Trial Outcomes & Findings for A Study of Avastin (Bevacizumab) in Combination With Chemotherapy in Patients With Breast Cancer Progressing After First-Line Therapy With Avastin and Chemotherapy (TANIA) (NCT NCT01250379)
NCT ID: NCT01250379
Last Updated: 2016-02-11
Results Overview
Second-line PFS was defined as the time from randomization to progressive disease (PD) or death due to any cause during their second-line of treatment with bevacizumab and/or chemotherapy, whichever occurred first. For target lesions (TLs), PD was defined at least a 20 percent (%) increase in the sum of the largest diameter (SLD), taking as reference the smallest SLD recorded from baseline or the appearance of one or more new lesions. For non-target lesions (NTLs), PD was defined as the appearance of 1 or more new lesions and/or unequivocal progression of existing NTLs. Participants without second-line PD or death were censored at the date of last tumor assessment where non-progression was documented.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
494 participants
Primary outcome timeframe
Baseline (less than or equal to [≤] 28 days after randomization), every 8-9 weeks thereafter according to the standard of care of the treatment site until approximately 3 years
Results posted on
2016-02-11
Participant Flow
A total of 556 participants were screened and of these, 494 were randomized.
Participant milestones
| Measure |
Chemotherapy (CT) Arm
Participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator's site until disease progression, unacceptable toxicity, participant request for withdrawal, until the maximum cumulative dose of anthracycline was reached, or end of study (24 months after randomization of the last participant). Upon second-line disease progression participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator's site until disease progression, unacceptable toxicity, participant request for withdrawal, or end of study. Upon subsequent disease progression participants received treatment according the standard of care of the treatment site until end of study.
|
Chemotherapy Plus Bevacizumab (CT+BV) Arm
Participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator's site plus bevacizumab, 15 milligrams per kilogram (mg/kg), intravenously (IV), every 3 weeks, or 10 mg/kg, IV, every 2 weeks until disease progression, unacceptable toxicity, participant request for withdrawal, until the maximum cumulative dose of anthracycline was reached, or end of study (24 months after randomization of the last participant). Upon second-line disease progression participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator's site plus bevacizumab, 15 mg/kg, IV, every 3 weeks, or 10 mg/kg, IV, every 2 weeks until disease progression, unacceptable toxicity, participant request for withdrawal, or end of study. Upon subsequent disease progression participants received treatment according the standard of care of the treatment site until end of study.
|
|---|---|---|
|
Overall Study
STARTED
|
247
|
247
|
|
Overall Study
COMPLETED
|
45
|
54
|
|
Overall Study
NOT COMPLETED
|
202
|
193
|
Reasons for withdrawal
| Measure |
Chemotherapy (CT) Arm
Participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator's site until disease progression, unacceptable toxicity, participant request for withdrawal, until the maximum cumulative dose of anthracycline was reached, or end of study (24 months after randomization of the last participant). Upon second-line disease progression participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator's site until disease progression, unacceptable toxicity, participant request for withdrawal, or end of study. Upon subsequent disease progression participants received treatment according the standard of care of the treatment site until end of study.
|
Chemotherapy Plus Bevacizumab (CT+BV) Arm
Participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator's site plus bevacizumab, 15 milligrams per kilogram (mg/kg), intravenously (IV), every 3 weeks, or 10 mg/kg, IV, every 2 weeks until disease progression, unacceptable toxicity, participant request for withdrawal, until the maximum cumulative dose of anthracycline was reached, or end of study (24 months after randomization of the last participant). Upon second-line disease progression participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator's site plus bevacizumab, 15 mg/kg, IV, every 3 weeks, or 10 mg/kg, IV, every 2 weeks until disease progression, unacceptable toxicity, participant request for withdrawal, or end of study. Upon subsequent disease progression participants received treatment according the standard of care of the treatment site until end of study.
|
|---|---|---|
|
Overall Study
Death
|
141
|
148
|
|
Overall Study
Withdrawal by Subject
|
32
|
20
|
|
Overall Study
Physician Decision
|
11
|
3
|
|
Overall Study
Protocol Violation
|
2
|
8
|
|
Overall Study
Lost to Follow-up
|
9
|
6
|
|
Overall Study
Adverse Event
|
5
|
4
|
|
Overall Study
Other
|
0
|
4
|
|
Overall Study
Participant noncompliance
|
2
|
0
|
Baseline Characteristics
A Study of Avastin (Bevacizumab) in Combination With Chemotherapy in Patients With Breast Cancer Progressing After First-Line Therapy With Avastin and Chemotherapy (TANIA)
Baseline characteristics by cohort
| Measure |
CT Arm
n=247 Participants
Participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator's site until disease progression, unacceptable toxicity, participant request for withdrawal, until the maximum cumulative dose of anthracycline was reached, or end of study (24 months after randomization of the last participant). Upon second-line disease progression participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator's site until disease progression, unacceptable toxicity, participant request for withdrawal, or end of study. Upon subsequent disease progression participants received treatment according the standard of care of the treatment site until end of study.
|
CT+BV Arm
n=247 Participants
Participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator's site plus bevacizumab, 15 mg/kg, IV, every 3 weeks, or 10 mg/kg, IV, every 2 weeks until disease progression, unacceptable toxicity, participant request for withdrawal, until the maximum cumulative dose of anthracycline was reached, or end of study (24 months after randomization of the last participant). Upon second-line disease progression participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator's site plus bevacizumab, 15 mg/kg, IV, every 3 weeks, or 10 mg/kg, IV, every 2 weeks until disease progression, unacceptable toxicity, participant request for withdrawal, or end of study. Upon subsequent disease progression participants received treatment according the standard of care of the treatment site until end of study.
|
Total
n=494 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
54.7 years
STANDARD_DEVIATION 10.83 • n=99 Participants
|
55.8 years
STANDARD_DEVIATION 11.17 • n=107 Participants
|
55.2 years
STANDARD_DEVIATION 11.01 • n=206 Participants
|
|
Sex: Female, Male
Female
|
247 Participants
n=99 Participants
|
247 Participants
n=107 Participants
|
494 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Baseline (less than or equal to [≤] 28 days after randomization), every 8-9 weeks thereafter according to the standard of care of the treatment site until approximately 3 yearsPopulation: Intent-to-Treat (ITT) population - all randomized participants.
Second-line PFS was defined as the time from randomization to progressive disease (PD) or death due to any cause during their second-line of treatment with bevacizumab and/or chemotherapy, whichever occurred first. For target lesions (TLs), PD was defined at least a 20 percent (%) increase in the sum of the largest diameter (SLD), taking as reference the smallest SLD recorded from baseline or the appearance of one or more new lesions. For non-target lesions (NTLs), PD was defined as the appearance of 1 or more new lesions and/or unequivocal progression of existing NTLs. Participants without second-line PD or death were censored at the date of last tumor assessment where non-progression was documented.
Outcome measures
| Measure |
CT Arm
n=247 Participants
Participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator's site until disease progression, unacceptable toxicity, participant request for withdrawal, until the maximum cumulative dose of anthracycline was reached, or end of study (24 months after randomization of the last participant). Upon second-line disease progression participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator's site until disease progression, unacceptable toxicity, participant request for withdrawal, or end of study. Upon subsequent disease progression participants received treatment according the standard of care of the treatment site until end of study.
|
CT+BV Arm
n=247 Participants
Participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator's site plus bevacizumab, 15 mg/kg, IV, every 3 weeks, or 10 mg/kg, IV, every 2 weeks until disease progression, unacceptable toxicity, participant request for withdrawal, until the maximum cumulative dose of anthracycline was reached, or end of study (24 months after randomization of the last participant). Upon second-line disease progression participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator's site plus bevacizumab, 15 mg/kg, IV, every 3 weeks, or 10 mg/kg, IV, every 2 weeks until disease progression, unacceptable toxicity, participant request for withdrawal, or end of study. Upon subsequent disease progression participants received treatment according the standard of care of the treatment site until end of study.
|
|---|---|---|
|
Percentage of Participants With Second-Line Progression-Free Survival (PFS) According to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 (v1.1)
|
88.7 percentage of participants
|
93.9 percentage of participants
|
PRIMARY outcome
Timeframe: Baseline (≤28 days after randomization), every 8-9 weeks thereafter according to the standard of care of the treatment site until approximately 3 yearsPopulation: ITT population
The median time, in months, from randomization to second-line PFS event. For TLs, PD was defined at least a 20% increase in the SLD, taking as reference the smallest SLD recorded from baseline or the appearance of one or more new lesions. For NTLs, PD was defined as the appearance of 1 or more new lesions and/or unequivocal progression of existing NTLs. Participants without second-line PD or death were censored at the date of last tumor assessment where non-progression was documented.
Outcome measures
| Measure |
CT Arm
n=247 Participants
Participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator's site until disease progression, unacceptable toxicity, participant request for withdrawal, until the maximum cumulative dose of anthracycline was reached, or end of study (24 months after randomization of the last participant). Upon second-line disease progression participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator's site until disease progression, unacceptable toxicity, participant request for withdrawal, or end of study. Upon subsequent disease progression participants received treatment according the standard of care of the treatment site until end of study.
|
CT+BV Arm
n=247 Participants
Participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator's site plus bevacizumab, 15 mg/kg, IV, every 3 weeks, or 10 mg/kg, IV, every 2 weeks until disease progression, unacceptable toxicity, participant request for withdrawal, until the maximum cumulative dose of anthracycline was reached, or end of study (24 months after randomization of the last participant). Upon second-line disease progression participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator's site plus bevacizumab, 15 mg/kg, IV, every 3 weeks, or 10 mg/kg, IV, every 2 weeks until disease progression, unacceptable toxicity, participant request for withdrawal, or end of study. Upon subsequent disease progression participants received treatment according the standard of care of the treatment site until end of study.
|
|---|---|---|
|
Second-Line PFS
|
4.2 months
Interval 3.9 to 5.3
|
6.3 months
Interval 5.5 to 7.6
|
PRIMARY outcome
Timeframe: Month 6Population: ITT population
Second-line PFS was defined as the time from randomization to PD or death due to any cause during their second-line of treatment with bevacizumab and/or chemotherapy, whichever occurred first. For TLs, PD was defined at least a 20% increase in the SLD, taking as reference the smallest SLD recorded from baseline or the appearance of one or more new lesions. For NTLs, PD was defined as the appearance of 1 or more new lesions and/or unequivocal progression of existing NTLs. Participants without second-line PD or death were censored at the date of last tumor assessment where non-progression was documented.
Outcome measures
| Measure |
CT Arm
n=247 Participants
Participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator's site until disease progression, unacceptable toxicity, participant request for withdrawal, until the maximum cumulative dose of anthracycline was reached, or end of study (24 months after randomization of the last participant). Upon second-line disease progression participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator's site until disease progression, unacceptable toxicity, participant request for withdrawal, or end of study. Upon subsequent disease progression participants received treatment according the standard of care of the treatment site until end of study.
|
CT+BV Arm
n=247 Participants
Participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator's site plus bevacizumab, 15 mg/kg, IV, every 3 weeks, or 10 mg/kg, IV, every 2 weeks until disease progression, unacceptable toxicity, participant request for withdrawal, until the maximum cumulative dose of anthracycline was reached, or end of study (24 months after randomization of the last participant). Upon second-line disease progression participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator's site plus bevacizumab, 15 mg/kg, IV, every 3 weeks, or 10 mg/kg, IV, every 2 weeks until disease progression, unacceptable toxicity, participant request for withdrawal, or end of study. Upon subsequent disease progression participants received treatment according the standard of care of the treatment site until end of study.
|
|---|---|---|
|
Percentage of Participants Estimated to be Alive and Free of Second-Line Disease Progression at Month 6
|
40.7 percentage of participants
Interval 34.3 to 47.0
|
54.2 percentage of participants
Interval 47.7 to 60.3
|
PRIMARY outcome
Timeframe: Month 12Population: ITT population
Second-line PFS was defined as the time from randomization to PD or death due to any cause during their second-line of treatment with bevacizumab and/or chemotherapy, whichever occurred first. For TLs, PD was defined at least a 20% increase in the SLD, taking as reference the smallest SLD recorded from baseline or the appearance of one or more new lesions. For NTLs, PD was defined as the appearance of 1 or more new lesions and/or unequivocal progression of existing NTLs. Participants without secondline PD or death were censored at the date of last tumor assessment where non-progression was documented.
Outcome measures
| Measure |
CT Arm
n=247 Participants
Participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator's site until disease progression, unacceptable toxicity, participant request for withdrawal, until the maximum cumulative dose of anthracycline was reached, or end of study (24 months after randomization of the last participant). Upon second-line disease progression participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator's site until disease progression, unacceptable toxicity, participant request for withdrawal, or end of study. Upon subsequent disease progression participants received treatment according the standard of care of the treatment site until end of study.
|
CT+BV Arm
n=247 Participants
Participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator's site plus bevacizumab, 15 mg/kg, IV, every 3 weeks, or 10 mg/kg, IV, every 2 weeks until disease progression, unacceptable toxicity, participant request for withdrawal, until the maximum cumulative dose of anthracycline was reached, or end of study (24 months after randomization of the last participant). Upon second-line disease progression participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator's site plus bevacizumab, 15 mg/kg, IV, every 3 weeks, or 10 mg/kg, IV, every 2 weeks until disease progression, unacceptable toxicity, participant request for withdrawal, or end of study. Upon subsequent disease progression participants received treatment according the standard of care of the treatment site until end of study.
|
|---|---|---|
|
Percentage of Participants Estimated to be Alive and Free of Second-Line Disease Progression at Month 12
|
16.9 percentage of participants
Interval 12.3 to 22.2
|
24.2 percentage of participants
Interval 19.0 to 29.9
|
PRIMARY outcome
Timeframe: Month 18Population: ITT population
Second-line PFS was defined as the time from randomization to PD or death due to any cause during their secondline of treatment with bevacizumab and/or chemotherapy, whichever occurred first. For TLs, PD was defined at least a 20% increase in the SLD, taking as reference the smallest SLD recorded from baseline or the appearance of one or more new lesions. For NTLs, PD was defined as the appearance of 1 or more new lesions and/or unequivocal progression of existing NTLs. Participants without second-line PD or death were censored at the date of last tumor assessment where non-progression was documented.
Outcome measures
| Measure |
CT Arm
n=247 Participants
Participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator's site until disease progression, unacceptable toxicity, participant request for withdrawal, until the maximum cumulative dose of anthracycline was reached, or end of study (24 months after randomization of the last participant). Upon second-line disease progression participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator's site until disease progression, unacceptable toxicity, participant request for withdrawal, or end of study. Upon subsequent disease progression participants received treatment according the standard of care of the treatment site until end of study.
|
CT+BV Arm
n=247 Participants
Participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator's site plus bevacizumab, 15 mg/kg, IV, every 3 weeks, or 10 mg/kg, IV, every 2 weeks until disease progression, unacceptable toxicity, participant request for withdrawal, until the maximum cumulative dose of anthracycline was reached, or end of study (24 months after randomization of the last participant). Upon second-line disease progression participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator's site plus bevacizumab, 15 mg/kg, IV, every 3 weeks, or 10 mg/kg, IV, every 2 weeks until disease progression, unacceptable toxicity, participant request for withdrawal, or end of study. Upon subsequent disease progression participants received treatment according the standard of care of the treatment site until end of study.
|
|---|---|---|
|
Percentage of Participants Estimated to be Alive and Free of Second-Line Disease Progression at Month 18
|
9.9 percentage of participants
Interval 6.4 to 14.3
|
11.0 percentage of participants
Interval 7.4 to 15.5
|
PRIMARY outcome
Timeframe: Month 24Population: ITT population
Second-line PFS was defined as the time from randomization to PD or death due to any cause during their second-line of treatment with bevacizumab and/or chemotherapy, whichever occurred first. For TLs, PD was defined at least a 20% increase in the SLD, taking as reference the smallest SLD recorded from baseline or the appearance of one or more new lesions. For NTLs, PD was defined as the appearance of 1 or more new lesions and/or unequivocal progression of existing NTLs. Participants without second-line PD or death were censored at the date of last tumor assessment where non-progression was documented.
Outcome measures
| Measure |
CT Arm
n=247 Participants
Participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator's site until disease progression, unacceptable toxicity, participant request for withdrawal, until the maximum cumulative dose of anthracycline was reached, or end of study (24 months after randomization of the last participant). Upon second-line disease progression participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator's site until disease progression, unacceptable toxicity, participant request for withdrawal, or end of study. Upon subsequent disease progression participants received treatment according the standard of care of the treatment site until end of study.
|
CT+BV Arm
n=247 Participants
Participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator's site plus bevacizumab, 15 mg/kg, IV, every 3 weeks, or 10 mg/kg, IV, every 2 weeks until disease progression, unacceptable toxicity, participant request for withdrawal, until the maximum cumulative dose of anthracycline was reached, or end of study (24 months after randomization of the last participant). Upon second-line disease progression participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator's site plus bevacizumab, 15 mg/kg, IV, every 3 weeks, or 10 mg/kg, IV, every 2 weeks until disease progression, unacceptable toxicity, participant request for withdrawal, or end of study. Upon subsequent disease progression participants received treatment according the standard of care of the treatment site until end of study.
|
|---|---|---|
|
Percentage of Participants Estimated to be Alive and Free of Second-Line Disease Progression at Month 24
|
6.4 percentage of participants
Interval 3.6 to 10.2
|
6.5 percentage of participants
Interval 3.7 to 10.2
|
SECONDARY outcome
Timeframe: Baseline (≤28 days after randomization), every 8-9 weeks thereafter according to the standard of care of the treatment site until approximately 3 yearsPopulation: ITT population. Here, Number of participants analyzed equals (=) participants evaluable for this outcome measure and number (n) = number of participants included in the analysis for the specified risk factor.
The median time, in months, from randomization to second-line PFS event according to the following baseline risk factors: hormone receptor negative, HER2 negative (triple negative), hormone receptor positive/HER-2 negative (HR-pos/HER-neg), first-line PFS less than (\<) 6 months, first-line PFS greater than or equal to (≥) 6 months, taxane chemotherapy (chemo), non-taxane chemo, vinorelbine chemo, LDH ≤ 1.5 upper limit of normal (ULN), LDH greater than (\>) 1.5 ULN, \< 65 years of age, ≥ 65 years of age, \< 70 years of age, ≥ 70 years of age, \< 3 metastatic organ sites, ≥ 3 metastatic organ sites, bevacizumab-free (B-free) interval ≤ 6 weeks, B-free \> 6 weeks, disease-free (D-free) interval ≤ 24 months, D-free \> 24 months, D-free ≤ 12 months, and D-free \> 12 months. Participants without second-line PD or death were censored at the date of last tumor assessment where non-progression was documented. PD: defined in Outcome measure 1. The 95% CI was estimated using Kaplan-Meier methodology.
Outcome measures
| Measure |
CT Arm
n=226 Participants
Participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator's site until disease progression, unacceptable toxicity, participant request for withdrawal, until the maximum cumulative dose of anthracycline was reached, or end of study (24 months after randomization of the last participant). Upon second-line disease progression participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator's site until disease progression, unacceptable toxicity, participant request for withdrawal, or end of study. Upon subsequent disease progression participants received treatment according the standard of care of the treatment site until end of study.
|
CT+BV Arm
n=219 Participants
Participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator's site plus bevacizumab, 15 mg/kg, IV, every 3 weeks, or 10 mg/kg, IV, every 2 weeks until disease progression, unacceptable toxicity, participant request for withdrawal, until the maximum cumulative dose of anthracycline was reached, or end of study (24 months after randomization of the last participant). Upon second-line disease progression participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator's site plus bevacizumab, 15 mg/kg, IV, every 3 weeks, or 10 mg/kg, IV, every 2 weeks until disease progression, unacceptable toxicity, participant request for withdrawal, or end of study. Upon subsequent disease progression participants received treatment according the standard of care of the treatment site until end of study.
|
|---|---|---|
|
Second-Line PFS by Baseline Risk Factor (Data Cutoff 20 December 2013)
HR-neg (n=60,56)
|
2.1 months
Interval 2.0 to 3.9
|
4.9 months
Interval 3.4 to 6.1
|
|
Second-Line PFS by Baseline Risk Factor (Data Cutoff 20 December 2013)
HR-pos/HER-neg (n=187,191)
|
4.7 months
Interval 4.2 to 6.2
|
6.7 months
Interval 6.0 to 7.8
|
|
Second-Line PFS by Baseline Risk Factor (Data Cutoff 20 December 2013)
PFS <6 months (n=69,68)
|
3.9 months
Interval 2.3 to 4.3
|
5.1 months
Interval 4.1 to 6.9
|
|
Second-Line PFS by Baseline Risk Factor (Data Cutoff 20 December 2013)
PFS ≥6 months (n=178,179)
|
4.6 months
Interval 3.9 to 6.1
|
6.4 months
Interval 5.8 to 7.6
|
|
Second-Line PFS by Baseline Risk Factor (Data Cutoff 20 December 2013)
Taxane chemo (n=32,32)
|
3.2 months
Interval 1.7 to 5.3
|
6.9 months
Interval 4.9 to 9.8
|
|
Second-Line PFS by Baseline Risk Factor (Data Cutoff 20 December 2013)
Non-taxane chemo (n=191,188)
|
4.4 months
Interval 3.9 to 5.8
|
6.0 months
Interval 4.9 to 6.8
|
|
Second-Line PFS by Baseline Risk Factor (Data Cutoff 20 December 2013)
Vinorelbine chemo (n=24,27)
|
2.4 months
Interval 1.8 to 4.3
|
6.5 months
Interval 4.2 to 11.1
|
|
Second-Line PFS by Baseline Risk Factor (Data Cutoff 20 December 2013)
LDH ≤ 1.5 ULN (n=207,210)
|
4.4 months
Interval 3.9 to 6.0
|
6.3 months
Interval 5.5 to 7.6
|
|
Second-Line PFS by Baseline Risk Factor (Data Cutoff 20 December 2013)
LDH > 1.5 ULN (n=40,37)
|
2.1 months
Interval 1.7 to 3.9
|
5.8 months
Interval 2.5 to 7.3
|
|
Second-Line PFS by Baseline Risk Factor (Data Cutoff 20 December 2013)
< 65 years of age (n=196,183)
|
4.2 months
Interval 3.9 to 4.7
|
6.1 months
Interval 4.7 to 6.9
|
|
Second-Line PFS by Baseline Risk Factor (Data Cutoff 20 December 2013)
≥ 65 years of age (n=51,64)
|
4.2 months
Interval 2.2 to 7.8
|
6.7 months
Interval 5.5 to 8.0
|
|
Second-Line PFS by Baseline Risk Factor (Data Cutoff 20 December 2013)
< 70 years of age (n=226,219)
|
4.2 months
Interval 3.7 to 4.6
|
6.2 months
Interval 5.3 to 7.3
|
|
Second-Line PFS by Baseline Risk Factor (Data Cutoff 20 December 2013)
≥ 70 years of age (n=21,28)
|
7.8 months
Interval 2.2 to 11.9
|
6.7 months
Interval 4.1 to 11.2
|
|
Second-Line PFS by Baseline Risk Factor (Data Cutoff 20 December 2013)
< 3 metastatic organ sites (n=158,167)
|
4.2 months
Interval 3.9 to 6.1
|
6.9 months
Interval 6.0 to 8.2
|
|
Second-Line PFS by Baseline Risk Factor (Data Cutoff 20 December 2013)
≥ 3 metastatic organ sites (n=88,80)
|
4.0 months
Interval 2.1 to 4.9
|
4.7 months
Interval 4.1 to 6.2
|
|
Second-Line PFS by Baseline Risk Factor (Data Cutoff 20 December 2013)
B-free ≤ 6 weeks (n=165,149)
|
4.2 months
Interval 3.6 to 4.6
|
5.8 months
Interval 4.4 to 6.6
|
|
Second-Line PFS by Baseline Risk Factor (Data Cutoff 20 December 2013)
B-free > 6 weeks (n=81,98)
|
4.4 months
Interval 3.3 to 6.3
|
7.6 months
Interval 6.0 to 9.5
|
|
Second-Line PFS by Baseline Risk Factor (Data Cutoff 20 December 2013)
D-free ≤ 24 months (n=58,53)
|
2.8 months
Interval 2.0 to 3.9
|
5.8 months
Interval 4.2 to 6.3
|
|
Second-Line PFS by Baseline Risk Factor (Data Cutoff 20 December 2013)
D-free > 24 months (n=138,156)
|
4.9 months
Interval 4.0 to 6.1
|
6.5 months
Interval 5.5 to 8.1
|
|
Second-Line PFS by Baseline Risk Factor (Data Cutoff 20 December 2013)
D-free ≤ 12 months (n=24,18)
|
2.1 months
Interval 1.3 to 5.8
|
5.8 months
Interval 3.9 to 9.7
|
|
Second-Line PFS by Baseline Risk Factor (Data Cutoff 20 December 2013)
D-free > 12 months (n=172,191)
|
4.3 months
Interval 3.9 to 5.7
|
6.3 months
Interval 5.3 to 7.6
|
SECONDARY outcome
Timeframe: Baseline (≤28 days after randomization), every 8-9 weeks thereafter according to the standard of care of the treatment site until approximately 3 yearsPopulation: ITT population; only randomized participants with measurable disease at baseline were included in the analysis.
BOR was defined as a confirmed CR or PR during second-line treatment. For TLs, CR was defined as the disappearance of all TLs, and PR was defined as at least a 30% decrease in the SLD of the TLs, taking as a reference the baseline SLD. For NTLs, CR was defined as the disappearance of all NTLs and normalization of tumor marker levels. The 95% Cl was determined using the Pearson-Clopper method.
