Trial Outcomes & Findings for BI 836845 in Estrogen Receptor Positive Metastatic Breast Cancer (NCT NCT02123823)
NCT ID: NCT02123823
Last Updated: 2025-07-15
Results Overview
Progression-free survival (PFS) in the phase II part is presented. Progression-free survival (PFS) was defined as the time from randomisation until radiological tumour progression according to RECIST 1.1, or death from any cause, whichever occurred earlier. Clinical disease progression was not considered for determination of a PFS event, unless the outcome of the progression was death. The cut-off date was 25th November 2016. At cut-off date, xentuzumab was discontinued in all patients in the experimental arm per sponsor decision, recruitment was also terminated. Patients who discontinued xentuzumab treatment continued with everolimus 10 mg + exemestane 25 mg treatment.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
164 participants
Primary outcome timeframe
From randomisation until radiological tumour progression according to RECIST 1.1, or death from any cause or data cut-off (25Nov2016), up to 30 months.
Results posted on
2025-07-15
Participant Flow
This is a phase Ib/II, randomized, open label study to determine the maximum tolerated dose (MTD) and the recommended phase II dose and to evaluate the anti-tumor activity of BI 836845 (xentuzumab) in combination with exemestane and everolimus versus exemestane and everolimus alone in women with locally advanced or metastatic breast cancer.
Only subjects that met all inclusion + none of exclusion criteria were to be entered. Subjects were free to withdraw from clinical trial at any time for any reason given. If subject continued to take trial drug, close monitoring was adhered to + adverse events recorded. Rules were implemented in all trials whereby doses would be reduced if required. If further events were reported, subject would be withdrawn from trial. Symptomatic treatment of tumor associated symptoms were allowed throughout.
Participant milestones
| Measure |
Xentuzumab (BI 836845) 750 mg + Everolimus 10 mg + Exemestane 25 mg - Phase Ib
Subjects received a single dose of 750 milligram (mg) BI 836845 (xentuzumab) as a 1 hour (h) intravenous infusion once a week on Day 1, 8, 15 and 22 in a 28-day course until disease progression, intolerable AEs or other reason necessitating withdrawal.
Subjects also received a single oral dose once daily (qd) of 2x 5 mg (10 mg total) tablets of everolimus and 1 tablet of 25 mg exemestane starting 7 days before first administration of BI 836845 (xentuzumab) continously until disease progression, intolerable AEs or other reason necessitating withdrawal.
|
Xentuzumab (BI 836845) 1000 mg + Everolimus 10 mg + Exemestane 25 mg - Phase Ib
Subjects received a single dose of 1000 milligram (mg) BI 836845 (xentuzumab) as a 1 hour (h) intravenous infusion once a week on Day 1, 8, 15 and 22 in a 28-day course until disease progression, intolerable AEs or other reason necessitating withdrawal.
Subjects also received a single oral dose once daily (qd) of 2x 5 mg (10 mg total) tablets of everolimus and 1 tablet of 25 mg exemestane starting 7 days before first administration of BI 836845 (xentuzumab) continously until disease progression, intolerable AEs or other reason necessitating withdrawal.
|
Xentuzumab (BI 836845) 1000 mg + Everolimus 10 mg + Exemestane 25 mg - Phase II
Subjects received a single dose of 1000 milligram (mg) BI 836845 (xentuzumab) as a 1 hour (h) intravenous infusion once a week on Day 1, 8, 15 and 22 in a 28-day course until disease progression, intolerable AEs or other reason necessitating withdrawal.
Subjects also received a single oral dose once daily (qd) of 2x 5 mg (10 mg total) tablets of everolimus and 1 tablet of 25 mg exemestane starting on Day 1 continously until disease progression, intolerable AEs or other reason necessitating withdrawal.
Administration of xentuzumab was stopped after 28th October 2016, and participants in this group who remained in the trial could continue with everolimus 10 mg + exemestane 25 mg.
|
Everolimus 10 mg + Exemestane 25 mg - Phase II
Subjects received a single oral dose once daily (qd) of 2x 5 mg (10 mg total) tablets of everolimus and 1 tablet of 25 mg exemestane starting on Day 1 continously until disease progression, intolerable AEs or other reason necessitating withdrawal.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
3
|
21
|
70
|
70
|
|
Overall Study
Treated
|
3
|
21
|
70
|
69
|
|
Overall Study
COMPLETED
|
0
|
0
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
3
|
21
|
70
|
70
|
Reasons for withdrawal
| Measure |
Xentuzumab (BI 836845) 750 mg + Everolimus 10 mg + Exemestane 25 mg - Phase Ib
Subjects received a single dose of 750 milligram (mg) BI 836845 (xentuzumab) as a 1 hour (h) intravenous infusion once a week on Day 1, 8, 15 and 22 in a 28-day course until disease progression, intolerable AEs or other reason necessitating withdrawal.
Subjects also received a single oral dose once daily (qd) of 2x 5 mg (10 mg total) tablets of everolimus and 1 tablet of 25 mg exemestane starting 7 days before first administration of BI 836845 (xentuzumab) continously until disease progression, intolerable AEs or other reason necessitating withdrawal.
|
Xentuzumab (BI 836845) 1000 mg + Everolimus 10 mg + Exemestane 25 mg - Phase Ib
Subjects received a single dose of 1000 milligram (mg) BI 836845 (xentuzumab) as a 1 hour (h) intravenous infusion once a week on Day 1, 8, 15 and 22 in a 28-day course until disease progression, intolerable AEs or other reason necessitating withdrawal.
Subjects also received a single oral dose once daily (qd) of 2x 5 mg (10 mg total) tablets of everolimus and 1 tablet of 25 mg exemestane starting 7 days before first administration of BI 836845 (xentuzumab) continously until disease progression, intolerable AEs or other reason necessitating withdrawal.
|
Xentuzumab (BI 836845) 1000 mg + Everolimus 10 mg + Exemestane 25 mg - Phase II
Subjects received a single dose of 1000 milligram (mg) BI 836845 (xentuzumab) as a 1 hour (h) intravenous infusion once a week on Day 1, 8, 15 and 22 in a 28-day course until disease progression, intolerable AEs or other reason necessitating withdrawal.
Subjects also received a single oral dose once daily (qd) of 2x 5 mg (10 mg total) tablets of everolimus and 1 tablet of 25 mg exemestane starting on Day 1 continously until disease progression, intolerable AEs or other reason necessitating withdrawal.
Administration of xentuzumab was stopped after 28th October 2016, and participants in this group who remained in the trial could continue with everolimus 10 mg + exemestane 25 mg.
|
Everolimus 10 mg + Exemestane 25 mg - Phase II
Subjects received a single oral dose once daily (qd) of 2x 5 mg (10 mg total) tablets of everolimus and 1 tablet of 25 mg exemestane starting on Day 1 continously until disease progression, intolerable AEs or other reason necessitating withdrawal.
|
|---|---|---|---|---|
|
Overall Study
Lack of Efficacy
|
0
|
2
|
8
|
10
|
|
Overall Study
Progressive disease
|
3
|
19
|
52
|
53
|
|
Overall Study
Withdrawal by Subject
|
0
|
0
|
7
|
2
|
|
Overall Study
Adverse Event
|
0
|
0
|
3
|
5
|
Baseline Characteristics
BI 836845 in Estrogen Receptor Positive Metastatic Breast Cancer
Baseline characteristics by cohort
| Measure |
Xentuzumab (BI 836845) 750 mg + Everolimus 10 mg + Exemestane 25 mg - Phase Ib
n=3 Participants
Subjects received a single dose of 750 milligram (mg) BI 836845 (xentuzumab) as a 1 hour (h) intravenous infusion once a week on Day 1, 8, 15 and 22 in a 28-day course until disease progression, intolerable AEs or other reason necessitating withdrawal.
