Trial Outcomes & Findings for BI 860585 Dose Escalation Single Agent and in Combination With Exemestane or With Paclitaxel in Patients With Various Advanced and/or Metastatic Solid Tumors (NCT NCT01938846)
NCT ID: NCT01938846
Last Updated: 2019-01-04
Results Overview
The number of patients with Dose-Limiting Toxicities (DLTs) in the first course of each treatment arm to identify the Maximum Tolerated Dose (MTD) for BI 860585 monotherapy and BI 860585 in combination with exemestane of paclitaxel.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
90 participants
Primary outcome timeframe
28 days (Maximum tolerated dose (MTD) evaluation period (First Treatment Cycle))
Results posted on
2019-01-04
Participant Flow
An open-label, Phase I, dose-finding study of BI 860585, a total of 90 patients received at least one dose of study medication.
All patients were screened for eligibility to participate in the trial. Patients attended specialist sites which would then ensure that all patients met all inclusion/exclusion criteria. Patients were not to be entered to trial treatment if any one of the specific entry criteria were not met.
Participant milestones
| Measure |
BI 860585 Monotherapy
Patients were administered with BI 860585 daily oral dose of 5 milligram starting dose) over 28-day treatment courses
|
BI 860585 + Exemestane
Patients were administered with daily oral dose of BI 860585 in combination with 25 milligram/day standard fixed dose of Exemestane over 28-day treatment courses
|
BI 860585 + Paclitaxel
Patients were administered with BI 860585 in combination with Paclitaxel weekly intravenous infusion of 60 milligram/meter\^2 for the first dose level/treatment cohort and 80 milligram/meter\^2 (the standard combination dose) for subsequent dose levels/treatment cohorts over 28-day treatment courses
|
|---|---|---|---|
|
Overall Study
STARTED
|
41
|
25
|
24
|
|
Overall Study
COMPLETED
|
0
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
41
|
25
|
24
|
Reasons for withdrawal
| Measure |
BI 860585 Monotherapy
Patients were administered with BI 860585 daily oral dose of 5 milligram starting dose) over 28-day treatment courses
|
BI 860585 + Exemestane
Patients were administered with daily oral dose of BI 860585 in combination with 25 milligram/day standard fixed dose of Exemestane over 28-day treatment courses
|
BI 860585 + Paclitaxel
Patients were administered with BI 860585 in combination with Paclitaxel weekly intravenous infusion of 60 milligram/meter\^2 for the first dose level/treatment cohort and 80 milligram/meter\^2 (the standard combination dose) for subsequent dose levels/treatment cohorts over 28-day treatment courses
|
|---|---|---|---|
|
Overall Study
Progressive disease
|
26
|
18
|
16
|
|
Overall Study
Adverse Event
|
8
|
4
|
3
|
|
Overall Study
Withdrawal by Subject
|
2
|
2
|
1
|
|
Overall Study
Other than listed
|
5
|
1
|
4
|
Baseline Characteristics
TS
Baseline characteristics by cohort
| Measure |
BI 860585 Monotherapy
n=41 Participants
Patients were administered with BI 860585 daily oral dose of 5 milligram starting dose) over 28-day treatment courses
|
BI 860585 + Exemestane
n=25 Participants
Patients were administered with daily oral dose of BI 860585 in combination with 25 milligram/day standard fixed dose of Exemestane over 28-day treatment courses
|
BI 860585 + Paclitaxel
n=24 Participants
Patients were administered with BI 860585 in combination with Paclitaxel weekly intravenous infusion of 60 milligram/meter\^2 for the first dose level/treatment cohort and 80 milligram/meter\^2 (the standard combination dose) for subsequent dose levels/treatment cohorts over 28-day treatment courses
|
Total
n=90 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
58.4 Years
STANDARD_DEVIATION 13.8 • n=5 Participants • TS
|
58.3 Years
STANDARD_DEVIATION 9.5 • n=7 Participants • TS
|
58.5 Years
STANDARD_DEVIATION 10.2 • n=5 Participants • TS
|
58.4 Years
STANDARD_DEVIATION 11.7 • n=4 Participants • TS
|
|
Sex: Female, Male
Female
|
13 Participants
n=5 Participants • TS
|
23 Participants
n=7 Participants • TS
|
12 Participants
n=5 Participants • TS
|
48 Participants
n=4 Participants • TS
|
|
Sex: Female, Male
Male
|
28 Participants
n=5 Participants • TS
|
2 Participants
n=7 Participants • TS
|
12 Participants
n=5 Participants • TS
|
42 Participants
n=4 Participants • TS
|
PRIMARY outcome
Timeframe: 28 days (Maximum tolerated dose (MTD) evaluation period (First Treatment Cycle))Population: Treated and Evaluable Set: The treated and evaluable set includes all patients who were administered at least one dose of study medication and who are evaluable with respect to DLT in the MTD evaluation period.
The number of patients with Dose-Limiting Toxicities (DLTs) in the first course of each treatment arm to identify the Maximum Tolerated Dose (MTD) for BI 860585 monotherapy and BI 860585 in combination with exemestane of paclitaxel.
Outcome measures
| Measure |
BI 860585 Monotherapy
n=36 Participants
Patients were administered with BI 860585 daily oral dose of 5 milligram starting dose) over 28-day treatment courses
|
BI 860585 + Exemestane
n=21 Participants
Patients were administered with daily oral dose of BI 860585 in combination with 25 milligram/day standard fixed dose of Exemestane over 28-day treatment courses
|
BI 860585 + Paclitaxel
n=18 Participants
Patients were administered with BI 860585 in combination with Paclitaxel weekly intravenous infusion of 60 milligram/meter\^2 for the first dose level/treatment cohort and 80 milligram/meter\^2 (the standard combination dose) for subsequent dose levels/treatment cohorts over 28-day treatment courses
|
40 mg BI 860585
Continuous daily oral dose of 40 milligram/day over 28-days treatment courses of BI 860585 Monotherapy
|
80 mg BI 860585
Continuous daily oral dose of 80 milligram/day over 28-days treatment courses of BI 860585 Monotherapy
|
120 mg BI 860585
Continuous daily oral dose of 120 milligram/day over 28-days treatment courses of BI 860585 Monotherapy
|
160 mg BI 860585
Continuous daily oral dose of 160 milligram/day over 28-days treatment courses of BI 860585 Monotherapy
|
220 mg BI 860585
Continuous daily oral dose of 220 milligram/day over 28-days treatment courses of BI 860585 Monotherapy
|
300 mg BI 860585
Continuous daily oral dose of 300 milligram/day over 28-days treatment courses of BI 860585 Monotherapy
|
40 mg BI 860585+25 mg Exemestane
Continuous daily oral dose of 25 mg/day standard fixed dose of exemestane over 28-day treatment courses combination with 40 mg BI 860585
|
80 mg BI 860585+25 mg Exemestane
Continuous daily oral dose of 25 mg/day standard fixed dose of exemestane over 28-day treatment courses combination with 80 mg BI 860585
|
120 mg BI 860585+25 mg Exemestane
Continuous daily oral dose of 25 mg/day standard fixed dose of exemestane over 28-day treatment courses combination with 120 mg BI 860585
|
160 mg BI 860585+25 mg Exemestane
Continuous daily oral dose of 25 mg/day standard fixed dose of exemestane over 28-day treatment courses combination with 160 mg BI 860585
|
80 mg BI 860585+60 mg/m^2 Paclitaxel
Patients were administered with 80 mg BI 860585 in combination with weekly intravenous infusion of 60 mg/m\^2 the standard combination dose of paclitaxel for the first dose level/treatment for subsequent dose levels/treatment cohorts over 28-day treatment courses
|
80 mg BI 860585+80 mg/m^2 Paclitaxel
Patients were administered with 80 mg BI 860585 in combination with weekly intravenous infusion of 80 mg/m\^2 the standard combination dose of paclitaxel for the first dose level/treatment for subsequent dose levels/treatment cohorts over 28-day treatment courses
|
120 mg BI 860585+80 mg/m^2 Paclitaxel
Patients were administered with 120 mg BI 860585 in combination with weekly intravenous infusion of 80 mg/m\^2 the standard combination dose of paclitaxel for the first dose level/treatment for subsequent dose levels/treatment cohorts over 28-day treatment courses
|
160 mg BI 860585+80 mg/m^2 Paclita
Continuous daily oral dose of 160 mg BI 860585 in combination with once weekly iv infusion of 80 mg/m\^2 paclitaxel
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
The Number of Patients With Dose-Limiting Toxicities (DLTs) in the First Course of Each Treatment Arm
Total with dose limiting toxicities
|
4 Participants
|
4 Participants
|
2 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: 28 days (Maximum tolerated dose (MTD) evaluation period (First Treatment Cycle))Population: Treated and Evaluable Set: The treated and evaluable set includes all patients who were administered at least one dose of study medication and who are evaluable with respect to DLT in the MTD evaluation period.
The Maximum Tolerated Dose (MTD) for each treatment arm was the dose that was 1 dose cohort below that at which ≥2 of 6 patients had experienced DLT. i.e., the MTD was the highest dose studied for which the DLT incidence was no more than 17% (i.e. 1 of 6 patients) during the first treatment course.
Outcome measures
| Measure |
BI 860585 Monotherapy
n=36 Participants
Patients were administered with BI 860585 daily oral dose of 5 milligram starting dose) over 28-day treatment courses
|
BI 860585 + Exemestane
n=21 Participants
Patients were administered with daily oral dose of BI 860585 in combination with 25 milligram/day standard fixed dose of Exemestane over 28-day treatment courses
|
BI 860585 + Paclitaxel
n=18 Participants
Patients were administered with BI 860585 in combination with Paclitaxel weekly intravenous infusion of 60 milligram/meter\^2 for the first dose level/treatment cohort and 80 milligram/meter\^2 (the standard combination dose) for subsequent dose levels/treatment cohorts over 28-day treatment courses
|
40 mg BI 860585
Continuous daily oral dose of 40 milligram/day over 28-days treatment courses of BI 860585 Monotherapy
|
80 mg BI 860585
Continuous daily oral dose of 80 milligram/day over 28-days treatment courses of BI 860585 Monotherapy
|
120 mg BI 860585
Continuous daily oral dose of 120 milligram/day over 28-days treatment courses of BI 860585 Monotherapy
|
160 mg BI 860585
Continuous daily oral dose of 160 milligram/day over 28-days treatment courses of BI 860585 Monotherapy
|
220 mg BI 860585
Continuous daily oral dose of 220 milligram/day over 28-days treatment courses of BI 860585 Monotherapy
|
300 mg BI 860585
Continuous daily oral dose of 300 milligram/day over 28-days treatment courses of BI 860585 Monotherapy
|
40 mg BI 860585+25 mg Exemestane
Continuous daily oral dose of 25 mg/day standard fixed dose of exemestane over 28-day treatment courses combination with 40 mg BI 860585
|
80 mg BI 860585+25 mg Exemestane
Continuous daily oral dose of 25 mg/day standard fixed dose of exemestane over 28-day treatment courses combination with 80 mg BI 860585
|
120 mg BI 860585+25 mg Exemestane
Continuous daily oral dose of 25 mg/day standard fixed dose of exemestane over 28-day treatment courses combination with 120 mg BI 860585
|
160 mg BI 860585+25 mg Exemestane
Continuous daily oral dose of 25 mg/day standard fixed dose of exemestane over 28-day treatment courses combination with 160 mg BI 860585
|
80 mg BI 860585+60 mg/m^2 Paclitaxel
Patients were administered with 80 mg BI 860585 in combination with weekly intravenous infusion of 60 mg/m\^2 the standard combination dose of paclitaxel for the first dose level/treatment for subsequent dose levels/treatment cohorts over 28-day treatment courses
|
80 mg BI 860585+80 mg/m^2 Paclitaxel
Patients were administered with 80 mg BI 860585 in combination with weekly intravenous infusion of 80 mg/m\^2 the standard combination dose of paclitaxel for the first dose level/treatment for subsequent dose levels/treatment cohorts over 28-day treatment courses
|
120 mg BI 860585+80 mg/m^2 Paclitaxel
Patients were administered with 120 mg BI 860585 in combination with weekly intravenous infusion of 80 mg/m\^2 the standard combination dose of paclitaxel for the first dose level/treatment for subsequent dose levels/treatment cohorts over 28-day treatment courses
|
160 mg BI 860585+80 mg/m^2 Paclita
Continuous daily oral dose of 160 mg BI 860585 in combination with once weekly iv infusion of 80 mg/m\^2 paclitaxel
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
The Maximum Tolerated Dose (MTD) for Each Treatment Arm
BI 860585
|
220 Milligram (mg)
|
160 Milligram (mg)
|
160 Milligram (mg)
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
The Maximum Tolerated Dose (MTD) for Each Treatment Arm
Exemestane
|
NA Milligram (mg)
Not applicable for this arm
|
25 Milligram (mg)
|
NA Milligram (mg)
Not applicable for this arm
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
The Maximum Tolerated Dose (MTD) for Each Treatment Arm
Paclitaxel
|
NA Milligram (mg)
Not applicable for this arm
|
NA Milligram (mg)
Not applicable for this arm
|
80 Milligram (mg)
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: From the date of first treatment administration until the earliest of disease progression, death, or last adequate tumour assessment before new anti-cancer therapy; data collected up to cut-off date 30 Jun 2017, Up to 1389 daysPopulation: Treated Set: The treated set includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane or paclitaxel).
As Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for objective response rate (Complete Response (CR), disappearance of all target lesions; Partial Response (PR), =30% decrease in the sum of the longest diameter of target lesions) for target lesions assessed by Magnetic resonance imaging (MRI) and Computed tomography (CT)
Outcome measures
| Measure |
BI 860585 Monotherapy
n=41 Participants
Patients were administered with BI 860585 daily oral dose of 5 milligram starting dose) over 28-day treatment courses
|
BI 860585 + Exemestane
n=25 Participants
Patients were administered with daily oral dose of BI 860585 in combination with 25 milligram/day standard fixed dose of Exemestane over 28-day treatment courses
|
BI 860585 + Paclitaxel
n=24 Participants
Patients were administered with BI 860585 in combination with Paclitaxel weekly intravenous infusion of 60 milligram/meter\^2 for the first dose level/treatment cohort and 80 milligram/meter\^2 (the standard combination dose) for subsequent dose levels/treatment cohorts over 28-day treatment courses
|
40 mg BI 860585
Continuous daily oral dose of 40 milligram/day over 28-days treatment courses of BI 860585 Monotherapy
|
80 mg BI 860585
Continuous daily oral dose of 80 milligram/day over 28-days treatment courses of BI 860585 Monotherapy
|
120 mg BI 860585
Continuous daily oral dose of 120 milligram/day over 28-days treatment courses of BI 860585 Monotherapy
|
160 mg BI 860585
Continuous daily oral dose of 160 milligram/day over 28-days treatment courses of BI 860585 Monotherapy
|
220 mg BI 860585
Continuous daily oral dose of 220 milligram/day over 28-days treatment courses of BI 860585 Monotherapy
|
300 mg BI 860585
Continuous daily oral dose of 300 milligram/day over 28-days treatment courses of BI 860585 Monotherapy
|
40 mg BI 860585+25 mg Exemestane
Continuous daily oral dose of 25 mg/day standard fixed dose of exemestane over 28-day treatment courses combination with 40 mg BI 860585
|
80 mg BI 860585+25 mg Exemestane
Continuous daily oral dose of 25 mg/day standard fixed dose of exemestane over 28-day treatment courses combination with 80 mg BI 860585
|
120 mg BI 860585+25 mg Exemestane
Continuous daily oral dose of 25 mg/day standard fixed dose of exemestane over 28-day treatment courses combination with 120 mg BI 860585
|
160 mg BI 860585+25 mg Exemestane
Continuous daily oral dose of 25 mg/day standard fixed dose of exemestane over 28-day treatment courses combination with 160 mg BI 860585
|
80 mg BI 860585+60 mg/m^2 Paclitaxel
Patients were administered with 80 mg BI 860585 in combination with weekly intravenous infusion of 60 mg/m\^2 the standard combination dose of paclitaxel for the first dose level/treatment for subsequent dose levels/treatment cohorts over 28-day treatment courses
|
80 mg BI 860585+80 mg/m^2 Paclitaxel
Patients were administered with 80 mg BI 860585 in combination with weekly intravenous infusion of 80 mg/m\^2 the standard combination dose of paclitaxel for the first dose level/treatment for subsequent dose levels/treatment cohorts over 28-day treatment courses
|
120 mg BI 860585+80 mg/m^2 Paclitaxel
Patients were administered with 120 mg BI 860585 in combination with weekly intravenous infusion of 80 mg/m\^2 the standard combination dose of paclitaxel for the first dose level/treatment for subsequent dose levels/treatment cohorts over 28-day treatment courses
|
160 mg BI 860585+80 mg/m^2 Paclita
Continuous daily oral dose of 160 mg BI 860585 in combination with once weekly iv infusion of 80 mg/m\^2 paclitaxel
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Objective Response Rate (Complete Response or Partial Response as Per the Response Evaluation Criteria In Solid Tumors Criteria [RECIST], Version 1.1)
|
0 Participants
|
4 Participants
|
5 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: From the date of first treatment administration until the earliest of disease progression, death, or last adequate tumour assessment before new anti-cancer therapy.Population: Treated Set: The treated set includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane or paclitaxel).
As Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for disease control rate/clinical benefit rate (Complete Response (CR), disappearance of all target lesions; Partial Response (PR), =30% decrease in the sum of the longest diameter of target lesions; Stable Disease (SD), neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for disease progression) for target lesions assessed by Magnetic resonance imaging (MRI) and Computed tomography (CT)
Outcome measures
| Measure |
BI 860585 Monotherapy
n=41 Participants
Patients were administered with BI 860585 daily oral dose of 5 milligram starting dose) over 28-day treatment courses
|
BI 860585 + Exemestane
n=25 Participants
Patients were administered with daily oral dose of BI 860585 in combination with 25 milligram/day standard fixed dose of Exemestane over 28-day treatment courses
|
BI 860585 + Paclitaxel
n=24 Participants
Patients were administered with BI 860585 in combination with Paclitaxel weekly intravenous infusion of 60 milligram/meter\^2 for the first dose level/treatment cohort and 80 milligram/meter\^2 (the standard combination dose) for subsequent dose levels/treatment cohorts over 28-day treatment courses
|
40 mg BI 860585
Continuous daily oral dose of 40 milligram/day over 28-days treatment courses of BI 860585 Monotherapy
|
80 mg BI 860585
Continuous daily oral dose of 80 milligram/day over 28-days treatment courses of BI 860585 Monotherapy
|
120 mg BI 860585
Continuous daily oral dose of 120 milligram/day over 28-days treatment courses of BI 860585 Monotherapy
|
160 mg BI 860585
Continuous daily oral dose of 160 milligram/day over 28-days treatment courses of BI 860585 Monotherapy
|
220 mg BI 860585
Continuous daily oral dose of 220 milligram/day over 28-days treatment courses of BI 860585 Monotherapy
|
300 mg BI 860585
Continuous daily oral dose of 300 milligram/day over 28-days treatment courses of BI 860585 Monotherapy
|
40 mg BI 860585+25 mg Exemestane
Continuous daily oral dose of 25 mg/day standard fixed dose of exemestane over 28-day treatment courses combination with 40 mg BI 860585
|
80 mg BI 860585+25 mg Exemestane
Continuous daily oral dose of 25 mg/day standard fixed dose of exemestane over 28-day treatment courses combination with 80 mg BI 860585
|
120 mg BI 860585+25 mg Exemestane
Continuous daily oral dose of 25 mg/day standard fixed dose of exemestane over 28-day treatment courses combination with 120 mg BI 860585
|
160 mg BI 860585+25 mg Exemestane
Continuous daily oral dose of 25 mg/day standard fixed dose of exemestane over 28-day treatment courses combination with 160 mg BI 860585
|
80 mg BI 860585+60 mg/m^2 Paclitaxel
Patients were administered with 80 mg BI 860585 in combination with weekly intravenous infusion of 60 mg/m\^2 the standard combination dose of paclitaxel for the first dose level/treatment for subsequent dose levels/treatment cohorts over 28-day treatment courses
|
80 mg BI 860585+80 mg/m^2 Paclitaxel
Patients were administered with 80 mg BI 860585 in combination with weekly intravenous infusion of 80 mg/m\^2 the standard combination dose of paclitaxel for the first dose level/treatment for subsequent dose levels/treatment cohorts over 28-day treatment courses
|
120 mg BI 860585+80 mg/m^2 Paclitaxel
Patients were administered with 120 mg BI 860585 in combination with weekly intravenous infusion of 80 mg/m\^2 the standard combination dose of paclitaxel for the first dose level/treatment for subsequent dose levels/treatment cohorts over 28-day treatment courses
|
160 mg BI 860585+80 mg/m^2 Paclita
Continuous daily oral dose of 160 mg BI 860585 in combination with once weekly iv infusion of 80 mg/m\^2 paclitaxel
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Disease Control Rate/Clinical Benefit Rate (Complete Response, Partial Response or Stable Disease as Per Response Evaluation Criteria In Solid Tumors Criteria [RECIST], Version 1.1)
|
8 Participants
|
7 Participants
|
14 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: From the date of first treatment administration until the earliest of disease progression, death, or last adequate tumour assessment before new anti-cancer therapy; data collected up to cut-off date 30 Jun 2017, Up to 1389 daysPopulation: Patients with disease control from the treated set (Treated Set: The treated set includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane or paclitaxel)).
Duration of clinical benefit (Disease control) was defined as the time between first treatment administration until the earliest of disease progression or death, for patients with disease control.
Outcome measures
| Measure |
BI 860585 Monotherapy
n=8 Participants
Patients were administered with BI 860585 daily oral dose of 5 milligram starting dose) over 28-day treatment courses
|
BI 860585 + Exemestane
n=7 Participants
Patients were administered with daily oral dose of BI 860585 in combination with 25 milligram/day standard fixed dose of Exemestane over 28-day treatment courses
|
BI 860585 + Paclitaxel
n=14 Participants
Patients were administered with BI 860585 in combination with Paclitaxel weekly intravenous infusion of 60 milligram/meter\^2 for the first dose level/treatment cohort and 80 milligram/meter\^2 (the standard combination dose) for subsequent dose levels/treatment cohorts over 28-day treatment courses
|
40 mg BI 860585
Continuous daily oral dose of 40 milligram/day over 28-days treatment courses of BI 860585 Monotherapy
|
80 mg BI 860585
Continuous daily oral dose of 80 milligram/day over 28-days treatment courses of BI 860585 Monotherapy
|
120 mg BI 860585
Continuous daily oral dose of 120 milligram/day over 28-days treatment courses of BI 860585 Monotherapy
|
160 mg BI 860585
Continuous daily oral dose of 160 milligram/day over 28-days treatment courses of BI 860585 Monotherapy
|
220 mg BI 860585
Continuous daily oral dose of 220 milligram/day over 28-days treatment courses of BI 860585 Monotherapy
|
300 mg BI 860585
Continuous daily oral dose of 300 milligram/day over 28-days treatment courses of BI 860585 Monotherapy
|
40 mg BI 860585+25 mg Exemestane
Continuous daily oral dose of 25 mg/day standard fixed dose of exemestane over 28-day treatment courses combination with 40 mg BI 860585
|
80 mg BI 860585+25 mg Exemestane
Continuous daily oral dose of 25 mg/day standard fixed dose of exemestane over 28-day treatment courses combination with 80 mg BI 860585
|
120 mg BI 860585+25 mg Exemestane
Continuous daily oral dose of 25 mg/day standard fixed dose of exemestane over 28-day treatment courses combination with 120 mg BI 860585
|
160 mg BI 860585+25 mg Exemestane
Continuous daily oral dose of 25 mg/day standard fixed dose of exemestane over 28-day treatment courses combination with 160 mg BI 860585
|
80 mg BI 860585+60 mg/m^2 Paclitaxel
Patients were administered with 80 mg BI 860585 in combination with weekly intravenous infusion of 60 mg/m\^2 the standard combination dose of paclitaxel for the first dose level/treatment for subsequent dose levels/treatment cohorts over 28-day treatment courses
|
80 mg BI 860585+80 mg/m^2 Paclitaxel
Patients were administered with 80 mg BI 860585 in combination with weekly intravenous infusion of 80 mg/m\^2 the standard combination dose of paclitaxel for the first dose level/treatment for subsequent dose levels/treatment cohorts over 28-day treatment courses
|
120 mg BI 860585+80 mg/m^2 Paclitaxel
Patients were administered with 120 mg BI 860585 in combination with weekly intravenous infusion of 80 mg/m\^2 the standard combination dose of paclitaxel for the first dose level/treatment for subsequent dose levels/treatment cohorts over 28-day treatment courses
|
160 mg BI 860585+80 mg/m^2 Paclita
Continuous daily oral dose of 160 mg BI 860585 in combination with once weekly iv infusion of 80 mg/m\^2 paclitaxel
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Duration of Clinical Benefit
|
8.31 Months
Standard Deviation 4.78
|
10.06 Months
Standard Deviation 7.26
|
7.79 Months
Standard Deviation 3.30
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: From the date of first treatment administration until the earliest of disease progression, death, or last adequate tumour assessment before new anti-cancer therapy; data collected up to cut-off date 30 Jun 2017, Up to 1389 daysPopulation: Patients with objective response from the treated set (Treated Set: The treated set includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane or paclitaxel)).
Duration of objective response was defined as the time from first objective response until the earliest of progression or death, for patients with objective response.
Outcome measures
| Measure |
BI 860585 Monotherapy
Patients were administered with BI 860585 daily oral dose of 5 milligram starting dose) over 28-day treatment courses
|
BI 860585 + Exemestane
n=4 Participants
Patients were administered with daily oral dose of BI 860585 in combination with 25 milligram/day standard fixed dose of Exemestane over 28-day treatment courses
|
BI 860585 + Paclitaxel
n=5 Participants
Patients were administered with BI 860585 in combination with Paclitaxel weekly intravenous infusion of 60 milligram/meter\^2 for the first dose level/treatment cohort and 80 milligram/meter\^2 (the standard combination dose) for subsequent dose levels/treatment cohorts over 28-day treatment courses
|
40 mg BI 860585
Continuous daily oral dose of 40 milligram/day over 28-days treatment courses of BI 860585 Monotherapy
|
80 mg BI 860585
Continuous daily oral dose of 80 milligram/day over 28-days treatment courses of BI 860585 Monotherapy
|
120 mg BI 860585
Continuous daily oral dose of 120 milligram/day over 28-days treatment courses of BI 860585 Monotherapy
|
160 mg BI 860585
Continuous daily oral dose of 160 milligram/day over 28-days treatment courses of BI 860585 Monotherapy
|
220 mg BI 860585
Continuous daily oral dose of 220 milligram/day over 28-days treatment courses of BI 860585 Monotherapy
|
300 mg BI 860585
Continuous daily oral dose of 300 milligram/day over 28-days treatment courses of BI 860585 Monotherapy
|
40 mg BI 860585+25 mg Exemestane
Continuous daily oral dose of 25 mg/day standard fixed dose of exemestane over 28-day treatment courses combination with 40 mg BI 860585
|
80 mg BI 860585+25 mg Exemestane
Continuous daily oral dose of 25 mg/day standard fixed dose of exemestane over 28-day treatment courses combination with 80 mg BI 860585
|
120 mg BI 860585+25 mg Exemestane
Continuous daily oral dose of 25 mg/day standard fixed dose of exemestane over 28-day treatment courses combination with 120 mg BI 860585
|
160 mg BI 860585+25 mg Exemestane
Continuous daily oral dose of 25 mg/day standard fixed dose of exemestane over 28-day treatment courses combination with 160 mg BI 860585
|
80 mg BI 860585+60 mg/m^2 Paclitaxel
Patients were administered with 80 mg BI 860585 in combination with weekly intravenous infusion of 60 mg/m\^2 the standard combination dose of paclitaxel for the first dose level/treatment for subsequent dose levels/treatment cohorts over 28-day treatment courses
|
80 mg BI 860585+80 mg/m^2 Paclitaxel
Patients were administered with 80 mg BI 860585 in combination with weekly intravenous infusion of 80 mg/m\^2 the standard combination dose of paclitaxel for the first dose level/treatment for subsequent dose levels/treatment cohorts over 28-day treatment courses
|
120 mg BI 860585+80 mg/m^2 Paclitaxel
Patients were administered with 120 mg BI 860585 in combination with weekly intravenous infusion of 80 mg/m\^2 the standard combination dose of paclitaxel for the first dose level/treatment for subsequent dose levels/treatment cohorts over 28-day treatment courses
|
160 mg BI 860585+80 mg/m^2 Paclita
Continuous daily oral dose of 160 mg BI 860585 in combination with once weekly iv infusion of 80 mg/m\^2 paclitaxel
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Duration of Objective Response
|
—
|
9.16 Months
Standard Deviation 9.83
|
4.42 Months
Standard Deviation 3.06
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Pharmacokinetic samples were collected at pre-dose and 0.5, 1, 2, 3, 4, 6, 8 and 23.917 hours after administration of BI 860585.Population: Pharmacokinetic Analysis Set (PKS): This patient set includes all evaluable patients in the treated set (TS) which provide at least one observation for at least one pharmacokinetic (PK) endpoint without important protocol violations relevant to the evaluation of PK.
