Trial Outcomes & Findings for S1222 Trial (Everolimus, Anastrozole and Fulvestrant) in Post-Menopausal Stage IV Breast Cancer (NCT NCT02137837)
NCT ID: NCT02137837
Last Updated: 2021-01-28
Results Overview
From date of registration to date of first documentation of progression or death due to any cause. Participants last known to be alive are censored at date of last contact.
Recruitment status
TERMINATED
Study phase
PHASE3
Target enrollment
37 participants
Primary outcome timeframe
up to 5 years
Results posted on
2021-01-28
Participant Flow
Participant milestones
| Measure |
Arm 1: Fulvestrant + Everolimus Placebo + Anastrozole Placebo
Participants receive an injection of fulvestrant in each buttock on Days 1 \&15 for Cycle 1 and then Day 1 only for subsequent cycles. Participants also receive an oral placebo daily for both everolimus and anastrozole. This treatment regimen will continue until disease progression or toxicity.
Fulvestrant
Placebo - Anastrozole
Placebo - Everolimus
|
Arm 2: Fulvestrant + Everolimus + Anastrozole Placebo
Participants receive an injection of fulvestrant in each buttock on Days 1 \&15 for Cycle 1 and then Day 1 only for subsequent cycles. Participants also receive an oral everolimus and an oral placebo for anastrozole daily. This treatment regimen will continue until disease progression or toxicity.
Fulvestrant
Everolimus
Placebo - Anastrozole
|
Arm 3: Fulvestrant + Everolimus + Anastrozole
Participants receive an injection of fulvestrant in each buttock on Days 1 \&15 for Cycle 1 and then Day 1 only for subsequent cycles. Participants also receive everolimus and anastrozole by mouth daily. This treatment regimen will continue until disease progression or toxicity.
Fulvestrant
Anastrozole
Everolimus
|
|---|---|---|---|
|
Overall Study
STARTED
|
13
|
12
|
12
|
|
Overall Study
Received Protocol Therapy
|
13
|
11
|
12
|
|
Overall Study
COMPLETED
|
0
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
13
|
12
|
12
|
Reasons for withdrawal
| Measure |
Arm 1: Fulvestrant + Everolimus Placebo + Anastrozole Placebo
Participants receive an injection of fulvestrant in each buttock on Days 1 \&15 for Cycle 1 and then Day 1 only for subsequent cycles. Participants also receive an oral placebo daily for both everolimus and anastrozole. This treatment regimen will continue until disease progression or toxicity.
Fulvestrant
Placebo - Anastrozole
Placebo - Everolimus
|
Arm 2: Fulvestrant + Everolimus + Anastrozole Placebo
Participants receive an injection of fulvestrant in each buttock on Days 1 \&15 for Cycle 1 and then Day 1 only for subsequent cycles. Participants also receive an oral everolimus and an oral placebo for anastrozole daily. This treatment regimen will continue until disease progression or toxicity.
Fulvestrant
Everolimus
Placebo - Anastrozole
|
Arm 3: Fulvestrant + Everolimus + Anastrozole
Participants receive an injection of fulvestrant in each buttock on Days 1 \&15 for Cycle 1 and then Day 1 only for subsequent cycles. Participants also receive everolimus and anastrozole by mouth daily. This treatment regimen will continue until disease progression or toxicity.
Fulvestrant
Anastrozole
Everolimus
|
|---|---|---|---|
|
Overall Study
Adverse Event
|
0
|
2
|
1
|
|
Overall Study
Refusal unrelated to adverse event
|
2
|
2
|
1
|
|
Overall Study
Progression/relapse
|
9
|
7
|
7
|
|
Overall Study
Not protocol specified
|
2
|
1
|
3
|
Baseline Characteristics
S1222 Trial (Everolimus, Anastrozole and Fulvestrant) in Post-Menopausal Stage IV Breast Cancer
Baseline characteristics by cohort
| Measure |
Arm 1: Fulvestrant + Everolimus Placebo + Anastrozole Placebo
n=13 Participants
Participants receive an injection of fulvestrant in each buttock on Days 1 \&15 for Cycle 1 and then Day 1 only for subsequent cycles. Participants also receive an oral placebo daily for both everolimus and anastrozole. This treatment regimen will continue until disease progression or toxicity.
Fulvestrant
Placebo - Anastrozole
Placebo - Everolimus
|
Arm 2: Fulvestrant + Everolimus + Anastrozole Placebo
n=12 Participants
Participants receive an injection of fulvestrant in each buttock on Days 1 \&15 for Cycle 1 and then Day 1 only for subsequent cycles. Participants also receive an oral everolimus and an oral placebo for anastrozole daily. This treatment regimen will continue until disease progression or toxicity.
Fulvestrant
Everolimus
Placebo - Anastrozole
|
Arm 3: Fulvestrant + Everolimus + Anastrozole
n=12 Participants
Participants receive an injection of fulvestrant in each buttock on Days 1 \&15 for Cycle 1 and then Day 1 only for subsequent cycles. Participants also receive everolimus and anastrozole by mouth daily. This treatment regimen will continue until disease progression or toxicity.
Fulvestrant
Anastrozole
Everolimus
|
Total
n=37 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
63.4 years
n=5 Participants
|
62.6 years
n=7 Participants
|
60.5 years
n=5 Participants
|
62.0 years
n=4 Participants
|
|
Sex: Female, Male
Female
|
13 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
37 Participants
n=4 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
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
12 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
34 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 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
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 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
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
9 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
28 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Disease
Measurable
|
9 participants
n=5 Participants
|
10 participants
n=7 Participants
|
9 participants
n=5 Participants
|
28 participants
n=4 Participants
|
|
Disease
Evaluable non-measurable disease
|
4 participants
n=5 Participants
|
2 participants
n=7 Participants
|
3 participants
n=5 Participants
|
9 participants
n=4 Participants
|
|
Prior Hormone
Prior adjuvant hormonal therapy completed >5 years ago
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
|
Prior Hormone
Prior adjuvant hormonal therapy completed 1-5 years ago
|
4 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
15 Participants
n=4 Participants
|
|
Prior Hormone
De novo presentation of metastatic disease or no prior adjuvant hormonal therapy
|
6 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
16 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: up to 5 yearsPopulation: Eligible participants randomized to study arms. This includes 1 participant on arm 2 who did not receive protocol treatment and is assumed to be a non-responder for response assessment.
From date of registration to date of first documentation of progression or death due to any cause. Participants last known to be alive are censored at date of last contact.
Outcome measures
| Measure |
Arm 1: Fulvestrant + Everolimus Placebo + Anastrozole Placebo
n=13 Participants
Participants receive an injection of fulvestrant in each buttock on Days 1 \&15 for Cycle 1 and then Day 1 only for subsequent cycles. Participants also receive an oral placebo daily for both everolimus and anastrozole. This treatment regimen will continue until disease progression or toxicity. (Note: after study unblinding at time of permanent study closure, participants on this arm received fulvestrant without continuing placebos.)
Fulvestrant
Placebo - Anastrozole
Placebo - Everolimus
|
Arm 2: Fulvestrant + Everolimus + Anastrozole Placebo
n=12 Participants
Participants receive an injection of fulvestrant in each buttock on Days 1 \&15 for Cycle 1 and then Day 1 only for subsequent cycles. Participants also receive an oral everolimus and an oral placebo for anastrozole daily. This treatment regimen will continue until disease progression or toxicity. (Note: after study unblinding at time of permanent study closure, participants on this arm received fulvestrant and unblinded everolimus without continuing placebos.)
Fulvestrant
Everolimus
Placebo - Anastrozole
|
Arm 3: Fulvestrant + Everolimus + Anastrozole
Participants receive an injection of fulvestrant in each buttock on Days 1 \&15 for Cycle 1 and then Day 1 only for subsequent cycles. Participants also receive everolimus and anastrozole by mouth daily. This treatment regimen will continue until disease progression or toxicity. (Note: after study unblinding at time of permanent study closure, participants on this arm received fulvestrant and unblinded everolimus and anastrozole.)
Fulvestrant
Anastrozole
Everolimus
|
|---|---|---|---|
|
Progression-Free Survival (Fulvestrant vs Fulvestrant + Everolimus )
|
14.0 months
Confidence intervals not calculated due to small sample size
|
11.3 months
Confidence intervals not calculated due to small sample size
|
—
|
PRIMARY outcome
Timeframe: up to 5 yearsPopulation: Eligible participants who were randomized to study arms and received protocol therapy
From date of registration to date of first documentation of progression or death due to any cause. Participants last known to be alive without report of progression are censored at date of last contact.
Outcome measures
| Measure |
Arm 1: Fulvestrant + Everolimus Placebo + Anastrozole Placebo
n=13 Participants
Participants receive an injection of fulvestrant in each buttock on Days 1 \&15 for Cycle 1 and then Day 1 only for subsequent cycles. Participants also receive an oral placebo daily for both everolimus and anastrozole. This treatment regimen will continue until disease progression or toxicity. (Note: after study unblinding at time of permanent study closure, participants on this arm received fulvestrant without continuing placebos.)
Fulvestrant
Placebo - Anastrozole
Placebo - Everolimus
|
Arm 2: Fulvestrant + Everolimus + Anastrozole Placebo
n=12 Participants
Participants receive an injection of fulvestrant in each buttock on Days 1 \&15 for Cycle 1 and then Day 1 only for subsequent cycles. Participants also receive an oral everolimus and an oral placebo for anastrozole daily. This treatment regimen will continue until disease progression or toxicity. (Note: after study unblinding at time of permanent study closure, participants on this arm received fulvestrant and unblinded everolimus without continuing placebos.)
Fulvestrant
Everolimus
Placebo - Anastrozole
|
Arm 3: Fulvestrant + Everolimus + Anastrozole
Participants receive an injection of fulvestrant in each buttock on Days 1 \&15 for Cycle 1 and then Day 1 only for subsequent cycles. Participants also receive everolimus and anastrozole by mouth daily. This treatment regimen will continue until disease progression or toxicity. (Note: after study unblinding at time of permanent study closure, participants on this arm received fulvestrant and unblinded everolimus and anastrozole.)
Fulvestrant
Anastrozole
Everolimus
|
|---|---|---|---|
|
Progression-free Survival (Fulvestrant Versus Fulvestrant + Everolimus + Anastrozole)
|
14.0 months
Confidence intervals not calculated due to small sample size
|
9.9 months
Confidence intervals not calculated due to small sample size
|
—
|
SECONDARY outcome
Timeframe: up to 5 yearsPopulation: Eligible participants randomized to study arms. This includes 1 participant on arm 2 who did not receive protocol treatment and is assumed to be a non-responder for response assessment.
From date of registration to date of first documentation of progression or death due to any cause. Participants last known to be alive without report of progression are censored at date of last contact.
Outcome measures
| Measure |
Arm 1: Fulvestrant + Everolimus Placebo + Anastrozole Placebo
n=12 Participants
Participants receive an injection of fulvestrant in each buttock on Days 1 \&15 for Cycle 1 and then Day 1 only for subsequent cycles. Participants also receive an oral placebo daily for both everolimus and anastrozole. This treatment regimen will continue until disease progression or toxicity. (Note: after study unblinding at time of permanent study closure, participants on this arm received fulvestrant without continuing placebos.)
Fulvestrant
Placebo - Anastrozole
Placebo - Everolimus
|
Arm 2: Fulvestrant + Everolimus + Anastrozole Placebo
n=12 Participants
Participants receive an injection of fulvestrant in each buttock on Days 1 \&15 for Cycle 1 and then Day 1 only for subsequent cycles. Participants also receive an oral everolimus and an oral placebo for anastrozole daily. This treatment regimen will continue until disease progression or toxicity. (Note: after study unblinding at time of permanent study closure, participants on this arm received fulvestrant and unblinded everolimus without continuing placebos.)
Fulvestrant
Everolimus
Placebo - Anastrozole
|
Arm 3: Fulvestrant + Everolimus + Anastrozole
Participants receive an injection of fulvestrant in each buttock on Days 1 \&15 for Cycle 1 and then Day 1 only for subsequent cycles. Participants also receive everolimus and anastrozole by mouth daily. This treatment regimen will continue until disease progression or toxicity. (Note: after study unblinding at time of permanent study closure, participants on this arm received fulvestrant and unblinded everolimus and anastrozole.)
Fulvestrant
Anastrozole
Everolimus
|
|---|---|---|---|
|
Progression Free Survival (Fulvestrant + Everolimus vs Fulvestrant + Everolimus + Anastrozole)
|
11.3 months
Confidence intervals not calculated due to small sample size
|
9.90 months
Confidence intervals not calculated due to small sample size
|
—
|
SECONDARY outcome
Timeframe: up to 5 yearsPopulation: Eligible participants randomized to study arms. This includes 1 participant on arm 2 who did not receive protocol treatment and is assumed to be a non-responder for response assessment.
From date of registration to date of death due to any cause. Participants last known to be alive without report of progression are censored at date of last contact.
Outcome measures
| Measure |
Arm 1: Fulvestrant + Everolimus Placebo + Anastrozole Placebo
n=13 Participants
Participants receive an injection of fulvestrant in each buttock on Days 1 \&15 for Cycle 1 and then Day 1 only for subsequent cycles. Participants also receive an oral placebo daily for both everolimus and anastrozole. This treatment regimen will continue until disease progression or toxicity. (Note: after study unblinding at time of permanent study closure, participants on this arm received fulvestrant without continuing placebos.)
Fulvestrant
Placebo - Anastrozole
Placebo - Everolimus
|
Arm 2: Fulvestrant + Everolimus + Anastrozole Placebo
n=12 Participants
Participants receive an injection of fulvestrant in each buttock on Days 1 \&15 for Cycle 1 and then Day 1 only for subsequent cycles. Participants also receive an oral everolimus and an oral placebo for anastrozole daily. This treatment regimen will continue until disease progression or toxicity. (Note: after study unblinding at time of permanent study closure, participants on this arm received fulvestrant and unblinded everolimus without continuing placebos.)