Subjects also received a single oral dose once daily (qd) of 2x 5 mg (10 mg total) tablets of everolimus and 1 tablet of 25 mg exemestane starting 7 days before first administration of BI 836845 (xentuzumab) continously until disease progression, intolerable AEs or other reason necessitating withdrawal.
|
Xentuzumab (BI 836845) 1000 mg + Everolimus 10 mg + Exemestane 25 mg - Phase Ib
n=21 Participants
Subjects received a single dose of 1000 milligram (mg) BI 836845 (xentuzumab) as a 1 hour (h) intravenous infusion once a week on Day 1, 8, 15 and 22 in a 28-day course until disease progression, intolerable AEs or other reason necessitating withdrawal.
Subjects also received a single oral dose once daily (qd) of 2x 5 mg (10 mg total) tablets of everolimus and 1 tablet of 25 mg exemestane starting 7 days before first administration of BI 836845 (xentuzumab) continously until disease progression, intolerable AEs or other reason necessitating withdrawal.
|
Xentuzumab (BI 836845) 1000 mg + Everolimus 10 mg + Exemestane 25 mg - Phase II
n=70 Participants
Subjects received a single dose of 1000 milligram (mg) BI 836845 (xentuzumab) as a 1 hour (h) intravenous infusion once a week on Day 1, 8, 15 and 22 in a 28-day course until disease progression, intolerable AEs or other reason necessitating withdrawal.
Subjects also received a single oral dose once daily (qd) of 2x 5 mg (10 mg total) tablets of everolimus and 1 tablet of 25 mg exemestane starting on Day 1 continously until disease progression, intolerable AEs or other reason necessitating withdrawal.
Administration of xentuzumab was stopped after 28th October 2016, and participants in this group who remained in the trial could continue with everolimus 10 mg + exemestane 25 mg.
|
Everolimus 10 mg + Exemestane 25 mg - Phase II
n=70 Participants
Subjects received a single oral dose once daily (qd) of 2x 5 mg (10 mg total) tablets of everolimus and 1 tablet of 25 mg exemestane starting on Day 1 continously until disease progression, intolerable AEs or other reason necessitating withdrawal.
|
Total
n=164 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
59.00 Years
STANDARD_DEVIATION 8.00 • n=5 Participants
|
64.33 Years
STANDARD_DEVIATION 7.84 • n=7 Participants
|
60.17 Years
STANDARD_DEVIATION 9.61 • n=5 Participants
|
60.67 Years
STANDARD_DEVIATION 9.07 • n=4 Participants
|
60.90 Years
STANDARD_DEVIATION 9.17 • n=21 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
70 Participants
n=5 Participants
|
70 Participants
n=4 Participants
|
164 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
8 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
3 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
62 Participants
n=5 Participants
|
57 Participants
n=4 Participants
|
141 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
15 Participants
n=21 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
12 Participants
n=4 Participants
|
24 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
White
|
3 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
53 Participants
n=5 Participants
|
51 Participants
n=4 Participants
|
128 Participants
n=21 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
12 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: From randomisation until radiological tumour progression according to RECIST 1.1, or death from any cause or data cut-off (25Nov2016), up to 30 months.Population: Randomised set (RS): This patient set included all randomised patients in the Phase II part, regardless of whether or not they received treatment. Patients were assigned to xentuzumab (BI 836845) in combination with exemestane and everolimus or exemestane and everolimus alone as randomised.
Progression-free survival (PFS) in the phase II part is presented. Progression-free survival (PFS) was defined as the time from randomisation until radiological tumour progression according to RECIST 1.1, or death from any cause, whichever occurred earlier. Clinical disease progression was not considered for determination of a PFS event, unless the outcome of the progression was death. The cut-off date was 25th November 2016. At cut-off date, xentuzumab was discontinued in all patients in the experimental arm per sponsor decision, recruitment was also terminated. Patients who discontinued xentuzumab treatment continued with everolimus 10 mg + exemestane 25 mg treatment.
Outcome measures
| Measure |
Xentuzumab (BI 836845) 1000 mg + Everolimus 10 mg + Exemestane 25 mg - Phase II
n=70 Participants
Subjects received a single dose of 1000 milligram (mg) BI 836845 (xentuzumab) as a 1 hour (h) intravenous infusion once a week on Day 1, 8, 15 and 22 in a 28-day course until disease progression, intolerable AEs or other reason necessitating withdrawal.
Subjects also received a single oral dose once daily (qd) of 2x 5 mg (10 mg total) tablets of everolimus and 1 tablet of 25 mg exemestane starting on Day 1 continously until disease progression, intolerable AEs or other reason necessitating withdrawal.
Administration of xentuzumab was stopped after 28th October 2016, and participants in this group who remained in the trial could continue with everolimus 10 mg + exemestane 25 mg.
|
Everolimus 10 mg + Exemestane 25 mg - Phase II
n=70 Participants
Subjects received a single oral dose once daily (qd) of 2x 5 mg (10 mg total) tablets of everolimus and 1 tablet of 25 mg exemestane starting on Day 1 continously until disease progression, intolerable AEs or other reason necessitating withdrawal.
|
|---|---|---|
|
Progression-free Survival (PFS) - Phase II Part
|
7.3 Months
Interval 3.3 to
Not enough events to calculate the value
|
5.6 Months
Interval 3.7 to 9.1
|
PRIMARY outcome
Timeframe: From first administration of study treatment until end of first treatment cycle, up to 28 days.Population: Maximum tolerated dose (MTD) set: The MTD set defined the set of patients in the Phase Ib part who were fully evaluable for determination of the MTD in the first treatment course. Patients in the TS who were replaced within the MTD evaluation period in the first part of the trial were excluded from the determination of the MTD.
Number of patients with dose limiting toxicity (DLT) in phase Ib part is presented.
Outcome measures
| Measure |
Xentuzumab (BI 836845) 1000 mg + Everolimus 10 mg + Exemestane 25 mg - Phase II
n=3 Participants
Subjects received a single dose of 1000 milligram (mg) BI 836845 (xentuzumab) as a 1 hour (h) intravenous infusion once a week on Day 1, 8, 15 and 22 in a 28-day course until disease progression, intolerable AEs or other reason necessitating withdrawal.
Subjects also received a single oral dose once daily (qd) of 2x 5 mg (10 mg total) tablets of everolimus and 1 tablet of 25 mg exemestane starting on Day 1 continously until disease progression, intolerable AEs or other reason necessitating withdrawal.
Administration of xentuzumab was stopped after 28th October 2016, and participants in this group who remained in the trial could continue with everolimus 10 mg + exemestane 25 mg.
|
Everolimus 10 mg + Exemestane 25 mg - Phase II
n=6 Participants
Subjects received a single oral dose once daily (qd) of 2x 5 mg (10 mg total) tablets of everolimus and 1 tablet of 25 mg exemestane starting on Day 1 continously until disease progression, intolerable AEs or other reason necessitating withdrawal.
|
|---|---|---|
|
Number of Patients With Dose Limiting Toxicity (DLT) - Phase Ib Part
|
0 Participants
|
1 Participants
|
PRIMARY outcome
Timeframe: up to 28 days.Population: Maximum tolerated dose (MTD) set: The MTD set defined the set of patients in the Phase Ib part who were fully evaluable for determination of the MTD in the first treatment course. Patients in the TS who were replaced within the MTD evaluation period in the first part of the trial were excluded from the determination of the MTD.
