28 (±3) days thereafter. In order to support the double-blind, double-dummy design of the trial, each patient randomised to receive fulvestrant, also received placebo to match the anastrozole schedule (tablets, once daily).
|
Anastrozole 1 mg
n=196 Participants
Patients received anastrozole (Arimidex™), administered orally as a single tablet at a dose of 1 mg/day from randomisation on Day 0 and once daily thereafter. In order to support the double-blind, double-dummy design of the trial, each patient randomised to receive anastrozole also received placebo to match the fulvestrant schedule (injections on Days 0, 14 \[±3\], 28 \[±3\] and every 28 \[±3\] days thereafter).
|
|---|---|---|
|
Expected Duration of Response (EDoR) for Fulvestrant Treatment Versus Anastrozole Treatment
|
346.84 Days
|
227.58 Days
|
SECONDARY outcome
Timeframe: Baseline RECIST 1.1 assessments (Day 0) and then every 12 weeks until disease progression or treatment discontinuation (up to approximately 38 months)Population: The ITT analysis set included all randomised patients.
CBR was defined as the percentage of patients who had a clinical benefit (i.e. best objective response of CR, PR or stable disease), that was maintained for at least 24 weeks, prior to any evidence of progression. Note that a minimum duration of 22 weeks for CBR was applicable in the analysis (rather than 24 weeks) to allow for the protocolled window of +/-2 weeks.
Outcome measures
| Measure |
Fulvestrant 500 mg
n=230 Participants
Patients received fulvestrant (Faslodex™) 500 mg, administered as two 5 mL intramuscular injections, 1 in each buttock, at each visit on Days 0, 14 (±3), 28 (±3) and every 28 (±3) days thereafter. In order to support the double-blind, double-dummy design of the trial, each patient randomised to receive fulvestrant, also received placebo to match the anastrozole schedule (tablets, once daily).
|
Anastrozole 1 mg
n=232 Participants
Patients received anastrozole (Arimidex™), administered orally as a single tablet at a dose of 1 mg/day from randomisation on Day 0 and once daily thereafter. In order to support the double-blind, double-dummy design of the trial, each patient randomised to receive anastrozole also received placebo to match the fulvestrant schedule (injections on Days 0, 14 \[±3\], 28 \[±3\] and every 28 \[±3\] days thereafter).
|
|---|---|---|
|
Clinical Benefit Rate (CBR) for Fulvestrant Treatment Versus Anastrozole Treatment
|
78.3 Percentage of participants
|
74.1 Percentage of participants
|
SECONDARY outcome
Timeframe: Baseline RECIST 1.1 assessments (Day 0) and then every 12 weeks until disease progression or treatment discontinuation (up to approximately 38 months)Population: Only patients in the ITT analysis set (which included all randomised patients) who also had a clinical benefit were included in the DoCB analysis (n=180 for Fulvestrant arm and n=172 for Anastrozole arm).
DoCB was defined only for patients who had clinical benefit, as the time in days from date of randomisation until the date of disease progression.
Outcome measures
| Measure |
Fulvestrant 500 mg
n=180 Participants
Patients received fulvestrant (Faslodex™) 500 mg, administered as two 5 mL intramuscular injections, 1 in each buttock, at each visit on Days 0, 14 (±3), 28 (±3) and every 28 (±3) days thereafter. In order to support the double-blind, double-dummy design of the trial, each patient randomised to receive fulvestrant, also received placebo to match the anastrozole schedule (tablets, once daily).
|
Anastrozole 1 mg
n=172 Participants
Patients received anastrozole (Arimidex™), administered orally as a single tablet at a dose of 1 mg/day from randomisation on Day 0 and once daily thereafter. In order to support the double-blind, double-dummy design of the trial, each patient randomised to receive anastrozole also received placebo to match the fulvestrant schedule (injections on Days 0, 14 \[±3\], 28 \[±3\] and every 28 \[±3\] days thereafter).
|
|---|---|---|
|
Duration of Clinical Benefit (DoCB) for Fulvestrant Treatment Versus Anastrozole Treatment
|
22.1 Months
Interval 11.2 to
75th percentile value not calculable due to insufficient data.
|
19.1 Months
Interval 11.3 to 30.4
|
SECONDARY outcome
Timeframe: Baseline RECIST 1.1 assessments (Day 0) and then every 12 weeks until disease progression or treatment discontinuation (up to approximately 38 months)Population: The ITT analysis set included all randomised patients.
EDoCB was estimated using the formula EDoCB = p Efp(x), where x = EDoCB, p = proportion of responders, and Efp(x) = mean duration of response for responders. The estimation was completed by using the maximum likelihood estimates of p and Efp(x), as described by Ellis (Ellis S et al. Analysis of duration of response in oncology trials, Contemp Clin Trials 2008; 29:456-65).
Outcome measures
| Measure |
Fulvestrant 500 mg
n=230 Participants
Patients received fulvestrant (Faslodex™) 500 mg, administered as two 5 mL intramuscular injections, 1 in each buttock, at each visit on Days 0, 14 (±3), 28 (±3) and every 28 (±3) days thereafter. In order to support the double-blind, double-dummy design of the trial, each patient randomised to receive fulvestrant, also received placebo to match the anastrozole schedule (tablets, once daily).
|
Anastrozole 1 mg
n=232 Participants
Patients received anastrozole (Arimidex™), administered orally as a single tablet at a dose of 1 mg/day from randomisation on Day 0 and once daily thereafter. In order to support the double-blind, double-dummy design of the trial, each patient randomised to receive anastrozole also received placebo to match the fulvestrant schedule (injections on Days 0, 14 \[±3\], 28 \[±3\] and every 28 \[±3\] days thereafter).
|
|---|---|---|
|
Expected Duration of Clinical Benefit (EDoCB) for Fulvestrant Treatment Versus Anastrozole Treatment
|
667.94 Days
|
532.04 Days
|
SECONDARY outcome
Timeframe: Quality of life questionnaires administered at 3 months post objective disease progression, then at 6-monthly intervals (approximately 75 months)Population: The ITT analysis set included all randomised patients.
The Functional Assessment of Cancer Therapy - Breast (FACT-B) questionnaire was the instrument selected to assess HRQoL and comprised of following subscales: physical well-being (PWB), functional well-being (FWB), social well-being, emotional well-being, and breast cancer subscale (BCS). The main outcome measure from the FACT-B questionnaire was the Trial Outcome Index (TOI), which was a summary of the following subscales: PWB, FWB, and BCS. Outcome measure is reported as median time to deterioration, defined as the interval from the date of baseline of final analysis to the first assessment of worsened without an improvement in the next 12 weeks in FACT-B TOI, or the date of death (by any cause in the absence of symptom deterioration). Time to deterioration as measured by FACT-B total score was derived similarly and is also reported.
Outcome measures
| Measure |
Fulvestrant 500 mg
n=230 Participants
Patients received fulvestrant (Faslodex™) 500 mg, administered as two 5 mL intramuscular injections, 1 in each buttock, at each visit on Days 0, 14 (±3), 28 (±3) and every 28 (±3) days thereafter. In order to support the double-blind, double-dummy design of the trial, each patient randomised to receive fulvestrant, also received placebo to match the anastrozole schedule (tablets, once daily).
|
Anastrozole 1 mg
n=232 Participants
Patients received anastrozole (Arimidex™), administered orally as a single tablet at a dose of 1 mg/day from randomisation on Day 0 and once daily thereafter. In order to support the double-blind, double-dummy design of the trial, each patient randomised to receive anastrozole also received placebo to match the fulvestrant schedule (injections on Days 0, 14 \[±3\], 28 \[±3\] and every 28 \[±3\] days thereafter).
|
|---|---|---|
|
Comparison of the Effect of Fulvestrant Treatment Versus Anastrozole Treatment on Time to Deterioration of Health-Related Quality of Life (HRQoL)
Time to TOI deterioration
|
14.1 months
Interval 5.5 to 44.1
|
11.1 months
Interval 5.5 to 38.3
|
|
Comparison of the Effect of Fulvestrant Treatment Versus Anastrozole Treatment on Time to Deterioration of Health-Related Quality of Life (HRQoL)
Time to FACT-B total score deterioration
|
13.8 months
Interval 5.5 to 38.7
|
11.1 months
Interval 4.8 to 33.6
|
Adverse Events
Fulvestrant 500 mg
Serious events: 39 serious events
Other events: 125 other events
Deaths: 157 deaths
Anastrozole 1 mg
Serious events: 36 serious events
Other events: 127 other events
Deaths: 159 deaths
Serious adverse events
| Measure |
Fulvestrant 500 mg
n=228 participants at risk
Patients received fulvestrant (Faslodex™) 500 mg, administered as two 5 mL intramuscular injections, 1 in each buttock, at each visit on Days 0, 14 (±3), 28 (±3) and every 28 (±3) days thereafter. In order to support the double-blind, double-dummy design of the trial, each patient randomised to receive fulvestrant, also received placebo to match the anastrozole schedule (tablets, once daily).
|
Anastrozole 1 mg
n=232 participants at risk
Patients received anastrozole (Arimidex™), administered orally as a single tablet at a dose of 1 mg/day from randomisation on Day 0 and once daily thereafter. In order to support the double-blind, double-dummy design of the trial, each patient randomised to receive anastrozole also received placebo to match the fulvestrant schedule (injections on Days 0, 14 \[±3\], 28 \[±3\] and every 28 \[±3\] days thereafter).
|
|---|---|---|
|
Psychiatric disorders
Anxiety
|
0.00%
0/228 • 116 months (duration from first patient enrolled to data cut-off for the final analysis)
All-Cause Mortality: The ITT analysis set included all randomised patients. For serious adverse events and other (non-serious) adverse events: Safety population was defined as all patients who received at least 1 dose of randomised study medication. 2 patients in the Fulvestrant 500 mg arm did not receive treatment and were not included in the safety population.
|
0.43%
1/232 • Number of events 1 • 116 months (duration from first patient enrolled to data cut-off for the final analysis)
All-Cause Mortality: The ITT analysis set included all randomised patients. For serious adverse events and other (non-serious) adverse events: Safety population was defined as all patients who received at least 1 dose of randomised study medication. 2 patients in the Fulvestrant 500 mg arm did not receive treatment and were not included in the safety population.
|
|
Blood and lymphatic system disorders
Anaemia
|
0.44%
1/228 • Number of events 1 • 116 months (duration from first patient enrolled to data cut-off for the final analysis)
All-Cause Mortality: The ITT analysis set included all randomised patients. For serious adverse events and other (non-serious) adverse events: Safety population was defined as all patients who received at least 1 dose of randomised study medication. 2 patients in the Fulvestrant 500 mg arm did not receive treatment and were not included in the safety population.
