Trial Outcomes & Findings for A Study Assessing the Safety and Efficacy of Adding Ipatasertib to Paclitaxel Treatment in Participants With Breast Cancer That Has Spread Beyond the Initial Site, and the Cancer Does Not Have Certain Hormonal Receptors (NCT NCT02162719)
NCT ID: NCT02162719
Last Updated: 2021-03-10
Results Overview
PFS was defined as the time from randomization to the first occurrence of disease progression, as determined by investigator review of tumor assessments by RECIST, v1.1 or death on study (\<=30 days after the last dose of study treatment regimen) from any cause, whichever occurred first.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
124 participants
Primary outcome timeframe
Baseline up to 30 days after the last dose of study drug administration (Clinical Cut Off Date: 07 June 2016)
Results posted on
2021-03-10
Participant Flow
The study was conducted at 44 centers in 8 countries.
A total of 166 participants were screened, out of which 42 participants failed screening. A total of 124 participants were enrolled at 44 sites. Results are reported here up to clinical cut-off date of 31st August 2019.
Participant milestones
| Measure |
Ipatasertib and Paclitaxel
Participants randomised to receive paclitaxel 80 mg/m\^2, intravenously on Days 1, 8, and 15 along with ipatasertib 400 mg, orally, once daily from Days 1-21 in each cycle of 28 days until disease progression, intolerable toxicity, elective withdrawal from the study, or study completion or termination.
|
Placebo and Paclitaxel
Participants randomised to receive paclitaxel 80 mg/m\^2, intravenously on Days 1, 8, and 15 along with placebo matching ipatasertib, orally, once daily from Days 1-21 in each cycle of 28 days until disease progression, intolerable toxicity, elective withdrawal from the study, or study completion or termination.
|
|---|---|---|
|
Overall Study
STARTED
|
62
|
62
|
|
Overall Study
COMPLETED
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
62
|
62
|
Reasons for withdrawal
| Measure |
Ipatasertib and Paclitaxel
Participants randomised to receive paclitaxel 80 mg/m\^2, intravenously on Days 1, 8, and 15 along with ipatasertib 400 mg, orally, once daily from Days 1-21 in each cycle of 28 days until disease progression, intolerable toxicity, elective withdrawal from the study, or study completion or termination.
|
Placebo and Paclitaxel
Participants randomised to receive paclitaxel 80 mg/m\^2, intravenously on Days 1, 8, and 15 along with placebo matching ipatasertib, orally, once daily from Days 1-21 in each cycle of 28 days until disease progression, intolerable toxicity, elective withdrawal from the study, or study completion or termination.
|
|---|---|---|
|
Overall Study
Death
|
41
|
46
|
|
Overall Study
Lost to Follow-up
|
1
|
3
|
|
Overall Study
Disease Progression
|
2
|
1
|
|
Overall Study
Withdrawal by Subject
|
8
|
2
|
|
Overall Study
Discontinuation of Overall Survival Follow-up
|
10
|
10
|
Baseline Characteristics
A Study Assessing the Safety and Efficacy of Adding Ipatasertib to Paclitaxel Treatment in Participants With Breast Cancer That Has Spread Beyond the Initial Site, and the Cancer Does Not Have Certain Hormonal Receptors
Baseline characteristics by cohort
| Measure |
Ipatasertib and Paclitaxel
n=62 Participants
Participants randomised to receive paclitaxel 80 mg/m\^2, intravenously on Days 1, 8, and 15 along with ipatasertib 400 mg, orally, once daily from Days 1-21 in each cycle of 28 days until disease progression, intolerable toxicity, elective withdrawal from the study, or study completion or termination.
|
Placebo and Paclitaxel
n=62 Participants
Participants randomised to receive paclitaxel 80 mg/m\^2, intravenously on Days 1, 8, and 15 along with placebo matching ipatasertib, orally, once daily from Days 1-21 in each cycle of 28 days until disease progression, intolerable toxicity, elective withdrawal from the study, or study completion or termination.
|
Total
n=124 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
53.6 years
STANDARD_DEVIATION 13.4 • n=5 Participants
|
54.4 years
STANDARD_DEVIATION 10.9 • n=7 Participants
|
54.0 years
STANDARD_DEVIATION 12.2 • n=5 Participants
|
|
Sex: Female, Male
Female
|
62 Participants
n=5 Participants
|
62 Participants
n=7 Participants
|
124 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Hispanic or Latino
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Not Hispanic or Latino
|
51 Participants
n=5 Participants
|
52 Participants
n=7 Participants
|
103 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Not Stated
|
5 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Unknown
|
4 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
28 Participants
n=5 Participants
|
30 Participants
n=7 Participants
|
58 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
5 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
26 Participants
n=5 Participants
|
28 Participants
n=7 Participants
|
54 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline up to 30 days after the last dose of study drug administration (Clinical Cut Off Date: 07 June 2016)Population: The Intent to treat (ITT) population was defined as all randomized participants allocated to the treatment arm to which they were randomized.
PFS was defined as the time from randomization to the first occurrence of disease progression, as determined by investigator review of tumor assessments by RECIST, v1.1 or death on study (\<=30 days after the last dose of study treatment regimen) from any cause, whichever occurred first.
Outcome measures
| Measure |
Ipatasertib and Paclitaxel
n=62 Participants
Participants randomised to receive paclitaxel 80 mg/m\^2, intravenously on Days 1, 8, and 15 along with ipatasertib 400 mg, orally, once daily from Days 1-21 in each cycle of 28 days until disease progression, intolerable toxicity, elective withdrawal from the study, or study completion or termination.
|
Placebo and Paclitaxel
n=62 Participants
Participants randomised to receive paclitaxel 80 mg/m\^2, intravenously on Days 1, 8, and 15 along with placebo matching ipatasertib, orally, once daily from Days 1-21 in each cycle of 28 days until disease progression, intolerable toxicity, elective withdrawal from the study, or study completion or termination.
|
|---|---|---|
|
Progression Free Survival (PFS)
|
6.18 Months
90% Confidence Interval 4.57 • Interval 4.57 to 7.33
|
4.93 Months
90% Confidence Interval 3.58 • Interval 3.58 to 5.36
|
PRIMARY outcome
Timeframe: Baseline up to 30 days after the last dose of study drug administration (Clinical Cut Off Date: 07 June 2016)Population: The ITT population included all randomized participants allocated to the treatment arm to which they were randomized. Participants with PTEN-low tumors were evaluated for this endpoint.
PFS was defined as the time from randomization to the first occurrence of disease progression, as determined by investigator review of tumor assessments by RECIST, v1.1 or death on study (\<=30 days after the last dose of study treatment regimen) from any cause, whichever occurred first.
Outcome measures
| Measure |
Ipatasertib and Paclitaxel
n=25 Participants
Participants randomised to receive paclitaxel 80 mg/m\^2, intravenously on Days 1, 8, and 15 along with ipatasertib 400 mg, orally, once daily from Days 1-21 in each cycle of 28 days until disease progression, intolerable toxicity, elective withdrawal from the study, or study completion or termination.
|
Placebo and Paclitaxel
n=23 Participants
Participants randomised to receive paclitaxel 80 mg/m\^2, intravenously on Days 1, 8, and 15 along with placebo matching ipatasertib, orally, once daily from Days 1-21 in each cycle of 28 days until disease progression, intolerable toxicity, elective withdrawal from the study, or study completion or termination.
|
|---|---|---|
|
PFS in Participants With Phosphatase and Tensin Homolog (PTEN)-Low Tumors
|
6.18 Months
90% Confidence Interval 3.65 • Interval 3.65 to 9.1
|
3.65 Months
90% Confidence Interval 2.53 • Interval 2.53 to 5.75
|
SECONDARY outcome
Timeframe: Baseline up to 30 days after the last dose of study drug administration (Clinical Cut Off Date: 07 June 2016)Population: The ITT population was defined as all randomized participants allocated to the treatment arm to which they were randomized. Participants with PIK3CA/AKT1/PTEN-altered tumors were evaluated for this endpoint.
PFS was defined as the time from randomization to the first occurrence of disease progression, as determined by investigator review of tumor assessments by RECIST, v1.1 or death on study (\<=30 days after the last dose of study treatment regimen) from any cause, whichever occurred first.
Outcome measures
| Measure |
Ipatasertib and Paclitaxel
n=26 Participants
Participants randomised to receive paclitaxel 80 mg/m\^2, intravenously on Days 1, 8, and 15 along with ipatasertib 400 mg, orally, once daily from Days 1-21 in each cycle of 28 days until disease progression, intolerable toxicity, elective withdrawal from the study, or study completion or termination.
|
Placebo and Paclitaxel
n=16 Participants
Participants randomised to receive paclitaxel 80 mg/m\^2, intravenously on Days 1, 8, and 15 along with placebo matching ipatasertib, orally, once daily from Days 1-21 in each cycle of 28 days until disease progression, intolerable toxicity, elective withdrawal from the study, or study completion or termination.
|
|---|---|---|
|
PFS in Participants With Phosphatidylinositol-4,5-bisphosphate 3-kinase Catalytic Subunit Alpha (PIK3CA)/ Protein Kinase B (AKT1)/ PTEN-altered Tumors
|
9.03 Months
90% Confidence Interval 4.57 • Interval 4.57 to 12.88
|
4.93 Months
90% Confidence Interval 3.58 • Interval 3.58 to 5.39
|
SECONDARY outcome
Timeframe: Baseline up to 30 days after the last dose of study drug administration (Clinical Cut Off Date: 31 August 2019)Population: The ITT population was defined as all randomized participants allocated to the treatment arm to which they were randomized.
OS was defined as the time from the date of randomization to the date of death from any cause.
Outcome measures
| Measure |
Ipatasertib and Paclitaxel
n=62 Participants
Participants randomised to receive paclitaxel 80 mg/m\^2, intravenously on Days 1, 8, and 15 along with ipatasertib 400 mg, orally, once daily from Days 1-21 in each cycle of 28 days until disease progression, intolerable toxicity, elective withdrawal from the study, or study completion or termination.
|
Placebo and Paclitaxel
n=62 Participants
Participants randomised to receive paclitaxel 80 mg/m\^2, intravenously on Days 1, 8, and 15 along with placebo matching ipatasertib, orally, once daily from Days 1-21 in each cycle of 28 days until disease progression, intolerable toxicity, elective withdrawal from the study, or study completion or termination.
|
|---|---|---|
|
Overall Survival (OS)
|
25.8 months
95% Confidence Interval 18.6 • Interval 18.6 to 28.6
|
16.9 months
95% Confidence Interval 14.6 • Interval 14.6 to 24.6
|
SECONDARY outcome
Timeframe: Baseline up to 30 days after the last dose of study drug administration (Clinical Cut Off Date: 31 August 2019)Population: The ITT population was defined as all randomized participants allocated to the treatment arm to which they were randomized. Participants with PTEN-low tumors were evaluated for this endpoint.
OS was defined as the time from the date of randomization to the date of death from any cause.
Outcome measures
| Measure |
Ipatasertib and Paclitaxel
n=25 Participants
Participants randomised to receive paclitaxel 80 mg/m\^2, intravenously on Days 1, 8, and 15 along with ipatasertib 400 mg, orally, once daily from Days 1-21 in each cycle of 28 days until disease progression, intolerable toxicity, elective withdrawal from the study, or study completion or termination.
|
Placebo and Paclitaxel
n=23 Participants
Participants randomised to receive paclitaxel 80 mg/m\^2, intravenously on Days 1, 8, and 15 along with placebo matching ipatasertib, orally, once daily from Days 1-21 in each cycle of 28 days until disease progression, intolerable toxicity, elective withdrawal from the study, or study completion or termination.
|
|---|---|---|
|
OS in Participants With PTEN-Low Tumors
|
23.1 months
95% Confidence Interval 18.3 • Interval 18.3 to 28.6
|
15.8 months
95% Confidence Interval 9.0 • Interval 9.0 to 29.1
|
SECONDARY outcome
Timeframe: Baseline up to 30 days after the last dose of study drug administration (Clinical Cut Off Date: 31 August 2019)Population: The ITT population was defined as all randomized participants allocated to the treatment arm to which they were randomized. Participants with PIK3CA/AKT1/PTEN-altered tumors were evaluated for this endpoint.
OS was defined as the time from the date of randomization to the date of death from any cause.
Outcome measures
| Measure |
Ipatasertib and Paclitaxel
n=26 Participants
Participants randomised to receive paclitaxel 80 mg/m\^2, intravenously on Days 1, 8, and 15 along with ipatasertib 400 mg, orally, once daily from Days 1-21 in each cycle of 28 days until disease progression, intolerable toxicity, elective withdrawal from the study, or study completion or termination.
|
Placebo and Paclitaxel
n=16 Participants
Participants randomised to receive paclitaxel 80 mg/m\^2, intravenously on Days 1, 8, and 15 along with placebo matching ipatasertib, orally, once daily from Days 1-21 in each cycle of 28 days until disease progression, intolerable toxicity, elective withdrawal from the study, or study completion or termination.
|
|---|---|---|
|
OS in Participants With PIK3CA/AKT1/PTEN-altered Tumors
|
25.8 months
95% Confidence Interval 18.6 • Interval 18.6 to 35.2
|
22.1 months
95% Confidence Interval 8.7 • Interval 8.7 to 999.0
|
SECONDARY outcome
Timeframe: Baseline up to every 8 weeks until documented disease progression (Clinical Cut Off Date: 07 June 2016)Population: The Intent to treat (ITT) population was defined as all randomized participants allocated to the treatment arm to which they were randomized.
Confirmed tumor ORR in participants with measurable disease at baseline was assessed by the investigator per RECIST, v1.1. Confirmed ORR was defined as the percentage of participants who achieved either a complete response or partial response based on the investigator assessment that was confirmed by a repeat assessment no less than 4 weeks after the criteria for response was first met. Participants for whom no records of post-baseline tumor assessments were reported were counted as non-responders. Complete response (CR): disappearance of all target lesions, any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm. Partial response (PR): at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters.
Outcome measures
| Measure |
Ipatasertib and Paclitaxel
n=62 Participants
Participants randomised to receive paclitaxel 80 mg/m\^2, intravenously on Days 1, 8, and 15 along with ipatasertib 400 mg, orally, once daily from Days 1-21 in each cycle of 28 days until disease progression, intolerable toxicity, elective withdrawal from the study, or study completion or termination.
|
Placebo and Paclitaxel
n=62 Participants
Participants randomised to receive paclitaxel 80 mg/m\^2, intravenously on Days 1, 8, and 15 along with placebo matching ipatasertib, orally, once daily from Days 1-21 in each cycle of 28 days until disease progression, intolerable toxicity, elective withdrawal from the study, or study completion or termination.
|
|---|---|---|
|
Objective Response Rate (ORR)
|
40.3 Percentage of Participants
90% Confidence Interval 30.64 • Interval 30.64 to 50.9
|
32.3 Percentage of Participants
90% Confidence Interval 23.35 • Interval 23.35 to 42.36
|
SECONDARY outcome
Timeframe: Baseline up to every 8 weeks until documented disease progression (Clinical Cut Off Date: 07 June 2016)Population: The ITT population was defined as all randomized participants allocated to the treatment arm to which they were randomized. Participants with PTEN-Low Tumors were evaluated for this endpoint.
Confirmed tumor ORR in participants with measurable disease at baseline was assessed by the investigator per RECIST, v1.1. Confirmed ORR was defined as the percentage of participants who achieved either a complete response or partial response based on the investigator assessment that was confirmed by a repeat assessment no less than 4 weeks after the criteria for response was first met. Participants for whom no records of post-baseline tumor assessments were reported were counted as non-responders. Complete response (CR): disappearance of all target lesions, any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm. Partial response (PR): at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters.
Outcome measures
| Measure |
Ipatasertib and Paclitaxel
n=25 Participants
Participants randomised to receive paclitaxel 80 mg/m\^2, intravenously on Days 1, 8, and 15 along with ipatasertib 400 mg, orally, once daily from Days 1-21 in each cycle of 28 days until disease progression, intolerable toxicity, elective withdrawal from the study, or study completion or termination.
|
Placebo and Paclitaxel
n=23 Participants
Participants randomised to receive paclitaxel 80 mg/m\^2, intravenously on Days 1, 8, and 15 along with placebo matching ipatasertib, orally, once daily from Days 1-21 in each cycle of 28 days until disease progression, intolerable toxicity, elective withdrawal from the study, or study completion or termination.
|
|---|---|---|
|
ORR in Participants With PTEN-Low Tumors
|
48.0 Percentage of Participants
90% Confidence Interval 30.73 • Interval 30.73 to 64.0
|
26.1 Percentage of Participants
90% Confidence Interval 12.02 • Interval 12.02 to 43.12
|
SECONDARY outcome
Timeframe: Baseline up to every 8 weeks until documented disease progression (Clinical Cut Off Date: 07 June 2016)Population: The ITT population was defined as all randomized participants allocated to the treatment arm to which they were randomized. Participants with PIK3CA/AKT1/PTEN-altered tumors were evaluated for this endpoint.