Outcome measures
| Measure |
CT Arm
n=185 Participants
Participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator's site until disease progression, unacceptable toxicity, participant request for withdrawal, until the maximum cumulative dose of anthracycline was reached, or end of study (24 months after randomization of the last participant). Upon second-line disease progression participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator's site until disease progression, unacceptable toxicity, participant request for withdrawal, or end of study. Upon subsequent disease progression participants received treatment according the standard of care of the treatment site until end of study.
|
CT+BV Arm
n=182 Participants
Participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator's site plus bevacizumab, 15 mg/kg, IV, every 3 weeks, or 10 mg/kg, IV, every 2 weeks until disease progression, unacceptable toxicity, participant request for withdrawal, until the maximum cumulative dose of anthracycline was reached, or end of study (24 months after randomization of the last participant). Upon second-line disease progression participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator's site plus bevacizumab, 15 mg/kg, IV, every 3 weeks, or 10 mg/kg, IV, every 2 weeks until disease progression, unacceptable toxicity, participant request for withdrawal, or end of study. Upon subsequent disease progression participants received treatment according the standard of care of the treatment site until end of study.
|
|---|---|---|
|
Percentage of Participants With a Second-Line Best Overall Response (BOR) of Complete Response (CR) or Partial Response (PR) According to RECIST v1.1 (Data Cutoff 20 December 2013)
|
16.8 percentage of participants
Interval 11.7 to 22.9
|
20.9 percentage of participants
Interval 15.2 to 27.5
|
SECONDARY outcome
Timeframe: Baseline (≤28 days after randomization), every 8-9 weeks thereafter according to the standard of care of the treatment site until approximately 3 yearsPopulation: ITT population; only randomized participants with measurable disease at baseline were included in the analysis.
For TLs, CR was defined as the disappearance of all TLs; PR was defined as at least a 30% decrease in the SLD of the TLs, taking as a reference the baseline SLD; SD was defined as neither sufficient decrease in SLD to qualify for PR nor sufficient increase in SLD to qualify for PD; and PD was defined as at least a 20% increase in the SLD of TLs, taking as reference the smallest SLD recorded since the treatment started. For NTLs, CR was defined as the disappearance of all NTLs and normalization of tumor marker levels; stable disease was defined as the persistence of 1 or more NTLs and/or maintenance of tumor marker levels above normal limits; and PD was defined as the appearance of 1 or more new lesions and/or unequivocal progression of existing NTLs. The 95% CI was determined using the Pearson-Clopper method.
Outcome measures
| Measure |
CT Arm
n=185 Participants
Participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator's site until disease progression, unacceptable toxicity, participant request for withdrawal, until the maximum cumulative dose of anthracycline was reached, or end of study (24 months after randomization of the last participant). Upon second-line disease progression participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator's site until disease progression, unacceptable toxicity, participant request for withdrawal, or end of study. Upon subsequent disease progression participants received treatment according the standard of care of the treatment site until end of study.
|
CT+BV Arm
n=182 Participants
Participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator's site plus bevacizumab, 15 mg/kg, IV, every 3 weeks, or 10 mg/kg, IV, every 2 weeks until disease progression, unacceptable toxicity, participant request for withdrawal, until the maximum cumulative dose of anthracycline was reached, or end of study (24 months after randomization of the last participant). Upon second-line disease progression participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator's site plus bevacizumab, 15 mg/kg, IV, every 3 weeks, or 10 mg/kg, IV, every 2 weeks until disease progression, unacceptable toxicity, participant request for withdrawal, or end of study. Upon subsequent disease progression participants received treatment according the standard of care of the treatment site until end of study.
|
|---|---|---|
|
Percentage of Participants With a Second-Line CR, PR, Stable Disease, and PD According to RECIST v1.1 (Data Cutoff 20 December 2013)
CR
|
1.1 percentage of participants
Interval 0.1 to 3.9
|
0.5 percentage of participants
Interval 0.0 to 3.0
|
|
Percentage of Participants With a Second-Line CR, PR, Stable Disease, and PD According to RECIST v1.1 (Data Cutoff 20 December 2013)
PR
|
15.7 percentage of participants
Interval 10.8 to 21.7
|
20.3 percentage of participants
Interval 14.7 to 26.9
|
|
Percentage of Participants With a Second-Line CR, PR, Stable Disease, and PD According to RECIST v1.1 (Data Cutoff 20 December 2013)
Stable disease
|
33.5 percentage of participants
Interval 26.8 to 40.8
|
48.9 percentage of participants
Interval 41.4 to 56.4
|
|
Percentage of Participants With a Second-Line CR, PR, Stable Disease, and PD According to RECIST v1.1 (Data Cutoff 20 December 2013)
PD
|
41.1 percentage of participants
Interval 33.9 to 48.5
|
24.2 percentage of participants
Interval 18.1 to 31.1
|
|
Percentage of Participants With a Second-Line CR, PR, Stable Disease, and PD According to RECIST v1.1 (Data Cutoff 20 December 2013)
Unable to assess
|
8.6 percentage of participants
Interval 5.0 to 13.7
|
6.0 percentage of participants
Interval 3.1 to 10.6
|
SECONDARY outcome
Timeframe: Baseline (≤28 days after randomization), every 8-9 weeks thereafter according to the standard of care of the treatment site until approximately 3 yearsPopulation: ITT population; only randomized participants with a CR or PR were included in the analysis.
The median time, in months, from the date of the first second-line documentation of CR or PR according to RECIST v1.1 to the date of the first second-line documentation of PD or death due to any cause. For TLs, CR was defined as the disappearance of all TLs; PR was defined as at least a 30% decrease in the SLD of the TLs, taking as a reference the baseline SLD; and PD was defined as at least a 20% increase in the SLD of TLs, taking as reference the smallest SLD recorded since the treatment started. For NTLs, CR was defined as the disappearance of all NTLs and normalization of tumor marker levels, and PD was defined as the appearance of 1 or more new lesions and/or unequivocal progression of existing NTLs. Participants with CR or PR who had experienced neither disease progression nor died were censored at the date of the last available tumor assessment when the participant was known to be progression free.
Outcome measures
| Measure |
CT Arm
n=31 Participants
Participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator's site until disease progression, unacceptable toxicity, participant request for withdrawal, until the maximum cumulative dose of anthracycline was reached, or end of study (24 months after randomization of the last participant). Upon second-line disease progression participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator's site until disease progression, unacceptable toxicity, participant request for withdrawal, or end of study. Upon subsequent disease progression participants received treatment according the standard of care of the treatment site until end of study.
|
CT+BV Arm
n=38 Participants
Participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator's site plus bevacizumab, 15 mg/kg, IV, every 3 weeks, or 10 mg/kg, IV, every 2 weeks until disease progression, unacceptable toxicity, participant request for withdrawal, until the maximum cumulative dose of anthracycline was reached, or end of study (24 months after randomization of the last participant). Upon second-line disease progression participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator's site plus bevacizumab, 15 mg/kg, IV, every 3 weeks, or 10 mg/kg, IV, every 2 weeks until disease progression, unacceptable toxicity, participant request for withdrawal, or end of study. Upon subsequent disease progression participants received treatment according the standard of care of the treatment site until end of study.
|
|---|---|---|
|
Duration of Second-Line Objective Response (Data Cutoff 20 December 2013)
|
10.6 months
Interval 4.4 to 16.7
|
8.3 months
Interval 6.1 to 10.3
|
SECONDARY outcome
Timeframe: Months 3, 6, and 9Population: ITT population; only randomized participants with a CR or PR were included in the analysis.
Duration of objective response was defined as the median time, in months, from the date of the first second-line documentation of CR or PR to the date of the first second-line documentation of PD or death due to any cause. For TLs, CR was defined as the disappearance of all TLs; PR was defined as at least a 30% decrease in the SLD of the TLs, taking as a reference the baseline SLD; and PD was defined as at least a 20% increase in the SLD of TLs, taking as reference the smallest SLD recorded since the treatment started. For NTLs, CR was defined as the disappearance of all NTLs and normalization of tumor marker levels, and PD was defined as the appearance of 1 or more new lesions and/or unequivocal progression of existing NTLs. Participants with CR or PR who had experienced neither disease progression nor died were censored at the date of the last available tumor assessment when the participant was known to be progression free.
Outcome measures
| Measure |
CT Arm
n=31 Participants
Participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator's site until disease progression, unacceptable toxicity, participant request for withdrawal, until the maximum cumulative dose of anthracycline was reached, or end of study (24 months after randomization of the last participant). Upon second-line disease progression participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator's site until disease progression, unacceptable toxicity, participant request for withdrawal, or end of study. Upon subsequent disease progression participants received treatment according the standard of care of the treatment site until end of study.
|
CT+BV Arm
n=38 Participants
Participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator's site plus bevacizumab, 15 mg/kg, IV, every 3 weeks, or 10 mg/kg, IV, every 2 weeks until disease progression, unacceptable toxicity, participant request for withdrawal, until the maximum cumulative dose of anthracycline was reached, or end of study (24 months after randomization of the last participant). Upon second-line disease progression participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator's site plus bevacizumab, 15 mg/kg, IV, every 3 weeks, or 10 mg/kg, IV, every 2 weeks until disease progression, unacceptable toxicity, participant request for withdrawal, or end of study. Upon subsequent disease progression participants received treatment according the standard of care of the treatment site until end of study.
|
|---|---|---|
|
Percentage of Participants With a Second-Line Documented CR or PR According to RECIST v1.1 Estimated to be Alive and Free of Disease Progression at Months 3, 6, and 9 (Data Cutoff 20 December 2013)
Month 3
|
96.7 percentage of participants
Interval 78.6 to 99.5
|
100.0 percentage of participants
95% CI data was not applicable (NA) because all participants were estimated to be alive and free of disease progression at this time point.
|
|
Percentage of Participants With a Second-Line Documented CR or PR According to RECIST v1.1 Estimated to be Alive and Free of Disease Progression at Months 3, 6, and 9 (Data Cutoff 20 December 2013)
Month 6
|
69.0 percentage of participants
Interval 48.9 to 82.5
|
72.8 percentage of participants
Interval 55.3 to 84.4
|
|
Percentage of Participants With a Second-Line Documented CR or PR According to RECIST v1.1 Estimated to be Alive and Free of Disease Progression at Months 3, 6, and 9 (Data Cutoff 20 December 2013)
Month 9
|
60.9 percentage of participants
Interval 40.4 to 76.3
|
40.8 percentage of participants
Interval 24.6 to 56.3
|
SECONDARY outcome
Timeframe: First dose of third-line treatment until PD or death due to any cause (assessed every 8-9 weeks, over a period of approximately 14 months)Population: Third line ITT population: all randomized participants who received third-line treatment.
Third-line PFS was defined as the time from the date of first dose of third-line bevacizumab and/or chemotherapy to the date of third-line PD or death due to any cause. For TLs, PD was defined at least a 20% increase in the SLD, taking as reference the smallest SLD recorded from baseline or the appearance of one or more new lesions. For NTLs, PD was defined as the appearance of 1 or more new lesions and/or unequivocal progression of existing NTLs. Participants without second-line PD or death were censored at the date of last tumor assessment where non-progression was documented. Participants without third-line PD or death were censored at the date of last tumor assessment where non-progression was documented.
Outcome measures
| Measure |
CT Arm
n=105 Participants
Participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator's site until disease progression, unacceptable toxicity, participant request for withdrawal, until the maximum cumulative dose of anthracycline was reached, or end of study (24 months after randomization of the last participant). Upon second-line disease progression participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator's site until disease progression, unacceptable toxicity, participant request for withdrawal, or end of study. Upon subsequent disease progression participants received treatment according the standard of care of the treatment site until end of study.
|
CT+BV Arm
n=129 Participants
Participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator's site plus bevacizumab, 15 mg/kg, IV, every 3 weeks, or 10 mg/kg, IV, every 2 weeks until disease progression, unacceptable toxicity, participant request for withdrawal, until the maximum cumulative dose of anthracycline was reached, or end of study (24 months after randomization of the last participant). Upon second-line disease progression participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator's site plus bevacizumab, 15 mg/kg, IV, every 3 weeks, or 10 mg/kg, IV, every 2 weeks until disease progression, unacceptable toxicity, participant request for withdrawal, or end of study. Upon subsequent disease progression participants received treatment according the standard of care of the treatment site until end of study.
|
|---|---|---|
|
Percentage of Participants With Third-Line PFS According to RECIST v1.1
|
94.3 percentage of participants
|
96.1 percentage of participants
|
SECONDARY outcome
Timeframe: First dose of third-line treatment until PD or death due to any cause (over a period of approximately 14 months)Population: Third line ITT population
The median time, in months, from the first dose of third-line bevacizumab and/or chemotherapy to third-line PD or death due to any cause. For TLs, PD was defined at least a 20% increase in the SLD, taking as reference the smallest SLD recorded from baseline or the appearance of one or more new lesions. For NTLs, PD was defined as the appearance of 1 or more new lesions and/or unequivocal progression of existing NTLs. Participants without third-line PD or death were censored at the date of last tumor assessment where non-progression was documented.
Outcome measures
| Measure |
CT Arm
n=105 Participants
Participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator's site until disease progression, unacceptable toxicity, participant request for withdrawal, until the maximum cumulative dose of anthracycline was reached, or end of study (24 months after randomization of the last participant). Upon second-line disease progression participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator's site until disease progression, unacceptable toxicity, participant request for withdrawal, or end of study. Upon subsequent disease progression participants received treatment according the standard of care of the treatment site until end of study.
|
CT+BV Arm
n=129 Participants
Participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator's site plus bevacizumab, 15 mg/kg, IV, every 3 weeks, or 10 mg/kg, IV, every 2 weeks until disease progression, unacceptable toxicity, participant request for withdrawal, until the maximum cumulative dose of anthracycline was reached, or end of study (24 months after randomization of the last participant). Upon second-line disease progression participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator's site plus bevacizumab, 15 mg/kg, IV, every 3 weeks, or 10 mg/kg, IV, every 2 weeks until disease progression, unacceptable toxicity, participant request for withdrawal, or end of study. Upon subsequent disease progression participants received treatment according the standard of care of the treatment site until end of study.
|
|---|---|---|
|
Third-Line PFS
|
2.9 months
Interval 2.2 to 3.9
|
3.8 months
Interval 2.4 to 5.1
|
SECONDARY outcome
Timeframe: Baseline (≤28 days after randomization), every 8-9 weeks thereafter according to the standard of care of the treatment site until approximately 4 yearsPopulation: ITT population
Second- and third-line PFS was defined as the time from the date randomization to the date of third-line PD or death due to any cause. For TLs, PD was defined at least a 20% increase in the SLD, taking as reference the smallest SLD recorded from baseline or the appearance of one or more new lesions. For NTLs, PD was defined as the appearance of 1 or more new lesions and/or unequivocal progression of existing NTLs. Participants without third-line PD or death were censored at the date of last tumor assessment where non-progression was documented.
Outcome measures
| Measure |
CT Arm
n=247 Participants
Participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator's site until disease progression, unacceptable toxicity, participant request for withdrawal, until the maximum cumulative dose of anthracycline was reached, or end of study (24 months after randomization of the last participant). Upon second-line disease progression participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator's site until disease progression, unacceptable toxicity, participant request for withdrawal, or end of study. Upon subsequent disease progression participants received treatment according the standard of care of the treatment site until end of study.
|
CT+BV Arm
n=247 Participants
Participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator's site plus bevacizumab, 15 mg/kg, IV, every 3 weeks, or 10 mg/kg, IV, every 2 weeks until disease progression, unacceptable toxicity, participant request for withdrawal, until the maximum cumulative dose of anthracycline was reached, or end of study (24 months after randomization of the last participant). Upon second-line disease progression participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator's site plus bevacizumab, 15 mg/kg, IV, every 3 weeks, or 10 mg/kg, IV, every 2 weeks until disease progression, unacceptable toxicity, participant request for withdrawal, or end of study. Upon subsequent disease progression participants received treatment according the standard of care of the treatment site until end of study.
|
|---|---|---|
|
Percentage of Participants With Second- and Third-Line PFS According to RECIST v1.1
|
71.7 percentage of participants
|
83.4 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline (≤28 days after randomization), every 8-9 weeks thereafter according to the standard of care of the treatment site until approximately 4 yearsPopulation: ITT population
The median time, in months, from randomization to second-line and third-line PFS event. For TLs, PD was defined at least a 20% increase in the SLD, taking as reference the smallest SLD recorded from baseline or the appearance of one or more new lesions. For NTLs, PD was defined as the appearance of 1 or more new lesions and/or unequivocal progression of existing NTLs. Participants without third-line PD or death were censored at the date of last tumor assessment where non-progression was documented.
Outcome measures
| Measure |
CT Arm
n=247 Participants
Participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator's site until disease progression, unacceptable toxicity, participant request for withdrawal, until the maximum cumulative dose of anthracycline was reached, or end of study (24 months after randomization of the last participant). Upon second-line disease progression participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator's site until disease progression, unacceptable toxicity, participant request for withdrawal, or end of study. Upon subsequent disease progression participants received treatment according the standard of care of the treatment site until end of study.
|
CT+BV Arm
n=247 Participants
Participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator's site plus bevacizumab, 15 mg/kg, IV, every 3 weeks, or 10 mg/kg, IV, every 2 weeks until disease progression, unacceptable toxicity, participant request for withdrawal, until the maximum cumulative dose of anthracycline was reached, or end of study (24 months after randomization of the last participant). Upon second-line disease progression participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator's site plus bevacizumab, 15 mg/kg, IV, every 3 weeks, or 10 mg/kg, IV, every 2 weeks until disease progression, unacceptable toxicity, participant request for withdrawal, or end of study. Upon subsequent disease progression participants received treatment according the standard of care of the treatment site until end of study.
|
|---|---|---|
|
Second- and Third-Line PFS
|
10.7 months
Interval 9.2 to 12.5
|
12.8 months
Interval 10.7 to 14.5
|
SECONDARY outcome
Timeframe: Baseline (≤28 days after randomization), every 8-9 weeks thereafter according to the standard of care of the treatment site until approximately 4 yearsPopulation: ITT population
Second- and third-line tumor progression was defined as occurrence of third-line PD according to RECIST v1.1 or death due to progression of disease. For TLs, PD was defined at least a 20% increase in the SLD, taking as reference the smallest SLD recorded from baseline or the appearance of one or more new lesions. For NTLs, PD was defined as the appearance of 1 or more new lesions and/or unequivocal progression of existing NTLs. Participants without third-line PD or death due to progression of disease were censored at the date of last tumor assessment where non-progression was documented.
Outcome measures
| Measure |
CT Arm
n=247 Participants
Participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator's site until disease progression, unacceptable toxicity, participant request for withdrawal, until the maximum cumulative dose of anthracycline was reached, or end of study (24 months after randomization of the last participant). Upon second-line disease progression participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator's site until disease progression, unacceptable toxicity, participant request for withdrawal, or end of study. Upon subsequent disease progression participants received treatment according the standard of care of the treatment site until end of study.
|
CT+BV Arm
n=247 Participants
Participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator's site plus bevacizumab, 15 mg/kg, IV, every 3 weeks, or 10 mg/kg, IV, every 2 weeks until disease progression, unacceptable toxicity, participant request for withdrawal, until the maximum cumulative dose of anthracycline was reached, or end of study (24 months after randomization of the last participant). Upon second-line disease progression participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator's site plus bevacizumab, 15 mg/kg, IV, every 3 weeks, or 10 mg/kg, IV, every 2 weeks until disease progression, unacceptable toxicity, participant request for withdrawal, or end of study. Upon subsequent disease progression participants received treatment according the standard of care of the treatment site until end of study.
|
|---|---|---|
|
Percentage of Participants With Second- and Third-Line Tumor Progression
|
67.2 percentage of participants
|
75.3 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline (≤28 days after randomization), every 8-9 weeks thereafter according to the standard of care of the treatment site until approximately 4 yearsPopulation: ITT population
The median time, in months, from randomization to second- and third-line tumor progression. Second- and third-line tumor progression was defined as third-line PD according to RECIST v1.1 or death due to progression of disease. For TLs, PD was defined at least a 20% increase in the SLD, taking as reference the smallest SLD recorded from baseline or the appearance of one or more new lesions. For NTLs, PD was defined as the appearance of 1 or more new lesions and/or unequivocal progression of existing NTLs. Participants without third-line PD or death were censored at the date of last tumor assessment where non-progression was documented.
Outcome measures
| Measure |
CT Arm
n=247 Participants
Participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator's site until disease progression, unacceptable toxicity, participant request for withdrawal, until the maximum cumulative dose of anthracycline was reached, or end of study (24 months after randomization of the last participant). Upon second-line disease progression participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator's site until disease progression, unacceptable toxicity, participant request for withdrawal, or end of study. Upon subsequent disease progression participants received treatment according the standard of care of the treatment site until end of study.
|
CT+BV Arm
n=247 Participants
Participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator's site plus bevacizumab, 15 mg/kg, IV, every 3 weeks, or 10 mg/kg, IV, every 2 weeks until disease progression, unacceptable toxicity, participant request for withdrawal, until the maximum cumulative dose of anthracycline was reached, or end of study (24 months after randomization of the last participant). Upon second-line disease progression participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator's site plus bevacizumab, 15 mg/kg, IV, every 3 weeks, or 10 mg/kg, IV, every 2 weeks until disease progression, unacceptable toxicity, participant request for withdrawal, or end of study. Upon subsequent disease progression participants received treatment according the standard of care of the treatment site until end of study.
|
|---|---|---|
|
Time to Second- and Third-Line Tumor Progression
|
11.2 months
Interval 9.4 to 12.7
|
13.3 months
Interval 12.0 to 15.5
|
SECONDARY outcome
Timeframe: Baseline until death (up to approximately 4 years)Population: ITT population
Percentage of participants who died due to any reason were reported.
Outcome measures
| Measure |
CT Arm
n=247 Participants
Participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator's site until disease progression, unacceptable toxicity, participant request for withdrawal, until the maximum cumulative dose of anthracycline was reached, or end of study (24 months after randomization of the last participant). Upon second-line disease progression participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator's site until disease progression, unacceptable toxicity, participant request for withdrawal, or end of study. Upon subsequent disease progression participants received treatment according the standard of care of the treatment site until end of study.
|
CT+BV Arm
n=247 Participants
Participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator's site plus bevacizumab, 15 mg/kg, IV, every 3 weeks, or 10 mg/kg, IV, every 2 weeks until disease progression, unacceptable toxicity, participant request for withdrawal, until the maximum cumulative dose of anthracycline was reached, or end of study (24 months after randomization of the last participant). Upon second-line disease progression participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator's site plus bevacizumab, 15 mg/kg, IV, every 3 weeks, or 10 mg/kg, IV, every 2 weeks until disease progression, unacceptable toxicity, participant request for withdrawal, or end of study. Upon subsequent disease progression participants received treatment according the standard of care of the treatment site until end of study.
|
|---|---|---|
|
Percentage of Participants Who Died
|
63.2 percentage of participants
|
66.0 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline until death (up to approximately 4 years)Population: ITT population
OS was defined as the median time, in months, from the date of randomization to the date of death, due to any cause. Participants who had not died were censored at the date the patient was last known to be alive.
Outcome measures
| Measure |
CT Arm
n=247 Participants
Participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator's site until disease progression, unacceptable toxicity, participant request for withdrawal, until the maximum cumulative dose of anthracycline was reached, or end of study (24 months after randomization of the last participant). Upon second-line disease progression participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator's site until disease progression, unacceptable toxicity, participant request for withdrawal, or end of study. Upon subsequent disease progression participants received treatment according the standard of care of the treatment site until end of study.
|
CT+BV Arm
n=247 Participants
Participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator's site plus bevacizumab, 15 mg/kg, IV, every 3 weeks, or 10 mg/kg, IV, every 2 weeks until disease progression, unacceptable toxicity, participant request for withdrawal, until the maximum cumulative dose of anthracycline was reached, or end of study (24 months after randomization of the last participant). Upon second-line disease progression participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator's site plus bevacizumab, 15 mg/kg, IV, every 3 weeks, or 10 mg/kg, IV, every 2 weeks until disease progression, unacceptable toxicity, participant request for withdrawal, or end of study. Upon subsequent disease progression participants received treatment according the standard of care of the treatment site until end of study.
|
|---|---|---|
|
Overall Survival (OS)
|
18.7 months
Interval 15.4 to 21.2
|
19.7 months
Interval 17.6 to 21.0
|
SECONDARY outcome
Timeframe: Months 6, 12, 18, and 24Population: ITT population
OS was defined as the median time, in months, from the date of randomization to the date of death, due to any cause.
Outcome measures
| Measure |
CT Arm
n=247 Participants
Participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator's site until disease progression, unacceptable toxicity, participant request for withdrawal, until the maximum cumulative dose of anthracycline was reached, or end of study (24 months after randomization of the last participant). Upon second-line disease progression participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator's site until disease progression, unacceptable toxicity, participant request for withdrawal, or end of study. Upon subsequent disease progression participants received treatment according the standard of care of the treatment site until end of study.
|
CT+BV Arm
n=247 Participants
Participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator's site plus bevacizumab, 15 mg/kg, IV, every 3 weeks, or 10 mg/kg, IV, every 2 weeks until disease progression, unacceptable toxicity, participant request for withdrawal, until the maximum cumulative dose of anthracycline was reached, or end of study (24 months after randomization of the last participant). Upon second-line disease progression participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator's site plus bevacizumab, 15 mg/kg, IV, every 3 weeks, or 10 mg/kg, IV, every 2 weeks until disease progression, unacceptable toxicity, participant request for withdrawal, or end of study. Upon subsequent disease progression participants received treatment according the standard of care of the treatment site until end of study.
|
|---|---|---|
|
Percentage of Participants Estimated to be Surviving at Months 6, 12, 18, and 24
Month 6
|
85.2 percentage of participants
Interval 79.9 to 89.2
|
90.4 percentage of participants
Interval 85.9 to 93.5
|
|
Percentage of Participants Estimated to be Surviving at Months 6, 12, 18, and 24
Month 12
|
68.6 percentage of participants
Interval 62.0 to 74.3
|
72.4 percentage of participants
Interval 66.2 to 77.7
|
|
Percentage of Participants Estimated to be Surviving at Months 6, 12, 18, and 24
Month 18
|
52.8 percentage of participants
Interval 46.0 to 59.3
|
54.9 percentage of participants
Interval 48.2 to 61.0
|
|
Percentage of Participants Estimated to be Surviving at Months 6, 12, 18, and 24
Month 24
|
38.4 percentage of participants
Interval 31.8 to 44.9
|
37.6 percentage of participants
Interval 31.3 to 43.9
|
SECONDARY outcome
Timeframe: Baseline, during second-line treatment at Weeks 8 and 16 (4-week cycles) or Weeks 9 and 18 (3-week cycles) and at second-line PD (up to approximately 3 years)Population: ITT population. Here, Number of participants analyzed = participants evaluable for this outcome measure and n=number of participants completing the questionnaires at the corresponding timepoint.