Fulvestrant
Everolimus
Placebo - Anastrozole
|
Arm 3: Fulvestrant + Everolimus + Anastrozole
n=12 Participants
Participants receive an injection of fulvestrant in each buttock on Days 1 \&15 for Cycle 1 and then Day 1 only for subsequent cycles. Participants also receive everolimus and anastrozole by mouth daily. This treatment regimen will continue until disease progression or toxicity. (Note: after study unblinding at time of permanent study closure, participants on this arm received fulvestrant and unblinded everolimus and anastrozole.)
Fulvestrant
Anastrozole
Everolimus
|
|---|---|---|---|
|
Overall Survival
|
46.8 months
Confidence intervals not calculated due to small sample size
|
56.6 months
Confidence intervals not calculated due to small sample size
|
33.6 months
Confidence intervals not calculated due to small sample size
|
SECONDARY outcome
Timeframe: Duration of treatment and follow up until death or 5 years post registrationPopulation: Eligible participants who received at least one dose of protocol treatment.
Adverse Events (AEs) are reported by CTCAE Version 4.0. Only adverse events that are possibly, probably or definitely related to study drug are reported.
Outcome measures
| Measure |
Arm 1: Fulvestrant + Everolimus Placebo + Anastrozole Placebo
n=13 Participants
Participants receive an injection of fulvestrant in each buttock on Days 1 \&15 for Cycle 1 and then Day 1 only for subsequent cycles. Participants also receive an oral placebo daily for both everolimus and anastrozole. This treatment regimen will continue until disease progression or toxicity. (Note: after study unblinding at time of permanent study closure, participants on this arm received fulvestrant without continuing placebos.)
Fulvestrant
Placebo - Anastrozole
Placebo - Everolimus
|
Arm 2: Fulvestrant + Everolimus + Anastrozole Placebo
n=11 Participants
Participants receive an injection of fulvestrant in each buttock on Days 1 \&15 for Cycle 1 and then Day 1 only for subsequent cycles. Participants also receive an oral everolimus and an oral placebo for anastrozole daily. This treatment regimen will continue until disease progression or toxicity. (Note: after study unblinding at time of permanent study closure, participants on this arm received fulvestrant and unblinded everolimus without continuing placebos.)
Fulvestrant
Everolimus
Placebo - Anastrozole
|
Arm 3: Fulvestrant + Everolimus + Anastrozole
n=12 Participants
Participants receive an injection of fulvestrant in each buttock on Days 1 \&15 for Cycle 1 and then Day 1 only for subsequent cycles. Participants also receive everolimus and anastrozole by mouth daily. This treatment regimen will continue until disease progression or toxicity. (Note: after study unblinding at time of permanent study closure, participants on this arm received fulvestrant and unblinded everolimus and anastrozole.)
Fulvestrant
Anastrozole
Everolimus
|
|---|---|---|---|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Abdominal pain
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Anorexia
|
0 Participants
|
1 Participants
|
1 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Aspartate aminotransferase increased
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Dehydration
|
0 Participants
|
2 Participants
|
1 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Diarrhea
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Fatigue
|
0 Participants
|
2 Participants
|
0 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Flu like symptoms
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Generalized muscle weakness
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Hyperglycemia
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Hypertension
|
0 Participants
|
2 Participants
|
2 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Hypocalcemia
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Hypokalemia
|
0 Participants
|
2 Participants
|
1 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Hyponatremia
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Hypophosphatemia
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Hypotension
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Localized edema
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Lymphocyte count decreased
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Mucositis oral
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Neutrophil count decreased
|
0 Participants
|
2 Participants
|
0 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Rash maculo-papular
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Resp, thoracic and mediastinal disorders - Other
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Sore throat
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Thromboembolic event
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Vomiting
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
White blood cell decreased
|
0 Participants
|
1 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: assessed every 12 weeks, up to 5 yearsPopulation: Eligible participants with measurable disease.
Proportion of participants who have confirmed or unconfirmed partial or complete response to therapy
Outcome measures
| Measure |
Arm 1: Fulvestrant + Everolimus Placebo + Anastrozole Placebo
n=9 Participants
Participants receive an injection of fulvestrant in each buttock on Days 1 \&15 for Cycle 1 and then Day 1 only for subsequent cycles. Participants also receive an oral placebo daily for both everolimus and anastrozole. This treatment regimen will continue until disease progression or toxicity. (Note: after study unblinding at time of permanent study closure, participants on this arm received fulvestrant without continuing placebos.)
Fulvestrant
Placebo - Anastrozole
Placebo - Everolimus
|
Arm 2: Fulvestrant + Everolimus + Anastrozole Placebo
n=10 Participants
Participants receive an injection of fulvestrant in each buttock on Days 1 \&15 for Cycle 1 and then Day 1 only for subsequent cycles. Participants also receive an oral everolimus and an oral placebo for anastrozole daily. This treatment regimen will continue until disease progression or toxicity. (Note: after study unblinding at time of permanent study closure, participants on this arm received fulvestrant and unblinded everolimus without continuing placebos.)
Fulvestrant
Everolimus
Placebo - Anastrozole
|
Arm 3: Fulvestrant + Everolimus + Anastrozole
n=9 Participants
Participants receive an injection of fulvestrant in each buttock on Days 1 \&15 for Cycle 1 and then Day 1 only for subsequent cycles. Participants also receive everolimus and anastrozole by mouth daily. This treatment regimen will continue until disease progression or toxicity. (Note: after study unblinding at time of permanent study closure, participants on this arm received fulvestrant and unblinded everolimus and anastrozole.)
Fulvestrant
Anastrozole
Everolimus
|
|---|---|---|---|
|
Response Rate
|
22 percentage of participants
|
60 percentage of participants
|
44 percentage of participants
|
SECONDARY outcome
Timeframe: assessed every 12 weeks, up to 5 yearsPopulation: Eligible participants randomized to study arms. This includes 1 participant on arm 2 who did not receive protocol treatment and is assumed to be a non-responder for response assessment.
Proportion of participants who have confirmed and unconfirmed partial response, complete response or stable disease.
Outcome measures
| Measure |
Arm 1: Fulvestrant + Everolimus Placebo + Anastrozole Placebo
n=13 Participants
Participants receive an injection of fulvestrant in each buttock on Days 1 \&15 for Cycle 1 and then Day 1 only for subsequent cycles. Participants also receive an oral placebo daily for both everolimus and anastrozole. This treatment regimen will continue until disease progression or toxicity. (Note: after study unblinding at time of permanent study closure, participants on this arm received fulvestrant without continuing placebos.)
Fulvestrant
Placebo - Anastrozole
Placebo - Everolimus
|
Arm 2: Fulvestrant + Everolimus + Anastrozole Placebo
n=12 Participants
Participants receive an injection of fulvestrant in each buttock on Days 1 \&15 for Cycle 1 and then Day 1 only for subsequent cycles. Participants also receive an oral everolimus and an oral placebo for anastrozole daily. This treatment regimen will continue until disease progression or toxicity. (Note: after study unblinding at time of permanent study closure, participants on this arm received fulvestrant and unblinded everolimus without continuing placebos.)
Fulvestrant
Everolimus
Placebo - Anastrozole
|
Arm 3: Fulvestrant + Everolimus + Anastrozole
n=12 Participants
Participants receive an injection of fulvestrant in each buttock on Days 1 \&15 for Cycle 1 and then Day 1 only for subsequent cycles. Participants also receive everolimus and anastrozole by mouth daily. This treatment regimen will continue until disease progression or toxicity. (Note: after study unblinding at time of permanent study closure, participants on this arm received fulvestrant and unblinded everolimus and anastrozole.)
Fulvestrant
Anastrozole
Everolimus
|
|---|---|---|---|
|
Clinical Benefit Rate
|
69 percentage of participants
|
83 percentage of participants
|
67 percentage of participants
|
SECONDARY outcome
Timeframe: Day 1, Day 29, time of progression (Day 29 to be collected only if Day 1 CTC was elevated.)Population: Participants with Day 1 whole blood specimen submitted.
CTC-Endocrine Therapy Index (CTC-ETI) on the CellSearch® platform. Based on enumeration of CTC/7.5 mL of whole blood, with \>= 5 being elevated. (Due to limited samples collected, full analysis was not able to be performed as planned, so outcome measure reported here is number with elevated Day 1 CTC.)
Outcome measures
| Measure |
Arm 1: Fulvestrant + Everolimus Placebo + Anastrozole Placebo
n=5 Participants
Participants receive an injection of fulvestrant in each buttock on Days 1 \&15 for Cycle 1 and then Day 1 only for subsequent cycles. Participants also receive an oral placebo daily for both everolimus and anastrozole. This treatment regimen will continue until disease progression or toxicity. (Note: after study unblinding at time of permanent study closure, participants on this arm received fulvestrant without continuing placebos.)
Fulvestrant
Placebo - Anastrozole
Placebo - Everolimus
|
Arm 2: Fulvestrant + Everolimus + Anastrozole Placebo
n=5 Participants
Participants receive an injection of fulvestrant in each buttock on Days 1 \&15 for Cycle 1 and then Day 1 only for subsequent cycles. Participants also receive an oral everolimus and an oral placebo for anastrozole daily. This treatment regimen will continue until disease progression or toxicity. (Note: after study unblinding at time of permanent study closure, participants on this arm received fulvestrant and unblinded everolimus without continuing placebos.)
Fulvestrant
Everolimus
Placebo - Anastrozole
|
Arm 3: Fulvestrant + Everolimus + Anastrozole
n=3 Participants
Participants receive an injection of fulvestrant in each buttock on Days 1 \&15 for Cycle 1 and then Day 1 only for subsequent cycles. Participants also receive everolimus and anastrozole by mouth daily. This treatment regimen will continue until disease progression or toxicity. (Note: after study unblinding at time of permanent study closure, participants on this arm received fulvestrant and unblinded everolimus and anastrozole.)
Fulvestrant
Anastrozole
Everolimus
|
|---|---|---|---|
|
Molecular Determinants of Response in Circulating Tumor Cells: CTC-ETI
|
1 Participants
|
1 Participants
|
0 Participants
|
Adverse Events
Arm 1: Fulvestrant + Everolimus Placebo + Anastrozole Placebo
Serious events: 0 serious events
Other events: 13 other events
Deaths: 8 deaths
Arm 2: Fulvestrant + Everolimus + Anastrozole Placebo
Serious events: 0 serious events
Other events: 11 other events
Deaths: 6 deaths
Arm 3: Fulvestrant + Everolimus + Anastrozole
Serious events: 0 serious events
Other events: 12 other events
Deaths: 6 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Arm 1: Fulvestrant + Everolimus Placebo + Anastrozole Placebo
n=13 participants at risk
Participants receive an injection of fulvestrant in each buttock on Days 1 \& 15 for Cycle 1 and then Day 1 only for subsequent cycles. Participants also receive an oral placebo daily for both everolimus and anastrozole. This treatment regimen will continue until disease progression or toxicity.
Fulvestrant
Placebo - Anastrozole
Placebo - Everolimus
|
Arm 2: Fulvestrant + Everolimus + Anastrozole Placebo
n=11 participants at risk
Participants receive an injection of fulvestrant in each buttock on Days 1 \& 15 for Cycle 1 and then Day 1 only for subsequent cycles. Participants also receive an oral everolimus and an oral placebo for anastrozole daily. This treatment regimen will continue until disease progression or toxicity.
Fulvestrant
Everolimus
Placebo - Anastrozole
|
Arm 3: Fulvestrant + Everolimus + Anastrozole
n=12 participants at risk
Participants receive an injection of fulvestrant in each buttock on Days 1 \& 15 for Cycle 1 and then Day 1 only for subsequent cycles. Participants also receive everolimus and anastrozole by mouth daily. This treatment regimen will continue until disease progression or toxicity.