Confirmed tumor ORR in subjects with measurable disease at baseline was assessed by the investigator per RECIST, v1.1. Confirmed ORR was defined as the percentage of subjects who achieved either a complete response or partial response based on the investigator assessment that was confirmed by a repeat assessment no less than 4 weeks after the criteria for response was first met. Subjects for whom no records of post-baseline tumor assessments were reported were counted as non-responders. Complete response (CR): disappearance of all target lesions, any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm. Partial response (PR): at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters.
Outcome measures
| Measure |
Ipatasertib and Paclitaxel
n=26 Participants
Participants randomised to receive paclitaxel 80 mg/m\^2, intravenously on Days 1, 8, and 15 along with ipatasertib 400 mg, orally, once daily from Days 1-21 in each cycle of 28 days until disease progression, intolerable toxicity, elective withdrawal from the study, or study completion or termination.
|
Placebo and Paclitaxel
n=16 Participants
Participants randomised to receive paclitaxel 80 mg/m\^2, intravenously on Days 1, 8, and 15 along with placebo matching ipatasertib, orally, once daily from Days 1-21 in each cycle of 28 days until disease progression, intolerable toxicity, elective withdrawal from the study, or study completion or termination.
|
|---|---|---|
|
ORR in Participants With PIK3CA/AKT1/PTEN-altered Tumors
|
50.0 Percentage of Participants
90% Confidence Interval 34.24 • Interval 34.24 to 65.76
|
43.8 Percentage of Participants
90% Confidence Interval 23.53 • Interval 23.53 to 66.66
|
SECONDARY outcome
Timeframe: Baseline up to every 8 weeks until documented disease progression (Clinical Cut Off Date: 07 June 2016)Population: The ITT population was defined as all randomized participants allocated to the treatment arm to which they were randomized. Only participants who achieved a confirmed objective response were included in the analysis.
Duration of objective response in subjects with measurable disease at baseline was defined as the time from first observation of an objective tumor response until first observation of disease progression, as assessed by the investigator per modified RECIST, v1.1.
Outcome measures
| Measure |
Ipatasertib and Paclitaxel
n=25 Participants
Participants randomised to receive paclitaxel 80 mg/m\^2, intravenously on Days 1, 8, and 15 along with ipatasertib 400 mg, orally, once daily from Days 1-21 in each cycle of 28 days until disease progression, intolerable toxicity, elective withdrawal from the study, or study completion or termination.
|
Placebo and Paclitaxel
n=20 Participants
Participants randomised to receive paclitaxel 80 mg/m\^2, intravenously on Days 1, 8, and 15 along with placebo matching ipatasertib, orally, once daily from Days 1-21 in each cycle of 28 days until disease progression, intolerable toxicity, elective withdrawal from the study, or study completion or termination.
|
|---|---|---|
|
Duration of Response
|
7.85 months
Interval 5.65 to
Upper Limit of Duration of Response was not reached due to low number of participants with events.
|
7.43 months
Interval 3.88 to 9.2
|
SECONDARY outcome
Timeframe: Baseline up to every 8 weeks until documented disease progression (Clinical Cut Off Date: 07 June 2016)Population: ITT population included all randomized participants allocated to the treatment arm to which they were randomized. Participants with PTEN-low tumors were evaluated for this endpoint. Only participants who achieved a confirmed objective response were included in the analysis.
Duration of objective response in subjects with measurable disease at baseline was defined as the time from first observation of an objective tumor response until first observation of disease progression, as assessed by the investigator per modified RECIST, v1.1.
Outcome measures
| Measure |
Ipatasertib and Paclitaxel
n=12 Participants
Participants randomised to receive paclitaxel 80 mg/m\^2, intravenously on Days 1, 8, and 15 along with ipatasertib 400 mg, orally, once daily from Days 1-21 in each cycle of 28 days until disease progression, intolerable toxicity, elective withdrawal from the study, or study completion or termination.
|
Placebo and Paclitaxel
n=6 Participants
Participants randomised to receive paclitaxel 80 mg/m\^2, intravenously on Days 1, 8, and 15 along with placebo matching ipatasertib, orally, once daily from Days 1-21 in each cycle of 28 days until disease progression, intolerable toxicity, elective withdrawal from the study, or study completion or termination.
|
|---|---|---|
|
Duration of Response in Participants With PTEN-Low Tumors
|
6.54 Months
Interval 4.44 to
Upper Limit of Duration of Response was not reached due to low number of participants with events.
|
7.49 Months
Interval 7.29 to
Upper Limit of Duration of Response was not reached due to low number of participants with events.
|
SECONDARY outcome
Timeframe: Baseline up to every 8 weeks until documented disease progression (Clinical Cut Off Date: 07 June 2016)Population: ITT population included all randomized participants allocated to the treatment arm to which they were randomized. Participants with PIK3CA/AKT1/PTEN-altered tumors were evaluated for this endpoint. Only participants who achieved a confirmed objective response were included in the analysis.
Duration of objective response in participants with measurable disease at baseline was defined as the time from first observation of an objective tumor response until first observation of disease progression, as assessed by the investigator per modified RECIST, v1.1.
Outcome measures
| Measure |
Ipatasertib and Paclitaxel
n=13 Participants
Participants randomised to receive paclitaxel 80 mg/m\^2, intravenously on Days 1, 8, and 15 along with ipatasertib 400 mg, orally, once daily from Days 1-21 in each cycle of 28 days until disease progression, intolerable toxicity, elective withdrawal from the study, or study completion or termination.
|
Placebo and Paclitaxel
n=7 Participants
Participants randomised to receive paclitaxel 80 mg/m\^2, intravenously on Days 1, 8, and 15 along with placebo matching ipatasertib, orally, once daily from Days 1-21 in each cycle of 28 days until disease progression, intolerable toxicity, elective withdrawal from the study, or study completion or termination.
|
|---|---|---|
|
Duration of Response in Participants With PIK3CA/AKT1/PTEN-altered Tumors
|
11.24 Months
Interval 5.59 to
Upper Limit of Duration of Response was not reached due to low number of participants with events.
|
6.06 Months
Interval 3.78 to 7.56
|
SECONDARY outcome
Timeframe: Baseline up to every 8 weeks until documented disease progression (Clinical Cut Off Date: 07 June 2016)Population: ITT population included all randomized participants allocated to the treatment arm to which they were randomized.
Time to disease progression was defined as the time from randomization to the first occurrence of disease progression, as determined by investigator review of tumor assessments by RECIST, v1.1.
Outcome measures
| Measure |
Ipatasertib and Paclitaxel
n=62 Participants
Participants randomised to receive paclitaxel 80 mg/m\^2, intravenously on Days 1, 8, and 15 along with ipatasertib 400 mg, orally, once daily from Days 1-21 in each cycle of 28 days until disease progression, intolerable toxicity, elective withdrawal from the study, or study completion or termination.
|
Placebo and Paclitaxel
n=62 Participants
Participants randomised to receive paclitaxel 80 mg/m\^2, intravenously on Days 1, 8, and 15 along with placebo matching ipatasertib, orally, once daily from Days 1-21 in each cycle of 28 days until disease progression, intolerable toxicity, elective withdrawal from the study, or study completion or termination.
|
|---|---|---|
|
Time to Disease Progression
|
6.18 Months
90% Confidence Interval 4.57 • Interval 4.57 to 7.33
|
4.96 Months
90% Confidence Interval 3.61 • Interval 3.61 to 5.39
|
SECONDARY outcome
Timeframe: Baseline up to every 8 weeks until documented disease progression (Clinical Cut Off Date: 07 June 2016)Population: ITT population included all randomized participants allocated to the treatment arm to which they were randomized. Participants with PTEN low tumors were evaluated for this endpoint.
Time to disease progression was defined as the time from randomization to the first occurrence of disease progression, as determined by investigator review of tumor assessments by RECIST, v1.1.
Outcome measures
| Measure |
Ipatasertib and Paclitaxel
n=25 Participants
Participants randomised to receive paclitaxel 80 mg/m\^2, intravenously on Days 1, 8, and 15 along with ipatasertib 400 mg, orally, once daily from Days 1-21 in each cycle of 28 days until disease progression, intolerable toxicity, elective withdrawal from the study, or study completion or termination.
|
Placebo and Paclitaxel
n=23 Participants
Participants randomised to receive paclitaxel 80 mg/m\^2, intravenously on Days 1, 8, and 15 along with placebo matching ipatasertib, orally, once daily from Days 1-21 in each cycle of 28 days until disease progression, intolerable toxicity, elective withdrawal from the study, or study completion or termination.
|
|---|---|---|
|
Time to Disease Progression in Participants With PTEN-Low Tumors
|
6.18 Months
90% Confidence Interval 3.65 • Interval 3.65 to 9.1
|
3.94 Months
90% Confidence Interval 2.53 • Interval 2.53 to 7.33
|
SECONDARY outcome
Timeframe: Baseline up to every 8 weeks until documented disease progression (Clinical Cut Off Date: 07 June 2016)Population: ITT population included all randomized participants allocated to the treatment arm to which they were randomized. Participants with PIK3CA/AKT1/PTEN-altered tumors were evaluated for this endpoint.
Time to disease progression was defined as the time from randomization to the first occurrence of disease progression, as determined by investigator review of tumor assessments by RECIST, v1.1.
Outcome measures
| Measure |
Ipatasertib and Paclitaxel
n=26 Participants
Participants randomised to receive paclitaxel 80 mg/m\^2, intravenously on Days 1, 8, and 15 along with ipatasertib 400 mg, orally, once daily from Days 1-21 in each cycle of 28 days until disease progression, intolerable toxicity, elective withdrawal from the study, or study completion or termination.
|
Placebo and Paclitaxel
n=16 Participants
Participants randomised to receive paclitaxel 80 mg/m\^2, intravenously on Days 1, 8, and 15 along with placebo matching ipatasertib, orally, once daily from Days 1-21 in each cycle of 28 days until disease progression, intolerable toxicity, elective withdrawal from the study, or study completion or termination.
|
|---|---|---|
|
Time to Disease Progression in Participants With PIK3CA/AKT1/PTEN-altered Tumors
|
9.03 Months
90% Confidence Interval 4.57 • Interval 4.57 to 12.88
|
4.93 Months
90% Confidence Interval 3.58 • Interval 3.58 to 5.39
|
SECONDARY outcome
Timeframe: Baseline up to 30 days after the last dose of study drug or until initiation of another anti-cancer therapy, whichever occurs first (up to 3 years, 3 months)Population: The Safety population included all treated participants with participants allocated to the treatment arm associated with the regimen that they actually received.
An adverse event was defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Outcome measures
| Measure |
Ipatasertib and Paclitaxel
n=61 Participants
Participants randomised to receive paclitaxel 80 mg/m\^2, intravenously on Days 1, 8, and 15 along with ipatasertib 400 mg, orally, once daily from Days 1-21 in each cycle of 28 days until disease progression, intolerable toxicity, elective withdrawal from the study, or study completion or termination.
|
Placebo and Paclitaxel
n=62 Participants
Participants randomised to receive paclitaxel 80 mg/m\^2, intravenously on Days 1, 8, and 15 along with placebo matching ipatasertib, orally, once daily from Days 1-21 in each cycle of 28 days until disease progression, intolerable toxicity, elective withdrawal from the study, or study completion or termination.
|
|---|---|---|
|
Safety: Percentage of Participants With Adverse Events
|
100.0 Percentage of Participants
|
96.8 Percentage of Participants
|
SECONDARY outcome
Timeframe: Cycle 1 Day 1, Cycle 1 Day 8Population: The PK Analysis population was defined as all participants who had evaluable PK data.
PK parameters were not calculated due to sparse PK sampling.
Outcome measures
| Measure |
Ipatasertib and Paclitaxel
n=61 Participants
Participants randomised to receive paclitaxel 80 mg/m\^2, intravenously on Days 1, 8, and 15 along with ipatasertib 400 mg, orally, once daily from Days 1-21 in each cycle of 28 days until disease progression, intolerable toxicity, elective withdrawal from the study, or study completion or termination.
|
Placebo and Paclitaxel
Participants randomised to receive paclitaxel 80 mg/m\^2, intravenously on Days 1, 8, and 15 along with placebo matching ipatasertib, orally, once daily from Days 1-21 in each cycle of 28 days until disease progression, intolerable toxicity, elective withdrawal from the study, or study completion or termination.
|
|---|---|---|
|
Pharmacokinetic Endpoint: Area Under the Plasma Concentration-time Curve Over the Time Interval From Zero to 24 Hours (AUC0-24h) of Ipatasertib
|
NA h*ng/mL/mg
Due to sparse PK sampling.
|
—
|
SECONDARY outcome
Timeframe: Cycle 1 Day 1, Cycle 1 Day 8Population: The PK Analysis population was defined as all participants who had evaluable PK data.
PK parameters were not calculated due to sparse PK sampling.
Outcome measures
| Measure |
Ipatasertib and Paclitaxel
n=61 Participants
Participants randomised to receive paclitaxel 80 mg/m\^2, intravenously on Days 1, 8, and 15 along with ipatasertib 400 mg, orally, once daily from Days 1-21 in each cycle of 28 days until disease progression, intolerable toxicity, elective withdrawal from the study, or study completion or termination.
|
Placebo and Paclitaxel
Participants randomised to receive paclitaxel 80 mg/m\^2, intravenously on Days 1, 8, and 15 along with placebo matching ipatasertib, orally, once daily from Days 1-21 in each cycle of 28 days until disease progression, intolerable toxicity, elective withdrawal from the study, or study completion or termination.
|
|---|---|---|
|
Pharmacokinetic Endpoint: Apparent Clearance Following Oral Dosing (CL/F) of Ipatasertib
|
NA ml/hr
Due to sparse PK sampling.
|
—
|
SECONDARY outcome
Timeframe: Baseline (Cycle 1 Day 1) up to Cycle 5 Day 1Population: The PRO Analysis population was defined as the ITT population with a baseline and at least one post baseline PRO assessment. Data presented below is only for participants included in the actual analysis.
EORTC QLQ-C30 included functional scales (physical, role, cognitive, emotional, and social), global health status, symptom scales (fatigue, pain, nausea/vomiting), single items (dyspnoea, appetite loss, insomnia, constipation/diarrhea, financial difficulties). Most questions used 4-point scale (1=Not at all to 4=Very much; 2 questions used 7-point scale \[1=very poor to 7=Excellent\]). Scores averaged, transformed to 0-100 scale; a higher score=better level of functioning. For symptom scale scores, higher level=severe level of symptoms. "A change of at least 10 points from baseline is considered clinically meaningful (Osoba D, Rodrigues G, Myles J, et al. Interpreting the significance of changes in health-related quality of life score. J Clin Oncol 1998;16:139-44). PRO measures were analyzed from baseline up to cycle 5. Scores from later timepoints were not analyzed due to attrition (in both arms, fewer than 50% of participants remained on treatment beyond cycle 5).