|
0.86%
2/232 • Number of events 6 • 116 months (duration from first patient enrolled to data cut-off for the final analysis)
All-Cause Mortality: The ITT analysis set included all randomised patients. For serious adverse events and other (non-serious) adverse events: Safety population was defined as all patients who received at least 1 dose of randomised study medication. 2 patients in the Fulvestrant 500 mg arm did not receive treatment and were not included in the safety population.
|
|
Blood and lymphatic system disorders
Anaemia macrocytic
|
0.44%
1/228 • Number of events 1 • 116 months (duration from first patient enrolled to data cut-off for the final analysis)
All-Cause Mortality: The ITT analysis set included all randomised patients. For serious adverse events and other (non-serious) adverse events: Safety population was defined as all patients who received at least 1 dose of randomised study medication. 2 patients in the Fulvestrant 500 mg arm did not receive treatment and were not included in the safety population.
|
0.00%
0/232 • 116 months (duration from first patient enrolled to data cut-off for the final analysis)
All-Cause Mortality: The ITT analysis set included all randomised patients. For serious adverse events and other (non-serious) adverse events: Safety population was defined as all patients who received at least 1 dose of randomised study medication. 2 patients in the Fulvestrant 500 mg arm did not receive treatment and were not included in the safety population.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/228 • 116 months (duration from first patient enrolled to data cut-off for the final analysis)
All-Cause Mortality: The ITT analysis set included all randomised patients. For serious adverse events and other (non-serious) adverse events: Safety population was defined as all patients who received at least 1 dose of randomised study medication. 2 patients in the Fulvestrant 500 mg arm did not receive treatment and were not included in the safety population.
|
0.43%
1/232 • Number of events 1 • 116 months (duration from first patient enrolled to data cut-off for the final analysis)
All-Cause Mortality: The ITT analysis set included all randomised patients. For serious adverse events and other (non-serious) adverse events: Safety population was defined as all patients who received at least 1 dose of randomised study medication. 2 patients in the Fulvestrant 500 mg arm did not receive treatment and were not included in the safety population.
|
|
Cardiac disorders
Atrial flutter
|
0.00%
0/228 • 116 months (duration from first patient enrolled to data cut-off for the final analysis)
All-Cause Mortality: The ITT analysis set included all randomised patients. For serious adverse events and other (non-serious) adverse events: Safety population was defined as all patients who received at least 1 dose of randomised study medication. 2 patients in the Fulvestrant 500 mg arm did not receive treatment and were not included in the safety population.
|
0.43%
1/232 • Number of events 1 • 116 months (duration from first patient enrolled to data cut-off for the final analysis)
All-Cause Mortality: The ITT analysis set included all randomised patients. For serious adverse events and other (non-serious) adverse events: Safety population was defined as all patients who received at least 1 dose of randomised study medication. 2 patients in the Fulvestrant 500 mg arm did not receive treatment and were not included in the safety population.
|
|
Cardiac disorders
Cardiac failure acute
|
0.00%
0/228 • 116 months (duration from first patient enrolled to data cut-off for the final analysis)
All-Cause Mortality: The ITT analysis set included all randomised patients. For serious adverse events and other (non-serious) adverse events: Safety population was defined as all patients who received at least 1 dose of randomised study medication. 2 patients in the Fulvestrant 500 mg arm did not receive treatment and were not included in the safety population.
|
0.43%
1/232 • Number of events 1 • 116 months (duration from first patient enrolled to data cut-off for the final analysis)
All-Cause Mortality: The ITT analysis set included all randomised patients. For serious adverse events and other (non-serious) adverse events: Safety population was defined as all patients who received at least 1 dose of randomised study medication. 2 patients in the Fulvestrant 500 mg arm did not receive treatment and were not included in the safety population.
|
|
Gastrointestinal disorders
Dysphagia
|
0.44%
1/228 • Number of events 1 • 116 months (duration from first patient enrolled to data cut-off for the final analysis)
All-Cause Mortality: The ITT analysis set included all randomised patients. For serious adverse events and other (non-serious) adverse events: Safety population was defined as all patients who received at least 1 dose of randomised study medication. 2 patients in the Fulvestrant 500 mg arm did not receive treatment and were not included in the safety population.
|
0.00%
0/232 • 116 months (duration from first patient enrolled to data cut-off for the final analysis)
All-Cause Mortality: The ITT analysis set included all randomised patients. For serious adverse events and other (non-serious) adverse events: Safety population was defined as all patients who received at least 1 dose of randomised study medication. 2 patients in the Fulvestrant 500 mg arm did not receive treatment and were not included in the safety population.
|
|
Infections and infestations
Appendicitis
|
0.44%
1/228 • Number of events 1 • 116 months (duration from first patient enrolled to data cut-off for the final analysis)
All-Cause Mortality: The ITT analysis set included all randomised patients. For serious adverse events and other (non-serious) adverse events: Safety population was defined as all patients who received at least 1 dose of randomised study medication. 2 patients in the Fulvestrant 500 mg arm did not receive treatment and were not included in the safety population.
|
0.00%
0/232 • 116 months (duration from first patient enrolled to data cut-off for the final analysis)
All-Cause Mortality: The ITT analysis set included all randomised patients. For serious adverse events and other (non-serious) adverse events: Safety population was defined as all patients who received at least 1 dose of randomised study medication. 2 patients in the Fulvestrant 500 mg arm did not receive treatment and were not included in the safety population.
|
|
Injury, poisoning and procedural complications
Skin abrasion
|
0.44%
1/228 • Number of events 1 • 116 months (duration from first patient enrolled to data cut-off for the final analysis)
All-Cause Mortality: The ITT analysis set included all randomised patients. For serious adverse events and other (non-serious) adverse events: Safety population was defined as all patients who received at least 1 dose of randomised study medication. 2 patients in the Fulvestrant 500 mg arm did not receive treatment and were not included in the safety population.
|
0.00%
0/232 • 116 months (duration from first patient enrolled to data cut-off for the final analysis)
All-Cause Mortality: The ITT analysis set included all randomised patients. For serious adverse events and other (non-serious) adverse events: Safety population was defined as all patients who received at least 1 dose of randomised study medication. 2 patients in the Fulvestrant 500 mg arm did not receive treatment and were not included in the safety population.
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/228 • 116 months (duration from first patient enrolled to data cut-off for the final analysis)
All-Cause Mortality: The ITT analysis set included all randomised patients. For serious adverse events and other (non-serious) adverse events: Safety population was defined as all patients who received at least 1 dose of randomised study medication. 2 patients in the Fulvestrant 500 mg arm did not receive treatment and were not included in the safety population.
|
0.43%
1/232 • Number of events 1 • 116 months (duration from first patient enrolled to data cut-off for the final analysis)
All-Cause Mortality: The ITT analysis set included all randomised patients. For serious adverse events and other (non-serious) adverse events: Safety population was defined as all patients who received at least 1 dose of randomised study medication. 2 patients in the Fulvestrant 500 mg arm did not receive treatment and were not included in the safety population.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/228 • 116 months (duration from first patient enrolled to data cut-off for the final analysis)
All-Cause Mortality: The ITT analysis set included all randomised patients. For serious adverse events and other (non-serious) adverse events: Safety population was defined as all patients who received at least 1 dose of randomised study medication. 2 patients in the Fulvestrant 500 mg arm did not receive treatment and were not included in the safety population.
|
0.43%
1/232 • Number of events 1 • 116 months (duration from first patient enrolled to data cut-off for the final analysis)
All-Cause Mortality: The ITT analysis set included all randomised patients. For serious adverse events and other (non-serious) adverse events: Safety population was defined as all patients who received at least 1 dose of randomised study medication. 2 patients in the Fulvestrant 500 mg arm did not receive treatment and were not included in the safety population.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.00%
0/228 • 116 months (duration from first patient enrolled to data cut-off for the final analysis)
All-Cause Mortality: The ITT analysis set included all randomised patients. For serious adverse events and other (non-serious) adverse events: Safety population was defined as all patients who received at least 1 dose of randomised study medication. 2 patients in the Fulvestrant 500 mg arm did not receive treatment and were not included in the safety population.
|
0.43%
1/232 • Number of events 1 • 116 months (duration from first patient enrolled to data cut-off for the final analysis)
All-Cause Mortality: The ITT analysis set included all randomised patients. For serious adverse events and other (non-serious) adverse events: Safety population was defined as all patients who received at least 1 dose of randomised study medication. 2 patients in the Fulvestrant 500 mg arm did not receive treatment and were not included in the safety population.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colorectal cancer
|
0.44%
1/228 • Number of events 1 • 116 months (duration from first patient enrolled to data cut-off for the final analysis)
All-Cause Mortality: The ITT analysis set included all randomised patients. For serious adverse events and other (non-serious) adverse events: Safety population was defined as all patients who received at least 1 dose of randomised study medication. 2 patients in the Fulvestrant 500 mg arm did not receive treatment and were not included in the safety population.
|
0.00%
0/232 • 116 months (duration from first patient enrolled to data cut-off for the final analysis)
All-Cause Mortality: The ITT analysis set included all randomised patients. For serious adverse events and other (non-serious) adverse events: Safety population was defined as all patients who received at least 1 dose of randomised study medication. 2 patients in the Fulvestrant 500 mg arm did not receive treatment and were not included in the safety population.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchiectasis
|
0.00%
0/228 • 116 months (duration from first patient enrolled to data cut-off for the final analysis)
All-Cause Mortality: The ITT analysis set included all randomised patients. For serious adverse events and other (non-serious) adverse events: Safety population was defined as all patients who received at least 1 dose of randomised study medication. 2 patients in the Fulvestrant 500 mg arm did not receive treatment and were not included in the safety population.
|
0.43%
1/232 • Number of events 1 • 116 months (duration from first patient enrolled to data cut-off for the final analysis)
All-Cause Mortality: The ITT analysis set included all randomised patients. For serious adverse events and other (non-serious) adverse events: Safety population was defined as all patients who received at least 1 dose of randomised study medication. 2 patients in the Fulvestrant 500 mg arm did not receive treatment and were not included in the safety population.
|
|
Cardiac disorders
Acute coronary syndrome
|
0.00%
0/228 • 116 months (duration from first patient enrolled to data cut-off for the final analysis)
All-Cause Mortality: The ITT analysis set included all randomised patients. For serious adverse events and other (non-serious) adverse events: Safety population was defined as all patients who received at least 1 dose of randomised study medication. 2 patients in the Fulvestrant 500 mg arm did not receive treatment and were not included in the safety population.
|
0.43%
1/232 • Number of events 1 • 116 months (duration from first patient enrolled to data cut-off for the final analysis)
All-Cause Mortality: The ITT analysis set included all randomised patients. For serious adverse events and other (non-serious) adverse events: Safety population was defined as all patients who received at least 1 dose of randomised study medication. 2 patients in the Fulvestrant 500 mg arm did not receive treatment and were not included in the safety population.