The EQ-5D is composed of 5 single-item measures where participants responded to questions assessing health status by responding with either "no problems", "some problems", or "extreme problems" in the following categories: mobility (M) ("no problems"="I have no problems in walking about" to "extreme problems"="I am confined to bed"), self-care (SC) ("no problems"="I have no problems with self-care" to "extreme problems"="I am unable to wash or dress myself"), usual activities (UA) ("no problems"="I have no problems performing my usual activities" to "extreme problems"="I am unable to perform my usual activities"), pain/discomfort (P/D) ("no problems"="I have no pain or discomfort" to "extreme problems"="I have extreme pain or discomfort"), and anxiety/depression (A/D) ("no problems"="I am not anxious or depressed" to "extreme problems"='I am extremely anxious or depressed").
Outcome measures
| Measure |
CT Arm
n=214 Participants
Participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator's site until disease progression, unacceptable toxicity, participant request for withdrawal, until the maximum cumulative dose of anthracycline was reached, or end of study (24 months after randomization of the last participant). Upon second-line disease progression participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator's site until disease progression, unacceptable toxicity, participant request for withdrawal, or end of study. Upon subsequent disease progression participants received treatment according the standard of care of the treatment site until end of study.
|
CT+BV Arm
n=224 Participants
Participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator's site plus bevacizumab, 15 mg/kg, IV, every 3 weeks, or 10 mg/kg, IV, every 2 weeks until disease progression, unacceptable toxicity, participant request for withdrawal, until the maximum cumulative dose of anthracycline was reached, or end of study (24 months after randomization of the last participant). Upon second-line disease progression participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator's site plus bevacizumab, 15 mg/kg, IV, every 3 weeks, or 10 mg/kg, IV, every 2 weeks until disease progression, unacceptable toxicity, participant request for withdrawal, or end of study. Upon subsequent disease progression participants received treatment according the standard of care of the treatment site until end of study.
|
|---|---|---|
|
Percentage of Participants Experiencing Problems by European Quality of Life Instrument (EQ-5D) Category (Data Cutoff 20 December 2013)
Week 16/18: SC, some problems (n=84,123)
|
14.3 percentage of participants
|
17.1 percentage of participants
|
|
Percentage of Participants Experiencing Problems by European Quality of Life Instrument (EQ-5D) Category (Data Cutoff 20 December 2013)
BL: M, no problems (n=214,224)
|
60.3 percentage of participants
|
64.3 percentage of participants
|
|
Percentage of Participants Experiencing Problems by European Quality of Life Instrument (EQ-5D) Category (Data Cutoff 20 December 2013)
BL: M, some problems (n=214,224)
|
36.4 percentage of participants
|
34.8 percentage of participants
|
|
Percentage of Participants Experiencing Problems by European Quality of Life Instrument (EQ-5D) Category (Data Cutoff 20 December 2013)
BL: M, extreme problems (n=214,224)
|
0.5 percentage of participants
|
0.4 percentage of participants
|
|
Percentage of Participants Experiencing Problems by European Quality of Life Instrument (EQ-5D) Category (Data Cutoff 20 December 2013)
BL: SC, no problems (n=214,224)
|
82.7 percentage of participants
|
85.7 percentage of participants
|
|
Percentage of Participants Experiencing Problems by European Quality of Life Instrument (EQ-5D) Category (Data Cutoff 20 December 2013)
BL: SC, some problems (n=214,224)
|
12.6 percentage of participants
|
11.2 percentage of participants
|
|
Percentage of Participants Experiencing Problems by European Quality of Life Instrument (EQ-5D) Category (Data Cutoff 20 December 2013)
BL: SC, extreme problems (n=214,224)
|
0.5 percentage of participants
|
1.8 percentage of participants
|
|
Percentage of Participants Experiencing Problems by European Quality of Life Instrument (EQ-5D) Category (Data Cutoff 20 December 2013)
BL: UA, no problems (n=214,224)
|
53.7 percentage of participants
|
46.4 percentage of participants
|
|
Percentage of Participants Experiencing Problems by European Quality of Life Instrument (EQ-5D) Category (Data Cutoff 20 December 2013)
BL: UA, some problems (n=214,224)
|
40.2 percentage of participants
|
48.7 percentage of participants
|
|
Percentage of Participants Experiencing Problems by European Quality of Life Instrument (EQ-5D) Category (Data Cutoff 20 December 2013)
BL: UA, extreme problems (n=214,224)
|
2.8 percentage of participants
|
4.0 percentage of participants
|
|
Percentage of Participants Experiencing Problems by European Quality of Life Instrument (EQ-5D) Category (Data Cutoff 20 December 2013)
BL: P/D, no problems (n=214,224)
|
24.3 percentage of participants
|
27.7 percentage of participants
|
|
Percentage of Participants Experiencing Problems by European Quality of Life Instrument (EQ-5D) Category (Data Cutoff 20 December 2013)
BL: P/D, some problems (n=214,224)
|
68.7 percentage of participants
|
66.1 percentage of participants
|
|
Percentage of Participants Experiencing Problems by European Quality of Life Instrument (EQ-5D) Category (Data Cutoff 20 December 2013)
BL: P/D, extreme problems (n=214,224)
|
4.2 percentage of participants
|
5.4 percentage of participants
|
|
Percentage of Participants Experiencing Problems by European Quality of Life Instrument (EQ-5D) Category (Data Cutoff 20 December 2013)
BL: A/D, no problems (n=214,224)
|
33.6 percentage of participants
|
34.8 percentage of participants
|
|
Percentage of Participants Experiencing Problems by European Quality of Life Instrument (EQ-5D) Category (Data Cutoff 20 December 2013)
BL: A/D, some problems (n=214,224)
|
56.5 percentage of participants
|
58.5 percentage of participants
|
|
Percentage of Participants Experiencing Problems by European Quality of Life Instrument (EQ-5D) Category (Data Cutoff 20 December 2013)
BL: A/D, extreme problems (n=214,224)
|
5.6 percentage of participants
|
5.8 percentage of participants
|
|
Percentage of Participants Experiencing Problems by European Quality of Life Instrument (EQ-5D) Category (Data Cutoff 20 December 2013)
Week 8/9: M, no problems (n=133,141)
|
61.7 percentage of participants
|
51.8 percentage of participants
|
|
Percentage of Participants Experiencing Problems by European Quality of Life Instrument (EQ-5D) Category (Data Cutoff 20 December 2013)
Week 8/9: M, some problems (n=133,141)
|
34.6 percentage of participants
|
43.3 percentage of participants
|
|
Percentage of Participants Experiencing Problems by European Quality of Life Instrument (EQ-5D) Category (Data Cutoff 20 December 2013)
Week 8/9: M, extreme problems (n=133,141)
|
1.5 percentage of participants
|
2.1 percentage of participants
|
|
Percentage of Participants Experiencing Problems by European Quality of Life Instrument (EQ-5D) Category (Data Cutoff 20 December 2013)
Week 8/9: SC, no problems (n=133,141)
|
82.0 percentage of participants
|
75.9 percentage of participants
|
|
Percentage of Participants Experiencing Problems by European Quality of Life Instrument (EQ-5D) Category (Data Cutoff 20 December 2013)
Week 8/9: SC, some problems (n=133,141)
|
13.5 percentage of participants
|
17.0 percentage of participants
|
|
Percentage of Participants Experiencing Problems by European Quality of Life Instrument (EQ-5D) Category (Data Cutoff 20 December 2013)
Week 8/9: SC, extreme problems (n=133,141)
|
1.5 percentage of participants
|
3.5 percentage of participants
|
|
Percentage of Participants Experiencing Problems by European Quality of Life Instrument (EQ-5D) Category (Data Cutoff 20 December 2013)
Week 8/9: UA, no problems (n=133,141)
|
53.4 percentage of participants
|
40.4 percentage of participants
|
|
Percentage of Participants Experiencing Problems by European Quality of Life Instrument (EQ-5D) Category (Data Cutoff 20 December 2013)
Week 8/9: UA, some problems (n=133,141)
|
40.6 percentage of participants
|
51.8 percentage of participants
|
|
Percentage of Participants Experiencing Problems by European Quality of Life Instrument (EQ-5D) Category (Data Cutoff 20 December 2013)
Week 8/9: UA, extreme problems (n=133,141)
|
3.0 percentage of participants
|
5.0 percentage of participants
|
|
Percentage of Participants Experiencing Problems by European Quality of Life Instrument (EQ-5D) Category (Data Cutoff 20 December 2013)
Week 8/9: P/D, no problems (n=133,141)
|
29.3 percentage of participants
|
23.4 percentage of participants
|
|
Percentage of Participants Experiencing Problems by European Quality of Life Instrument (EQ-5D) Category (Data Cutoff 20 December 2013)
Week 8/9: P/D, some problems (n=133,141)
|
61.7 percentage of participants
|
68.1 percentage of participants
|
|
Percentage of Participants Experiencing Problems by European Quality of Life Instrument (EQ-5D) Category (Data Cutoff 20 December 2013)
Week 8/9: P/D, extreme problems (n=133,141)
|
5.3 percentage of participants
|
6.4 percentage of participants
|
|
Percentage of Participants Experiencing Problems by European Quality of Life Instrument (EQ-5D) Category (Data Cutoff 20 December 2013)
Week 8/9: A/D, no problems (n=133,141)
|
49.6 percentage of participants
|
46.8 percentage of participants
|
|
Percentage of Participants Experiencing Problems by European Quality of Life Instrument (EQ-5D) Category (Data Cutoff 20 December 2013)
Week 8/9: A/D, some problems (n=133,141)
|
40.6 percentage of participants
|
48.2 percentage of participants
|
|
Percentage of Participants Experiencing Problems by European Quality of Life Instrument (EQ-5D) Category (Data Cutoff 20 December 2013)
Week 8/9: A/D, extreme problems (n=133,141)
|
6.8 percentage of participants
|
2.8 percentage of participants
|
|
Percentage of Participants Experiencing Problems by European Quality of Life Instrument (EQ-5D) Category (Data Cutoff 20 December 2013)
Week 16/18: M, no problems (n=84,123)
|
66.7 percentage of participants
|
49.6 percentage of participants
|
|
Percentage of Participants Experiencing Problems by European Quality of Life Instrument (EQ-5D) Category (Data Cutoff 20 December 2013)
Week 16/18: M, some problems (n=84,123)
|
29.8 percentage of participants
|
47.2 percentage of participants
|
|
Percentage of Participants Experiencing Problems by European Quality of Life Instrument (EQ-5D) Category (Data Cutoff 20 December 2013)
Week 16/18: M, extreme problems (n=84,123)
|
0.0 percentage of participants
|
2.4 percentage of participants
|
|
Percentage of Participants Experiencing Problems by European Quality of Life Instrument (EQ-5D) Category (Data Cutoff 20 December 2013)
Week 16/18: SC, no problems (n=84,123)
|
81.0 percentage of participants
|
78.9 percentage of participants
|
|
Percentage of Participants Experiencing Problems by European Quality of Life Instrument (EQ-5D) Category (Data Cutoff 20 December 2013)
Week 16/18: SC, extreme problems (n=84,123)
|
0.0 percentage of participants
|
3.3 percentage of participants
|
|
Percentage of Participants Experiencing Problems by European Quality of Life Instrument (EQ-5D) Category (Data Cutoff 20 December 2013)
Week 16/18: UA, no problems (n=84,123)
|
50.0 percentage of participants
|
36.6 percentage of participants
|
|
Percentage of Participants Experiencing Problems by European Quality of Life Instrument (EQ-5D) Category (Data Cutoff 20 December 2013)
Week 16/18: UA, some problems (n=84,123)
|
42.9 percentage of participants
|
56.1 percentage of participants
|
|
Percentage of Participants Experiencing Problems by European Quality of Life Instrument (EQ-5D) Category (Data Cutoff 20 December 2013)
Week 16/18: UA, extreme problems (n=84,123)
|
3.6 percentage of participants
|
4.1 percentage of participants
|
|
Percentage of Participants Experiencing Problems by European Quality of Life Instrument (EQ-5D) Category (Data Cutoff 20 December 2013)
Week 16/18: P/D, no problems (n=84,123)
|
34.5 percentage of participants
|
19.5 percentage of participants
|
|
Percentage of Participants Experiencing Problems by European Quality of Life Instrument (EQ-5D) Category (Data Cutoff 20 December 2013)
Week 16/18: P/D, some problems (n=84,123)
|
59.5 percentage of participants
|
76.4 percentage of participants
|
|
Percentage of Participants Experiencing Problems by European Quality of Life Instrument (EQ-5D) Category (Data Cutoff 20 December 2013)
Week 16/18: P/D, extreme problems (n=84,123)
|
1.2 percentage of participants
|
3.3 percentage of participants
|
|
Percentage of Participants Experiencing Problems by European Quality of Life Instrument (EQ-5D) Category (Data Cutoff 20 December 2013)
Week 16/18: A/D, no problems (n=84,123)
|
51.2 percentage of participants
|
49.6 percentage of participants
|
|
Percentage of Participants Experiencing Problems by European Quality of Life Instrument (EQ-5D) Category (Data Cutoff 20 December 2013)
Week 16/18: A/D, some problems (n=84,123)
|
44.0 percentage of participants
|
43.1 percentage of participants
|
|
Percentage of Participants Experiencing Problems by European Quality of Life Instrument (EQ-5D) Category (Data Cutoff 20 December 2013)
Week 16/18: A/D, extreme problems (n=84,123)
|
0.0 percentage of participants
|
5.7 percentage of participants
|
|
Percentage of Participants Experiencing Problems by European Quality of Life Instrument (EQ-5D) Category (Data Cutoff 20 December 2013)
Second-line PD: M, no problems (n=82,76)
|
59.8 percentage of participants
|
47.4 percentage of participants
|
|
Percentage of Participants Experiencing Problems by European Quality of Life Instrument (EQ-5D) Category (Data Cutoff 20 December 2013)
Second-line PD: M, some problems (n=82,76)
|
34.1 percentage of participants
|
48.7 percentage of participants
|
|
Percentage of Participants Experiencing Problems by European Quality of Life Instrument (EQ-5D) Category (Data Cutoff 20 December 2013)
Second-line PD: M, extreme problems (n=82,76)
|
2.4 percentage of participants
|
3.9 percentage of participants
|
|
Percentage of Participants Experiencing Problems by European Quality of Life Instrument (EQ-5D) Category (Data Cutoff 20 December 2013)
Second-line PD: SC, no problems (n=82,76)
|
76.8 percentage of participants
|
75.0 percentage of participants
|
|
Percentage of Participants Experiencing Problems by European Quality of Life Instrument (EQ-5D) Category (Data Cutoff 20 December 2013)
Second-line PD: SC, some problems (n=82,76)
|
15.9 percentage of participants
|
18.4 percentage of participants
|
|
Percentage of Participants Experiencing Problems by European Quality of Life Instrument (EQ-5D) Category (Data Cutoff 20 December 2013)
Second-line PD: SC, extreme problems (n=82,76)
|
1.2 percentage of participants
|
6.6 percentage of participants
|
|
Percentage of Participants Experiencing Problems by European Quality of Life Instrument (EQ-5D) Category (Data Cutoff 20 December 2013)
Second-line PD: UA, no problems (n=82,76)
|
39.0 percentage of participants
|
30.3 percentage of participants
|
|
Percentage of Participants Experiencing Problems by European Quality of Life Instrument (EQ-5D) Category (Data Cutoff 20 December 2013)
Second-line PD: UA, some problems (n=82,76)
|
50.0 percentage of participants
|
59.2 percentage of participants
|
|
Percentage of Participants Experiencing Problems by European Quality of Life Instrument (EQ-5D) Category (Data Cutoff 20 December 2013)
Second-line PD: UA, extreme problems (n=82,76)
|
6.1 percentage of participants
|
10.5 percentage of participants
|
|
Percentage of Participants Experiencing Problems by European Quality of Life Instrument (EQ-5D) Category (Data Cutoff 20 December 2013)
Second-line PD: P/D, no problems (n=82,76)
|
19.5 percentage of participants
|
18.4 percentage of participants
|
|
Percentage of Participants Experiencing Problems by European Quality of Life Instrument (EQ-5D) Category (Data Cutoff 20 December 2013)
Second-line PD: P/D, some problems (n=82,76)
|
67.1 percentage of participants
|
69.7 percentage of participants
|
|
Percentage of Participants Experiencing Problems by European Quality of Life Instrument (EQ-5D) Category (Data Cutoff 20 December 2013)
Second-line PD: P/D, extreme problems (n=82,76)
|
8.5 percentage of participants
|
11.8 percentage of participants
|
|
Percentage of Participants Experiencing Problems by European Quality of Life Instrument (EQ-5D) Category (Data Cutoff 20 December 2013)
Second-line PD: A/D, no problems (n=82,76)
|
36.6 percentage of participants
|
26.3 percentage of participants
|
|
Percentage of Participants Experiencing Problems by European Quality of Life Instrument (EQ-5D) Category (Data Cutoff 20 December 2013)
Second-line PD: A/D, some problems (n=82,76)
|
50.0 percentage of participants
|
61.8 percentage of participants
|
|
Percentage of Participants Experiencing Problems by European Quality of Life Instrument (EQ-5D) Category (Data Cutoff 20 December 2013)
Second-line PD: A/D, extreme problems (n=82,76)
|
7.3 percentage of participants
|
11.8 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline, during second-line treatment at Weeks 8 and 16 (4-week cycles) or Weeks 9 and 18 (3-week cycles) and at second-line PD (up to approximately 3 years)Population: ITT population. Here, Number of participants analyzed = participants evaluable for this outcome measure and n=number of participants who completed the assessment at the specified timepoint
The EQ-5D is composed of 5 single-item measures where participants responded to questions assessing health status by responding with either "no problems", "some problems", or "extreme problems" in the following categories: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Based on large population surveys, an algorithm was used to combine the responses to each of these 5 measures into 1 single EQ-5D index score ranging from -0.59 (extreme problems) to +1 (no problems).
Outcome measures
| Measure |
CT Arm
n=202 Participants
Participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator's site until disease progression, unacceptable toxicity, participant request for withdrawal, until the maximum cumulative dose of anthracycline was reached, or end of study (24 months after randomization of the last participant). Upon second-line disease progression participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator's site until disease progression, unacceptable toxicity, participant request for withdrawal, or end of study. Upon subsequent disease progression participants received treatment according the standard of care of the treatment site until end of study.
|
CT+BV Arm
n=219 Participants
Participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator's site plus bevacizumab, 15 mg/kg, IV, every 3 weeks, or 10 mg/kg, IV, every 2 weeks until disease progression, unacceptable toxicity, participant request for withdrawal, until the maximum cumulative dose of anthracycline was reached, or end of study (24 months after randomization of the last participant). Upon second-line disease progression participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator's site plus bevacizumab, 15 mg/kg, IV, every 3 weeks, or 10 mg/kg, IV, every 2 weeks until disease progression, unacceptable toxicity, participant request for withdrawal, or end of study. Upon subsequent disease progression participants received treatment according the standard of care of the treatment site until end of study.
|
|---|---|---|
|
Quality of Life Assessed As an Index Score Using the EQ-5D (Data Cutoff 20 December 2013)
Week 8/9 (n=127,135)
|
0.6953 score on a scale
Interval 0.647 to 0.7437
|
0.6515 score on a scale
Interval 0.6057 to 0.6973
|
|
Quality of Life Assessed As an Index Score Using the EQ-5D (Data Cutoff 20 December 2013)
BL (n=202,219)
|
0.6806 score on a scale
Interval 0.6489 to 0.7122
|
0.6725 score on a scale
Interval 0.6389 to 0.7061
|
|
Quality of Life Assessed As an Index Score Using the EQ-5D (Data Cutoff 20 December 2013)
Week 16/18 (n=80,118)
|
0.7496 score on a scale
Interval 0.7114 to 0.7879
|
0.6534 score on a scale
Interval 0.6058 to 0.701
|
|
Quality of Life Assessed As an Index Score Using the EQ-5D (Data Cutoff 20 December 2013)
Second-line PD (n=77,76)
|
0.6290 score on a scale
Interval 0.5642 to 0.6938
|
0.5553 score on a scale
Interval 0.4736 to 0.637
|
SECONDARY outcome
Timeframe: Baseline, during second-line treatment at Weeks 8 and 16 (4-week cycles) or Weeks 9 and 18 (3-week cycles) and at second-line PD (up to approximately 3 years)Population: ITT population. Here, Number of participants analyzed = participants evaluable for this outcome measure and n=number of participants who completed the assessment at the specified timepoint.
The EQ-5D is composed of 5 single-item measures where participants responded to questions assessing health status by responding with either "no problems", "some problems", or "extreme problems" in the following categories: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Based on large population surveys, an algorithm was used to combine the responses to each of these 5 measures into 1 single EQ-5D index score ranging from -0.59 (extreme problems) to +1 (no problems) where a negative value indicated a worsening of perceived quality of life and a positive value indicated an improvement of perceived quality of life.
Outcome measures
| Measure |
CT Arm
n=107 Participants
Participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator's site until disease progression, unacceptable toxicity, participant request for withdrawal, until the maximum cumulative dose of anthracycline was reached, or end of study (24 months after randomization of the last participant). Upon second-line disease progression participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator's site until disease progression, unacceptable toxicity, participant request for withdrawal, or end of study. Upon subsequent disease progression participants received treatment according the standard of care of the treatment site until end of study.
|
CT+BV Arm
n=122 Participants
Participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator's site plus bevacizumab, 15 mg/kg, IV, every 3 weeks, or 10 mg/kg, IV, every 2 weeks until disease progression, unacceptable toxicity, participant request for withdrawal, until the maximum cumulative dose of anthracycline was reached, or end of study (24 months after randomization of the last participant). Upon second-line disease progression participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator's site plus bevacizumab, 15 mg/kg, IV, every 3 weeks, or 10 mg/kg, IV, every 2 weeks until disease progression, unacceptable toxicity, participant request for withdrawal, or end of study. Upon subsequent disease progression participants received treatment according the standard of care of the treatment site until end of study.
|
|---|---|---|
|
Change From Baseline in EQ-5D Index Scores (Data Cutoff 20 December 2013)
Week 8/9 (n=107,122)
|
-0.0103 score on a scale
Interval -0.0482 to 0.0276
|
-0.0370 score on a scale
Interval -0.0868 to 0.0127
|
|
Change From Baseline in EQ-5D Index Scores (Data Cutoff 20 December 2013)
Week 16/18 (n=68,110)
|
0.0387 score on a scale
Interval -0.0025 to 0.08
|
-0.0508 score on a scale
Interval -0.1038 to 0.0021
|
|
Change From Baseline in EQ-5D Index Scores (Data Cutoff 20 December 2013)
Second-line PD (n=69,71)
|
-0.0884 score on a scale
Interval -0.1398 to -0.0371
|
-0.0878 score on a scale
Interval -0.1649 to -0.0107
|
SECONDARY outcome
Timeframe: Baseline, during second-line treatment at Weeks 8 and 16 (4-week cycles) or Weeks 9 and 18 (3-week cycles) and at second-line PD (up to approximately 3 years)Population: ITT population; n=number of participants who completed the assessment at the specified timepoint.
The participant was asked to rate their overall health on a 0-100 millimeter (mm) vertical scale, where the lowest endpoint=0 (labeled as worst imaginable health state) and the highest endpoint =100 (labeled as the best imaginable health state). The participant marked the line corresponding to their assessment and the distance from the bottom was measured in millimeters. A higher value indicated a better health state.
Outcome measures
| Measure |
CT Arm
n=200 Participants
Participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator's site until disease progression, unacceptable toxicity, participant request for withdrawal, until the maximum cumulative dose of anthracycline was reached, or end of study (24 months after randomization of the last participant). Upon second-line disease progression participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator's site until disease progression, unacceptable toxicity, participant request for withdrawal, or end of study. Upon subsequent disease progression participants received treatment according the standard of care of the treatment site until end of study.
|
CT+BV Arm
n=212 Participants
Participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator's site plus bevacizumab, 15 mg/kg, IV, every 3 weeks, or 10 mg/kg, IV, every 2 weeks until disease progression, unacceptable toxicity, participant request for withdrawal, until the maximum cumulative dose of anthracycline was reached, or end of study (24 months after randomization of the last participant). Upon second-line disease progression participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator's site plus bevacizumab, 15 mg/kg, IV, every 3 weeks, or 10 mg/kg, IV, every 2 weeks until disease progression, unacceptable toxicity, participant request for withdrawal, or end of study. Upon subsequent disease progression participants received treatment according the standard of care of the treatment site until end of study.
|
|---|---|---|
|
Quality of Life Assessed Using the EQ-5D Visual Analogue Scale (VAS) Scores (Data Cutoff 20 December 2013)
BL (n=200,212)
|
66.5 mm
Interval 64.1 to 69.0
|
63.4 mm
Interval 60.8 to 65.9
|
|
Quality of Life Assessed Using the EQ-5D Visual Analogue Scale (VAS) Scores (Data Cutoff 20 December 2013)
Week 8/9 (n=123,135)
|
69.3 mm
Interval 66.4 to 72.1
|
66.5 mm
Interval 63.7 to 69.2
|
|
Quality of Life Assessed Using the EQ-5D Visual Analogue Scale (VAS) Scores (Data Cutoff 20 December 2013)
Week 16/18 (n=75,119)
|
67.3 mm
Interval 63.3 to 71.3
|
66.4 mm
Interval 63.2 to 69.5
|
|
Quality of Life Assessed Using the EQ-5D Visual Analogue Scale (VAS) Scores (Data Cutoff 20 December 2013)
Second-line PD (n=78,75)
|
63.7 mm
Interval 59.5 to 68.0
|
61.7 mm
Interval 57.0 to 66.5
|
SECONDARY outcome
Timeframe: Baseline, during second-line treatment at Weeks 8 and 16 (4-week cycles) or Weeks 9 and 18 (3-week cycles) and at second-line PD (up to approximately 3 years)Population: ITT population. Here, Number of participants analyzed = participants evaluable for this outcome measure and n=number of participants who completed the assessment at the specified timepoint.