The Maximum Tolerated Dose (MTD) in this study was defined as the highest dose level examined of trial medication, at which no more than 1 out of 6 patients experienced a DLT during the MTD evaluation period. The MTD evaluation period was defined as the time from the first administration of xentuzumab up to start of cycle 2. A "3+3" Phase Ib dose finding phase was performed to determine the MTD.
Outcome measures
| Measure |
Xentuzumab (BI 836845) 1000 mg + Everolimus 10 mg + Exemestane 25 mg - Phase II
n=9 Participants
Subjects received a single dose of 1000 milligram (mg) BI 836845 (xentuzumab) as a 1 hour (h) intravenous infusion once a week on Day 1, 8, 15 and 22 in a 28-day course until disease progression, intolerable AEs or other reason necessitating withdrawal.
Subjects also received a single oral dose once daily (qd) of 2x 5 mg (10 mg total) tablets of everolimus and 1 tablet of 25 mg exemestane starting on Day 1 continously until disease progression, intolerable AEs or other reason necessitating withdrawal.
Administration of xentuzumab was stopped after 28th October 2016, and participants in this group who remained in the trial could continue with everolimus 10 mg + exemestane 25 mg.
|
Everolimus 10 mg + Exemestane 25 mg - Phase II
Subjects received a single oral dose once daily (qd) of 2x 5 mg (10 mg total) tablets of everolimus and 1 tablet of 25 mg exemestane starting on Day 1 continously until disease progression, intolerable AEs or other reason necessitating withdrawal.
|
|---|---|---|
|
Maximum Tolerated Dose (MTD) - Phase Ib Part
|
1000 milligrams (mg)
|
—
|
SECONDARY outcome
Timeframe: From randomisation until the earliest of disease progression, death or last evaluable tumour assessment before start of subsequent anti-cancer therapy or data cut-off (25Nov2016), up to 30 months.Population: Randomised set (RS): This patient set included all randomised patients in the Phase II part, regardless of whether or not they received treatment. Patients were assigned to xentuzumab (BI 836845) in combination with exemestane and everolimus or exemestane and everolimus alone as randomised.
Objective response (OR) - phase II part is presented. Objective response (OR), defined as best overall response of complete response (CR) or partial response (PR), where best overall response was determined according to RECIST 1.1 from date of randomisation until the earliest of disease progression, death or last evaluable tumour assessment before start of subsequent anti-cancer therapy.
Outcome measures
| Measure |
Xentuzumab (BI 836845) 1000 mg + Everolimus 10 mg + Exemestane 25 mg - Phase II
n=70 Participants
Subjects received a single dose of 1000 milligram (mg) BI 836845 (xentuzumab) as a 1 hour (h) intravenous infusion once a week on Day 1, 8, 15 and 22 in a 28-day course until disease progression, intolerable AEs or other reason necessitating withdrawal.
Subjects also received a single oral dose once daily (qd) of 2x 5 mg (10 mg total) tablets of everolimus and 1 tablet of 25 mg exemestane starting on Day 1 continously until disease progression, intolerable AEs or other reason necessitating withdrawal.
Administration of xentuzumab was stopped after 28th October 2016, and participants in this group who remained in the trial could continue with everolimus 10 mg + exemestane 25 mg.
|
Everolimus 10 mg + Exemestane 25 mg - Phase II
n=70 Participants
Subjects received a single oral dose once daily (qd) of 2x 5 mg (10 mg total) tablets of everolimus and 1 tablet of 25 mg exemestane starting on Day 1 continously until disease progression, intolerable AEs or other reason necessitating withdrawal.
|
|---|---|---|
|
Number of Patients With Objective Response (OR) - Phase II Part
|
5 Participants
Interval 2.4 to 15.9
|
7 Participants
Interval 4.1 to 19.5
|
SECONDARY outcome
Timeframe: From randomisation until the date of the first objective tumour progression according to RECIST 1.1. or data cut-off (25Nov2016), up to 30 months.Population: Randomised set (RS): This patient set included all randomised patients in the Phase II part, regardless of whether or not they received treatment. Patients were assigned to xentuzumab (BI 836845) in combination with exemestane and everolimus or exemestane and everolimus alone as randomised. Only patients with progression were analysed.
Time to progression (TTP) is presented. Time to progression (TTP), defined as the time from the date of randomization until the date of the first objective tumour progression according to RECIST 1.1.
Outcome measures
| Measure |
Xentuzumab (BI 836845) 1000 mg + Everolimus 10 mg + Exemestane 25 mg - Phase II
n=70 Participants
Subjects received a single dose of 1000 milligram (mg) BI 836845 (xentuzumab) as a 1 hour (h) intravenous infusion once a week on Day 1, 8, 15 and 22 in a 28-day course until disease progression, intolerable AEs or other reason necessitating withdrawal.
Subjects also received a single oral dose once daily (qd) of 2x 5 mg (10 mg total) tablets of everolimus and 1 tablet of 25 mg exemestane starting on Day 1 continously until disease progression, intolerable AEs or other reason necessitating withdrawal.
Administration of xentuzumab was stopped after 28th October 2016, and participants in this group who remained in the trial could continue with everolimus 10 mg + exemestane 25 mg.
|
Everolimus 10 mg + Exemestane 25 mg - Phase II
n=70 Participants
Subjects received a single oral dose once daily (qd) of 2x 5 mg (10 mg total) tablets of everolimus and 1 tablet of 25 mg exemestane starting on Day 1 continously until disease progression, intolerable AEs or other reason necessitating withdrawal.
|
|---|---|---|
|
Time to Progression (TTP) - Phase II Part
|
7.3 Months
Interval 3.7 to
Not enough events to calculate the value
|
5.6 Months
Interval 5.3 to 9.1
|
SECONDARY outcome
Timeframe: From randomisation until data cut-off (25Nov2016), up to 30 months.Population: Randomised set (RS): This patient set included all randomised patients in the Phase II part, regardless of whether or not they received treatment. Patients were assigned to xentuzumab (BI 836845) in combination with exemestane and everolimus or exemestane and everolimus alone as randomised.
Disease control is defined as best overall response of complete response (CR) or partial response (PR), or stable disease (SD) \>= 24 weeks, or Non-CR/Non-PD for \>= 24 weeks. PD=Progressive disease.
Outcome measures
| Measure |
Xentuzumab (BI 836845) 1000 mg + Everolimus 10 mg + Exemestane 25 mg - Phase II
n=70 Participants
Subjects received a single dose of 1000 milligram (mg) BI 836845 (xentuzumab) as a 1 hour (h) intravenous infusion once a week on Day 1, 8, 15 and 22 in a 28-day course until disease progression, intolerable AEs or other reason necessitating withdrawal.
Subjects also received a single oral dose once daily (qd) of 2x 5 mg (10 mg total) tablets of everolimus and 1 tablet of 25 mg exemestane starting on Day 1 continously until disease progression, intolerable AEs or other reason necessitating withdrawal.