AUC0-∞, area under the concentration-time curve in plasma of BI 860585 over the time interval from 0 to infinity after single administration of BI 860585
Outcome measures
| Measure |
BI 860585 Monotherapy
n=3 Participants
Patients were administered with BI 860585 daily oral dose of 5 milligram starting dose) over 28-day treatment courses
|
BI 860585 + Exemestane
n=2 Participants
Patients were administered with daily oral dose of BI 860585 in combination with 25 milligram/day standard fixed dose of Exemestane over 28-day treatment courses
|
BI 860585 + Paclitaxel
n=2 Participants
Patients were administered with BI 860585 in combination with Paclitaxel weekly intravenous infusion of 60 milligram/meter\^2 for the first dose level/treatment cohort and 80 milligram/meter\^2 (the standard combination dose) for subsequent dose levels/treatment cohorts over 28-day treatment courses
|
40 mg BI 860585
n=3 Participants
Continuous daily oral dose of 40 milligram/day over 28-days treatment courses of BI 860585 Monotherapy
|
80 mg BI 860585
n=3 Participants
Continuous daily oral dose of 80 milligram/day over 28-days treatment courses of BI 860585 Monotherapy
|
120 mg BI 860585
Continuous daily oral dose of 120 milligram/day over 28-days treatment courses of BI 860585 Monotherapy
|
160 mg BI 860585
n=5 Participants
Continuous daily oral dose of 160 milligram/day over 28-days treatment courses of BI 860585 Monotherapy
|
220 mg BI 860585
n=4 Participants
Continuous daily oral dose of 220 milligram/day over 28-days treatment courses of BI 860585 Monotherapy
|
300 mg BI 860585
n=3 Participants
Continuous daily oral dose of 300 milligram/day over 28-days treatment courses of BI 860585 Monotherapy
|
40 mg BI 860585+25 mg Exemestane
Continuous daily oral dose of 25 mg/day standard fixed dose of exemestane over 28-day treatment courses combination with 40 mg BI 860585
|
80 mg BI 860585+25 mg Exemestane
Continuous daily oral dose of 25 mg/day standard fixed dose of exemestane over 28-day treatment courses combination with 80 mg BI 860585
|
120 mg BI 860585+25 mg Exemestane
Continuous daily oral dose of 25 mg/day standard fixed dose of exemestane over 28-day treatment courses combination with 120 mg BI 860585
|
160 mg BI 860585+25 mg Exemestane
Continuous daily oral dose of 25 mg/day standard fixed dose of exemestane over 28-day treatment courses combination with 160 mg BI 860585
|
80 mg BI 860585+60 mg/m^2 Paclitaxel
Patients were administered with 80 mg BI 860585 in combination with weekly intravenous infusion of 60 mg/m\^2 the standard combination dose of paclitaxel for the first dose level/treatment for subsequent dose levels/treatment cohorts over 28-day treatment courses
|
80 mg BI 860585+80 mg/m^2 Paclitaxel
Patients were administered with 80 mg BI 860585 in combination with weekly intravenous infusion of 80 mg/m\^2 the standard combination dose of paclitaxel for the first dose level/treatment for subsequent dose levels/treatment cohorts over 28-day treatment courses
|
120 mg BI 860585+80 mg/m^2 Paclitaxel
Patients were administered with 120 mg BI 860585 in combination with weekly intravenous infusion of 80 mg/m\^2 the standard combination dose of paclitaxel for the first dose level/treatment for subsequent dose levels/treatment cohorts over 28-day treatment courses
|
160 mg BI 860585+80 mg/m^2 Paclita
Continuous daily oral dose of 160 mg BI 860585 in combination with once weekly iv infusion of 80 mg/m\^2 paclitaxel
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Area Under the Concentration-time Curve in Plasma of BI 860585 Over the Time Interval From 0 to Infinity (AUC0-∞)
|
21100 nanomol*hour/ Litre [nmol*h/L]
Geometric Coefficient of Variation 27.3
|
51100 nanomol*hour/ Litre [nmol*h/L]
Geometric Coefficient of Variation 65.4
|
70300 nanomol*hour/ Litre [nmol*h/L]
Geometric Coefficient of Variation 26.4
|
126000 nanomol*hour/ Litre [nmol*h/L]
Geometric Coefficient of Variation 17.7
|
425000 nanomol*hour/ Litre [nmol*h/L]
Geometric Coefficient of Variation 28.5
|
—
|
680000 nanomol*hour/ Litre [nmol*h/L]
Geometric Coefficient of Variation 38.9
|
791000 nanomol*hour/ Litre [nmol*h/L]
Geometric Coefficient of Variation 12.3
|
1030000 nanomol*hour/ Litre [nmol*h/L]
Geometric Coefficient of Variation 10.5
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Pharmacokinetic samples were collected at pre-dose and 0.5, 1, 2, 3, 4, 6, 8 and 23.917 hours after administration of BI 860585.Population: PKS
AUC0-24, area under the concentration-time curve in plasma of BI 860585 over the time interval from 0 to 24 hours after single administration of BI 860585
Outcome measures
| Measure |
BI 860585 Monotherapy
n=3 Participants
Patients were administered with BI 860585 daily oral dose of 5 milligram starting dose) over 28-day treatment courses
|
BI 860585 + Exemestane
n=3 Participants
Patients were administered with daily oral dose of BI 860585 in combination with 25 milligram/day standard fixed dose of Exemestane over 28-day treatment courses
|
BI 860585 + Paclitaxel
n=2 Participants
Patients were administered with BI 860585 in combination with Paclitaxel weekly intravenous infusion of 60 milligram/meter\^2 for the first dose level/treatment cohort and 80 milligram/meter\^2 (the standard combination dose) for subsequent dose levels/treatment cohorts over 28-day treatment courses
|
40 mg BI 860585
n=3 Participants
Continuous daily oral dose of 40 milligram/day over 28-days treatment courses of BI 860585 Monotherapy
|
80 mg BI 860585
n=3 Participants
Continuous daily oral dose of 80 milligram/day over 28-days treatment courses of BI 860585 Monotherapy
|
120 mg BI 860585
n=5 Participants
Continuous daily oral dose of 120 milligram/day over 28-days treatment courses of BI 860585 Monotherapy
|
160 mg BI 860585
n=5 Participants
Continuous daily oral dose of 160 milligram/day over 28-days treatment courses of BI 860585 Monotherapy
|
220 mg BI 860585
n=4 Participants
Continuous daily oral dose of 220 milligram/day over 28-days treatment courses of BI 860585 Monotherapy
|
300 mg BI 860585
n=3 Participants
Continuous daily oral dose of 300 milligram/day over 28-days treatment courses of BI 860585 Monotherapy
|
40 mg BI 860585+25 mg Exemestane
Continuous daily oral dose of 25 mg/day standard fixed dose of exemestane over 28-day treatment courses combination with 40 mg BI 860585
|
80 mg BI 860585+25 mg Exemestane
Continuous daily oral dose of 25 mg/day standard fixed dose of exemestane over 28-day treatment courses combination with 80 mg BI 860585
|
120 mg BI 860585+25 mg Exemestane
Continuous daily oral dose of 25 mg/day standard fixed dose of exemestane over 28-day treatment courses combination with 120 mg BI 860585
|
160 mg BI 860585+25 mg Exemestane
Continuous daily oral dose of 25 mg/day standard fixed dose of exemestane over 28-day treatment courses combination with 160 mg BI 860585
|
80 mg BI 860585+60 mg/m^2 Paclitaxel
Patients were administered with 80 mg BI 860585 in combination with weekly intravenous infusion of 60 mg/m\^2 the standard combination dose of paclitaxel for the first dose level/treatment for subsequent dose levels/treatment cohorts over 28-day treatment courses
|
80 mg BI 860585+80 mg/m^2 Paclitaxel
Patients were administered with 80 mg BI 860585 in combination with weekly intravenous infusion of 80 mg/m\^2 the standard combination dose of paclitaxel for the first dose level/treatment for subsequent dose levels/treatment cohorts over 28-day treatment courses
|
120 mg BI 860585+80 mg/m^2 Paclitaxel
Patients were administered with 120 mg BI 860585 in combination with weekly intravenous infusion of 80 mg/m\^2 the standard combination dose of paclitaxel for the first dose level/treatment for subsequent dose levels/treatment cohorts over 28-day treatment courses
|
160 mg BI 860585+80 mg/m^2 Paclita
Continuous daily oral dose of 160 mg BI 860585 in combination with once weekly iv infusion of 80 mg/m\^2 paclitaxel
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Area Under the Concentration-time Curve in Plasma of BI 860585 Over the Time Interval From 0 to 24 Hours (AUC0-24)
|
12900 nanomol*hour/ Litre [nmol*h/L]
Geometric Coefficient of Variation 20.0
|
23400 nanomol*hour/ Litre [nmol*h/L]
Geometric Coefficient of Variation 30.7
|
45400 nanomol*hour/ Litre [nmol*h/L]
Geometric Coefficient of Variation 29.6
|
83200 nanomol*hour/ Litre [nmol*h/L]
Geometric Coefficient of Variation 24.7
|
236000 nanomol*hour/ Litre [nmol*h/L]
Geometric Coefficient of Variation 15.6
|
299000 nanomol*hour/ Litre [nmol*h/L]
Geometric Coefficient of Variation 21.1
|
401000 nanomol*hour/ Litre [nmol*h/L]
Geometric Coefficient of Variation 21.4
|
470000 nanomol*hour/ Litre [nmol*h/L]
Geometric Coefficient of Variation 6.09
|
641000 nanomol*hour/ Litre [nmol*h/L]
Geometric Coefficient of Variation 8.43
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Pharmacokinetic samples were collected at pre-dose and 0.5, 1, 2, 3, 4, 6, 8 and 23.917 hours after administration of BI 860585.Population: PKS
t ½, half-life of BI 860585 in plasma over a dosing interval after single administration of BI 860585
Outcome measures
| Measure |
BI 860585 Monotherapy
n=3 Participants
Patients were administered with BI 860585 daily oral dose of 5 milligram starting dose) over 28-day treatment courses
|
BI 860585 + Exemestane
n=2 Participants
Patients were administered with daily oral dose of BI 860585 in combination with 25 milligram/day standard fixed dose of Exemestane over 28-day treatment courses
|
BI 860585 + Paclitaxel
n=2 Participants
Patients were administered with BI 860585 in combination with Paclitaxel weekly intravenous infusion of 60 milligram/meter\^2 for the first dose level/treatment cohort and 80 milligram/meter\^2 (the standard combination dose) for subsequent dose levels/treatment cohorts over 28-day treatment courses
|
40 mg BI 860585
n=3 Participants
Continuous daily oral dose of 40 milligram/day over 28-days treatment courses of BI 860585 Monotherapy
|
80 mg BI 860585
n=3 Participants
Continuous daily oral dose of 80 milligram/day over 28-days treatment courses of BI 860585 Monotherapy
|
120 mg BI 860585
Continuous daily oral dose of 120 milligram/day over 28-days treatment courses of BI 860585 Monotherapy
|
160 mg BI 860585
n=5 Participants
Continuous daily oral dose of 160 milligram/day over 28-days treatment courses of BI 860585 Monotherapy
|
220 mg BI 860585
n=4 Participants
Continuous daily oral dose of 220 milligram/day over 28-days treatment courses of BI 860585 Monotherapy
|
300 mg BI 860585
n=3 Participants
Continuous daily oral dose of 300 milligram/day over 28-days treatment courses of BI 860585 Monotherapy
|
40 mg BI 860585+25 mg Exemestane
Continuous daily oral dose of 25 mg/day standard fixed dose of exemestane over 28-day treatment courses combination with 40 mg BI 860585
|
80 mg BI 860585+25 mg Exemestane
Continuous daily oral dose of 25 mg/day standard fixed dose of exemestane over 28-day treatment courses combination with 80 mg BI 860585
|
120 mg BI 860585+25 mg Exemestane
Continuous daily oral dose of 25 mg/day standard fixed dose of exemestane over 28-day treatment courses combination with 120 mg BI 860585
|
160 mg BI 860585+25 mg Exemestane
Continuous daily oral dose of 25 mg/day standard fixed dose of exemestane over 28-day treatment courses combination with 160 mg BI 860585
|
80 mg BI 860585+60 mg/m^2 Paclitaxel
Patients were administered with 80 mg BI 860585 in combination with weekly intravenous infusion of 60 mg/m\^2 the standard combination dose of paclitaxel for the first dose level/treatment for subsequent dose levels/treatment cohorts over 28-day treatment courses
|
80 mg BI 860585+80 mg/m^2 Paclitaxel
Patients were administered with 80 mg BI 860585 in combination with weekly intravenous infusion of 80 mg/m\^2 the standard combination dose of paclitaxel for the first dose level/treatment for subsequent dose levels/treatment cohorts over 28-day treatment courses
|
120 mg BI 860585+80 mg/m^2 Paclitaxel
Patients were administered with 120 mg BI 860585 in combination with weekly intravenous infusion of 80 mg/m\^2 the standard combination dose of paclitaxel for the first dose level/treatment for subsequent dose levels/treatment cohorts over 28-day treatment courses
|
160 mg BI 860585+80 mg/m^2 Paclita
Continuous daily oral dose of 160 mg BI 860585 in combination with once weekly iv infusion of 80 mg/m\^2 paclitaxel
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Half Life of BI 860585 (t1/2)
|
17.1 Hour (h)
Geometric Coefficient of Variation 14.5
|
21.6 Hour (h)
Geometric Coefficient of Variation 50.1
|
15.6 Hour (h)
Geometric Coefficient of Variation 11.8
|
14.2 Hour (h)
Geometric Coefficient of Variation 27.2
|
19.7 Hour (h)
Geometric Coefficient of Variation 28.0
|
—
|
17.2 Hour (h)
Geometric Coefficient of Variation 33.7
|
17.4 Hour (h)
Geometric Coefficient of Variation 11.0
|
16.9 Hour (h)
Geometric Coefficient of Variation 6.14
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Pharmacokinetic samples were collected at pre-dose and 0.5, 1, 2, 3, 4, 6, 8 and 23.917 hours after administration of BI 860585.Population: PKS
Cmax, maximum measured concentration of BI 860585 in plasma over a dosing interval after single administration of BI 860585
Outcome measures
| Measure |
BI 860585 Monotherapy
n=3 Participants
Patients were administered with BI 860585 daily oral dose of 5 milligram starting dose) over 28-day treatment courses
|
BI 860585 + Exemestane
n=3 Participants
Patients were administered with daily oral dose of BI 860585 in combination with 25 milligram/day standard fixed dose of Exemestane over 28-day treatment courses
|
BI 860585 + Paclitaxel
n=3 Participants
Patients were administered with BI 860585 in combination with Paclitaxel weekly intravenous infusion of 60 milligram/meter\^2 for the first dose level/treatment cohort and 80 milligram/meter\^2 (the standard combination dose) for subsequent dose levels/treatment cohorts over 28-day treatment courses
|
40 mg BI 860585
n=3 Participants
Continuous daily oral dose of 40 milligram/day over 28-days treatment courses of BI 860585 Monotherapy
|
80 mg BI 860585
n=3 Participants
Continuous daily oral dose of 80 milligram/day over 28-days treatment courses of BI 860585 Monotherapy
|
120 mg BI 860585
n=4 Participants
Continuous daily oral dose of 120 milligram/day over 28-days treatment courses of BI 860585 Monotherapy
|
160 mg BI 860585
n=6 Participants
Continuous daily oral dose of 160 milligram/day over 28-days treatment courses of BI 860585 Monotherapy
|
220 mg BI 860585
n=4 Participants
Continuous daily oral dose of 220 milligram/day over 28-days treatment courses of BI 860585 Monotherapy
|
300 mg BI 860585
n=3 Participants
Continuous daily oral dose of 300 milligram/day over 28-days treatment courses of BI 860585 Monotherapy
|
40 mg BI 860585+25 mg Exemestane
Continuous daily oral dose of 25 mg/day standard fixed dose of exemestane over 28-day treatment courses combination with 40 mg BI 860585
|
80 mg BI 860585+25 mg Exemestane
Continuous daily oral dose of 25 mg/day standard fixed dose of exemestane over 28-day treatment courses combination with 80 mg BI 860585
|
120 mg BI 860585+25 mg Exemestane
Continuous daily oral dose of 25 mg/day standard fixed dose of exemestane over 28-day treatment courses combination with 120 mg BI 860585
|
160 mg BI 860585+25 mg Exemestane
Continuous daily oral dose of 25 mg/day standard fixed dose of exemestane over 28-day treatment courses combination with 160 mg BI 860585
|
80 mg BI 860585+60 mg/m^2 Paclitaxel
Patients were administered with 80 mg BI 860585 in combination with weekly intravenous infusion of 60 mg/m\^2 the standard combination dose of paclitaxel for the first dose level/treatment for subsequent dose levels/treatment cohorts over 28-day treatment courses
|
80 mg BI 860585+80 mg/m^2 Paclitaxel
Patients were administered with 80 mg BI 860585 in combination with weekly intravenous infusion of 80 mg/m\^2 the standard combination dose of paclitaxel for the first dose level/treatment for subsequent dose levels/treatment cohorts over 28-day treatment courses
|
120 mg BI 860585+80 mg/m^2 Paclitaxel
Patients were administered with 120 mg BI 860585 in combination with weekly intravenous infusion of 80 mg/m\^2 the standard combination dose of paclitaxel for the first dose level/treatment for subsequent dose levels/treatment cohorts over 28-day treatment courses
|
160 mg BI 860585+80 mg/m^2 Paclita
Continuous daily oral dose of 160 mg BI 860585 in combination with once weekly iv infusion of 80 mg/m\^2 paclitaxel
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Maximum Measured Concentration of BI 860585 (Cmax)
|
995 nanomole/Litre [nmol/L]
Geometric Coefficient of Variation 26.3
|
1590 nanomole/Litre [nmol/L]
Geometric Coefficient of Variation 21.5
|
3330 nanomole/Litre [nmol/L]
Geometric Coefficient of Variation 4.76
|
6770 nanomole/Litre [nmol/L]
Geometric Coefficient of Variation 37.6
|
16900 nanomole/Litre [nmol/L]
Geometric Coefficient of Variation 15.0
|
18800 nanomole/Litre [nmol/L]
Geometric Coefficient of Variation 16.4
|
28000 nanomole/Litre [nmol/L]
Geometric Coefficient of Variation 36.0
|
32400 nanomole/Litre [nmol/L]
Geometric Coefficient of Variation 18.5
|
51500 nanomole/Litre [nmol/L]
Geometric Coefficient of Variation 10.7
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Pharmacokinetic samples were collected at pre-dose and 0.5, 1, 2, 3, 4, 6, 8 and 23.917 hours after administration of BI 860585.Population: PKS
Tmax, Time to maximum concentration of BI 860585 in plasma over a dosing interval after single administration of BI 860585
Outcome measures
| Measure |
BI 860585 Monotherapy
n=3 Participants
Patients were administered with BI 860585 daily oral dose of 5 milligram starting dose) over 28-day treatment courses
|
BI 860585 + Exemestane
n=3 Participants
Patients were administered with daily oral dose of BI 860585 in combination with 25 milligram/day standard fixed dose of Exemestane over 28-day treatment courses
|
BI 860585 + Paclitaxel
n=3 Participants
Patients were administered with BI 860585 in combination with Paclitaxel weekly intravenous infusion of 60 milligram/meter\^2 for the first dose level/treatment cohort and 80 milligram/meter\^2 (the standard combination dose) for subsequent dose levels/treatment cohorts over 28-day treatment courses
|
40 mg BI 860585
n=3 Participants
Continuous daily oral dose of 40 milligram/day over 28-days treatment courses of BI 860585 Monotherapy
|
80 mg BI 860585
n=3 Participants
Continuous daily oral dose of 80 milligram/day over 28-days treatment courses of BI 860585 Monotherapy
|
120 mg BI 860585
n=4 Participants
Continuous daily oral dose of 120 milligram/day over 28-days treatment courses of BI 860585 Monotherapy
|
160 mg BI 860585
n=6 Participants
Continuous daily oral dose of 160 milligram/day over 28-days treatment courses of BI 860585 Monotherapy
|
220 mg BI 860585
n=4 Participants
Continuous daily oral dose of 220 milligram/day over 28-days treatment courses of BI 860585 Monotherapy
|
300 mg BI 860585
n=3 Participants
Continuous daily oral dose of 300 milligram/day over 28-days treatment courses of BI 860585 Monotherapy
|
40 mg BI 860585+25 mg Exemestane
Continuous daily oral dose of 25 mg/day standard fixed dose of exemestane over 28-day treatment courses combination with 40 mg BI 860585
|
80 mg BI 860585+25 mg Exemestane
Continuous daily oral dose of 25 mg/day standard fixed dose of exemestane over 28-day treatment courses combination with 80 mg BI 860585
|
120 mg BI 860585+25 mg Exemestane
Continuous daily oral dose of 25 mg/day standard fixed dose of exemestane over 28-day treatment courses combination with 120 mg BI 860585
|
160 mg BI 860585+25 mg Exemestane
Continuous daily oral dose of 25 mg/day standard fixed dose of exemestane over 28-day treatment courses combination with 160 mg BI 860585
|
80 mg BI 860585+60 mg/m^2 Paclitaxel
Patients were administered with 80 mg BI 860585 in combination with weekly intravenous infusion of 60 mg/m\^2 the standard combination dose of paclitaxel for the first dose level/treatment for subsequent dose levels/treatment cohorts over 28-day treatment courses
|
80 mg BI 860585+80 mg/m^2 Paclitaxel
Patients were administered with 80 mg BI 860585 in combination with weekly intravenous infusion of 80 mg/m\^2 the standard combination dose of paclitaxel for the first dose level/treatment for subsequent dose levels/treatment cohorts over 28-day treatment courses
|
120 mg BI 860585+80 mg/m^2 Paclitaxel
Patients were administered with 120 mg BI 860585 in combination with weekly intravenous infusion of 80 mg/m\^2 the standard combination dose of paclitaxel for the first dose level/treatment for subsequent dose levels/treatment cohorts over 28-day treatment courses
|
160 mg BI 860585+80 mg/m^2 Paclita
Continuous daily oral dose of 160 mg BI 860585 in combination with once weekly iv infusion of 80 mg/m\^2 paclitaxel
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Time to Maximum Concentration of BI 860585 (Tmax)
|
3.03 Hour (h)
Interval 1.98 to 3.03
|
4.00 Hour (h)
Interval 2.0 to 8.0
|
3.00 Hour (h)
Interval 1.07 to 3.17
|
2.00 Hour (h)
Interval 1.0 to 5.98
|
3.00 Hour (h)
Interval 1.05 to 3.0
|
6.00 Hour (h)
Interval 3.0 to 8.02
|
3.47 Hour (h)
Interval 2.0 to 8.0
|
3.00 Hour (h)
Interval 2.0 to 6.0
|
2.00 Hour (h)
Interval 2.0 to 3.2
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Pharmacokinetic samples were collected at pre-dose and at 504.5, 505, 506, 507, 508, 510, 512, 527.917 hours after drug administration.Population: PKS
AUCτ,ss, area under the concentration-time curve of BI 860585 in plasma over the dosing interval at steady state after multiple administration of BI 860585 (Day 22) in BI 860585 monotherapy and in combination with exemestane and paclitaxel.