The participant was asked to rate their overall health on a 0-100 mm vertical scale, where the lowest endpoint = 0 (labeled as worst imaginable health state) and the highest endpoint =100 (labeled as the best imaginable health state). The participant marked the line corresponding to their assessment and the distance from the bottom was measured in millimeters. A negative value indicated a worsening of perceived quality of life and a positive value indicated an improvement of perceived quality of life.
Outcome measures
| Measure |
CT Arm
n=106 Participants
Participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator's site until disease progression, unacceptable toxicity, participant request for withdrawal, until the maximum cumulative dose of anthracycline was reached, or end of study (24 months after randomization of the last participant). Upon second-line disease progression participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator's site until disease progression, unacceptable toxicity, participant request for withdrawal, or end of study. Upon subsequent disease progression participants received treatment according the standard of care of the treatment site until end of study.
|
CT+BV Arm
n=118 Participants
Participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator's site plus bevacizumab, 15 mg/kg, IV, every 3 weeks, or 10 mg/kg, IV, every 2 weeks until disease progression, unacceptable toxicity, participant request for withdrawal, until the maximum cumulative dose of anthracycline was reached, or end of study (24 months after randomization of the last participant). Upon second-line disease progression participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator's site plus bevacizumab, 15 mg/kg, IV, every 3 weeks, or 10 mg/kg, IV, every 2 weeks until disease progression, unacceptable toxicity, participant request for withdrawal, or end of study. Upon subsequent disease progression participants received treatment according the standard of care of the treatment site until end of study.
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|---|---|---|
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Change From Baseline in VAS Scores (Data Cutoff 20 December 2013)
Week 8/9 (n=106,118)
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-2.0 mm
Interval -4.8 to 0.9
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2.0 mm
Interval -1.4 to 5.3
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Change From Baseline in VAS Scores (Data Cutoff 20 December 2013)
Week 16/18 (n=66,107)
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-0.2 mm
Interval -4.7 to 4.3
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2.0 mm
Interval -1.6 to 5.5
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Change From Baseline in VAS Scores (Data Cutoff 20 December 2013)
Second-line PD (n=70,69)
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-5.1 mm
Interval -9.1 to -1.0
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-1.3 mm
Interval -5.5 to 3.0
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SECONDARY outcome
Timeframe: Baseline (≤28 days after randomization), every 8-9 weeks thereafter until second-line PD (up to approximately 3 years)Population: ITT population. Here, Number of participants analyzed = participants evaluable for this outcome measure and n=number of participants who completed the questionnaire at the specified timepoints.
The Functional Assessment of Cancer Therapy-Breast (FACT-B) is composed of 5 multi-item sections where participants responded to questions assessing symptoms (scale: 0-4; 0="not at all" and 4="very much"), as follows: physical well-being (PWB) (7 items, total score 0-28), social/family well-being (SWB) (7 items, total score 0-28), emotional well-being (EWB) (6 items, total score 0-24), functional well-being (FWB) (7 items, total score 0-28); and breast cancer score based on the additional concerns section of FACT-B (10 items, total score 0-40). The FACT-B Trial Outcomes Index (TOI) score=sum of PWB, FWB, and breast cancer score subscale scores (total score 0-96). The Functional Assessment of Cancer Therapy-General (FACT-G) total score=sum of PWB, SWB, EWB, and FWB subscales scores (total score 0-108). The FACT-B total score=sum of PWB, SWB, EWB, FWB, and breast cancer score subscales scores (total score 0-148). In all cases a higher value indicated a better perceived quality of life.
Outcome measures
| Measure |
CT Arm
n=215 Participants
Participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator's site until disease progression, unacceptable toxicity, participant request for withdrawal, until the maximum cumulative dose of anthracycline was reached, or end of study (24 months after randomization of the last participant). Upon second-line disease progression participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator's site until disease progression, unacceptable toxicity, participant request for withdrawal, or end of study. Upon subsequent disease progression participants received treatment according the standard of care of the treatment site until end of study.
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CT+BV Arm
n=224 Participants
Participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator's site plus bevacizumab, 15 mg/kg, IV, every 3 weeks, or 10 mg/kg, IV, every 2 weeks until disease progression, unacceptable toxicity, participant request for withdrawal, until the maximum cumulative dose of anthracycline was reached, or end of study (24 months after randomization of the last participant). Upon second-line disease progression participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator's site plus bevacizumab, 15 mg/kg, IV, every 3 weeks, or 10 mg/kg, IV, every 2 weeks until disease progression, unacceptable toxicity, participant request for withdrawal, or end of study. Upon subsequent disease progression participants received treatment according the standard of care of the treatment site until end of study.
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|---|---|---|
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Functional Assessment of Cancer Therapy-Breast (FACT-B) Scores (Data Cutoff 20 December 2013)
Week 88/99: FACT-B TOI (n=0,1)
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NA score on a scale
Zero participants analyzed.
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78.000 score on a scale
SD not calculated as only 1 participant was analyzed.
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Functional Assessment of Cancer Therapy-Breast (FACT-B) Scores (Data Cutoff 20 December 2013)
Week 88/99: Total FACT-G (n=0,1)
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NA score on a scale
Zero participants analyzed.
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86.333 score on a scale
SD not calculated as only 1 participant was analyzed.
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Functional Assessment of Cancer Therapy-Breast (FACT-B) Scores (Data Cutoff 20 December 2013)
Week 88/99: Total FACT-B (n=0,1)
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NA score on a scale
Zero participants analyzed.
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121.333 score on a scale
SD not calculated as only 1 participant was analyzed.
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Functional Assessment of Cancer Therapy-Breast (FACT-B) Scores (Data Cutoff 20 December 2013)
BL: PWB (n=215,222)
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20.621 score on a scale
Interval 19.9 to 21.342
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20.253 score on a scale
Interval 19.5 to 21.006
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Functional Assessment of Cancer Therapy-Breast (FACT-B) Scores (Data Cutoff 20 December 2013)
BL: SWB (n=214,223)
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20.722 score on a scale
Interval 20.028 to 21.416
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20.674 score on a scale
Interval 19.923 to 21.425
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Functional Assessment of Cancer Therapy-Breast (FACT-B) Scores (Data Cutoff 20 December 2013)
BL: EWB (n=215,224)
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14.847 score on a scale
Interval 14.176 to 15.519
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15.062 score on a scale
Interval 14.419 to 15.704
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Functional Assessment of Cancer Therapy-Breast (FACT-B) Scores (Data Cutoff 20 December 2013)
BL: FWB (n=215,224)
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16.091 score on a scale
Interval 15.289 to 16.894
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15.726 score on a scale
Interval 14.951 to 16.502
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Functional Assessment of Cancer Therapy-Breast (FACT-B) Scores (Data Cutoff 20 December 2013)
BL: Breast Cancer Score (n=210,224)
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24.986 score on a scale
Interval 24.103 to 25.869
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24.388 score on a scale
Interval 23.578 to 25.198
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Functional Assessment of Cancer Therapy-Breast (FACT-B) Scores (Data Cutoff 20 December 2013)
BL: FACT-B TOI (n=204,219)
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61.677 score on a scale
Interval 59.658 to 63.696
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60.277 score on a scale
Interval 58.365 to 62.189
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Functional Assessment of Cancer Therapy-Breast (FACT-B) Scores (Data Cutoff 20 December 2013)
BL: Total FACT-G Score (n=207,218)
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72.169 score on a scale
Interval 69.919 to 74.419
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71.864 score on a scale
Interval 69.786 to 73.942
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Functional Assessment of Cancer Therapy-Breast (FACT-B) Scores (Data Cutoff 20 December 2013)
BL: Total FACT-B Score (n=201,218)
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96.908 score on a scale
Interval 94.063 to 99.753
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96.115 score on a scale
Interval 93.485 to 98.746
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Functional Assessment of Cancer Therapy-Breast (FACT-B) Scores (Data Cutoff 20 December 2013)
Week 8/9: PWB (n=129,138)
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20.413 score on a scale
Interval 19.413 to 21.413
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19.156 score on a scale
Interval 18.158 to 20.153
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Functional Assessment of Cancer Therapy-Breast (FACT-B) Scores (Data Cutoff 20 December 2013)
Week 8/9: SWB (n=127,135)
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20.833 score on a scale
Interval 19.888 to 21.779
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21.116 score on a scale
Interval 20.245 to 21.987
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Functional Assessment of Cancer Therapy-Breast (FACT-B) Scores (Data Cutoff 20 December 2013)
Week 8/9: EWB (n=129,139)
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15.943 score on a scale
Interval 15.07 to 16.815
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16.671 score on a scale
Interval 15.9 to 17.441
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Functional Assessment of Cancer Therapy-Breast (FACT-B) Scores (Data Cutoff 20 December 2013)
Week 8/9: FWB (n=129,139)
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16.662 score on a scale
Interval 15.609 to 17.715
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16.169 score on a scale
Interval 15.18 to 17.158
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Functional Assessment of Cancer Therapy-Breast (FACT-B) Scores (Data Cutoff 20 December 2013)
Week 8/9: Breast Cancer Score (n=128,139)
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26.276 score on a scale
Interval 25.188 to 27.364
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25.884 score on a scale
Interval 24.928 to 26.839
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Functional Assessment of Cancer Therapy-Breast (FACT-B) Scores (Data Cutoff 20 December 2013)
Week 8/9: FACT-B TOI (n=126,136)
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63.547 score on a scale
Interval 60.975 to 66.118
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61.279 score on a scale
Interval 58.811 to 63.747
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Functional Assessment of Cancer Therapy-Breast (FACT-B) Scores (Data Cutoff 20 December 2013)
Week 8/9: Total FACT-G Score (n=122,134)
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74.255 score on a scale
Interval 71.212 to 77.299
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73.393 score on a scale
Interval 70.603 to 76.184
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Functional Assessment of Cancer Therapy-Breast (FACT-B) Scores (Data Cutoff 20 December 2013)
Week 8/9: Total FACT-B Score (n=123,134)
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100.375 score on a scale
Interval 96.582 to 104.169
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99.213 score on a scale
Interval 95.667 to 102.76
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Functional Assessment of Cancer Therapy-Breast (FACT-B) Scores (Data Cutoff 20 December 2013)
Week 16/18: PWB (n=83,107)
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21.733 score on a scale
Interval 20.721 to 22.744
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19.629 score on a scale
Interval 18.571 to 20.688
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Functional Assessment of Cancer Therapy-Breast (FACT-B) Scores (Data Cutoff 20 December 2013)
Week 16/18: SWB (n=80,105)
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20.930 score on a scale
Interval 19.855 to 22.006
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20.843 score on a scale
Interval 19.829 to 21.857
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Functional Assessment of Cancer Therapy-Breast (FACT-B) Scores (Data Cutoff 20 December 2013)
Week 16/18: EWB (n=80,107)
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17.330 score on a scale
Interval 16.26 to 18.4
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16.806 score on a scale
Interval 15.961 to 17.65
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Functional Assessment of Cancer Therapy-Breast (FACT-B) Scores (Data Cutoff 20 December 2013)
Week 16/18: FWB (n=81,106)
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17.055 score on a scale
Interval 15.818 to 18.291
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15.920 score on a scale
Interval 14.787 to 17.053
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Functional Assessment of Cancer Therapy-Breast (FACT-B) Scores (Data Cutoff 20 December 2013)
Week 16/18: Breast Cancer (n=81,106)
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26.923 score on a scale
Interval 25.493 to 28.354
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25.755 score on a scale
Interval 24.63 to 26.88
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Functional Assessment of Cancer Therapy-Breast (FACT-B) Scores (Data Cutoff 20 December 2013)
Week 16/18: FACT-B TOI (n=78,105)
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65.628 score on a scale
Interval 62.539 to 68.717
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61.107 score on a scale
Interval 58.309 to 63.905
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Functional Assessment of Cancer Therapy-Breast (FACT-B) Scores (Data Cutoff 20 December 2013)
Week 16/18: Total FACT-G (n=78,102)
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76.794 score on a scale
Interval 73.269 to 80.318
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73.269 score on a scale
Interval 70.116 to 76.421
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Functional Assessment of Cancer Therapy-Breast (FACT-B) Scores (Data Cutoff 20 December 2013)
Week 16/18: Total FACT-B (n=76,103)
|
103.503 score on a scale
Interval 98.819 to 108.187
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98.906 score on a scale
Interval 94.865 to 102.948
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Functional Assessment of Cancer Therapy-Breast (FACT-B) Scores (Data Cutoff 20 December 2013)
Week 24/27: PWB (n=48,80)
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21.940 score on a scale
Interval 20.599 to 23.282
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18.965 score on a scale
Interval 17.515 to 20.416
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Functional Assessment of Cancer Therapy-Breast (FACT-B) Scores (Data Cutoff 20 December 2013)
Week 24/27: SWB (n=47,78)
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20.840 score on a scale
Interval 19.468 to 22.211
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21.399 score on a scale
Interval 20.192 to 22.606
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Functional Assessment of Cancer Therapy-Breast (FACT-B) Scores (Data Cutoff 20 December 2013)
Week 24/27: EWB (n=45,78)
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17.098 score on a scale
Interval 15.719 to 18.477
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16.438 score on a scale
Interval 15.411 to 17.436
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Functional Assessment of Cancer Therapy-Breast (FACT-B) Scores (Data Cutoff 20 December 2013)
Week 24/27: FWB (n=45,79)
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18.244 score on a scale
Interval 16.754 to 19.734
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16.051 score on a scale
Interval 14.861 to 17.241
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Functional Assessment of Cancer Therapy-Breast (FACT-B) Scores (Data Cutoff 20 December 2013)
Week 24/27: Breast Cancer (n=46,79)
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26.067 score on a scale
Interval 24.146 to 27.988
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24.632 score on a scale
Interval 23.231 to 26.033
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Functional Assessment of Cancer Therapy-Breast (FACT-B) Scores (Data Cutoff 20 December 2013)
Week 24/27: FACT-B TOI (n=44,77)
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65.882 score on a scale
Interval 61.991 to 69.653
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60.014 score on a scale
Interval 56.548 to 63.48
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Functional Assessment of Cancer Therapy-Breast (FACT-B) Scores (Data Cutoff 20 December 2013)
Week 24/27: Total FACT-G (n=44,77)
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78.305 score on a scale
Interval 74.166 to 82.443
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73.083 score on a scale
Interval 69.365 to 76.801
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Functional Assessment of Cancer Therapy-Breast (FACT-B) Scores (Data Cutoff 20 December 2013)
Week 24/27: Total FACT-B (n=43,77)
|
104.011 score on a scale
Interval 98.433 to 109.588
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97.795 score on a scale
Interval 92.995 to 102.595
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Functional Assessment of Cancer Therapy-Breast (FACT-B) Scores (Data Cutoff 20 December 2013)
Week 32/36: PWB (n=26,44)
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22.949 score on a scale
Interval 21.427 to 24.471
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19.686 score on a scale
Interval 18.121 to 21.25
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Functional Assessment of Cancer Therapy-Breast (FACT-B) Scores (Data Cutoff 20 December 2013)
Week 32/36: SWB (n=25,43)
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22.140 score on a scale
Interval 20.433 to 23.847
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21.222 score on a scale
Interval 19.645 to 22.798
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Functional Assessment of Cancer Therapy-Breast (FACT-B) Scores (Data Cutoff 20 December 2013)
Week 32/36: EWB (n=26,44)
|
18.385 score on a scale
Interval 16.69 to 20.079
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16.755 score on a scale
Interval 15.481 to 18.028
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Functional Assessment of Cancer Therapy-Breast (FACT-B) Scores (Data Cutoff 20 December 2013)
Week 32/36: FWB (n=26,44)
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19.615 score on a scale
Interval 17.875 to 21.356
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17.195 score on a scale
Interval 15.585 to 18.805
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Functional Assessment of Cancer Therapy-Breast (FACT-B) Scores (Data Cutoff 20 December 2013)
Week 32/36: Breast Cancer (n=26,43)
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29.568 score on a scale
Interval 27.722 to 31.415
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26.163 score on a scale
Interval 24.457 to 27.869
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Functional Assessment of Cancer Therapy-Breast (FACT-B) Scores (Data Cutoff 20 December 2013)
Week 32/36: FACT-B TOI (n=26,42)
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72.132 score on a scale
Interval 68.549 to 75.716
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63.017 score on a scale
Interval 59.199 to 66.836
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Functional Assessment of Cancer Therapy-Breast (FACT-B) Scores (Data Cutoff 20 December 2013)
Week 32/36: Total FACT-G (n=25,42)
|
83.087 score on a scale
Interval 78.178 to 87.995
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74.879 score on a scale
Interval 70.566 to 79.191
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Functional Assessment of Cancer Therapy-Breast (FACT-B) Scores (Data Cutoff 20 December 2013)
Week 32/36: Total FACT-B (n=25,42)
|
112.904 score on a scale
Interval 107.315 to 118.494
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100.904 score on a scale
Interval 95.302 to 106.506
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Functional Assessment of Cancer Therapy-Breast (FACT-B) Scores (Data Cutoff 20 December 2013)
Week 40/45: PWB (n=20,27)
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22.215 score on a scale
Interval 20.583 to 23.847
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20.630 score on a scale
Interval 18.82 to 22.44
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Functional Assessment of Cancer Therapy-Breast (FACT-B) Scores (Data Cutoff 20 December 2013)
Week 40/45: SWB (n=21,26)
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19.658 score on a scale
Interval 17.955 to 21.361
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20.915 score on a scale
Interval 19.146 to 22.685
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Functional Assessment of Cancer Therapy-Breast (FACT-B) Scores (Data Cutoff 20 December 2013)
Week 40/45: EWB (n=20,27)
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17.560 score on a scale
Interval 15.708 to 19.412
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16.067 score on a scale
Interval 13.875 to 18.259
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Functional Assessment of Cancer Therapy-Breast (FACT-B) Scores (Data Cutoff 20 December 2013)
Week 40/45: FWB (n=20,27)
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18.450 score on a scale
Interval 16.12 to 20.78
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16.519 score on a scale
Interval 13.901 to 19.136
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Functional Assessment of Cancer Therapy-Breast (FACT-B) Scores (Data Cutoff 20 December 2013)
Week 40/45: Breast Cancer (n=21,27)
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29.386 score on a scale
Interval 27.156 to 31.616
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23.819 score on a scale
Interval 21.013 to 26.625
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Functional Assessment of Cancer Therapy-Breast (FACT-B) Scores (Data Cutoff 20 December 2013)
Week 40/45: FACT-B TOI (n=19,27)
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68.750 score on a scale
Interval 63.981 to 73.518
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60.967 score on a scale
Interval 55.065 to 66.87
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Functional Assessment of Cancer Therapy-Breast (FACT-B) Scores (Data Cutoff 20 December 2013)
Week 40/45: Total FACT-G (n=19,26)
|
76.955 score on a scale
Interval 71.48 to 82.43
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75.235 score on a scale
Interval 68.901 to 81.568
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Functional Assessment of Cancer Therapy-Breast (FACT-B) Scores (Data Cutoff 20 December 2013)
Week 40/45: Total FACT-B (n=19,26)
|
105.540 score on a scale
Interval 98.512 to 112.568
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99.072 score on a scale
Interval 90.613 to 107.531
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Functional Assessment of Cancer Therapy-Breast (FACT-B) Scores (Data Cutoff 20 December 2013)
Week 48/54: PWB (n=13,24)
|
23.308 score on a scale
Interval 21.283 to 25.333
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20.033 score on a scale
Interval 18.124 to 21.943
|
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Functional Assessment of Cancer Therapy-Breast (FACT-B) Scores (Data Cutoff 20 December 2013)
Week 48/54: SWB (n=13,23)
|
20.740 score on a scale
Interval 18.953 to 22.527
|
20.450 score on a scale
Interval 18.31 to 22.59
|
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Functional Assessment of Cancer Therapy-Breast (FACT-B) Scores (Data Cutoff 20 December 2013)
Week 48/54: EWB (n=13,23)
|
19.308 score on a scale
Interval 17.522 to 21.093
|
17.270 score on a scale
Interval 15.494 to 19.045
|
|
Functional Assessment of Cancer Therapy-Breast (FACT-B) Scores (Data Cutoff 20 December 2013)
Week 48/54: FWB (n=13,23)
|
18.538 score on a scale
Interval 16.586 to 20.491
|
16.268 score on a scale
Interval 13.949 to 18.587
|
|
Functional Assessment of Cancer Therapy-Breast (FACT-B) Scores (Data Cutoff 20 December 2013)
Week 48/54: Breast Cancer (n=13,23)
|
28.912 score on a scale
Interval 26.879 to 30.945
|
26.237 score on a scale
Interval 22.842 to 29.632
|
|
Functional Assessment of Cancer Therapy-Breast (FACT-B) Scores (Data Cutoff 20 December 2013)
Week 48/54: Fact-B TOI (n=13,23)
|
70.758 score on a scale
Interval 66.403 to 75.114
|
62.679 score on a scale
Interval 55.941 to 69.418
|
|
Functional Assessment of Cancer Therapy-Breast (FACT-B) Scores (Data Cutoff 20 December 2013)
Week 48/54: Total FACT-G (n=13,23)
|
81.894 score on a scale
Interval 76.424 to 87.363
|
74.162 score on a scale
Interval 67.865 to 80.458
|
|
Functional Assessment of Cancer Therapy-Breast (FACT-B) Scores (Data Cutoff 20 December 2013)
Week 48/54: Total FACT-B (n=13,23)
|
110.806 score on a scale
Interval 104.704 to 116.908
|
100.399 score on a scale
Interval 91.294 to 109.503
|
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Functional Assessment of Cancer Therapy-Breast (FACT-B) Scores (Data Cutoff 20 December 2013)
Week 56/63: PWB (n=8,14)
|
21.792 score on a scale
Interval 18.958 to 24.626
|
20.298 score on a scale
Interval 17.412 to 23.184
|
|
Functional Assessment of Cancer Therapy-Breast (FACT-B) Scores (Data Cutoff 20 December 2013)
Week 56/63: SWB (n=8,14)
|
19.583 score on a scale
Interval 15.598 to 23.569
|
20.817 score on a scale
Interval 17.629 to 24.004
|
|
Functional Assessment of Cancer Therapy-Breast (FACT-B) Scores (Data Cutoff 20 December 2013)
Week 56/63: EWB (n=7,14)
|
17.143 score on a scale
Interval 13.389 to 20.897
|
15.714 score on a scale
Interval 12.606 to 18.823
|
|
Functional Assessment of Cancer Therapy-Breast (FACT-B) Scores (Data Cutoff 20 December 2013)
Week 56/63: FWB (n=7,14)
|
17.143 score on a scale
Interval 13.876 to 20.41
|
16.476 score on a scale
Interval 12.633 to 20.319
|
|
Functional Assessment of Cancer Therapy-Breast (FACT-B) Scores (Data Cutoff 20 December 2013)
Week 56/63: Breast Cancer (n=8,14)
|
28.240 score on a scale
Interval 23.931 to 32.548
|
25.459 score on a scale
Interval 21.407 to 29.512
|
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Functional Assessment of Cancer Therapy-Breast (FACT-B) Scores (Data Cutoff 20 December 2013)
Week 56/63: FACT-B TOI (n=7,14)
|
66.179 score on a scale
Interval 55.888 to 76.469
|
62.233 score on a scale
Interval 53.524 to 70.942
|
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Functional Assessment of Cancer Therapy-Breast (FACT-B) Scores (Data Cutoff 20 December 2013)
Week 56/63: Total FACT-G (n=6,14)
|
73.667 score on a scale
Interval 58.381 to 88.952
|
73.305 score on a scale
Interval 62.863 to 83.746
|
|
Functional Assessment of Cancer Therapy-Breast (FACT-B) Scores (Data Cutoff 20 December 2013)
Week 56/63: Total FACT-B (n=6,14)
|
101.042 score on a scale
Interval 81.841 to 120.242
|
98.764 score on a scale
Interval 85.368 to 112.16
|
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Functional Assessment of Cancer Therapy-Breast (FACT-B) Scores (Data Cutoff 20 December 2013)
Week 64/72: PWB (n=7,9)
|
21.857 score on a scale
Interval 17.376 to 26.338
|
21.889 score on a scale
Interval 19.569 to 24.209
|
|
Functional Assessment of Cancer Therapy-Breast (FACT-B) Scores (Data Cutoff 20 December 2013)
Week 64/72: SWB (n=7,9)
|
18.976 score on a scale
Interval 16.352 to 21.6
|
22.685 score on a scale
Interval 19.417 to 25.953
|
|
Functional Assessment of Cancer Therapy-Breast (FACT-B) Scores (Data Cutoff 20 December 2013)
Week 64/72: EWB (n=7,9)
|
18.143 score on a scale
Interval 13.758 to 22.527
|
17.889 score on a scale
Interval 14.274 to 21.503
|
|
Functional Assessment of Cancer Therapy-Breast (FACT-B) Scores (Data Cutoff 20 December 2013)
Week 64/72: FWB (n=7,9)
|
18.429 score on a scale
Interval 14.658 to 22.199
|
16.037 score on a scale
Interval 12.89 to 19.184
|
|
Functional Assessment of Cancer Therapy-Breast (FACT-B) Scores (Data Cutoff 20 December 2013)
Week 64/72: Breast Cancer (n=7,9)
|
27.464 score on a scale
Interval 22.941 to 31.988
|
26.889 score on a scale
Interval 22.584 to 31.194
|
|
Functional Assessment of Cancer Therapy-Breast (FACT-B) Scores (Data Cutoff 20 December 2013)
Week 64/72: FACT-B TOI (n=7,9)
|
67.750 score on a scale
Interval 56.306 to 79.194
|
64.815 score on a scale
Interval 56.516 to 73.114
|
|
Functional Assessment of Cancer Therapy-Breast (FACT-B) Scores (Data Cutoff 20 December 2013)
Week 64/72: Total FACT-G (n=7,9)
|
77.405 score on a scale
Interval 63.847 to 90.963
|
78.500 score on a scale
Interval 68.852 to 88.148
|
|
Functional Assessment of Cancer Therapy-Breast (FACT-B) Scores (Data Cutoff 20 December 2013)
Week 64/72: Total FACT-B (n=7,9)
|
104.869 score on a scale
Interval 87.586 to 122.152
|
105.389 score on a scale
Interval 92.415 to 118.363
|
|
Functional Assessment of Cancer Therapy-Breast (FACT-B) Scores (Data Cutoff 20 December 2013)
Week 72/81: PWB (n=6,7)
|
23.083 score on a scale
Interval 18.906 to 27.26
|
21.000 score on a scale
Interval 16.407 to 25.593
|
|
Functional Assessment of Cancer Therapy-Breast (FACT-B) Scores (Data Cutoff 20 December 2013)
Week 72/81: SWB (n=5,7)
|
19.667 score on a scale
Interval 16.238 to 23.095
|
20.043 score on a scale
Interval 14.019 to 26.067
|
|
Functional Assessment of Cancer Therapy-Breast (FACT-B) Scores (Data Cutoff 20 December 2013)
Week 72/81: EWB (n=6,7)
|
17.500 score on a scale
Interval 13.476 to 21.524
|
18.114 score on a scale
Interval 14.13 to 22.098
|
|
Functional Assessment of Cancer Therapy-Breast (FACT-B) Scores (Data Cutoff 20 December 2013)
Week 72/81: FWB (n=6,7)
|
17.333 score on a scale
Interval 14.316 to 20.351
|
16.429 score on a scale
Interval 11.339 to 21.518
|
|
Functional Assessment of Cancer Therapy-Breast (FACT-B) Scores (Data Cutoff 20 December 2013)
Week 72/81: Breast Cancer (n=6,6)
|
28.597 score on a scale
Interval 24.421 to 32.774
|
25.333 score on a scale
Interval 20.25 to 30.417
|
|
Functional Assessment of Cancer Therapy-Breast (FACT-B) Scores (Data Cutoff 20 December 2013)
Week 72/81: FACT-B TOI (n=6,6)
|
69.014 score on a scale
Interval 59.566 to 78.462
|
60.833 score on a scale
Interval 47.031 to 74.635
|
|
Functional Assessment of Cancer Therapy-Breast (FACT-B) Scores (Data Cutoff 20 December 2013)
Week 72/81: Total FACT-G (n=5,7)
|
76.467 score on a scale
Interval 62.045 to 90.889
|
75.586 score on a scale
Interval 57.141 to 94.03
|
|
Functional Assessment of Cancer Therapy-Breast (FACT-B) Scores (Data Cutoff 20 December 2013)
Week 72/81: Total FACT-B (n=5,6)
|
106.117 score on a scale
Interval 88.146 to 124.087
|
97.211 score on a scale
Interval 73.196 to 121.226
|
|
Functional Assessment of Cancer Therapy-Breast (FACT-B) Scores (Data Cutoff 20 December 2013)
Week 80/90: PWB (n=2,3)
|
19.250 score on a scale
Interval -32.634 to 71.134
|
18.000 score on a scale
Interval 2.487 to 33.513
|
|
Functional Assessment of Cancer Therapy-Breast (FACT-B) Scores (Data Cutoff 20 December 2013)
Week 80/90: SWB (n=2,3)
|
18.375 score on a scale
Interval 7.257 to 29.493
|
19.944 score on a scale
Interval 3.434 to 36.455
|
|
Functional Assessment of Cancer Therapy-Breast (FACT-B) Scores (Data Cutoff 20 December 2013)
Week 80/90: EWB (n=2,3)
|
14.000 score on a scale
Interval -49.531 to 77.531
|
15.733 score on a scale
Interval -3.285 to 34.752
|
|
Functional Assessment of Cancer Therapy-Breast (FACT-B) Scores (Data Cutoff 20 December 2013)
Week 80/90: FWB (n=2,3)
|
15.000 score on a scale
Interval -35.825 to 65.825
|
12.333 score on a scale
Interval -1.348 to 26.015
|
|
Functional Assessment of Cancer Therapy-Breast (FACT-B) Scores (Data Cutoff 20 December 2013)
Week 80/90: Breast Cancer (n=2,3)
|
21.667 score on a scale
Interval 0.49 to 42.844
|
25.000 score on a scale
Interval 14.172 to 35.828
|
|
Functional Assessment of Cancer Therapy-Breast (FACT-B) Scores (Data Cutoff 20 December 2013)
Week 80/90: FACT-B TOI (n=2,3)
|
55.917 score on a scale
Interval -67.969 to 179.802
|
55.333 score on a scale
Interval 20.085 to 90.581
|
|
Functional Assessment of Cancer Therapy-Breast (FACT-B) Scores (Data Cutoff 20 December 2013)
Week 80/90: Total FACT-G (n=2,3)
|
66.625 score on a scale
Interval -110.732 to 243.982
|
66.011 score on a scale
Interval 2.191 to 129.831
|
|
Functional Assessment of Cancer Therapy-Breast (FACT-B) Scores (Data Cutoff 20 December 2013)
Week 80/90: Total FACT-B (n=2,3)
|
88.292 score on a scale
Interval -110.243 to 286.826
|
91.011 score on a scale
Interval 20.313 to 161.709
|
|
Functional Assessment of Cancer Therapy-Breast (FACT-B) Scores (Data Cutoff 20 December 2013)
Week 88/99: PWB (n=0,1)
|
NA score on a scale
Zero participants analyzed.