Administration of xentuzumab was stopped after 28th October 2016, and participants in this group who remained in the trial could continue with everolimus 10 mg + exemestane 25 mg.
|
Everolimus 10 mg + Exemestane 25 mg - Phase II
n=70 Participants
Subjects received a single oral dose once daily (qd) of 2x 5 mg (10 mg total) tablets of everolimus and 1 tablet of 25 mg exemestane starting on Day 1 continously until disease progression, intolerable AEs or other reason necessitating withdrawal.
|
|---|---|---|
|
Number of Patients With Disease Control (DC) - Phase II Part
|
13 Participants
Interval 10.3 to 29.7
|
17 Participants
Interval 14.8 to 36.0
|
SECONDARY outcome
Timeframe: From randomisation until first documented complete response (CR) or partial response (PR) or data cut-off (25Nov2016), up to 30 months.Population: Randomised set (RS): This patient set included all randomised patients in the Phase II part, regardless of whether or not they received treatment. Patients were assigned to xentuzumab (BI 836845) in combination with exemestane and everolimus or exemestane and everolimus alone as randomised. Only patients with objective response were analysed.
Time to objective response is presented. Time to objective response is defined as the time from randomisation until first documented complete response (CR) or partial response (PR).
Outcome measures
| Measure |
Xentuzumab (BI 836845) 1000 mg + Everolimus 10 mg + Exemestane 25 mg - Phase II
n=5 Participants
Subjects received a single dose of 1000 milligram (mg) BI 836845 (xentuzumab) as a 1 hour (h) intravenous infusion once a week on Day 1, 8, 15 and 22 in a 28-day course until disease progression, intolerable AEs or other reason necessitating withdrawal.
Subjects also received a single oral dose once daily (qd) of 2x 5 mg (10 mg total) tablets of everolimus and 1 tablet of 25 mg exemestane starting on Day 1 continously until disease progression, intolerable AEs or other reason necessitating withdrawal.
Administration of xentuzumab was stopped after 28th October 2016, and participants in this group who remained in the trial could continue with everolimus 10 mg + exemestane 25 mg.
|
Everolimus 10 mg + Exemestane 25 mg - Phase II
n=7 Participants
Subjects received a single oral dose once daily (qd) of 2x 5 mg (10 mg total) tablets of everolimus and 1 tablet of 25 mg exemestane starting on Day 1 continously until disease progression, intolerable AEs or other reason necessitating withdrawal.
|
|---|---|---|
|
Time to Objective Response - Phase II Part
|
3.7 Months
Interval 3.6 to 5.3
|
1.8 Months
Interval 1.7 to 5.3
|
SECONDARY outcome
Timeframe: From randomisation until the earliest of disease progression or death or data cut-off (25Nov2016), up to 30 months.Population: Randomised set (RS): This patient set included all randomised patients in the Phase II part, regardless of whether or not they received treatment. Patients were assigned to xentuzumab (BI 836845) in combination with exemestane and everolimus or exemestane and everolimus alone as randomised. Only patients with objective response were analysed.
Duration of objective response is presented. Duration of objective response is defined as the time from first documented complete response (CR) or partial response (PR) until the earliest of disease progression or death among patients with objective response (OR).
Outcome measures
| Measure |
Xentuzumab (BI 836845) 1000 mg + Everolimus 10 mg + Exemestane 25 mg - Phase II
n=5 Participants
Subjects received a single dose of 1000 milligram (mg) BI 836845 (xentuzumab) as a 1 hour (h) intravenous infusion once a week on Day 1, 8, 15 and 22 in a 28-day course until disease progression, intolerable AEs or other reason necessitating withdrawal.
Subjects also received a single oral dose once daily (qd) of 2x 5 mg (10 mg total) tablets of everolimus and 1 tablet of 25 mg exemestane starting on Day 1 continously until disease progression, intolerable AEs or other reason necessitating withdrawal.
Administration of xentuzumab was stopped after 28th October 2016, and participants in this group who remained in the trial could continue with everolimus 10 mg + exemestane 25 mg.
|
Everolimus 10 mg + Exemestane 25 mg - Phase II
n=7 Participants
Subjects received a single oral dose once daily (qd) of 2x 5 mg (10 mg total) tablets of everolimus and 1 tablet of 25 mg exemestane starting on Day 1 continously until disease progression, intolerable AEs or other reason necessitating withdrawal.
|
|---|---|---|
|
Duration of Objective Response - Phase II Part
|
5.6 Months
Interval 5.6 to 5.6
|
NA Months
Not enough events to calculate the value
|
SECONDARY outcome
Timeframe: From randomisation until the earliest of disease progression or death or data cut-off (25Nov2016), up to 30 months.Population: Randomised set (RS): This patient set included all randomised patients in the Phase II part, regardless of whether or not they received treatment. Patients were assigned to xentuzumab (BI 836845) in combination with exemestane and everolimus or exemestane and everolimus alone as randomised. Only patients with disease control were analysed.
Duration of disease control is presented. Duration of disease control is defined as the time from randomisation until the earliest of disease progression or death, among patients with disease control.
Outcome measures
| Measure |
Xentuzumab (BI 836845) 1000 mg + Everolimus 10 mg + Exemestane 25 mg - Phase II
n=13 Participants
Subjects received a single dose of 1000 milligram (mg) BI 836845 (xentuzumab) as a 1 hour (h) intravenous infusion once a week on Day 1, 8, 15 and 22 in a 28-day course until disease progression, intolerable AEs or other reason necessitating withdrawal.
Subjects also received a single oral dose once daily (qd) of 2x 5 mg (10 mg total) tablets of everolimus and 1 tablet of 25 mg exemestane starting on Day 1 continously until disease progression, intolerable AEs or other reason necessitating withdrawal.
Administration of xentuzumab was stopped after 28th October 2016, and participants in this group who remained in the trial could continue with everolimus 10 mg + exemestane 25 mg.
|
Everolimus 10 mg + Exemestane 25 mg - Phase II
n=17 Participants
Subjects received a single oral dose once daily (qd) of 2x 5 mg (10 mg total) tablets of everolimus and 1 tablet of 25 mg exemestane starting on Day 1 continously until disease progression, intolerable AEs or other reason necessitating withdrawal.
|
|---|---|---|
|
Duration of Disease Control - Phase II Part
|
NA Months
Interval 10.9 to
Not enough events to calculate the value
|
9.3 Months
Interval 9.1 to
Not enough events to calculate the value
|
Adverse Events
Xentuzumab (BI 836845) 750 mg + Everolimus 10 mg + Exemestane 25 mg - Phase Ib
Serious events: 3 serious events
Other events: 3 other events
Deaths: 0 deaths
Xentuzumab (BI 836845) 1000 mg + Everolimus 10 mg + Exemestane 25 mg - Phase Ib
Serious events: 10 serious events
Other events: 21 other events
Deaths: 2 deaths
Xentuzumab (BI 836845) 1000 mg + Everolimus 10 mg + Exemestane 25 mg - Phase II
Serious events: 20 serious events
Other events: 70 other events
Deaths: 9 deaths
Everolimus 10 mg + Exemestane 25 mg - Phase II
Serious events: 29 serious events
Other events: 68 other events
Deaths: 11 deaths
Serious adverse events
| Measure |
Xentuzumab (BI 836845) 750 mg + Everolimus 10 mg + Exemestane 25 mg - Phase Ib
n=3 participants at risk
Subjects received a single dose of 750 milligram (mg) BI 836845 (xentuzumab) as a 1 hour (h) intravenous infusion once a week on Day 1, 8, 15 and 22 in a 28-day course until disease progression, intolerable AEs or other reason necessitating withdrawal.