Outcome measures
| Measure |
BI 860585 Monotherapy
n=3 Participants
Patients were administered with BI 860585 daily oral dose of 5 milligram starting dose) over 28-day treatment courses
|
BI 860585 + Exemestane
n=2 Participants
Patients were administered with daily oral dose of BI 860585 in combination with 25 milligram/day standard fixed dose of Exemestane over 28-day treatment courses
|
BI 860585 + Paclitaxel
n=2 Participants
Patients were administered with BI 860585 in combination with Paclitaxel weekly intravenous infusion of 60 milligram/meter\^2 for the first dose level/treatment cohort and 80 milligram/meter\^2 (the standard combination dose) for subsequent dose levels/treatment cohorts over 28-day treatment courses
|
40 mg BI 860585
n=3 Participants
Continuous daily oral dose of 40 milligram/day over 28-days treatment courses of BI 860585 Monotherapy
|
80 mg BI 860585
n=3 Participants
Continuous daily oral dose of 80 milligram/day over 28-days treatment courses of BI 860585 Monotherapy
|
120 mg BI 860585
Continuous daily oral dose of 120 milligram/day over 28-days treatment courses of BI 860585 Monotherapy
|
160 mg BI 860585
n=5 Participants
Continuous daily oral dose of 160 milligram/day over 28-days treatment courses of BI 860585 Monotherapy
|
220 mg BI 860585
n=5 Participants
Continuous daily oral dose of 220 milligram/day over 28-days treatment courses of BI 860585 Monotherapy
|
300 mg BI 860585
n=3 Participants
Continuous daily oral dose of 300 milligram/day over 28-days treatment courses of BI 860585 Monotherapy
|
40 mg BI 860585+25 mg Exemestane
n=3 Participants
Continuous daily oral dose of 25 mg/day standard fixed dose of exemestane over 28-day treatment courses combination with 40 mg BI 860585
|
80 mg BI 860585+25 mg Exemestane
n=3 Participants
Continuous daily oral dose of 25 mg/day standard fixed dose of exemestane over 28-day treatment courses combination with 80 mg BI 860585
|
120 mg BI 860585+25 mg Exemestane
n=5 Participants
Continuous daily oral dose of 25 mg/day standard fixed dose of exemestane over 28-day treatment courses combination with 120 mg BI 860585
|
160 mg BI 860585+25 mg Exemestane
n=7 Participants
Continuous daily oral dose of 25 mg/day standard fixed dose of exemestane over 28-day treatment courses combination with 160 mg BI 860585
|
80 mg BI 860585+60 mg/m^2 Paclitaxel
n=2 Participants
Patients were administered with 80 mg BI 860585 in combination with weekly intravenous infusion of 60 mg/m\^2 the standard combination dose of paclitaxel for the first dose level/treatment for subsequent dose levels/treatment cohorts over 28-day treatment courses
|
80 mg BI 860585+80 mg/m^2 Paclitaxel
Patients were administered with 80 mg BI 860585 in combination with weekly intravenous infusion of 80 mg/m\^2 the standard combination dose of paclitaxel for the first dose level/treatment for subsequent dose levels/treatment cohorts over 28-day treatment courses
|
120 mg BI 860585+80 mg/m^2 Paclitaxel
n=4 Participants
Patients were administered with 120 mg BI 860585 in combination with weekly intravenous infusion of 80 mg/m\^2 the standard combination dose of paclitaxel for the first dose level/treatment for subsequent dose levels/treatment cohorts over 28-day treatment courses
|
160 mg BI 860585+80 mg/m^2 Paclita
n=3 Participants
Continuous daily oral dose of 160 mg BI 860585 in combination with once weekly iv infusion of 80 mg/m\^2 paclitaxel
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Area Under the Concentration-time Curve of BI 860585 in Plasma Over a Dosing Interval at Steady State (AUCτ,ss)
|
32000 nanomol*hour/ Litre [nmol*h/L]
Geometric Coefficient of Variation 9.28
|
63100 nanomol*hour/ Litre [nmol*h/L]
Geometric Coefficient of Variation 86.1
|
103000 nanomol*hour/ Litre [nmol*h/L]
Geometric Coefficient of Variation 3.91
|
163000 nanomol*hour/ Litre [nmol*h/L]
Geometric Coefficient of Variation 6.34
|
442000 nanomol*hour/ Litre [nmol*h/L]
Geometric Coefficient of Variation 21.8
|
—
|
840000 nanomol*hour/ Litre [nmol*h/L]
Geometric Coefficient of Variation 23.9
|
838000 nanomol*hour/ Litre [nmol*h/L]
Geometric Coefficient of Variation 24.3
|
1350000 nanomol*hour/ Litre [nmol*h/L]
Geometric Coefficient of Variation 12.3
|
271000 nanomol*hour/ Litre [nmol*h/L]
Geometric Coefficient of Variation 12.9
|
281000 nanomol*hour/ Litre [nmol*h/L]
Geometric Coefficient of Variation 31.8
|
676000 nanomol*hour/ Litre [nmol*h/L]
Geometric Coefficient of Variation 30.7
|
988000 nanomol*hour/ Litre [nmol*h/L]
Geometric Coefficient of Variation 19.1
|
374000 nanomol*hour/ Litre [nmol*h/L]
Geometric Coefficient of Variation 4.69
|
—
|
630000 nanomol*hour/ Litre [nmol*h/L]
Geometric Coefficient of Variation 54.8
|
730000 nanomol*hour/ Litre [nmol*h/L]
Geometric Coefficient of Variation 20.3
|
SECONDARY outcome
Timeframe: Pharmacokinetic samples were collected at pre-dose and at 504.5, 505, 506, 507, 508, 510, 512, 527.917 hours after drug administration.Population: PKS
t1/2,ss, half-life of BI 860585 in plasma at steady state after multiple administration of BI 860585 (Day 22) in BI 860585 monotherapy and in combination with exemestane and paclitaxel.
Outcome measures
| Measure |
BI 860585 Monotherapy
n=3 Participants
Patients were administered with BI 860585 daily oral dose of 5 milligram starting dose) over 28-day treatment courses
|
BI 860585 + Exemestane
n=2 Participants
Patients were administered with daily oral dose of BI 860585 in combination with 25 milligram/day standard fixed dose of Exemestane over 28-day treatment courses
|
BI 860585 + Paclitaxel
n=2 Participants
Patients were administered with BI 860585 in combination with Paclitaxel weekly intravenous infusion of 60 milligram/meter\^2 for the first dose level/treatment cohort and 80 milligram/meter\^2 (the standard combination dose) for subsequent dose levels/treatment cohorts over 28-day treatment courses
|
40 mg BI 860585
n=3 Participants
Continuous daily oral dose of 40 milligram/day over 28-days treatment courses of BI 860585 Monotherapy
|
80 mg BI 860585
n=3 Participants
Continuous daily oral dose of 80 milligram/day over 28-days treatment courses of BI 860585 Monotherapy
|
120 mg BI 860585
Continuous daily oral dose of 120 milligram/day over 28-days treatment courses of BI 860585 Monotherapy
|
160 mg BI 860585
n=5 Participants
Continuous daily oral dose of 160 milligram/day over 28-days treatment courses of BI 860585 Monotherapy
|
220 mg BI 860585
n=5 Participants
Continuous daily oral dose of 220 milligram/day over 28-days treatment courses of BI 860585 Monotherapy
|
300 mg BI 860585
Continuous daily oral dose of 300 milligram/day over 28-days treatment courses of BI 860585 Monotherapy
|
40 mg BI 860585+25 mg Exemestane
n=3 Participants
Continuous daily oral dose of 25 mg/day standard fixed dose of exemestane over 28-day treatment courses combination with 40 mg BI 860585
|
80 mg BI 860585+25 mg Exemestane
n=3 Participants
Continuous daily oral dose of 25 mg/day standard fixed dose of exemestane over 28-day treatment courses combination with 80 mg BI 860585
|
120 mg BI 860585+25 mg Exemestane
n=5 Participants
Continuous daily oral dose of 25 mg/day standard fixed dose of exemestane over 28-day treatment courses combination with 120 mg BI 860585
|
160 mg BI 860585+25 mg Exemestane
n=7 Participants
Continuous daily oral dose of 25 mg/day standard fixed dose of exemestane over 28-day treatment courses combination with 160 mg BI 860585
|
80 mg BI 860585+60 mg/m^2 Paclitaxel
Patients were administered with 80 mg BI 860585 in combination with weekly intravenous infusion of 60 mg/m\^2 the standard combination dose of paclitaxel for the first dose level/treatment for subsequent dose levels/treatment cohorts over 28-day treatment courses
|
80 mg BI 860585+80 mg/m^2 Paclitaxel
Patients were administered with 80 mg BI 860585 in combination with weekly intravenous infusion of 80 mg/m\^2 the standard combination dose of paclitaxel for the first dose level/treatment for subsequent dose levels/treatment cohorts over 28-day treatment courses
|
120 mg BI 860585+80 mg/m^2 Paclitaxel
n=4 Participants
Patients were administered with 120 mg BI 860585 in combination with weekly intravenous infusion of 80 mg/m\^2 the standard combination dose of paclitaxel for the first dose level/treatment for subsequent dose levels/treatment cohorts over 28-day treatment courses
|
160 mg BI 860585+80 mg/m^2 Paclita
Continuous daily oral dose of 160 mg BI 860585 in combination with once weekly iv infusion of 80 mg/m\^2 paclitaxel
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Half Life of BI 860585 at Steady State (t1/2,ss)
|
31.5 Hour (h)
Geometric Coefficient of Variation 8.73
|
28.9 Hour (h)
Geometric Coefficient of Variation 47.4
|
33.1 Hour (h)
Geometric Coefficient of Variation 10.2
|
21.3 Hour (h)
Geometric Coefficient of Variation 20.0
|
29.8 Hour (h)
Geometric Coefficient of Variation 7.67
|
—
|
27.6 Hour (h)
Geometric Coefficient of Variation 18.3
|
24.9 Hour (h)
Geometric Coefficient of Variation 22.2
|
—
|
22.9 Hour (h)
Geometric Coefficient of Variation 13.8
|
24.7 Hour (h)
Geometric Coefficient of Variation 68.4
|
23.3 Hour (h)
Geometric Coefficient of Variation 7.82
|
25.3 Hour (h)
Geometric Coefficient of Variation 25.9
|
—
|
—
|
24.2 Hour (h)
Geometric Coefficient of Variation 37.2
|
—
|
SECONDARY outcome
Timeframe: Pharmacokinetic samples were collected at pre-dose and at 504.5, 505, 506, 507, 508, 510, 512, 527.917 hours after drug administration.Population: PKS
tmax,ss, Time to maximum concentration of BI 860585 at steady state after multiple administration of BI 860585 (Day 22) in BI 860585 monotherapy and in combination with exemestane and paclitaxel.