|
|
Cardiac disorders
Acute myocardial infarction
|
0.00%
0/228 • 116 months (duration from first patient enrolled to data cut-off for the final analysis)
All-Cause Mortality: The ITT analysis set included all randomised patients. For serious adverse events and other (non-serious) adverse events: Safety population was defined as all patients who received at least 1 dose of randomised study medication. 2 patients in the Fulvestrant 500 mg arm did not receive treatment and were not included in the safety population.
|
0.43%
1/232 • Number of events 1 • 116 months (duration from first patient enrolled to data cut-off for the final analysis)
All-Cause Mortality: The ITT analysis set included all randomised patients. For serious adverse events and other (non-serious) adverse events: Safety population was defined as all patients who received at least 1 dose of randomised study medication. 2 patients in the Fulvestrant 500 mg arm did not receive treatment and were not included in the safety population.
|
|
Cardiac disorders
Angina pectoris
|
0.44%
1/228 • Number of events 1 • 116 months (duration from first patient enrolled to data cut-off for the final analysis)
All-Cause Mortality: The ITT analysis set included all randomised patients. For serious adverse events and other (non-serious) adverse events: Safety population was defined as all patients who received at least 1 dose of randomised study medication. 2 patients in the Fulvestrant 500 mg arm did not receive treatment and were not included in the safety population.
|
0.00%
0/232 • 116 months (duration from first patient enrolled to data cut-off for the final analysis)
All-Cause Mortality: The ITT analysis set included all randomised patients. For serious adverse events and other (non-serious) adverse events: Safety population was defined as all patients who received at least 1 dose of randomised study medication. 2 patients in the Fulvestrant 500 mg arm did not receive treatment and were not included in the safety population.
|
|
Hepatobiliary disorders
Bile duct stone
|
0.00%
0/228 • 116 months (duration from first patient enrolled to data cut-off for the final analysis)
All-Cause Mortality: The ITT analysis set included all randomised patients. For serious adverse events and other (non-serious) adverse events: Safety population was defined as all patients who received at least 1 dose of randomised study medication. 2 patients in the Fulvestrant 500 mg arm did not receive treatment and were not included in the safety population.
|
0.43%
1/232 • Number of events 1 • 116 months (duration from first patient enrolled to data cut-off for the final analysis)
All-Cause Mortality: The ITT analysis set included all randomised patients. For serious adverse events and other (non-serious) adverse events: Safety population was defined as all patients who received at least 1 dose of randomised study medication. 2 patients in the Fulvestrant 500 mg arm did not receive treatment and were not included in the safety population.
|
|
Hepatobiliary disorders
Cholecystitis
|
0.44%
1/228 • Number of events 1 • 116 months (duration from first patient enrolled to data cut-off for the final analysis)
All-Cause Mortality: The ITT analysis set included all randomised patients. For serious adverse events and other (non-serious) adverse events: Safety population was defined as all patients who received at least 1 dose of randomised study medication. 2 patients in the Fulvestrant 500 mg arm did not receive treatment and were not included in the safety population.
|
0.00%
0/232 • 116 months (duration from first patient enrolled to data cut-off for the final analysis)
All-Cause Mortality: The ITT analysis set included all randomised patients. For serious adverse events and other (non-serious) adverse events: Safety population was defined as all patients who received at least 1 dose of randomised study medication. 2 patients in the Fulvestrant 500 mg arm did not receive treatment and were not included in the safety population.
|
|
Hepatobiliary disorders
Jaundice cholestatic
|
0.00%
0/228 • 116 months (duration from first patient enrolled to data cut-off for the final analysis)
All-Cause Mortality: The ITT analysis set included all randomised patients. For serious adverse events and other (non-serious) adverse events: Safety population was defined as all patients who received at least 1 dose of randomised study medication. 2 patients in the Fulvestrant 500 mg arm did not receive treatment and were not included in the safety population.
|
0.43%
1/232 • Number of events 1 • 116 months (duration from first patient enrolled to data cut-off for the final analysis)
All-Cause Mortality: The ITT analysis set included all randomised patients. For serious adverse events and other (non-serious) adverse events: Safety population was defined as all patients who received at least 1 dose of randomised study medication. 2 patients in the Fulvestrant 500 mg arm did not receive treatment and were not included in the safety population.
|
|
Immune system disorders
Drug hypersensitivity
|
0.44%
1/228 • Number of events 1 • 116 months (duration from first patient enrolled to data cut-off for the final analysis)
All-Cause Mortality: The ITT analysis set included all randomised patients. For serious adverse events and other (non-serious) adverse events: Safety population was defined as all patients who received at least 1 dose of randomised study medication. 2 patients in the Fulvestrant 500 mg arm did not receive treatment and were not included in the safety population.
|
0.00%
0/232 • 116 months (duration from first patient enrolled to data cut-off for the final analysis)
All-Cause Mortality: The ITT analysis set included all randomised patients. For serious adverse events and other (non-serious) adverse events: Safety population was defined as all patients who received at least 1 dose of randomised study medication. 2 patients in the Fulvestrant 500 mg arm did not receive treatment and were not included in the safety population.
|
|
Infections and infestations
Bronchitis
|
0.00%
0/228 • 116 months (duration from first patient enrolled to data cut-off for the final analysis)
All-Cause Mortality: The ITT analysis set included all randomised patients. For serious adverse events and other (non-serious) adverse events: Safety population was defined as all patients who received at least 1 dose of randomised study medication. 2 patients in the Fulvestrant 500 mg arm did not receive treatment and were not included in the safety population.
|
0.43%
1/232 • Number of events 1 • 116 months (duration from first patient enrolled to data cut-off for the final analysis)
All-Cause Mortality: The ITT analysis set included all randomised patients. For serious adverse events and other (non-serious) adverse events: Safety population was defined as all patients who received at least 1 dose of randomised study medication. 2 patients in the Fulvestrant 500 mg arm did not receive treatment and were not included in the safety population.
|
|
Infections and infestations
COVID-19
|
0.00%
0/228 • 116 months (duration from first patient enrolled to data cut-off for the final analysis)
All-Cause Mortality: The ITT analysis set included all randomised patients. For serious adverse events and other (non-serious) adverse events: Safety population was defined as all patients who received at least 1 dose of randomised study medication. 2 patients in the Fulvestrant 500 mg arm did not receive treatment and were not included in the safety population.
|
0.86%
2/232 • Number of events 2 • 116 months (duration from first patient enrolled to data cut-off for the final analysis)
All-Cause Mortality: The ITT analysis set included all randomised patients. For serious adverse events and other (non-serious) adverse events: Safety population was defined as all patients who received at least 1 dose of randomised study medication. 2 patients in the Fulvestrant 500 mg arm did not receive treatment and were not included in the safety population.
|
|
Infections and infestations
Device related sepsis
|
0.44%
1/228 • Number of events 1 • 116 months (duration from first patient enrolled to data cut-off for the final analysis)
All-Cause Mortality: The ITT analysis set included all randomised patients. For serious adverse events and other (non-serious) adverse events: Safety population was defined as all patients who received at least 1 dose of randomised study medication. 2 patients in the Fulvestrant 500 mg arm did not receive treatment and were not included in the safety population.
|
0.00%
0/232 • 116 months (duration from first patient enrolled to data cut-off for the final analysis)
All-Cause Mortality: The ITT analysis set included all randomised patients. For serious adverse events and other (non-serious) adverse events: Safety population was defined as all patients who received at least 1 dose of randomised study medication. 2 patients in the Fulvestrant 500 mg arm did not receive treatment and were not included in the safety population.
|
|
Cardiac disorders
Atrial fibrillation
|
0.44%
1/228 • Number of events 1 • 116 months (duration from first patient enrolled to data cut-off for the final analysis)
All-Cause Mortality: The ITT analysis set included all randomised patients. For serious adverse events and other (non-serious) adverse events: Safety population was defined as all patients who received at least 1 dose of randomised study medication. 2 patients in the Fulvestrant 500 mg arm did not receive treatment and were not included in the safety population.
|
0.86%
2/232 • Number of events 2 • 116 months (duration from first patient enrolled to data cut-off for the final analysis)
All-Cause Mortality: The ITT analysis set included all randomised patients. For serious adverse events and other (non-serious) adverse events: Safety population was defined as all patients who received at least 1 dose of randomised study medication. 2 patients in the Fulvestrant 500 mg arm did not receive treatment and were not included in the safety population.
|
|
Infections and infestations
Gastroenteritis
|
0.44%
1/228 • Number of events 1 • 116 months (duration from first patient enrolled to data cut-off for the final analysis)
All-Cause Mortality: The ITT analysis set included all randomised patients. For serious adverse events and other (non-serious) adverse events: Safety population was defined as all patients who received at least 1 dose of randomised study medication. 2 patients in the Fulvestrant 500 mg arm did not receive treatment and were not included in the safety population.
|
0.00%
0/232 • 116 months (duration from first patient enrolled to data cut-off for the final analysis)
All-Cause Mortality: The ITT analysis set included all randomised patients. For serious adverse events and other (non-serious) adverse events: Safety population was defined as all patients who received at least 1 dose of randomised study medication. 2 patients in the Fulvestrant 500 mg arm did not receive treatment and were not included in the safety population.
|
|
Infections and infestations
Infection
|
0.00%
0/228 • 116 months (duration from first patient enrolled to data cut-off for the final analysis)
All-Cause Mortality: The ITT analysis set included all randomised patients. For serious adverse events and other (non-serious) adverse events: Safety population was defined as all patients who received at least 1 dose of randomised study medication. 2 patients in the Fulvestrant 500 mg arm did not receive treatment and were not included in the safety population.
|
0.43%
1/232 • Number of events 1 • 116 months (duration from first patient enrolled to data cut-off for the final analysis)
All-Cause Mortality: The ITT analysis set included all randomised patients. For serious adverse events and other (non-serious) adverse events: Safety population was defined as all patients who received at least 1 dose of randomised study medication. 2 patients in the Fulvestrant 500 mg arm did not receive treatment and were not included in the safety population.
|
|
Infections and infestations
Lower respiratory tract infection
|
0.44%
1/228 • Number of events 1 • 116 months (duration from first patient enrolled to data cut-off for the final analysis)
All-Cause Mortality: The ITT analysis set included all randomised patients. For serious adverse events and other (non-serious) adverse events: Safety population was defined as all patients who received at least 1 dose of randomised study medication. 2 patients in the Fulvestrant 500 mg arm did not receive treatment and were not included in the safety population.