Outcome measures
| Measure |
Ipatasertib and Paclitaxel
n=57 Participants
Participants randomised to receive paclitaxel 80 mg/m\^2, intravenously on Days 1, 8, and 15 along with ipatasertib 400 mg, orally, once daily from Days 1-21 in each cycle of 28 days until disease progression, intolerable toxicity, elective withdrawal from the study, or study completion or termination.
|
Placebo and Paclitaxel
n=53 Participants
Participants randomised to receive paclitaxel 80 mg/m\^2, intravenously on Days 1, 8, and 15 along with placebo matching ipatasertib, orally, once daily from Days 1-21 in each cycle of 28 days until disease progression, intolerable toxicity, elective withdrawal from the study, or study completion or termination.
|
|---|---|---|
|
Patient Reported Outcome (PRO) Measure: Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30-item (EORTC QLQ-C30) Score
Global health status Cycle 3 Day 1
|
-8.15 unit on a scale
Standard Deviation 21.55
|
3.29 unit on a scale
Standard Deviation 21.37
|
|
Patient Reported Outcome (PRO) Measure: Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30-item (EORTC QLQ-C30) Score
Global health status Cycle 4 Day 1
|
-8.50 unit on a scale
Standard Deviation 21.62
|
-1.46 unit on a scale
Standard Deviation 26.61
|
|
Patient Reported Outcome (PRO) Measure: Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30-item (EORTC QLQ-C30) Score
Global health status Cycle 5 Day 1
|
-6.48 unit on a scale
Standard Deviation 22.55
|
-5.00 unit on a scale
Standard Deviation 21.62
|
|
Patient Reported Outcome (PRO) Measure: Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30-item (EORTC QLQ-C30) Score
Role Functioning Cycle 2 Day 1
|
-5.85 unit on a scale
Standard Deviation 20.04
|
0.63 unit on a scale
Standard Deviation 22.40
|
|
Patient Reported Outcome (PRO) Measure: Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30-item (EORTC QLQ-C30) Score
Role Functioning Cycle 3 Day 1
|
-10.51 unit on a scale
Standard Deviation 24.43
|
-2.71 unit on a scale
Standard Deviation 22.69
|
|
Patient Reported Outcome (PRO) Measure: Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30-item (EORTC QLQ-C30) Score
Role Functioning Cycle 4 Day 1
|
-13.95 unit on a scale
Standard Deviation 25.76
|
-6.25 unit on a scale
Standard Deviation 26.34
|
|
Patient Reported Outcome (PRO) Measure: Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30-item (EORTC QLQ-C30) Score
Role Functioning Cycle 5 Day 1
|
-11.57 unit on a scale
Standard Deviation 21.76
|
-7.22 unit on a scale
Standard Deviation 21.30
|
|
Patient Reported Outcome (PRO) Measure: Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30-item (EORTC QLQ-C30) Score
Social Functioning Cycle 2 Day 1
|
-2.05 unit on a scale
Standard Deviation 26.92
|
0.00 unit on a scale
Standard Deviation 23.34
|
|
Patient Reported Outcome (PRO) Measure: Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30-item (EORTC QLQ-C30) Score
Social Functioning Cycle 3 Day 1
|
-2.17 unit on a scale
Standard Deviation 23.99
|
-3.49 unit on a scale
Standard Deviation 26.11
|
|
Patient Reported Outcome (PRO) Measure: Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30-item (EORTC QLQ-C30) Score
Social Functioning Cycle 4 Day 1
|
-7.14 unit on a scale
Standard Deviation 27.00
|
-5.83 unit on a scale
Standard Deviation 23.74
|
|
Patient Reported Outcome (PRO) Measure: Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30-item (EORTC QLQ-C30) Score
Social Functioning Cycle 5 Day 1
|
-4.76 unit on a scale
Standard Deviation 31.72
|
-9.44 unit on a scale
Standard Deviation 24.24
|
|
Patient Reported Outcome (PRO) Measure: Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30-item (EORTC QLQ-C30) Score
Insomnia Cycle 2 Day 1
|
2.92 unit on a scale
Standard Deviation 31.67
|
-5.03 unit on a scale
Standard Deviation 24.80
|
|
Patient Reported Outcome (PRO) Measure: Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30-item (EORTC QLQ-C30) Score
Insomnia Cycle 3 Day 1
|
2.90 unit on a scale
Standard Deviation 25.17
|
-3.10 unit on a scale
Standard Deviation 25.00
|
|
Patient Reported Outcome (PRO) Measure: Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30-item (EORTC QLQ-C30) Score
Insomnia Cycle 4 Day 1
|
7.48 unit on a scale
Standard Deviation 28.27
|
5.83 unit on a scale
Standard Deviation 31.02
|
|
Patient Reported Outcome (PRO) Measure: Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30-item (EORTC QLQ-C30) Score
Insomnia Cycle 5 Day 1
|
1.85 unit on a scale
Standard Deviation 34.68
|
-5.56 unit on a scale
Standard Deviation 29.14
|
|
Patient Reported Outcome (PRO) Measure: Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30-item (EORTC QLQ-C30) Score
Appetite loss:Cycle 2
|
7.60 unit on a scale
Standard Deviation 28.18
|
-0.63 unit on a scale
Standard Deviation 24.88
|
|
Patient Reported Outcome (PRO) Measure: Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30-item (EORTC QLQ-C30) Score
Appetite loss:Cycle 3
|
9.42 unit on a scale
Standard Deviation 21.84
|
-3.88 unit on a scale
Standard Deviation 24.35
|
|
Patient Reported Outcome (PRO) Measure: Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30-item (EORTC QLQ-C30) Score
Appetite loss:Cycle 4
|
5.44 unit on a scale
Standard Deviation 23.91
|
-4.17 unit on a scale
Standard Deviation 25.25
|
|
Patient Reported Outcome (PRO) Measure: Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30-item (EORTC QLQ-C30) Score
Appetite loss:Cycle 5
|
0.00 unit on a scale
Standard Deviation 18.08
|
-1.11 unit on a scale
Standard Deviation 25.50
|
|
Patient Reported Outcome (PRO) Measure: Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30-item (EORTC QLQ-C30) Score
Cognitive Functioning: Cycle 2 Day 1
|
1.17 unit on a scale
Standard Deviation 14.04
|
0.63 unit on a scale
Standard Deviation 17.28
|
|
Patient Reported Outcome (PRO) Measure: Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30-item (EORTC QLQ-C30) Score
Cognitive Functioning: Cycle 3 Day 1
|
-1.81 unit on a scale
Standard Deviation 19.64
|
-1.81 unit on a scale
Standard Deviation 19.64
|
|
Patient Reported Outcome (PRO) Measure: Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30-item (EORTC QLQ-C30) Score
Cognitive Functioning: Cycle 4 Day 1
|
-3.40 unit on a scale
Standard Deviation 15.95
|
0.00 unit on a scale
Standard Deviation 20.32
|
|
Patient Reported Outcome (PRO) Measure: Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30-item (EORTC QLQ-C30) Score
Cognitive Functioning: Cycle 5 Day 1
|
0.00 unit on a scale
Standard Deviation 13.80
|
-4.44 unit on a scale
Standard Deviation 19.54
|
|
Patient Reported Outcome (PRO) Measure: Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30-item (EORTC QLQ-C30) Score
Constipation: Cycle 2 Day 1
|
5.85 unit on a scale
Standard Deviation 24.50
|
0.63 unit on a scale
Standard Deviation 25.73
|
|
Patient Reported Outcome (PRO) Measure: Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30-item (EORTC QLQ-C30) Score
Constipation: Cycle 3 Day 1
|
2.90 unit on a scale
Standard Deviation 19.66
|
1.59 unit on a scale
Standard Deviation 22.03
|
|
Patient Reported Outcome (PRO) Measure: Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30-item (EORTC QLQ-C30) Score
Constipation: Cycle 4 Day 1
|
1.39 unit on a scale
Standard Deviation 16.78
|
0.83 unit on a scale
Standard Deviation 30.65
|
|
Patient Reported Outcome (PRO) Measure: Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30-item (EORTC QLQ-C30) Score
Constipation: Cycle 5 Day 1
|
2.78 unit on a scale
Standard Deviation 14.64
|
1.11 unit on a scale
Standard Deviation 20.50
|
|
Patient Reported Outcome (PRO) Measure: Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30-item (EORTC QLQ-C30) Score
Diarrhoea: Cycle 2 Day 1
|
17.54 unit on a scale
Standard Deviation 30.28
|
1.89 unit on a scale
Standard Deviation 15.21
|
|
Patient Reported Outcome (PRO) Measure: Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30-item (EORTC QLQ-C30) Score
Diarrhoea: Cycle 3 Day 1
|
23.91 unit on a scale
Standard Deviation 34.90
|
3.88 unit on a scale
Standard Deviation 18.13
|
|
Patient Reported Outcome (PRO) Measure: Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30-item (EORTC QLQ-C30) Score
Diarrhoea: Cycle 4 Day 1
|
19.73 unit on a scale
Standard Deviation 34.64
|
0.83 unit on a scale
Standard Deviation 15.99
|
|
Patient Reported Outcome (PRO) Measure: Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30-item (EORTC QLQ-C30) Score
Diarrhoea: Cycle 5 Day 1
|
21.90 unit on a scale
Standard Deviation 37.87
|
1.11 unit on a scale
Standard Deviation 16.34
|
|
Patient Reported Outcome (PRO) Measure: Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30-item (EORTC QLQ-C30) Score
Dyspnea: Cycle 2 Day 1
|
2.92 unit on a scale
Standard Deviation 19.19
|
0.00 unit on a scale
Standard Deviation 18.67
|
|
Patient Reported Outcome (PRO) Measure: Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30-item (EORTC QLQ-C30) Score
Dyspnea: Cycle 3 Day 1
|
5.07 unit on a scale
Standard Deviation 23.27
|
2.44 unit on a scale
Standard Deviation 22.84
|
|
Patient Reported Outcome (PRO) Measure: Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30-item (EORTC QLQ-C30) Score
Dyspnea: Cycle 4 Day 1
|
3.40 unit on a scale
Standard Deviation 25.68
|
5.13 unit on a scale
Standard Deviation 22.35
|
|
Patient Reported Outcome (PRO) Measure: Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30-item (EORTC QLQ-C30) Score
Dyspnea: Cycle 5 Day 1
|
5.56 unit on a scale
Standard Deviation 25.82
|
4.76 unit on a scale
Standard Deviation 23.51
|
|
Patient Reported Outcome (PRO) Measure: Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30-item (EORTC QLQ-C30) Score
Emotional Functioning: Cycle 2 Day 1
|
12.09 unit on a scale
Standard Deviation 15.90
|
4.72 unit on a scale
Standard Deviation 16.87
|
|
Patient Reported Outcome (PRO) Measure: Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30-item (EORTC QLQ-C30) Score
Emotional Functioning: Cycle 3 Day 1
|
7.37 unit on a scale
Standard Deviation 17.18
|
3.88 unit on a scale
Standard Deviation 20.36
|
|
Patient Reported Outcome (PRO) Measure: Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30-item (EORTC QLQ-C30) Score
Emotional Functioning: Cycle 4 Day 1
|
8.22 unit on a scale
Standard Deviation 16.53
|
2.71 unit on a scale
Standard Deviation 21.47
|
|
Patient Reported Outcome (PRO) Measure: Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30-item (EORTC QLQ-C30) Score
Emotional Functioning: Cycle 5 Day 1
|
8.73 unit on a scale
Standard Deviation 16.30
|
1.39 unit on a scale
Standard Deviation 17.79
|
|
Patient Reported Outcome (PRO) Measure: Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30-item (EORTC QLQ-C30) Score
Fatigue: Cycle 2 Day 1
|
7.99 unit on a scale
Standard Deviation 22.69
|
-1.36 unit on a scale
Standard Deviation 16.98
|
|
Patient Reported Outcome (PRO) Measure: Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30-item (EORTC QLQ-C30) Score
Fatigue: Cycle 3 Day 1
|
9.18 unit on a scale
Standard Deviation 22.63
|
1.42 unit on a scale
Standard Deviation 19.44
|
|
Patient Reported Outcome (PRO) Measure: Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30-item (EORTC QLQ-C30) Score
Fatigue: Cycle 4 Day 1
|
7.94 unit on a scale
Standard Deviation 20.91
|
1.85 unit on a scale
Standard Deviation 21.64
|
|
Patient Reported Outcome (PRO) Measure: Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30-item (EORTC QLQ-C30) Score
Fatigue: Cycle 5 Day 1
|
10.32 unit on a scale
Standard Deviation 20.35
|
1.67 unit on a scale
Standard Deviation 20.59
|
|
Patient Reported Outcome (PRO) Measure: Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30-item (EORTC QLQ-C30) Score
Financial difficulties Cycle 2 Day 1
|
3.57 unit on a scale
Standard Deviation 21.72
|
0.00 unit on a scale
Standard Deviation 20.87
|
|
Patient Reported Outcome (PRO) Measure: Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30-item (EORTC QLQ-C30) Score
Financial difficulties Cycle 3 Day 1
|
0.72 unit on a scale
Standard Deviation 22.76
|
-3.88 unit on a scale
Standard Deviation 24.35
|
|
Patient Reported Outcome (PRO) Measure: Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30-item (EORTC QLQ-C30) Score
Financial difficulties Cycle 4 Day 1
|
3.40 unit on a scale
Standard Deviation 23.81
|
-0.83 unit on a scale
Standard Deviation 29.71
|
|
Patient Reported Outcome (PRO) Measure: Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30-item (EORTC QLQ-C30) Score
Financial difficulties Cycle 5 Day 1
|
2.78 unit on a scale
Standard Deviation 25.67
|
1.11 unit on a scale
Standard Deviation 26.96
|
|
Patient Reported Outcome (PRO) Measure: Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30-item (EORTC QLQ-C30) Score
Nausea/Vomiting Cycle 2 Day 1
|
9.06 unit on a scale
Standard Deviation 19.43
|
2.83 unit on a scale
Standard Deviation 15.24
|
|
Patient Reported Outcome (PRO) Measure: Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30-item (EORTC QLQ-C30) Score
Nausea/Vomiting Cycle 3 Day 1
|
6.52 unit on a scale
Standard Deviation 14.26
|
3.10 unit on a scale
Standard Deviation 14.21
|
|
Patient Reported Outcome (PRO) Measure: Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30-item (EORTC QLQ-C30) Score
Nausea/Vomiting Cycle 4 Day 1
|
6.80 unit on a scale
Standard Deviation 17.32
|
3.75 unit on a scale
Standard Deviation 17.50
|
|
Patient Reported Outcome (PRO) Measure: Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30-item (EORTC QLQ-C30) Score
Nausea/Vomiting Cycle 5 Day 1
|
3.70 unit on a scale
Standard Deviation 7.03
|
0.00 unit on a scale
Standard Deviation 23.16
|
|
Patient Reported Outcome (PRO) Measure: Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30-item (EORTC QLQ-C30) Score
Pain Cycle 2 Day 1
|
-3.80 unit on a scale
Standard Deviation 22.93
|
-7.86 unit on a scale
Standard Deviation 23.02
|
|
Patient Reported Outcome (PRO) Measure: Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30-item (EORTC QLQ-C30) Score
Pain Cycle 3 Day 1
|
-4.71 unit on a scale
Standard Deviation 26.45
|
-7.36 unit on a scale
Standard Deviation 26.80
|
|
Patient Reported Outcome (PRO) Measure: Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30-item (EORTC QLQ-C30) Score
Pain Cycle 4 Day 1
|
1.36 unit on a scale
Standard Deviation 28.63
|
-3.33 unit on a scale
Standard Deviation 31.62
|
|
Patient Reported Outcome (PRO) Measure: Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30-item (EORTC QLQ-C30) Score
Pain Cycle 5 Day 1
|
0.00 unit on a scale
Standard Deviation 26.13
|
-5.56 unit on a scale
Standard Deviation 25.27
|
|
Patient Reported Outcome (PRO) Measure: Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30-item (EORTC QLQ-C30) Score
Physical Functioning Cycle 2 Day 1
|
-4.53 unit on a scale
Standard Deviation 14.23
|
-0.16 unit on a scale
Standard Deviation 12.96
|
|
Patient Reported Outcome (PRO) Measure: Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30-item (EORTC QLQ-C30) Score
Physical Functioning Cycle 3 Day 1
|
-5.94 unit on a scale
Standard Deviation 15.54
|
-1.71 unit on a scale
Standard Deviation 13.88
|
|
Patient Reported Outcome (PRO) Measure: Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30-item (EORTC QLQ-C30) Score
Physical Functioning Cycle 4 Day 1
|
-9.12 unit on a scale
Standard Deviation 13.92
|
-3.17 unit on a scale
Standard Deviation 16.54
|
|
Patient Reported Outcome (PRO) Measure: Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30-item (EORTC QLQ-C30) Score
Physical Functioning Cycle 5 Day 1
|
-8.56 unit on a scale
Standard Deviation 13.47
|
-4.44 unit on a scale
Standard Deviation 14.26
|
|
Patient Reported Outcome (PRO) Measure: Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30-item (EORTC QLQ-C30) Score
Global health status Cycle 2 Day 1
|
-4.68 unit on a scale
Standard Deviation 22.33
|
4.72 unit on a scale
Standard Deviation 18.38
|
SECONDARY outcome
Timeframe: Baseline (Cycle 1 Day 1) up to Cycle 5 Day 1Population: The PRO Analysis population was defined as the ITT population with a baseline and at least one post baseline PRO assessment. Data presented below is only for participants included in the actual analysis.
Subjects reporting \>/= 10-point increase compared to baseline (Cycle 1 Day 1) were considered "improved", those reporting \<10-point difference were considered "remained stable", and those reporting \>/=10-point decrease were considered "worsened". A change of at least 10 points from baseline is considered clinically meaningful (Osoba D, Rodrigues G, Myles J, et al. Interpreting the significance of changes in health-related quality of life score. J Clin Oncol 1998;16:139-44). Patient reported outcome measures were analyzed from baseline up to and including cycle 5. Scores from later timepoints were not analyzed due to attrition (in both arms, fewer than 50% of participants remained on treatment beyond cycle 5).