Outcome measures
| Measure |
BI 860585 Monotherapy
n=3 Participants
Patients were administered with BI 860585 daily oral dose of 5 milligram starting dose) over 28-day treatment courses
|
BI 860585 + Exemestane
n=3 Participants
Patients were administered with daily oral dose of BI 860585 in combination with 25 milligram/day standard fixed dose of Exemestane over 28-day treatment courses
|
BI 860585 + Paclitaxel
n=3 Participants
Patients were administered with BI 860585 in combination with Paclitaxel weekly intravenous infusion of 60 milligram/meter\^2 for the first dose level/treatment cohort and 80 milligram/meter\^2 (the standard combination dose) for subsequent dose levels/treatment cohorts over 28-day treatment courses
|
40 mg BI 860585
n=3 Participants
Continuous daily oral dose of 40 milligram/day over 28-days treatment courses of BI 860585 Monotherapy
|
80 mg BI 860585
n=3 Participants
Continuous daily oral dose of 80 milligram/day over 28-days treatment courses of BI 860585 Monotherapy
|
120 mg BI 860585
n=6 Participants
Continuous daily oral dose of 120 milligram/day over 28-days treatment courses of BI 860585 Monotherapy
|
160 mg BI 860585
n=5 Participants
Continuous daily oral dose of 160 milligram/day over 28-days treatment courses of BI 860585 Monotherapy
|
220 mg BI 860585
n=5 Participants
Continuous daily oral dose of 220 milligram/day over 28-days treatment courses of BI 860585 Monotherapy
|
300 mg BI 860585
n=2 Participants
Continuous daily oral dose of 300 milligram/day over 28-days treatment courses of BI 860585 Monotherapy
|
40 mg BI 860585+25 mg Exemestane
n=3 Participants
Continuous daily oral dose of 25 mg/day standard fixed dose of exemestane over 28-day treatment courses combination with 40 mg BI 860585
|
80 mg BI 860585+25 mg Exemestane
n=3 Participants
Continuous daily oral dose of 25 mg/day standard fixed dose of exemestane over 28-day treatment courses combination with 80 mg BI 860585
|
120 mg BI 860585+25 mg Exemestane
n=5 Participants
Continuous daily oral dose of 25 mg/day standard fixed dose of exemestane over 28-day treatment courses combination with 120 mg BI 860585
|
160 mg BI 860585+25 mg Exemestane
n=7 Participants
Continuous daily oral dose of 25 mg/day standard fixed dose of exemestane over 28-day treatment courses combination with 160 mg BI 860585
|
80 mg BI 860585+60 mg/m^2 Paclitaxel
n=2 Participants
Patients were administered with 80 mg BI 860585 in combination with weekly intravenous infusion of 60 mg/m\^2 the standard combination dose of paclitaxel for the first dose level/treatment for subsequent dose levels/treatment cohorts over 28-day treatment courses
|
80 mg BI 860585+80 mg/m^2 Paclitaxel
n=4 Participants
Patients were administered with 80 mg BI 860585 in combination with weekly intravenous infusion of 80 mg/m\^2 the standard combination dose of paclitaxel for the first dose level/treatment for subsequent dose levels/treatment cohorts over 28-day treatment courses
|
120 mg BI 860585+80 mg/m^2 Paclitaxel
n=4 Participants
Patients were administered with 120 mg BI 860585 in combination with weekly intravenous infusion of 80 mg/m\^2 the standard combination dose of paclitaxel for the first dose level/treatment for subsequent dose levels/treatment cohorts over 28-day treatment courses
|
160 mg BI 860585+80 mg/m^2 Paclita
n=4 Participants
Continuous daily oral dose of 160 mg BI 860585 in combination with once weekly iv infusion of 80 mg/m\^2 paclitaxel
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Time to Maximum Concentration of BI 860585 at Steady State (Tmax,ss)
|
6.00 Hour (h)
Interval 1.95 to 6.0
|
2.02 Hour (h)
Interval 2.02 to 4.0
|
2.00 Hour (h)
Interval 1.0 to 4.07
|
3.00 Hour (h)
Interval 2.02 to 3.18
|
2.00 Hour (h)
Interval 0.983 to 3.03
|
3.61 Hour (h)
Interval 3.0 to 7.97
|
3.10 Hour (h)
Interval 2.98 to 4.05
|
3.03 Hour (h)
Interval 2.08 to 6.0
|
5.00 Hour (h)
Interval 2.0 to 8.0
|
3.98 Hour (h)
Interval 2.0 to 4.0
|
2.00 Hour (h)
Interval 1.0 to 2.97
|
3.00 Hour (h)
Interval 1.0 to 6.0
|
2.02 Hour (h)
Interval 1.5 to 4.02
|
2.03 Hour (h)
Interval 2.0 to 2.05
|
4.92 Hour (h)
Interval 3.05 to 8.12
|
2.50 Hour (h)
Interval 1.0 to 3.0
|
6.00 Hour (h)
Interval 3.98 to 8.0
|
SECONDARY outcome
Timeframe: Pharmacokinetic samples were collected at pre-dose and at 504.5, 505, 506, 507, 508, 510, 512, 527.917 hours after drug administration.Population: PKS
Cmax,ss, maximum measured concentration at steady state after multiple administration of BI 860585 (Day 22) in BI 860585 monotherapy and in combination with exemestane and paclitaxel.
Outcome measures
| Measure |
BI 860585 Monotherapy
n=3 Participants
Patients were administered with BI 860585 daily oral dose of 5 milligram starting dose) over 28-day treatment courses
|
BI 860585 + Exemestane
n=3 Participants
Patients were administered with daily oral dose of BI 860585 in combination with 25 milligram/day standard fixed dose of Exemestane over 28-day treatment courses
|
BI 860585 + Paclitaxel
n=3 Participants
Patients were administered with BI 860585 in combination with Paclitaxel weekly intravenous infusion of 60 milligram/meter\^2 for the first dose level/treatment cohort and 80 milligram/meter\^2 (the standard combination dose) for subsequent dose levels/treatment cohorts over 28-day treatment courses
|
40 mg BI 860585
n=3 Participants
Continuous daily oral dose of 40 milligram/day over 28-days treatment courses of BI 860585 Monotherapy
|
80 mg BI 860585
n=3 Participants
Continuous daily oral dose of 80 milligram/day over 28-days treatment courses of BI 860585 Monotherapy
|
120 mg BI 860585
n=6 Participants
Continuous daily oral dose of 120 milligram/day over 28-days treatment courses of BI 860585 Monotherapy
|
160 mg BI 860585
n=5 Participants
Continuous daily oral dose of 160 milligram/day over 28-days treatment courses of BI 860585 Monotherapy
|
220 mg BI 860585
n=5 Participants
Continuous daily oral dose of 220 milligram/day over 28-days treatment courses of BI 860585 Monotherapy
|
300 mg BI 860585
n=2 Participants
Continuous daily oral dose of 300 milligram/day over 28-days treatment courses of BI 860585 Monotherapy
|
40 mg BI 860585+25 mg Exemestane
n=3 Participants
Continuous daily oral dose of 25 mg/day standard fixed dose of exemestane over 28-day treatment courses combination with 40 mg BI 860585
|
80 mg BI 860585+25 mg Exemestane
n=3 Participants
Continuous daily oral dose of 25 mg/day standard fixed dose of exemestane over 28-day treatment courses combination with 80 mg BI 860585
|
120 mg BI 860585+25 mg Exemestane
n=5 Participants
Continuous daily oral dose of 25 mg/day standard fixed dose of exemestane over 28-day treatment courses combination with 120 mg BI 860585
|
160 mg BI 860585+25 mg Exemestane
n=7 Participants
Continuous daily oral dose of 25 mg/day standard fixed dose of exemestane over 28-day treatment courses combination with 160 mg BI 860585
|
80 mg BI 860585+60 mg/m^2 Paclitaxel
n=2 Participants
Patients were administered with 80 mg BI 860585 in combination with weekly intravenous infusion of 60 mg/m\^2 the standard combination dose of paclitaxel for the first dose level/treatment for subsequent dose levels/treatment cohorts over 28-day treatment courses
|
80 mg BI 860585+80 mg/m^2 Paclitaxel
n=4 Participants
Patients were administered with 80 mg BI 860585 in combination with weekly intravenous infusion of 80 mg/m\^2 the standard combination dose of paclitaxel for the first dose level/treatment for subsequent dose levels/treatment cohorts over 28-day treatment courses
|
120 mg BI 860585+80 mg/m^2 Paclitaxel
n=4 Participants
Patients were administered with 120 mg BI 860585 in combination with weekly intravenous infusion of 80 mg/m\^2 the standard combination dose of paclitaxel for the first dose level/treatment for subsequent dose levels/treatment cohorts over 28-day treatment courses
|
160 mg BI 860585+80 mg/m^2 Paclita
n=4 Participants
Continuous daily oral dose of 160 mg BI 860585 in combination with once weekly iv infusion of 80 mg/m\^2 paclitaxel
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Maximum Measured Concentration of BI 860585 in Plasma at Steady State (Cmax,ss)
|
1730 nanomol/ Litre [nmol/L]
Geometric Coefficient of Variation 18.5
|
3720 nanomol/ Litre [nmol/L]
Geometric Coefficient of Variation 47
|
6630 nanomol/ Litre [nmol/L]
Geometric Coefficient of Variation 0.832
|
11600 nanomol/ Litre [nmol/L]
Geometric Coefficient of Variation 21.5
|
29700 nanomol/ Litre [nmol/L]
Geometric Coefficient of Variation 28.2
|
33700 nanomol/ Litre [nmol/L]
Geometric Coefficient of Variation 26.6
|
50100 nanomol/ Litre [nmol/L]
Geometric Coefficient of Variation 16.7
|
50500 nanomol/ Litre [nmol/L]
Geometric Coefficient of Variation 27.1
|
75700 nanomol/ Litre [nmol/L]
Geometric Coefficient of Variation 17.5
|
16700 nanomol/ Litre [nmol/L]
Geometric Coefficient of Variation 3.63
|
19600 nanomol/ Litre [nmol/L]
Geometric Coefficient of Variation 31.2
|
43800 nanomol/ Litre [nmol/L]
Geometric Coefficient of Variation 30.5
|
61400 nanomol/ Litre [nmol/L]
Geometric Coefficient of Variation 25.7
|
20500 nanomol/ Litre [nmol/L]
Geometric Coefficient of Variation 13.8
|
20700 nanomol/ Litre [nmol/L]
Geometric Coefficient of Variation 39.6
|
38900 nanomol/ Litre [nmol/L]
Geometric Coefficient of Variation 56.4
|
35400 nanomol/ Litre [nmol/L]
Geometric Coefficient of Variation 40.7
|
Adverse Events
5 mg BI 860585
Serious events: 2 serious events
Other events: 3 other events
Deaths: 1 deaths
10 mg BI 860585
Serious events: 1 serious events
Other events: 3 other events
Deaths: 1 deaths
20 mg BI 860585
Serious events: 2 serious events
Other events: 3 other events
Deaths: 1 deaths
40 mg BI 860585
Serious events: 1 serious events
Other events: 3 other events
Deaths: 0 deaths
80 mg BI 860585
Serious events: 2 serious events
Other events: 3 other events
Deaths: 0 deaths
120 mg BI 860585
Serious events: 4 serious events
Other events: 7 other events
Deaths: 1 deaths
160 mg BI 860585
Serious events: 4 serious events
Other events: 7 other events
Deaths: 1 deaths
220 mg BI 860585
Serious events: 4 serious events
Other events: 9 other events
Deaths: 0 deaths
300 mg BI 860585
Serious events: 2 serious events
Other events: 3 other events
Deaths: 0 deaths
40 mg BI 860585+25 mg Exemestane
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
80 mg BI 860585+25 mg Exemestane
Serious events: 4 serious events
Other events: 4 other events
Deaths: 3 deaths
120 mg BI 860585+25 mg Exemestane
Serious events: 3 serious events
Other events: 7 other events
Deaths: 1 deaths
160 mg BI 860585+25 mg Exemestane
Serious events: 2 serious events
Other events: 8 other events
Deaths: 0 deaths
220 mg BI 860585+25 mg Exemestane
Serious events: 1 serious events
Other events: 3 other events
Deaths: 0 deaths
80 mg BI 860585+60 mg/m^2 Paclitaxel
Serious events: 2 serious events
Other events: 3 other events
Deaths: 0 deaths
80 mg BI 860585+80 mg/m^2 Paclitaxel
Serious events: 3 serious events
Other events: 4 other events
Deaths: 0 deaths
120 mg BI 860585+80 mg/m^2 Paclitaxel
Serious events: 3 serious events
Other events: 7 other events
Deaths: 0 deaths
160 mg BI 860585+80 mg/m^2 Paclitaxel
Serious events: 4 serious events
Other events: 7 other events
Deaths: 0 deaths
220 mg BI 860585+80 mg/m^2 Paclitaxel
Serious events: 1 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
5 mg BI 860585
n=3 participants at risk
Continuous daily oral dose of 5 milligram/day (starting dose) over 28-day treatment courses of BI 860585 Monotherapy
|
10 mg BI 860585
n=3 participants at risk
Continuous daily oral dose of 10 milligram/day over 28-days treatment courses of BI 860585 Monotherapy
|
20 mg BI 860585
n=3 participants at risk
Continuous daily oral dose of 20 milligram/day over 28-days treatment courses of BI 860585 Monotherapy
|
40 mg BI 860585
n=3 participants at risk
Continuous daily oral dose of 40 milligram/day over 28-days treatment courses of BI 860585 Monotherapy
|
80 mg BI 860585
n=3 participants at risk
Continuous daily oral dose of 80 milligram/day over 28-days treatment courses of BI 860585 Monotherapy
|
120 mg BI 860585
n=7 participants at risk
Continuous daily oral dose of 120 milligram/day over 28-days treatment courses of BI 860585 Monotherapy
|
160 mg BI 860585
n=7 participants at risk
Continuous daily oral dose of 160 milligram/day over 28-days treatment courses of BI 860585 Monotherapy
|
220 mg BI 860585
n=9 participants at risk
Continuous daily oral dose of 220 milligram/day over 28-days treatment courses of BI 860585 Monotherapy
|
300 mg BI 860585
n=3 participants at risk
Continuous daily oral dose of 300 milligram/day over 28-days treatment courses of BI 860585 Monotherapy
|
40 mg BI 860585+25 mg Exemestane
n=3 participants at risk
Patients were administered with daily oral dose of 40 mg BI 860585 in combination with 25 mg exemestane standard fixed dose over 28-day treatment courses
|
80 mg BI 860585+25 mg Exemestane
n=4 participants at risk
Patients were administered with daily oral dose of 80 mg BI 860585 in combination with 25 mg exemestane standard fixed dose over 28-day treatment courses
|
120 mg BI 860585+25 mg Exemestane
n=7 participants at risk
Patients were administered with daily oral dose of 120 mg BI 860585 in combination with 25 mg exemestane standard fixed dose over 28-day treatment courses
|
160 mg BI 860585+25 mg Exemestane
n=8 participants at risk
Patients were administered with daily oral dose of 160 mg BI 860585 in combination with 25 mg exemestane standard fixed dose over 28-day treatment courses
|
220 mg BI 860585+25 mg Exemestane
n=3 participants at risk
Patients were administered with daily oral dose of 220 mg BI 860585 in combination with 25 mg exemestane standard fixed dose over 28-day treatment courses
|
80 mg BI 860585+60 mg/m^2 Paclitaxel
n=3 participants at risk
Patients were administered with 80 mg BI 860585 in combination with weekly intravenous infusion of 60 mg/m\^2 the standard combination dose of paclitaxel for the first dose level/treatment for subsequent dose levels/treatment cohorts over 28-day treatment courses
|
80 mg BI 860585+80 mg/m^2 Paclitaxel
n=4 participants at risk
Patients were administered with 80 mg BI 860585 in combination with weekly intravenous infusion of 80 mg/m\^2 the standard combination dose of paclitaxel for the first dose level/treatment for subsequent dose levels/treatment cohorts over 28-day treatment courses
|
120 mg BI 860585+80 mg/m^2 Paclitaxel
n=7 participants at risk
Patients were administered with 120 mg BI 860585 in combination with weekly intravenous infusion of 80 mg/m\^2 the standard combination dose of paclitaxel for the first dose level/treatment for subsequent dose levels/treatment cohorts over 28-day treatment courses
|
160 mg BI 860585+80 mg/m^2 Paclitaxel
n=7 participants at risk
Patients were administered with 160 mg BI 860585 in combination with weekly intravenous infusion of 80 mg/m\^2 the standard combination dose of paclitaxel for the first dose level/treatment for subsequent dose levels/treatment cohorts over 28-day treatment courses
|
220 mg BI 860585+80 mg/m^2 Paclitaxel
n=3 participants at risk
Patients were administered with 220 mg BI 860585 in combination with weekly intravenous infusion of 80 mg/m\^2 the standard combination dose of paclitaxel for the first dose level/treatment for subsequent dose levels/treatment cohorts over 28-day treatment courses
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Infections and infestations
Perihepatic abscess
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
14.3%
1/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/9 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/4 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/8 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/4 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
11.1%
1/9 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/4 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/8 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/4 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/9 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
25.0%
1/4 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/8 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
25.0%
1/4 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/9 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/4 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/8 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/4 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
14.3%
1/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
|
Gastrointestinal disorders
Colonic fistula
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/9 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/4 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/8 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
25.0%
1/4 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
14.3%
1/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/9 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/4 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
12.5%
1/8 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/4 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
14.3%
1/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/9 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/4 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/8 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/4 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
14.3%
1/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
|
Gastrointestinal disorders
Haemorrhoidal haemorrhage
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
11.1%
1/9 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/4 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/8 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/4 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
|
Gastrointestinal disorders
Intestinal obstruction
|
33.3%
1/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/9 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/4 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/8 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/4 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/9 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
25.0%
1/4 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/8 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/4 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
|
Gastrointestinal disorders
Oesophagitis
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
14.3%
1/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/9 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/4 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/8 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/4 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
14.3%
1/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/9 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/4 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/8 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/4 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
14.3%
1/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
|
General disorders
Chest pain
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/9 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/4 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/8 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
25.0%
1/4 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
|
General disorders
Condition aggravated
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
11.1%
1/9 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/4 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/8 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/4 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
|
General disorders
Fatigue
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/9 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/4 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/8 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/4 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
14.3%
1/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
|
General disorders
General physical health deterioration
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
33.3%
1/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
33.3%
1/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/9 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
25.0%
1/4 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/8 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/4 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
|
General disorders
Oedema peripheral
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/9 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/4 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
14.3%
1/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/8 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/4 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
|
Hepatobiliary disorders
Bile duct obstruction
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
14.3%
1/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/9 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/4 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/8 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/4 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
|
Hepatobiliary disorders
Hepatic failure
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
14.3%
1/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/9 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/4 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/8 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/4 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
14.3%
1/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
|
Infections and infestations
Biliary tract infection
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
14.3%
1/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/9 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/4 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/8 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/4 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
|
Infections and infestations
Peritonitis
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/9 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/4 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
14.3%
1/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/8 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/4 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/9 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
33.3%
1/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/4 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/8 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
33.3%
1/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/4 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
|
Infections and infestations
Sepsis
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/9 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/4 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
14.3%
1/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/8 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/4 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/9 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/4 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/8 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
33.3%
1/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/4 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
|
Infections and infestations
Viral oesophagitis
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/9 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/4 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/8 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/4 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
14.3%
1/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
|
Injury, poisoning and procedural complications
Anaesthetic complication pulmonary
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/9 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/4 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
14.3%
1/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/8 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/4 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
|
Injury, poisoning and procedural complications
Craniocerebral injury
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
14.3%
1/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/9 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/4 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/8 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/4 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
|
Injury, poisoning and procedural complications
Overdose
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/9 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/4 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
12.5%
1/8 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
25.0%
1/4 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
14.3%
1/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/9 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/4 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/8 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/4 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
14.3%
1/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/9 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/4 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/8 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/4 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
33.3%
1/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/9 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/4 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
12.5%
1/8 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/4 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/9 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
25.0%
1/4 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/8 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/4 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
28.6%
2/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/9 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/4 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/8 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
33.3%
1/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/4 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
14.3%
1/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/9 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
25.0%
1/4 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/8 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/4 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/9 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/4 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/8 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/4 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
14.3%
1/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
33.3%
1/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/9 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/4 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/8 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/4 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/9 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/4 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
12.5%
1/8 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/4 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
|
Nervous system disorders
Syncope
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/9 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/4 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
14.3%
1/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/8 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/4 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
33.3%
1/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/9 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/4 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/8 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/4 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
14.3%
1/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/9 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/4 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/8 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/4 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/9 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/4 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/8 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
25.0%
1/4 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cancer pain
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/9 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/4 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
14.3%
1/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/8 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/4 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant neoplasm progression
|
33.3%
1/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
33.3%
1/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
33.3%
1/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
11.1%
1/9 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
50.0%
2/4 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/8 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
25.0%
1/4 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to central nervous system
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
28.6%
2/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/9 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/4 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/8 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/4 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
|
Nervous system disorders
Ischaemic stroke
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
33.3%
1/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/9 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/4 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/8 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/4 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
33.3%
1/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
|
Nervous system disorders
Neurological decompensation
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/9 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
33.3%
1/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/4 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/8 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/4 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
|
Nervous system disorders
Neurotoxicity
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/9 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/4 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/8 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
25.0%
1/4 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
|
Nervous system disorders
Paraparesis
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
11.1%
1/9 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/4 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/8 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/4 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
|
Psychiatric disorders
Suicidal ideation
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
11.1%
1/9 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/4 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/8 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/4 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/9 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/4 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/8 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/4 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
14.3%
1/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
|
Renal and urinary disorders
Renal failure
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/9 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
25.0%
1/4 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/8 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/4 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/9 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/4 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/8 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/4 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
14.3%
1/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/9 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/4 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
14.3%
1/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/8 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/4 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/9 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/4 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/8 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
25.0%
1/4 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/9 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/4 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/8 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/4 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
14.3%
1/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
33.3%
1/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/9 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/4 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/8 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
25.0%
1/4 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
14.3%
1/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
14.3%
1/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/9 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/4 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/8 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/4 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
14.3%
1/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/9 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/4 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/8 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/4 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
14.3%
1/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
14.3%
1/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/9 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/4 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/8 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
33.3%
1/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/4 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
|
Vascular disorders
Aorto-duodenal fistula
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/9 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
25.0%
1/4 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/8 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/4 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
|
Vascular disorders
Deep vein thrombosis
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
11.1%
1/9 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/4 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/8 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/4 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
|
Vascular disorders
Shock
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/9 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
25.0%
1/4 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/8 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/4 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
Other adverse events
| Measure |
5 mg BI 860585
n=3 participants at risk
Continuous daily oral dose of 5 milligram/day (starting dose) over 28-day treatment courses of BI 860585 Monotherapy
|
10 mg BI 860585
n=3 participants at risk
Continuous daily oral dose of 10 milligram/day over 28-days treatment courses of BI 860585 Monotherapy
|
20 mg BI 860585
n=3 participants at risk
Continuous daily oral dose of 20 milligram/day over 28-days treatment courses of BI 860585 Monotherapy
|
40 mg BI 860585
n=3 participants at risk
Continuous daily oral dose of 40 milligram/day over 28-days treatment courses of BI 860585 Monotherapy
|
80 mg BI 860585
n=3 participants at risk
Continuous daily oral dose of 80 milligram/day over 28-days treatment courses of BI 860585 Monotherapy
|
120 mg BI 860585
n=7 participants at risk
Continuous daily oral dose of 120 milligram/day over 28-days treatment courses of BI 860585 Monotherapy
|
160 mg BI 860585
n=7 participants at risk
Continuous daily oral dose of 160 milligram/day over 28-days treatment courses of BI 860585 Monotherapy
|
220 mg BI 860585
n=9 participants at risk
Continuous daily oral dose of 220 milligram/day over 28-days treatment courses of BI 860585 Monotherapy
|
300 mg BI 860585
n=3 participants at risk
Continuous daily oral dose of 300 milligram/day over 28-days treatment courses of BI 860585 Monotherapy
|
40 mg BI 860585+25 mg Exemestane
n=3 participants at risk
Patients were administered with daily oral dose of 40 mg BI 860585 in combination with 25 mg exemestane standard fixed dose over 28-day treatment courses
|
80 mg BI 860585+25 mg Exemestane
n=4 participants at risk
Patients were administered with daily oral dose of 80 mg BI 860585 in combination with 25 mg exemestane standard fixed dose over 28-day treatment courses
|
120 mg BI 860585+25 mg Exemestane
n=7 participants at risk
Patients were administered with daily oral dose of 120 mg BI 860585 in combination with 25 mg exemestane standard fixed dose over 28-day treatment courses
|
160 mg BI 860585+25 mg Exemestane
n=8 participants at risk
Patients were administered with daily oral dose of 160 mg BI 860585 in combination with 25 mg exemestane standard fixed dose over 28-day treatment courses
|
220 mg BI 860585+25 mg Exemestane
n=3 participants at risk
Patients were administered with daily oral dose of 220 mg BI 860585 in combination with 25 mg exemestane standard fixed dose over 28-day treatment courses
|
80 mg BI 860585+60 mg/m^2 Paclitaxel
n=3 participants at risk
Patients were administered with 80 mg BI 860585 in combination with weekly intravenous infusion of 60 mg/m\^2 the standard combination dose of paclitaxel for the first dose level/treatment for subsequent dose levels/treatment cohorts over 28-day treatment courses
|
80 mg BI 860585+80 mg/m^2 Paclitaxel
n=4 participants at risk
Patients were administered with 80 mg BI 860585 in combination with weekly intravenous infusion of 80 mg/m\^2 the standard combination dose of paclitaxel for the first dose level/treatment for subsequent dose levels/treatment cohorts over 28-day treatment courses
|
120 mg BI 860585+80 mg/m^2 Paclitaxel
n=7 participants at risk
Patients were administered with 120 mg BI 860585 in combination with weekly intravenous infusion of 80 mg/m\^2 the standard combination dose of paclitaxel for the first dose level/treatment for subsequent dose levels/treatment cohorts over 28-day treatment courses
|
160 mg BI 860585+80 mg/m^2 Paclitaxel
n=7 participants at risk