|
0.43%
1/232 • Number of events 1 • 116 months (duration from first patient enrolled to data cut-off for the final analysis)
All-Cause Mortality: The ITT analysis set included all randomised patients. For serious adverse events and other (non-serious) adverse events: Safety population was defined as all patients who received at least 1 dose of randomised study medication. 2 patients in the Fulvestrant 500 mg arm did not receive treatment and were not included in the safety population.
|
|
Infections and infestations
Peritonitis
|
0.88%
2/228 • Number of events 2 • 116 months (duration from first patient enrolled to data cut-off for the final analysis)
All-Cause Mortality: The ITT analysis set included all randomised patients. For serious adverse events and other (non-serious) adverse events: Safety population was defined as all patients who received at least 1 dose of randomised study medication. 2 patients in the Fulvestrant 500 mg arm did not receive treatment and were not included in the safety population.
|
0.00%
0/232 • 116 months (duration from first patient enrolled to data cut-off for the final analysis)
All-Cause Mortality: The ITT analysis set included all randomised patients. For serious adverse events and other (non-serious) adverse events: Safety population was defined as all patients who received at least 1 dose of randomised study medication. 2 patients in the Fulvestrant 500 mg arm did not receive treatment and were not included in the safety population.
|
|
Infections and infestations
Pneumonia
|
1.3%
3/228 • Number of events 3 • 116 months (duration from first patient enrolled to data cut-off for the final analysis)
All-Cause Mortality: The ITT analysis set included all randomised patients. For serious adverse events and other (non-serious) adverse events: Safety population was defined as all patients who received at least 1 dose of randomised study medication. 2 patients in the Fulvestrant 500 mg arm did not receive treatment and were not included in the safety population.
|
1.7%
4/232 • Number of events 7 • 116 months (duration from first patient enrolled to data cut-off for the final analysis)
All-Cause Mortality: The ITT analysis set included all randomised patients. For serious adverse events and other (non-serious) adverse events: Safety population was defined as all patients who received at least 1 dose of randomised study medication. 2 patients in the Fulvestrant 500 mg arm did not receive treatment and were not included in the safety population.
|
|
Infections and infestations
Pyelonephritis
|
0.00%
0/228 • 116 months (duration from first patient enrolled to data cut-off for the final analysis)
All-Cause Mortality: The ITT analysis set included all randomised patients. For serious adverse events and other (non-serious) adverse events: Safety population was defined as all patients who received at least 1 dose of randomised study medication. 2 patients in the Fulvestrant 500 mg arm did not receive treatment and were not included in the safety population.
|
0.43%
1/232 • Number of events 1 • 116 months (duration from first patient enrolled to data cut-off for the final analysis)
All-Cause Mortality: The ITT analysis set included all randomised patients. For serious adverse events and other (non-serious) adverse events: Safety population was defined as all patients who received at least 1 dose of randomised study medication. 2 patients in the Fulvestrant 500 mg arm did not receive treatment and were not included in the safety population.
|
|
Infections and infestations
Septic shock
|
0.44%
1/228 • Number of events 1 • 116 months (duration from first patient enrolled to data cut-off for the final analysis)
All-Cause Mortality: The ITT analysis set included all randomised patients. For serious adverse events and other (non-serious) adverse events: Safety population was defined as all patients who received at least 1 dose of randomised study medication. 2 patients in the Fulvestrant 500 mg arm did not receive treatment and were not included in the safety population.
|
0.00%
0/232 • 116 months (duration from first patient enrolled to data cut-off for the final analysis)
All-Cause Mortality: The ITT analysis set included all randomised patients. For serious adverse events and other (non-serious) adverse events: Safety population was defined as all patients who received at least 1 dose of randomised study medication. 2 patients in the Fulvestrant 500 mg arm did not receive treatment and were not included in the safety population.
|
|
Infections and infestations
Urinary tract infection
|
0.88%
2/228 • Number of events 2 • 116 months (duration from first patient enrolled to data cut-off for the final analysis)
All-Cause Mortality: The ITT analysis set included all randomised patients. For serious adverse events and other (non-serious) adverse events: Safety population was defined as all patients who received at least 1 dose of randomised study medication. 2 patients in the Fulvestrant 500 mg arm did not receive treatment and were not included in the safety population.
|
0.00%
0/232 • 116 months (duration from first patient enrolled to data cut-off for the final analysis)
All-Cause Mortality: The ITT analysis set included all randomised patients. For serious adverse events and other (non-serious) adverse events: Safety population was defined as all patients who received at least 1 dose of randomised study medication. 2 patients in the Fulvestrant 500 mg arm did not receive treatment and were not included in the safety population.
|
|
Cardiac disorders
Cardiac arrest
|
0.00%
0/228 • 116 months (duration from first patient enrolled to data cut-off for the final analysis)
All-Cause Mortality: The ITT analysis set included all randomised patients. For serious adverse events and other (non-serious) adverse events: Safety population was defined as all patients who received at least 1 dose of randomised study medication. 2 patients in the Fulvestrant 500 mg arm did not receive treatment and were not included in the safety population.
|
0.43%
1/232 • Number of events 1 • 116 months (duration from first patient enrolled to data cut-off for the final analysis)
All-Cause Mortality: The ITT analysis set included all randomised patients. For serious adverse events and other (non-serious) adverse events: Safety population was defined as all patients who received at least 1 dose of randomised study medication. 2 patients in the Fulvestrant 500 mg arm did not receive treatment and were not included in the safety population.
|
|
Injury, poisoning and procedural complications
Ankle fracture
|
0.00%
0/228 • 116 months (duration from first patient enrolled to data cut-off for the final analysis)
All-Cause Mortality: The ITT analysis set included all randomised patients. For serious adverse events and other (non-serious) adverse events: Safety population was defined as all patients who received at least 1 dose of randomised study medication. 2 patients in the Fulvestrant 500 mg arm did not receive treatment and were not included in the safety population.
|
0.43%
1/232 • Number of events 1 • 116 months (duration from first patient enrolled to data cut-off for the final analysis)
All-Cause Mortality: The ITT analysis set included all randomised patients. For serious adverse events and other (non-serious) adverse events: Safety population was defined as all patients who received at least 1 dose of randomised study medication. 2 patients in the Fulvestrant 500 mg arm did not receive treatment and were not included in the safety population.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/228 • 116 months (duration from first patient enrolled to data cut-off for the final analysis)
All-Cause Mortality: The ITT analysis set included all randomised patients. For serious adverse events and other (non-serious) adverse events: Safety population was defined as all patients who received at least 1 dose of randomised study medication. 2 patients in the Fulvestrant 500 mg arm did not receive treatment and were not included in the safety population.
|
0.43%
1/232 • Number of events 1 • 116 months (duration from first patient enrolled to data cut-off for the final analysis)
All-Cause Mortality: The ITT analysis set included all randomised patients. For serious adverse events and other (non-serious) adverse events: Safety population was defined as all patients who received at least 1 dose of randomised study medication. 2 patients in the Fulvestrant 500 mg arm did not receive treatment and were not included in the safety population.
|
|
Cardiac disorders
Cardiac failure
|
0.00%
0/228 • 116 months (duration from first patient enrolled to data cut-off for the final analysis)
All-Cause Mortality: The ITT analysis set included all randomised patients. For serious adverse events and other (non-serious) adverse events: Safety population was defined as all patients who received at least 1 dose of randomised study medication. 2 patients in the Fulvestrant 500 mg arm did not receive treatment and were not included in the safety population.
|
1.3%
3/232 • Number of events 3 • 116 months (duration from first patient enrolled to data cut-off for the final analysis)
All-Cause Mortality: The ITT analysis set included all randomised patients. For serious adverse events and other (non-serious) adverse events: Safety population was defined as all patients who received at least 1 dose of randomised study medication. 2 patients in the Fulvestrant 500 mg arm did not receive treatment and were not included in the safety population.
|
|
Injury, poisoning and procedural complications
Humerus fracture
|
0.44%
1/228 • Number of events 1 • 116 months (duration from first patient enrolled to data cut-off for the final analysis)
All-Cause Mortality: The ITT analysis set included all randomised patients. For serious adverse events and other (non-serious) adverse events: Safety population was defined as all patients who received at least 1 dose of randomised study medication. 2 patients in the Fulvestrant 500 mg arm did not receive treatment and were not included in the safety population.
|
0.00%
0/232 • 116 months (duration from first patient enrolled to data cut-off for the final analysis)
All-Cause Mortality: The ITT analysis set included all randomised patients. For serious adverse events and other (non-serious) adverse events: Safety population was defined as all patients who received at least 1 dose of randomised study medication. 2 patients in the Fulvestrant 500 mg arm did not receive treatment and were not included in the safety population.
|
|
Injury, poisoning and procedural complications
Radius fracture
|
0.88%
2/228 • Number of events 2 • 116 months (duration from first patient enrolled to data cut-off for the final analysis)
All-Cause Mortality: The ITT analysis set included all randomised patients. For serious adverse events and other (non-serious) adverse events: Safety population was defined as all patients who received at least 1 dose of randomised study medication. 2 patients in the Fulvestrant 500 mg arm did not receive treatment and were not included in the safety population.
|
0.00%
0/232 • 116 months (duration from first patient enrolled to data cut-off for the final analysis)
All-Cause Mortality: The ITT analysis set included all randomised patients. For serious adverse events and other (non-serious) adverse events: Safety population was defined as all patients who received at least 1 dose of randomised study medication. 2 patients in the Fulvestrant 500 mg arm did not receive treatment and were not included in the safety population.
|
|
Injury, poisoning and procedural complications
Subdural haematoma
|
0.44%
1/228 • Number of events 1 • 116 months (duration from first patient enrolled to data cut-off for the final analysis)
All-Cause Mortality: The ITT analysis set included all randomised patients. For serious adverse events and other (non-serious) adverse events: Safety population was defined as all patients who received at least 1 dose of randomised study medication. 2 patients in the Fulvestrant 500 mg arm did not receive treatment and were not included in the safety population.
|
0.00%
0/232 • 116 months (duration from first patient enrolled to data cut-off for the final analysis)
All-Cause Mortality: The ITT analysis set included all randomised patients. For serious adverse events and other (non-serious) adverse events: Safety population was defined as all patients who received at least 1 dose of randomised study medication. 2 patients in the Fulvestrant 500 mg arm did not receive treatment and were not included in the safety population.
|
|
Injury, poisoning and procedural complications
Traumatic spinal cord compression
|
0.44%
1/228 • Number of events 1 • 116 months (duration from first patient enrolled to data cut-off for the final analysis)
All-Cause Mortality: The ITT analysis set included all randomised patients. For serious adverse events and other (non-serious) adverse events: Safety population was defined as all patients who received at least 1 dose of randomised study medication. 2 patients in the Fulvestrant 500 mg arm did not receive treatment and were not included in the safety population.
|
0.00%
0/232 • 116 months (duration from first patient enrolled to data cut-off for the final analysis)
All-Cause Mortality: The ITT analysis set included all randomised patients. For serious adverse events and other (non-serious) adverse events: Safety population was defined as all patients who received at least 1 dose of randomised study medication. 2 patients in the Fulvestrant 500 mg arm did not receive treatment and were not included in the safety population.