Outcome measures
| Measure |
Ipatasertib and Paclitaxel
n=57 Participants
Participants randomised to receive paclitaxel 80 mg/m\^2, intravenously on Days 1, 8, and 15 along with ipatasertib 400 mg, orally, once daily from Days 1-21 in each cycle of 28 days until disease progression, intolerable toxicity, elective withdrawal from the study, or study completion or termination.
|
Placebo and Paclitaxel
n=53 Participants
Participants randomised to receive paclitaxel 80 mg/m\^2, intravenously on Days 1, 8, and 15 along with placebo matching ipatasertib, orally, once daily from Days 1-21 in each cycle of 28 days until disease progression, intolerable toxicity, elective withdrawal from the study, or study completion or termination.
|
|---|---|---|
|
PRO Measure: Percentage of Participants With Improved, Worsened, or Remained Stable for Bothersome Side Effects of Treatment Measured by the Scales of the EORTC QLQ-C30
Improved Appetite Loss: Cycle 2
|
10.5 Percentage of Participants
|
18.9 Percentage of Participants
|
|
PRO Measure: Percentage of Participants With Improved, Worsened, or Remained Stable for Bothersome Side Effects of Treatment Measured by the Scales of the EORTC QLQ-C30
Maintained Appetite Loss: Cycle 2
|
64.9 Percentage of Participants
|
66.0 Percentage of Participants
|
|
PRO Measure: Percentage of Participants With Improved, Worsened, or Remained Stable for Bothersome Side Effects of Treatment Measured by the Scales of the EORTC QLQ-C30
Worsened Appetite Loss: Cycle 2
|
24.6 Percentage of Participants
|
15.1 Percentage of Participants
|
|
PRO Measure: Percentage of Participants With Improved, Worsened, or Remained Stable for Bothersome Side Effects of Treatment Measured by the Scales of the EORTC QLQ-C30
Improved Appetite Loss: Cycle 3
|
8.7 Percentage of Participants
|
27.9 Percentage of Participants
|
|
PRO Measure: Percentage of Participants With Improved, Worsened, or Remained Stable for Bothersome Side Effects of Treatment Measured by the Scales of the EORTC QLQ-C30
Maintained Appetite Loss: Cycle 3
|
56.5 Percentage of Participants
|
53.5 Percentage of Participants
|
|
PRO Measure: Percentage of Participants With Improved, Worsened, or Remained Stable for Bothersome Side Effects of Treatment Measured by the Scales of the EORTC QLQ-C30
Worsened Appetite Loss: Cycle 3
|
34.8 Percentage of Participants
|
18.6 Percentage of Participants
|
|
PRO Measure: Percentage of Participants With Improved, Worsened, or Remained Stable for Bothersome Side Effects of Treatment Measured by the Scales of the EORTC QLQ-C30
Improved Appetite Loss: Cycle 4
|
10.2 Percentage of Participants
|
30.0 Percentage of Participants
|
|
PRO Measure: Percentage of Participants With Improved, Worsened, or Remained Stable for Bothersome Side Effects of Treatment Measured by the Scales of the EORTC QLQ-C30
Maintained Appetite Loss: Cycle 4
|
65.3 Percentage of Participants
|
57.5 Percentage of Participants
|
|
PRO Measure: Percentage of Participants With Improved, Worsened, or Remained Stable for Bothersome Side Effects of Treatment Measured by the Scales of the EORTC QLQ-C30
Worsened Appetite Loss: Cycle 4
|
24.5 Percentage of Participants
|
12.5 Percentage of Participants
|
|
PRO Measure: Percentage of Participants With Improved, Worsened, or Remained Stable for Bothersome Side Effects of Treatment Measured by the Scales of the EORTC QLQ-C30
Improved Appetite Loss: Cycle 5
|
8.6 Percentage of Participants
|
26.7 Percentage of Participants
|
|
PRO Measure: Percentage of Participants With Improved, Worsened, or Remained Stable for Bothersome Side Effects of Treatment Measured by the Scales of the EORTC QLQ-C30
Maintained Appetite Loss: Cycle 5
|
80.0 Percentage of Participants
|
53.3 Percentage of Participants
|
|
PRO Measure: Percentage of Participants With Improved, Worsened, or Remained Stable for Bothersome Side Effects of Treatment Measured by the Scales of the EORTC QLQ-C30
Worsened Appetite Loss: Cycle 5
|
11.4 Percentage of Participants
|
20.0 Percentage of Participants
|
|
PRO Measure: Percentage of Participants With Improved, Worsened, or Remained Stable for Bothersome Side Effects of Treatment Measured by the Scales of the EORTC QLQ-C30
Improved Diarrhea: Cycle 2
|
3.5 Percentage of Participants
|
7.5 Percentage of Participants
|
|
PRO Measure: Percentage of Participants With Improved, Worsened, or Remained Stable for Bothersome Side Effects of Treatment Measured by the Scales of the EORTC QLQ-C30
Maintained Diarrhea: Cycle 2
|
50.9 Percentage of Participants
|
79.2 Percentage of Participants
|
|
PRO Measure: Percentage of Participants With Improved, Worsened, or Remained Stable for Bothersome Side Effects of Treatment Measured by the Scales of the EORTC QLQ-C30
Worsened Diarrhea: Cycle 2
|
45.6 Percentage of Participants
|
13.2 Percentage of Participants
|
|
PRO Measure: Percentage of Participants With Improved, Worsened, or Remained Stable for Bothersome Side Effects of Treatment Measured by the Scales of the EORTC QLQ-C30
Improved Diarrhea: Cycle 3
|
8.7 Percentage of Participants
|
9.3 Percentage of Participants
|
|
PRO Measure: Percentage of Participants With Improved, Worsened, or Remained Stable for Bothersome Side Effects of Treatment Measured by the Scales of the EORTC QLQ-C30
Maintained Diarrhea: Cycle 3
|
39.1 Percentage of Participants
|
69.8 Percentage of Participants
|
|
PRO Measure: Percentage of Participants With Improved, Worsened, or Remained Stable for Bothersome Side Effects of Treatment Measured by the Scales of the EORTC QLQ-C30
Worsened Diarrhea: Cycle 3
|
52.2 Percentage of Participants
|
20.9 Percentage of Participants
|
|
PRO Measure: Percentage of Participants With Improved, Worsened, or Remained Stable for Bothersome Side Effects of Treatment Measured by the Scales of the EORTC QLQ-C30
Improved Diarrhea: Cycle 4
|
10.2 Percentage of Participants
|
10.0 Percentage of Participants
|
|
PRO Measure: Percentage of Participants With Improved, Worsened, or Remained Stable for Bothersome Side Effects of Treatment Measured by the Scales of the EORTC QLQ-C30
Maintained Diarrhea: Cycle 4
|
38.8 Percentage of Participants
|
77.5 Percentage of Participants
|
|
PRO Measure: Percentage of Participants With Improved, Worsened, or Remained Stable for Bothersome Side Effects of Treatment Measured by the Scales of the EORTC QLQ-C30
Worsened Diarrhea: Cycle 4
|
51.0 Percentage of Participants
|
12.5 Percentage of Participants
|
|
PRO Measure: Percentage of Participants With Improved, Worsened, or Remained Stable for Bothersome Side Effects of Treatment Measured by the Scales of the EORTC QLQ-C30
Improved Diarrhea: Cycle 5
|
14.3 Percentage of Participants
|
10.0 Percentage of Participants
|
|
PRO Measure: Percentage of Participants With Improved, Worsened, or Remained Stable for Bothersome Side Effects of Treatment Measured by the Scales of the EORTC QLQ-C30
Maintained Diarrhea: Cycle 5
|
34.3 Percentage of Participants
|
76.7 Percentage of Participants
|
|
PRO Measure: Percentage of Participants With Improved, Worsened, or Remained Stable for Bothersome Side Effects of Treatment Measured by the Scales of the EORTC QLQ-C30
Worsened Diarrhea: Cycle 5
|
51.4 Percentage of Participants
|
13.3 Percentage of Participants
|
|
PRO Measure: Percentage of Participants With Improved, Worsened, or Remained Stable for Bothersome Side Effects of Treatment Measured by the Scales of the EORTC QLQ-C30
Improved Fatigue: Cycle 2
|
21.1 Percentage of Participants
|
34.0 Percentage of Participants
|
|
PRO Measure: Percentage of Participants With Improved, Worsened, or Remained Stable for Bothersome Side Effects of Treatment Measured by the Scales of the EORTC QLQ-C30
Maintained Fatigue: Cycle 2
|
29.85 Percentage of Participants
|
30.2 Percentage of Participants
|
|
PRO Measure: Percentage of Participants With Improved, Worsened, or Remained Stable for Bothersome Side Effects of Treatment Measured by the Scales of the EORTC QLQ-C30
Worsened Fatigue: Cycle 2
|
49.1 Percentage of Participants
|
35.8 Percentage of Participants
|
|
PRO Measure: Percentage of Participants With Improved, Worsened, or Remained Stable for Bothersome Side Effects of Treatment Measured by the Scales of the EORTC QLQ-C30
Improved Fatigue: Cycle 3
|
23.9 Percentage of Participants
|
34.9 Percentage of Participants
|
|
PRO Measure: Percentage of Participants With Improved, Worsened, or Remained Stable for Bothersome Side Effects of Treatment Measured by the Scales of the EORTC QLQ-C30
Maintained Fatigue: Cycle 3
|
15.2 Percentage of Participants
|
30.2 Percentage of Participants
|
|
PRO Measure: Percentage of Participants With Improved, Worsened, or Remained Stable for Bothersome Side Effects of Treatment Measured by the Scales of the EORTC QLQ-C30
Worsened Fatigue: Cycle 3
|
60.9 Percentage of Participants
|
34.9 Percentage of Participants
|
|
PRO Measure: Percentage of Participants With Improved, Worsened, or Remained Stable for Bothersome Side Effects of Treatment Measured by the Scales of the EORTC QLQ-C30
Improved Fatigue: Cycle 4
|
24.5 Percentage of Participants
|
28.2 Percentage of Participants
|
|
PRO Measure: Percentage of Participants With Improved, Worsened, or Remained Stable for Bothersome Side Effects of Treatment Measured by the Scales of the EORTC QLQ-C30
Maintained Fatigue: Cycle 4
|
28.6 Percentage of Participants
|
28.2 Percentage of Participants
|
|
PRO Measure: Percentage of Participants With Improved, Worsened, or Remained Stable for Bothersome Side Effects of Treatment Measured by the Scales of the EORTC QLQ-C30
Worsened Fatigue: Cycle 4
|
46.9 Percentage of Participants
|
43.6 Percentage of Participants
|
|
PRO Measure: Percentage of Participants With Improved, Worsened, or Remained Stable for Bothersome Side Effects of Treatment Measured by the Scales of the EORTC QLQ-C30
Improved Fatigue: Cycle 5
|
20.0 Percentage of Participants
|
30.0 Percentage of Participants
|
|
PRO Measure: Percentage of Participants With Improved, Worsened, or Remained Stable for Bothersome Side Effects of Treatment Measured by the Scales of the EORTC QLQ-C30
Maintained Fatigue: Cycle 5
|
20.0 Percentage of Participants
|
43.3 Percentage of Participants
|
|
PRO Measure: Percentage of Participants With Improved, Worsened, or Remained Stable for Bothersome Side Effects of Treatment Measured by the Scales of the EORTC QLQ-C30
Worsened Fatigue: Cycle 5
|
60.0 Percentage of Participants
|
26.7 Percentage of Participants
|
|
PRO Measure: Percentage of Participants With Improved, Worsened, or Remained Stable for Bothersome Side Effects of Treatment Measured by the Scales of the EORTC QLQ-C30
Improved Nausea/Vomiting Cycle 2
|
3.5 Percentage of Participants
|
11.3 Percentage of Participants
|
|
PRO Measure: Percentage of Participants With Improved, Worsened, or Remained Stable for Bothersome Side Effects of Treatment Measured by the Scales of the EORTC QLQ-C30
Maintained Nausea/Vomiting Cycle 2
|
61.4 Percentage of Participants
|
64.2 Percentage of Participants
|
|
PRO Measure: Percentage of Participants With Improved, Worsened, or Remained Stable for Bothersome Side Effects of Treatment Measured by the Scales of the EORTC QLQ-C30
Worsened Nausea/Vomiting Cycle 2
|
35.1 Percentage of Participants
|
24.5 Percentage of Participants
|
|
PRO Measure: Percentage of Participants With Improved, Worsened, or Remained Stable for Bothersome Side Effects of Treatment Measured by the Scales of the EORTC QLQ-C30
Improved Nausea/Vomiting Cycle 3
|
4.3 Percentage of Participants
|
9.3 Percentage of Participants
|
|
PRO Measure: Percentage of Participants With Improved, Worsened, or Remained Stable for Bothersome Side Effects of Treatment Measured by the Scales of the EORTC QLQ-C30
Maintained Nausea/Vomiting Cycle 3
|
65.2 Percentage of Participants
|
62.8 Percentage of Participants
|
|
PRO Measure: Percentage of Participants With Improved, Worsened, or Remained Stable for Bothersome Side Effects of Treatment Measured by the Scales of the EORTC QLQ-C30
Worsened Nausea/Vomiting Cycle 3
|
30.4 Percentage of Participants
|
27.9 Percentage of Participants
|
|
PRO Measure: Percentage of Participants With Improved, Worsened, or Remained Stable for Bothersome Side Effects of Treatment Measured by the Scales of the EORTC QLQ-C30
Improved Nausea/Vomiting Cycle 4
|
2.0 Percentage of Participants
|
7.5 Percentage of Participants
|
|
PRO Measure: Percentage of Participants With Improved, Worsened, or Remained Stable for Bothersome Side Effects of Treatment Measured by the Scales of the EORTC QLQ-C30
Maintained Nausea/Vomiting Cycle 4
|
73.5 Percentage of Participants
|
67.5 Percentage of Participants
|
|
PRO Measure: Percentage of Participants With Improved, Worsened, or Remained Stable for Bothersome Side Effects of Treatment Measured by the Scales of the EORTC QLQ-C30
Worsened Nausea/Vomiting Cycle 4
|
24.5 Percentage of Participants
|
25.0 Percentage of Participants
|
|
PRO Measure: Percentage of Participants With Improved, Worsened, or Remained Stable for Bothersome Side Effects of Treatment Measured by the Scales of the EORTC QLQ-C30
Improved Nausea/Vomiting Cycle 5
|
0 Percentage of Participants
|
16.7 Percentage of Participants
|
|
PRO Measure: Percentage of Participants With Improved, Worsened, or Remained Stable for Bothersome Side Effects of Treatment Measured by the Scales of the EORTC QLQ-C30
Maintained Nausea/Vomiting Cycle 5
|
77.8 Percentage of Participants
|
60.0 Percentage of Participants
|
|
PRO Measure: Percentage of Participants With Improved, Worsened, or Remained Stable for Bothersome Side Effects of Treatment Measured by the Scales of the EORTC QLQ-C30
Worsened Nausea/Vomiting Cycle 5
|
22.2 Percentage of Participants
|
23.3 Percentage of Participants
|
|
PRO Measure: Percentage of Participants With Improved, Worsened, or Remained Stable for Bothersome Side Effects of Treatment Measured by the Scales of the EORTC QLQ-C30
Improved Cognitive Functioning Cycle 2
|
22.8 Percentage of Participants
|
17.0 Percentage of Participants
|
|
PRO Measure: Percentage of Participants With Improved, Worsened, or Remained Stable for Bothersome Side Effects of Treatment Measured by the Scales of the EORTC QLQ-C30
Maintained Cognitive Function Cycle 2
|
61.4 Percentage of Participants
|
60.4 Percentage of Participants
|
|
PRO Measure: Percentage of Participants With Improved, Worsened, or Remained Stable for Bothersome Side Effects of Treatment Measured by the Scales of the EORTC QLQ-C30
Worsened Cognitive Function Cycle 2
|
15.8 Percentage of Participants
|
22.6 Percentage of Participants
|
|
PRO Measure: Percentage of Participants With Improved, Worsened, or Remained Stable for Bothersome Side Effects of Treatment Measured by the Scales of the EORTC QLQ-C30
Improved Cognitive Functioning Cycle 3
|
26.1 Percentage of Participants
|
16.3 Percentage of Participants
|
|
PRO Measure: Percentage of Participants With Improved, Worsened, or Remained Stable for Bothersome Side Effects of Treatment Measured by the Scales of the EORTC QLQ-C30
Maintained Cognitive Functioning Cycle 3
|
47.8 Percentage of Participants
|
53.5 Percentage of Participants
|
|
PRO Measure: Percentage of Participants With Improved, Worsened, or Remained Stable for Bothersome Side Effects of Treatment Measured by the Scales of the EORTC QLQ-C30
Worsened Cognitive Functioning Cycle 3
|
26.1 Percentage of Participants
|
30.2 Percentage of Participants
|
|
PRO Measure: Percentage of Participants With Improved, Worsened, or Remained Stable for Bothersome Side Effects of Treatment Measured by the Scales of the EORTC QLQ-C30
Improved Cognitive Functioning Cycle 4
|
20.4 Percentage of Participants
|
22.5 Percentage of Participants
|
|
PRO Measure: Percentage of Participants With Improved, Worsened, or Remained Stable for Bothersome Side Effects of Treatment Measured by the Scales of the EORTC QLQ-C30
Maintained Cognitive Functioning Cycle 4
|
51.0 Percentage of Participants