Fulvestrant
Anastrozole
Everolimus
|
|---|---|---|---|
|
General disorders
Chills
|
7.7%
1/13 • Duration of treatment and follow up until death or 5 years post registration
36 participants who were eligible and received protocol therapy were assessed for AEs.
|
18.2%
2/11 • Duration of treatment and follow up until death or 5 years post registration
36 participants who were eligible and received protocol therapy were assessed for AEs.
|
8.3%
1/12 • Duration of treatment and follow up until death or 5 years post registration
36 participants who were eligible and received protocol therapy were assessed for AEs.
|
|
General disorders
Edema face
|
0.00%
0/13 • Duration of treatment and follow up until death or 5 years post registration
36 participants who were eligible and received protocol therapy were assessed for AEs.
|
9.1%
1/11 • Duration of treatment and follow up until death or 5 years post registration
36 participants who were eligible and received protocol therapy were assessed for AEs.
|
0.00%
0/12 • Duration of treatment and follow up until death or 5 years post registration
36 participants who were eligible and received protocol therapy were assessed for AEs.
|
|
General disorders
Edema limbs
|
30.8%
4/13 • Duration of treatment and follow up until death or 5 years post registration
36 participants who were eligible and received protocol therapy were assessed for AEs.
|
54.5%
6/11 • Duration of treatment and follow up until death or 5 years post registration
36 participants who were eligible and received protocol therapy were assessed for AEs.
|
25.0%
3/12 • Duration of treatment and follow up until death or 5 years post registration
36 participants who were eligible and received protocol therapy were assessed for AEs.
|
|
General disorders
Fatigue
|
76.9%
10/13 • Duration of treatment and follow up until death or 5 years post registration
36 participants who were eligible and received protocol therapy were assessed for AEs.
|
90.9%
10/11 • Duration of treatment and follow up until death or 5 years post registration
36 participants who were eligible and received protocol therapy were assessed for AEs.
|
58.3%
7/12 • Duration of treatment and follow up until death or 5 years post registration
36 participants who were eligible and received protocol therapy were assessed for AEs.
|
|
General disorders
Fever
|
23.1%
3/13 • Duration of treatment and follow up until death or 5 years post registration
36 participants who were eligible and received protocol therapy were assessed for AEs.
|
27.3%
3/11 • Duration of treatment and follow up until death or 5 years post registration
36 participants who were eligible and received protocol therapy were assessed for AEs.
|
8.3%
1/12 • Duration of treatment and follow up until death or 5 years post registration
36 participants who were eligible and received protocol therapy were assessed for AEs.
|
|
General disorders
Flu like symptoms
|
0.00%
0/13 • Duration of treatment and follow up until death or 5 years post registration
36 participants who were eligible and received protocol therapy were assessed for AEs.
|
9.1%
1/11 • Duration of treatment and follow up until death or 5 years post registration
36 participants who were eligible and received protocol therapy were assessed for AEs.
|
8.3%
1/12 • Duration of treatment and follow up until death or 5 years post registration
36 participants who were eligible and received protocol therapy were assessed for AEs.
|
|
General disorders
General disorders and admin site conditions - Other
|
7.7%
1/13 • Duration of treatment and follow up until death or 5 years post registration
36 participants who were eligible and received protocol therapy were assessed for AEs.
|
27.3%
3/11 • Duration of treatment and follow up until death or 5 years post registration
36 participants who were eligible and received protocol therapy were assessed for AEs.
|
0.00%
0/12 • Duration of treatment and follow up until death or 5 years post registration
36 participants who were eligible and received protocol therapy were assessed for AEs.
|
|
General disorders
Injection site reaction
|
15.4%
2/13 • Duration of treatment and follow up until death or 5 years post registration
36 participants who were eligible and received protocol therapy were assessed for AEs.
|
9.1%
1/11 • Duration of treatment and follow up until death or 5 years post registration
36 participants who were eligible and received protocol therapy were assessed for AEs.
|
0.00%
0/12 • Duration of treatment and follow up until death or 5 years post registration
36 participants who were eligible and received protocol therapy were assessed for AEs.
|
|
General disorders
Localized edema
|
0.00%
0/13 • Duration of treatment and follow up until death or 5 years post registration
36 participants who were eligible and received protocol therapy were assessed for AEs.
|
27.3%
3/11 • Duration of treatment and follow up until death or 5 years post registration
36 participants who were eligible and received protocol therapy were assessed for AEs.
|
8.3%
1/12 • Duration of treatment and follow up until death or 5 years post registration
36 participants who were eligible and received protocol therapy were assessed for AEs.
|
|
Blood and lymphatic system disorders
Anemia
|
30.8%
4/13 • Duration of treatment and follow up until death or 5 years post registration
36 participants who were eligible and received protocol therapy were assessed for AEs.
|
72.7%
8/11 • Duration of treatment and follow up until death or 5 years post registration
36 participants who were eligible and received protocol therapy were assessed for AEs.
|
50.0%
6/12 • Duration of treatment and follow up until death or 5 years post registration
36 participants who were eligible and received protocol therapy were assessed for AEs.
|
|
Blood and lymphatic system disorders
Blood and lymphatic system disorders - Other
|
0.00%
0/13 • Duration of treatment and follow up until death or 5 years post registration
36 participants who were eligible and received protocol therapy were assessed for AEs.
|
18.2%
2/11 • Duration of treatment and follow up until death or 5 years post registration
36 participants who were eligible and received protocol therapy were assessed for AEs.
|
0.00%
0/12 • Duration of treatment and follow up until death or 5 years post registration
36 participants who were eligible and received protocol therapy were assessed for AEs.
|
|
Cardiac disorders
Atrial fibrillation
|
7.7%
1/13 • Duration of treatment and follow up until death or 5 years post registration
36 participants who were eligible and received protocol therapy were assessed for AEs.
|
0.00%
0/11 • Duration of treatment and follow up until death or 5 years post registration
36 participants who were eligible and received protocol therapy were assessed for AEs.
|
8.3%
1/12 • Duration of treatment and follow up until death or 5 years post registration
36 participants who were eligible and received protocol therapy were assessed for AEs.
|
|
Cardiac disorders
Atrioventricular block first degree
|
0.00%
0/13 • Duration of treatment and follow up until death or 5 years post registration
36 participants who were eligible and received protocol therapy were assessed for AEs.
|
0.00%
0/11 • Duration of treatment and follow up until death or 5 years post registration
36 participants who were eligible and received protocol therapy were assessed for AEs.
|
8.3%
1/12 • Duration of treatment and follow up until death or 5 years post registration
36 participants who were eligible and received protocol therapy were assessed for AEs.
|
|
Cardiac disorders
Cardiac disorders-Other
|
0.00%
0/13 • Duration of treatment and follow up until death or 5 years post registration
36 participants who were eligible and received protocol therapy were assessed for AEs.
|
9.1%
1/11 • Duration of treatment and follow up until death or 5 years post registration
36 participants who were eligible and received protocol therapy were assessed for AEs.
|
0.00%
0/12 • Duration of treatment and follow up until death or 5 years post registration
36 participants who were eligible and received protocol therapy were assessed for AEs.
|
|
Cardiac disorders
Chest pain - cardiac
|
0.00%
0/13 • Duration of treatment and follow up until death or 5 years post registration
36 participants who were eligible and received protocol therapy were assessed for AEs.
|
9.1%
1/11 • Duration of treatment and follow up until death or 5 years post registration
36 participants who were eligible and received protocol therapy were assessed for AEs.
|
0.00%
0/12 • Duration of treatment and follow up until death or 5 years post registration
36 participants who were eligible and received protocol therapy were assessed for AEs.
|
|
Cardiac disorders
Left ventricular systolic dysfunction
|
0.00%
0/13 • Duration of treatment and follow up until death or 5 years post registration
36 participants who were eligible and received protocol therapy were assessed for AEs.
|
9.1%
1/11 • Duration of treatment and follow up until death or 5 years post registration
36 participants who were eligible and received protocol therapy were assessed for AEs.
|
0.00%
0/12 • Duration of treatment and follow up until death or 5 years post registration
36 participants who were eligible and received protocol therapy were assessed for AEs.
|
|
Cardiac disorders
Palpitations
|
7.7%
1/13 • Duration of treatment and follow up until death or 5 years post registration
36 participants who were eligible and received protocol therapy were assessed for AEs.
|
9.1%
1/11 • Duration of treatment and follow up until death or 5 years post registration
36 participants who were eligible and received protocol therapy were assessed for AEs.
|
0.00%
0/12 • Duration of treatment and follow up until death or 5 years post registration
36 participants who were eligible and received protocol therapy were assessed for AEs.
|
|
Cardiac disorders
Pericardial effusion
|
7.7%
1/13 • Duration of treatment and follow up until death or 5 years post registration
36 participants who were eligible and received protocol therapy were assessed for AEs.
|
0.00%
0/11 • Duration of treatment and follow up until death or 5 years post registration
36 participants who were eligible and received protocol therapy were assessed for AEs.
|
0.00%
0/12 • Duration of treatment and follow up until death or 5 years post registration
36 participants who were eligible and received protocol therapy were assessed for AEs.
|
|
Cardiac disorders
Sinus tachycardia
|
7.7%
1/13 • Duration of treatment and follow up until death or 5 years post registration
36 participants who were eligible and received protocol therapy were assessed for AEs.
|
27.3%
3/11 • Duration of treatment and follow up until death or 5 years post registration
36 participants who were eligible and received protocol therapy were assessed for AEs.
|
0.00%
0/12 • Duration of treatment and follow up until death or 5 years post registration
36 participants who were eligible and received protocol therapy were assessed for AEs.
|
|
Ear and labyrinth disorders
Ear and labyrinth disorders-Other
|
0.00%
0/13 • Duration of treatment and follow up until death or 5 years post registration
36 participants who were eligible and received protocol therapy were assessed for AEs.
|
9.1%
1/11 • Duration of treatment and follow up until death or 5 years post registration
36 participants who were eligible and received protocol therapy were assessed for AEs.
|
0.00%
0/12 • Duration of treatment and follow up until death or 5 years post registration
36 participants who were eligible and received protocol therapy were assessed for AEs.
|
|
Ear and labyrinth disorders
Ear pain
|
0.00%
0/13 • Duration of treatment and follow up until death or 5 years post registration
36 participants who were eligible and received protocol therapy were assessed for AEs.
|
0.00%
0/11 • Duration of treatment and follow up until death or 5 years post registration
36 participants who were eligible and received protocol therapy were assessed for AEs.
|
8.3%
1/12 • Duration of treatment and follow up until death or 5 years post registration
36 participants who were eligible and received protocol therapy were assessed for AEs.
|
|
Ear and labyrinth disorders
External ear inflammation
|
0.00%
0/13 • Duration of treatment and follow up until death or 5 years post registration
36 participants who were eligible and received protocol therapy were assessed for AEs.
|
0.00%
0/11 • Duration of treatment and follow up until death or 5 years post registration
36 participants who were eligible and received protocol therapy were assessed for AEs.
|
8.3%
1/12 • Duration of treatment and follow up until death or 5 years post registration
36 participants who were eligible and received protocol therapy were assessed for AEs.
|
|
Ear and labyrinth disorders
Tinnitus
|
0.00%
0/13 • Duration of treatment and follow up until death or 5 years post registration
36 participants who were eligible and received protocol therapy were assessed for AEs.
|
9.1%
1/11 • Duration of treatment and follow up until death or 5 years post registration
36 participants who were eligible and received protocol therapy were assessed for AEs.
|
0.00%
0/12 • Duration of treatment and follow up until death or 5 years post registration
36 participants who were eligible and received protocol therapy were assessed for AEs.
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/13 • Duration of treatment and follow up until death or 5 years post registration
36 participants who were eligible and received protocol therapy were assessed for AEs.
|
9.1%
1/11 • Duration of treatment and follow up until death or 5 years post registration
36 participants who were eligible and received protocol therapy were assessed for AEs.
|
0.00%
0/12 • Duration of treatment and follow up until death or 5 years post registration
36 participants who were eligible and received protocol therapy were assessed for AEs.
|
|
Eye disorders
Blurred vision
|
0.00%
0/13 • Duration of treatment and follow up until death or 5 years post registration
36 participants who were eligible and received protocol therapy were assessed for AEs.
|
9.1%
1/11 • Duration of treatment and follow up until death or 5 years post registration
36 participants who were eligible and received protocol therapy were assessed for AEs.
|
8.3%
1/12 • Duration of treatment and follow up until death or 5 years post registration
36 participants who were eligible and received protocol therapy were assessed for AEs.
|
|
Eye disorders
Conjunctivitis
|
0.00%
0/13 • Duration of treatment and follow up until death or 5 years post registration
36 participants who were eligible and received protocol therapy were assessed for AEs.
|
9.1%
1/11 • Duration of treatment and follow up until death or 5 years post registration
36 participants who were eligible and received protocol therapy were assessed for AEs.
|
0.00%
0/12 • Duration of treatment and follow up until death or 5 years post registration
36 participants who were eligible and received protocol therapy were assessed for AEs.
|
|
Eye disorders
Eye disorders-Other
|
15.4%
2/13 • Duration of treatment and follow up until death or 5 years post registration
36 participants who were eligible and received protocol therapy were assessed for AEs.
|
9.1%
1/11 • Duration of treatment and follow up until death or 5 years post registration
36 participants who were eligible and received protocol therapy were assessed for AEs.
|
0.00%
0/12 • Duration of treatment and follow up until death or 5 years post registration
36 participants who were eligible and received protocol therapy were assessed for AEs.
|
|
Eye disorders
Floaters
|
0.00%
0/13 • Duration of treatment and follow up until death or 5 years post registration
36 participants who were eligible and received protocol therapy were assessed for AEs.
|
9.1%
1/11 • Duration of treatment and follow up until death or 5 years post registration
36 participants who were eligible and received protocol therapy were assessed for AEs.
|
0.00%
0/12 • Duration of treatment and follow up until death or 5 years post registration
36 participants who were eligible and received protocol therapy were assessed for AEs.
|
|
Eye disorders
Watering eyes
|
0.00%
0/13 • Duration of treatment and follow up until death or 5 years post registration
36 participants who were eligible and received protocol therapy were assessed for AEs.
|
9.1%
1/11 • Duration of treatment and follow up until death or 5 years post registration
36 participants who were eligible and received protocol therapy were assessed for AEs.
|
0.00%
0/12 • Duration of treatment and follow up until death or 5 years post registration
36 participants who were eligible and received protocol therapy were assessed for AEs.
|
|
Gastrointestinal disorders
Abdominal pain
|
23.1%
3/13 • Duration of treatment and follow up until death or 5 years post registration
36 participants who were eligible and received protocol therapy were assessed for AEs.
|
36.4%
4/11 • Duration of treatment and follow up until death or 5 years post registration
36 participants who were eligible and received protocol therapy were assessed for AEs.
|
8.3%
1/12 • Duration of treatment and follow up until death or 5 years post registration
36 participants who were eligible and received protocol therapy were assessed for AEs.
|
|
Gastrointestinal disorders
Anal hemorrhage
|
0.00%
0/13 • Duration of treatment and follow up until death or 5 years post registration
36 participants who were eligible and received protocol therapy were assessed for AEs.
|
9.1%
1/11 • Duration of treatment and follow up until death or 5 years post registration
36 participants who were eligible and received protocol therapy were assessed for AEs.
|
0.00%
0/12 • Duration of treatment and follow up until death or 5 years post registration
36 participants who were eligible and received protocol therapy were assessed for AEs.
|
|
Gastrointestinal disorders
Ascites
|
0.00%
0/13 • Duration of treatment and follow up until death or 5 years post registration
36 participants who were eligible and received protocol therapy were assessed for AEs.
|
0.00%
0/11 • Duration of treatment and follow up until death or 5 years post registration
36 participants who were eligible and received protocol therapy were assessed for AEs.
|
8.3%
1/12 • Duration of treatment and follow up until death or 5 years post registration
36 participants who were eligible and received protocol therapy were assessed for AEs.
|
|
Gastrointestinal disorders
Bloating
|
0.00%
0/13 • Duration of treatment and follow up until death or 5 years post registration
36 participants who were eligible and received protocol therapy were assessed for AEs.
|
9.1%
1/11 • Duration of treatment and follow up until death or 5 years post registration
36 participants who were eligible and received protocol therapy were assessed for AEs.
|
8.3%
1/12 • Duration of treatment and follow up until death or 5 years post registration
36 participants who were eligible and received protocol therapy were assessed for AEs.