Subjects also received a single oral dose once daily (qd) of 2x 5 mg (10 mg total) tablets of everolimus and 1 tablet of 25 mg exemestane starting 7 days before first administration of BI 836845 (xentuzumab) continously until disease progression, intolerable AEs or other reason necessitating withdrawal.
|
Xentuzumab (BI 836845) 1000 mg + Everolimus 10 mg + Exemestane 25 mg - Phase Ib
n=21 participants at risk
Subjects received a single dose of 1000 milligram (mg) BI 836845 (xentuzumab) as a 1 hour (h) intravenous infusion once a week on Day 1, 8, 15 and 22 in a 28-day course until disease progression, intolerable AEs or other reason necessitating withdrawal.
Subjects also received a single oral dose once daily (qd) of 2x 5 mg (10 mg total) tablets of everolimus and 1 tablet of 25 mg exemestane starting 7 days before first administration of BI 836845 (xentuzumab) continously until disease progression, intolerable AEs or other reason necessitating withdrawal.
|
Xentuzumab (BI 836845) 1000 mg + Everolimus 10 mg + Exemestane 25 mg - Phase II
n=70 participants at risk
Subjects received a single dose of 1000 milligram (mg) BI 836845 (xentuzumab) as a 1 hour (h) intravenous infusion once a week on Day 1, 8, 15 and 22 in a 28-day course until disease progression, intolerable AEs or other reason necessitating withdrawal.
Subjects also received a single oral dose once daily (qd) of 2x 5 mg (10 mg total) tablets of everolimus and 1 tablet of 25 mg exemestane starting on Day 1 continously until disease progression, intolerable AEs or other reason necessitating withdrawal.
Administration of xentuzumab was stopped after 28th October 2016, and participants in this group who remained in the trial could continue with everolimus 10 mg + exemestane 25 mg.
|
Everolimus 10 mg + Exemestane 25 mg - Phase II
n=69 participants at risk
Subjects received a single oral dose once daily (qd) of 2x 5 mg (10 mg total) tablets of everolimus and 1 tablet of 25 mg exemestane starting on Day 1 continously until disease progression, intolerable AEs or other reason necessitating withdrawal.
|
|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/3 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
0.00%
0/21 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
0.00%
0/70 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
1.4%
1/69 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
33.3%
1/3 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
0.00%
0/21 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
0.00%
0/70 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
0.00%
0/69 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/3 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
0.00%
0/21 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
1.4%
1/70 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
0.00%
0/69 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
|
Cardiac disorders
Angina pectoris
|
0.00%
0/3 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
0.00%
0/21 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
0.00%
0/70 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
1.4%
1/69 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
|
Cardiac disorders
Pericardial effusion
|
0.00%
0/3 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
0.00%
0/21 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
0.00%
0/70 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
1.4%
1/69 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
|
Ear and labyrinth disorders
Deafness
|
0.00%
0/3 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
4.8%
1/21 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
0.00%
0/70 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
0.00%
0/69 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/3 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
0.00%
0/21 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
0.00%
0/70 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
1.4%
1/69 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/3 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
0.00%
0/21 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
0.00%
0/70 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
1.4%
1/69 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
|
Gastrointestinal disorders
Ascites
|
0.00%
0/3 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
0.00%
0/21 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
0.00%
0/70 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
1.4%
1/69 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/3 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
0.00%
0/21 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
1.4%
1/70 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
0.00%
0/69 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.00%
0/3 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
4.8%
1/21 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
0.00%
0/70 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
0.00%
0/69 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
|
Gastrointestinal disorders
Subileus
|
0.00%
0/3 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
4.8%
1/21 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
0.00%
0/70 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
0.00%
0/69 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/3 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
0.00%
0/21 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
1.4%
1/70 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
0.00%
0/69 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
|
General disorders
Asthenia
|
0.00%
0/3 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
0.00%
0/21 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
0.00%
0/70 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
1.4%
1/69 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
|
General disorders
Chest pain
|
0.00%
0/3 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
0.00%
0/21 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
0.00%
0/70 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
1.4%
1/69 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
|
General disorders
Fatigue
|
0.00%
0/3 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
0.00%
0/21 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
1.4%
1/70 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
0.00%
0/69 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
|
General disorders
Feeling cold
|
0.00%
0/3 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
0.00%
0/21 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
1.4%
1/70 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
0.00%
0/69 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
|
General disorders
Pain
|
0.00%
0/3 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
0.00%
0/21 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
0.00%
0/70 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
1.4%
1/69 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
|
General disorders
Pyrexia
|
0.00%
0/3 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
9.5%
2/21 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
1.4%
1/70 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
0.00%
0/69 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
|
Hepatobiliary disorders
Cholecystitis chronic
|
0.00%
0/3 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
0.00%
0/21 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
1.4%
1/70 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
0.00%
0/69 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.00%
0/3 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
0.00%
0/21 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
2.9%
2/70 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
0.00%
0/69 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
|
Hepatobiliary disorders
Liver injury
|
0.00%
0/3 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
0.00%
0/21 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
1.4%
1/70 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
0.00%
0/69 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
|
Infections and infestations
Cellulitis
|
0.00%
0/3 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
0.00%
0/21 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
0.00%
0/70 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
1.4%
1/69 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/3 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
4.8%
1/21 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
0.00%
0/70 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
0.00%
0/69 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/3 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
0.00%
0/21 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
2.9%
2/70 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
2.9%
2/69 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
|
Infections and infestations
Pyelonephritis
|
0.00%
0/3 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
4.8%
1/21 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
0.00%
0/70 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
0.00%
0/69 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
|
Infections and infestations
Respiratory syncytial virus infection
|
0.00%
0/3 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
0.00%
0/21 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
1.4%
1/70 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
0.00%
0/69 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
|
Infections and infestations
Respiratory tract infection
|
0.00%
0/3 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
0.00%
0/21 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
0.00%
0/70 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
1.4%
1/69 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
|
Infections and infestations
Scrub typhus
|
0.00%
0/3 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
0.00%
0/21 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
0.00%
0/70 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
1.4%
1/69 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
|
Infections and infestations
Soft tissue infection
|
0.00%
0/3 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
0.00%
0/21 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
1.4%
1/70 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
1.4%
1/69 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/3 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
0.00%
0/21 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
2.9%
2/70 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
2.9%
2/69 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
|
Injury, poisoning and procedural complications
Brain contusion
|
0.00%
0/3 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
0.00%
0/21 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
1.4%
1/70 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
0.00%
0/69 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
|
Injury, poisoning and procedural complications
Pelvic fracture
|
0.00%
0/3 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
0.00%
0/21 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
0.00%
0/70 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
1.4%
1/69 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
|
Investigations
Neutrophil count decreased
|
0.00%
0/3 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
4.8%
1/21 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
0.00%
0/70 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
0.00%
0/69 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/3 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
0.00%
0/21 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
1.4%
1/70 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
0.00%