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/228 • 116 months (duration from first patient enrolled to data cut-off for the final analysis)
All-Cause Mortality: The ITT analysis set included all randomised patients. For serious adverse events and other (non-serious) adverse events: Safety population was defined as all patients who received at least 1 dose of randomised study medication. 2 patients in the Fulvestrant 500 mg arm did not receive treatment and were not included in the safety population.
|
0.43%
1/232 • Number of events 1 • 116 months (duration from first patient enrolled to data cut-off for the final analysis)
All-Cause Mortality: The ITT analysis set included all randomised patients. For serious adverse events and other (non-serious) adverse events: Safety population was defined as all patients who received at least 1 dose of randomised study medication. 2 patients in the Fulvestrant 500 mg arm did not receive treatment and were not included in the safety population.
|
|
Investigations
Hepatic enzyme increased
|
0.00%
0/228 • 116 months (duration from first patient enrolled to data cut-off for the final analysis)
All-Cause Mortality: The ITT analysis set included all randomised patients. For serious adverse events and other (non-serious) adverse events: Safety population was defined as all patients who received at least 1 dose of randomised study medication. 2 patients in the Fulvestrant 500 mg arm did not receive treatment and were not included in the safety population.
|
0.43%
1/232 • Number of events 2 • 116 months (duration from first patient enrolled to data cut-off for the final analysis)
All-Cause Mortality: The ITT analysis set included all randomised patients. For serious adverse events and other (non-serious) adverse events: Safety population was defined as all patients who received at least 1 dose of randomised study medication. 2 patients in the Fulvestrant 500 mg arm did not receive treatment and were not included in the safety population.
|
|
Cardiac disorders
Cardio-respiratory arrest
|
0.00%
0/228 • 116 months (duration from first patient enrolled to data cut-off for the final analysis)
All-Cause Mortality: The ITT analysis set included all randomised patients. For serious adverse events and other (non-serious) adverse events: Safety population was defined as all patients who received at least 1 dose of randomised study medication. 2 patients in the Fulvestrant 500 mg arm did not receive treatment and were not included in the safety population.
|
0.43%
1/232 • Number of events 1 • 116 months (duration from first patient enrolled to data cut-off for the final analysis)
All-Cause Mortality: The ITT analysis set included all randomised patients. For serious adverse events and other (non-serious) adverse events: Safety population was defined as all patients who received at least 1 dose of randomised study medication. 2 patients in the Fulvestrant 500 mg arm did not receive treatment and were not included in the safety population.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/228 • 116 months (duration from first patient enrolled to data cut-off for the final analysis)
All-Cause Mortality: The ITT analysis set included all randomised patients. For serious adverse events and other (non-serious) adverse events: Safety population was defined as all patients who received at least 1 dose of randomised study medication. 2 patients in the Fulvestrant 500 mg arm did not receive treatment and were not included in the safety population.
|
0.86%
2/232 • Number of events 2 • 116 months (duration from first patient enrolled to data cut-off for the final analysis)
All-Cause Mortality: The ITT analysis set included all randomised patients. For serious adverse events and other (non-serious) adverse events: Safety population was defined as all patients who received at least 1 dose of randomised study medication. 2 patients in the Fulvestrant 500 mg arm did not receive treatment and were not included in the safety population.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Acoustic neuroma
|
0.00%
0/228 • 116 months (duration from first patient enrolled to data cut-off for the final analysis)
All-Cause Mortality: The ITT analysis set included all randomised patients. For serious adverse events and other (non-serious) adverse events: Safety population was defined as all patients who received at least 1 dose of randomised study medication. 2 patients in the Fulvestrant 500 mg arm did not receive treatment and were not included in the safety population.
|
0.43%
1/232 • Number of events 1 • 116 months (duration from first patient enrolled to data cut-off for the final analysis)
All-Cause Mortality: The ITT analysis set included all randomised patients. For serious adverse events and other (non-serious) adverse events: Safety population was defined as all patients who received at least 1 dose of randomised study medication. 2 patients in the Fulvestrant 500 mg arm did not receive treatment and were not included in the safety population.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenocarcinoma of colon
|
0.44%
1/228 • Number of events 1 • 116 months (duration from first patient enrolled to data cut-off for the final analysis)
All-Cause Mortality: The ITT analysis set included all randomised patients. For serious adverse events and other (non-serious) adverse events: Safety population was defined as all patients who received at least 1 dose of randomised study medication. 2 patients in the Fulvestrant 500 mg arm did not receive treatment and were not included in the safety population.
|
0.43%
1/232 • Number of events 1 • 116 months (duration from first patient enrolled to data cut-off for the final analysis)
All-Cause Mortality: The ITT analysis set included all randomised patients. For serious adverse events and other (non-serious) adverse events: Safety population was defined as all patients who received at least 1 dose of randomised study medication. 2 patients in the Fulvestrant 500 mg arm did not receive treatment and were not included in the safety population.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
0.00%
0/228 • 116 months (duration from first patient enrolled to data cut-off for the final analysis)
All-Cause Mortality: The ITT analysis set included all randomised patients. For serious adverse events and other (non-serious) adverse events: Safety population was defined as all patients who received at least 1 dose of randomised study medication. 2 patients in the Fulvestrant 500 mg arm did not receive treatment and were not included in the safety population.
|
0.43%
1/232 • Number of events 1 • 116 months (duration from first patient enrolled to data cut-off for the final analysis)
All-Cause Mortality: The ITT analysis set included all randomised patients. For serious adverse events and other (non-serious) adverse events: Safety population was defined as all patients who received at least 1 dose of randomised study medication. 2 patients in the Fulvestrant 500 mg arm did not receive treatment and were not included in the safety population.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer
|
0.44%
1/228 • Number of events 1 • 116 months (duration from first patient enrolled to data cut-off for the final analysis)
All-Cause Mortality: The ITT analysis set included all randomised patients. For serious adverse events and other (non-serious) adverse events: Safety population was defined as all patients who received at least 1 dose of randomised study medication. 2 patients in the Fulvestrant 500 mg arm did not receive treatment and were not included in the safety population.
|
1.3%
3/232 • Number of events 3 • 116 months (duration from first patient enrolled to data cut-off for the final analysis)
All-Cause Mortality: The ITT analysis set included all randomised patients. For serious adverse events and other (non-serious) adverse events: Safety population was defined as all patients who received at least 1 dose of randomised study medication. 2 patients in the Fulvestrant 500 mg arm did not receive treatment and were not included in the safety population.
|
|
Cardiac disorders
Palpitations
|
0.44%
1/228 • Number of events 1 • 116 months (duration from first patient enrolled to data cut-off for the final analysis)
All-Cause Mortality: The ITT analysis set included all randomised patients. For serious adverse events and other (non-serious) adverse events: Safety population was defined as all patients who received at least 1 dose of randomised study medication. 2 patients in the Fulvestrant 500 mg arm did not receive treatment and were not included in the safety population.
|
0.00%
0/232 • 116 months (duration from first patient enrolled to data cut-off for the final analysis)
All-Cause Mortality: The ITT analysis set included all randomised patients. For serious adverse events and other (non-serious) adverse events: Safety population was defined as all patients who received at least 1 dose of randomised study medication. 2 patients in the Fulvestrant 500 mg arm did not receive treatment and were not included in the safety population.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lymphoma
|
0.44%
1/228 • Number of events 1 • 116 months (duration from first patient enrolled to data cut-off for the final analysis)
All-Cause Mortality: The ITT analysis set included all randomised patients. For serious adverse events and other (non-serious) adverse events: Safety population was defined as all patients who received at least 1 dose of randomised study medication. 2 patients in the Fulvestrant 500 mg arm did not receive treatment and were not included in the safety population.
|
0.00%
0/232 • 116 months (duration from first patient enrolled to data cut-off for the final analysis)
All-Cause Mortality: The ITT analysis set included all randomised patients. For serious adverse events and other (non-serious) adverse events: Safety population was defined as all patients who received at least 1 dose of randomised study medication. 2 patients in the Fulvestrant 500 mg arm did not receive treatment and were not included in the safety population.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma of the oral cavity
|
0.44%
1/228 • Number of events 1 • 116 months (duration from first patient enrolled to data cut-off for the final analysis)
All-Cause Mortality: The ITT analysis set included all randomised patients. For serious adverse events and other (non-serious) adverse events: Safety population was defined as all patients who received at least 1 dose of randomised study medication. 2 patients in the Fulvestrant 500 mg arm did not receive treatment and were not included in the safety population.
|
0.00%
0/232 • 116 months (duration from first patient enrolled to data cut-off for the final analysis)
All-Cause Mortality: The ITT analysis set included all randomised patients. For serious adverse events and other (non-serious) adverse events: Safety population was defined as all patients who received at least 1 dose of randomised study medication. 2 patients in the Fulvestrant 500 mg arm did not receive treatment and were not included in the safety population.
|
|
Nervous system disorders
Brain oedema
|
0.44%
1/228 • Number of events 1 • 116 months (duration from first patient enrolled to data cut-off for the final analysis)
All-Cause Mortality: The ITT analysis set included all randomised patients. For serious adverse events and other (non-serious) adverse events: Safety population was defined as all patients who received at least 1 dose of randomised study medication. 2 patients in the Fulvestrant 500 mg arm did not receive treatment and were not included in the safety population.
|
0.00%
0/232 • 116 months (duration from first patient enrolled to data cut-off for the final analysis)
All-Cause Mortality: The ITT analysis set included all randomised patients. For serious adverse events and other (non-serious) adverse events: Safety population was defined as all patients who received at least 1 dose of randomised study medication. 2 patients in the Fulvestrant 500 mg arm did not receive treatment and were not included in the safety population.
|
|
Nervous system disorders
Cerebral haemorrhage
|
0.00%
0/228 • 116 months (duration from first patient enrolled to data cut-off for the final analysis)
All-Cause Mortality: The ITT analysis set included all randomised patients. For serious adverse events and other (non-serious) adverse events: Safety population was defined as all patients who received at least 1 dose of randomised study medication. 2 patients in the Fulvestrant 500 mg arm did not receive treatment and were not included in the safety population.
|
0.43%
1/232 • Number of events 1 • 116 months (duration from first patient enrolled to data cut-off for the final analysis)
All-Cause Mortality: The ITT analysis set included all randomised patients. For serious adverse events and other (non-serious) adverse events: Safety population was defined as all patients who received at least 1 dose of randomised study medication. 2 patients in the Fulvestrant 500 mg arm did not receive treatment and were not included in the safety population.