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/13 • Duration of treatment and follow up until death or 5 years post registration
36 participants who were eligible and received protocol therapy were assessed for AEs.
|
0.00%
0/11 • Duration of treatment and follow up until death or 5 years post registration
36 participants who were eligible and received protocol therapy were assessed for AEs.
|
8.3%
1/12 • Duration of treatment and follow up until death or 5 years post registration
36 participants who were eligible and received protocol therapy were assessed for AEs.
|
|
Gastrointestinal disorders
Constipation
|
30.8%
4/13 • Duration of treatment and follow up until death or 5 years post registration
36 participants who were eligible and received protocol therapy were assessed for AEs.
|
54.5%
6/11 • Duration of treatment and follow up until death or 5 years post registration
36 participants who were eligible and received protocol therapy were assessed for AEs.
|
58.3%
7/12 • Duration of treatment and follow up until death or 5 years post registration
36 participants who were eligible and received protocol therapy were assessed for AEs.
|
|
Gastrointestinal disorders
Dental caries
|
7.7%
1/13 • Duration of treatment and follow up until death or 5 years post registration
36 participants who were eligible and received protocol therapy were assessed for AEs.
|
0.00%
0/11 • Duration of treatment and follow up until death or 5 years post registration
36 participants who were eligible and received protocol therapy were assessed for AEs.
|
8.3%
1/12 • Duration of treatment and follow up until death or 5 years post registration
36 participants who were eligible and received protocol therapy were assessed for AEs.
|
|
Gastrointestinal disorders
Diarrhea
|
15.4%
2/13 • Duration of treatment and follow up until death or 5 years post registration
36 participants who were eligible and received protocol therapy were assessed for AEs.
|
45.5%
5/11 • Duration of treatment and follow up until death or 5 years post registration
36 participants who were eligible and received protocol therapy were assessed for AEs.
|
33.3%
4/12 • Duration of treatment and follow up until death or 5 years post registration
36 participants who were eligible and received protocol therapy were assessed for AEs.
|
|
Gastrointestinal disorders
Dry mouth
|
23.1%
3/13 • Duration of treatment and follow up until death or 5 years post registration
36 participants who were eligible and received protocol therapy were assessed for AEs.
|
27.3%
3/11 • Duration of treatment and follow up until death or 5 years post registration
36 participants who were eligible and received protocol therapy were assessed for AEs.
|
0.00%
0/12 • Duration of treatment and follow up until death or 5 years post registration
36 participants who were eligible and received protocol therapy were assessed for AEs.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/13 • Duration of treatment and follow up until death or 5 years post registration
36 participants who were eligible and received protocol therapy were assessed for AEs.
|
36.4%
4/11 • Duration of treatment and follow up until death or 5 years post registration
36 participants who were eligible and received protocol therapy were assessed for AEs.
|
25.0%
3/12 • Duration of treatment and follow up until death or 5 years post registration
36 participants who were eligible and received protocol therapy were assessed for AEs.
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/13 • Duration of treatment and follow up until death or 5 years post registration
36 participants who were eligible and received protocol therapy were assessed for AEs.
|
18.2%
2/11 • Duration of treatment and follow up until death or 5 years post registration
36 participants who were eligible and received protocol therapy were assessed for AEs.
|
0.00%
0/12 • Duration of treatment and follow up until death or 5 years post registration
36 participants who were eligible and received protocol therapy were assessed for AEs.
|
|
Gastrointestinal disorders
Esophagitis
|
0.00%
0/13 • Duration of treatment and follow up until death or 5 years post registration
36 participants who were eligible and received protocol therapy were assessed for AEs.
|
18.2%
2/11 • Duration of treatment and follow up until death or 5 years post registration
36 participants who were eligible and received protocol therapy were assessed for AEs.
|
0.00%
0/12 • Duration of treatment and follow up until death or 5 years post registration
36 participants who were eligible and received protocol therapy were assessed for AEs.
|
|
Gastrointestinal disorders
Fecal incontinence
|
0.00%
0/13 • Duration of treatment and follow up until death or 5 years post registration
36 participants who were eligible and received protocol therapy were assessed for AEs.
|
0.00%
0/11 • Duration of treatment and follow up until death or 5 years post registration
36 participants who were eligible and received protocol therapy were assessed for AEs.
|
8.3%
1/12 • Duration of treatment and follow up until death or 5 years post registration
36 participants who were eligible and received protocol therapy were assessed for AEs.
|
|
Gastrointestinal disorders
Flatulence
|
7.7%
1/13 • Duration of treatment and follow up until death or 5 years post registration
36 participants who were eligible and received protocol therapy were assessed for AEs.
|
0.00%
0/11 • Duration of treatment and follow up until death or 5 years post registration
36 participants who were eligible and received protocol therapy were assessed for AEs.
|
0.00%
0/12 • Duration of treatment and follow up until death or 5 years post registration
36 participants who were eligible and received protocol therapy were assessed for AEs.
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
7.7%
1/13 • Duration of treatment and follow up until death or 5 years post registration
36 participants who were eligible and received protocol therapy were assessed for AEs.
|
0.00%
0/11 • Duration of treatment and follow up until death or 5 years post registration
36 participants who were eligible and received protocol therapy were assessed for AEs.
|
0.00%
0/12 • Duration of treatment and follow up until death or 5 years post registration
36 participants who were eligible and received protocol therapy were assessed for AEs.
|
|
Gastrointestinal disorders
Gastrointestinal disorders-Other
|
7.7%
1/13 • Duration of treatment and follow up until death or 5 years post registration
36 participants who were eligible and received protocol therapy were assessed for AEs.
|
18.2%
2/11 • Duration of treatment and follow up until death or 5 years post registration
36 participants who were eligible and received protocol therapy were assessed for AEs.
|
0.00%
0/12 • Duration of treatment and follow up until death or 5 years post registration
36 participants who were eligible and received protocol therapy were assessed for AEs.
|
|
Gastrointestinal disorders
Gastrointestinal pain
|
0.00%
0/13 • Duration of treatment and follow up until death or 5 years post registration
36 participants who were eligible and received protocol therapy were assessed for AEs.
|
9.1%
1/11 • Duration of treatment and follow up until death or 5 years post registration
36 participants who were eligible and received protocol therapy were assessed for AEs.
|
0.00%
0/12 • Duration of treatment and follow up until death or 5 years post registration
36 participants who were eligible and received protocol therapy were assessed for AEs.
|
|
Gastrointestinal disorders
Ileus
|
0.00%
0/13 • Duration of treatment and follow up until death or 5 years post registration
36 participants who were eligible and received protocol therapy were assessed for AEs.
|
9.1%
1/11 • Duration of treatment and follow up until death or 5 years post registration
36 participants who were eligible and received protocol therapy were assessed for AEs.
|
0.00%
0/12 • Duration of treatment and follow up until death or 5 years post registration
36 participants who were eligible and received protocol therapy were assessed for AEs.
|
|
Gastrointestinal disorders
Mucositis oral
|
23.1%
3/13 • Duration of treatment and follow up until death or 5 years post registration
36 participants who were eligible and received protocol therapy were assessed for AEs.
|
63.6%
7/11 • Duration of treatment and follow up until death or 5 years post registration
36 participants who were eligible and received protocol therapy were assessed for AEs.
|
66.7%
8/12 • Duration of treatment and follow up until death or 5 years post registration
36 participants who were eligible and received protocol therapy were assessed for AEs.
|
|
Gastrointestinal disorders
Nausea
|
38.5%
5/13 • Duration of treatment and follow up until death or 5 years post registration
36 participants who were eligible and received protocol therapy were assessed for AEs.
|
54.5%
6/11 • Duration of treatment and follow up until death or 5 years post registration
36 participants who were eligible and received protocol therapy were assessed for AEs.
|
33.3%
4/12 • Duration of treatment and follow up until death or 5 years post registration
36 participants who were eligible and received protocol therapy were assessed for AEs.
|
|
Gastrointestinal disorders
Oral pain
|
15.4%
2/13 • Duration of treatment and follow up until death or 5 years post registration
36 participants who were eligible and received protocol therapy were assessed for AEs.
|
18.2%
2/11 • Duration of treatment and follow up until death or 5 years post registration
36 participants who were eligible and received protocol therapy were assessed for AEs.
|
25.0%
3/12 • Duration of treatment and follow up until death or 5 years post registration
36 participants who were eligible and received protocol therapy were assessed for AEs.
|
|
Gastrointestinal disorders
Rectal hemorrhage
|
7.7%
1/13 • Duration of treatment and follow up until death or 5 years post registration
36 participants who were eligible and received protocol therapy were assessed for AEs.
|
9.1%
1/11 • Duration of treatment and follow up until death or 5 years post registration
36 participants who were eligible and received protocol therapy were assessed for AEs.
|
0.00%
0/12 • Duration of treatment and follow up until death or 5 years post registration
36 participants who were eligible and received protocol therapy were assessed for AEs.
|
|
Gastrointestinal disorders
Stomach pain
|
0.00%
0/13 • Duration of treatment and follow up until death or 5 years post registration
36 participants who were eligible and received protocol therapy were assessed for AEs.
|
18.2%
2/11 • Duration of treatment and follow up until death or 5 years post registration
36 participants who were eligible and received protocol therapy were assessed for AEs.
|
0.00%
0/12 • Duration of treatment and follow up until death or 5 years post registration
36 participants who were eligible and received protocol therapy were assessed for AEs.
|
|
Gastrointestinal disorders
Vomiting
|
7.7%
1/13 • Duration of treatment and follow up until death or 5 years post registration
36 participants who were eligible and received protocol therapy were assessed for AEs.
|
27.3%
3/11 • Duration of treatment and follow up until death or 5 years post registration
36 participants who were eligible and received protocol therapy were assessed for AEs.
|
33.3%
4/12 • Duration of treatment and follow up until death or 5 years post registration
36 participants who were eligible and received protocol therapy were assessed for AEs.
|
|
General disorders
Malaise
|
0.00%
0/13 • Duration of treatment and follow up until death or 5 years post registration
36 participants who were eligible and received protocol therapy were assessed for AEs.
|
0.00%
0/11 • Duration of treatment and follow up until death or 5 years post registration
36 participants who were eligible and received protocol therapy were assessed for AEs.
|
8.3%
1/12 • Duration of treatment and follow up until death or 5 years post registration
36 participants who were eligible and received protocol therapy were assessed for AEs.
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/13 • Duration of treatment and follow up until death or 5 years post registration
36 participants who were eligible and received protocol therapy were assessed for AEs.
|
18.2%
2/11 • Duration of treatment and follow up until death or 5 years post registration
36 participants who were eligible and received protocol therapy were assessed for AEs.
|
8.3%
1/12 • Duration of treatment and follow up until death or 5 years post registration
36 participants who were eligible and received protocol therapy were assessed for AEs.
|
|
General disorders
Pain
|
30.8%
4/13 • Duration of treatment and follow up until death or 5 years post registration
36 participants who were eligible and received protocol therapy were assessed for AEs.
|
18.2%
2/11 • Duration of treatment and follow up until death or 5 years post registration
36 participants who were eligible and received protocol therapy were assessed for AEs.
|
25.0%
3/12 • Duration of treatment and follow up until death or 5 years post registration
36 participants who were eligible and received protocol therapy were assessed for AEs.
|
|
Immune system disorders
Allergic reaction
|
7.7%
1/13 • Duration of treatment and follow up until death or 5 years post registration
36 participants who were eligible and received protocol therapy were assessed for AEs.
|
9.1%
1/11 • Duration of treatment and follow up until death or 5 years post registration
36 participants who were eligible and received protocol therapy were assessed for AEs.
|
0.00%
0/12 • Duration of treatment and follow up until death or 5 years post registration
36 participants who were eligible and received protocol therapy were assessed for AEs.
|
|
Immune system disorders
Immune system disorders-Other
|
0.00%
0/13 • Duration of treatment and follow up until death or 5 years post registration
36 participants who were eligible and received protocol therapy were assessed for AEs.
|
18.2%
2/11 • Duration of treatment and follow up until death or 5 years post registration
36 participants who were eligible and received protocol therapy were assessed for AEs.
|
0.00%
0/12 • Duration of treatment and follow up until death or 5 years post registration
36 participants who were eligible and received protocol therapy were assessed for AEs.
|
|
Infections and infestations
Infections and infestations-Other
|
7.7%
1/13 • Duration of treatment and follow up until death or 5 years post registration
36 participants who were eligible and received protocol therapy were assessed for AEs.
|
36.4%
4/11 • Duration of treatment and follow up until death or 5 years post registration
36 participants who were eligible and received protocol therapy were assessed for AEs.
|
16.7%
2/12 • Duration of treatment and follow up until death or 5 years post registration
36 participants who were eligible and received protocol therapy were assessed for AEs.
|
|
Infections and infestations
Mucosal infection
|
0.00%
0/13 • Duration of treatment and follow up until death or 5 years post registration
36 participants who were eligible and received protocol therapy were assessed for AEs.
|
0.00%
0/11 • Duration of treatment and follow up until death or 5 years post registration
36 participants who were eligible and received protocol therapy were assessed for AEs.
|
8.3%
1/12 • Duration of treatment and follow up until death or 5 years post registration
36 participants who were eligible and received protocol therapy were assessed for AEs.