Patients were administered with 160 mg BI 860585 in combination with weekly intravenous infusion of 80 mg/m\^2 the standard combination dose of paclitaxel for the first dose level/treatment for subsequent dose levels/treatment cohorts over 28-day treatment courses
|
220 mg BI 860585+80 mg/m^2 Paclitaxel
n=3 participants at risk
Patients were administered with 220 mg BI 860585 in combination with weekly intravenous infusion of 80 mg/m\^2 the standard combination dose of paclitaxel for the first dose level/treatment for subsequent dose levels/treatment cohorts over 28-day treatment courses
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Infections and infestations
Viral infection
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/9 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/4 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
12.5%
1/8 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/4 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
|
Infections and infestations
Paronychia
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
33.3%
1/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/9 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/4 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/8 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
66.7%
2/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/4 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
14.3%
1/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
14.3%
1/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
|
Gastrointestinal disorders
Oesophagitis
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/9 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/4 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/8 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/4 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
14.3%
1/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
|
Infections and infestations
Cystitis
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/9 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
33.3%
1/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/4 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
14.3%
1/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
12.5%
1/8 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/4 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
33.3%
1/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
|
Infections and infestations
Nail infection
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/9 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/4 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/8 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
33.3%
1/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/4 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
|
Infections and infestations
Oral fungal infection
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/9 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/4 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/8 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/4 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
14.3%
1/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
|
Gastrointestinal disorders
Vomiting
|
100.0%
3/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
33.3%
1/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
33.3%
1/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
57.1%
4/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
42.9%
3/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
44.4%
4/9 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
33.3%
1/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
75.0%
3/4 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
42.9%
3/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/8 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
33.3%
1/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
33.3%
1/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
25.0%
1/4 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
28.6%
2/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
14.3%
1/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
33.3%
1/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
|
General disorders
Asthenia
|
66.7%
2/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
33.3%
1/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
33.3%
1/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
28.6%
2/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
11.1%
1/9 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
33.3%
1/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
25.0%
1/4 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
14.3%
1/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/8 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
33.3%
1/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
25.0%
1/4 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
14.3%
1/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
14.3%
1/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
|
General disorders
Chest pain
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
33.3%
1/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
28.6%
2/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
11.1%
1/9 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
33.3%
1/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
33.3%
1/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
25.0%
1/4 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
28.6%
2/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/8 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
33.3%
1/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
33.3%
1/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
25.0%
1/4 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
|
General disorders
Chills
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
33.3%
1/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/9 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/4 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/8 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/4 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
|
General disorders
Cyst
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/9 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/4 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
12.5%
1/8 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/4 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
|
General disorders
Disease progression
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/9 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
33.3%
1/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/4 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/8 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/4 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
|
General disorders
Facial pain
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/9 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/4 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
12.5%
1/8 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/4 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
|
General disorders
Fatigue
|
33.3%
1/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
66.7%
2/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
66.7%
2/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
33.3%
1/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
66.7%
2/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
14.3%
1/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
28.6%
2/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
55.6%
5/9 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
100.0%
3/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
66.7%
2/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
50.0%
2/4 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
42.9%
3/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
50.0%
4/8 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
66.7%
2/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
66.7%
2/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
75.0%
3/4 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
71.4%
5/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
85.7%
6/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
33.3%
1/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
|
General disorders
Gait disturbance
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/9 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/4 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/8 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
25.0%
1/4 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
|
General disorders
General physical health deterioration
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/9 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/4 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/8 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
33.3%
1/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/4 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
|
General disorders
Generalised oedema
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/9 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/4 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
14.3%
1/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/8 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/4 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
|
General disorders
Hyperpyrexia
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/9 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/4 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
12.5%
1/8 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/4 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
14.3%
1/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
|
General disorders
Impaired healing
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
11.1%
1/9 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/4 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/8 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/4 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
|
General disorders
Influenza like illness
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
11.1%
1/9 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/4 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/8 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
25.0%
1/4 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
14.3%
1/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
|
General disorders
Localised oedema
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/9 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/4 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
14.3%
1/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/8 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/4 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
|
General disorders
Malaise
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
33.3%
1/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
11.1%
1/9 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/4 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/8 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
25.0%
1/4 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
|
General disorders
Mucosal inflammation
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
14.3%
1/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/9 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/4 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/8 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/4 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
14.3%
1/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
33.3%
1/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
|
General disorders
Oedema peripheral
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
33.3%
1/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
14.3%
1/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
11.1%
1/9 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
33.3%
1/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/4 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
42.9%
3/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
25.0%
2/8 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
33.3%
1/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
25.0%
1/4 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
|
General disorders
Pain
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
14.3%
1/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/9 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/4 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/8 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
25.0%
1/4 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
|
General disorders
Pyrexia
|
33.3%
1/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
33.3%
1/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
33.3%
1/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
33.3%
1/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
33.3%
1/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
14.3%
1/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
28.6%
2/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
11.1%
1/9 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/4 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
14.3%
1/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
25.0%
2/8 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
33.3%
1/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
50.0%
2/4 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
28.6%
2/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
28.6%
2/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
|
Hepatobiliary disorders
Hepatitis
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/9 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/4 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
12.5%
1/8 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/4 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
|
Immune system disorders
Hypersensitivity
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/9 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/4 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/8 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
33.3%
1/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/4 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
|
Infections and infestations
Body tinea
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
14.3%
1/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/9 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/4 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/8 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/4 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
|
Infections and infestations
Bronchiolitis
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/9 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/4 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
12.5%
1/8 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/4 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
|
Infections and infestations
Bronchitis
|
33.3%
1/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
33.3%
1/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/9 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/4 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
12.5%
1/8 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/4 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
|
Infections and infestations
Conjunctivitis
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/9 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/4 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
12.5%
1/8 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/4 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
|
Infections and infestations
Erysipelas
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/9 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/4 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
12.5%
1/8 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/4 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
|
Infections and infestations
Escherichia urinary tract infection
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/9 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/4 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/8 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/4 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
14.3%
1/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
|
Infections and infestations
Eye infection
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/9 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/4 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
12.5%
1/8 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/4 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
|
Infections and infestations
Folliculitis
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
14.3%
1/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/9 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/4 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
12.5%
1/8 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/4 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
33.3%
1/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
|
Infections and infestations
Fungal skin infection
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
33.3%
1/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/9 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/4 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/8 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/4 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
33.3%
1/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/9 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/4 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/8 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/4 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
|
Infections and infestations
Gastroenteritis viral
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/9 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/4 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/8 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
33.3%
1/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
33.3%
1/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/4 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
|
Infections and infestations
Herpes zoster
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/9 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
33.3%
1/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/4 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
14.3%
1/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/8 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/4 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
33.3%
1/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
|
Infections and infestations
Influenza
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/9 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/4 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/8 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/4 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
14.3%
1/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
|
Infections and infestations
Lip infection
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/9 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/4 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/8 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/4 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
14.3%
1/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
|
Infections and infestations
Lung infection
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
11.1%
1/9 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/4 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
12.5%
1/8 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/4 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/9 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
33.3%
1/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/4 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/8 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
33.3%
1/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/4 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
|
Infections and infestations
Rash pustular
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
11.1%
1/9 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/4 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/8 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/4 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
|
Infections and infestations
Respiratory tract infection
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/9 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/4 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/8 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/4 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
33.3%
1/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
|
Infections and infestations
Rhinitis
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
33.3%
1/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
14.3%
1/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/9 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
33.3%
1/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/4 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
12.5%
1/8 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/4 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
14.3%
1/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
|
Infections and infestations
Sinusitis
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/9 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
25.0%
1/4 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
12.5%
1/8 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/4 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
|
Infections and infestations
Skin infection
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/9 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/4 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/8 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/4 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
28.6%
2/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
|
Infections and infestations
Tooth infection
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/9 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/4 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/8 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
25.0%
1/4 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
11.1%
1/9 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/4 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/8 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
33.3%
1/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/4 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
14.3%
1/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/9 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/4 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
14.3%
1/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/8 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
66.7%
2/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/4 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
14.3%
1/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
|
Infections and infestations
Urinary tract infection bacterial
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
14.3%
1/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/9 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/4 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/8 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/4 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
|
Infections and infestations
Viral oesophagitis
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/9 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/4 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/8 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/4 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
14.3%
1/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
|
Gastrointestinal disorders
Faeces soft
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/9 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/4 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/8 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
25.0%
1/4 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
|
Infections and infestations
Viral upper respiratory tract infection
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/9 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/4 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
14.3%
1/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
12.5%
1/8 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
33.3%
1/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/4 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
33.3%
1/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
14.3%
1/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/9 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/4 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
12.5%
1/8 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/4 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
|
Injury, poisoning and procedural complications
Laceration
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/9 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/4 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
12.5%
1/8 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/4 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
|
Infections and infestations
Vulvovaginal candidiasis
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/9 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/4 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
12.5%
1/8 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/4 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
|
Injury, poisoning and procedural complications
Eye contusion
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/9 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/4 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/8 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/4 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
14.3%
1/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
33.3%
1/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/9 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/4 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/8 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/4 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
|
Blood and lymphatic system disorders
Anaemia
|
33.3%
1/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
33.3%
1/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
33.3%
1/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
14.3%
1/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
22.2%
2/9 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
33.3%
1/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
50.0%
2/4 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
28.6%
2/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
25.0%
2/8 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
33.3%
1/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
66.7%
2/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
75.0%
3/4 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
42.9%
3/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
57.1%
4/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
|
Blood and lymphatic system disorders
Leukopenia
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
14.3%
1/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/9 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/4 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/8 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/4 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
14.3%
1/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
14.3%
1/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
|
Blood and lymphatic system disorders
Lymphopenia
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/9 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/4 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/8 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/4 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
14.3%
1/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
33.3%
1/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
14.3%
1/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/9 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/4 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/8 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
66.7%
2/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/4 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
42.9%
3/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
14.3%
1/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
33.3%
1/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
14.3%
1/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
11.1%
1/9 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/4 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
12.5%
1/8 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/4 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
14.3%
1/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
|
Cardiac disorders
Bradycardia
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
14.3%
1/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/9 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/4 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/8 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/4 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
|
Cardiac disorders
Sinus tachycardia
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/9 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/4 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/8 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/4 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
14.3%
1/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/9 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
33.3%
1/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
25.0%
1/4 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/8 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/4 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
|
Ear and labyrinth disorders
Ear pain
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/9 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/4 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
14.3%
1/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/8 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/4 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
|
Ear and labyrinth disorders
Tinnitus
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/9 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/4 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/8 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/4 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
14.3%
1/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
14.3%
1/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/9 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/4 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
14.3%
1/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/8 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
25.0%
1/4 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
14.3%
1/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
|
Eye disorders
Cataract
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/9 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/4 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/8 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
33.3%
1/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/4 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
|
Eye disorders
Dry eye
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/9 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/4 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/8 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
33.3%
1/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/4 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
28.6%
2/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
|
Eye disorders
Lacrimation increased
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/9 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
33.3%
1/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/4 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/8 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/4 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
|
Eye disorders
Maculopathy
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/9 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/4 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/8 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/4 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
14.3%
1/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
|
Eye disorders
Vision blurred
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/9 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
33.3%
1/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/4 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/8 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/4 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
|
Eye disorders
Visual acuity reduced
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/9 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/4 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
14.3%
1/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/8 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/4 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
|
Eye disorders
Xerophthalmia
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/9 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/4 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/8 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/4 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
14.3%
1/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
11.1%
1/9 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/4 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/8 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
25.0%
1/4 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
|
Gastrointestinal disorders
Abdominal pain
|
100.0%
3/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
33.3%
1/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
28.6%
2/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
11.1%
1/9 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
33.3%
1/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/4 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
28.6%
2/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
25.0%
2/8 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
66.7%
2/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
75.0%
3/4 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
57.1%
4/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
28.6%
2/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
|
Gastrointestinal disorders
Abdominal pain lower
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/9 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
25.0%
1/4 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/8 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/4 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
33.3%
1/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
14.3%
1/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/9 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
33.3%
1/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/4 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
14.3%
1/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
12.5%
1/8 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
25.0%
1/4 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
14.3%
1/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
28.6%
2/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
|
Gastrointestinal disorders
Abnormal faeces
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/9 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/4 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/8 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
25.0%
1/4 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
|
Gastrointestinal disorders
Anal haemorrhage
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
11.1%
1/9 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/4 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/8 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/4 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
|
Gastrointestinal disorders
Aphthous ulcer
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/9 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/4 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/8 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/4 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
14.3%
1/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
|
Gastrointestinal disorders
Ascites
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
14.3%
1/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/9 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
25.0%
1/4 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/8 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/4 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
|
Gastrointestinal disorders
Constipation
|
33.3%
1/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
33.3%
1/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
14.3%
1/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
28.6%
2/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/9 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
33.3%
1/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/4 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
14.3%
1/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
12.5%
1/8 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
25.0%
1/4 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
28.6%
2/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
|
Gastrointestinal disorders
Diarrhoea
|
33.3%
1/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
100.0%
3/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
33.3%
1/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
42.9%
3/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
42.9%
3/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
66.7%
6/9 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
100.0%
3/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
33.3%
1/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/4 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
42.9%
3/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
75.0%
6/8 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
66.7%
2/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