|
|
Nervous system disorders
Cerebral infarction
|
0.00%
0/228 • 116 months (duration from first patient enrolled to data cut-off for the final analysis)
All-Cause Mortality: The ITT analysis set included all randomised patients. For serious adverse events and other (non-serious) adverse events: Safety population was defined as all patients who received at least 1 dose of randomised study medication. 2 patients in the Fulvestrant 500 mg arm did not receive treatment and were not included in the safety population.
|
0.43%
1/232 • Number of events 1 • 116 months (duration from first patient enrolled to data cut-off for the final analysis)
All-Cause Mortality: The ITT analysis set included all randomised patients. For serious adverse events and other (non-serious) adverse events: Safety population was defined as all patients who received at least 1 dose of randomised study medication. 2 patients in the Fulvestrant 500 mg arm did not receive treatment and were not included in the safety population.
|
|
Nervous system disorders
Cerebrovascular accident
|
0.88%
2/228 • Number of events 2 • 116 months (duration from first patient enrolled to data cut-off for the final analysis)
All-Cause Mortality: The ITT analysis set included all randomised patients. For serious adverse events and other (non-serious) adverse events: Safety population was defined as all patients who received at least 1 dose of randomised study medication. 2 patients in the Fulvestrant 500 mg arm did not receive treatment and were not included in the safety population.
|
0.00%
0/232 • 116 months (duration from first patient enrolled to data cut-off for the final analysis)
All-Cause Mortality: The ITT analysis set included all randomised patients. For serious adverse events and other (non-serious) adverse events: Safety population was defined as all patients who received at least 1 dose of randomised study medication. 2 patients in the Fulvestrant 500 mg arm did not receive treatment and were not included in the safety population.
|
|
Nervous system disorders
Haemorrhagic stroke
|
0.44%
1/228 • Number of events 1 • 116 months (duration from first patient enrolled to data cut-off for the final analysis)
All-Cause Mortality: The ITT analysis set included all randomised patients. For serious adverse events and other (non-serious) adverse events: Safety population was defined as all patients who received at least 1 dose of randomised study medication. 2 patients in the Fulvestrant 500 mg arm did not receive treatment and were not included in the safety population.
|
0.00%
0/232 • 116 months (duration from first patient enrolled to data cut-off for the final analysis)
All-Cause Mortality: The ITT analysis set included all randomised patients. For serious adverse events and other (non-serious) adverse events: Safety population was defined as all patients who received at least 1 dose of randomised study medication. 2 patients in the Fulvestrant 500 mg arm did not receive treatment and were not included in the safety population.
|
|
Nervous system disorders
Transient ischaemic attack
|
0.44%
1/228 • Number of events 1 • 116 months (duration from first patient enrolled to data cut-off for the final analysis)
All-Cause Mortality: The ITT analysis set included all randomised patients. For serious adverse events and other (non-serious) adverse events: Safety population was defined as all patients who received at least 1 dose of randomised study medication. 2 patients in the Fulvestrant 500 mg arm did not receive treatment and were not included in the safety population.
|
0.00%
0/232 • 116 months (duration from first patient enrolled to data cut-off for the final analysis)
All-Cause Mortality: The ITT analysis set included all randomised patients. For serious adverse events and other (non-serious) adverse events: Safety population was defined as all patients who received at least 1 dose of randomised study medication. 2 patients in the Fulvestrant 500 mg arm did not receive treatment and were not included in the safety population.
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/228 • 116 months (duration from first patient enrolled to data cut-off for the final analysis)
All-Cause Mortality: The ITT analysis set included all randomised patients. For serious adverse events and other (non-serious) adverse events: Safety population was defined as all patients who received at least 1 dose of randomised study medication. 2 patients in the Fulvestrant 500 mg arm did not receive treatment and were not included in the safety population.
|
0.86%
2/232 • Number of events 2 • 116 months (duration from first patient enrolled to data cut-off for the final analysis)
All-Cause Mortality: The ITT analysis set included all randomised patients. For serious adverse events and other (non-serious) adverse events: Safety population was defined as all patients who received at least 1 dose of randomised study medication. 2 patients in the Fulvestrant 500 mg arm did not receive treatment and were not included in the safety population.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.00%
0/228 • 116 months (duration from first patient enrolled to data cut-off for the final analysis)
All-Cause Mortality: The ITT analysis set included all randomised patients. For serious adverse events and other (non-serious) adverse events: Safety population was defined as all patients who received at least 1 dose of randomised study medication. 2 patients in the Fulvestrant 500 mg arm did not receive treatment and were not included in the safety population.
|
0.43%
1/232 • Number of events 1 • 116 months (duration from first patient enrolled to data cut-off for the final analysis)
All-Cause Mortality: The ITT analysis set included all randomised patients. For serious adverse events and other (non-serious) adverse events: Safety population was defined as all patients who received at least 1 dose of randomised study medication. 2 patients in the Fulvestrant 500 mg arm did not receive treatment and were not included in the safety population.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.88%
2/228 • Number of events 2 • 116 months (duration from first patient enrolled to data cut-off for the final analysis)
All-Cause Mortality: The ITT analysis set included all randomised patients. For serious adverse events and other (non-serious) adverse events: Safety population was defined as all patients who received at least 1 dose of randomised study medication. 2 patients in the Fulvestrant 500 mg arm did not receive treatment and were not included in the safety population.
|
0.00%
0/232 • 116 months (duration from first patient enrolled to data cut-off for the final analysis)
All-Cause Mortality: The ITT analysis set included all randomised patients. For serious adverse events and other (non-serious) adverse events: Safety population was defined as all patients who received at least 1 dose of randomised study medication. 2 patients in the Fulvestrant 500 mg arm did not receive treatment and were not included in the safety population.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/228 • 116 months (duration from first patient enrolled to data cut-off for the final analysis)
All-Cause Mortality: The ITT analysis set included all randomised patients. For serious adverse events and other (non-serious) adverse events: Safety population was defined as all patients who received at least 1 dose of randomised study medication. 2 patients in the Fulvestrant 500 mg arm did not receive treatment and were not included in the safety population.
|
0.43%
1/232 • Number of events 1 • 116 months (duration from first patient enrolled to data cut-off for the final analysis)
All-Cause Mortality: The ITT analysis set included all randomised patients. For serious adverse events and other (non-serious) adverse events: Safety population was defined as all patients who received at least 1 dose of randomised study medication. 2 patients in the Fulvestrant 500 mg arm did not receive treatment and were not included in the safety population.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
3.1%
7/228 • Number of events 10 • 116 months (duration from first patient enrolled to data cut-off for the final analysis)
All-Cause Mortality: The ITT analysis set included all randomised patients. For serious adverse events and other (non-serious) adverse events: Safety population was defined as all patients who received at least 1 dose of randomised study medication. 2 patients in the Fulvestrant 500 mg arm did not receive treatment and were not included in the safety population.
|
0.86%
2/232 • Number of events 2 • 116 months (duration from first patient enrolled to data cut-off for the final analysis)
All-Cause Mortality: The ITT analysis set included all randomised patients. For serious adverse events and other (non-serious) adverse events: Safety population was defined as all patients who received at least 1 dose of randomised study medication. 2 patients in the Fulvestrant 500 mg arm did not receive treatment and were not included in the safety population.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
1.3%
3/228 • Number of events 4 • 116 months (duration from first patient enrolled to data cut-off for the final analysis)
All-Cause Mortality: The ITT analysis set included all randomised patients. For serious adverse events and other (non-serious) adverse events: Safety population was defined as all patients who received at least 1 dose of randomised study medication. 2 patients in the Fulvestrant 500 mg arm did not receive treatment and were not included in the safety population.
|
0.43%
1/232 • Number of events 1 • 116 months (duration from first patient enrolled to data cut-off for the final analysis)
All-Cause Mortality: The ITT analysis set included all randomised patients. For serious adverse events and other (non-serious) adverse events: Safety population was defined as all patients who received at least 1 dose of randomised study medication. 2 patients in the Fulvestrant 500 mg arm did not receive treatment and were not included in the safety population.
|
|
Vascular disorders
Circulatory collapse
|
0.00%
0/228 • 116 months (duration from first patient enrolled to data cut-off for the final analysis)
All-Cause Mortality: The ITT analysis set included all randomised patients. For serious adverse events and other (non-serious) adverse events: Safety population was defined as all patients who received at least 1 dose of randomised study medication. 2 patients in the Fulvestrant 500 mg arm did not receive treatment and were not included in the safety population.
|
0.43%
1/232 • Number of events 1 • 116 months (duration from first patient enrolled to data cut-off for the final analysis)
All-Cause Mortality: The ITT analysis set included all randomised patients. For serious adverse events and other (non-serious) adverse events: Safety population was defined as all patients who received at least 1 dose of randomised study medication. 2 patients in the Fulvestrant 500 mg arm did not receive treatment and were not included in the safety population.
|
|
Vascular disorders
Deep vein thrombosis
|
0.00%
0/228 • 116 months (duration from first patient enrolled to data cut-off for the final analysis)
All-Cause Mortality: The ITT analysis set included all randomised patients. For serious adverse events and other (non-serious) adverse events: Safety population was defined as all patients who received at least 1 dose of randomised study medication. 2 patients in the Fulvestrant 500 mg arm did not receive treatment and were not included in the safety population.
|
0.86%
2/232 • Number of events 2 • 116 months (duration from first patient enrolled to data cut-off for the final analysis)
All-Cause Mortality: The ITT analysis set included all randomised patients. For serious adverse events and other (non-serious) adverse events: Safety population was defined as all patients who received at least 1 dose of randomised study medication. 2 patients in the Fulvestrant 500 mg arm did not receive treatment and were not included in the safety population.
|
|
Vascular disorders
Hypertensive crisis
|
0.88%
2/228 • Number of events 2 • 116 months (duration from first patient enrolled to data cut-off for the final analysis)
All-Cause Mortality: The ITT analysis set included all randomised patients. For serious adverse events and other (non-serious) adverse events: Safety population was defined as all patients who received at least 1 dose of randomised study medication. 2 patients in the Fulvestrant 500 mg arm did not receive treatment and were not included in the safety population.
|
0.00%
0/232 • 116 months (duration from first patient enrolled to data cut-off for the final analysis)
All-Cause Mortality: The ITT analysis set included all randomised patients. For serious adverse events and other (non-serious) adverse events: Safety population was defined as all patients who received at least 1 dose of randomised study medication. 2 patients in the Fulvestrant 500 mg arm did not receive treatment and were not included in the safety population.