|
|
Infections and infestations
Rhinitis infective
|
0.00%
0/13 • Duration of treatment and follow up until death or 5 years post registration
36 participants who were eligible and received protocol therapy were assessed for AEs.
|
9.1%
1/11 • Duration of treatment and follow up until death or 5 years post registration
36 participants who were eligible and received protocol therapy were assessed for AEs.
|
0.00%
0/12 • Duration of treatment and follow up until death or 5 years post registration
36 participants who were eligible and received protocol therapy were assessed for AEs.
|
|
Infections and infestations
Sinusitis
|
0.00%
0/13 • Duration of treatment and follow up until death or 5 years post registration
36 participants who were eligible and received protocol therapy were assessed for AEs.
|
0.00%
0/11 • Duration of treatment and follow up until death or 5 years post registration
36 participants who were eligible and received protocol therapy were assessed for AEs.
|
8.3%
1/12 • Duration of treatment and follow up until death or 5 years post registration
36 participants who were eligible and received protocol therapy were assessed for AEs.
|
|
Infections and infestations
Skin infection
|
0.00%
0/13 • Duration of treatment and follow up until death or 5 years post registration
36 participants who were eligible and received protocol therapy were assessed for AEs.
|
0.00%
0/11 • Duration of treatment and follow up until death or 5 years post registration
36 participants who were eligible and received protocol therapy were assessed for AEs.
|
8.3%
1/12 • Duration of treatment and follow up until death or 5 years post registration
36 participants who were eligible and received protocol therapy were assessed for AEs.
|
|
Infections and infestations
Tooth infection
|
7.7%
1/13 • Duration of treatment and follow up until death or 5 years post registration
36 participants who were eligible and received protocol therapy were assessed for AEs.
|
0.00%
0/11 • Duration of treatment and follow up until death or 5 years post registration
36 participants who were eligible and received protocol therapy were assessed for AEs.
|
8.3%
1/12 • Duration of treatment and follow up until death or 5 years post registration
36 participants who were eligible and received protocol therapy were assessed for AEs.
|
|
Infections and infestations
Upper respiratory infection
|
15.4%
2/13 • Duration of treatment and follow up until death or 5 years post registration
36 participants who were eligible and received protocol therapy were assessed for AEs.
|
9.1%
1/11 • Duration of treatment and follow up until death or 5 years post registration
36 participants who were eligible and received protocol therapy were assessed for AEs.
|
25.0%
3/12 • Duration of treatment and follow up until death or 5 years post registration
36 participants who were eligible and received protocol therapy were assessed for AEs.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/13 • Duration of treatment and follow up until death or 5 years post registration
36 participants who were eligible and received protocol therapy were assessed for AEs.
|
0.00%
0/11 • Duration of treatment and follow up until death or 5 years post registration
36 participants who were eligible and received protocol therapy were assessed for AEs.
|
16.7%
2/12 • Duration of treatment and follow up until death or 5 years post registration
36 participants who were eligible and received protocol therapy were assessed for AEs.
|
|
Infections and infestations
Vaginal infection
|
7.7%
1/13 • Duration of treatment and follow up until death or 5 years post registration
36 participants who were eligible and received protocol therapy were assessed for AEs.
|
0.00%
0/11 • Duration of treatment and follow up until death or 5 years post registration
36 participants who were eligible and received protocol therapy were assessed for AEs.
|
0.00%
0/12 • Duration of treatment and follow up until death or 5 years post registration
36 participants who were eligible and received protocol therapy were assessed for AEs.
|
|
Injury, poisoning and procedural complications
Burn
|
0.00%
0/13 • Duration of treatment and follow up until death or 5 years post registration
36 participants who were eligible and received protocol therapy were assessed for AEs.
|
0.00%
0/11 • Duration of treatment and follow up until death or 5 years post registration
36 participants who were eligible and received protocol therapy were assessed for AEs.
|
8.3%
1/12 • Duration of treatment and follow up until death or 5 years post registration
36 participants who were eligible and received protocol therapy were assessed for AEs.
|
|
Injury, poisoning and procedural complications
Dermatitis radiation
|
7.7%
1/13 • Duration of treatment and follow up until death or 5 years post registration
36 participants who were eligible and received protocol therapy were assessed for AEs.
|
0.00%
0/11 • Duration of treatment and follow up until death or 5 years post registration
36 participants who were eligible and received protocol therapy were assessed for AEs.
|
0.00%
0/12 • Duration of treatment and follow up until death or 5 years post registration
36 participants who were eligible and received protocol therapy were assessed for AEs.
|
|
Injury, poisoning and procedural complications
Fracture
|
0.00%
0/13 • Duration of treatment and follow up until death or 5 years post registration
36 participants who were eligible and received protocol therapy were assessed for AEs.
|
9.1%
1/11 • Duration of treatment and follow up until death or 5 years post registration
36 participants who were eligible and received protocol therapy were assessed for AEs.
|
0.00%
0/12 • Duration of treatment and follow up until death or 5 years post registration
36 participants who were eligible and received protocol therapy were assessed for AEs.
|
|
Investigations
Alanine aminotransferase increased
|
15.4%
2/13 • Duration of treatment and follow up until death or 5 years post registration
36 participants who were eligible and received protocol therapy were assessed for AEs.
|
54.5%
6/11 • Duration of treatment and follow up until death or 5 years post registration
36 participants who were eligible and received protocol therapy were assessed for AEs.
|
25.0%
3/12 • Duration of treatment and follow up until death or 5 years post registration
36 participants who were eligible and received protocol therapy were assessed for AEs.
|
|
Investigations
Alkaline phosphatase increased
|
23.1%
3/13 • Duration of treatment and follow up until death or 5 years post registration
36 participants who were eligible and received protocol therapy were assessed for AEs.
|
18.2%
2/11 • Duration of treatment and follow up until death or 5 years post registration
36 participants who were eligible and received protocol therapy were assessed for AEs.
|
8.3%
1/12 • Duration of treatment and follow up until death or 5 years post registration
36 participants who were eligible and received protocol therapy were assessed for AEs.
|
|
Investigations
Aspartate aminotransferase increased
|
30.8%
4/13 • Duration of treatment and follow up until death or 5 years post registration
36 participants who were eligible and received protocol therapy were assessed for AEs.
|
63.6%
7/11 • Duration of treatment and follow up until death or 5 years post registration
36 participants who were eligible and received protocol therapy were assessed for AEs.
|
33.3%
4/12 • Duration of treatment and follow up until death or 5 years post registration
36 participants who were eligible and received protocol therapy were assessed for AEs.
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/13 • Duration of treatment and follow up until death or 5 years post registration
36 participants who were eligible and received protocol therapy were assessed for AEs.
|
0.00%
0/11 • Duration of treatment and follow up until death or 5 years post registration
36 participants who were eligible and received protocol therapy were assessed for AEs.
|
8.3%
1/12 • Duration of treatment and follow up until death or 5 years post registration
36 participants who were eligible and received protocol therapy were assessed for AEs.
|
|
Investigations
Cholesterol high
|
30.8%
4/13 • Duration of treatment and follow up until death or 5 years post registration
36 participants who were eligible and received protocol therapy were assessed for AEs.
|
90.9%
10/11 • Duration of treatment and follow up until death or 5 years post registration
36 participants who were eligible and received protocol therapy were assessed for AEs.
|
41.7%
5/12 • Duration of treatment and follow up until death or 5 years post registration
36 participants who were eligible and received protocol therapy were assessed for AEs.
|
|
Investigations
Creatinine increased
|
0.00%
0/13 • Duration of treatment and follow up until death or 5 years post registration
36 participants who were eligible and received protocol therapy were assessed for AEs.
|
9.1%
1/11 • Duration of treatment and follow up until death or 5 years post registration
36 participants who were eligible and received protocol therapy were assessed for AEs.
|
16.7%
2/12 • Duration of treatment and follow up until death or 5 years post registration
36 participants who were eligible and received protocol therapy were assessed for AEs.
|
|
Investigations
Electrocardiogram QT corrected interval prolonged
|
0.00%
0/13 • Duration of treatment and follow up until death or 5 years post registration
36 participants who were eligible and received protocol therapy were assessed for AEs.
|
9.1%
1/11 • Duration of treatment and follow up until death or 5 years post registration
36 participants who were eligible and received protocol therapy were assessed for AEs.
|
0.00%
0/12 • Duration of treatment and follow up until death or 5 years post registration
36 participants who were eligible and received protocol therapy were assessed for AEs.
|
|
Investigations
INR increased
|
7.7%
1/13 • Duration of treatment and follow up until death or 5 years post registration
36 participants who were eligible and received protocol therapy were assessed for AEs.
|
0.00%
0/11 • Duration of treatment and follow up until death or 5 years post registration
36 participants who were eligible and received protocol therapy were assessed for AEs.
|
0.00%
0/12 • Duration of treatment and follow up until death or 5 years post registration
36 participants who were eligible and received protocol therapy were assessed for AEs.
|
|
Investigations
Investigations-Other
|
0.00%
0/13 • Duration of treatment and follow up until death or 5 years post registration
36 participants who were eligible and received protocol therapy were assessed for AEs.
|
18.2%
2/11 • Duration of treatment and follow up until death or 5 years post registration
36 participants who were eligible and received protocol therapy were assessed for AEs.
|
8.3%
1/12 • Duration of treatment and follow up until death or 5 years post registration
36 participants who were eligible and received protocol therapy were assessed for AEs.
|
|
Investigations
Lipase increased
|
0.00%
0/13 • Duration of treatment and follow up until death or 5 years post registration
36 participants who were eligible and received protocol therapy were assessed for AEs.
|
9.1%
1/11 • Duration of treatment and follow up until death or 5 years post registration
36 participants who were eligible and received protocol therapy were assessed for AEs.
|
0.00%
0/12 • Duration of treatment and follow up until death or 5 years post registration
36 participants who were eligible and received protocol therapy were assessed for AEs.
|
|
Investigations
Lymphocyte count decreased
|
7.7%
1/13 • Duration of treatment and follow up until death or 5 years post registration
36 participants who were eligible and received protocol therapy were assessed for AEs.
|
63.6%
7/11 • Duration of treatment and follow up until death or 5 years post registration
36 participants who were eligible and received protocol therapy were assessed for AEs.
|
33.3%
4/12 • Duration of treatment and follow up until death or 5 years post registration
36 participants who were eligible and received protocol therapy were assessed for AEs.
|
|
Investigations
Neutrophil count decreased
|
0.00%
0/13 • Duration of treatment and follow up until death or 5 years post registration
36 participants who were eligible and received protocol therapy were assessed for AEs.
|
27.3%
3/11 • Duration of treatment and follow up until death or 5 years post registration
36 participants who were eligible and received protocol therapy were assessed for AEs.
|
8.3%
1/12 • Duration of treatment and follow up until death or 5 years post registration
36 participants who were eligible and received protocol therapy were assessed for AEs.
|
|
Investigations
Platelet count decreased
|
7.7%
1/13 • Duration of treatment and follow up until death or 5 years post registration
36 participants who were eligible and received protocol therapy were assessed for AEs.
|
36.4%
4/11 • Duration of treatment and follow up until death or 5 years post registration
36 participants who were eligible and received protocol therapy were assessed for AEs.
|
33.3%
4/12 • Duration of treatment and follow up until death or 5 years post registration
36 participants who were eligible and received protocol therapy were assessed for AEs.
|
|
Investigations
Weight gain
|
7.7%
1/13 • Duration of treatment and follow up until death or 5 years post registration
36 participants who were eligible and received protocol therapy were assessed for AEs.
|
9.1%
1/11 • Duration of treatment and follow up until death or 5 years post registration
36 participants who were eligible and received protocol therapy were assessed for AEs.
|
16.7%
2/12 • Duration of treatment and follow up until death or 5 years post registration
36 participants who were eligible and received protocol therapy were assessed for AEs.
|
|
Investigations
Weight loss
|
15.4%
2/13 • Duration of treatment and follow up until death or 5 years post registration
36 participants who were eligible and received protocol therapy were assessed for AEs.
|
54.5%
6/11 • Duration of treatment and follow up until death or 5 years post registration
36 participants who were eligible and received protocol therapy were assessed for AEs.
|
25.0%
3/12 • Duration of treatment and follow up until death or 5 years post registration
36 participants who were eligible and received protocol therapy were assessed for AEs.
|
|
Investigations
White blood cell decreased
|
0.00%
0/13 • Duration of treatment and follow up until death or 5 years post registration
36 participants who were eligible and received protocol therapy were assessed for AEs.
|
63.6%
7/11 • Duration of treatment and follow up until death or 5 years post registration
36 participants who were eligible and received protocol therapy were assessed for AEs.
|
33.3%
4/12 • Duration of treatment and follow up until death or 5 years post registration
36 participants who were eligible and received protocol therapy were assessed for AEs.
|
|
Metabolism and nutrition disorders
Anorexia
|
23.1%
3/13 • Duration of treatment and follow up until death or 5 years post registration
36 participants who were eligible and received protocol therapy were assessed for AEs.
|
63.6%
7/11 • Duration of treatment and follow up until death or 5 years post registration
36 participants who were eligible and received protocol therapy were assessed for AEs.
|
25.0%
3/12 • Duration of treatment and follow up until death or 5 years post registration
36 participants who were eligible and received protocol therapy were assessed for AEs.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/13 • Duration of treatment and follow up until death or 5 years post registration
36 participants who were eligible and received protocol therapy were assessed for AEs.
|
27.3%
3/11 • Duration of treatment and follow up until death or 5 years post registration
36 participants who were eligible and received protocol therapy were assessed for AEs.
|
8.3%
1/12 • Duration of treatment and follow up until death or 5 years post registration
36 participants who were eligible and received protocol therapy were assessed for AEs.
|
|
Metabolism and nutrition disorders
Glucose intolerance
|
0.00%
0/13 • Duration of treatment and follow up until death or 5 years post registration
36 participants who were eligible and received protocol therapy were assessed for AEs.
|
9.1%
1/11 • Duration of treatment and follow up until death or 5 years post registration
36 participants who were eligible and received protocol therapy were assessed for AEs.
|
0.00%
0/12 • Duration of treatment and follow up until death or 5 years post registration
36 participants who were eligible and received protocol therapy were assessed for AEs.