|
22.000 score on a scale
Standard deviation (SD) not calculated as only 1 participant was analyzed.
|
|
Functional Assessment of Cancer Therapy-Breast (FACT-B) Scores (Data Cutoff 20 December 2013)
Week 88/99: SWB (n=0,1)
|
NA score on a scale
Zero participants analyzed.
|
23.333 score on a scale
SD not calculated as only 1 participant was analyzed.
|
|
Functional Assessment of Cancer Therapy-Breast (FACT-B) Scores (Data Cutoff 20 December 2013)
Week 88/99: EWB (n=0,1)
|
NA score on a scale
Zero participants analyzed.
|
20.000 score on a scale
SD not calculated as only 1 participant was analyzed.
|
|
Functional Assessment of Cancer Therapy-Breast (FACT-B) Scores (Data Cutoff 20 December 2013)
Week 88/99: FWB (n=0,1)
|
NA score on a scale
Zero participants analyzed.
|
21.000 score on a scale
SD not calculated as only 1 participant was analyzed.
|
|
Functional Assessment of Cancer Therapy-Breast (FACT-B) Scores (Data Cutoff 20 December 2013)
Week 88/99: Breast Cancer (n=0,1)
|
NA score on a scale
Zero participants analyzed.
|
35.000 score on a scale
SD not calculated as only 1 participant was analyzed.
|
|
Functional Assessment of Cancer Therapy-Breast (FACT-B) Scores (Data Cutoff 20 December 2013)
Week 96/108: PWB (n=2,1)
|
26.000 score on a scale
SD not calculated as only 1 participant was analyzed.
|
22.000 score on a scale
SD not calculated as only 1 participant was analyzed.
|
|
Functional Assessment of Cancer Therapy-Breast (FACT-B) Scores (Data Cutoff 20 December 2013)
Week 96/108: SWB (n=2,1)
|
24.383 score on a scale
Interval -3.782 to 52.549
|
21.000 score on a scale
SD not calculated as only 1 participant was analyzed.
|
|
Functional Assessment of Cancer Therapy-Breast (FACT-B) Scores (Data Cutoff 20 December 2013)
Week 96/108: EWB (n=2,2)
|
22.000 score on a scale
Interval 9.294 to 34.706
|
18.000 score on a scale
Interval -7.412 to 43.412
|
|
Functional Assessment of Cancer Therapy-Breast (FACT-B) Scores (Data Cutoff 20 December 2013)
Week 96/108: FWB (n=2,2)
|
21.083 score on a scale
Interval 7.318 to 34.848
|
10.500 score on a scale
Interval -46.678 to 67.678
|
|
Functional Assessment of Cancer Therapy-Breast (FACT-B) Scores (Data Cutoff 20 December 2013)
Week 96/108: Breast Cancer (n=2,2)
|
30.389 score on a scale
Interval -2.788 to 63.566
|
24.500 score on a scale
Interval -7.266 to 56.266
|
|
Functional Assessment of Cancer Therapy-Breast (FACT-B) Scores (Data Cutoff 20 December 2013)
Week 96/108: FACT-B TOI (n=2,1)
|
77.472 score on a scale
Interval 58.06 to 96.884
|
59.000 score on a scale
SD not calculated as only 1 participant was analyzed.
|
|
Functional Assessment of Cancer Therapy-Breast (FACT-B) Scores (Data Cutoff 20 December 2013)
Week 96/108: Total FACT-G (n=2,1)
|
93.467 score on a scale
Interval 38.83 to 148.103
|
74.000 score on a scale
SD not calculated as only 1 participant was analyzed.
|
|
Functional Assessment of Cancer Therapy-Breast (FACT-B) Scores (Data Cutoff 20 December 2013)
Week 112/126: FWB (n=0,1)
|
NA score on a scale
Zero participants analyzed.
|
11.000 score on a scale
SD not calculated as only 1 participant was analyzed.
|
|
Functional Assessment of Cancer Therapy-Breast (FACT-B) Scores (Data Cutoff 20 December 2013)
Week 96/108: Total FACT-B (n=2,1)
|
123.856 score on a scale
Interval 102.396 to 145.315
|
96.000 score on a scale
SD not calculated as only 1 participant was analyzed.
|
|
Functional Assessment of Cancer Therapy-Breast (FACT-B) Scores (Data Cutoff 20 December 2013)
Week 104/117: PWB (n=1,3)
|
27.000 score on a scale
SD not calculated as only 1 participant was analyzed.
|
21.333 score on a scale
Interval 17.539 to 25.128
|
|
Functional Assessment of Cancer Therapy-Breast (FACT-B) Scores (Data Cutoff 20 December 2013)
Week 104/117: SWB (n=1,2)
|
26.600 score on a scale
SD not calculated as only 1 participant was analyzed.
|
20.5000 score on a scale
Interval 14.147 to 26.853
|
|
Functional Assessment of Cancer Therapy-Breast (FACT-B) Scores (Data Cutoff 20 December 2013)
Week 104/117: EWB (n=1,3)
|
22.000 score on a scale
SD not calculated as only 1 participant was analyzed.
|
18.000 score on a scale
Interval 6.616 to 29.384
|
|
Functional Assessment of Cancer Therapy-Breast (FACT-B) Scores (Data Cutoff 20 December 2013)
Week 104/117: FWB (n=1,3)
|
22.000 score on a scale
SD not calculated as only 1 participant was analyzed.
|
11.000 score on a scale
Interval -1.908 to 23.908
|
|
Functional Assessment of Cancer Therapy-Breast (FACT-B) Scores (Data Cutoff 20 December 2013)
Week 104/117: Breast Cancer (n=1,3)
|
27.143 score on a scale
SD not calculated as only 1 participant was analyzed.
|
28.000 score on a scale
Interval 19.395 to 36.605
|
|
Functional Assessment of Cancer Therapy-Breast (FACT-B) Scores (Data Cutoff 20 December 2013)
Week 104/117: FACT-B TOI (n=1,3)
|
76.143 score on a scale
SD not calculated as only 1 participant was analyzed.
|
60.333 score on a scale
Interval 45.778 to 74.889
|
|
Functional Assessment of Cancer Therapy-Breast (FACT-B) Scores (Data Cutoff 20 December 2013)
Week 104/117: Total FACT-G (n=1,2)
|
97.600 score on a scale
SD not calculated as only 1 participant was analyzed.
|
70.500 score on a scale
Interval -50.209 to 191.209
|
|
Functional Assessment of Cancer Therapy-Breast (FACT-B) Scores (Data Cutoff 20 December 2013)
Week 104/117: Total FACT-B (n=1,2)
|
124.743 score on a scale
SD not calculated as only 1 participant was analyzed.
|
100.500 score on a scale
Interval -20.209 to 221.209
|
|
Functional Assessment of Cancer Therapy-Breast (FACT-B) Scores (Data Cutoff 20 December 2013)
Week 112/126: PWB (n=0,1)
|
NA score on a scale
Zero participants analyzed.
|
14.000 score on a scale
SD not calculated as only 1 participant was analyzed.
|
|
Functional Assessment of Cancer Therapy-Breast (FACT-B) Scores (Data Cutoff 20 December 2013)
Week 112/126: SWB (n=0,1)
|
NA score on a scale
Zero participants analyzed.
|
15.400 score on a scale
SD not calculated as only 1 participant was analyzed.
|
|
Functional Assessment of Cancer Therapy-Breast (FACT-B) Scores (Data Cutoff 20 December 2013)
Week 112/126: EWB (n=0,1)
|
NA score on a scale
Zero participants analyzed.
|
15.000 score on a scale
SD not calculated as only 1 participant was analyzed.
|
|
Functional Assessment of Cancer Therapy-Breast (FACT-B) Scores (Data Cutoff 20 December 2013)
Week 112/126: Breast Cancer (n=0,1)
|
NA score on a scale
Zero participants analyzed.
|
20.000 score on a scale
SD not calculated as only 1 participant was analyzed.
|
|
Functional Assessment of Cancer Therapy-Breast (FACT-B) Scores (Data Cutoff 20 December 2013)
Week 112/126: FACT-B TOI (n=0,1)
|
NA score on a scale
Zero participants analyzed.
|
45.000 score on a scale
SD not calculated as only 1 participant was analyzed.
|
|
Functional Assessment of Cancer Therapy-Breast (FACT-B) Scores (Data Cutoff 20 December 2013)
Week 112/126: Total FACT-G (n=0,1)
|
NA score on a scale
Zero participants analyzed.
|
55.400 score on a scale
SD not calculated as only 1 participant was analyzed.
|
|
Functional Assessment of Cancer Therapy-Breast (FACT-B) Scores (Data Cutoff 20 December 2013)
Week 112/126: Total FACT-B (n=0,1)
|
NA score on a scale
Zero participants analyzed.
|
75.400 score on a scale
SD not calculated as only 1 participant was analyzed.
|
|
Functional Assessment of Cancer Therapy-Breast (FACT-B) Scores (Data Cutoff 20 December 2013)
Second-Line PD: PWB (n=89,81)
|
19.086 score on a scale
Interval 17.873 to 20.299
|
17.412 score on a scale
Interval 15.977 to 18.846
|
|
Functional Assessment of Cancer Therapy-Breast (FACT-B) Scores (Data Cutoff 20 December 2013)
Second-Line PD: SWB (n=88,79)
|
20.623 score on a scale
Interval 19.456 to 21.79
|
21.487 score on a scale
Interval 20.335 to 22.639
|
|
Functional Assessment of Cancer Therapy-Breast (FACT-B) Scores (Data Cutoff 20 December 2013)
Second-Line PD: EWB (n=88,80)
|
15.111 score on a scale
Interval 14.102 to 16.121
|
14.175 score on a scale
Interval 12.872 to 15.478
|
|
Functional Assessment of Cancer Therapy-Breast (FACT-B) Scores (Data Cutoff 20 December 2013)
Second-Line PD: FWB (n=88,80)
|
15.447 score on a scale
Interval 14.122 to 16.772
|
15.235 score on a scale
Interval 13.877 to 16.593
|
|
Functional Assessment of Cancer Therapy-Breast (FACT-B) Scores (Data Cutoff 20 December 2013)
Second-Line PD: Breast Cancer (n=85,81)
|
24.978 score on a scale
Interval 23.602 to 26.354
|
24.445 score on a scale
Interval 22.989 to 25.901
|
|
Functional Assessment of Cancer Therapy-Breast (FACT-B) Scores (Data Cutoff 20 December 2013)
Second-Line PD: FACT-B TOI (n=84,80)
|
59.230 score on a scale
Interval 56.033 to 62.428
|
57.002 score on a scale
Interval 53.234 to 60.77
|
|
Functional Assessment of Cancer Therapy-Breast (FACT-B) Scores (Data Cutoff 20 December 2013)
Second-Line PD: Total FACT-G (n=86,78)
|
69.829 score on a scale
Interval 66.264 to 73.393
|
68.485 score on a scale
Interval 64.384 to 72.586
|
|
Functional Assessment of Cancer Therapy-Breast (FACT-B) Scores (Data Cutoff 20 December 2013)
Second-Line PD: Total FACT-B (n=82,78)
|
94.930 score on a scale
Interval 90.24 to 99.619
|
92.983 score on a scale
Interval 87.645 to 98.32
|
SECONDARY outcome
Timeframe: Baseline (≤28 days after randomization), every 8-9 weeks thereafter until second-line PD (up to approximately 3 years)Population: ITT population. Here, Number of participants analyzed = participants evaluable for this outcome measure and n=number of participants who completed the assessment at the specified timepoint.
The FACT-B is composed of 5 multi-item sections where participants responded to questions assessing symptoms (scale: 0-4; 0="not at all" and 4="very much"), as follows: PWB (7 items, total score 0-28), SWB (7 items, total score 0-28), EWB (6 items, total score 0-24), FWB (7 items, total score 0-28); and breast cancer score based on the additional concerns section of FACT-B (10 items, total score 0-40). The FACT-B TOI score=sum of PWB, FWB, and breast cancer score subscale scores (total score 0-96). The FACT-G total score=sum of PWB, SWB, EWB, and FWB subscales scores (total score 0-108). The FACT-B total score=sum of PWB, SWB, EWB, FWB, and breast cancer score subscale scores (total score 0-148). In all cases a higher value indicated a better perceived quality of life.
Outcome measures
| Measure |
CT Arm
n=118 Participants
Participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator's site until disease progression, unacceptable toxicity, participant request for withdrawal, until the maximum cumulative dose of anthracycline was reached, or end of study (24 months after randomization of the last participant). Upon second-line disease progression participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator's site until disease progression, unacceptable toxicity, participant request for withdrawal, or end of study. Upon subsequent disease progression participants received treatment according the standard of care of the treatment site until end of study.
|
CT+BV Arm
n=128 Participants
Participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator's site plus bevacizumab, 15 mg/kg, IV, every 3 weeks, or 10 mg/kg, IV, every 2 weeks until disease progression, unacceptable toxicity, participant request for withdrawal, until the maximum cumulative dose of anthracycline was reached, or end of study (24 months after randomization of the last participant). Upon second-line disease progression participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator's site plus bevacizumab, 15 mg/kg, IV, every 3 weeks, or 10 mg/kg, IV, every 2 weeks until disease progression, unacceptable toxicity, participant request for withdrawal, or end of study. Upon subsequent disease progression participants received treatment according the standard of care of the treatment site until end of study.