|
|
Gastrointestinal disorders
Duodenal stenosis
|
0.44%
1/228 • Number of events 1 • 116 months (duration from first patient enrolled to data cut-off for the final analysis)
All-Cause Mortality: The ITT analysis set included all randomised patients. For serious adverse events and other (non-serious) adverse events: Safety population was defined as all patients who received at least 1 dose of randomised study medication. 2 patients in the Fulvestrant 500 mg arm did not receive treatment and were not included in the safety population.
|
0.00%
0/232 • 116 months (duration from first patient enrolled to data cut-off for the final analysis)
All-Cause Mortality: The ITT analysis set included all randomised patients. For serious adverse events and other (non-serious) adverse events: Safety population was defined as all patients who received at least 1 dose of randomised study medication. 2 patients in the Fulvestrant 500 mg arm did not receive treatment and were not included in the safety population.
|
|
Gastrointestinal disorders
Gastric ulcer haemorrhage
|
0.00%
0/228 • 116 months (duration from first patient enrolled to data cut-off for the final analysis)
All-Cause Mortality: The ITT analysis set included all randomised patients. For serious adverse events and other (non-serious) adverse events: Safety population was defined as all patients who received at least 1 dose of randomised study medication. 2 patients in the Fulvestrant 500 mg arm did not receive treatment and were not included in the safety population.
|
0.43%
1/232 • Number of events 1 • 116 months (duration from first patient enrolled to data cut-off for the final analysis)
All-Cause Mortality: The ITT analysis set included all randomised patients. For serious adverse events and other (non-serious) adverse events: Safety population was defined as all patients who received at least 1 dose of randomised study medication. 2 patients in the Fulvestrant 500 mg arm did not receive treatment and were not included in the safety population.
|
|
Gastrointestinal disorders
Large intestine perforation
|
0.44%
1/228 • Number of events 1 • 116 months (duration from first patient enrolled to data cut-off for the final analysis)
All-Cause Mortality: The ITT analysis set included all randomised patients. For serious adverse events and other (non-serious) adverse events: Safety population was defined as all patients who received at least 1 dose of randomised study medication. 2 patients in the Fulvestrant 500 mg arm did not receive treatment and were not included in the safety population.
|
0.00%
0/232 • 116 months (duration from first patient enrolled to data cut-off for the final analysis)
All-Cause Mortality: The ITT analysis set included all randomised patients. For serious adverse events and other (non-serious) adverse events: Safety population was defined as all patients who received at least 1 dose of randomised study medication. 2 patients in the Fulvestrant 500 mg arm did not receive treatment and were not included in the safety population.
|
|
Gastrointestinal disorders
Oesophageal dilatation
|
0.00%
0/228 • 116 months (duration from first patient enrolled to data cut-off for the final analysis)
All-Cause Mortality: The ITT analysis set included all randomised patients. For serious adverse events and other (non-serious) adverse events: Safety population was defined as all patients who received at least 1 dose of randomised study medication. 2 patients in the Fulvestrant 500 mg arm did not receive treatment and were not included in the safety population.
|
0.43%
1/232 • Number of events 1 • 116 months (duration from first patient enrolled to data cut-off for the final analysis)
All-Cause Mortality: The ITT analysis set included all randomised patients. For serious adverse events and other (non-serious) adverse events: Safety population was defined as all patients who received at least 1 dose of randomised study medication. 2 patients in the Fulvestrant 500 mg arm did not receive treatment and were not included in the safety population.
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.44%
1/228 • Number of events 2 • 116 months (duration from first patient enrolled to data cut-off for the final analysis)
All-Cause Mortality: The ITT analysis set included all randomised patients. For serious adverse events and other (non-serious) adverse events: Safety population was defined as all patients who received at least 1 dose of randomised study medication. 2 patients in the Fulvestrant 500 mg arm did not receive treatment and were not included in the safety population.
|
0.00%
0/232 • 116 months (duration from first patient enrolled to data cut-off for the final analysis)
All-Cause Mortality: The ITT analysis set included all randomised patients. For serious adverse events and other (non-serious) adverse events: Safety population was defined as all patients who received at least 1 dose of randomised study medication. 2 patients in the Fulvestrant 500 mg arm did not receive treatment and were not included in the safety population.
|
Other adverse events
| Measure |
Fulvestrant 500 mg
n=228 participants at risk
Patients received fulvestrant (Faslodex™) 500 mg, administered as two 5 mL intramuscular injections, 1 in each buttock, at each visit on Days 0, 14 (±3), 28 (±3) and every 28 (±3) days thereafter. In order to support the double-blind, double-dummy design of the trial, each patient randomised to receive fulvestrant, also received placebo to match the anastrozole schedule (tablets, once daily).
|
Anastrozole 1 mg
n=232 participants at risk
Patients received anastrozole (Arimidex™), administered orally as a single tablet at a dose of 1 mg/day from randomisation on Day 0 and once daily thereafter. In order to support the double-blind, double-dummy design of the trial, each patient randomised to receive anastrozole also received placebo to match the fulvestrant schedule (injections on Days 0, 14 \[±3\], 28 \[±3\] and every 28 \[±3\] days thereafter).
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
3.9%
9/228 • Number of events 10 • 116 months (duration from first patient enrolled to data cut-off for the final analysis)
All-Cause Mortality: The ITT analysis set included all randomised patients. For serious adverse events and other (non-serious) adverse events: Safety population was defined as all patients who received at least 1 dose of randomised study medication. 2 patients in the Fulvestrant 500 mg arm did not receive treatment and were not included in the safety population.
|
8.6%
20/232 • Number of events 21 • 116 months (duration from first patient enrolled to data cut-off for the final analysis)
All-Cause Mortality: The ITT analysis set included all randomised patients. For serious adverse events and other (non-serious) adverse events: Safety population was defined as all patients who received at least 1 dose of randomised study medication. 2 patients in the Fulvestrant 500 mg arm did not receive treatment and were not included in the safety population.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
5.3%
12/228 • Number of events 15 • 116 months (duration from first patient enrolled to data cut-off for the final analysis)
All-Cause Mortality: The ITT analysis set included all randomised patients. For serious adverse events and other (non-serious) adverse events: Safety population was defined as all patients who received at least 1 dose of randomised study medication. 2 patients in the Fulvestrant 500 mg arm did not receive treatment and were not included in the safety population.
|
3.9%
9/232 • Number of events 12 • 116 months (duration from first patient enrolled to data cut-off for the final analysis)
All-Cause Mortality: The ITT analysis set included all randomised patients. For serious adverse events and other (non-serious) adverse events: Safety population was defined as all patients who received at least 1 dose of randomised study medication. 2 patients in the Fulvestrant 500 mg arm did not receive treatment and were not included in the safety population.
|
|
General disorders
Fatigue
|
12.7%
29/228 • Number of events 35 • 116 months (duration from first patient enrolled to data cut-off for the final analysis)
All-Cause Mortality: The ITT analysis set included all randomised patients. For serious adverse events and other (non-serious) adverse events: Safety population was defined as all patients who received at least 1 dose of randomised study medication. 2 patients in the Fulvestrant 500 mg arm did not receive treatment and were not included in the safety population.
|
7.8%
18/232 • Number of events 20 • 116 months (duration from first patient enrolled to data cut-off for the final analysis)
All-Cause Mortality: The ITT analysis set included all randomised patients. For serious adverse events and other (non-serious) adverse events: Safety population was defined as all patients who received at least 1 dose of randomised study medication. 2 patients in the Fulvestrant 500 mg arm did not receive treatment and were not included in the safety population.
|
|
General disorders
Injection site pain
|
5.3%
12/228 • Number of events 15 • 116 months (duration from first patient enrolled to data cut-off for the final analysis)
All-Cause Mortality: The ITT analysis set included all randomised patients. For serious adverse events and other (non-serious) adverse events: Safety population was defined as all patients who received at least 1 dose of randomised study medication. 2 patients in the Fulvestrant 500 mg arm did not receive treatment and were not included in the safety population.
|
4.3%
10/232 • Number of events 23 • 116 months (duration from first patient enrolled to data cut-off for the final analysis)
All-Cause Mortality: The ITT analysis set included all randomised patients. For serious adverse events and other (non-serious) adverse events: Safety population was defined as all patients who received at least 1 dose of randomised study medication. 2 patients in the Fulvestrant 500 mg arm did not receive treatment and were not included in the safety population.
|
|
General disorders
Oedema peripheral
|
4.8%
11/228 • Number of events 11 • 116 months (duration from first patient enrolled to data cut-off for the final analysis)
All-Cause Mortality: The ITT analysis set included all randomised patients. For serious adverse events and other (non-serious) adverse events: Safety population was defined as all patients who received at least 1 dose of randomised study medication. 2 patients in the Fulvestrant 500 mg arm did not receive treatment and were not included in the safety population.
|
6.0%
14/232 • Number of events 15 • 116 months (duration from first patient enrolled to data cut-off for the final analysis)
All-Cause Mortality: The ITT analysis set included all randomised patients. For serious adverse events and other (non-serious) adverse events: Safety population was defined as all patients who received at least 1 dose of randomised study medication. 2 patients in the Fulvestrant 500 mg arm did not receive treatment and were not included in the safety population.
|
|
Investigations
Alanine aminotransferase increased
|
7.0%
16/228 • Number of events 18 • 116 months (duration from first patient enrolled to data cut-off for the final analysis)
All-Cause Mortality: The ITT analysis set included all randomised patients. For serious adverse events and other (non-serious) adverse events: Safety population was defined as all patients who received at least 1 dose of randomised study medication. 2 patients in the Fulvestrant 500 mg arm did not receive treatment and were not included in the safety population.
|
3.4%
8/232 • Number of events 8 • 116 months (duration from first patient enrolled to data cut-off for the final analysis)
All-Cause Mortality: The ITT analysis set included all randomised patients. For serious adverse events and other (non-serious) adverse events: Safety population was defined as all patients who received at least 1 dose of randomised study medication. 2 patients in the Fulvestrant 500 mg arm did not receive treatment and were not included in the safety population.
|
|
Investigations
Aspartate aminotransferase increased
|
5.3%
12/228 • Number of events 13 • 116 months (duration from first patient enrolled to data cut-off for the final analysis)
All-Cause Mortality: The ITT analysis set included all randomised patients. For serious adverse events and other (non-serious) adverse events: Safety population was defined as all patients who received at least 1 dose of randomised study medication. 2 patients in the Fulvestrant 500 mg arm did not receive treatment and were not included in the safety population.
|
3.9%
9/232 • Number of events 9 • 116 months (duration from first patient enrolled to data cut-off for the final analysis)
All-Cause Mortality: The ITT analysis set included all randomised patients. For serious adverse events and other (non-serious) adverse events: Safety population was defined as all patients who received at least 1 dose of randomised study medication. 2 patients in the Fulvestrant 500 mg arm did not receive treatment and were not included in the safety population.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
18.4%
42/228 • Number of events 65 • 116 months (duration from first patient enrolled to data cut-off for the final analysis)
All-Cause Mortality: The ITT analysis set included all randomised patients. For serious adverse events and other (non-serious) adverse events: Safety population was defined as all patients who received at least 1 dose of randomised study medication. 2 patients in the Fulvestrant 500 mg arm did not receive treatment and were not included in the safety population.