|
52.5 Percentage of Participants
|
|
PRO Measure: Percentage of Participants With Improved, Worsened, or Remained Stable for Bothersome Side Effects of Treatment Measured by the Scales of the EORTC QLQ-C30
Worsened Cognitive Functioning Cycle 4
|
28.6 Percentage of Participants
|
25.0 Percentage of Participants
|
|
PRO Measure: Percentage of Participants With Improved, Worsened, or Remained Stable for Bothersome Side Effects of Treatment Measured by the Scales of the EORTC QLQ-C30
Improved Cognitive Functioning Cycle 5
|
19.4 Percentage of Participants
|
20.0 Percentage of Participants
|
|
PRO Measure: Percentage of Participants With Improved, Worsened, or Remained Stable for Bothersome Side Effects of Treatment Measured by the Scales of the EORTC QLQ-C30
Maintained Cognitive Functioning Cycle 5
|
58.3 Percentage of Participants
|
46.7 Percentage of Participants
|
|
PRO Measure: Percentage of Participants With Improved, Worsened, or Remained Stable for Bothersome Side Effects of Treatment Measured by the Scales of the EORTC QLQ-C30
Worsened Cognitive Functioning Cycle 5
|
22.2 Percentage of Participants
|
33.3 Percentage of Participants
|
|
PRO Measure: Percentage of Participants With Improved, Worsened, or Remained Stable for Bothersome Side Effects of Treatment Measured by the Scales of the EORTC QLQ-C30
Improved Constipation Cycle 2
|
8.8 Percentage of Participants
|
17.0 Percentage of Participants
|
|
PRO Measure: Percentage of Participants With Improved, Worsened, or Remained Stable for Bothersome Side Effects of Treatment Measured by the Scales of the EORTC QLQ-C30
Maintained Constipation Cycle 2
|
73.7 Percentage of Participants
|
64.2 Percentage of Participants
|
|
PRO Measure: Percentage of Participants With Improved, Worsened, or Remained Stable for Bothersome Side Effects of Treatment Measured by the Scales of the EORTC QLQ-C30
Worsened Constipation Cycle 2
|
17.5 Percentage of Participants
|
18.9 Percentage of Participants
|
|
PRO Measure: Percentage of Participants With Improved, Worsened, or Remained Stable for Bothersome Side Effects of Treatment Measured by the Scales of the EORTC QLQ-C30
Improved Constipation Cycle 3
|
10.9 Percentage of Participants
|
9.5 Percentage of Participants
|
|
PRO Measure: Percentage of Participants With Improved, Worsened, or Remained Stable for Bothersome Side Effects of Treatment Measured by the Scales of the EORTC QLQ-C30
Maintained Constipation Cycle 3
|
71.7 Percentage of Participants
|
71.4 Percentage of Participants
|
|
PRO Measure: Percentage of Participants With Improved, Worsened, or Remained Stable for Bothersome Side Effects of Treatment Measured by the Scales of the EORTC QLQ-C30
Worsened Constipation Cycle 3
|
17.4 Percentage of Participants
|
19.0 Percentage of Participants
|
|
PRO Measure: Percentage of Participants With Improved, Worsened, or Remained Stable for Bothersome Side Effects of Treatment Measured by the Scales of the EORTC QLQ-C30
Improved Constipation Cycle 4
|
10.4 Percentage of Participants
|
15.0 Percentage of Participants
|
|
PRO Measure: Percentage of Participants With Improved, Worsened, or Remained Stable for Bothersome Side Effects of Treatment Measured by the Scales of the EORTC QLQ-C30
Maintained Constipation Cycle 4
|
75.0 Percentage of Participants
|
60.0 Percentage of Participants
|
|
PRO Measure: Percentage of Participants With Improved, Worsened, or Remained Stable for Bothersome Side Effects of Treatment Measured by the Scales of the EORTC QLQ-C30
Worsened Constipation Cycle 4
|
14.6 Percentage of Participants
|
25.0 Percentage of Participants
|
|
PRO Measure: Percentage of Participants With Improved, Worsened, or Remained Stable for Bothersome Side Effects of Treatment Measured by the Scales of the EORTC QLQ-C30
Improved Constipation Cycle 5
|
5.6 Percentage of Participants
|
13.3 Percentage of Participants
|
|
PRO Measure: Percentage of Participants With Improved, Worsened, or Remained Stable for Bothersome Side Effects of Treatment Measured by the Scales of the EORTC QLQ-C30
Maintained Constipation Cycle 5
|
80.6 Percentage of Participants
|
73.3 Percentage of Participants
|
|
PRO Measure: Percentage of Participants With Improved, Worsened, or Remained Stable for Bothersome Side Effects of Treatment Measured by the Scales of the EORTC QLQ-C30
Worsened Constipation Cycle 5
|
13.9 Percentage of Participants
|
13.3 Percentage of Participants
|
|
PRO Measure: Percentage of Participants With Improved, Worsened, or Remained Stable for Bothersome Side Effects of Treatment Measured by the Scales of the EORTC QLQ-C30
Improved Dyspnea Cycle 2
|
5.3 Percentage of Participants
|
15.4 Percentage of Participants
|
|
PRO Measure: Percentage of Participants With Improved, Worsened, or Remained Stable for Bothersome Side Effects of Treatment Measured by the Scales of the EORTC QLQ-C30
Maintained Dyspnea Cycle 2
|
77.2 Percentage of Participants
|
69.2 Percentage of Participants
|
|
PRO Measure: Percentage of Participants With Improved, Worsened, or Remained Stable for Bothersome Side Effects of Treatment Measured by the Scales of the EORTC QLQ-C30
Worsened Dyspnea Cycle 2
|
17.5 Percentage of Participants
|
15.4 Percentage of Participants
|
|
PRO Measure: Percentage of Participants With Improved, Worsened, or Remained Stable for Bothersome Side Effects of Treatment Measured by the Scales of the EORTC QLQ-C30
Improved Dyspnea Cycle 3
|
6.5 Percentage of Participants
|
14.6 Percentage of Participants
|
|
PRO Measure: Percentage of Participants With Improved, Worsened, or Remained Stable for Bothersome Side Effects of Treatment Measured by the Scales of the EORTC QLQ-C30
Maintained Dyspnea Cycle 3
|
67.4 Percentage of Participants
|
68.3 Percentage of Participants
|
|
PRO Measure: Percentage of Participants With Improved, Worsened, or Remained Stable for Bothersome Side Effects of Treatment Measured by the Scales of the EORTC QLQ-C30
Worsened Dyspnea Cycle 3
|
26.1 Percentage of Participants
|
17.1 Percentage of Participants
|
|
PRO Measure: Percentage of Participants With Improved, Worsened, or Remained Stable for Bothersome Side Effects of Treatment Measured by the Scales of the EORTC QLQ-C30
Improved Dyspnea Cycle 4
|
10.2 Percentage of Participants
|
12.8 Percentage of Participants
|
|
PRO Measure: Percentage of Participants With Improved, Worsened, or Remained Stable for Bothersome Side Effects of Treatment Measured by the Scales of the EORTC QLQ-C30
Maintained Dyspnea Cycle 4
|
69.4 Percentage of Participants
|
61.5 Percentage of Participants
|
|
PRO Measure: Percentage of Participants With Improved, Worsened, or Remained Stable for Bothersome Side Effects of Treatment Measured by the Scales of the EORTC QLQ-C30
Worsened Dyspnea Cycle 4
|
20.4 Percentage of Participants
|
25.6 Percentage of Participants
|
|
PRO Measure: Percentage of Participants With Improved, Worsened, or Remained Stable for Bothersome Side Effects of Treatment Measured by the Scales of the EORTC QLQ-C30
Improved Dyspnea Cycle 5
|
8.3 Percentage of Participants
|
14.3 Percentage of Participants
|
|
PRO Measure: Percentage of Participants With Improved, Worsened, or Remained Stable for Bothersome Side Effects of Treatment Measured by the Scales of the EORTC QLQ-C30
Maintained Dyspnea Cycle 5
|
69.4 Percentage of Participants
|
60.7 Percentage of Participants
|
|
PRO Measure: Percentage of Participants With Improved, Worsened, or Remained Stable for Bothersome Side Effects of Treatment Measured by the Scales of the EORTC QLQ-C30
Worsened Dyspnea Cycle 5
|
22.2 Percentage of Participants
|
25.0 Percentage of Participants
|
|
PRO Measure: Percentage of Participants With Improved, Worsened, or Remained Stable for Bothersome Side Effects of Treatment Measured by the Scales of the EORTC QLQ-C30
Improved Emotional Functioning Cycle 2
|
50.9 Percentage of Participants
|
35.8 Percentage of Participants
|
|
PRO Measure: Percentage of Participants With Improved, Worsened, or Remained Stable for Bothersome Side Effects of Treatment Measured by the Scales of the EORTC QLQ-C30
Maintained Emotional Functioning Cycle 2
|
43.9 Percentage of Participants
|
50.9 Percentage of Participants
|
|
PRO Measure: Percentage of Participants With Improved, Worsened, or Remained Stable for Bothersome Side Effects of Treatment Measured by the Scales of the EORTC QLQ-C30
Worsened Emotional Functioning Cycle 2
|
5.3 Percentage of Participants
|
13.2 Percentage of Participants
|
|
PRO Measure: Percentage of Participants With Improved, Worsened, or Remained Stable for Bothersome Side Effects of Treatment Measured by the Scales of the EORTC QLQ-C30
Improved Emotional Functioning Cycle 3
|
45.7 Percentage of Participants
|
37.2 Percentage of Participants
|
|
PRO Measure: Percentage of Participants With Improved, Worsened, or Remained Stable for Bothersome Side Effects of Treatment Measured by the Scales of the EORTC QLQ-C30
Maintained Emotional Functioning Cycle 3
|
45.7 Percentage of Participants
|
41.9 Percentage of Participants
|
|
PRO Measure: Percentage of Participants With Improved, Worsened, or Remained Stable for Bothersome Side Effects of Treatment Measured by the Scales of the EORTC QLQ-C30
Worsened Emotional Functioning Cycle 3
|
8.7 Percentage of Participants
|
20.9 Percentage of Participants
|
|
PRO Measure: Percentage of Participants With Improved, Worsened, or Remained Stable for Bothersome Side Effects of Treatment Measured by the Scales of the EORTC QLQ-C30
Improved Emotional Functioning Cycle 4
|
42.9 Percentage of Participants
|
30.0 Percentage of Participants
|
|
PRO Measure: Percentage of Participants With Improved, Worsened, or Remained Stable for Bothersome Side Effects of Treatment Measured by the Scales of the EORTC QLQ-C30
Maintained Emotional Functioning Cycle 4
|
49.0 Percentage of Participants
|
45.0 Percentage of Participants
|
|
PRO Measure: Percentage of Participants With Improved, Worsened, or Remained Stable for Bothersome Side Effects of Treatment Measured by the Scales of the EORTC QLQ-C30
Worsened Emotional Functioning Cycle 4
|
8.2 Percentage of Participants
|
25.0 Percentage of Participants
|
|
PRO Measure: Percentage of Participants With Improved, Worsened, or Remained Stable for Bothersome Side Effects of Treatment Measured by the Scales of the EORTC QLQ-C30
Improved Emotional Functioning Cycle 5
|
42.9 Percentage of Participants
|
36.7 Percentage of Participants
|
|
PRO Measure: Percentage of Participants With Improved, Worsened, or Remained Stable for Bothersome Side Effects of Treatment Measured by the Scales of the EORTC QLQ-C30
Maintained Emotional Functioning Cycle 5
|
48.6 Percentage of Participants
|
36.7 Percentage of Participants
|
|
PRO Measure: Percentage of Participants With Improved, Worsened, or Remained Stable for Bothersome Side Effects of Treatment Measured by the Scales of the EORTC QLQ-C30
Worsened Emotional Functioning Cycle 5
|
8.6 Percentage of Participants
|
26.7 Percentage of Participants
|
|
PRO Measure: Percentage of Participants With Improved, Worsened, or Remained Stable for Bothersome Side Effects of Treatment Measured by the Scales of the EORTC QLQ-C30
Improved Financial Difficulties Cycle 2
|
10.7 Percentage of Participants
|
13.5 Percentage of Participants
|
|
PRO Measure: Percentage of Participants With Improved, Worsened, or Remained Stable for Bothersome Side Effects of Treatment Measured by the Scales of the EORTC QLQ-C30
Maintained Financial Difficulties Cycle 2
|
73.2 Percentage of Participants
|
73.1 Percentage of Participants
|
|
PRO Measure: Percentage of Participants With Improved, Worsened, or Remained Stable for Bothersome Side Effects of Treatment Measured by the Scales of the EORTC QLQ-C30
Worsened Financial Difficulties Cycle 2
|
16.1 Percentage of Participants
|
13.5 Percentage of Participants
|
|
PRO Measure: Percentage of Participants With Improved, Worsened, or Remained Stable for Bothersome Side Effects of Treatment Measured by the Scales of the EORTC QLQ-C30
Improved Financial Difficulties Cycle 3
|
13.0 Percentage of Participants
|
18.6 Percentage of Participants
|
|
PRO Measure: Percentage of Participants With Improved, Worsened, or Remained Stable for Bothersome Side Effects of Treatment Measured by the Scales of the EORTC QLQ-C30
Maintained Financial Difficulties Cycle 3
|
73.9 Percentage of Participants
|
72.1 Percentage of Participants
|
|
PRO Measure: Percentage of Participants With Improved, Worsened, or Remained Stable for Bothersome Side Effects of Treatment Measured by the Scales of the EORTC QLQ-C30
Worsened Financial Difficulties Cycle 3
|
13.0 Percentage of Participants
|
9.3 Percentage of Participants
|
|
PRO Measure: Percentage of Participants With Improved, Worsened, or Remained Stable for Bothersome Side Effects of Treatment Measured by the Scales of the EORTC QLQ-C30
Improved Financial Difficulties Cycle 4
|
10.2 Percentage of Participants
|
17.5 Percentage of Participants
|
|
PRO Measure: Percentage of Participants With Improved, Worsened, or Remained Stable for Bothersome Side Effects of Treatment Measured by the Scales of the EORTC QLQ-C30
Maintained Financial Difficulties Cycle 4
|
73.5 Percentage of Participants
|
70.0 Percentage of Participants
|
|
PRO Measure: Percentage of Participants With Improved, Worsened, or Remained Stable for Bothersome Side Effects of Treatment Measured by the Scales of the EORTC QLQ-C30
Worsened Financial Difficulties Cycle 4
|
16.3 Percentage of Participants
|
12.5 Percentage of Participants
|
|
PRO Measure: Percentage of Participants With Improved, Worsened, or Remained Stable for Bothersome Side Effects of Treatment Measured by the Scales of the EORTC QLQ-C30
Improved Financial Difficulties Cycle 5
|
13.9 Percentage of Participants
|
20.0 Percentage of Participants
|
|
PRO Measure: Percentage of Participants With Improved, Worsened, or Remained Stable for Bothersome Side Effects of Treatment Measured by the Scales of the EORTC QLQ-C30
Maintained Financial Difficulties Cycle 5
|
66.7 Percentage of Participants
|
63.3 Percentage of Participants
|
|
PRO Measure: Percentage of Participants With Improved, Worsened, or Remained Stable for Bothersome Side Effects of Treatment Measured by the Scales of the EORTC QLQ-C30
Worsened Financial Difficulties Cycle 5
|
19.4 Percentage of Participants
|
16.7 Percentage of Participants
|
|
PRO Measure: Percentage of Participants With Improved, Worsened, or Remained Stable for Bothersome Side Effects of Treatment Measured by the Scales of the EORTC QLQ-C30
Improved Pain Cycle 2
|
35.1 Percentage of Participants
|
35.8 Percentage of Participants
|
|
PRO Measure: Percentage of Participants With Improved, Worsened, or Remained Stable for Bothersome Side Effects of Treatment Measured by the Scales of the EORTC QLQ-C30
Maintained Pain Cycle 2
|
40.4 Percentage of Participants
|
45.3 Percentage of Participants
|
|
PRO Measure: Percentage of Participants With Improved, Worsened, or Remained Stable for Bothersome Side Effects of Treatment Measured by the Scales of the EORTC QLQ-C30
Worsened Pain Cycle 2
|
24.6 Percentage of Participants
|
18.9 Percentage of Participants
|
|
PRO Measure: Percentage of Participants With Improved, Worsened, or Remained Stable for Bothersome Side Effects of Treatment Measured by the Scales of the EORTC QLQ-C30
Improved Pain Cycle 3
|
37.0 Percentage of Participants
|
39.5 Percentage of Participants
|
|
PRO Measure: Percentage of Participants With Improved, Worsened, or Remained Stable for Bothersome Side Effects of Treatment Measured by the Scales of the EORTC QLQ-C30
Maintained Pain Cycle 3
|
39.1 Percentage of Participants
|
39.5 Percentage of Participants
|
|
PRO Measure: Percentage of Participants With Improved, Worsened, or Remained Stable for Bothersome Side Effects of Treatment Measured by the Scales of the EORTC QLQ-C30
Worsened Pain Cycle
|
23.9 Percentage of Participants
|
20.9 Percentage of Participants
|
|