0/69 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/3 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
4.8%
1/21 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
0.00%
0/70 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
0.00%
0/69 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/3 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
0.00%
0/21 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
0.00%
0/70 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
1.4%
1/69 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/3 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
0.00%
0/21 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
0.00%
0/70 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
1.4%
1/69 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
0.00%
0/3 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
4.8%
1/21 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
0.00%
0/70 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
0.00%
0/69 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
0.00%
0/3 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
0.00%
0/21 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
1.4%
1/70 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
0.00%
0/69 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
|
Musculoskeletal and connective tissue disorders
Osteonecrosis of jaw
|
0.00%
0/3 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
0.00%
0/21 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
0.00%
0/70 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
2.9%
2/69 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/3 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
0.00%
0/21 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
1.4%
1/70 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
0.00%
0/69 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
|
Musculoskeletal and connective tissue disorders
Pathological fracture
|
0.00%
0/3 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
0.00%
0/21 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
0.00%
0/70 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
1.4%
1/69 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
0.00%
0/3 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
0.00%
0/21 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
1.4%
1/70 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
0.00%
0/69 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Burkitt's lymphoma
|
0.00%
0/3 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
0.00%
0/21 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
0.00%
0/70 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
1.4%
1/69 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lymphangiosis carcinomatosa
|
0.00%
0/3 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
0.00%
0/21 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
1.4%
1/70 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
0.00%
0/69 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant neoplasm progression
|
100.0%
3/3 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
23.8%
5/21 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
0.00%
0/70 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
0.00%
0/69 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to peritoneum
|
0.00%
0/3 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
0.00%
0/21 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
0.00%
0/70 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
1.4%
1/69 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Sarcoma uterus
|
0.00%
0/3 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
0.00%
0/21 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
0.00%
0/70 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
1.4%
1/69 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
|
Nervous system disorders
Cerebral infarction
|
0.00%
0/3 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
0.00%
0/21 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
1.4%
1/70 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
0.00%
0/69 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
|
Nervous system disorders
Intracranial aneurysm
|
0.00%
0/3 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
0.00%
0/21 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
1.4%
1/70 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
0.00%
0/69 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
|
Nervous system disorders
Syncope
|
0.00%
0/3 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
0.00%
0/21 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
1.4%
1/70 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
0.00%
0/69 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/3 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
0.00%
0/21 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
0.00%
0/70 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
2.9%
2/69 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
|
Renal and urinary disorders
Renal failure
|
0.00%
0/3 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
0.00%
0/21 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
1.4%
1/70 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
0.00%
0/69 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/3 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
4.8%
1/21 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
0.00%
0/70 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
0.00%
0/69 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/3 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
0.00%
0/21 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
0.00%
0/70 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
1.4%
1/69 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/3 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
0.00%
0/21 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
0.00%
0/70 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
1.4%
1/69 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
|
Respiratory, thoracic and mediastinal disorders
Interstitial lung disease
|
0.00%
0/3 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
0.00%
0/21 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
1.4%
1/70 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
2.9%
2/69 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
|
Respiratory, thoracic and mediastinal disorders
Lung disorder
|
0.00%
0/3 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
0.00%
0/21 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
0.00%
0/70 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
1.4%
1/69 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/3 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
0.00%
0/21 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
0.00%
0/70 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
2.9%
2/69 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.00%
0/3 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
0.00%
0/21 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
2.9%
2/70 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
7.2%
5/69 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.00%
0/3 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
0.00%
0/21 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
1.4%
1/70 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
0.00%
0/69 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/3 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
0.00%
0/21 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
0.00%
0/70 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
1.4%
1/69 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
|
Respiratory, thoracic and mediastinal disorders
Reexpansion pulmonary oedema
|
0.00%
0/3 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
0.00%
0/21 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
0.00%
0/70 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
1.4%
1/69 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.00%
0/3 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
0.00%
0/21 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
1.4%
1/70 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
0.00%
0/69 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
|
Vascular disorders
Deep vein thrombosis
|
0.00%
0/3 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
0.00%
0/21 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
1.4%
1/70 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
4.3%
3/69 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
|
Vascular disorders
Lymphoedema
|
0.00%
0/3 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
0.00%
0/21 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
0.00%
0/70 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
1.4%
1/69 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
|
Vascular disorders
Peripheral venous disease
|
0.00%
0/3 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
0.00%
0/21 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
1.4%
1/70 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
0.00%
0/69 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
|
Vascular disorders
Subclavian vein thrombosis
|
0.00%
0/3 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
0.00%
0/21 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
1.4%
1/70 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
0.00%
0/69 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
Other adverse events
| Measure |
Xentuzumab (BI 836845) 750 mg + Everolimus 10 mg + Exemestane 25 mg - Phase Ib
n=3 participants at risk
Subjects received a single dose of 750 milligram (mg) BI 836845 (xentuzumab) as a 1 hour (h) intravenous infusion once a week on Day 1, 8, 15 and 22 in a 28-day course until disease progression, intolerable AEs or other reason necessitating withdrawal.
Subjects also received a single oral dose once daily (qd) of 2x 5 mg (10 mg total) tablets of everolimus and 1 tablet of 25 mg exemestane starting 7 days before first administration of BI 836845 (xentuzumab) continously until disease progression, intolerable AEs or other reason necessitating withdrawal.
|
Xentuzumab (BI 836845) 1000 mg + Everolimus 10 mg + Exemestane 25 mg - Phase Ib
n=21 participants at risk
Subjects received a single dose of 1000 milligram (mg) BI 836845 (xentuzumab) as a 1 hour (h) intravenous infusion once a week on Day 1, 8, 15 and 22 in a 28-day course until disease progression, intolerable AEs or other reason necessitating withdrawal.
Subjects also received a single oral dose once daily (qd) of 2x 5 mg (10 mg total) tablets of everolimus and 1 tablet of 25 mg exemestane starting 7 days before first administration of BI 836845 (xentuzumab) continously until disease progression, intolerable AEs or other reason necessitating withdrawal.
|
Xentuzumab (BI 836845) 1000 mg + Everolimus 10 mg + Exemestane 25 mg - Phase II
n=70 participants at risk
Subjects received a single dose of 1000 milligram (mg) BI 836845 (xentuzumab) as a 1 hour (h) intravenous infusion once a week on Day 1, 8, 15 and 22 in a 28-day course until disease progression, intolerable AEs or other reason necessitating withdrawal.
Subjects also received a single oral dose once daily (qd) of 2x 5 mg (10 mg total) tablets of everolimus and 1 tablet of 25 mg exemestane starting on Day 1 continously until disease progression, intolerable AEs or other reason necessitating withdrawal.
Administration of xentuzumab was stopped after 28th October 2016, and participants in this group who remained in the trial could continue with everolimus 10 mg + exemestane 25 mg.
|
Everolimus 10 mg + Exemestane 25 mg - Phase II
n=69 participants at risk
Subjects received a single oral dose once daily (qd) of 2x 5 mg (10 mg total) tablets of everolimus and 1 tablet of 25 mg exemestane starting on Day 1 continously until disease progression, intolerable AEs or other reason necessitating withdrawal.