|
13.4%
31/232 • Number of events 40 • 116 months (duration from first patient enrolled to data cut-off for the final analysis)
All-Cause Mortality: The ITT analysis set included all randomised patients. For serious adverse events and other (non-serious) adverse events: Safety population was defined as all patients who received at least 1 dose of randomised study medication. 2 patients in the Fulvestrant 500 mg arm did not receive treatment and were not included in the safety population.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
9.6%
22/228 • Number of events 25 • 116 months (duration from first patient enrolled to data cut-off for the final analysis)
All-Cause Mortality: The ITT analysis set included all randomised patients. For serious adverse events and other (non-serious) adverse events: Safety population was defined as all patients who received at least 1 dose of randomised study medication. 2 patients in the Fulvestrant 500 mg arm did not receive treatment and were not included in the safety population.
|
7.8%
18/232 • Number of events 19 • 116 months (duration from first patient enrolled to data cut-off for the final analysis)
All-Cause Mortality: The ITT analysis set included all randomised patients. For serious adverse events and other (non-serious) adverse events: Safety population was defined as all patients who received at least 1 dose of randomised study medication. 2 patients in the Fulvestrant 500 mg arm did not receive treatment and were not included in the safety population.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
7.0%
16/228 • Number of events 19 • 116 months (duration from first patient enrolled to data cut-off for the final analysis)
All-Cause Mortality: The ITT analysis set included all randomised patients. For serious adverse events and other (non-serious) adverse events: Safety population was defined as all patients who received at least 1 dose of randomised study medication. 2 patients in the Fulvestrant 500 mg arm did not receive treatment and were not included in the safety population.
|
3.4%
8/232 • Number of events 11 • 116 months (duration from first patient enrolled to data cut-off for the final analysis)
All-Cause Mortality: The ITT analysis set included all randomised patients. For serious adverse events and other (non-serious) adverse events: Safety population was defined as all patients who received at least 1 dose of randomised study medication. 2 patients in the Fulvestrant 500 mg arm did not receive treatment and were not included in the safety population.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
7.5%
17/228 • Number of events 22 • 116 months (duration from first patient enrolled to data cut-off for the final analysis)
All-Cause Mortality: The ITT analysis set included all randomised patients. For serious adverse events and other (non-serious) adverse events: Safety population was defined as all patients who received at least 1 dose of randomised study medication. 2 patients in the Fulvestrant 500 mg arm did not receive treatment and were not included in the safety population.
|
4.7%
11/232 • Number of events 15 • 116 months (duration from first patient enrolled to data cut-off for the final analysis)
All-Cause Mortality: The ITT analysis set included all randomised patients. For serious adverse events and other (non-serious) adverse events: Safety population was defined as all patients who received at least 1 dose of randomised study medication. 2 patients in the Fulvestrant 500 mg arm did not receive treatment and were not included in the safety population.
|
|
Nervous system disorders
Headache
|
5.3%
12/228 • Number of events 13 • 116 months (duration from first patient enrolled to data cut-off for the final analysis)
All-Cause Mortality: The ITT analysis set included all randomised patients. For serious adverse events and other (non-serious) adverse events: Safety population was defined as all patients who received at least 1 dose of randomised study medication. 2 patients in the Fulvestrant 500 mg arm did not receive treatment and were not included in the safety population.
|
5.2%
12/232 • Number of events 12 • 116 months (duration from first patient enrolled to data cut-off for the final analysis)
All-Cause Mortality: The ITT analysis set included all randomised patients. For serious adverse events and other (non-serious) adverse events: Safety population was defined as all patients who received at least 1 dose of randomised study medication. 2 patients in the Fulvestrant 500 mg arm did not receive treatment and were not included in the safety population.
|
|
Psychiatric disorders
Anxiety
|
5.3%
12/228 • Number of events 13 • 116 months (duration from first patient enrolled to data cut-off for the final analysis)
All-Cause Mortality: The ITT analysis set included all randomised patients. For serious adverse events and other (non-serious) adverse events: Safety population was defined as all patients who received at least 1 dose of randomised study medication. 2 patients in the Fulvestrant 500 mg arm did not receive treatment and were not included in the safety population.
|
1.7%
4/232 • Number of events 4 • 116 months (duration from first patient enrolled to data cut-off for the final analysis)
All-Cause Mortality: The ITT analysis set included all randomised patients. For serious adverse events and other (non-serious) adverse events: Safety population was defined as all patients who received at least 1 dose of randomised study medication. 2 patients in the Fulvestrant 500 mg arm did not receive treatment and were not included in the safety population.
|
|
Psychiatric disorders
Insomnia
|
7.9%
18/228 • Number of events 19 • 116 months (duration from first patient enrolled to data cut-off for the final analysis)
All-Cause Mortality: The ITT analysis set included all randomised patients. For serious adverse events and other (non-serious) adverse events: Safety population was defined as all patients who received at least 1 dose of randomised study medication. 2 patients in the Fulvestrant 500 mg arm did not receive treatment and were not included in the safety population.
|
6.5%
15/232 • Number of events 16 • 116 months (duration from first patient enrolled to data cut-off for the final analysis)
All-Cause Mortality: The ITT analysis set included all randomised patients. For serious adverse events and other (non-serious) adverse events: Safety population was defined as all patients who received at least 1 dose of randomised study medication. 2 patients in the Fulvestrant 500 mg arm did not receive treatment and were not included in the safety population.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
4.4%
10/228 • Number of events 10 • 116 months (duration from first patient enrolled to data cut-off for the final analysis)
All-Cause Mortality: The ITT analysis set included all randomised patients. For serious adverse events and other (non-serious) adverse events: Safety population was defined as all patients who received at least 1 dose of randomised study medication. 2 patients in the Fulvestrant 500 mg arm did not receive treatment and were not included in the safety population.
|
6.5%
15/232 • Number of events 17 • 116 months (duration from first patient enrolled to data cut-off for the final analysis)
All-Cause Mortality: The ITT analysis set included all randomised patients. For serious adverse events and other (non-serious) adverse events: Safety population was defined as all patients who received at least 1 dose of randomised study medication. 2 patients in the Fulvestrant 500 mg arm did not receive treatment and were not included in the safety population.
|
|
Vascular disorders
Hot flush
|
11.4%
26/228 • Number of events 35 • 116 months (duration from first patient enrolled to data cut-off for the final analysis)
All-Cause Mortality: The ITT analysis set included all randomised patients. For serious adverse events and other (non-serious) adverse events: Safety population was defined as all patients who received at least 1 dose of randomised study medication. 2 patients in the Fulvestrant 500 mg arm did not receive treatment and were not included in the safety population.
|
10.3%
24/232 • Number of events 32 • 116 months (duration from first patient enrolled to data cut-off for the final analysis)
All-Cause Mortality: The ITT analysis set included all randomised patients. For serious adverse events and other (non-serious) adverse events: Safety population was defined as all patients who received at least 1 dose of randomised study medication. 2 patients in the Fulvestrant 500 mg arm did not receive treatment and were not included in the safety population.
|
|
Vascular disorders
Hypertension
|
7.9%
18/228 • Number of events 19 • 116 months (duration from first patient enrolled to data cut-off for the final analysis)
All-Cause Mortality: The ITT analysis set included all randomised patients. For serious adverse events and other (non-serious) adverse events: Safety population was defined as all patients who received at least 1 dose of randomised study medication. 2 patients in the Fulvestrant 500 mg arm did not receive treatment and were not included in the safety population.
|
9.5%
22/232 • Number of events 25 • 116 months (duration from first patient enrolled to data cut-off for the final analysis)
All-Cause Mortality: The ITT analysis set included all randomised patients. For serious adverse events and other (non-serious) adverse events: Safety population was defined as all patients who received at least 1 dose of randomised study medication. 2 patients in the Fulvestrant 500 mg arm did not receive treatment and were not included in the safety population.
|
|
Gastrointestinal disorders
Constipation
|
7.0%
16/228 • Number of events 16 • 116 months (duration from first patient enrolled to data cut-off for the final analysis)
All-Cause Mortality: The ITT analysis set included all randomised patients. For serious adverse events and other (non-serious) adverse events: Safety population was defined as all patients who received at least 1 dose of randomised study medication. 2 patients in the Fulvestrant 500 mg arm did not receive treatment and were not included in the safety population.
|
4.7%
11/232 • Number of events 13 • 116 months (duration from first patient enrolled to data cut-off for the final analysis)
All-Cause Mortality: The ITT analysis set included all randomised patients. For serious adverse events and other (non-serious) adverse events: Safety population was defined as all patients who received at least 1 dose of randomised study medication. 2 patients in the Fulvestrant 500 mg arm did not receive treatment and were not included in the safety population.
|
|
Gastrointestinal disorders
Diarrhoea
|
6.6%
15/228 • Number of events 20 • 116 months (duration from first patient enrolled to data cut-off for the final analysis)
All-Cause Mortality: The ITT analysis set included all randomised patients. For serious adverse events and other (non-serious) adverse events: Safety population was defined as all patients who received at least 1 dose of randomised study medication. 2 patients in the Fulvestrant 500 mg arm did not receive treatment and were not included in the safety population.
|
6.5%
15/232 • Number of events 17 • 116 months (duration from first patient enrolled to data cut-off for the final analysis)
All-Cause Mortality: The ITT analysis set included all randomised patients. For serious adverse events and other (non-serious) adverse events: Safety population was defined as all patients who received at least 1 dose of randomised study medication. 2 patients in the Fulvestrant 500 mg arm did not receive treatment and were not included in the safety population.
|
|
Gastrointestinal disorders
Nausea
|
11.0%
25/228 • Number of events 29 • 116 months (duration from first patient enrolled to data cut-off for the final analysis)
All-Cause Mortality: The ITT analysis set included all randomised patients. For serious adverse events and other (non-serious) adverse events: Safety population was defined as all patients who received at least 1 dose of randomised study medication. 2 patients in the Fulvestrant 500 mg arm did not receive treatment and were not included in the safety population.
|
10.8%
25/232 • Number of events 27 • 116 months (duration from first patient enrolled to data cut-off for the final analysis)
All-Cause Mortality: The ITT analysis set included all randomised patients. For serious adverse events and other (non-serious) adverse events: Safety population was defined as all patients who received at least 1 dose of randomised study medication. 2 patients in the Fulvestrant 500 mg arm did not receive treatment and were not included in the safety population.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place