PRO Measure: Percentage of Participants With Improved, Worsened, or Remained Stable for Bothersome Side Effects of Treatment Measured by the Scales of the EORTC QLQ-C30
Improved Pain Cycle 4
|
32.7 Percentage of Participants
|
37.5 Percentage of Participants
|
|
PRO Measure: Percentage of Participants With Improved, Worsened, or Remained Stable for Bothersome Side Effects of Treatment Measured by the Scales of the EORTC QLQ-C30
Maintained Pain Cycle 4
|
32.7 Percentage of Participants
|
35.0 Percentage of Participants
|
|
PRO Measure: Percentage of Participants With Improved, Worsened, or Remained Stable for Bothersome Side Effects of Treatment Measured by the Scales of the EORTC QLQ-C30
Worsened Pain Cycle 4
|
34.7 Percentage of Participants
|
27.5 Percentage of Participants
|
|
PRO Measure: Percentage of Participants With Improved, Worsened, or Remained Stable for Bothersome Side Effects of Treatment Measured by the Scales of the EORTC QLQ-C30
Improved Pain Cycle 5
|
33.3 Percentage of Participants
|
33.3 Percentage of Participants
|
|
PRO Measure: Percentage of Participants With Improved, Worsened, or Remained Stable for Bothersome Side Effects of Treatment Measured by the Scales of the EORTC QLQ-C30
Maintained Pain Cycle 5
|
30.6 Percentage of Participants
|
40.0 Percentage of Participants
|
|
PRO Measure: Percentage of Participants With Improved, Worsened, or Remained Stable for Bothersome Side Effects of Treatment Measured by the Scales of the EORTC QLQ-C30
Worsened Pain Cycle 5
|
36.1 Percentage of Participants
|
26.7 Percentage of Participants
|
|
PRO Measure: Percentage of Participants With Improved, Worsened, or Remained Stable for Bothersome Side Effects of Treatment Measured by the Scales of the EORTC QLQ-C30
Improved Physical Functioning Cycle 2
|
7.0 Percentage of Participants
|
13.2 Percentage of Participants
|
|
PRO Measure: Percentage of Participants With Improved, Worsened, or Remained Stable for Bothersome Side Effects of Treatment Measured by the Scales of the EORTC QLQ-C30
Maintained Physical Functioning Cycle 2
|
68.4 Percentage of Participants
|
75.5 Percentage of Participants
|
|
PRO Measure: Percentage of Participants With Improved, Worsened, or Remained Stable for Bothersome Side Effects of Treatment Measured by the Scales of the EORTC QLQ-C30
Worsened Physical Functioning Cycle 2
|
24.6 Percentage of Participants
|
11.3 Percentage of Participants
|
|
PRO Measure: Percentage of Participants With Improved, Worsened, or Remained Stable for Bothersome Side Effects of Treatment Measured by the Scales of the EORTC QLQ-C30
Improved Physical Functioning Cycle 3
|
8.7 Percentage of Participants
|
16.3 Percentage of Participants
|
|
PRO Measure: Percentage of Participants With Improved, Worsened, or Remained Stable for Bothersome Side Effects of Treatment Measured by the Scales of the EORTC QLQ-C30
Maintained Physical Functioning Cycle 3
|
67.4 Percentage of Participants
|
60.5 Percentage of Participants
|
|
PRO Measure: Percentage of Participants With Improved, Worsened, or Remained Stable for Bothersome Side Effects of Treatment Measured by the Scales of the EORTC QLQ-C30
Worsened Physical Functioning Cycle 3
|
23.9 Percentage of Participants
|
23.3 Percentage of Participants
|
|
PRO Measure: Percentage of Participants With Improved, Worsened, or Remained Stable for Bothersome Side Effects of Treatment Measured by the Scales of the EORTC QLQ-C30
Improved Physical Functioning Cycle 4
|
4.1 Percentage of Participants
|
17.5 Percentage of Participants
|
|
PRO Measure: Percentage of Participants With Improved, Worsened, or Remained Stable for Bothersome Side Effects of Treatment Measured by the Scales of the EORTC QLQ-C30
Maintained Physical Functioning Cycle 4
|
55.1 Percentage of Participants
|
57.5 Percentage of Participants
|
|
PRO Measure: Percentage of Participants With Improved, Worsened, or Remained Stable for Bothersome Side Effects of Treatment Measured by the Scales of the EORTC QLQ-C30
Worsened Physical Functioning Cycle 4
|
40.8 Percentage of Participants
|
25.0 Percentage of Participants
|
|
PRO Measure: Percentage of Participants With Improved, Worsened, or Remained Stable for Bothersome Side Effects of Treatment Measured by the Scales of the EORTC QLQ-C30
Improved Physical Functioning Cycle 5
|
8.3 Percentage of Participants
|
16.7 Percentage of Participants
|
|
PRO Measure: Percentage of Participants With Improved, Worsened, or Remained Stable for Bothersome Side Effects of Treatment Measured by the Scales of the EORTC QLQ-C30
Maintained Physical Functioning Cycle 5
|
44.4 Percentage of Participants
|
46.7 Percentage of Participants
|
|
PRO Measure: Percentage of Participants With Improved, Worsened, or Remained Stable for Bothersome Side Effects of Treatment Measured by the Scales of the EORTC QLQ-C30
Worsened Physical Functioning Cycle 5
|
47.2 Percentage of Participants
|
36.7 Percentage of Participants
|
|
PRO Measure: Percentage of Participants With Improved, Worsened, or Remained Stable for Bothersome Side Effects of Treatment Measured by the Scales of the EORTC QLQ-C30
Improved Global Health Status/QoL Cycle 2
|
19.3 Percentage of Participants
|
26.4 Percentage of Participants
|
|
PRO Measure: Percentage of Participants With Improved, Worsened, or Remained Stable for Bothersome Side Effects of Treatment Measured by the Scales of the EORTC QLQ-C30
Maintained Global Health Status/QoL Cycle 2
|
45.6 Percentage of Participants
|
58.5 Percentage of Participants
|
|
PRO Measure: Percentage of Participants With Improved, Worsened, or Remained Stable for Bothersome Side Effects of Treatment Measured by the Scales of the EORTC QLQ-C30
Worsened Global Health Status/QoL Cycle 2
|
35.1 Percentage of Participants
|
15.1 Percentage of Participants
|
|
PRO Measure: Percentage of Participants With Improved, Worsened, or Remained Stable for Bothersome Side Effects of Treatment Measured by the Scales of the EORTC QLQ-C30
Improved Global Health Status/QoL Cycle 3
|
17.4 Percentage of Participants
|
25.6 Percentage of Participants
|
|
PRO Measure: Percentage of Participants With Improved, Worsened, or Remained Stable for Bothersome Side Effects of Treatment Measured by the Scales of the EORTC QLQ-C30
Maintained Global Health Status/QoL Cycle 3
|
37.0 Percentage of Participants
|
60.5 Percentage of Participants
|
|
PRO Measure: Percentage of Participants With Improved, Worsened, or Remained Stable for Bothersome Side Effects of Treatment Measured by the Scales of the EORTC QLQ-C30
Worsened Global Health Status/QoL Cycle 3
|
45.7 Percentage of Participants
|
14.0 Percentage of Participants
|
|
PRO Measure: Percentage of Participants With Improved, Worsened, or Remained Stable for Bothersome Side Effects of Treatment Measured by the Scales of the EORTC QLQ-C30
Improved Global Health Status/QoL Cycle 4
|
14.3 Percentage of Participants
|
25.0 Percentage of Participants
|
|
PRO Measure: Percentage of Participants With Improved, Worsened, or Remained Stable for Bothersome Side Effects of Treatment Measured by the Scales of the EORTC QLQ-C30
Maintained Global Health Status/QoL Cycle 4
|
51.0 Percentage of Participants
|
42.5 Percentage of Participants
|
|
PRO Measure: Percentage of Participants With Improved, Worsened, or Remained Stable for Bothersome Side Effects of Treatment Measured by the Scales of the EORTC QLQ-C30
Worsened Global Health Status/QoL Cycle 4
|
34.7 Percentage of Participants
|
32.5 Percentage of Participants
|
|
PRO Measure: Percentage of Participants With Improved, Worsened, or Remained Stable for Bothersome Side Effects of Treatment Measured by the Scales of the EORTC QLQ-C30
Improved Global Health Status/QoL Cycle 5
|
11.1 Percentage of Participants
|
20.0 Percentage of Participants
|
|
PRO Measure: Percentage of Participants With Improved, Worsened, or Remained Stable for Bothersome Side Effects of Treatment Measured by the Scales of the EORTC QLQ-C30
Maintained Global Health Status/QoL Cycle 5
|
58.3 Percentage of Participants
|
46.7 Percentage of Participants
|
|
PRO Measure: Percentage of Participants With Improved, Worsened, or Remained Stable for Bothersome Side Effects of Treatment Measured by the Scales of the EORTC QLQ-C30
Worsened Global Health Status/QoL Cycle 5
|
30.6 Percentage of Participants
|
33.3 Percentage of Participants
|
|
PRO Measure: Percentage of Participants With Improved, Worsened, or Remained Stable for Bothersome Side Effects of Treatment Measured by the Scales of the EORTC QLQ-C30
Improved Role Functioning Cycle 2
|
17.5 Percentage of Participants
|
24.5 Percentage of Participants
|
|
PRO Measure: Percentage of Participants With Improved, Worsened, or Remained Stable for Bothersome Side Effects of Treatment Measured by the Scales of the EORTC QLQ-C30
Maintained Role Functioning Cycle 2
|
52.6 Percentage of Participants
|
45.3 Percentage of Participants
|
|
PRO Measure: Percentage of Participants With Improved, Worsened, or Remained Stable for Bothersome Side Effects of Treatment Measured by the Scales of the EORTC QLQ-C30
Worsened Role Functioning Cycle 2
|
29.8 Percentage of Participants
|
30.2 Percentage of Participants
|
|
PRO Measure: Percentage of Participants With Improved, Worsened, or Remained Stable for Bothersome Side Effects of Treatment Measured by the Scales of the EORTC QLQ-C30
Improved Role Functioning Cycle 3
|
13.0 Percentage of Participants
|
27.9 Percentage of Participants
|
|
PRO Measure: Percentage of Participants With Improved, Worsened, or Remained Stable for Bothersome Side Effects of Treatment Measured by the Scales of the EORTC QLQ-C30
Maintained Role Functioning Cycle 3
|
47.8 Percentage of Participants
|
46.5 Percentage of Participants
|
|
PRO Measure: Percentage of Participants With Improved, Worsened, or Remained Stable for Bothersome Side Effects of Treatment Measured by the Scales of the EORTC QLQ-C30
Worsened Role Functioning Cycle 3
|
39.1 Percentage of Participants
|
25.6 Percentage of Participants
|
|
PRO Measure: Percentage of Participants With Improved, Worsened, or Remained Stable for Bothersome Side Effects of Treatment Measured by the Scales of the EORTC QLQ-C30
Improved Role Functioning Cycle 4
|
12.2 Percentage of Participants
|
25.0 Percentage of Participants
|
|
PRO Measure: Percentage of Participants With Improved, Worsened, or Remained Stable for Bothersome Side Effects of Treatment Measured by the Scales of the EORTC QLQ-C30
Maintained Role Functioning Cycle 4
|
38.8 Percentage of Participants
|
37.5 Percentage of Participants
|
|
PRO Measure: Percentage of Participants With Improved, Worsened, or Remained Stable for Bothersome Side Effects of Treatment Measured by the Scales of the EORTC QLQ-C30
Worsened Role Functioning Cycle 4
|
49.0 Percentage of Participants
|
37.5 Percentage of Participants
|
|
PRO Measure: Percentage of Participants With Improved, Worsened, or Remained Stable for Bothersome Side Effects of Treatment Measured by the Scales of the EORTC QLQ-C30
Improved Role Functioning Cycle 5
|
11.1 Percentage of Participants
|
16.7 Percentage of Participants
|
|
PRO Measure: Percentage of Participants With Improved, Worsened, or Remained Stable for Bothersome Side Effects of Treatment Measured by the Scales of the EORTC QLQ-C30
Maintained Role Functioning Cycle 5
|
47.2 Percentage of Participants
|
40.0 Percentage of Participants
|
|
PRO Measure: Percentage of Participants With Improved, Worsened, or Remained Stable for Bothersome Side Effects of Treatment Measured by the Scales of the EORTC QLQ-C30
Worsened Role Functioning Cycle 5
|
41.7 Percentage of Participants
|
43.3 Percentage of Participants
|
|
PRO Measure: Percentage of Participants With Improved, Worsened, or Remained Stable for Bothersome Side Effects of Treatment Measured by the Scales of the EORTC QLQ-C30
Improved Social Functioning Cycle 2
|
21.1 Percentage of Participants
|
22.6 Percentage of Participants
|
|
PRO Measure: Percentage of Participants With Improved, Worsened, or Remained Stable for Bothersome Side Effects of Treatment Measured by the Scales of the EORTC QLQ-C30
Maintained Social Functioning Cycle 2
|
49.1 Percentage of Participants
|
49.1 Percentage of Participants
|
|
PRO Measure: Percentage of Participants With Improved, Worsened, or Remained Stable for Bothersome Side Effects of Treatment Measured by the Scales of the EORTC QLQ-C30
Worsened Social Functioning Cycle 2
|
29.8 Percentage of Participants
|
28.3 Percentage of Participants
|
|
PRO Measure: Percentage of Participants With Improved, Worsened, or Remained Stable for Bothersome Side Effects of Treatment Measured by the Scales of the EORTC QLQ-C30
Improved Social Functioning Cycle 3
|
17.4 Percentage of Participants
|
16.3 Percentage of Participants
|
|
PRO Measure: Percentage of Participants With Improved, Worsened, or Remained Stable for Bothersome Side Effects of Treatment Measured by the Scales of the EORTC QLQ-C30
Maintained Social Functioning Cycle 3
|
52.2 Percentage of Participants
|
53.5 Percentage of Participants
|
|
PRO Measure: Percentage of Participants With Improved, Worsened, or Remained Stable for Bothersome Side Effects of Treatment Measured by the Scales of the EORTC QLQ-C30
Worsened Social Functioning Cycle 3
|
30.4 Percentage of Participants
|
30.2 Percentage of Participants
|
|
PRO Measure: Percentage of Participants With Improved, Worsened, or Remained Stable for Bothersome Side Effects of Treatment Measured by the Scales of the EORTC QLQ-C30
Improved Social Functioning Cycle 4
|
16.3 Percentage of Participants
|
10.0 Percentage of Participants
|
|
PRO Measure: Percentage of Participants With Improved, Worsened, or Remained Stable for Bothersome Side Effects of Treatment Measured by the Scales of the EORTC QLQ-C30
Maintained Social Functioning Cycle 4
|
49.0 Percentage of Participants
|
47.5 Percentage of Participants
|
|
PRO Measure: Percentage of Participants With Improved, Worsened, or Remained Stable for Bothersome Side Effects of Treatment Measured by the Scales of the EORTC QLQ-C30
Worsened Social Functioning Cycle 4
|
34.7 Percentage of Participants
|
42.5 Percentage of Participants
|
|
PRO Measure: Percentage of Participants With Improved, Worsened, or Remained Stable for Bothersome Side Effects of Treatment Measured by the Scales of the EORTC QLQ-C30
Improved Social Functioning Cycle 5
|
17.1 Percentage of Participants
|
13.3 Percentage of Participants
|
|
PRO Measure: Percentage of Participants With Improved, Worsened, or Remained Stable for Bothersome Side Effects of Treatment Measured by the Scales of the EORTC QLQ-C30
Maintained Social Functioning Cycle 5
|
48.6 Percentage of Participants
|
36.7 Percentage of Participants
|
|
PRO Measure: Percentage of Participants With Improved, Worsened, or Remained Stable for Bothersome Side Effects of Treatment Measured by the Scales of the EORTC QLQ-C30
Worsened Social Functioning Cycle 5
|
34.3 Percentage of Participants
|
50.0 Percentage of Participants
|
Adverse Events
Ipatasertib and Paclitaxel
Serious events: 18 serious events
Other events: 61 other events
Deaths: 41 deaths
Placebo and Paclitaxel
Serious events: 12 serious events
Other events: 59 other events
Deaths: 46 deaths
Serious adverse events
| Measure |
Ipatasertib and Paclitaxel
n=61 participants at risk
Participants randomised to receive paclitaxel 80 mg/m\^2, intravenously on Days 1, 8, and 15 along with ipatasertib 400 mg, orally, once daily from Days 1-21 in each cycle of 28 days until disease progression, intolerable toxicity, elective withdrawal from the study, or study completion or termination.
|
Placebo and Paclitaxel
n=62 participants at risk
Participants randomised to receive paclitaxel 80 mg/m\^2, intravenously on Days 1, 8, and 15 along with placebo matching ipatasertib, orally, once daily from Days 1-21 in each cycle of 28 days until disease progression, intolerable toxicity, elective withdrawal from the study, or study completion or termination.