|
|---|---|---|
|
Change From Baseline in FACT-B Scores (Data Cutoff 20 December 2013)
Week 8/9: PWB (n=118,125)
|
-1.281 score on a scale
Interval -2.219 to -0.344
|
-1.289 score on a scale
Interval -2.239 to -0.338
|
|
Change From Baseline in FACT-B Scores (Data Cutoff 20 December 2013)
Week 8/9: SWB (n=116,125)
|
0.356 score on a scale
Interval -0.283 to 0.994
|
0.707 score on a scale
Interval -0.226 to 1.64
|
|
Change From Baseline in FACT-B Scores (Data Cutoff 20 December 2013)
Week 8/9: EWB (n=116,128)
|
0.408 score on a scale
Interval -0.274 to 1.089
|
1.024 score on a scale
Interval 0.314 to 1.734
|
|
Change From Baseline in FACT-B Scores (Data Cutoff 20 December 2013)
Week 8/9: FWB (n=117,128)
|
-0.226 score on a scale
Interval -1.043 to 0.591
|
-0.240 score on a scale
Interval -1.027 to 0.548
|
|
Change From Baseline in FACT-B Scores (Data Cutoff 20 December 2013)
Week 8/9: Breast Cancer Score (n=113,128)
|
0.228 score on a scale
Interval -0.659 to 1.116
|
0.950 score on a scale
Interval 0.121 to 1.78
|
|
Change From Baseline in FACT-B Scores (Data Cutoff 20 December 2013)
Week 8/9: FACT-B TOI (n=110,122)
|
-1.361 score on a scale
Interval -3.295 to 0.573
|
-0.357 score on a scale
Interval -2.407 to 1.693
|
|
Change From Baseline in FACT-B Scores (Data Cutoff 20 December 2013)
Week 8/9: Total FACT-G Score (n=110,122)
|
-0.760 score on a scale
Interval -2.92 to 1.399
|
0.369 score on a scale
Interval -1.945 to 2.684
|
|
Change From Baseline in FACT-B Scores (Data Cutoff 20 December 2013)
Week 8/9: Total FACT-B Score (n=108,120)
|
-0.728 score on a scale
Interval -3.332 to 1.876
|
1.342 score on a scale
Interval -1.544 to 4.229
|
|
Change From Baseline in FACT-B Scores (Data Cutoff 20 December 2013)
Week 16/18: PWB (n=77,97)
|
0.294 score on a scale
Interval to 1.322
|
-1.823 score on a scale
Interval -2.871 to -0.775
|
|
Change From Baseline in FACT-B Scores (Data Cutoff 20 December 2013)
Week 16/18: SWB (n=74,97)
|
-0.443 score on a scale
Interval -1.411 to 0.525
|
0.359 score on a scale
Interval -0.678 to 1.397
|
|
Change From Baseline in FACT-B Scores (Data Cutoff 20 December 2013)
Week 16/18: EWB (n=73,98)
|
1.197 score on a scale
Interval 0.415 to 1.979
|
0.921 score on a scale
Interval 0.186 to 1.657
|
|
Change From Baseline in FACT-B Scores (Data Cutoff 20 December 2013)
Week 16/18: FWB (n=75,98)
|
-0.548 score on a scale
Interval -1.666 to 0.57
|
-0.517 score on a scale
Interval -1.422 to 0.389
|
|
Change From Baseline in FACT-B Scores (Data Cutoff 20 December 2013)
Week 16/18: Breast Cancer (n=72,97)
|
0.578 score on a scale
Interval -0.658 to 1.815
|
0.546 score on a scale
Interval -0.423 to 1.514
|
|
Change From Baseline in FACT-B Scores (Data Cutoff 20 December 2013)
Week 16/18: FACT-TOI (n=68,95)
|
-0.483 score on a scale
Interval -3.149 to 2.183
|
-1.732 score on a scale
Interval -4.049 to 0.586
|
|
Change From Baseline in FACT-B Scores (Data Cutoff 20 December 2013)
Week 16/18: Total FACT-G (n=71,93)
|
-0.019 score on a scale
Interval -2.97 to 2.931
|
-0.836 score on a scale
Interval -3.494 to 1.821
|
|
Change From Baseline in FACT-B Scores (Data Cutoff 20 December 2013)
Week 16/18: Total Fact-B (n=66,93)
|
-0.007 score on a scale
Interval -3.744 to 3.73
|
-0.127 score on a scale
Interval -3.421 to 3.167
|
|
Change From Baseline in FACT-B Scores (Data Cutoff 20 December 2013)
Week 24/27: PWB (n=44,73)
|
0.181 score on a scale
Interval -1.236 to 1.598
|
-1.996 score on a scale
Interval -3.306 to -0.685
|
|
Change From Baseline in FACT-B Scores (Data Cutoff 20 December 2013)
Week 24/27: SWB (n=44,72)
|
-0.193 score on a scale
Interval -1.49 to 1.104
|
1.375 score on a scale
Interval -0.001 to 2.75
|
|
Change From Baseline in FACT-B Scores (Data Cutoff 20 December 2013)
Week 24/27: EWB (n=42,72)
|
0.867 score on a scale
Interval -0.101 to 1.834
|
1.217 score on a scale
Interval 0.366 to 2.067
|
|
Change From Baseline in FACT-B Scores (Data Cutoff 20 December 2013)
Week 24/27: FWB (n=42,72)
|
0.119 score on a scale
Interval -1.405 to 1.643
|
0.056 score on a scale
Interval -1.053 to 1.166
|
|
Change From Baseline in FACT-B Scores (Data Cutoff 20 December 2013)
Week 24/27: Breast Cancer (n=40,72)
|
-0.038 score on a scale
Interval -1.723 to 1.647
|
0.078 score on a scale
Interval -1.106 to 1.262
|
|
Change From Baseline in FACT-B Scores (Data Cutoff 20 December 2013)
Week 24/27: FACT-B TOI (n=38,70)
|
0.221 score on a scale
Interval -3.411 to 3.853
|
-1.573 score on a scale
Interval -4.383 to 1.238
|
|
Change From Baseline in FACT-B Scores (Data Cutoff 20 December 2013)
Week 24/27: Total FACT-G (n=40,70)
|
0.764 score on a scale
Interval -3.066 to 4.595
|
0.817 score on a scale
Interval -2.497 to 4.131
|
|
Change From Baseline in FACT-B Scores (Data Cutoff 20 December 2013)
Week 24/27: Total FACT-B (n=37,70)
|
0.793 score on a scale
Interval -4.106 to 5.693
|
1.157 score on a scale
Interval -2.828 to 5.142
|
|
Change From Baseline in FACT-B Scores (Data Cutoff 20 December 2013)
Week 32/36: PWB (n=25,39)
|
0.880 score on a scale
Interval -0.913 to 2.673
|
-1.235 score on a scale
Interval -2.799 to 0.329
|
|
Change From Baseline in FACT-B Scores (Data Cutoff 20 December 2013)
Week 32/36: SWB (n=24,40)
|
-0.388 score on a scale
Interval -1.754 to 0.979
|
1.036 score on a scale
Interval -1.209 to 3.281
|
|
Change From Baseline in FACT-B Scores (Data Cutoff 20 December 2013)
Week 32/36: EWB (n=25,40)
|
1.064 score on a scale
Interval -0.298 to 2.426
|
1.555 score on a scale
Interval 0.204 to 2.906
|
|
Change From Baseline in FACT-B Scores (Data Cutoff 20 December 2013)
Week 32/36: FWB (n=25,40)
|
1.380 score on a scale
Interval -0.103 to 2.863
|
1.635 score on a scale
Interval -0.201 to 3.471
|
|
Change From Baseline in FACT-B Scores (Data Cutoff 20 December 2013)
Week 32/36: Breast Cancer (n=23,40)
|
0.928 score on a scale
Interval -1.916 to 3.771
|
1.278 score on a scale
Interval -0.435 to 2.99
|
|
Change From Baseline in FACT-B Scores (Data Cutoff 20 December 2013)
Week 32/36: FACT-B TOI (n=23,38)
|
3.123 score on a scale
Interval -1.39 to 7.637
|
1.471 score on a scale
Interval -2.522 to 5.464
|
|
Change From Baseline in FACT-B Scores (Data Cutoff 20 December 2013)
Week 32/36: Total FACT-G (n=24,39)
|
2.617 score on a scale
Interval -1.313 to 6.547
|
3.197 score on a scale
Interval -1.346 to 7.74
|
|
Change From Baseline in FACT-B Scores (Data Cutoff 20 December 2013)
Week 32/36: Total FACT-B (n=22,38)
|
3.529 score on a scale
Interval -2.074 to 9.132
|
3.896 score on a scale
Interval -1.579 to 9.37
|
|
Change From Baseline in FACT-B Scores (Data Cutoff 20 December 2013)
Week 40/45: PWB (n=18,25)
|
0.137 score on a scale
Interval -2.051 to 2.325
|
-0.680 score on a scale
Interval -2.93 to 1.57
|
|
Change From Baseline in FACT-B Scores (Data Cutoff 20 December 2013)
Week 40/45: SWB (n=19,24)
|
-0.589 score on a scale
Interval -2.436 to 1.259
|
0.951 score on a scale
Interval -1.59 to 3.492
|
|
Change From Baseline in FACT-B Scores (Data Cutoff 20 December 2013)
Week 40/45: EWB (n=18,25)
|
0.200 score on a scale
Interval -1.598 to 1.998
|
1.048 score on a scale
Interval -0.658 to 2.754
|
|
Change From Baseline in FACT-B Scores (Data Cutoff 20 December 2013)
Week 40/45: FWB (n=18,25)
|
1.417 score on a scale
Interval -0.562 to 3.395
|
0.857 score on a scale
Interval -0.893 to 2.608
|
|
Change From Baseline in FACT-B Scores (Data Cutoff 20 December 2013)
Week 40/45: Breast Cancer (n=18,25)
|
1.395 score on a scale
Interval -1.268 to 4.058
|
0.444 score on a scale
Interval -2.358 to 3.247
|
|
Change From Baseline in FACT-B Scores (Data Cutoff 20 December 2013)
Week 40/45: FACT-B TOI (n=16,25)
|
2.432 score on a scale
Interval -2.496 to 7.36
|
0.622 score on a scale
Interval -4.688 to 5.932
|
|
Change From Baseline in FACT-B Scores (Data Cutoff 20 December 2013)
Week 40/45: Total FACT-G (n=17,24)
|
1.444 score on a scale
Interval -3.342 to 6.231
|
2.432 score on a scale
Interval -3.035 to 7.899
|
|
Change From Baseline in FACT-B Scores (Data Cutoff 20 December 2013)
Week 40/45: Total FACT-B (n=16,24)
|
1.916 score on a scale
Interval -3.95 to 7.782
|
2.673 score on a scale
Interval -4.258 to 9.603
|
|
Change From Baseline in FACT-B Scores (Data Cutoff 20 December 2013)
Week 48/54: PWB (n=13,20)
|
1.295 score on a scale
Interval -2.037 to 4.627
|
-1.833 score on a scale
Interval -3.721 to 0.055
|
|
Change From Baseline in FACT-B Scores (Data Cutoff 20 December 2013)
Week 48/54: SWB (n=13,20)
|
1.529 score on a scale
Interval -0.316 to 3.375
|
2.008 score on a scale
Interval -1.083 to 5.099
|
|
Change From Baseline in FACT-B Scores (Data Cutoff 20 December 2013)
Week 48/54: EWB (n=13,20)
|
1.492 score on a scale
Interval 0.492 to 2.492
|
1.710 score on a scale
Interval -0.183 to 3.603
|
|
Change From Baseline in FACT-B Scores (Data Cutoff 20 December 2013)
Week 48/54: FWB (n=13,20)
|
2.269 score on a scale
Interval 0.174 to 4.365
|
1.592 score on a scale
Interval -0.872 to 4.055
|
|
Change From Baseline in FACT-B Scores (Data Cutoff 20 December 2013)
Week 48/54: Breast Cancer (n=12,20)
|
0.599 score on a scale
Interval -1.714 to 2.912
|
1.897 score on a scale
Interval -0.463 to 4.258
|
|
Change From Baseline in FACT-B Scores (Data Cutoff 20 December 2013)
Week 48/54: FACT-B TOI (n=12,20)
|
4.044 score on a scale
Interval -2.832 to 10.919
|
1.656 score on a scale
Interval -3.691 to 7.002
|
|
Change From Baseline in FACT-B Scores (Data Cutoff 20 December 2013)
Week 48/54: Total FACT-G (n=13,20)
|
6.586 score on a scale
Interval 1.392 to 11.78
|
3.477 score on a scale
Interval -2.596 to 9.55
|
|
Change From Baseline in FACT-B Scores (Data Cutoff 20 December 2013)
Week 48/54: Total FACT-B (n=12,20)
|
7.067 score on a scale
Interval 0.241 to 13.894
|
5.374 score on a scale
Interval -2.391 to 13.139
|
|
Change From Baseline in FACT-B Scores (Data Cutoff 20 December 2013)
Week 56/63: PWB (n=8,13)
|
-2.063 score on a scale
Interval -6.094 to 1.969
|
-0.526 score on a scale
Interval -3.996 to 2.944
|
|
Change From Baseline in FACT-B Scores (Data Cutoff 20 December 2013)
Week 56/63: SWB (n=8,13)
|
-1.500 score on a scale
Interval -5.699 to 2.699
|
3.033 score on a scale
Interval -1.729 to 7.796
|
|
Change From Baseline in FACT-B Scores (Data Cutoff 20 December 2013)
Week 56/63: EWB (n=7,13)
|
0.857 score on a scale
Interval -2.781 to 4.495
|
0.954 score on a scale
Interval -2.19 to 4.097
|
|
Change From Baseline in FACT-B Scores (Data Cutoff 20 December 2013)
Week 56/63: FWB (n=7,13)
|
0.000 score on a scale
Interval -4.835 to 4.835
|
5.654 score on a scale
Interval 0.511 to 10.797
|
|
Change From Baseline in FACT-B Scores (Data Cutoff 20 December 2013)
Week 56/63: Breast Cancer (n=8,13)
|
-0.830 score on a scale
Interval -6.133 to 4.474
|
1.675 score on a scale
Interval -1.291 to 4.641
|
|
Change From Baseline in FACT-B Scores (Data Cutoff 20 December 2013)
Week 56/63: FACT-B TOI (n=7,13)
|
-3.591 score on a scale
Interval -17.803 to 10.621
|
6.803 score on a scale
Interval 1.093 to 14.699
|
|
Change From Baseline in FACT-B Scores (Data Cutoff 20 December 2013)
Week 56/63: Total FACT-G (n=6,13)
|
-4.083 score on a scale
Interval -22.93 to 14.764
|
9.115 score on a scale
Interval -3.82 to 22.05
|
|
Change From Baseline in FACT-B Scores (Data Cutoff 20 December 2013)
Week 56/63: Total FACT-B (n=6,13)
|
-5.301 score on a scale
Interval -29.74 to 19.138
|
10.791 score on a scale
Interval -3.114 to 24.695
|
|
Change From Baseline in FACT-B Scores (Data Cutoff 20 December 2013)
Week 64/72: PWB (n=7,9)
|
0.000 score on a scale
Interval -6.733 to 6.733
|
0.926 score on a scale
Interval -1.491 to 3.342
|
|
Change From Baseline in FACT-B Scores (Data Cutoff 20 December 2013)
Week 64/72: SWB (n=7,9)
|
-2.014 score on a scale
Interval -5.182 to 1.154
|
3.570 score on a scale
Interval -1.034 to 8.174
|
|
Change From Baseline in FACT-B Scores (Data Cutoff 20 December 2013)
Week 64/72: EWB (n=7,9)
|
-0.057 score on a scale
Interval -3.537 to 3.423
|
3.667 score on a scale
Interval -0.63 to 7.964
|
|
Change From Baseline in FACT-B Scores (Data Cutoff 20 December 2013)
Week 64/72: FWB (n=7,9)
|
0.214 score on a scale
Interval -4.531 to 4.959
|
3.222 score on a scale
Interval -2.143 to 8.588
|
|
Change From Baseline in FACT-B Scores (Data Cutoff 20 December 2013)
Week 64/72: Breast Cancer (n=7,9)
|
-2.298 score on a scale
Interval -7.507 to 2.912
|
3.086 score on a scale
Interval -1.361 to 7.534
|
|
Change From Baseline in FACT-B Scores (Data Cutoff 20 December 2013)
Week 64/72: FACT-B TOI (n=7,9)
|
-2.083 score on a scale
Interval -17.13 to 12.963
|
7.235 score on a scale
Interval -3.624 to 18.093
|
|
Change From Baseline in FACT-B Scores (Data Cutoff 20 December 2013)
Week 64/72: Total FACT-G (n=7,9)
|
-1.857 score on a scale
Interval -17.855 to 14.14
|
11.385 score on a scale
Interval -3.116 to 25.886
|
|
Change From Baseline in FACT-B Scores (Data Cutoff 20 December 2013)
Week 64/72: Total FACT-B (n=7,9)
|
-4.155 score on a scale
Interval -24.302 to 15.993
|
14.472 score on a scale
Interval -4.192 to 33.135
|
|
Change From Baseline in FACT-B Scores (Data Cutoff 20 December 2013)
Week 72/81: PWB (n=5,7)
|
2.133 score on a scale
Interval -6.045 to 10.311
|
-0.429 score on a scale
Interval -3.965 to 3.108
|
|
Change From Baseline in FACT-B Scores (Data Cutoff 20 December 2013)
Week 72/81: SWB (n=4,7)
|
-1.208 score on a scale
Interval -5.126 to 2.71
|
6.829 score on a scale
Interval -3.189 to 16.846
|
|
Change From Baseline in FACT-B Scores (Data Cutoff 20 December 2013)
Week 72/81: EWB (n=5,7)
|
-0.600 score on a scale
Interval -5.042 to 3.842
|
4.686 score on a scale
Interval -0.608 to 9.979
|
|
Change From Baseline in FACT-B Scores (Data Cutoff 20 December 2013)
Week 72/81: FWB (n=5,7)
|
0.000 score on a scale
Interval -5.341 to 5.341
|
7.381 score on a scale
Interval -1.169 to 15.931
|
|
Change From Baseline in FACT-B Scores (Data Cutoff 20 December 2013)
Week 72/81: Breast Cancer (n=5,6)
|
-0.461 score on a scale
Interval -6.531 to 5.609
|
3.667 score on a scale
Interval -3.41 to 10.743
|
|
Change From Baseline in FACT-B Scores (Data Cutoff 20 December 2013)
Week 72/81: FACT-B TOI (n=5,6)
|
1.672 score on a scale
Interval -12.563 to 15.907
|
8.278 score on a scale
Interval -7.45 to 24.005
|
|
Change From Baseline in FACT-B Scores (Data Cutoff 20 December 2013)
Week 72/81: Total FACT-G (n=4,7)
|
-0.167 score on a scale
Interval -22.161 to 21.828
|
18.467 score on a scale
Interval -1.867 to 38.801
|
|
Change From Baseline in FACT-B Scores (Data Cutoff 20 December 2013)
Week 72/81: Total FACT-B (n=4,6)
|
1.174 score on a scale
Interval -23.085 to 25.432
|
16.906 score on a scale
Interval -9.207 to 43.018
|
|
Change From Baseline in FACT-B Scores (Data Cutoff 20 December 2013)
Week 80/90: PWB (n=2,3)
|
-3.750 score on a scale
Interval -30.221 to 22.721
|
-3.000 score on a scale
Interval -11.605 to 5.605
|
|
Change From Baseline in FACT-B Scores (Data Cutoff 20 December 2013)
Week 80/90: SWB (n=2,3)
|
-0.875 score on a scale
Interval -34.229 to 32.479
|
7.344 score on a scale
Interval -9.614 to 24.303
|
|
Change From Baseline in FACT-B Scores (Data Cutoff 20 December 2013)
Week 80/90: EWB (n=2,3)
|
-4.000 score on a scale
Interval -42.119 to 34.119
|
4.733 score on a scale
Interval -18.466 to 27.932
|
|
Change From Baseline in FACT-B Scores (Data Cutoff 20 December 2013)
Week 80/90: FWB (n=2,3)
|
-1.000 score on a scale
Interval -64.531 to 62.531
|
2.556 score on a scale
Interval -9.165 to 14.276
|
|
Change From Baseline in FACT-B Scores (Data Cutoff 20 December 2013)
Week 80/90: Breast Cancer (n=2,3)
|
-5.833 score on a scale
Interval -29.128 to 17.461
|
3.667 score on a scale
Interval -11.512 to 18.845
|
|
Change From Baseline in FACT-B Scores (Data Cutoff 20 December 2013)
Week 80/90: FACT-B TOI (n=2,3)
|
-10.583 score on a scale
Interval -77.291 to 56.124
|
3.222 score on a scale
Interval -30.212 to 36.657
|
|
Change From Baseline in FACT-B Scores (Data Cutoff 20 December 2013)
Week 80/90: Total FACT-G (n=2,3)
|
-9.625 score on a scale
Interval -171.1 to 151.85
|
11.633 score on a scale
Interval -41.554 to 64.821
|
|
Change From Baseline in FACT-B Scores (Data Cutoff 20 December 2013)
Week 80/90: Total FACT-B (n=2,3)
|
-15.458 score on a scale
Interval -153.638 to 122.722
|
15.300 score on a scale
Interval -48.177 to 78.777
|
|
Change From Baseline in FACT-B Scores (Data Cutoff 20 December 2013)
Week 88/99: PWB (n=0,1)
|
NA score on a scale
Zero participants analyzed.
|
-6.000 score on a scale
SD not calculated as only 1 participant was analyzed.
|
|
Change From Baseline in FACT-B Scores (Data Cutoff 20 December 2013)
Week 88/99: SWB (n=0,1)
|
NA score on a scale
Zero participants analyzed.
|
23.333 score on a scale
SD not calculated as only 1 participant was analyzed.
|
|
Change From Baseline in FACT-B Scores (Data Cutoff 20 December 2013)
Week 88/99: EWB (n=0,1)
|
NA score on a scale
Zero participants analyzed.
|
0.000 score on a scale
SD not calculated as only 1 participant was analyzed.
|
|
Change From Baseline in FACT-B Scores (Data Cutoff 20 December 2013)
Week 88/99: FWB (n=0,1)
|
NA score on a scale
Zero participants analyzed.
|
21.000 score on a scale
SD not calculated as only 1 participant was analyzed.
|
|
Change From Baseline in FACT-B Scores (Data Cutoff 20 December 2013)
Week 88/99: Breast Cancer (n=0,1)
|
NA score on a scale
Zero participants analyzed.
|
3.000 score on a scale
SD not calculated as only 1 participant was analyzed.
|
|
Change From Baseline in FACT-B Scores (Data Cutoff 20 December 2013)
Week 88/99: FACT TOI (n=0,1)
|
NA score on a scale
Zero participants analyzed.
|
18.000 score on a scale
SD not calculated as only 1 participant was analyzed.
|
|
Change From Baseline in FACT-B Scores (Data Cutoff 20 December 2013)
Week 88/99: Total FACT-G (n=0,1)
|
NA score on a scale
Zero participants analyzed.
|
38.333 score on a scale
SD not calculated as only 1 participant was analyzed.
|
|
Change From Baseline in FACT-B Scores (Data Cutoff 20 December 2013)
Week 88/99: Total FACT-B (n=0,1)
|
NA score on a scale
Zero participants analyzed.
|
41.333 score on a scale
SD not calculated as only 1 participant was analyzed.
|
|
Change From Baseline in FACT-B Scores (Data Cutoff 20 December 2013)
Week 96/108: PWB (n=2,1)
|
7.333 score on a scale
Interval -51.962 to 66.629
|
-3.000 score on a scale
SD not calculated as only 1 participant was analyzed.
|
|
Change From Baseline in FACT-B Scores (Data Cutoff 20 December 2013)
Week 96/108: SWB (n=2,1)
|
2.183 score on a scale
Interval -23.441 to 27.808
|
1.400 score on a scale
SD not calculated as only 1 participant was analyzed.
|
|
Change From Baseline in FACT-B Scores (Data Cutoff 20 December 2013)
Week 96/108: EWB (n=2,1)
|
0.000 score on a scale
Interval -12.706 to 12.706
|
6.000 score on a scale
SD not calculated as only 1 participant was analyzed.
|
|
Change From Baseline in FACT-B Scores (Data Cutoff 20 December 2013)
Week 96/108: FWB (n=2,1)
|
6.583 score on a scale
Interval -13.535 to 26.701
|
-1.333 score on a scale
SD not calculated as only 1 participant was analyzed.
|
|
Change From Baseline in FACT-B Scores (Data Cutoff 20 December 2013)
Week 96/108: Breast Cancer (n=2,1)
|
3.167 score on a scale
Interval -41.305 to 47.638
|
-3.000 score on a scale
SD not calculated as only 1 participant was analyzed.
|
|
Change From Baseline in FACT-B Scores (Data Cutoff 20 December 2013)
Week 96/108: FACT-B TOI (n=2,1)
|
17.083 score on a scale
Interval 11.789 to 22.378
|
-7.333 score on a scale
SD not calculated as only 1 participant was analyzed.
|
|
Change From Baseline in FACT-B Scores (Data Cutoff 20 December 2013)
Week 96/108: Total FACT-G (n=2,1)
|
16.100 score on a scale
Interval 15.253 to 16.947
|
3.067 score on a scale
SD not calculated as only 1 participant was analyzed.
|
|
Change From Baseline in FACT-B Scores (Data Cutoff 20 December 2013)
Week 96/108: Total FACT-B (n=2,1)
|
19.267 score on a scale
Interval -24.358 to 62.891
|
0.067 score on a scale
SD not calculated as only 1 participant was analyzed.
|
|
Change From Baseline in FACT-B Scores (Data Cutoff 20 December 2013)
Week 104/117: PWB (n=1,2)
|
3.667 score on a scale
SD not calculated as only 1 participant was analyzed.
|
-2.000 score on a scale
Interval -40.119 to 36.119
|
|
Change From Baseline in FACT-B Scores (Data Cutoff 20 December 2013)
Week 104/117: SWB (n=1,1)
|
4.200 score on a scale
SD not calculated as only 1 participant was analyzed.
|
8.800 score on a scale
SD not calculated as only 1 participant was analyzed.
|
|
Change From Baseline in FACT-B Scores (Data Cutoff 20 December 2013)
Week 104/117: EWB (n=1,2)
|
0.000 score on a scale
SD not calculated as only 1 participant was analyzed.
|
10.000 score on a scale
Interval -28.119 to 48.119
|
|
Change From Baseline in FACT-B Scores (Data Cutoff 20 December 2013)
Week 104/117: FWB (n=1,2)
|
8.000 score on a scale
SD not calculated as only 1 participant was analyzed.
|
2.333 score on a scale
Interval -56.962 to 61.629
|
|
Change From Baseline in FACT-B Scores (Data Cutoff 20 December 2013)
Week 104/117: Breast Cancer (n=1,2)
|
6.032 score on a scale
SD not calculated as only 1 participant was analyzed.
|
4.000 score on a scale
Interval -59.531 to 67.531
|
|
Change From Baseline in FACT-B Scores (Data Cutoff 20 December 2013)
Week 104/117: FACT-B TOI (n=1,2)
|
17.698 score on a scale
SD not calculated as only 1 participant was analyzed.
|
4.333 score on a scale
Interval -156.612 to 165.279
|
|
Change From Baseline in FACT-B Scores (Data Cutoff 20 December 2013)
Week 104/117: Total FACT-G (n=1,1)
|
15.867 score on a scale
SD not calculated as only 1 participant was analyzed.
|
29.800 score on a scale
SD not calculated as only 1 participant was analyzed.
|
|
Change From Baseline in FACT-B Scores (Data Cutoff 20 December 2013)
Week 104/117: Total GACT-B (n=1,1)
|
21.898 score on a scale
SD not calculated as only 1 participant was analyzed.
|
38.800 score on a scale
SD not calculated as only 1 participant was analyzed.
|
|
Change From Baseline in FACT-B Scores (Data Cutoff 20 December 2013)
Week 112/126: PWB (n=0,1)
|
NA score on a scale
Zero participants analyzed.
|
-11.000 score on a scale
SD not calculated as only 1 participant was analyzed.
|
|
Change From Baseline in FACT-B Scores (Data Cutoff 20 December 2013)
Week 112/126: SWB (n=0,1)
|
NA score on a scale
Zero participants analyzed.
|
-4.200 score on a scale
SD not calculated as only 1 participant was analyzed.
|
|
Change From Baseline in FACT-B Scores (Data Cutoff 20 December 2013)
Week 112/126: EWB (n=0,1)
|
NA score on a scale
Zero participants analyzed.
|
5.000 score on a scale
SD not calculated as only 1 participant was analyzed.
|
|
Change From Baseline in FACT-B Scores (Data Cutoff 20 December 2013)
Week 112/126: FWB (n=0,1)
|
NA score on a scale
Zero participants analyzed.
|
-5.333 score on a scale
SD not calculated as only 1 participant was analyzed.
|
|
Change From Baseline in FACT-B Scores (Data Cutoff 20 December 2013)
Week 112/126: Breast Cancer (n=0,1)
|
NA score on a scale
Zero participants analyzed.
|
-5.000 score on a scale
SD not calculated as only 1 participant was analyzed.
|
|
Change From Baseline in FACT-B Scores (Data Cutoff 20 December 2013)
Week 112/126: FACT-B TOI (n=0,1)
|
NA score on a scale
Zero participants analyzed.
|
-21.333 score on a scale
SD not calculated as only 1 participant was analyzed.
|
|
Change From Baseline in FACT-B Scores (Data Cutoff 20 December 2013)
Week 112/126: Total FACT-G (n=0,1)
|
NA score on a scale
Zero participants analyzed.
|
-15.533 score on a scale
SD not calculated as only 1 participant was analyzed.
|
|
Change From Baseline in FACT-B Scores (Data Cutoff 20 December 2013)
Week 112/126: Total FACT-B (n=0,1)
|
NA score on a scale
Zero participants analyzed.
|
-20.533 score on a scale
SD not calculated as only 1 participant was analyzed.
|
|
Change From Baseline in FACT-B Scores (Data Cutoff 20 December 2013)
Second-Line PD: PWB (n=81,77)
|
-0.871 score on a scale
Interval -1.916 to 0.174
|
-2.507 score on a scale
Interval -3.783 to -1.231
|
|
Change From Baseline in FACT-B Scores (Data Cutoff 20 December 2013)
Second-Line PD: SWB (n=80,75)
|
-0.106 score on a scale
Interval -0.902 to 0.69
|
-0.766 score on a scale
Interval -1.788 to 0.256
|
|
Change From Baseline in FACT-B Scores (Data Cutoff 20 December 2013)
Second-Line PD: EWB (n=80,76)
|
-0.440 score on a scale
Interval -1.553 to 0.673
|
-0.508 score on a scale
Interval -1.562 to 0.546
|
|
Change From Baseline in FACT-B Scores (Data Cutoff 20 December 2013)
Second-Line PD: FWB (n=80,76)
|
-1.415 score on a scale
Interval -2.59 to -0.239
|
-0.773 score on a scale
Interval -1.809 to 0.263
|
|
Change From Baseline in FACT-B Scores (Data Cutoff 20 December 2013)
Second-Line PD: Breast Cancer (n=77,77)
|
0.120 score on a scale
Interval -1.182 to 1.421
|
0.241 score on a scale
Interval -0.878 to 1.36
|
|
Change From Baseline in FACT-B Scores (Data Cutoff 20 December 2013)
Second-Line PD: FACT-B TOI (n=74,76)
|
-2.311 score on a scale
Interval -5.07 to 0.447
|
-3.003 score on a scale
Interval -5.734 to -0.273
|
|
Change From Baseline in FACT-B Scores (Data Cutoff 20 December 2013)
Second-Line PD: Total FACT-G (n=76,74)
|
-2.771 score on a scale
Interval -5.902 to 0.361
|
-4.702 score on a scale
Interval -7.941 to -1.462
|
|
Change From Baseline in FACT-B Scores (Data Cutoff 20 December 2013)
Second-Line PD: Total FACT-B (n=72,74)
|
-2.719 score on a scale
Interval -6.633 to 1.195
|
-4.440 score on a scale
Interval -8.515 to -0.366
|
Adverse Events
CT Arm
Serious events: 55 serious events
Other events: 181 other events
Deaths: 0 deaths
CT+BV Arm
Serious events: 89 serious events
Other events: 218 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
CT Arm
n=238 participants at risk
Participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator's site until disease progression, unacceptable toxicity, participant request for withdrawal, until the maximum cumulative dose of anthracycline was reached, or end of study (24 months after randomization of the last participant). Upon second-line disease progression participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator's site until disease progression, unacceptable toxicity, participant request for withdrawal, or end of study. Upon subsequent disease progression participants received treatment according the standard of care of the treatment site until end of study.
|
CT+BV Arm
n=245 participants at risk
Participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator's site plus bevacizumab, 15 mg/kg, IV, every 3 weeks, or 10 mg/kg, IV, every 2 weeks until disease progression, unacceptable toxicity, participant request for withdrawal, until the maximum cumulative dose of anthracycline was reached, or end of study (24 months after randomization of the last participant). Upon second-line disease progression participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator's site plus bevacizumab, 15 mg/kg, IV, every 3 weeks, or 10 mg/kg, IV, every 2 weeks until disease progression, unacceptable toxicity, participant request for withdrawal, or end of study. Upon subsequent disease progression participants received treatment according the standard of care of the treatment site until end of study.
|
|---|---|---|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
2.1%
5/238 • Baseline up to approximately 4 years.
All randomized participants who received at least 1 dose of bevacizumab and/or chemotherapy were included in the analysis.
|
4.9%
12/245 • Baseline up to approximately 4 years.
All randomized participants who received at least 1 dose of bevacizumab and/or chemotherapy were included in the analysis.
|
|
Blood and lymphatic system disorders
Neutropenia
|
2.5%
6/238 • Baseline up to approximately 4 years.
All randomized participants who received at least 1 dose of bevacizumab and/or chemotherapy were included in the analysis.
|
4.1%
10/245 • Baseline up to approximately 4 years.