|
|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
100.0%
3/3 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
61.9%
13/21 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
22.9%
16/70 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
23.2%
16/69 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
|
Blood and lymphatic system disorders
Iron deficiency anaemia
|
0.00%
0/3 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
9.5%
2/21 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
1.4%
1/70 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
0.00%
0/69 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
|
Blood and lymphatic system disorders
Leukopenia
|
33.3%
1/3 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
28.6%
6/21 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
10.0%
7/70 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
7.2%
5/69 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
|
Blood and lymphatic system disorders
Lymphopenia
|
0.00%
0/3 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
14.3%
3/21 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
8.6%
6/70 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
8.7%
6/69 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
|
Blood and lymphatic system disorders
Neutropenia
|
33.3%
1/3 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
38.1%
8/21 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
28.6%
20/70 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
15.9%
11/69 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
33.3%
1/3 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
19.0%
4/21 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
24.3%
17/70 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
14.5%
10/69 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
|
Eye disorders
Visual acuity reduced
|
33.3%
1/3 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
0.00%
0/21 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
1.4%
1/70 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
0.00%
0/69 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
|
Eye disorders
Xerophthalmia
|
33.3%
1/3 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
0.00%
0/21 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
0.00%
0/70 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
0.00%
0/69 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
|
Gastrointestinal disorders
Abdominal pain
|
33.3%
1/3 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
19.0%
4/21 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
15.7%
11/70 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
8.7%
6/69 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
33.3%
1/3 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
23.8%
5/21 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
8.6%
6/70 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
8.7%
6/69 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
|
Gastrointestinal disorders
Aphthous ulcer
|
0.00%
0/3 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
0.00%
0/21 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
1.4%
1/70 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
5.8%
4/69 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
|
Gastrointestinal disorders
Constipation
|
33.3%
1/3 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
14.3%
3/21 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
21.4%
15/70 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
10.1%
7/69 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/3 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
57.1%
12/21 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
44.3%
31/70 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
33.3%
23/69 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/3 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
9.5%
2/21 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
4.3%
3/70 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
10.1%
7/69 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
|
Gastrointestinal disorders
Dyspepsia
|
33.3%
1/3 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
9.5%
2/21 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
7.1%
5/70 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
2.9%
2/69 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/3 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
9.5%
2/21 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
4.3%
3/70 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
2.9%
2/69 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
|
Gastrointestinal disorders
Mouth ulceration
|
0.00%
0/3 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
9.5%
2/21 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
4.3%
3/70 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
17.4%
12/69 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
|
Gastrointestinal disorders
Nausea
|
33.3%
1/3 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
42.9%
9/21 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
34.3%
24/70 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
23.2%
16/69 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
|
Gastrointestinal disorders
Odynophagia
|
33.3%
1/3 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
4.8%
1/21 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
4.3%
3/70 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
2.9%
2/69 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
|
Gastrointestinal disorders
Stomatitis
|
0.00%
0/3 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
38.1%
8/21 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
34.3%
24/70 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
37.7%
26/69 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
|
Gastrointestinal disorders
Tooth loss
|
33.3%
1/3 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
0.00%
0/21 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
0.00%
0/70 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
0.00%
0/69 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/3 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
9.5%
2/21 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
0.00%
0/70 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
4.3%
3/69 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
|
Gastrointestinal disorders
Vomiting
|
33.3%
1/3 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
33.3%
7/21 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
20.0%
14/70 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
21.7%
15/69 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
|
General disorders
Asthenia
|
100.0%
3/3 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
42.9%
9/21 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
32.9%
23/70 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
34.8%
24/69 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
|
General disorders
Calcinosis
|
33.3%
1/3 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
0.00%
0/21 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
0.00%
0/70 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
0.00%
0/69 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
|
General disorders
Chest pain
|
0.00%
0/3 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
0.00%
0/21 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
7.1%
5/70 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
8.7%
6/69 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
|
General disorders
Fatigue
|
0.00%
0/3 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
42.9%
9/21 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
27.1%
19/70 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
24.6%
17/69 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
|
General disorders
Influenza like illness
|
0.00%
0/3 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
0.00%
0/21 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
1.4%
1/70 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
7.2%
5/69 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
|
General disorders
Mucosal dryness
|
0.00%
0/3 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
9.5%
2/21 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
2.9%
2/70 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
1.4%
1/69 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
|
General disorders
Mucosal inflammation
|
100.0%
3/3 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
47.6%
10/21 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
38.6%
27/70 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
31.9%
22/69 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
|
General disorders
Oedema peripheral
|
33.3%
1/3 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
23.8%
5/21 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
15.7%
11/70 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
23.2%
16/69 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
|
General disorders
Pyrexia
|
33.3%
1/3 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
33.3%
7/21 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
14.3%
10/70 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
10.1%
7/69 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
|
Infections and infestations
Bronchitis
|
0.00%
0/3 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
4.8%
1/21 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
5.7%
4/70 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
4.3%
3/69 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
|
Infections and infestations
Cystitis
|
0.00%
0/3 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
9.5%
2/21 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
5.7%
4/70 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
0.00%
0/69 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
|
Infections and infestations
Diverticulitis
|
33.3%
1/3 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
0.00%
0/21 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
0.00%
0/70 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
0.00%
0/69 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/3 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
14.3%
3/21 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
2.9%
2/70 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
1.4%
1/69 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
|
Infections and infestations
Gingivitis
|
0.00%
0/3 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
4.8%
1/21 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
4.3%
3/70 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
5.8%
4/69 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/3 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
23.8%
5/21 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
17.1%
12/70 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
17.4%
12/69 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
|
Infections and infestations
Oral herpes
|
0.00%
0/3 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
4.8%
1/21 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
2.9%
2/70 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
5.8%
4/69 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
|
Infections and infestations
Paronychia
|
33.3%
1/3 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
0.00%
0/21 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
0.00%
0/70 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
1.4%
1/69 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
|
Infections and infestations
Rhinitis
|
33.3%
1/3 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
9.5%
2/21 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
2.9%
2/70 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
4.3%
3/69 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
|
Infections and infestations
Tooth abscess
|
0.00%
0/3 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
9.5%
2/21 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
2.9%
2/70 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
1.4%
1/69 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
|
Infections and infestations
Tooth infection
|
0.00%
0/3 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
9.5%
2/21 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
1.4%
1/70 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
1.4%
1/69 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/3 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
14.3%
3/21 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
7.1%
5/70 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
14.5%
10/69 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/3 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
28.6%
6/21 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
10.0%
7/70 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
13.0%
9/69 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/3 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
9.5%
2/21 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
1.4%
1/70 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
1.4%
1/69 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
0.00%
0/3 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
9.5%
2/21 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
2.9%
2/70 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
0.00%
0/69 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
|
Investigations
Alanine aminotransferase increased
|
33.3%
1/3 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
23.8%
5/21 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
25.7%
18/70 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
15.9%
11/69 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
|
Investigations
Aspartate aminotransferase increased
|
33.3%
1/3 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
19.0%
4/21 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
20.0%
14/70 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
20.3%
14/69 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
|
Investigations
Blood alkaline phosphatase increased
|
33.3%
1/3 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
9.5%
2/21 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
1.4%
1/70 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
2.9%
2/69 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
|
Investigations
Blood cholesterol increased
|
0.00%
0/3 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
14.3%
3/21 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
1.4%
1/70 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
8.7%
6/69 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
|
Investigations
Blood creatine phosphokinase increased
|
66.7%
2/3 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
33.3%
7/21 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
15.7%
11/70 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
10.1%
7/69 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
|
Investigations
Blood creatinine increased
|
33.3%
1/3 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
23.8%
5/21 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
4.3%
3/70 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
5.8%
4/69 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
|
Investigations
Blood glucose increased
|
0.00%
0/3 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
9.5%
2/21 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
1.4%
1/70 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
1.4%
1/69 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
|
Investigations
Blood iron decreased
|
0.00%
0/3 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
9.5%
2/21 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
1.4%
1/70 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
2.9%
2/69 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
|
Investigations
Blood phosphorus decreased
|
0.00%
0/3 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
9.5%
2/21 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
4.3%
3/70 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
2.9%
2/69 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