|
|---|---|---|
|
Blood and lymphatic system disorders
Pancytopenia
|
0.00%
0/61 • Baseline up to 30 days after the last dose of study drug or until initiation of another anti-cancer therapy, whichever occurs first (up to 3 years, 3 months)
|
1.6%
1/62 • Number of events 1 • Baseline up to 30 days after the last dose of study drug or until initiation of another anti-cancer therapy, whichever occurs first (up to 3 years, 3 months)
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/61 • Baseline up to 30 days after the last dose of study drug or until initiation of another anti-cancer therapy, whichever occurs first (up to 3 years, 3 months)
|
1.6%
1/62 • Number of events 1 • Baseline up to 30 days after the last dose of study drug or until initiation of another anti-cancer therapy, whichever occurs first (up to 3 years, 3 months)
|
|
Gastrointestinal disorders
Diarrhoea
|
4.9%
3/61 • Number of events 3 • Baseline up to 30 days after the last dose of study drug or until initiation of another anti-cancer therapy, whichever occurs first (up to 3 years, 3 months)
|
0.00%
0/62 • Baseline up to 30 days after the last dose of study drug or until initiation of another anti-cancer therapy, whichever occurs first (up to 3 years, 3 months)
|
|
Gastrointestinal disorders
Nausea
|
1.6%
1/61 • Number of events 2 • Baseline up to 30 days after the last dose of study drug or until initiation of another anti-cancer therapy, whichever occurs first (up to 3 years, 3 months)
|
0.00%
0/62 • Baseline up to 30 days after the last dose of study drug or until initiation of another anti-cancer therapy, whichever occurs first (up to 3 years, 3 months)
|
|
Gastrointestinal disorders
Pancreatitis
|
1.6%
1/61 • Number of events 1 • Baseline up to 30 days after the last dose of study drug or until initiation of another anti-cancer therapy, whichever occurs first (up to 3 years, 3 months)
|
0.00%
0/62 • Baseline up to 30 days after the last dose of study drug or until initiation of another anti-cancer therapy, whichever occurs first (up to 3 years, 3 months)
|
|
Hepatobiliary disorders
Cholestasis
|
0.00%
0/61 • Baseline up to 30 days after the last dose of study drug or until initiation of another anti-cancer therapy, whichever occurs first (up to 3 years, 3 months)
|
1.6%
1/62 • Number of events 1 • Baseline up to 30 days after the last dose of study drug or until initiation of another anti-cancer therapy, whichever occurs first (up to 3 years, 3 months)
|
|
Infections and infestations
Atypical Pneumonia
|
1.6%
1/61 • Number of events 1 • Baseline up to 30 days after the last dose of study drug or until initiation of another anti-cancer therapy, whichever occurs first (up to 3 years, 3 months)
|
0.00%
0/62 • Baseline up to 30 days after the last dose of study drug or until initiation of another anti-cancer therapy, whichever occurs first (up to 3 years, 3 months)
|
|
Infections and infestations
Cystitis
|
0.00%
0/61 • Baseline up to 30 days after the last dose of study drug or until initiation of another anti-cancer therapy, whichever occurs first (up to 3 years, 3 months)
|
1.6%
1/62 • Number of events 1 • Baseline up to 30 days after the last dose of study drug or until initiation of another anti-cancer therapy, whichever occurs first (up to 3 years, 3 months)
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/61 • Baseline up to 30 days after the last dose of study drug or until initiation of another anti-cancer therapy, whichever occurs first (up to 3 years, 3 months)
|
1.6%
1/62 • Number of events 1 • Baseline up to 30 days after the last dose of study drug or until initiation of another anti-cancer therapy, whichever occurs first (up to 3 years, 3 months)
|
|
Infections and infestations
Influenza
|
0.00%
0/61 • Baseline up to 30 days after the last dose of study drug or until initiation of another anti-cancer therapy, whichever occurs first (up to 3 years, 3 months)
|
1.6%
1/62 • Number of events 1 • Baseline up to 30 days after the last dose of study drug or until initiation of another anti-cancer therapy, whichever occurs first (up to 3 years, 3 months)
|
|
Infections and infestations
Pneumonia
|
4.9%
3/61 • Number of events 3 • Baseline up to 30 days after the last dose of study drug or until initiation of another anti-cancer therapy, whichever occurs first (up to 3 years, 3 months)
|
0.00%
0/62 • Baseline up to 30 days after the last dose of study drug or until initiation of another anti-cancer therapy, whichever occurs first (up to 3 years, 3 months)
|
|
Infections and infestations
Retroperitoneal Infection
|
1.6%
1/61 • Number of events 1 • Baseline up to 30 days after the last dose of study drug or until initiation of another anti-cancer therapy, whichever occurs first (up to 3 years, 3 months)
|
0.00%
0/62 • Baseline up to 30 days after the last dose of study drug or until initiation of another anti-cancer therapy, whichever occurs first (up to 3 years, 3 months)
|
|
Infections and infestations
Tuberculosis
|
1.6%
1/61 • Number of events 1 • Baseline up to 30 days after the last dose of study drug or until initiation of another anti-cancer therapy, whichever occurs first (up to 3 years, 3 months)
|
0.00%
0/62 • Baseline up to 30 days after the last dose of study drug or until initiation of another anti-cancer therapy, whichever occurs first (up to 3 years, 3 months)
|
|
Infections and infestations
Upper Respiratory Tract Infection
|
1.6%
1/61 • Number of events 1 • Baseline up to 30 days after the last dose of study drug or until initiation of another anti-cancer therapy, whichever occurs first (up to 3 years, 3 months)
|
0.00%
0/62 • Baseline up to 30 days after the last dose of study drug or until initiation of another anti-cancer therapy, whichever occurs first (up to 3 years, 3 months)
|
|
Infections and infestations
Wound Infection
|
1.6%
1/61 • Number of events 1 • Baseline up to 30 days after the last dose of study drug or until initiation of another anti-cancer therapy, whichever occurs first (up to 3 years, 3 months)
|
0.00%
0/62 • Baseline up to 30 days after the last dose of study drug or until initiation of another anti-cancer therapy, whichever occurs first (up to 3 years, 3 months)
|
|
Investigations
Neutrophil Count Decreased
|
1.6%
1/61 • Number of events 1 • Baseline up to 30 days after the last dose of study drug or until initiation of another anti-cancer therapy, whichever occurs first (up to 3 years, 3 months)
|
0.00%
0/62 • Baseline up to 30 days after the last dose of study drug or until initiation of another anti-cancer therapy, whichever occurs first (up to 3 years, 3 months)
|
|
Metabolism and nutrition disorders
Cell Death
|
0.00%
0/61 • Baseline up to 30 days after the last dose of study drug or until initiation of another anti-cancer therapy, whichever occurs first (up to 3 years, 3 months)
|
1.6%
1/62 • Number of events 1 • Baseline up to 30 days after the last dose of study drug or until initiation of another anti-cancer therapy, whichever occurs first (up to 3 years, 3 months)
|
|
Metabolism and nutrition disorders
Decreased Appetite
|
1.6%
1/61 • Number of events 1 • Baseline up to 30 days after the last dose of study drug or until initiation of another anti-cancer therapy, whichever occurs first (up to 3 years, 3 months)
|
0.00%
0/62 • Baseline up to 30 days after the last dose of study drug or until initiation of another anti-cancer therapy, whichever occurs first (up to 3 years, 3 months)
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/61 • Baseline up to 30 days after the last dose of study drug or until initiation of another anti-cancer therapy, whichever occurs first (up to 3 years, 3 months)
|
1.6%
1/62 • Number of events 1 • Baseline up to 30 days after the last dose of study drug or until initiation of another anti-cancer therapy, whichever occurs first (up to 3 years, 3 months)
|
|
Musculoskeletal and connective tissue disorders
Bone Pain
|
0.00%
0/61 • Baseline up to 30 days after the last dose of study drug or until initiation of another anti-cancer therapy, whichever occurs first (up to 3 years, 3 months)
|
1.6%
1/62 • Number of events 1 • Baseline up to 30 days after the last dose of study drug or until initiation of another anti-cancer therapy, whichever occurs first (up to 3 years, 3 months)
|
|
Nervous system disorders
Spinal Cord Compression
|
1.6%
1/61 • Number of events 1 • Baseline up to 30 days after the last dose of study drug or until initiation of another anti-cancer therapy, whichever occurs first (up to 3 years, 3 months)
|
0.00%
0/62 • Baseline up to 30 days after the last dose of study drug or until initiation of another anti-cancer therapy, whichever occurs first (up to 3 years, 3 months)
|
|
Psychiatric disorders
Depression
|
1.6%
1/61 • Number of events 1 • Baseline up to 30 days after the last dose of study drug or until initiation of another anti-cancer therapy, whichever occurs first (up to 3 years, 3 months)
|
0.00%
0/62 • Baseline up to 30 days after the last dose of study drug or until initiation of another anti-cancer therapy, whichever occurs first (up to 3 years, 3 months)
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/61 • Baseline up to 30 days after the last dose of study drug or until initiation of another anti-cancer therapy, whichever occurs first (up to 3 years, 3 months)
|
1.6%
1/62 • Number of events 2 • Baseline up to 30 days after the last dose of study drug or until initiation of another anti-cancer therapy, whichever occurs first (up to 3 years, 3 months)
|
|
Vascular disorders
Embolism
|
1.6%
1/61 • Number of events 1 • Baseline up to 30 days after the last dose of study drug or until initiation of another anti-cancer therapy, whichever occurs first (up to 3 years, 3 months)
|
0.00%
0/62 • Baseline up to 30 days after the last dose of study drug or until initiation of another anti-cancer therapy, whichever occurs first (up to 3 years, 3 months)
|
|
Blood and lymphatic system disorders
Febrile Neutropenia
|
3.3%
2/61 • Number of events 2 • Baseline up to 30 days after the last dose of study drug or until initiation of another anti-cancer therapy, whichever occurs first (up to 3 years, 3 months)
|
0.00%
0/62 • Baseline up to 30 days after the last dose of study drug or until initiation of another anti-cancer therapy, whichever occurs first (up to 3 years, 3 months)
|
|
General disorders
Death
|
0.00%
0/61 • Baseline up to 30 days after the last dose of study drug or until initiation of another anti-cancer therapy, whichever occurs first (up to 3 years, 3 months)
|
1.6%
1/62 • Number of events 1 • Baseline up to 30 days after the last dose of study drug or until initiation of another anti-cancer therapy, whichever occurs first (up to 3 years, 3 months)
|
|
General disorders
Pyrexia
|
3.3%
2/61 • Number of events 3 • Baseline up to 30 days after the last dose of study drug or until initiation of another anti-cancer therapy, whichever occurs first (up to 3 years, 3 months)
|
1.6%
1/62 • Number of events 1 • Baseline up to 30 days after the last dose of study drug or until initiation of another anti-cancer therapy, whichever occurs first (up to 3 years, 3 months)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Triple negative breast cancer
|
0.00%
0/61 • Baseline up to 30 days after the last dose of study drug or until initiation of another anti-cancer therapy, whichever occurs first (up to 3 years, 3 months)
|
1.6%
1/62 • Number of events 1 • Baseline up to 30 days after the last dose of study drug or until initiation of another anti-cancer therapy, whichever occurs first (up to 3 years, 3 months)
|
|
Infections and infestations
Vascular device infection
|
1.6%
1/61 • Number of events 1 • Baseline up to 30 days after the last dose of study drug or until initiation of another anti-cancer therapy, whichever occurs first (up to 3 years, 3 months)
|
0.00%
0/62 • Baseline up to 30 days after the last dose of study drug or until initiation of another anti-cancer therapy, whichever occurs first (up to 3 years, 3 months)
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.00%
0/61 • Baseline up to 30 days after the last dose of study drug or until initiation of another anti-cancer therapy, whichever occurs first (up to 3 years, 3 months)
|
1.6%
1/62 • Number of events 1 • Baseline up to 30 days after the last dose of study drug or until initiation of another anti-cancer therapy, whichever occurs first (up to 3 years, 3 months)
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/61 • Baseline up to 30 days after the last dose of study drug or until initiation of another anti-cancer therapy, whichever occurs first (up to 3 years, 3 months)
|
1.6%
1/62 • Number of events 1 • Baseline up to 30 days after the last dose of study drug or until initiation of another anti-cancer therapy, whichever occurs first (up to 3 years, 3 months)
|
Other adverse events
| Measure |
Ipatasertib and Paclitaxel
n=61 participants at risk
Participants randomised to receive paclitaxel 80 mg/m\^2, intravenously on Days 1, 8, and 15 along with ipatasertib 400 mg, orally, once daily from Days 1-21 in each cycle of 28 days until disease progression, intolerable toxicity, elective withdrawal from the study, or study completion or termination.
|
Placebo and Paclitaxel
n=62 participants at risk
Participants randomised to receive paclitaxel 80 mg/m\^2, intravenously on Days 1, 8, and 15 along with placebo matching ipatasertib, orally, once daily from Days 1-21 in each cycle of 28 days until disease progression, intolerable toxicity, elective withdrawal from the study, or study completion or termination.
|
|---|---|---|
|
Psychiatric disorders
Anxiety
|
3.3%
2/61 • Number of events 3 • Baseline up to 30 days after the last dose of study drug or until initiation of another anti-cancer therapy, whichever occurs first (up to 3 years, 3 months)
|
6.5%
4/62 • Number of events 6 • Baseline up to 30 days after the last dose of study drug or until initiation of another anti-cancer therapy, whichever occurs first (up to 3 years, 3 months)
|
|
Psychiatric disorders
Insomnia
|
21.3%
13/61 • Number of events 19 • Baseline up to 30 days after the last dose of study drug or until initiation of another anti-cancer therapy, whichever occurs first (up to 3 years, 3 months)
|
12.9%
8/62 • Number of events 9 • Baseline up to 30 days after the last dose of study drug or until initiation of another anti-cancer therapy, whichever occurs first (up to 3 years, 3 months)
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
14.8%
9/61 • Number of events 11 • Baseline up to 30 days after the last dose of study drug or until initiation of another anti-cancer therapy, whichever occurs first (up to 3 years, 3 months)
|
12.9%
8/62 • Number of events 12 • Baseline up to 30 days after the last dose of study drug or until initiation of another anti-cancer therapy, whichever occurs first (up to 3 years, 3 months)
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
11.5%
7/61 • Number of events 8 • Baseline up to 30 days after the last dose of study drug or until initiation of another anti-cancer therapy, whichever occurs first (up to 3 years, 3 months)
|
3.2%
2/62 • Number of events 2 • Baseline up to 30 days after the last dose of study drug or until initiation of another anti-cancer therapy, whichever occurs first (up to 3 years, 3 months)
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
54.1%
33/61 • Number of events 37 • Baseline up to 30 days after the last dose of study drug or until initiation of another anti-cancer therapy, whichever occurs first (up to 3 years, 3 months)
|
46.8%
29/62 • Number of events 34 • Baseline up to 30 days after the last dose of study drug or until initiation of another anti-cancer therapy, whichever occurs first (up to 3 years, 3 months)
|
|
Skin and subcutaneous tissue disorders
Dermatitis Acneiform
|
16.4%
10/61 • Number of events 17 • Baseline up to 30 days after the last dose of study drug or until initiation of another anti-cancer therapy, whichever occurs first (up to 3 years, 3 months)
|
8.1%
5/62 • Number of events 5 • Baseline up to 30 days after the last dose of study drug or until initiation of another anti-cancer therapy, whichever occurs first (up to 3 years, 3 months)
|
|
Skin and subcutaneous tissue disorders
Nail Disorder
|
6.6%
4/61 • Number of events 7 • Baseline up to 30 days after the last dose of study drug or until initiation of another anti-cancer therapy, whichever occurs first (up to 3 years, 3 months)
|
6.5%
4/62 • Number of events 4 • Baseline up to 30 days after the last dose of study drug or until initiation of another anti-cancer therapy, whichever occurs first (up to 3 years, 3 months)
|
|
Skin and subcutaneous tissue disorders
Onycholysis
|
6.6%
4/61 • Number of events 4 • Baseline up to 30 days after the last dose of study drug or until initiation of another anti-cancer therapy, whichever occurs first (up to 3 years, 3 months)
|
1.6%
1/62 • Number of events 1 • Baseline up to 30 days after the last dose of study drug or until initiation of another anti-cancer therapy, whichever occurs first (up to 3 years, 3 months)
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
14.8%
9/61 • Number of events 14 • Baseline up to 30 days after the last dose of study drug or until initiation of another anti-cancer therapy, whichever occurs first (up to 3 years, 3 months)
|
8.1%
5/62 • Number of events 5 • Baseline up to 30 days after the last dose of study drug or until initiation of another anti-cancer therapy, whichever occurs first (up to 3 years, 3 months)
|
|
Skin and subcutaneous tissue disorders
Rash
|
27.9%
17/61 • Number of events 28 • Baseline up to 30 days after the last dose of study drug or until initiation of another anti-cancer therapy, whichever occurs first (up to 3 years, 3 months)
|
21.0%
13/62 • Number of events 17 • Baseline up to 30 days after the last dose of study drug or until initiation of another anti-cancer therapy, whichever occurs first (up to 3 years, 3 months)
|
|
Skin and subcutaneous tissue disorders
Rash Maculo-Papular
|
1.6%
1/61 • Number of events 1 • Baseline up to 30 days after the last dose of study drug or until initiation of another anti-cancer therapy, whichever occurs first (up to 3 years, 3 months)
|
6.5%