All randomized participants who received at least 1 dose of bevacizumab and/or chemotherapy were included in the analysis.
|
|
Blood and lymphatic system disorders
Leukopenia
|
0.42%
1/238 • Baseline up to approximately 4 years.
All randomized participants who received at least 1 dose of bevacizumab and/or chemotherapy were included in the analysis.
|
0.82%
2/245 • Baseline up to approximately 4 years.
All randomized participants who received at least 1 dose of bevacizumab and/or chemotherapy were included in the analysis.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/238 • Baseline up to approximately 4 years.
All randomized participants who received at least 1 dose of bevacizumab and/or chemotherapy were included in the analysis.
|
2.0%
5/245 • Baseline up to approximately 4 years.
All randomized participants who received at least 1 dose of bevacizumab and/or chemotherapy were included in the analysis.
|
|
Blood and lymphatic system disorders
Anaemia
|
0.42%
1/238 • Baseline up to approximately 4 years.
All randomized participants who received at least 1 dose of bevacizumab and/or chemotherapy were included in the analysis.
|
0.41%
1/245 • Baseline up to approximately 4 years.
All randomized participants who received at least 1 dose of bevacizumab and/or chemotherapy were included in the analysis.
|
|
Blood and lymphatic system disorders
Pancytopenia
|
0.00%
0/238 • Baseline up to approximately 4 years.
All randomized participants who received at least 1 dose of bevacizumab and/or chemotherapy were included in the analysis.
|
0.41%
1/245 • Baseline up to approximately 4 years.
All randomized participants who received at least 1 dose of bevacizumab and/or chemotherapy were included in the analysis.
|
|
Infections and infestations
Infection
|
0.84%
2/238 • Baseline up to approximately 4 years.
All randomized participants who received at least 1 dose of bevacizumab and/or chemotherapy were included in the analysis.
|
1.2%
3/245 • Baseline up to approximately 4 years.
All randomized participants who received at least 1 dose of bevacizumab and/or chemotherapy were included in the analysis.
|
|
Infections and infestations
Bronchitis
|
0.00%
0/238 • Baseline up to approximately 4 years.
All randomized participants who received at least 1 dose of bevacizumab and/or chemotherapy were included in the analysis.
|
1.2%
3/245 • Baseline up to approximately 4 years.
All randomized participants who received at least 1 dose of bevacizumab and/or chemotherapy were included in the analysis.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/238 • Baseline up to approximately 4 years.
All randomized participants who received at least 1 dose of bevacizumab and/or chemotherapy were included in the analysis.
|
0.82%
2/245 • Baseline up to approximately 4 years.
All randomized participants who received at least 1 dose of bevacizumab and/or chemotherapy were included in the analysis.
|
|
Infections and infestations
Device related infection
|
0.42%
1/238 • Baseline up to approximately 4 years.
All randomized participants who received at least 1 dose of bevacizumab and/or chemotherapy were included in the analysis.
|
0.00%
0/245 • Baseline up to approximately 4 years.
All randomized participants who received at least 1 dose of bevacizumab and/or chemotherapy were included in the analysis.
|
|
Infections and infestations
Device related sepsis
|
0.42%
1/238 • Baseline up to approximately 4 years.
All randomized participants who received at least 1 dose of bevacizumab and/or chemotherapy were included in the analysis.
|
0.00%
0/245 • Baseline up to approximately 4 years.
All randomized participants who received at least 1 dose of bevacizumab and/or chemotherapy were included in the analysis.
|
|
Infections and infestations
Ear infection
|
0.42%
1/238 • Baseline up to approximately 4 years.
All randomized participants who received at least 1 dose of bevacizumab and/or chemotherapy were included in the analysis.
|
0.00%
0/245 • Baseline up to approximately 4 years.
All randomized participants who received at least 1 dose of bevacizumab and/or chemotherapy were included in the analysis.
|
|
Infections and infestations
Enterocolitis infectious
|
0.42%
1/238 • Baseline up to approximately 4 years.
All randomized participants who received at least 1 dose of bevacizumab and/or chemotherapy were included in the analysis.
|
0.00%
0/245 • Baseline up to approximately 4 years.
All randomized participants who received at least 1 dose of bevacizumab and/or chemotherapy were included in the analysis.
|
|
Infections and infestations
Erysipelas
|
0.42%
1/238 • Baseline up to approximately 4 years.
All randomized participants who received at least 1 dose of bevacizumab and/or chemotherapy were included in the analysis.
|
0.00%
0/245 • Baseline up to approximately 4 years.
All randomized participants who received at least 1 dose of bevacizumab and/or chemotherapy were included in the analysis.
|
|
Infections and infestations
Herpes zoster
|
0.42%
1/238 • Baseline up to approximately 4 years.
All randomized participants who received at least 1 dose of bevacizumab and/or chemotherapy were included in the analysis.
|
0.00%
0/245 • Baseline up to approximately 4 years.
All randomized participants who received at least 1 dose of bevacizumab and/or chemotherapy were included in the analysis.
|
|
Infections and infestations
Injection site infection
|
0.42%
1/238 • Baseline up to approximately 4 years.
All randomized participants who received at least 1 dose of bevacizumab and/or chemotherapy were included in the analysis.
|
0.00%
0/245 • Baseline up to approximately 4 years.
All randomized participants who received at least 1 dose of bevacizumab and/or chemotherapy were included in the analysis.
|
|
Infections and infestations
Osteomyelitis
|
0.00%
0/238 • Baseline up to approximately 4 years.
All randomized participants who received at least 1 dose of bevacizumab and/or chemotherapy were included in the analysis.
|
0.41%
1/245 • Baseline up to approximately 4 years.
All randomized participants who received at least 1 dose of bevacizumab and/or chemotherapy were included in the analysis.
|
|
Infections and infestations
Sepsis
|
0.00%
0/238 • Baseline up to approximately 4 years.
All randomized participants who received at least 1 dose of bevacizumab and/or chemotherapy were included in the analysis.
|
0.82%
2/245 • Baseline up to approximately 4 years.
All randomized participants who received at least 1 dose of bevacizumab and/or chemotherapy were included in the analysis.
|
|
Infections and infestations
Tooth infection
|
0.00%
0/238 • Baseline up to approximately 4 years.
All randomized participants who received at least 1 dose of bevacizumab and/or chemotherapy were included in the analysis.
|
0.41%
1/245 • Baseline up to approximately 4 years.
All randomized participants who received at least 1 dose of bevacizumab and/or chemotherapy were included in the analysis.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/238 • Baseline up to approximately 4 years.
All randomized participants who received at least 1 dose of bevacizumab and/or chemotherapy were included in the analysis.
|
0.41%
1/245 • Baseline up to approximately 4 years.
All randomized participants who received at least 1 dose of bevacizumab and/or chemotherapy were included in the analysis.
|
|
Infections and infestations
Wound infection
|
0.00%
0/238 • Baseline up to approximately 4 years.
All randomized participants who received at least 1 dose of bevacizumab and/or chemotherapy were included in the analysis.
|
0.41%
1/245 • Baseline up to approximately 4 years.
All randomized participants who received at least 1 dose of bevacizumab and/or chemotherapy were included in the analysis.
|
|
General disorders
Pyrexia
|
0.84%
2/238 • Baseline up to approximately 4 years.
All randomized participants who received at least 1 dose of bevacizumab and/or chemotherapy were included in the analysis.
|
1.6%
4/245 • Baseline up to approximately 4 years.
All randomized participants who received at least 1 dose of bevacizumab and/or chemotherapy were included in the analysis.
|
|
General disorders
Fatigue
|
0.84%
2/238 • Baseline up to approximately 4 years.
All randomized participants who received at least 1 dose of bevacizumab and/or chemotherapy were included in the analysis.
|
0.82%
2/245 • Baseline up to approximately 4 years.
All randomized participants who received at least 1 dose of bevacizumab and/or chemotherapy were included in the analysis.
|
|
General disorders
General physical health deterioration
|
0.42%
1/238 • Baseline up to approximately 4 years.
All randomized participants who received at least 1 dose of bevacizumab and/or chemotherapy were included in the analysis.
|
0.82%
2/245 • Baseline up to approximately 4 years.
All randomized participants who received at least 1 dose of bevacizumab and/or chemotherapy were included in the analysis.
|
|
General disorders
Chest discomfort
|
0.42%
1/238 • Baseline up to approximately 4 years.
All randomized participants who received at least 1 dose of bevacizumab and/or chemotherapy were included in the analysis.
|
0.00%
0/245 • Baseline up to approximately 4 years.
All randomized participants who received at least 1 dose of bevacizumab and/or chemotherapy were included in the analysis.
|
|
General disorders
Chest pain
|
0.42%
1/238 • Baseline up to approximately 4 years.
All randomized participants who received at least 1 dose of bevacizumab and/or chemotherapy were included in the analysis.
|
0.00%
0/245 • Baseline up to approximately 4 years.
All randomized participants who received at least 1 dose of bevacizumab and/or chemotherapy were included in the analysis.
|
|
General disorders
Device failure
|
0.00%
0/238 • Baseline up to approximately 4 years.
All randomized participants who received at least 1 dose of bevacizumab and/or chemotherapy were included in the analysis.
|
0.41%
1/245 • Baseline up to approximately 4 years.
All randomized participants who received at least 1 dose of bevacizumab and/or chemotherapy were included in the analysis.
|
|
General disorders
Mucosal inflammation
|
0.42%
1/238 • Baseline up to approximately 4 years.
All randomized participants who received at least 1 dose of bevacizumab and/or chemotherapy were included in the analysis.
|
1.2%
3/245 • Baseline up to approximately 4 years.
All randomized participants who received at least 1 dose of bevacizumab and/or chemotherapy were included in the analysis.
|
|
General disorders
Pain
|
0.42%
1/238 • Baseline up to approximately 4 years.
All randomized participants who received at least 1 dose of bevacizumab and/or chemotherapy were included in the analysis.
|
0.00%
0/245 • Baseline up to approximately 4 years.
All randomized participants who received at least 1 dose of bevacizumab and/or chemotherapy were included in the analysis.
|
|
General disorders
Sudden death
|
0.00%
0/238 • Baseline up to approximately 4 years.
All randomized participants who received at least 1 dose of bevacizumab and/or chemotherapy were included in the analysis.
|
0.41%
1/245 • Baseline up to approximately 4 years.
All randomized participants who received at least 1 dose of bevacizumab and/or chemotherapy were included in the analysis.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.84%
2/238 • Baseline up to approximately 4 years.
All randomized participants who received at least 1 dose of bevacizumab and/or chemotherapy were included in the analysis.
|
1.6%
4/245 • Baseline up to approximately 4 years.
All randomized participants who received at least 1 dose of bevacizumab and/or chemotherapy were included in the analysis.
|
|
Gastrointestinal disorders
Vomiting
|
0.42%
1/238 • Baseline up to approximately 4 years.
All randomized participants who received at least 1 dose of bevacizumab and/or chemotherapy were included in the analysis.
|
0.82%
2/245 • Baseline up to approximately 4 years.
All randomized participants who received at least 1 dose of bevacizumab and/or chemotherapy were included in the analysis.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.42%
1/238 • Baseline up to approximately 4 years.
All randomized participants who received at least 1 dose of bevacizumab and/or chemotherapy were included in the analysis.
|
0.41%
1/245 • Baseline up to approximately 4 years.
All randomized participants who received at least 1 dose of bevacizumab and/or chemotherapy were included in the analysis.
|
|
Gastrointestinal disorders
Anal fissure
|
0.00%
0/238 • Baseline up to approximately 4 years.
All randomized participants who received at least 1 dose of bevacizumab and/or chemotherapy were included in the analysis.
|
0.41%
1/245 • Baseline up to approximately 4 years.
All randomized participants who received at least 1 dose of bevacizumab and/or chemotherapy were included in the analysis.
|
|
Gastrointestinal disorders
Diverticular perforation
|
0.00%
0/238 • Baseline up to approximately 4 years.
All randomized participants who received at least 1 dose of bevacizumab and/or chemotherapy were included in the analysis.
|
0.41%
1/245 • Baseline up to approximately 4 years.
All randomized participants who received at least 1 dose of bevacizumab and/or chemotherapy were included in the analysis.
|
|
Gastrointestinal disorders
Faecaloma
|
0.00%
0/238 • Baseline up to approximately 4 years.
All randomized participants who received at least 1 dose of bevacizumab and/or chemotherapy were included in the analysis.
|
0.41%
1/245 • Baseline up to approximately 4 years.
All randomized participants who received at least 1 dose of bevacizumab and/or chemotherapy were included in the analysis.
|
|
Gastrointestinal disorders
Melaena
|
0.00%
0/238 • Baseline up to approximately 4 years.
All randomized participants who received at least 1 dose of bevacizumab and/or chemotherapy were included in the analysis.
|
0.41%
1/245 • Baseline up to approximately 4 years.
All randomized participants who received at least 1 dose of bevacizumab and/or chemotherapy were included in the analysis.
|
|
Gastrointestinal disorders
Nausea
|
0.42%
1/238 • Baseline up to approximately 4 years.
All randomized participants who received at least 1 dose of bevacizumab and/or chemotherapy were included in the analysis.
|
0.41%
1/245 • Baseline up to approximately 4 years.
All randomized participants who received at least 1 dose of bevacizumab and/or chemotherapy were included in the analysis.
|
|
Gastrointestinal disorders
Pancreatitis
|
0.42%
1/238 • Baseline up to approximately 4 years.
All randomized participants who received at least 1 dose of bevacizumab and/or chemotherapy were included in the analysis.
|
0.00%
0/245 • Baseline up to approximately 4 years.
All randomized participants who received at least 1 dose of bevacizumab and/or chemotherapy were included in the analysis.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.84%
2/238 • Baseline up to approximately 4 years.
All randomized participants who received at least 1 dose of bevacizumab and/or chemotherapy were included in the analysis.
|
2.4%
6/245 • Baseline up to approximately 4 years.
All randomized participants who received at least 1 dose of bevacizumab and/or chemotherapy were included in the analysis.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.42%
1/238 • Baseline up to approximately 4 years.
All randomized participants who received at least 1 dose of bevacizumab and/or chemotherapy were included in the analysis.
|
0.82%
2/245 • Baseline up to approximately 4 years.
All randomized participants who received at least 1 dose of bevacizumab and/or chemotherapy were included in the analysis.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.42%
1/238 • Baseline up to approximately 4 years.
All randomized participants who received at least 1 dose of bevacizumab and/or chemotherapy were included in the analysis.
|
1.2%
3/245 • Baseline up to approximately 4 years.
All randomized participants who received at least 1 dose of bevacizumab and/or chemotherapy were included in the analysis.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.00%
0/238 • Baseline up to approximately 4 years.
All randomized participants who received at least 1 dose of bevacizumab and/or chemotherapy were included in the analysis.
|
0.41%
1/245 • Baseline up to approximately 4 years.
All randomized participants who received at least 1 dose of bevacizumab and/or chemotherapy were included in the analysis.
|
|
Nervous system disorders
Ischaemic stoke
|
0.84%
2/238 • Baseline up to approximately 4 years.
All randomized participants who received at least 1 dose of bevacizumab and/or chemotherapy were included in the analysis.
|
0.00%
0/245 • Baseline up to approximately 4 years.
All randomized participants who received at least 1 dose of bevacizumab and/or chemotherapy were included in the analysis.
|
|
Nervous system disorders
Cerebrovascular accident
|
0.42%
1/238 • Baseline up to approximately 4 years.
All randomized participants who received at least 1 dose of bevacizumab and/or chemotherapy were included in the analysis.
|
0.00%
0/245 • Baseline up to approximately 4 years.
All randomized participants who received at least 1 dose of bevacizumab and/or chemotherapy were included in the analysis.
|
|
Nervous system disorders
Cerebrovascular disorder
|
0.42%
1/238 • Baseline up to approximately 4 years.
All randomized participants who received at least 1 dose of bevacizumab and/or chemotherapy were included in the analysis.
|
0.00%
0/245 • Baseline up to approximately 4 years.
All randomized participants who received at least 1 dose of bevacizumab and/or chemotherapy were included in the analysis.
|
|
Nervous system disorders
Convulsion
|
0.00%
0/238 • Baseline up to approximately 4 years.
All randomized participants who received at least 1 dose of bevacizumab and/or chemotherapy were included in the analysis.
|
0.82%
2/245 • Baseline up to approximately 4 years.
All randomized participants who received at least 1 dose of bevacizumab and/or chemotherapy were included in the analysis.
|
|
Nervous system disorders
Headache
|
0.42%
1/238 • Baseline up to approximately 4 years.
All randomized participants who received at least 1 dose of bevacizumab and/or chemotherapy were included in the analysis.
|
0.00%
0/245 • Baseline up to approximately 4 years.
All randomized participants who received at least 1 dose of bevacizumab and/or chemotherapy were included in the analysis.
|
|
Nervous system disorders
Motor dysfunction
|
0.42%
1/238 • Baseline up to approximately 4 years.
All randomized participants who received at least 1 dose of bevacizumab and/or chemotherapy were included in the analysis.
|
0.00%
0/245 • Baseline up to approximately 4 years.
All randomized participants who received at least 1 dose of bevacizumab and/or chemotherapy were included in the analysis.
|
|
Nervous system disorders
Partial seizures
|
0.42%
1/238 • Baseline up to approximately 4 years.
All randomized participants who received at least 1 dose of bevacizumab and/or chemotherapy were included in the analysis.
|
0.00%
0/245 • Baseline up to approximately 4 years.
All randomized participants who received at least 1 dose of bevacizumab and/or chemotherapy were included in the analysis.
|
|
Nervous system disorders
Polyneuropathy
|
0.42%
1/238 • Baseline up to approximately 4 years.
All randomized participants who received at least 1 dose of bevacizumab and/or chemotherapy were included in the analysis.
|
0.00%
0/245 • Baseline up to approximately 4 years.
All randomized participants who received at least 1 dose of bevacizumab and/or chemotherapy were included in the analysis.
|
|
Nervous system disorders
Spinal cord compression
|
0.42%
1/238 • Baseline up to approximately 4 years.
All randomized participants who received at least 1 dose of bevacizumab and/or chemotherapy were included in the analysis.
|
0.00%
0/245 • Baseline up to approximately 4 years.
All randomized participants who received at least 1 dose of bevacizumab and/or chemotherapy were included in the analysis.
|
|
Cardiac disorders
Cardiac failure
|
0.42%
1/238 • Baseline up to approximately 4 years.
All randomized participants who received at least 1 dose of bevacizumab and/or chemotherapy were included in the analysis.
|
0.82%
2/245 • Baseline up to approximately 4 years.
All randomized participants who received at least 1 dose of bevacizumab and/or chemotherapy were included in the analysis.
|
|
Cardiac disorders
Acute coronary syndrome
|
0.00%
0/238 • Baseline up to approximately 4 years.
All randomized participants who received at least 1 dose of bevacizumab and/or chemotherapy were included in the analysis.
|
0.41%
1/245 • Baseline up to approximately 4 years.
All randomized participants who received at least 1 dose of bevacizumab and/or chemotherapy were included in the analysis.
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/238 • Baseline up to approximately 4 years.
All randomized participants who received at least 1 dose of bevacizumab and/or chemotherapy were included in the analysis.
|
0.41%
1/245 • Baseline up to approximately 4 years.
All randomized participants who received at least 1 dose of bevacizumab and/or chemotherapy were included in the analysis.
|
|
Cardiac disorders
Cardiac failure congestive
|
0.00%
0/238 • Baseline up to approximately 4 years.
All randomized participants who received at least 1 dose of bevacizumab and/or chemotherapy were included in the analysis.
|
0.82%
2/245 • Baseline up to approximately 4 years.
All randomized participants who received at least 1 dose of bevacizumab and/or chemotherapy were included in the analysis.
|
|
Cardiac disorders
Cardiotoxicity
|
0.00%
0/238 • Baseline up to approximately 4 years.
All randomized participants who received at least 1 dose of bevacizumab and/or chemotherapy were included in the analysis.
|
0.41%
1/245 • Baseline up to approximately 4 years.
All randomized participants who received at least 1 dose of bevacizumab and/or chemotherapy were included in the analysis.
|
|
Cardiac disorders
Left ventricular failure
|
0.00%
0/238 • Baseline up to approximately 4 years.
All randomized participants who received at least 1 dose of bevacizumab and/or chemotherapy were included in the analysis.
|
0.41%
1/245 • Baseline up to approximately 4 years.
All randomized participants who received at least 1 dose of bevacizumab and/or chemotherapy were included in the analysis.
|
|
Cardiac disorders
Sinus tachycardia
|
0.42%
1/238 • Baseline up to approximately 4 years.
All randomized participants who received at least 1 dose of bevacizumab and/or chemotherapy were included in the analysis.
|
0.00%
0/245 • Baseline up to approximately 4 years.
All randomized participants who received at least 1 dose of bevacizumab and/or chemotherapy were included in the analysis.
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/238 • Baseline up to approximately 4 years.
All randomized participants who received at least 1 dose of bevacizumab and/or chemotherapy were included in the analysis.
|
0.41%
1/245 • Baseline up to approximately 4 years.
All randomized participants who received at least 1 dose of bevacizumab and/or chemotherapy were included in the analysis.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
0.42%
1/238 • Baseline up to approximately 4 years.
All randomized participants who received at least 1 dose of bevacizumab and/or chemotherapy were included in the analysis.
|
0.82%
2/245 • Baseline up to approximately 4 years.
All randomized participants who received at least 1 dose of bevacizumab and/or chemotherapy were included in the analysis.
|
|
Musculoskeletal and connective tissue disorders
Osteonecrosis of jaw
|
0.00%
0/238 • Baseline up to approximately 4 years.
All randomized participants who received at least 1 dose of bevacizumab and/or chemotherapy were included in the analysis.
|
0.82%
2/245 • Baseline up to approximately 4 years.
All randomized participants who received at least 1 dose of bevacizumab and/or chemotherapy were included in the analysis.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/238 • Baseline up to approximately 4 years.
All randomized participants who received at least 1 dose of bevacizumab and/or chemotherapy were included in the analysis.
|
0.41%
1/245 • Baseline up to approximately 4 years.
All randomized participants who received at least 1 dose of bevacizumab and/or chemotherapy were included in the analysis.
|
|
Musculoskeletal and connective tissue disorders
Pathological fracture
|
0.42%
1/238 • Baseline up to approximately 4 years.
All randomized participants who received at least 1 dose of bevacizumab and/or chemotherapy were included in the analysis.
|
0.00%
0/245 • Baseline up to approximately 4 years.
All randomized participants who received at least 1 dose of bevacizumab and/or chemotherapy were included in the analysis.
|
|
Investigations
Gamma-glutamyltransferase increased
|
0.42%
1/238 • Baseline up to approximately 4 years.
All randomized participants who received at least 1 dose of bevacizumab and/or chemotherapy were included in the analysis.
|
0.41%
1/245 • Baseline up to approximately 4 years.
All randomized participants who received at least 1 dose of bevacizumab and/or chemotherapy were included in the analysis.
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/238 • Baseline up to approximately 4 years.
All randomized participants who received at least 1 dose of bevacizumab and/or chemotherapy were included in the analysis.
|
0.41%
1/245 • Baseline up to approximately 4 years.
All randomized participants who received at least 1 dose of bevacizumab and/or chemotherapy were included in the analysis.
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/238 • Baseline up to approximately 4 years.
All randomized participants who received at least 1 dose of bevacizumab and/or chemotherapy were included in the analysis.
|
0.41%
1/245 • Baseline up to approximately 4 years.
All randomized participants who received at least 1 dose of bevacizumab and/or chemotherapy were included in the analysis.
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/238 • Baseline up to approximately 4 years.
All randomized participants who received at least 1 dose of bevacizumab and/or chemotherapy were included in the analysis.
|
0.41%
1/245 • Baseline up to approximately 4 years.
All randomized participants who received at least 1 dose of bevacizumab and/or chemotherapy were included in the analysis.
|
|
Investigations
Blood potassium increased
|
0.42%
1/238 • Baseline up to approximately 4 years.
All randomized participants who received at least 1 dose of bevacizumab and/or chemotherapy were included in the analysis.
|
0.00%
0/245 • Baseline up to approximately 4 years.
All randomized participants who received at least 1 dose of bevacizumab and/or chemotherapy were included in the analysis.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.42%
1/238 • Baseline up to approximately 4 years.
All randomized participants who received at least 1 dose of bevacizumab and/or chemotherapy were included in the analysis.
|
0.82%
2/245 • Baseline up to approximately 4 years.
All randomized participants who received at least 1 dose of bevacizumab and/or chemotherapy were included in the analysis.
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
0.42%
1/238 • Baseline up to approximately 4 years.
All randomized participants who received at least 1 dose of bevacizumab and/or chemotherapy were included in the analysis.
|
0.41%
1/245 • Baseline up to approximately 4 years.
All randomized participants who received at least 1 dose of bevacizumab and/or chemotherapy were included in the analysis.
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
0.00%
0/238 • Baseline up to approximately 4 years.
All randomized participants who received at least 1 dose of bevacizumab and/or chemotherapy were included in the analysis.
|
0.41%
1/245 • Baseline up to approximately 4 years.
All randomized participants who received at least 1 dose of bevacizumab and/or chemotherapy were included in the analysis.
|
|
Vascular disorders
Embolism venous
|
0.42%
1/238 • Baseline up to approximately 4 years.
All randomized participants who received at least 1 dose of bevacizumab and/or chemotherapy were included in the analysis.
|
1.2%
3/245 • Baseline up to approximately 4 years.
All randomized participants who received at least 1 dose of bevacizumab and/or chemotherapy were included in the analysis.
|
|
Vascular disorders
Haemorrhage
|
0.42%
1/238 • Baseline up to approximately 4 years.
All randomized participants who received at least 1 dose of bevacizumab and/or chemotherapy were included in the analysis.
|
0.41%
1/245 • Baseline up to approximately 4 years.
All randomized participants who received at least 1 dose of bevacizumab and/or chemotherapy were included in the analysis.
|
|
Psychiatric disorders
Depression
|
0.42%
1/238 • Baseline up to approximately 4 years.
All randomized participants who received at least 1 dose of bevacizumab and/or chemotherapy were included in the analysis.
|
0.41%
1/245 • Baseline up to approximately 4 years.