33.3%
1/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
75.0%
3/4 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
57.1%
4/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
71.4%
5/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
100.0%
3/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
33.3%
1/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
14.3%
1/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
11.1%
1/9 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
50.0%
2/4 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
28.6%
2/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
12.5%
1/8 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
33.3%
1/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
66.7%
2/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
25.0%
1/4 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
14.3%
1/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
28.6%
2/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
|
Gastrointestinal disorders
Duodenal stenosis
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
14.3%
1/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/9 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/4 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/8 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/4 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
|
Gastrointestinal disorders
Duodenogastric reflux
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
14.3%
1/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/9 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/4 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/8 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/4 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
33.3%
1/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
33.3%
1/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/9 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
33.3%
1/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
50.0%
2/4 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/8 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/4 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
14.3%
1/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/9 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/4 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
14.3%
1/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/8 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/4 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
28.6%
2/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
|
Gastrointestinal disorders
Enterocolitis
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
33.3%
1/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/9 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/4 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/8 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/4 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
|
Gastrointestinal disorders
Faecaloma
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
14.3%
1/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/9 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/4 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/8 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/4 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
|
Gastrointestinal disorders
Gastrointestinal disorder
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
14.3%
1/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/9 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/4 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/8 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/4 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/9 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
25.0%
1/4 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/8 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/4 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/9 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
33.3%
1/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/4 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
25.0%
2/8 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/4 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
14.3%
1/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
33.3%
1/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
|
Gastrointestinal disorders
Glossitis
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/9 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/4 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/8 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/4 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
14.3%
1/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
|
Gastrointestinal disorders
Glossodynia
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/9 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/4 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
12.5%
1/8 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/4 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
|
Gastrointestinal disorders
Haematemesis
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/9 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
25.0%
1/4 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/8 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/4 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
|
Gastrointestinal disorders
Haemorrhoidal haemorrhage
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
22.2%
2/9 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/4 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/8 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/4 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
11.1%
1/9 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/4 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/8 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/4 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
14.3%
1/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
|
Gastrointestinal disorders
Melaena
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/9 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
25.0%
1/4 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/8 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/4 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
|
Gastrointestinal disorders
Mouth ulceration
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/9 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/4 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/8 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
25.0%
1/4 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
|
Gastrointestinal disorders
Nausea
|
33.3%
1/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
66.7%
2/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
66.7%
2/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
33.3%
1/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
42.9%
3/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
57.1%
4/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
44.4%
4/9 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
66.7%
2/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
75.0%
3/4 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
57.1%
4/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
25.0%
2/8 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
33.3%
1/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
66.7%
2/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
50.0%
2/4 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
42.9%
3/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
28.6%
2/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
33.3%
1/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
|
Gastrointestinal disorders
Odynophagia
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/9 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/4 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/8 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/4 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
14.3%
1/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
|
Gastrointestinal disorders
Periodontal disease
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/9 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/4 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/8 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
33.3%
1/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/4 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
|
Gastrointestinal disorders
Proctalgia
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
11.1%
1/9 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/4 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/8 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/4 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
|
Gastrointestinal disorders
Proctitis
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/9 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
33.3%
1/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/4 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/8 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/4 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
|
Gastrointestinal disorders
Stomatitis
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
66.7%
2/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
33.3%
1/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
33.3%
1/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
42.9%
3/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
28.6%
2/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/9 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
66.7%
2/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/4 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
42.9%
3/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
62.5%
5/8 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
66.7%
2/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
66.7%
2/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
25.0%
1/4 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
14.3%
1/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
28.6%
2/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
33.3%
1/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
|
Gastrointestinal disorders
Swollen tongue
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
14.3%
1/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/9 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/4 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/8 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/4 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
|
Gastrointestinal disorders
Tongue ulceration
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
14.3%
1/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/9 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/4 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
14.3%
1/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/8 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/4 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
|
Gastrointestinal disorders
Umbilical hernia
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/9 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/4 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/8 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
25.0%
1/4 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
|
Investigations
Eosinophil count increased
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/9 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/4 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
12.5%
1/8 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/4 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
|
Metabolism and nutrition disorders
Iron deficiency
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
33.3%
1/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/9 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/4 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/8 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/4 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
|
Nervous system disorders
Neuropathy peripheral
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/9 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/4 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/8 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
25.0%
1/4 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
33.3%
1/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
|
Investigations
Alanine aminotransferase increased
|
33.3%
1/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
42.9%
3/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/9 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
66.7%
2/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/4 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
37.5%
3/8 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
33.3%
1/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/4 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
14.3%
1/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
33.3%
1/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
|
Investigations
Ammonia increased
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/9 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/4 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/8 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
25.0%
1/4 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
|
Investigations
Amylase increased
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
33.3%
1/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
11.1%
1/9 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
33.3%
1/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
25.0%
1/4 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/8 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
33.3%
1/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
25.0%
1/4 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
|
Investigations
Aspartate aminotransferase increased
|
33.3%
1/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
33.3%
1/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
33.3%
1/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
42.9%
3/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
11.1%
1/9 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
33.3%
1/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
66.7%
2/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
25.0%
1/4 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
28.6%
2/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
37.5%
3/8 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
33.3%
1/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
25.0%
1/4 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
14.3%
1/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
66.7%
2/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
|
Investigations
Blood albumin decreased
|
33.3%
1/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/9 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/4 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/8 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/4 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
|
Investigations
Blood alkaline phosphatase increased
|
66.7%
2/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
33.3%
1/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
33.3%
1/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
14.3%
1/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/9 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
33.3%
1/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
66.7%
2/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
25.0%
1/4 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
28.6%
2/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
25.0%
2/8 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
33.3%
1/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/4 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
28.6%
2/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
|
Investigations
Blood bilirubin increased
|
33.3%
1/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
33.3%
1/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
28.6%
2/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/9 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
25.0%
1/4 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
14.3%
1/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
12.5%
1/8 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/4 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
|
Investigations
Blood cholesterol increased
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/9 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/4 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/8 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
33.3%
1/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/4 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
|
Investigations
Blood creatine phosphokinase increased
|
66.7%
2/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
33.3%
1/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
28.6%
2/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
14.3%
1/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
11.1%
1/9 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
66.7%
2/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
66.7%
2/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
25.0%
1/4 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
14.3%
1/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
37.5%
3/8 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
33.3%
1/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
25.0%
1/4 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
14.3%
1/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
33.3%
1/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
|
Investigations
Blood creatinine increased
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
33.3%
1/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
33.3%
1/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
42.9%
3/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
22.2%
2/9 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
33.3%
1/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
25.0%
1/4 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
14.3%
1/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
25.0%
2/8 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
33.3%
1/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
25.0%
1/4 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
14.3%
1/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
14.3%
1/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
|
Investigations
C-reactive protein increased
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/9 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/4 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/8 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
25.0%
1/4 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
|
Investigations
Electrocardiogram QT prolonged
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
14.3%
1/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/9 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/4 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
14.3%
1/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/8 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/4 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
|
Investigations
Electrocardiogram T wave inversion
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/9 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/4 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
14.3%
1/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/8 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/4 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
|
Investigations
Gamma-glutamyltransferase increased
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/9 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
33.3%
1/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
25.0%
1/4 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
25.0%
2/8 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
33.3%
1/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/4 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
28.6%
2/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
|
Investigations
Glycosylated haemoglobin increased
|
33.3%
1/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/9 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/4 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/8 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
33.3%
1/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/4 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
14.3%
1/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
|
Investigations
International normalised ratio increased
|
33.3%
1/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
14.3%
1/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/9 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/4 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/8 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/4 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
14.3%
1/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
14.3%
1/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
|
Investigations
Lipase increased
|
33.3%
1/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
14.3%
1/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
11.1%
1/9 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
100.0%
3/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
33.3%
1/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
25.0%
1/4 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
37.5%
3/8 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
33.3%
1/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
25.0%
1/4 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
|
Investigations
Neutrophil count decreased
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/9 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/4 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
14.3%
1/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/8 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/4 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
14.3%
1/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
|
Investigations
Platelet count decreased
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/9 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
33.3%
1/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/4 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
28.6%
2/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/8 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/4 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
14.3%
1/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
|
Investigations
Weight decreased
|
33.3%
1/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
33.3%
1/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/9 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
66.7%
2/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/4 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
12.5%
1/8 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/4 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
57.1%
4/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
28.6%
2/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
33.3%
1/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
|
Investigations
White blood cell count decreased
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/9 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/4 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
14.3%
1/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/8 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
66.7%
2/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/4 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
42.9%
3/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
14.3%
1/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
66.7%
2/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
100.0%
3/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
66.7%
2/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
33.3%
1/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
42.9%
3/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
42.9%
3/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
33.3%
3/9 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
66.7%
2/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
33.3%
1/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
50.0%
2/4 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
14.3%
1/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
50.0%
4/8 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
33.3%
1/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
33.3%
1/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
50.0%
2/4 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
85.7%
6/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
42.9%
3/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
66.7%
2/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
33.3%
1/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/9 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/4 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
12.5%
1/8 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/4 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
14.3%
1/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
14.3%
1/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
|
Metabolism and nutrition disorders
Gout
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/9 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/4 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
12.5%
1/8 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/4 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
14.3%
1/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
|
Metabolism and nutrition disorders
Hyperammonaemia
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
14.3%
1/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/9 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/4 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/8 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/4 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
33.3%
1/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
33.3%
1/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/9 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
33.3%
1/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/4 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
14.3%
1/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/8 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
33.3%
1/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/4 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
33.3%
1/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
|
Metabolism and nutrition disorders
Hypercholesterolaemia
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
33.3%
1/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
14.3%
1/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
14.3%
1/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
11.1%
1/9 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
66.7%
2/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
33.3%
1/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/4 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
28.6%
2/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
12.5%
1/8 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
33.3%
1/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
25.0%
1/4 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
14.3%
1/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
28.6%
2/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
33.3%
1/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
33.3%
1/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
66.7%
2/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
66.7%
2/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
71.4%
5/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
71.4%
5/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
55.6%
5/9 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
100.0%
3/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/4 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
42.9%
3/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
62.5%
5/8 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
33.3%
1/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
100.0%
3/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
100.0%
4/4 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
100.0%
7/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
85.7%
6/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
100.0%
3/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
14.3%
1/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
11.1%
1/9 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/4 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/8 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
33.3%
1/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
25.0%
1/4 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
|
Metabolism and nutrition disorders
Hyperlipasaemia
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/9 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
33.3%
1/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/4 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/8 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/4 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
14.3%
1/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
|
Metabolism and nutrition disorders
Hypertriglyceridaemia
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
33.3%
1/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
14.3%
1/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
57.1%
4/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
22.2%
2/9 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
33.3%
1/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/4 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/8 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/4 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
14.3%
1/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
33.3%
1/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
|
Metabolism and nutrition disorders
Hyperuricaemia
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
33.3%
1/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
22.2%
2/9 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/4 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/8 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
33.3%
1/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
25.0%
1/4 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
14.3%
1/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/9 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
25.0%
1/4 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
14.3%
1/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/8 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/4 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
14.3%
1/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
28.6%
2/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
11.1%
1/9 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
33.3%
1/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
25.0%
1/4 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/8 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
25.0%
1/4 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
14.3%
1/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
28.6%
2/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/9 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
25.0%
1/4 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
42.9%
3/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
12.5%
1/8 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
25.0%
1/4 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
14.3%
1/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
28.6%
2/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
33.3%
1/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
14.3%
1/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
11.1%
1/9 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
25.0%
1/4 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/8 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
25.0%
1/4 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
28.6%
2/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
42.9%
3/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
33.3%
1/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
33.3%
1/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
33.3%
1/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
33.3%
1/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
14.3%
1/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/9 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/4 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
12.5%
1/8 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/4 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
28.6%
2/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
33.3%
1/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/9 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/4 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/8 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/4 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
14.3%
1/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
|
Metabolism and nutrition disorders
Malnutrition
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
14.3%
1/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/9 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/4 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/8 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/4 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
|
Metabolism and nutrition disorders
Metabolic acidosis
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/9 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
25.0%
1/4 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/8 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/4 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
66.7%
2/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
33.3%
1/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
14.3%
1/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/9 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
33.3%
1/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/4 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
14.3%
1/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
12.5%
1/8 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/4 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
33.3%
1/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
66.7%
2/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
33.3%
1/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
14.3%
1/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
22.2%
2/9 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
25.0%
1/4 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
57.1%
4/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/8 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
50.0%
2/4 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
42.9%
3/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
14.3%
1/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
33.3%
1/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
33.3%
1/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
14.3%
1/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/9 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/4 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/8 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/4 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
33.3%
1/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/9 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/4 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/8 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
25.0%
1/4 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
|
Musculoskeletal and connective tissue disorders
Groin pain
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/9 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/4 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/8 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/4 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
14.3%
1/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
|
Musculoskeletal and connective tissue disorders
Muscle atrophy
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/9 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/4 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/8 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/4 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
14.3%
1/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
33.3%
1/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/9 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
33.3%
1/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/4 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
14.3%
1/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/8 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/4 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
14.3%
1/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
33.3%
1/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
33.3%
1/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/9 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/4 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
14.3%
1/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
25.0%
2/8 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/4 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
14.3%
1/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
14.3%
1/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
33.3%
1/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/9 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/4 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/8 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/4 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
33.3%
1/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
28.6%
2/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
14.3%
1/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
11.1%
1/9 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
33.3%
1/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/4 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
14.3%
1/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/8 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
33.3%
1/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/4 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
33.3%