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
7.7%
1/13 • Duration of treatment and follow up until death or 5 years post registration
36 participants who were eligible and received protocol therapy were assessed for AEs.
|
0.00%
0/11 • Duration of treatment and follow up until death or 5 years post registration
36 participants who were eligible and received protocol therapy were assessed for AEs.
|
0.00%
0/12 • Duration of treatment and follow up until death or 5 years post registration
36 participants who were eligible and received protocol therapy were assessed for AEs.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
61.5%
8/13 • Duration of treatment and follow up until death or 5 years post registration
36 participants who were eligible and received protocol therapy were assessed for AEs.
|
63.6%
7/11 • Duration of treatment and follow up until death or 5 years post registration
36 participants who were eligible and received protocol therapy were assessed for AEs.
|
41.7%
5/12 • Duration of treatment and follow up until death or 5 years post registration
36 participants who were eligible and received protocol therapy were assessed for AEs.
|
|
Metabolism and nutrition disorders
Hypernatremia
|
0.00%
0/13 • Duration of treatment and follow up until death or 5 years post registration
36 participants who were eligible and received protocol therapy were assessed for AEs.
|
18.2%
2/11 • Duration of treatment and follow up until death or 5 years post registration
36 participants who were eligible and received protocol therapy were assessed for AEs.
|
25.0%
3/12 • Duration of treatment and follow up until death or 5 years post registration
36 participants who were eligible and received protocol therapy were assessed for AEs.
|
|
Metabolism and nutrition disorders
Hypertriglyceridemia
|
30.8%
4/13 • Duration of treatment and follow up until death or 5 years post registration
36 participants who were eligible and received protocol therapy were assessed for AEs.
|
72.7%
8/11 • Duration of treatment and follow up until death or 5 years post registration
36 participants who were eligible and received protocol therapy were assessed for AEs.
|
50.0%
6/12 • Duration of treatment and follow up until death or 5 years post registration
36 participants who were eligible and received protocol therapy were assessed for AEs.
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
7.7%
1/13 • Duration of treatment and follow up until death or 5 years post registration
36 participants who were eligible and received protocol therapy were assessed for AEs.
|
63.6%
7/11 • Duration of treatment and follow up until death or 5 years post registration
36 participants who were eligible and received protocol therapy were assessed for AEs.
|
8.3%
1/12 • Duration of treatment and follow up until death or 5 years post registration
36 participants who were eligible and received protocol therapy were assessed for AEs.
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
15.4%
2/13 • Duration of treatment and follow up until death or 5 years post registration
36 participants who were eligible and received protocol therapy were assessed for AEs.
|
18.2%
2/11 • Duration of treatment and follow up until death or 5 years post registration
36 participants who were eligible and received protocol therapy were assessed for AEs.
|
16.7%
2/12 • Duration of treatment and follow up until death or 5 years post registration
36 participants who were eligible and received protocol therapy were assessed for AEs.
|
|
Metabolism and nutrition disorders
Hypokalemia
|
15.4%
2/13 • Duration of treatment and follow up until death or 5 years post registration
36 participants who were eligible and received protocol therapy were assessed for AEs.
|
45.5%
5/11 • Duration of treatment and follow up until death or 5 years post registration
36 participants who were eligible and received protocol therapy were assessed for AEs.
|
25.0%
3/12 • Duration of treatment and follow up until death or 5 years post registration
36 participants who were eligible and received protocol therapy were assessed for AEs.
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
0.00%
0/13 • Duration of treatment and follow up until death or 5 years post registration
36 participants who were eligible and received protocol therapy were assessed for AEs.
|
9.1%
1/11 • Duration of treatment and follow up until death or 5 years post registration
36 participants who were eligible and received protocol therapy were assessed for AEs.
|
8.3%
1/12 • Duration of treatment and follow up until death or 5 years post registration
36 participants who were eligible and received protocol therapy were assessed for AEs.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
15.4%
2/13 • Duration of treatment and follow up until death or 5 years post registration
36 participants who were eligible and received protocol therapy were assessed for AEs.
|
36.4%
4/11 • Duration of treatment and follow up until death or 5 years post registration
36 participants who were eligible and received protocol therapy were assessed for AEs.
|
16.7%
2/12 • Duration of treatment and follow up until death or 5 years post registration
36 participants who were eligible and received protocol therapy were assessed for AEs.
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
7.7%
1/13 • Duration of treatment and follow up until death or 5 years post registration
36 participants who were eligible and received protocol therapy were assessed for AEs.
|
9.1%
1/11 • Duration of treatment and follow up until death or 5 years post registration
36 participants who were eligible and received protocol therapy were assessed for AEs.
|
8.3%
1/12 • Duration of treatment and follow up until death or 5 years post registration
36 participants who were eligible and received protocol therapy were assessed for AEs.
|
|
Metabolism and nutrition disorders
Metabolism and nutrition disorders - Other, specify
|
0.00%
0/13 • Duration of treatment and follow up until death or 5 years post registration
36 participants who were eligible and received protocol therapy were assessed for AEs.
|
18.2%
2/11 • Duration of treatment and follow up until death or 5 years post registration
36 participants who were eligible and received protocol therapy were assessed for AEs.
|
8.3%
1/12 • Duration of treatment and follow up until death or 5 years post registration
36 participants who were eligible and received protocol therapy were assessed for AEs.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
7.7%
1/13 • Duration of treatment and follow up until death or 5 years post registration
36 participants who were eligible and received protocol therapy were assessed for AEs.
|
27.3%
3/11 • Duration of treatment and follow up until death or 5 years post registration
36 participants who were eligible and received protocol therapy were assessed for AEs.
|
33.3%
4/12 • Duration of treatment and follow up until death or 5 years post registration
36 participants who were eligible and received protocol therapy were assessed for AEs.
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.00%
0/13 • Duration of treatment and follow up until death or 5 years post registration
36 participants who were eligible and received protocol therapy were assessed for AEs.
|
18.2%
2/11 • Duration of treatment and follow up until death or 5 years post registration
36 participants who were eligible and received protocol therapy were assessed for AEs.
|
0.00%
0/12 • Duration of treatment and follow up until death or 5 years post registration
36 participants who were eligible and received protocol therapy were assessed for AEs.
|
|
Musculoskeletal and connective tissue disorders
Avascular necrosis
|
7.7%
1/13 • Duration of treatment and follow up until death or 5 years post registration
36 participants who were eligible and received protocol therapy were assessed for AEs.
|
0.00%
0/11 • Duration of treatment and follow up until death or 5 years post registration
36 participants who were eligible and received protocol therapy were assessed for AEs.
|
0.00%
0/12 • Duration of treatment and follow up until death or 5 years post registration
36 participants who were eligible and received protocol therapy were assessed for AEs.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
23.1%
3/13 • Duration of treatment and follow up until death or 5 years post registration
36 participants who were eligible and received protocol therapy were assessed for AEs.
|
18.2%
2/11 • Duration of treatment and follow up until death or 5 years post registration
36 participants who were eligible and received protocol therapy were assessed for AEs.
|
8.3%
1/12 • Duration of treatment and follow up until death or 5 years post registration
36 participants who were eligible and received protocol therapy were assessed for AEs.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
38.5%
5/13 • Duration of treatment and follow up until death or 5 years post registration
36 participants who were eligible and received protocol therapy were assessed for AEs.
|
18.2%
2/11 • Duration of treatment and follow up until death or 5 years post registration
36 participants who were eligible and received protocol therapy were assessed for AEs.
|
25.0%
3/12 • Duration of treatment and follow up until death or 5 years post registration
36 participants who were eligible and received protocol therapy were assessed for AEs.
|
|
Musculoskeletal and connective tissue disorders
Chest wall pain
|
0.00%
0/13 • Duration of treatment and follow up until death or 5 years post registration
36 participants who were eligible and received protocol therapy were assessed for AEs.
|
9.1%
1/11 • Duration of treatment and follow up until death or 5 years post registration
36 participants who were eligible and received protocol therapy were assessed for AEs.
|
0.00%
0/12 • Duration of treatment and follow up until death or 5 years post registration
36 participants who were eligible and received protocol therapy were assessed for AEs.
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
7.7%
1/13 • Duration of treatment and follow up until death or 5 years post registration
36 participants who were eligible and received protocol therapy were assessed for AEs.
|
18.2%
2/11 • Duration of treatment and follow up until death or 5 years post registration
36 participants who were eligible and received protocol therapy were assessed for AEs.
|
0.00%
0/12 • Duration of treatment and follow up until death or 5 years post registration
36 participants who were eligible and received protocol therapy were assessed for AEs.
|
|
Musculoskeletal and connective tissue disorders
Joint range of motion decreased
|
0.00%
0/13 • Duration of treatment and follow up until death or 5 years post registration
36 participants who were eligible and received protocol therapy were assessed for AEs.
|
9.1%
1/11 • Duration of treatment and follow up until death or 5 years post registration
36 participants who were eligible and received protocol therapy were assessed for AEs.
|
0.00%
0/12 • Duration of treatment and follow up until death or 5 years post registration
36 participants who were eligible and received protocol therapy were assessed for AEs.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal and connective tiss disorder - Other
|
7.7%
1/13 • Duration of treatment and follow up until death or 5 years post registration
36 participants who were eligible and received protocol therapy were assessed for AEs.
|
27.3%
3/11 • Duration of treatment and follow up until death or 5 years post registration
36 participants who were eligible and received protocol therapy were assessed for AEs.
|
0.00%
0/12 • Duration of treatment and follow up until death or 5 years post registration
36 participants who were eligible and received protocol therapy were assessed for AEs.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
30.8%
4/13 • Duration of treatment and follow up until death or 5 years post registration
36 participants who were eligible and received protocol therapy were assessed for AEs.
|
9.1%
1/11 • Duration of treatment and follow up until death or 5 years post registration
36 participants who were eligible and received protocol therapy were assessed for AEs.
|
16.7%
2/12 • Duration of treatment and follow up until death or 5 years post registration
36 participants who were eligible and received protocol therapy were assessed for AEs.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
7.7%
1/13 • Duration of treatment and follow up until death or 5 years post registration
36 participants who were eligible and received protocol therapy were assessed for AEs.
|
9.1%
1/11 • Duration of treatment and follow up until death or 5 years post registration
36 participants who were eligible and received protocol therapy were assessed for AEs.
|
0.00%
0/12 • Duration of treatment and follow up until death or 5 years post registration
36 participants who were eligible and received protocol therapy were assessed for AEs.
|
|
Musculoskeletal and connective tissue disorders
Osteonecrosis of jaw
|
7.7%
1/13 • Duration of treatment and follow up until death or 5 years post registration
36 participants who were eligible and received protocol therapy were assessed for AEs.
|
0.00%
0/11 • Duration of treatment and follow up until death or 5 years post registration
36 participants who were eligible and received protocol therapy were assessed for AEs.
|
8.3%
1/12 • Duration of treatment and follow up until death or 5 years post registration
36 participants who were eligible and received protocol therapy were assessed for AEs.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
38.5%
5/13 • Duration of treatment and follow up until death or 5 years post registration
36 participants who were eligible and received protocol therapy were assessed for AEs.
|
45.5%
5/11 • Duration of treatment and follow up until death or 5 years post registration
36 participants who were eligible and received protocol therapy were assessed for AEs.
|
8.3%
1/12 • Duration of treatment and follow up until death or 5 years post registration
36 participants who were eligible and received protocol therapy were assessed for AEs.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumor pain
|
7.7%
1/13 • Duration of treatment and follow up until death or 5 years post registration
36 participants who were eligible and received protocol therapy were assessed for AEs.
|
0.00%
0/11 • Duration of treatment and follow up until death or 5 years post registration
36 participants who were eligible and received protocol therapy were assessed for AEs.
|
0.00%
0/12 • Duration of treatment and follow up until death or 5 years post registration
36 participants who were eligible and received protocol therapy were assessed for AEs.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/13 • Duration of treatment and follow up until death or 5 years post registration
36 participants who were eligible and received protocol therapy were assessed for AEs.
|
18.2%
2/11 • Duration of treatment and follow up until death or 5 years post registration
36 participants who were eligible and received protocol therapy were assessed for AEs.
|
8.3%
1/12 • Duration of treatment and follow up until death or 5 years post registration
36 participants who were eligible and received protocol therapy were assessed for AEs.
|
|
Nervous system disorders
Dysesthesia
|
0.00%
0/13 • Duration of treatment and follow up until death or 5 years post registration
36 participants who were eligible and received protocol therapy were assessed for AEs.
|
0.00%
0/11 • Duration of treatment and follow up until death or 5 years post registration
36 participants who were eligible and received protocol therapy were assessed for AEs.
|
8.3%
1/12 • Duration of treatment and follow up until death or 5 years post registration
36 participants who were eligible and received protocol therapy were assessed for AEs.
|
|
Nervous system disorders
Dysgeusia
|
7.7%
1/13 • Duration of treatment and follow up until death or 5 years post registration
36 participants who were eligible and received protocol therapy were assessed for AEs.
|
54.5%
6/11 • Duration of treatment and follow up until death or 5 years post registration
36 participants who were eligible and received protocol therapy were assessed for AEs.
|
0.00%
0/12 • Duration of treatment and follow up until death or 5 years post registration
36 participants who were eligible and received protocol therapy were assessed for AEs.
|
|
Nervous system disorders
Headache
|
30.8%
4/13 • Duration of treatment and follow up until death or 5 years post registration
36 participants who were eligible and received protocol therapy were assessed for AEs.
|
36.4%
4/11 • Duration of treatment and follow up until death or 5 years post registration
36 participants who were eligible and received protocol therapy were assessed for AEs.