All randomized participants who received at least 1 dose of bevacizumab and/or chemotherapy were included in the analysis.
|
|
Psychiatric disorders
Confusional state
|
0.42%
1/238 • Baseline up to approximately 4 years.
All randomized participants who received at least 1 dose of bevacizumab and/or chemotherapy were included in the analysis.
|
0.00%
0/245 • Baseline up to approximately 4 years.
All randomized participants who received at least 1 dose of bevacizumab and/or chemotherapy were included in the analysis.
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.00%
0/238 • Baseline up to approximately 4 years.
All randomized participants who received at least 1 dose of bevacizumab and/or chemotherapy were included in the analysis.
|
0.82%
2/245 • Baseline up to approximately 4 years.
All randomized participants who received at least 1 dose of bevacizumab and/or chemotherapy were included in the analysis.
|
|
Hepatobiliary disorders
Cholecystitis
|
0.00%
0/238 • Baseline up to approximately 4 years.
All randomized participants who received at least 1 dose of bevacizumab and/or chemotherapy were included in the analysis.
|
0.41%
1/245 • Baseline up to approximately 4 years.
All randomized participants who received at least 1 dose of bevacizumab and/or chemotherapy were included in the analysis.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Endometrial adenocarcinoma
|
0.00%
0/238 • Baseline up to approximately 4 years.
All randomized participants who received at least 1 dose of bevacizumab and/or chemotherapy were included in the analysis.
|
0.41%
1/245 • Baseline up to approximately 4 years.
All randomized participants who received at least 1 dose of bevacizumab and/or chemotherapy were included in the analysis.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to liver
|
0.00%
0/238 • Baseline up to approximately 4 years.
All randomized participants who received at least 1 dose of bevacizumab and/or chemotherapy were included in the analysis.
|
0.41%
1/245 • Baseline up to approximately 4 years.
All randomized participants who received at least 1 dose of bevacizumab and/or chemotherapy were included in the analysis.
|
|
Renal and urinary disorders
Obstructive uropathy
|
0.42%
1/238 • Baseline up to approximately 4 years.
All randomized participants who received at least 1 dose of bevacizumab and/or chemotherapy were included in the analysis.
|
0.00%
0/245 • Baseline up to approximately 4 years.
All randomized participants who received at least 1 dose of bevacizumab and/or chemotherapy were included in the analysis.
|
|
Renal and urinary disorders
Postrenal failure
|
0.00%
0/238 • Baseline up to approximately 4 years.
All randomized participants who received at least 1 dose of bevacizumab and/or chemotherapy were included in the analysis.
|
0.41%
1/245 • Baseline up to approximately 4 years.
All randomized participants who received at least 1 dose of bevacizumab and/or chemotherapy were included in the analysis.
|
|
Reproductive system and breast disorders
Menstrual disorder
|
0.42%
1/238 • Baseline up to approximately 4 years.
All randomized participants who received at least 1 dose of bevacizumab and/or chemotherapy were included in the analysis.
|
0.00%
0/245 • Baseline up to approximately 4 years.
All randomized participants who received at least 1 dose of bevacizumab and/or chemotherapy were included in the analysis.
|
|
Reproductive system and breast disorders
Metrorrhagia
|
0.42%
1/238 • Baseline up to approximately 4 years.
All randomized participants who received at least 1 dose of bevacizumab and/or chemotherapy were included in the analysis.
|
0.00%
0/245 • Baseline up to approximately 4 years.
All randomized participants who received at least 1 dose of bevacizumab and/or chemotherapy were included in the analysis.
|
|
Surgical and medical procedures
Salpingo-oophorectomy
|
0.00%
0/238 • Baseline up to approximately 4 years.
All randomized participants who received at least 1 dose of bevacizumab and/or chemotherapy were included in the analysis.
|
0.41%
1/245 • Baseline up to approximately 4 years.
All randomized participants who received at least 1 dose of bevacizumab and/or chemotherapy were included in the analysis.
|
|
Surgical and medical procedures
Tooth extraction
|
0.42%
1/238 • Baseline up to approximately 4 years.
All randomized participants who received at least 1 dose of bevacizumab and/or chemotherapy were included in the analysis.
|
0.00%
0/245 • Baseline up to approximately 4 years.
All randomized participants who received at least 1 dose of bevacizumab and/or chemotherapy were included in the analysis.
|
|
Injury, poisoning and procedural complications
Foot fracture
|
0.42%
1/238 • Baseline up to approximately 4 years.
All randomized participants who received at least 1 dose of bevacizumab and/or chemotherapy were included in the analysis.
|
0.00%
0/245 • Baseline up to approximately 4 years.
All randomized participants who received at least 1 dose of bevacizumab and/or chemotherapy were included in the analysis.
|
|
Skin and subcutaneous tissue disorders
Skin ulcer
|
0.00%
0/238 • Baseline up to approximately 4 years.
All randomized participants who received at least 1 dose of bevacizumab and/or chemotherapy were included in the analysis.
|
0.41%
1/245 • Baseline up to approximately 4 years.
All randomized participants who received at least 1 dose of bevacizumab and/or chemotherapy were included in the analysis.
|
|
Infections and infestations
Anal abscess
|
0.00%
0/238 • Baseline up to approximately 4 years.
All randomized participants who received at least 1 dose of bevacizumab and/or chemotherapy were included in the analysis.
|
0.41%
1/245 • Baseline up to approximately 4 years.
All randomized participants who received at least 1 dose of bevacizumab and/or chemotherapy were included in the analysis.
|
|
Infections and infestations
Peritonitis bacterial
|
0.00%
0/238 • Baseline up to approximately 4 years.
All randomized participants who received at least 1 dose of bevacizumab and/or chemotherapy were included in the analysis.
|
0.41%
1/245 • Baseline up to approximately 4 years.
All randomized participants who received at least 1 dose of bevacizumab and/or chemotherapy were included in the analysis.
|
|
Infections and infestations
Pseudomembranous colitis
|
0.00%
0/238 • Baseline up to approximately 4 years.
All randomized participants who received at least 1 dose of bevacizumab and/or chemotherapy were included in the analysis.
|
0.41%
1/245 • Baseline up to approximately 4 years.
All randomized participants who received at least 1 dose of bevacizumab and/or chemotherapy were included in the analysis.
|
|
Infections and infestations
Urosepsis
|
0.00%
0/238 • Baseline up to approximately 4 years.
All randomized participants who received at least 1 dose of bevacizumab and/or chemotherapy were included in the analysis.
|
0.41%
1/245 • Baseline up to approximately 4 years.
All randomized participants who received at least 1 dose of bevacizumab and/or chemotherapy were included in the analysis.
|
|
Injury, poisoning and procedural complications
Femoral neck fracture
|
0.42%
1/238 • Baseline up to approximately 4 years.
All randomized participants who received at least 1 dose of bevacizumab and/or chemotherapy were included in the analysis.
|
0.41%
1/245 • Baseline up to approximately 4 years.
All randomized participants who received at least 1 dose of bevacizumab and/or chemotherapy were included in the analysis.
|
|
Injury, poisoning and procedural complications
Head injury
|
0.00%
0/238 • Baseline up to approximately 4 years.
All randomized participants who received at least 1 dose of bevacizumab and/or chemotherapy were included in the analysis.
|
0.41%
1/245 • Baseline up to approximately 4 years.
All randomized participants who received at least 1 dose of bevacizumab and/or chemotherapy were included in the analysis.
|
|
Injury, poisoning and procedural complications
Subdural haematoma
|
0.00%
0/238 • Baseline up to approximately 4 years.
All randomized participants who received at least 1 dose of bevacizumab and/or chemotherapy were included in the analysis.
|
0.41%
1/245 • Baseline up to approximately 4 years.
All randomized participants who received at least 1 dose of bevacizumab and/or chemotherapy were included in the analysis.
|
|
Investigations
Biopsy liver
|
0.42%
1/238 • Baseline up to approximately 4 years.
All randomized participants who received at least 1 dose of bevacizumab and/or chemotherapy were included in the analysis.
|
0.00%
0/245 • Baseline up to approximately 4 years.
All randomized participants who received at least 1 dose of bevacizumab and/or chemotherapy were included in the analysis.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.00%
0/238 • Baseline up to approximately 4 years.
All randomized participants who received at least 1 dose of bevacizumab and/or chemotherapy were included in the analysis.
|
0.41%
1/245 • Baseline up to approximately 4 years.
All randomized participants who received at least 1 dose of bevacizumab and/or chemotherapy were included in the analysis.
|
|
Nervous system disorders
Facial paresis
|
0.00%
0/238 • Baseline up to approximately 4 years.
All randomized participants who received at least 1 dose of bevacizumab and/or chemotherapy were included in the analysis.
|
0.41%
1/245 • Baseline up to approximately 4 years.
All randomized participants who received at least 1 dose of bevacizumab and/or chemotherapy were included in the analysis.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia aspiration
|
0.42%
1/238 • Baseline up to approximately 4 years.
All randomized participants who received at least 1 dose of bevacizumab and/or chemotherapy were included in the analysis.
|
0.00%
0/245 • Baseline up to approximately 4 years.
All randomized participants who received at least 1 dose of bevacizumab and/or chemotherapy were included in the analysis.
|
|
Cardiac disorders
Angina pectoris
|
0.42%
1/238 • Baseline up to approximately 4 years.
All randomized participants who received at least 1 dose of bevacizumab and/or chemotherapy were included in the analysis.
|
0.41%
1/245 • Baseline up to approximately 4 years.
All randomized participants who received at least 1 dose of bevacizumab and/or chemotherapy were included in the analysis.
|
|
Cardiac disorders
Atrial tachycardia
|
0.42%
1/238 • Baseline up to approximately 4 years.
All randomized participants who received at least 1 dose of bevacizumab and/or chemotherapy were included in the analysis.
|
0.00%
0/245 • Baseline up to approximately 4 years.
All randomized participants who received at least 1 dose of bevacizumab and/or chemotherapy were included in the analysis.
|
|
Cardiac disorders
Congestive cardiomyopathy
|
0.00%
0/238 • Baseline up to approximately 4 years.
All randomized participants who received at least 1 dose of bevacizumab and/or chemotherapy were included in the analysis.
|
0.41%
1/245 • Baseline up to approximately 4 years.
All randomized participants who received at least 1 dose of bevacizumab and/or chemotherapy were included in the analysis.
|
|
Cardiac disorders
Left ventricular dysfunction
|
0.00%
0/238 • Baseline up to approximately 4 years.
All randomized participants who received at least 1 dose of bevacizumab and/or chemotherapy were included in the analysis.
|
0.41%
1/245 • Baseline up to approximately 4 years.
All randomized participants who received at least 1 dose of bevacizumab and/or chemotherapy were included in the analysis.
|
|
Cardiac disorders
Mitral valve incompetence
|
0.42%
1/238 • Baseline up to approximately 4 years.
All randomized participants who received at least 1 dose of bevacizumab and/or chemotherapy were included in the analysis.
|
0.00%
0/245 • Baseline up to approximately 4 years.
All randomized participants who received at least 1 dose of bevacizumab and/or chemotherapy were included in the analysis.
|
|
Gastrointestinal disorders
Ileus paralytic
|
0.42%
1/238 • Baseline up to approximately 4 years.
All randomized participants who received at least 1 dose of bevacizumab and/or chemotherapy were included in the analysis.
|
0.00%
0/245 • Baseline up to approximately 4 years.
All randomized participants who received at least 1 dose of bevacizumab and/or chemotherapy were included in the analysis.
|
|
Gastrointestinal disorders
Subileus
|
0.00%
0/238 • Baseline up to approximately 4 years.
All randomized participants who received at least 1 dose of bevacizumab and/or chemotherapy were included in the analysis.
|
0.41%
1/245 • Baseline up to approximately 4 years.
All randomized participants who received at least 1 dose of bevacizumab and/or chemotherapy were included in the analysis.
|
|
General disorders
Device dislocation
|
0.42%
1/238 • Baseline up to approximately 4 years.
All randomized participants who received at least 1 dose of bevacizumab and/or chemotherapy were included in the analysis.
|
0.00%
0/245 • Baseline up to approximately 4 years.
All randomized participants who received at least 1 dose of bevacizumab and/or chemotherapy were included in the analysis.
|
|
General disorders
Device occlusion
|
0.42%
1/238 • Baseline up to approximately 4 years.
All randomized participants who received at least 1 dose of bevacizumab and/or chemotherapy were included in the analysis.
|
0.00%
0/245 • Baseline up to approximately 4 years.
All randomized participants who received at least 1 dose of bevacizumab and/or chemotherapy were included in the analysis.
|
|
General disorders
Impaired healing
|
0.00%
0/238 • Baseline up to approximately 4 years.
All randomized participants who received at least 1 dose of bevacizumab and/or chemotherapy were included in the analysis.
|
0.41%
1/245 • Baseline up to approximately 4 years.
All randomized participants who received at least 1 dose of bevacizumab and/or chemotherapy were included in the analysis.
|
|
General disorders
Multi-organ failure
|
0.00%
0/238 • Baseline up to approximately 4 years.
All randomized participants who received at least 1 dose of bevacizumab and/or chemotherapy were included in the analysis.
|
0.41%
1/245 • Baseline up to approximately 4 years.
All randomized participants who received at least 1 dose of bevacizumab and/or chemotherapy were included in the analysis.
|
|
Hepatobiliary disorders
Cholangitis
|
0.42%
1/238 • Baseline up to approximately 4 years.
All randomized participants who received at least 1 dose of bevacizumab and/or chemotherapy were included in the analysis.
|
0.00%
0/245 • Baseline up to approximately 4 years.
All randomized participants who received at least 1 dose of bevacizumab and/or chemotherapy were included in the analysis.
|
|
Hepatobiliary disorders
Hepatitis toxic
|
0.00%
0/238 • Baseline up to approximately 4 years.
All randomized participants who received at least 1 dose of bevacizumab and/or chemotherapy were included in the analysis.
|
0.41%
1/245 • Baseline up to approximately 4 years.
All randomized participants who received at least 1 dose of bevacizumab and/or chemotherapy were included in the analysis.
|
|
Cardiac disorders
Supraventricular tachycardia
|
0.00%
0/238 • Baseline up to approximately 4 years.
All randomized participants who received at least 1 dose of bevacizumab and/or chemotherapy were included in the analysis.
|
0.41%
1/245 • Baseline up to approximately 4 years.
All randomized participants who received at least 1 dose of bevacizumab and/or chemotherapy were included in the analysis.
|
|
Gastrointestinal disorders
Gastrointestinal disorder
|
0.00%
0/238 • Baseline up to approximately 4 years.
All randomized participants who received at least 1 dose of bevacizumab and/or chemotherapy were included in the analysis.
|
0.41%
1/245 • Baseline up to approximately 4 years.
All randomized participants who received at least 1 dose of bevacizumab and/or chemotherapy were included in the analysis.
|
|
General disorders
Patient-device incompatibility
|
0.00%
0/238 • Baseline up to approximately 4 years.
All randomized participants who received at least 1 dose of bevacizumab and/or chemotherapy were included in the analysis.
|
0.41%
1/245 • Baseline up to approximately 4 years.
All randomized participants who received at least 1 dose of bevacizumab and/or chemotherapy were included in the analysis.
|
|
Musculoskeletal and connective tissue disorders
Osteolysis
|
0.00%
0/238 • Baseline up to approximately 4 years.
All randomized participants who received at least 1 dose of bevacizumab and/or chemotherapy were included in the analysis.
|
0.41%
1/245 • Baseline up to approximately 4 years.
All randomized participants who received at least 1 dose of bevacizumab and/or chemotherapy were included in the analysis.
|
|
Cardiac disorders
Ischaemic cardiomyopathy
|
0.42%
1/238 • Baseline up to approximately 4 years.
All randomized participants who received at least 1 dose of bevacizumab and/or chemotherapy were included in the analysis.
|
0.00%
0/245 • Baseline up to approximately 4 years.
All randomized participants who received at least 1 dose of bevacizumab and/or chemotherapy were included in the analysis.
|
|
Nervous system disorders
Ruptured cerebral aneurysm
|
0.00%
0/238 • Baseline up to approximately 4 years.
All randomized participants who received at least 1 dose of bevacizumab and/or chemotherapy were included in the analysis.
|
0.41%
1/245 • Baseline up to approximately 4 years.
All randomized participants who received at least 1 dose of bevacizumab and/or chemotherapy were included in the analysis.
|
|
Surgical and medical procedures
Large intestine anastomosis
|
0.42%
1/238 • Baseline up to approximately 4 years.
All randomized participants who received at least 1 dose of bevacizumab and/or chemotherapy were included in the analysis.
|
0.00%
0/245 • Baseline up to approximately 4 years.
All randomized participants who received at least 1 dose of bevacizumab and/or chemotherapy were included in the analysis.
|
|
Vascular disorders
Embolism arterial
|
0.00%
0/238 • Baseline up to approximately 4 years.
All randomized participants who received at least 1 dose of bevacizumab and/or chemotherapy were included in the analysis.
|
0.41%
1/245 • Baseline up to approximately 4 years.
All randomized participants who received at least 1 dose of bevacizumab and/or chemotherapy were included in the analysis.
|
|
Vascular disorders
Infarction
|
0.00%
0/238 • Baseline up to approximately 4 years.
All randomized participants who received at least 1 dose of bevacizumab and/or chemotherapy were included in the analysis.
|
0.41%
1/245 • Baseline up to approximately 4 years.
All randomized participants who received at least 1 dose of bevacizumab and/or chemotherapy were included in the analysis.
|
Other adverse events
| Measure |
CT Arm
n=238 participants at risk
Participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator's site until disease progression, unacceptable toxicity, participant request for withdrawal, until the maximum cumulative dose of anthracycline was reached, or end of study (24 months after randomization of the last participant). Upon second-line disease progression participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator's site until disease progression, unacceptable toxicity, participant request for withdrawal, or end of study. Upon subsequent disease progression participants received treatment according the standard of care of the treatment site until end of study.
|
CT+BV Arm
n=245 participants at risk
Participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator's site plus bevacizumab, 15 mg/kg, IV, every 3 weeks, or 10 mg/kg, IV, every 2 weeks until disease progression, unacceptable toxicity, participant request for withdrawal, until the maximum cumulative dose of anthracycline was reached, or end of study (24 months after randomization of the last participant). Upon second-line disease progression participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator's site plus bevacizumab, 15 mg/kg, IV, every 3 weeks, or 10 mg/kg, IV, every 2 weeks until disease progression, unacceptable toxicity, participant request for withdrawal, or end of study. Upon subsequent disease progression participants received treatment according the standard of care of the treatment site until end of study.
|
|---|---|---|
|
Renal and urinary disorders
Proteinuria
|
29.4%
70/238 • Baseline up to approximately 4 years.
All randomized participants who received at least 1 dose of bevacizumab and/or chemotherapy were included in the analysis.
|
54.3%
133/245 • Baseline up to approximately 4 years.
All randomized participants who received at least 1 dose of bevacizumab and/or chemotherapy were included in the analysis.
|
|
Vascular disorders
Hypertension
|
23.1%
55/238 • Baseline up to approximately 4 years.
All randomized participants who received at least 1 dose of bevacizumab and/or chemotherapy were included in the analysis.
|
36.7%
90/245 • Baseline up to approximately 4 years.
All randomized participants who received at least 1 dose of bevacizumab and/or chemotherapy were included in the analysis.
|
|
Vascular disorders
Haemorrhage
|
2.9%
7/238 • Baseline up to approximately 4 years.
All randomized participants who received at least 1 dose of bevacizumab and/or chemotherapy were included in the analysis.
|
11.8%
29/245 • Baseline up to approximately 4 years.
All randomized participants who received at least 1 dose of bevacizumab and/or chemotherapy were included in the analysis.
|
|
Skin and subcutaneous tissue disorders
Palmar-plantar erythrodysaesthesia syndrome
|
24.4%
58/238 • Baseline up to approximately 4 years.
All randomized participants who received at least 1 dose of bevacizumab and/or chemotherapy were included in the analysis.
|
29.4%
72/245 • Baseline up to approximately 4 years.
All randomized participants who received at least 1 dose of bevacizumab and/or chemotherapy were included in the analysis.
|
|
Blood and lymphatic system disorders
Neutropenia
|
23.1%
55/238 • Baseline up to approximately 4 years.
All randomized participants who received at least 1 dose of bevacizumab and/or chemotherapy were included in the analysis.
|
26.1%
64/245 • Baseline up to approximately 4 years.
All randomized participants who received at least 1 dose of bevacizumab and/or chemotherapy were included in the analysis.
|
|
Blood and lymphatic system disorders
Leukopenia
|
7.6%
18/238 • Baseline up to approximately 4 years.
All randomized participants who received at least 1 dose of bevacizumab and/or chemotherapy were included in the analysis.
|
12.2%
30/245 • Baseline up to approximately 4 years.
All randomized participants who received at least 1 dose of bevacizumab and/or chemotherapy were included in the analysis.
|
|
Blood and lymphatic system disorders
Anaemia
|
5.5%
13/238 • Baseline up to approximately 4 years.
All randomized participants who received at least 1 dose of bevacizumab and/or chemotherapy were included in the analysis.
|
9.0%
22/245 • Baseline up to approximately 4 years.
All randomized participants who received at least 1 dose of bevacizumab and/or chemotherapy were included in the analysis.
|
|
Gastrointestinal disorders
Diarrhoea
|
11.3%
27/238 • Baseline up to approximately 4 years.
All randomized participants who received at least 1 dose of bevacizumab and/or chemotherapy were included in the analysis.
|
14.3%
35/245 • Baseline up to approximately 4 years.
All randomized participants who received at least 1 dose of bevacizumab and/or chemotherapy were included in the analysis.
|
|
Gastrointestinal disorders
Nausea
|
13.0%
31/238 • Baseline up to approximately 4 years.
All randomized participants who received at least 1 dose of bevacizumab and/or chemotherapy were included in the analysis.
|
13.5%
33/245 • Baseline up to approximately 4 years.
All randomized participants who received at least 1 dose of bevacizumab and/or chemotherapy were included in the analysis.
|
|
Gastrointestinal disorders
Vomiting
|
9.2%
22/238 • Baseline up to approximately 4 years.
All randomized participants who received at least 1 dose of bevacizumab and/or chemotherapy were included in the analysis.
|
6.5%
16/245 • Baseline up to approximately 4 years.
All randomized participants who received at least 1 dose of bevacizumab and/or chemotherapy were included in the analysis.
|
|
General disorders
Fatigue
|
13.9%
33/238 • Baseline up to approximately 4 years.
All randomized participants who received at least 1 dose of bevacizumab and/or chemotherapy were included in the analysis.
|
20.0%
49/245 • Baseline up to approximately 4 years.
All randomized participants who received at least 1 dose of bevacizumab and/or chemotherapy were included in the analysis.
|
|
General disorders
Mucosal inflammation
|
3.8%
9/238 • Baseline up to approximately 4 years.
All randomized participants who received at least 1 dose of bevacizumab and/or chemotherapy were included in the analysis.
|
10.6%
26/245 • Baseline up to approximately 4 years.
All randomized participants who received at least 1 dose of bevacizumab and/or chemotherapy were included in the analysis.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
1.7%
4/238 • Baseline up to approximately 4 years.
All randomized participants who received at least 1 dose of bevacizumab and/or chemotherapy were included in the analysis.
|
6.5%
16/245 • Baseline up to approximately 4 years.
All randomized participants who received at least 1 dose of bevacizumab and/or chemotherapy were included in the analysis.
|
|
Gastrointestinal disorders
Abdominal pain
|
1.3%
3/238 • Baseline up to approximately 4 years.
All randomized participants who received at least 1 dose of bevacizumab and/or chemotherapy were included in the analysis.
|
6.1%
15/245 • Baseline up to approximately 4 years.
All randomized participants who received at least 1 dose of bevacizumab and/or chemotherapy were included in the analysis.
|
|
Gastrointestinal disorders
Constipation
|
3.8%
9/238 • Baseline up to approximately 4 years.
All randomized participants who received at least 1 dose of bevacizumab and/or chemotherapy were included in the analysis.
|
5.3%
13/245 • Baseline up to approximately 4 years.
All randomized participants who received at least 1 dose of bevacizumab and/or chemotherapy were included in the analysis.
|
|
General disorders
Asthenia
|
2.1%
5/238 • Baseline up to approximately 4 years.
All randomized participants who received at least 1 dose of bevacizumab and/or chemotherapy were included in the analysis.
|
5.7%
14/245 • Baseline up to approximately 4 years.
All randomized participants who received at least 1 dose of bevacizumab and/or chemotherapy were included in the analysis.
|
|
General disorders
Pyrexia
|
4.6%
11/238 • Baseline up to approximately 4 years.
All randomized participants who received at least 1 dose of bevacizumab and/or chemotherapy were included in the analysis.
|
5.7%
14/245 • Baseline up to approximately 4 years.
All randomized participants who received at least 1 dose of bevacizumab and/or chemotherapy were included in the analysis.
|
|
Infections and infestations
Urinary tract infection
|
0.84%
2/238 • Baseline up to approximately 4 years.
All randomized participants who received at least 1 dose of bevacizumab and/or chemotherapy were included in the analysis.
|
6.5%
16/245 • Baseline up to approximately 4 years.
All randomized participants who received at least 1 dose of bevacizumab and/or chemotherapy were included in the analysis.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
1.7%
4/238 • Baseline up to approximately 4 years.
All randomized participants who received at least 1 dose of bevacizumab and/or chemotherapy were included in the analysis.
|
8.6%
21/245 • Baseline up to approximately 4 years.
All randomized participants who received at least 1 dose of bevacizumab and/or chemotherapy were included in the analysis.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
4.2%
10/238 • Baseline up to approximately 4 years.
All randomized participants who received at least 1 dose of bevacizumab and/or chemotherapy were included in the analysis.
|
6.1%
15/245 • Baseline up to approximately 4 years.
All randomized participants who received at least 1 dose of bevacizumab and/or chemotherapy were included in the analysis.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
1.3%
3/238 • Baseline up to approximately 4 years.
All randomized participants who received at least 1 dose of bevacizumab and/or chemotherapy were included in the analysis.
|
7.3%
18/245 • Baseline up to approximately 4 years.
All randomized participants who received at least 1 dose of bevacizumab and/or chemotherapy were included in the analysis.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.
- Publication restrictions are in place
Restriction type: OTHER