1/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
14.3%
1/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/9 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
33.3%
1/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/4 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
12.5%
1/8 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
25.0%
1/4 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
14.3%
1/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
14.3%
1/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
33.3%
1/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
33.3%
1/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
14.3%
1/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
14.3%
1/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/9 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/4 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/8 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/4 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
14.3%
1/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/9 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/4 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
12.5%
1/8 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/4 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
33.3%
1/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
11.1%
1/9 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
33.3%
1/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/4 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
14.3%
1/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/8 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/4 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
14.3%
1/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
|
Musculoskeletal and connective tissue disorders
Pain in jaw
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
14.3%
1/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/9 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/4 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/8 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/4 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
|
Musculoskeletal and connective tissue disorders
Spinal pain
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
28.6%
2/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/9 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
66.7%
2/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/4 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
14.3%
1/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/8 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/4 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Paraneoplastic syndrome
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/9 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/4 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/8 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/4 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
14.3%
1/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour associated fever
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
14.3%
1/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/9 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/4 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/8 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/4 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
|
Nervous system disorders
Cognitive disorder
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/9 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
33.3%
1/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/4 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/8 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/4 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
|
Nervous system disorders
Depressed level of consciousness
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
14.3%
1/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/9 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/4 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
28.6%
2/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/8 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/4 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
14.3%
1/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/9 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/4 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
14.3%
1/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/8 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/4 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
14.3%
1/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
33.3%
1/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
|
Nervous system disorders
Dizziness postural
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/9 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/4 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
12.5%
1/8 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/4 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
14.3%
1/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
|
Nervous system disorders
Dysgeusia
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
14.3%
1/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/9 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
25.0%
1/4 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
12.5%
1/8 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/4 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
28.6%
2/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
|
Nervous system disorders
Facial nerve disorder
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/9 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
33.3%
1/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/4 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/8 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/4 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
|
Nervous system disorders
Head titubation
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/9 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/4 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/8 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/4 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
33.3%
1/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
|
Nervous system disorders
Headache
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
33.3%
1/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
42.9%
3/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
33.3%
3/9 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
33.3%
1/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
33.3%
1/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/4 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/8 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
33.3%
1/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/4 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
33.3%
1/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
|
Nervous system disorders
Hypoaesthesia
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/9 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/4 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
14.3%
1/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/8 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/4 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
|
Nervous system disorders
Neuralgia
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/9 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/4 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/8 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/4 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
14.3%
1/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
33.3%
1/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
33.3%
1/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
11.1%
1/9 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/4 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/8 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
25.0%
1/4 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
14.3%
1/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
33.3%
1/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
|
Nervous system disorders
Peripheral motor neuropathy
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/9 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/4 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/8 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
33.3%
1/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/4 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
|
Nervous system disorders
Polyneuropathy
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
11.1%
1/9 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
33.3%
1/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/4 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/8 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
66.7%
2/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/4 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
28.6%
2/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
42.9%
3/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
|
Nervous system disorders
Postural tremor
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
33.3%
1/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/9 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/4 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/8 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/4 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
|
Nervous system disorders
Sciatica
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
33.3%
1/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/9 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/4 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
12.5%
1/8 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
33.3%
1/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/4 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
|
Nervous system disorders
Somnolence
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
14.3%
1/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
11.1%
1/9 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/4 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/8 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/4 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
|
Nervous system disorders
Tremor
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/9 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/4 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
14.3%
1/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/8 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/4 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
|
Psychiatric disorders
Agitation
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/9 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/4 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/8 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/4 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
14.3%
1/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
14.3%
1/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
44.4%
4/9 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/4 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
28.6%
2/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/8 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
50.0%
2/4 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
14.3%
1/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
|
Psychiatric disorders
Confusional state
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/9 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/4 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
14.3%
1/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/8 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/4 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
|
Psychiatric disorders
Depressed mood
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
11.1%
1/9 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/4 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/8 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/4 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
|
Psychiatric disorders
Depression
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/9 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/4 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
14.3%
1/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/8 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
25.0%
1/4 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
|
Psychiatric disorders
Hallucination
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/9 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/4 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/8 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
25.0%
1/4 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
|
Psychiatric disorders
Hallucination, visual
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/9 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/4 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/8 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
25.0%
1/4 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
|
Psychiatric disorders
Insomnia
|
66.7%
2/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
33.3%
1/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
33.3%
1/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
11.1%
1/9 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
33.3%
1/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/4 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/8 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
25.0%
1/4 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
28.6%
2/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
|
Psychiatric disorders
Mood altered
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
33.3%
1/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/9 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/4 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/8 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
25.0%
1/4 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
|
Psychiatric disorders
Nervousness
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
11.1%
1/9 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/4 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/8 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/4 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
33.3%
1/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
|
Renal and urinary disorders
Chronic kidney disease
|
33.3%
1/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/9 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
33.3%
1/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/4 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/8 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/4 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
14.3%
1/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
|
Renal and urinary disorders
Dysuria
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
33.3%
1/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
11.1%
1/9 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
33.3%
1/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/4 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/8 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
33.3%
1/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/4 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
|
Skin and subcutaneous tissue disorders
Night sweats
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/9 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/4 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/8 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/4 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
14.3%
1/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
33.3%
1/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/9 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/4 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/8 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/4 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
|
Renal and urinary disorders
Oliguria
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/9 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/4 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/8 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
33.3%
1/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/4 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
|
Renal and urinary disorders
Proteinuria
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
33.3%
1/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/9 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/4 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/8 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
33.3%
1/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/4 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
|
Renal and urinary disorders
Urinary retention
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/9 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/4 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
14.3%
1/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/8 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/4 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
|
Renal and urinary disorders
Vesical fistula
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/9 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/4 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/8 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/4 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
14.3%
1/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
|
Reproductive system and breast disorders
Breast pain
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
33.3%
1/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/9 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/4 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/8 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/4 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
|
Reproductive system and breast disorders
Erectile dysfunction
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/9 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/4 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/8 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/4 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
33.3%
1/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
|
Reproductive system and breast disorders
Pelvic pain
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
14.3%
1/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/9 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/4 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/8 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/4 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
14.3%
1/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
14.3%
1/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
|
Reproductive system and breast disorders
Vaginal discharge
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/9 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/4 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
14.3%
1/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/8 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/4 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
|
Reproductive system and breast disorders
Vulvovaginal dryness
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/9 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/4 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/8 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
33.3%
1/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/4 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
33.3%
1/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
33.3%
1/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
33.3%
1/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
28.6%
2/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
14.3%
1/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
22.2%
2/9 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
33.3%
1/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
66.7%
2/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/4 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
25.0%
2/8 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
33.3%
1/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
33.3%
1/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
25.0%
1/4 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
28.6%
2/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
28.6%
2/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
33.3%
1/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/9 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/4 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/8 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
25.0%
1/4 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
14.3%
1/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
33.3%
1/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
33.3%
1/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
33.3%
1/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
66.7%
2/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
33.3%
1/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
14.3%
1/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/9 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
33.3%
1/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/4 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
12.5%
1/8 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
33.3%
1/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/4 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
14.3%
1/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
42.9%
3/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/9 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
33.3%
1/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/4 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
28.6%
2/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/8 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/4 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
14.3%
1/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
11.1%
1/9 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/4 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/8 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/4 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
28.6%
2/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
28.6%
2/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/9 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
33.3%
1/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/4 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
12.5%
1/8 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
25.0%
1/4 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
14.3%
1/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/9 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/4 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/8 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/4 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
14.3%
1/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/9 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/4 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/8 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/4 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
|
Respiratory, thoracic and mediastinal disorders
Interstitial lung disease
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/9 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
33.3%
1/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/4 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/8 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/4 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
33.3%
1/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal dryness
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/9 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
33.3%
1/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/4 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
14.3%
1/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/8 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
66.7%
2/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
25.0%
1/4 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
14.3%
1/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
14.3%
1/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
14.3%
1/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
11.1%
1/9 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/4 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/8 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/4 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
33.3%
1/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
33.3%
1/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
14.3%
1/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/9 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/4 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/8 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/4 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
14.3%
1/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/9 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/4 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/8 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/4 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
14.3%
1/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/9 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
33.3%
1/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/4 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/8 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/4 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
14.3%
1/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/9 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
33.3%
1/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/4 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/8 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/4 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
14.3%
1/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/9 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/4 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/8 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/4 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
42.9%
3/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
66.7%
2/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
|
Skin and subcutaneous tissue disorders
Dermatitis allergic
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/9 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/4 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/8 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
33.3%
1/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/4 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
11.1%
1/9 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/4 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/8 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
33.3%
1/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
25.0%
1/4 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
14.3%
1/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
28.6%
2/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
|
Skin and subcutaneous tissue disorders
Eczema
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/9 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/4 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
12.5%
1/8 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/4 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
28.6%
2/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
|
Skin and subcutaneous tissue disorders
Nail disorder
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/9 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/4 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/8 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
50.0%
2/4 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
|
Skin and subcutaneous tissue disorders
Nail ridging
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/9 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/4 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/8 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/4 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
14.3%
1/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
|
Skin and subcutaneous tissue disorders
Onychoclasis
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/9 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/4 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
14.3%
1/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/8 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/4 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
|
Skin and subcutaneous tissue disorders
Onycholysis
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/9 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
33.3%
1/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/4 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/8 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/4 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
|
Skin and subcutaneous tissue disorders
Photosensitivity reaction
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/9 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/4 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
12.5%
1/8 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/4 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
14.3%
1/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
14.3%
1/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
44.4%
4/9 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
33.3%
1/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/4 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
28.6%
2/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
37.5%
3/8 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
33.3%
1/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
25.0%
1/4 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
14.3%
1/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
28.6%
2/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
33.3%
1/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
33.3%
1/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
33.3%
1/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
28.6%
2/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
42.9%
3/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
33.3%
3/9 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
66.7%
2/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/4 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
42.9%
3/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
37.5%
3/8 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
66.7%
2/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
25.0%
1/4 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
42.9%
3/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
28.6%
2/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
33.3%
1/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
|
Skin and subcutaneous tissue disorders
Rash erythematous
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/9 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/4 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/8 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
33.3%
1/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/4 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
|
Skin and subcutaneous tissue disorders
Rash macular
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/9 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/4 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
14.3%
1/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/8 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/4 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
33.3%
1/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/9 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/4 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
14.3%
1/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/8 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/4 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
|
Skin and subcutaneous tissue disorders
Scar pain
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
33.3%
1/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
14.3%
1/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/9 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/4 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/8 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/4 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
|
Skin and subcutaneous tissue disorders
Seborrhoeic dermatitis
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
14.3%
1/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/9 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/4 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/8 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/4 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
33.3%
1/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
|
Skin and subcutaneous tissue disorders
Skin depigmentation
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
33.3%
1/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/9 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/4 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/8 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/4 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
|
Skin and subcutaneous tissue disorders
Skin discolouration
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
33.3%
1/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/9 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/4 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/8 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/4 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
|
Skin and subcutaneous tissue disorders
Skin fissures
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/9 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/4 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/8 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
25.0%
1/4 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
|
Skin and subcutaneous tissue disorders
Skin toxicity
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/9 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
33.3%
1/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/4 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
14.3%
1/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
12.5%
1/8 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
33.3%
1/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/4 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
14.3%
1/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
|
Skin and subcutaneous tissue disorders
Skin ulcer
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/9 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/4 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/8 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/4 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
14.3%
1/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
|
Skin and subcutaneous tissue disorders
Xeroderma
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/9 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
33.3%
1/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/4 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/8 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/4 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
|
Vascular disorders
Hot flush
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/9 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/4 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
28.6%
2/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/8 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/4 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
|
Vascular disorders
Hypertension
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
28.6%
2/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/9 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/4 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/8 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/4 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
|
Vascular disorders
Hypotension
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
14.3%
1/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/9 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/4 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
14.3%
1/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/8 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
25.0%
1/4 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
14.3%
1/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
|
Vascular disorders
Lymphoedema
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/9 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/4 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/8 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
33.3%
1/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/4 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
|
Vascular disorders
Venous thrombosis
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/9 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/4 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/8 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/4 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
14.3%
1/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
|
Vascular disorders
Venous thrombosis limb
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
14.3%
1/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/9 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/4 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/8 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/4 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/7 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
0.00%
0/3 • From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
|
Additional Information
Boehringer Ingelheim, Call Centre
Boehringer Ingelheim
Phone: 1-800-243-0127
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee Boehringer Ingelheim (BI) acknowledges that investigators have the right to publish the study results. Investigators shall provide BI with a copy of any publication or presentation for review prior to any submission. Such review will be done with regard to proprietary information, information related to patentable inventions, medical, scientific, and statistical accuracy within 60 days. BI may request a delay of the publication in order to protect BI's intellectual property rights.
- Publication restrictions are in place
Restriction type: OTHER