|
41.7%
5/12 • Duration of treatment and follow up until death or 5 years post registration
36 participants who were eligible and received protocol therapy were assessed for AEs.
|
|
Nervous system disorders
Memory impairment
|
7.7%
1/13 • Duration of treatment and follow up until death or 5 years post registration
36 participants who were eligible and received protocol therapy were assessed for AEs.
|
0.00%
0/11 • Duration of treatment and follow up until death or 5 years post registration
36 participants who were eligible and received protocol therapy were assessed for AEs.
|
0.00%
0/12 • Duration of treatment and follow up until death or 5 years post registration
36 participants who were eligible and received protocol therapy were assessed for AEs.
|
|
Nervous system disorders
Nervous system disorders-Other
|
0.00%
0/13 • Duration of treatment and follow up until death or 5 years post registration
36 participants who were eligible and received protocol therapy were assessed for AEs.
|
18.2%
2/11 • Duration of treatment and follow up until death or 5 years post registration
36 participants who were eligible and received protocol therapy were assessed for AEs.
|
0.00%
0/12 • Duration of treatment and follow up until death or 5 years post registration
36 participants who were eligible and received protocol therapy were assessed for AEs.
|
|
Nervous system disorders
Paresthesia
|
0.00%
0/13 • Duration of treatment and follow up until death or 5 years post registration
36 participants who were eligible and received protocol therapy were assessed for AEs.
|
18.2%
2/11 • Duration of treatment and follow up until death or 5 years post registration
36 participants who were eligible and received protocol therapy were assessed for AEs.
|
0.00%
0/12 • Duration of treatment and follow up until death or 5 years post registration
36 participants who were eligible and received protocol therapy were assessed for AEs.
|
|
Nervous system disorders
Peripheral motor neuropathy
|
0.00%
0/13 • Duration of treatment and follow up until death or 5 years post registration
36 participants who were eligible and received protocol therapy were assessed for AEs.
|
18.2%
2/11 • Duration of treatment and follow up until death or 5 years post registration
36 participants who were eligible and received protocol therapy were assessed for AEs.
|
16.7%
2/12 • Duration of treatment and follow up until death or 5 years post registration
36 participants who were eligible and received protocol therapy were assessed for AEs.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
23.1%
3/13 • Duration of treatment and follow up until death or 5 years post registration
36 participants who were eligible and received protocol therapy were assessed for AEs.
|
45.5%
5/11 • Duration of treatment and follow up until death or 5 years post registration
36 participants who were eligible and received protocol therapy were assessed for AEs.
|
8.3%
1/12 • Duration of treatment and follow up until death or 5 years post registration
36 participants who were eligible and received protocol therapy were assessed for AEs.
|
|
Nervous system disorders
Syncope
|
0.00%
0/13 • Duration of treatment and follow up until death or 5 years post registration
36 participants who were eligible and received protocol therapy were assessed for AEs.
|
0.00%
0/11 • Duration of treatment and follow up until death or 5 years post registration
36 participants who were eligible and received protocol therapy were assessed for AEs.
|
8.3%
1/12 • Duration of treatment and follow up until death or 5 years post registration
36 participants who were eligible and received protocol therapy were assessed for AEs.
|
|
Psychiatric disorders
Agitation
|
0.00%
0/13 • Duration of treatment and follow up until death or 5 years post registration
36 participants who were eligible and received protocol therapy were assessed for AEs.
|
0.00%
0/11 • Duration of treatment and follow up until death or 5 years post registration
36 participants who were eligible and received protocol therapy were assessed for AEs.
|
8.3%
1/12 • Duration of treatment and follow up until death or 5 years post registration
36 participants who were eligible and received protocol therapy were assessed for AEs.
|
|
Psychiatric disorders
Anxiety
|
7.7%
1/13 • Duration of treatment and follow up until death or 5 years post registration
36 participants who were eligible and received protocol therapy were assessed for AEs.
|
18.2%
2/11 • Duration of treatment and follow up until death or 5 years post registration
36 participants who were eligible and received protocol therapy were assessed for AEs.
|
8.3%
1/12 • Duration of treatment and follow up until death or 5 years post registration
36 participants who were eligible and received protocol therapy were assessed for AEs.
|
|
Psychiatric disorders
Depression
|
15.4%
2/13 • Duration of treatment and follow up until death or 5 years post registration
36 participants who were eligible and received protocol therapy were assessed for AEs.
|
0.00%
0/11 • Duration of treatment and follow up until death or 5 years post registration
36 participants who were eligible and received protocol therapy were assessed for AEs.
|
8.3%
1/12 • Duration of treatment and follow up until death or 5 years post registration
36 participants who were eligible and received protocol therapy were assessed for AEs.
|
|
Psychiatric disorders
Insomnia
|
23.1%
3/13 • Duration of treatment and follow up until death or 5 years post registration
36 participants who were eligible and received protocol therapy were assessed for AEs.
|
27.3%
3/11 • Duration of treatment and follow up until death or 5 years post registration
36 participants who were eligible and received protocol therapy were assessed for AEs.
|
16.7%
2/12 • Duration of treatment and follow up until death or 5 years post registration
36 participants who were eligible and received protocol therapy were assessed for AEs.
|
|
Psychiatric disorders
Restlessness
|
7.7%
1/13 • Duration of treatment and follow up until death or 5 years post registration
36 participants who were eligible and received protocol therapy were assessed for AEs.
|
0.00%
0/11 • Duration of treatment and follow up until death or 5 years post registration
36 participants who were eligible and received protocol therapy were assessed for AEs.
|
0.00%
0/12 • Duration of treatment and follow up until death or 5 years post registration
36 participants who were eligible and received protocol therapy were assessed for AEs.
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/13 • Duration of treatment and follow up until death or 5 years post registration
36 participants who were eligible and received protocol therapy were assessed for AEs.
|
9.1%
1/11 • Duration of treatment and follow up until death or 5 years post registration
36 participants who were eligible and received protocol therapy were assessed for AEs.
|
8.3%
1/12 • Duration of treatment and follow up until death or 5 years post registration
36 participants who were eligible and received protocol therapy were assessed for AEs.
|
|
Renal and urinary disorders
Chronic kidney disease
|
0.00%
0/13 • Duration of treatment and follow up until death or 5 years post registration
36 participants who were eligible and received protocol therapy were assessed for AEs.
|
0.00%
0/11 • Duration of treatment and follow up until death or 5 years post registration
36 participants who were eligible and received protocol therapy were assessed for AEs.
|
8.3%
1/12 • Duration of treatment and follow up until death or 5 years post registration
36 participants who were eligible and received protocol therapy were assessed for AEs.
|
|
Renal and urinary disorders
Cystitis noninfective
|
0.00%
0/13 • Duration of treatment and follow up until death or 5 years post registration
36 participants who were eligible and received protocol therapy were assessed for AEs.
|
9.1%
1/11 • Duration of treatment and follow up until death or 5 years post registration
36 participants who were eligible and received protocol therapy were assessed for AEs.
|
0.00%
0/12 • Duration of treatment and follow up until death or 5 years post registration
36 participants who were eligible and received protocol therapy were assessed for AEs.
|
|
Renal and urinary disorders
Hematuria
|
0.00%
0/13 • Duration of treatment and follow up until death or 5 years post registration
36 participants who were eligible and received protocol therapy were assessed for AEs.
|
9.1%
1/11 • Duration of treatment and follow up until death or 5 years post registration
36 participants who were eligible and received protocol therapy were assessed for AEs.
|
0.00%
0/12 • Duration of treatment and follow up until death or 5 years post registration
36 participants who were eligible and received protocol therapy were assessed for AEs.
|
|
Renal and urinary disorders
Renal and urinary disorders-Other
|
7.7%
1/13 • Duration of treatment and follow up until death or 5 years post registration
36 participants who were eligible and received protocol therapy were assessed for AEs.
|
9.1%
1/11 • Duration of treatment and follow up until death or 5 years post registration
36 participants who were eligible and received protocol therapy were assessed for AEs.
|
0.00%
0/12 • Duration of treatment and follow up until death or 5 years post registration
36 participants who were eligible and received protocol therapy were assessed for AEs.
|
|
Renal and urinary disorders
Urinary frequency
|
7.7%
1/13 • Duration of treatment and follow up until death or 5 years post registration
36 participants who were eligible and received protocol therapy were assessed for AEs.
|
9.1%
1/11 • Duration of treatment and follow up until death or 5 years post registration
36 participants who were eligible and received protocol therapy were assessed for AEs.
|
16.7%
2/12 • Duration of treatment and follow up until death or 5 years post registration
36 participants who were eligible and received protocol therapy were assessed for AEs.
|
|
Renal and urinary disorders
Urinary incontinence
|
0.00%
0/13 • Duration of treatment and follow up until death or 5 years post registration
36 participants who were eligible and received protocol therapy were assessed for AEs.
|
0.00%
0/11 • Duration of treatment and follow up until death or 5 years post registration
36 participants who were eligible and received protocol therapy were assessed for AEs.
|
8.3%
1/12 • Duration of treatment and follow up until death or 5 years post registration
36 participants who were eligible and received protocol therapy were assessed for AEs.
|
|
Renal and urinary disorders
Urinary tract pain
|
0.00%
0/13 • Duration of treatment and follow up until death or 5 years post registration
36 participants who were eligible and received protocol therapy were assessed for AEs.
|
9.1%
1/11 • Duration of treatment and follow up until death or 5 years post registration
36 participants who were eligible and received protocol therapy were assessed for AEs.
|
0.00%
0/12 • Duration of treatment and follow up until death or 5 years post registration
36 participants who were eligible and received protocol therapy were assessed for AEs.
|
|
Renal and urinary disorders
Urinary urgency
|
0.00%
0/13 • Duration of treatment and follow up until death or 5 years post registration
36 participants who were eligible and received protocol therapy were assessed for AEs.
|
9.1%
1/11 • Duration of treatment and follow up until death or 5 years post registration
36 participants who were eligible and received protocol therapy were assessed for AEs.
|
16.7%
2/12 • Duration of treatment and follow up until death or 5 years post registration
36 participants who were eligible and received protocol therapy were assessed for AEs.
|
|
Reproductive system and breast disorders
Reproductive system and breast disorders - Other
|
0.00%
0/13 • Duration of treatment and follow up until death or 5 years post registration
36 participants who were eligible and received protocol therapy were assessed for AEs.
|
18.2%
2/11 • Duration of treatment and follow up until death or 5 years post registration
36 participants who were eligible and received protocol therapy were assessed for AEs.
|
0.00%
0/12 • Duration of treatment and follow up until death or 5 years post registration
36 participants who were eligible and received protocol therapy were assessed for AEs.
|
|
Reproductive system and breast disorders
Vaginal discharge
|
7.7%
1/13 • Duration of treatment and follow up until death or 5 years post registration
36 participants who were eligible and received protocol therapy were assessed for AEs.
|
0.00%
0/11 • Duration of treatment and follow up until death or 5 years post registration
36 participants who were eligible and received protocol therapy were assessed for AEs.
|
0.00%
0/12 • Duration of treatment and follow up until death or 5 years post registration
36 participants who were eligible and received protocol therapy were assessed for AEs.
|
|
Reproductive system and breast disorders
Vaginal pain
|
7.7%
1/13 • Duration of treatment and follow up until death or 5 years post registration
36 participants who were eligible and received protocol therapy were assessed for AEs.
|
0.00%
0/11 • Duration of treatment and follow up until death or 5 years post registration
36 participants who were eligible and received protocol therapy were assessed for AEs.
|
0.00%
0/12 • Duration of treatment and follow up until death or 5 years post registration
36 participants who were eligible and received protocol therapy were assessed for AEs.
|
|
Respiratory, thoracic and mediastinal disorders
Allergic rhinitis
|
15.4%
2/13 • Duration of treatment and follow up until death or 5 years post registration
36 participants who were eligible and received protocol therapy were assessed for AEs.
|
9.1%
1/11 • Duration of treatment and follow up until death or 5 years post registration
36 participants who were eligible and received protocol therapy were assessed for AEs.
|
0.00%
0/12 • Duration of treatment and follow up until death or 5 years post registration
36 participants who were eligible and received protocol therapy were assessed for AEs.