|
Investigations
Blood triglycerides increased
|
33.3%
1/3 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
9.5%
2/21 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
7.1%
5/70 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
2.9%
2/69 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
|
Investigations
Gamma-glutamyltransferase increased
|
0.00%
0/3 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
23.8%
5/21 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
11.4%
8/70 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
10.1%
7/69 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
|
Investigations
Haemoglobin decreased
|
0.00%
0/3 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
19.0%
4/21 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
2.9%
2/70 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
1.4%
1/69 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
|
Investigations
Low density lipoprotein increased
|
0.00%
0/3 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
14.3%
3/21 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
4.3%
3/70 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
1.4%
1/69 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
|
Investigations
Neutrophil count decreased
|
33.3%
1/3 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
19.0%
4/21 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
11.4%
8/70 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
2.9%
2/69 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
|
Investigations
Platelet count decreased
|
66.7%
2/3 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
19.0%
4/21 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
20.0%
14/70 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
4.3%
3/69 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
|
Investigations
Weight decreased
|
33.3%
1/3 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
52.4%
11/21 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
8.6%
6/70 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
13.0%
9/69 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
33.3%
1/3 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
61.9%
13/21 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
25.7%
18/70 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
31.9%
22/69 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
|
Metabolism and nutrition disorders
Hypercholesterolaemia
|
33.3%
1/3 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
23.8%
5/21 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
10.0%
7/70 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
8.7%
6/69 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
100.0%
3/3 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
52.4%
11/21 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
25.7%
18/70 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
24.6%
17/69 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
|
Metabolism and nutrition disorders
Hypertriglyceridaemia
|
0.00%
0/3 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
14.3%
3/21 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
7.1%
5/70 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
14.5%
10/69 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
33.3%
1/3 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
19.0%
4/21 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
10.0%
7/70 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
5.8%
4/69 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/3 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
19.0%
4/21 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
5.7%
4/70 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
7.2%
5/69 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
0.00%
0/3 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
9.5%
2/21 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
1.4%
1/70 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
0.00%
0/69 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
33.3%
1/3 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
33.3%
7/21 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
15.7%
11/70 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
11.6%
8/69 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
33.3%
1/3 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
19.0%
4/21 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
15.7%
11/70 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
24.6%
17/69 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/3 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
28.6%
6/21 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
17.1%
12/70 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
18.8%
13/69 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
0.00%
0/3 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
4.8%
1/21 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
7.1%
5/70 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
5.8%
4/69 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
33.3%
1/3 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
19.0%
4/21 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
11.4%
8/70 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
1.4%
1/69 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.00%
0/3 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
19.0%
4/21 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
11.4%
8/70 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
7.2%
5/69 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/3 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
14.3%
3/21 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
8.6%
6/70 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
5.8%
4/69 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/3 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
14.3%
3/21 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
11.4%
8/70 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
10.1%
7/69 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
|
Musculoskeletal and connective tissue disorders
Pain in jaw
|
0.00%
0/3 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
9.5%
2/21 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
2.9%
2/70 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
4.3%
3/69 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/3 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
9.5%
2/21 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
5.7%
4/70 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
7.2%
5/69 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
|
Nervous system disorders
Dysgeusia
|
33.3%
1/3 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
38.1%
8/21 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
14.3%
10/70 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
13.0%
9/69 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
|
Nervous system disorders
Headache
|
0.00%
0/3 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
23.8%
5/21 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
24.3%
17/70 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
14.5%
10/69 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/3 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
14.3%
3/21 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
11.4%
8/70 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
11.6%
8/69 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
|
Psychiatric disorders
Sleep disorder
|
0.00%
0/3 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
9.5%
2/21 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
1.4%
1/70 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
0.00%
0/69 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
|
Renal and urinary disorders
Dysuria
|
0.00%
0/3 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
19.0%
4/21 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
1.4%
1/70 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
4.3%
3/69 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
|
Renal and urinary disorders
Urinary incontinence
|
0.00%
0/3 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
9.5%
2/21 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
0.00%
0/70 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
0.00%
0/69 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
|
Reproductive system and breast disorders
Vulvovaginal inflammation
|
0.00%
0/3 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
0.00%
0/21 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
5.7%
4/70 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
0.00%
0/69 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
|
Respiratory, thoracic and mediastinal disorders
Aphonia
|
33.3%
1/3 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
0.00%
0/21 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
0.00%
0/70 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
0.00%
0/69 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
33.3%
1/3 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
47.6%
10/21 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
35.7%
25/70 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
26.1%
18/69 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
33.3%
1/3 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
0.00%
0/21 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
2.9%
2/70 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
2.9%
2/69 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
33.3%
1/3 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
28.6%
6/21 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
17.1%
12/70 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
26.1%
18/69 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
0.00%
0/3 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
0.00%
0/21 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
5.7%
4/70 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
7.2%
5/69 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/3 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
42.9%
9/21 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
18.6%
13/70 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
17.4%
12/69 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
|
Respiratory, thoracic and mediastinal disorders
Interstitial lung disease
|
0.00%
0/3 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
4.8%
1/21 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
0.00%
0/70 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
7.2%
5/69 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal dryness
|
0.00%
0/3 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
14.3%
3/21 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
0.00%
0/70 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
0.00%
0/69 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
33.3%
1/3 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
42.9%
9/21 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
10.0%
7/70 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
11.6%
8/69 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
0.00%
0/3 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
4.8%
1/21 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
7.1%
5/70 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
2.9%
2/69 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
33.3%
1/3 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
9.5%
2/21 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
4.3%
3/70 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
5.8%
4/69 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
0.00%
0/3 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
9.5%
2/21 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
1.4%
1/70 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
0.00%
0/69 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.00%
0/3 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
14.3%
3/21 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
11.4%
8/70 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
8.7%
6/69 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
|
Skin and subcutaneous tissue disorders
Eczema
|
0.00%
0/3 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
9.5%
2/21 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
4.3%
3/70 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
0.00%
0/69 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.00%
0/3 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
0.00%
0/21 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
7.1%
5/70 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
7.2%
5/69 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
|
Skin and subcutaneous tissue disorders
Nail disorder
|
0.00%
0/3 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
9.5%
2/21 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
7.1%
5/70 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
1.4%
1/69 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
|
Skin and subcutaneous tissue disorders
Nail dystrophy
|
0.00%
0/3 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
23.8%
5/21 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
2.9%
2/70 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
5.8%
4/69 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
|
Skin and subcutaneous tissue disorders
Onychoclasis
|
0.00%
0/3 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
4.8%
1/21 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
4.3%
3/70 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
5.8%
4/69 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/3 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
28.6%
6/21 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
20.0%
14/70 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
21.7%
15/69 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
|
Skin and subcutaneous tissue disorders
Rash
|
66.7%
2/3 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
28.6%
6/21 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
35.7%
25/70 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
33.3%
23/69 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
0.00%
0/3 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
4.8%
1/21 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
4.3%
3/70 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
5.8%
4/69 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.00%
0/3 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
9.5%
2/21 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
2.9%
2/70 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
0.00%
0/69 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
|
Vascular disorders
Hot flush
|
0.00%
0/3 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
14.3%
3/21 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
5.7%
4/70 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
1.4%
1/69 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
|
Vascular disorders
Hypertension
|
0.00%
0/3 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
42.9%
9/21 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
11.4%
8/70 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
10.1%
7/69 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
|
Vascular disorders
Lymphoedema
|
0.00%
0/3 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
4.8%
1/21 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
10.0%
7/70 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
2.9%
2/69 • For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days
Treated set (Phase Ib): including all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Randomised set (Phase II): including all randomised patients, regardless of whether or not they received treatment. Patients were assigned to xentuzumab + exemestane (Ex) + everolimus (Ev) or Ex+Ev as randomised. Adverse events were reported by initial treatment groups as planned in the Statistical Analysis Plan.
|
Additional Information
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Boehringer Ingelheim
Phone: 1-800-243-0127
Email: [email protected]
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