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
0.00%
0/13 • Duration of treatment and follow up until death or 5 years post registration
36 participants who were eligible and received protocol therapy were assessed for AEs.
|
9.1%
1/11 • Duration of treatment and follow up until death or 5 years post registration
36 participants who were eligible and received protocol therapy were assessed for AEs.
|
0.00%
0/12 • Duration of treatment and follow up until death or 5 years post registration
36 participants who were eligible and received protocol therapy were assessed for AEs.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
38.5%
5/13 • Duration of treatment and follow up until death or 5 years post registration
36 participants who were eligible and received protocol therapy were assessed for AEs.
|
63.6%
7/11 • Duration of treatment and follow up until death or 5 years post registration
36 participants who were eligible and received protocol therapy were assessed for AEs.
|
33.3%
4/12 • Duration of treatment and follow up until death or 5 years post registration
36 participants who were eligible and received protocol therapy were assessed for AEs.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
46.2%
6/13 • Duration of treatment and follow up until death or 5 years post registration
36 participants who were eligible and received protocol therapy were assessed for AEs.
|
27.3%
3/11 • Duration of treatment and follow up until death or 5 years post registration
36 participants who were eligible and received protocol therapy were assessed for AEs.
|
25.0%
3/12 • Duration of treatment and follow up until death or 5 years post registration
36 participants who were eligible and received protocol therapy were assessed for AEs.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/13 • Duration of treatment and follow up until death or 5 years post registration
36 participants who were eligible and received protocol therapy were assessed for AEs.
|
9.1%
1/11 • Duration of treatment and follow up until death or 5 years post registration
36 participants who were eligible and received protocol therapy were assessed for AEs.
|
16.7%
2/12 • Duration of treatment and follow up until death or 5 years post registration
36 participants who were eligible and received protocol therapy were assessed for AEs.
|
|
Respiratory, thoracic and mediastinal disorders
Hoarseness
|
15.4%
2/13 • Duration of treatment and follow up until death or 5 years post registration
36 participants who were eligible and received protocol therapy were assessed for AEs.
|
0.00%
0/11 • Duration of treatment and follow up until death or 5 years post registration
36 participants who were eligible and received protocol therapy were assessed for AEs.
|
8.3%
1/12 • Duration of treatment and follow up until death or 5 years post registration
36 participants who were eligible and received protocol therapy were assessed for AEs.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/13 • Duration of treatment and follow up until death or 5 years post registration
36 participants who were eligible and received protocol therapy were assessed for AEs.
|
9.1%
1/11 • Duration of treatment and follow up until death or 5 years post registration
36 participants who were eligible and received protocol therapy were assessed for AEs.
|
16.7%
2/12 • Duration of treatment and follow up until death or 5 years post registration
36 participants who were eligible and received protocol therapy were assessed for AEs.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
15.4%
2/13 • Duration of treatment and follow up until death or 5 years post registration
36 participants who were eligible and received protocol therapy were assessed for AEs.
|
0.00%
0/11 • Duration of treatment and follow up until death or 5 years post registration
36 participants who were eligible and received protocol therapy were assessed for AEs.
|
0.00%
0/12 • Duration of treatment and follow up until death or 5 years post registration
36 participants who were eligible and received protocol therapy were assessed for AEs.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.00%
0/13 • Duration of treatment and follow up until death or 5 years post registration
36 participants who were eligible and received protocol therapy were assessed for AEs.
|
27.3%
3/11 • Duration of treatment and follow up until death or 5 years post registration
36 participants who were eligible and received protocol therapy were assessed for AEs.
|
8.3%
1/12 • Duration of treatment and follow up until death or 5 years post registration
36 participants who were eligible and received protocol therapy were assessed for AEs.
|
|
Respiratory, thoracic and mediastinal disorders
Postnasal drip
|
0.00%
0/13 • Duration of treatment and follow up until death or 5 years post registration
36 participants who were eligible and received protocol therapy were assessed for AEs.
|
0.00%
0/11 • Duration of treatment and follow up until death or 5 years post registration
36 participants who were eligible and received protocol therapy were assessed for AEs.
|
8.3%
1/12 • Duration of treatment and follow up until death or 5 years post registration
36 participants who were eligible and received protocol therapy were assessed for AEs.
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
7.7%
1/13 • Duration of treatment and follow up until death or 5 years post registration
36 participants who were eligible and received protocol therapy were assessed for AEs.
|
0.00%
0/11 • Duration of treatment and follow up until death or 5 years post registration
36 participants who were eligible and received protocol therapy were assessed for AEs.
|
0.00%
0/12 • Duration of treatment and follow up until death or 5 years post registration
36 participants who were eligible and received protocol therapy were assessed for AEs.
|
|
Respiratory, thoracic and mediastinal disorders
Resp, thoracic and mediastinal disorders - Other
|
0.00%
0/13 • Duration of treatment and follow up until death or 5 years post registration
36 participants who were eligible and received protocol therapy were assessed for AEs.
|
27.3%
3/11 • Duration of treatment and follow up until death or 5 years post registration
36 participants who were eligible and received protocol therapy were assessed for AEs.
|
8.3%
1/12 • Duration of treatment and follow up until death or 5 years post registration
36 participants who were eligible and received protocol therapy were assessed for AEs.
|
|
Respiratory, thoracic and mediastinal disorders
Sleep apnea
|
0.00%
0/13 • Duration of treatment and follow up until death or 5 years post registration
36 participants who were eligible and received protocol therapy were assessed for AEs.
|
9.1%
1/11 • Duration of treatment and follow up until death or 5 years post registration
36 participants who were eligible and received protocol therapy were assessed for AEs.
|
0.00%
0/12 • Duration of treatment and follow up until death or 5 years post registration
36 participants who were eligible and received protocol therapy were assessed for AEs.
|
|
Respiratory, thoracic and mediastinal disorders
Sore throat
|
23.1%
3/13 • Duration of treatment and follow up until death or 5 years post registration
36 participants who were eligible and received protocol therapy were assessed for AEs.
|
27.3%
3/11 • Duration of treatment and follow up until death or 5 years post registration
36 participants who were eligible and received protocol therapy were assessed for AEs.
|
16.7%
2/12 • Duration of treatment and follow up until death or 5 years post registration
36 participants who were eligible and received protocol therapy were assessed for AEs.
|
|
Respiratory, thoracic and mediastinal disorders
Voice alteration
|
0.00%
0/13 • Duration of treatment and follow up until death or 5 years post registration
36 participants who were eligible and received protocol therapy were assessed for AEs.
|
9.1%
1/11 • Duration of treatment and follow up until death or 5 years post registration
36 participants who were eligible and received protocol therapy were assessed for AEs.
|
0.00%
0/12 • Duration of treatment and follow up until death or 5 years post registration
36 participants who were eligible and received protocol therapy were assessed for AEs.
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
7.7%
1/13 • Duration of treatment and follow up until death or 5 years post registration
36 participants who were eligible and received protocol therapy were assessed for AEs.
|
9.1%
1/11 • Duration of treatment and follow up until death or 5 years post registration
36 participants who were eligible and received protocol therapy were assessed for AEs.
|
16.7%
2/12 • Duration of treatment and follow up until death or 5 years post registration
36 participants who were eligible and received protocol therapy were assessed for AEs.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
7.7%
1/13 • Duration of treatment and follow up until death or 5 years post registration
36 participants who were eligible and received protocol therapy were assessed for AEs.
|
9.1%
1/11 • Duration of treatment and follow up until death or 5 years post registration
36 participants who were eligible and received protocol therapy were assessed for AEs.
|
8.3%
1/12 • Duration of treatment and follow up until death or 5 years post registration
36 participants who were eligible and received protocol therapy were assessed for AEs.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
7.7%
1/13 • Duration of treatment and follow up until death or 5 years post registration
36 participants who were eligible and received protocol therapy were assessed for AEs.
|
27.3%
3/11 • Duration of treatment and follow up until death or 5 years post registration
36 participants who were eligible and received protocol therapy were assessed for AEs.
|
8.3%
1/12 • Duration of treatment and follow up until death or 5 years post registration
36 participants who were eligible and received protocol therapy were assessed for AEs.
|
|
Skin and subcutaneous tissue disorders
Erythema multiforme
|
0.00%
0/13 • Duration of treatment and follow up until death or 5 years post registration
36 participants who were eligible and received protocol therapy were assessed for AEs.
|
9.1%
1/11 • Duration of treatment and follow up until death or 5 years post registration
36 participants who were eligible and received protocol therapy were assessed for AEs.
|
8.3%
1/12 • Duration of treatment and follow up until death or 5 years post registration
36 participants who were eligible and received protocol therapy were assessed for AEs.
|
|
Skin and subcutaneous tissue disorders
Nail discoloration
|
0.00%
0/13 • Duration of treatment and follow up until death or 5 years post registration
36 participants who were eligible and received protocol therapy were assessed for AEs.
|
9.1%
1/11 • Duration of treatment and follow up until death or 5 years post registration
36 participants who were eligible and received protocol therapy were assessed for AEs.
|
0.00%
0/12 • Duration of treatment and follow up until death or 5 years post registration
36 participants who were eligible and received protocol therapy were assessed for AEs.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/13 • Duration of treatment and follow up until death or 5 years post registration
36 participants who were eligible and received protocol therapy were assessed for AEs.
|
18.2%
2/11 • Duration of treatment and follow up until death or 5 years post registration
36 participants who were eligible and received protocol therapy were assessed for AEs.
|
8.3%
1/12 • Duration of treatment and follow up until death or 5 years post registration
36 participants who were eligible and received protocol therapy were assessed for AEs.
|
|
Skin and subcutaneous tissue disorders
Rash acneiform
|
7.7%
1/13 • Duration of treatment and follow up until death or 5 years post registration
36 participants who were eligible and received protocol therapy were assessed for AEs.
|
36.4%
4/11 • Duration of treatment and follow up until death or 5 years post registration
36 participants who were eligible and received protocol therapy were assessed for AEs.
|
8.3%
1/12 • Duration of treatment and follow up until death or 5 years post registration
36 participants who were eligible and received protocol therapy were assessed for AEs.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
0.00%
0/13 • Duration of treatment and follow up until death or 5 years post registration
36 participants who were eligible and received protocol therapy were assessed for AEs.
|
36.4%
4/11 • Duration of treatment and follow up until death or 5 years post registration
36 participants who were eligible and received protocol therapy were assessed for AEs.
|
25.0%
3/12 • Duration of treatment and follow up until death or 5 years post registration
36 participants who were eligible and received protocol therapy were assessed for AEs.
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders - Other
|
15.4%
2/13 • Duration of treatment and follow up until death or 5 years post registration
36 participants who were eligible and received protocol therapy were assessed for AEs.
|
18.2%
2/11 • Duration of treatment and follow up until death or 5 years post registration
36 participants who were eligible and received protocol therapy were assessed for AEs.
|
0.00%
0/12 • Duration of treatment and follow up until death or 5 years post registration
36 participants who were eligible and received protocol therapy were assessed for AEs.
|
|
Skin and subcutaneous tissue disorders
Skin hyperpigmentation
|
0.00%
0/13 • Duration of treatment and follow up until death or 5 years post registration
36 participants who were eligible and received protocol therapy were assessed for AEs.
|
0.00%
0/11 • Duration of treatment and follow up until death or 5 years post registration
36 participants who were eligible and received protocol therapy were assessed for AEs.
|
8.3%
1/12 • Duration of treatment and follow up until death or 5 years post registration
36 participants who were eligible and received protocol therapy were assessed for AEs.
|
|
Skin and subcutaneous tissue disorders
Skin induration
|
0.00%
0/13 • Duration of treatment and follow up until death or 5 years post registration
36 participants who were eligible and received protocol therapy were assessed for AEs.
|
0.00%
0/11 • Duration of treatment and follow up until death or 5 years post registration
36 participants who were eligible and received protocol therapy were assessed for AEs.
|
8.3%
1/12 • Duration of treatment and follow up until death or 5 years post registration
36 participants who were eligible and received protocol therapy were assessed for AEs.
|
|
Skin and subcutaneous tissue disorders
Skin ulceration
|
7.7%
1/13 • Duration of treatment and follow up until death or 5 years post registration
36 participants who were eligible and received protocol therapy were assessed for AEs.
|
0.00%
0/11 • Duration of treatment and follow up until death or 5 years post registration
36 participants who were eligible and received protocol therapy were assessed for AEs.
|
0.00%
0/12 • Duration of treatment and follow up until death or 5 years post registration
36 participants who were eligible and received protocol therapy were assessed for AEs.
|
|
Vascular disorders
Flushing
|
0.00%
0/13 • Duration of treatment and follow up until death or 5 years post registration
36 participants who were eligible and received protocol therapy were assessed for AEs.
|
9.1%
1/11 • Duration of treatment and follow up until death or 5 years post registration
36 participants who were eligible and received protocol therapy were assessed for AEs.
|
0.00%
0/12 • Duration of treatment and follow up until death or 5 years post registration
36 participants who were eligible and received protocol therapy were assessed for AEs.
|
|
Vascular disorders
Hot flashes
|
46.2%
6/13 • Duration of treatment and follow up until death or 5 years post registration
36 participants who were eligible and received protocol therapy were assessed for AEs.
|
54.5%
6/11 • Duration of treatment and follow up until death or 5 years post registration
36 participants who were eligible and received protocol therapy were assessed for AEs.
|
41.7%
5/12 • Duration of treatment and follow up until death or 5 years post registration
36 participants who were eligible and received protocol therapy were assessed for AEs.
|
|
Vascular disorders
Hypertension
|
15.4%
2/13 • Duration of treatment and follow up until death or 5 years post registration
36 participants who were eligible and received protocol therapy were assessed for AEs.
|
45.5%
5/11 • Duration of treatment and follow up until death or 5 years post registration
36 participants who were eligible and received protocol therapy were assessed for AEs.
|
33.3%
4/12 • Duration of treatment and follow up until death or 5 years post registration
36 participants who were eligible and received protocol therapy were assessed for AEs.
|
|
Vascular disorders
Hypotension
|
0.00%
0/13 • Duration of treatment and follow up until death or 5 years post registration
36 participants who were eligible and received protocol therapy were assessed for AEs.
|
0.00%
0/11 • Duration of treatment and follow up until death or 5 years post registration
36 participants who were eligible and received protocol therapy were assessed for AEs.
|
8.3%
1/12 • Duration of treatment and follow up until death or 5 years post registration
36 participants who were eligible and received protocol therapy were assessed for AEs.
|
|
Vascular disorders
Thromboembolic event
|
0.00%
0/13 • Duration of treatment and follow up until death or 5 years post registration
36 participants who were eligible and received protocol therapy were assessed for AEs.
|
0.00%
0/11 • Duration of treatment and follow up until death or 5 years post registration
36 participants who were eligible and received protocol therapy were assessed for AEs.
|
8.3%
1/12 • Duration of treatment and follow up until death or 5 years post registration
36 participants who were eligible and received protocol therapy were assessed for AEs.
|
|
Vascular disorders
Vascular disorders-Other
|
0.00%
0/13 • Duration of treatment and follow up until death or 5 years post registration
36 participants who were eligible and received protocol therapy were assessed for AEs.
|
18.2%
2/11 • Duration of treatment and follow up until death or 5 years post registration
36 participants who were eligible and received protocol therapy were assessed for AEs.
|
0.00%
0/12 • Duration of treatment and follow up until death or 5 years post registration
36 participants who were eligible and received protocol therapy were assessed for AEs.
|
Additional Information
Breast Committee Statistician
SWOG Statistics and Data Management Center
Phone: 2066674623
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place