4/62 • Number of events 7 • Baseline up to 30 days after the last dose of study drug or until initiation of another anti-cancer therapy, whichever occurs first (up to 3 years, 3 months)
|
|
Vascular disorders
Flushing
|
6.6%
4/61 • Number of events 4 • Baseline up to 30 days after the last dose of study drug or until initiation of another anti-cancer therapy, whichever occurs first (up to 3 years, 3 months)
|
4.8%
3/62 • Number of events 3 • Baseline up to 30 days after the last dose of study drug or until initiation of another anti-cancer therapy, whichever occurs first (up to 3 years, 3 months)
|
|
Vascular disorders
Hot Flush
|
8.2%
5/61 • Number of events 5 • Baseline up to 30 days after the last dose of study drug or until initiation of another anti-cancer therapy, whichever occurs first (up to 3 years, 3 months)
|
4.8%
3/62 • Number of events 3 • Baseline up to 30 days after the last dose of study drug or until initiation of another anti-cancer therapy, whichever occurs first (up to 3 years, 3 months)
|
|
Infections and infestations
Nasopharyngitis
|
13.1%
8/61 • Number of events 12 • Baseline up to 30 days after the last dose of study drug or until initiation of another anti-cancer therapy, whichever occurs first (up to 3 years, 3 months)
|
8.1%
5/62 • Number of events 6 • Baseline up to 30 days after the last dose of study drug or until initiation of another anti-cancer therapy, whichever occurs first (up to 3 years, 3 months)
|
|
Infections and infestations
Upper Respiratory Tract Infection
|
16.4%
10/61 • Number of events 15 • Baseline up to 30 days after the last dose of study drug or until initiation of another anti-cancer therapy, whichever occurs first (up to 3 years, 3 months)
|
6.5%
4/62 • Number of events 10 • Baseline up to 30 days after the last dose of study drug or until initiation of another anti-cancer therapy, whichever occurs first (up to 3 years, 3 months)
|
|
Infections and infestations
Urinary Tract Infection
|
8.2%
5/61 • Number of events 6 • Baseline up to 30 days after the last dose of study drug or until initiation of another anti-cancer therapy, whichever occurs first (up to 3 years, 3 months)
|
6.5%
4/62 • Number of events 4 • Baseline up to 30 days after the last dose of study drug or until initiation of another anti-cancer therapy, whichever occurs first (up to 3 years, 3 months)
|
|
Investigations
Alanine Aminotransferase Increased
|
4.9%
3/61 • Number of events 5 • Baseline up to 30 days after the last dose of study drug or until initiation of another anti-cancer therapy, whichever occurs first (up to 3 years, 3 months)
|
6.5%
4/62 • Number of events 4 • Baseline up to 30 days after the last dose of study drug or until initiation of another anti-cancer therapy, whichever occurs first (up to 3 years, 3 months)
|
|
Investigations
Aspartate Aminotransferase Increased
|
8.2%
5/61 • Number of events 8 • Baseline up to 30 days after the last dose of study drug or until initiation of another anti-cancer therapy, whichever occurs first (up to 3 years, 3 months)
|
4.8%
3/62 • Number of events 6 • Baseline up to 30 days after the last dose of study drug or until initiation of another anti-cancer therapy, whichever occurs first (up to 3 years, 3 months)
|
|
Investigations
Neutrophil Count Decreased
|
13.1%
8/61 • Number of events 19 • Baseline up to 30 days after the last dose of study drug or until initiation of another anti-cancer therapy, whichever occurs first (up to 3 years, 3 months)
|
14.5%
9/62 • Number of events 20 • Baseline up to 30 days after the last dose of study drug or until initiation of another anti-cancer therapy, whichever occurs first (up to 3 years, 3 months)
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
19.7%
12/61 • Number of events 16 • Baseline up to 30 days after the last dose of study drug or until initiation of another anti-cancer therapy, whichever occurs first (up to 3 years, 3 months)
|
8.1%
5/62 • Number of events 5 • Baseline up to 30 days after the last dose of study drug or until initiation of another anti-cancer therapy, whichever occurs first (up to 3 years, 3 months)
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
11.5%
7/61 • Number of events 10 • Baseline up to 30 days after the last dose of study drug or until initiation of another anti-cancer therapy, whichever occurs first (up to 3 years, 3 months)
|
9.7%
6/62 • Number of events 7 • Baseline up to 30 days after the last dose of study drug or until initiation of another anti-cancer therapy, whichever occurs first (up to 3 years, 3 months)
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal Chest Pain
|
6.6%
4/61 • Number of events 9 • Baseline up to 30 days after the last dose of study drug or until initiation of another anti-cancer therapy, whichever occurs first (up to 3 years, 3 months)
|
6.5%
4/62 • Number of events 4 • Baseline up to 30 days after the last dose of study drug or until initiation of another anti-cancer therapy, whichever occurs first (up to 3 years, 3 months)
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal Pain
|
4.9%
3/61 • Number of events 4 • Baseline up to 30 days after the last dose of study drug or until initiation of another anti-cancer therapy, whichever occurs first (up to 3 years, 3 months)
|
6.5%
4/62 • Number of events 4 • Baseline up to 30 days after the last dose of study drug or until initiation of another anti-cancer therapy, whichever occurs first (up to 3 years, 3 months)
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
27.9%
17/61 • Number of events 42 • Baseline up to 30 days after the last dose of study drug or until initiation of another anti-cancer therapy, whichever occurs first (up to 3 years, 3 months)
|
24.2%
15/62 • Number of events 25 • Baseline up to 30 days after the last dose of study drug or until initiation of another anti-cancer therapy, whichever occurs first (up to 3 years, 3 months)
|
|
Musculoskeletal and connective tissue disorders
Pain in Extremity
|
8.2%
5/61 • Number of events 8 • Baseline up to 30 days after the last dose of study drug or until initiation of another anti-cancer therapy, whichever occurs first (up to 3 years, 3 months)
|
3.2%
2/62 • Number of events 2 • Baseline up to 30 days after the last dose of study drug or until initiation of another anti-cancer therapy, whichever occurs first (up to 3 years, 3 months)
|
|
Nervous system disorders
Dizziness
|
18.0%
11/61 • Number of events 19 • Baseline up to 30 days after the last dose of study drug or until initiation of another anti-cancer therapy, whichever occurs first (up to 3 years, 3 months)
|
14.5%
9/62 • Number of events 10 • Baseline up to 30 days after the last dose of study drug or until initiation of another anti-cancer therapy, whichever occurs first (up to 3 years, 3 months)
|
|
Nervous system disorders
Dysgeusia
|
6.6%
4/61 • Number of events 4 • Baseline up to 30 days after the last dose of study drug or until initiation of another anti-cancer therapy, whichever occurs first (up to 3 years, 3 months)
|
8.1%
5/62 • Number of events 5 • Baseline up to 30 days after the last dose of study drug or until initiation of another anti-cancer therapy, whichever occurs first (up to 3 years, 3 months)
|
|
Nervous system disorders
Headache
|
18.0%
11/61 • Number of events 15 • Baseline up to 30 days after the last dose of study drug or until initiation of another anti-cancer therapy, whichever occurs first (up to 3 years, 3 months)
|
21.0%
13/62 • Number of events 14 • Baseline up to 30 days after the last dose of study drug or until initiation of another anti-cancer therapy, whichever occurs first (up to 3 years, 3 months)
|
|
Nervous system disorders
Hypoaesthesia
|
6.6%
4/61 • Number of events 6 • Baseline up to 30 days after the last dose of study drug or until initiation of another anti-cancer therapy, whichever occurs first (up to 3 years, 3 months)
|
0.00%
0/62 • Baseline up to 30 days after the last dose of study drug or until initiation of another anti-cancer therapy, whichever occurs first (up to 3 years, 3 months)
|
|
Nervous system disorders
Neuropathy Peripheral
|
19.7%
12/61 • Number of events 17 • Baseline up to 30 days after the last dose of study drug or until initiation of another anti-cancer therapy, whichever occurs first (up to 3 years, 3 months)
|
22.6%
14/62 • Number of events 18 • Baseline up to 30 days after the last dose of study drug or until initiation of another anti-cancer therapy, whichever occurs first (up to 3 years, 3 months)
|
|
Nervous system disorders
Paraesthesia
|
9.8%
6/61 • Number of events 10 • Baseline up to 30 days after the last dose of study drug or until initiation of another anti-cancer therapy, whichever occurs first (up to 3 years, 3 months)
|
11.3%
7/62 • Number of events 10 • Baseline up to 30 days after the last dose of study drug or until initiation of another anti-cancer therapy, whichever occurs first (up to 3 years, 3 months)
|
|
Nervous system disorders
Peripheral Sensory Neuropathy
|
26.2%
16/61 • Number of events 33 • Baseline up to 30 days after the last dose of study drug or until initiation of another anti-cancer therapy, whichever occurs first (up to 3 years, 3 months)
|
16.1%
10/62 • Number of events 16 • Baseline up to 30 days after the last dose of study drug or until initiation of another anti-cancer therapy, whichever occurs first (up to 3 years, 3 months)
|
|
Blood and lymphatic system disorders
Anaemia
|
14.8%
9/61 • Number of events 17 • Baseline up to 30 days after the last dose of study drug or until initiation of another anti-cancer therapy, whichever occurs first (up to 3 years, 3 months)
|
12.9%
8/62 • Number of events 11 • Baseline up to 30 days after the last dose of study drug or until initiation of another anti-cancer therapy, whichever occurs first (up to 3 years, 3 months)
|
|
Blood and lymphatic system disorders
Leukopenia
|
3.3%
2/61 • Number of events 3 • Baseline up to 30 days after the last dose of study drug or until initiation of another anti-cancer therapy, whichever occurs first (up to 3 years, 3 months)
|
6.5%
4/62 • Number of events 6 • Baseline up to 30 days after the last dose of study drug or until initiation of another anti-cancer therapy, whichever occurs first (up to 3 years, 3 months)
|
|
Blood and lymphatic system disorders
Neutropenia
|
21.3%
13/61 • Number of events 38 • Baseline up to 30 days after the last dose of study drug or until initiation of another anti-cancer therapy, whichever occurs first (up to 3 years, 3 months)
|
24.2%
15/62 • Number of events 36 • Baseline up to 30 days after the last dose of study drug or until initiation of another anti-cancer therapy, whichever occurs first (up to 3 years, 3 months)
|
|
Gastrointestinal disorders
Abdominal Pain
|
14.8%
9/61 • Number of events 13 • Baseline up to 30 days after the last dose of study drug or until initiation of another anti-cancer therapy, whichever occurs first (up to 3 years, 3 months)
|
11.3%
7/62 • Number of events 9 • Baseline up to 30 days after the last dose of study drug or until initiation of another anti-cancer therapy, whichever occurs first (up to 3 years, 3 months)
|
|
Gastrointestinal disorders
Abdominal Pain Upper
|
6.6%
4/61 • Number of events 4 • Baseline up to 30 days after the last dose of study drug or until initiation of another anti-cancer therapy, whichever occurs first (up to 3 years, 3 months)
|
6.5%
4/62 • Number of events 5 • Baseline up to 30 days after the last dose of study drug or until initiation of another anti-cancer therapy, whichever occurs first (up to 3 years, 3 months)
|
|
Gastrointestinal disorders
Constipation
|
19.7%
12/61 • Number of events 17 • Baseline up to 30 days after the last dose of study drug or until initiation of another anti-cancer therapy, whichever occurs first (up to 3 years, 3 months)
|
14.5%
9/62 • Number of events 11 • Baseline up to 30 days after the last dose of study drug or until initiation of another anti-cancer therapy, whichever occurs first (up to 3 years, 3 months)
|
|
Gastrointestinal disorders
Diarrhoea
|
91.8%
56/61 • Number of events 205 • Baseline up to 30 days after the last dose of study drug or until initiation of another anti-cancer therapy, whichever occurs first (up to 3 years, 3 months)
|
21.0%
13/62 • Number of events 19 • Baseline up to 30 days after the last dose of study drug or until initiation of another anti-cancer therapy, whichever occurs first (up to 3 years, 3 months)
|
|
Gastrointestinal disorders
Dry Mouth
|
3.3%
2/61 • Number of events 3 • Baseline up to 30 days after the last dose of study drug or until initiation of another anti-cancer therapy, whichever occurs first (up to 3 years, 3 months)
|
8.1%
5/62 • Number of events 5 • Baseline up to 30 days after the last dose of study drug or until initiation of another anti-cancer therapy, whichever occurs first (up to 3 years, 3 months)
|
|
Gastrointestinal disorders
Dyspepsia
|
13.1%
8/61 • Number of events 11 • Baseline up to 30 days after the last dose of study drug or until initiation of another anti-cancer therapy, whichever occurs first (up to 3 years, 3 months)
|
9.7%
6/62 • Number of events 6 • Baseline up to 30 days after the last dose of study drug or until initiation of another anti-cancer therapy, whichever occurs first (up to 3 years, 3 months)
|
|
Gastrointestinal disorders
Flatulence
|
6.6%
4/61 • Number of events 4 • Baseline up to 30 days after the last dose of study drug or until initiation of another anti-cancer therapy, whichever occurs first (up to 3 years, 3 months)
|
3.2%
2/62 • Number of events 2 • Baseline up to 30 days after the last dose of study drug or until initiation of another anti-cancer therapy, whichever occurs first (up to 3 years, 3 months)
|
|
Gastrointestinal disorders
Gastritis
|
6.6%
4/61 • Number of events 5 • Baseline up to 30 days after the last dose of study drug or until initiation of another anti-cancer therapy, whichever occurs first (up to 3 years, 3 months)
|
0.00%
0/62 • Baseline up to 30 days after the last dose of study drug or until initiation of another anti-cancer therapy, whichever occurs first (up to 3 years, 3 months)
|
|
Gastrointestinal disorders
Nausea
|
52.5%
32/61 • Number of events 67 • Baseline up to 30 days after the last dose of study drug or until initiation of another anti-cancer therapy, whichever occurs first (up to 3 years, 3 months)
|
33.9%
21/62 • Number of events 28 • Baseline up to 30 days after the last dose of study drug or until initiation of another anti-cancer therapy, whichever occurs first (up to 3 years, 3 months)
|
|
Gastrointestinal disorders
Stomatitis
|
18.0%
11/61 • Number of events 14 • Baseline up to 30 days after the last dose of study drug or until initiation of another anti-cancer therapy, whichever occurs first (up to 3 years, 3 months)
|
8.1%
5/62 • Number of events 6 • Baseline up to 30 days after the last dose of study drug or until initiation of another anti-cancer therapy, whichever occurs first (up to 3 years, 3 months)
|
|
Gastrointestinal disorders
Vomiting
|
27.9%
17/61 • Number of events 39 • Baseline up to 30 days after the last dose of study drug or until initiation of another anti-cancer therapy, whichever occurs first (up to 3 years, 3 months)
|
22.6%
14/62 • Number of events 15 • Baseline up to 30 days after the last dose of study drug or until initiation of another anti-cancer therapy, whichever occurs first (up to 3 years, 3 months)
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
14.8%
9/61 • Number of events 13 • Baseline up to 30 days after the last dose of study drug or until initiation of another anti-cancer therapy, whichever occurs first (up to 3 years, 3 months)
|
8.1%
5/62 • Number of events 6 • Baseline up to 30 days after the last dose of study drug or until initiation of another anti-cancer therapy, whichever occurs first (up to 3 years, 3 months)
|
|
General disorders
Asthenia
|
27.9%
17/61 • Number of events 41 • Baseline up to 30 days after the last dose of study drug or until initiation of another anti-cancer therapy, whichever occurs first (up to 3 years, 3 months)
|
11.3%
7/62 • Number of events 7 • Baseline up to 30 days after the last dose of study drug or until initiation of another anti-cancer therapy, whichever occurs first (up to 3 years, 3 months)
|
|
General disorders
Chest Discomfort
|
6.6%
4/61 • Number of events 4 • Baseline up to 30 days after the last dose of study drug or until initiation of another anti-cancer therapy, whichever occurs first (up to 3 years, 3 months)
|
1.6%
1/62 • Number of events 1 • Baseline up to 30 days after the last dose of study drug or until initiation of another anti-cancer therapy, whichever occurs first (up to 3 years, 3 months)
|
|
General disorders
Chest Pain
|
6.6%
4/61 • Number of events 5 • Baseline up to 30 days after the last dose of study drug or until initiation of another anti-cancer therapy, whichever occurs first (up to 3 years, 3 months)
|
9.7%
6/62 • Number of events 6 • Baseline up to 30 days after the last dose of study drug or until initiation of another anti-cancer therapy, whichever occurs first (up to 3 years, 3 months)
|
|
General disorders
Fatigue
|
29.5%
18/61 • Number of events 26 • Baseline up to 30 days after the last dose of study drug or until initiation of another anti-cancer therapy, whichever occurs first (up to 3 years, 3 months)
|
32.3%
20/62 • Number of events 32 • Baseline up to 30 days after the last dose of study drug or until initiation of another anti-cancer therapy, whichever occurs first (up to 3 years, 3 months)
|
|
General disorders
Mucosal Inflammation
|
6.6%
4/61 • Number of events 7 • Baseline up to 30 days after the last dose of study drug or until initiation of another anti-cancer therapy, whichever occurs first (up to 3 years, 3 months)
|
6.5%
4/62 • Number of events 5 • Baseline up to 30 days after the last dose of study drug or until initiation of another anti-cancer therapy, whichever occurs first (up to 3 years, 3 months)
|
|
General disorders
Oedema Peripheral
|
11.5%
7/61 • Number of events 9 • Baseline up to 30 days after the last dose of study drug or until initiation of another anti-cancer therapy, whichever occurs first (up to 3 years, 3 months)
|
8.1%
5/62 • Number of events 6 • Baseline up to 30 days after the last dose of study drug or until initiation of another anti-cancer therapy, whichever occurs first (up to 3 years, 3 months)
|
|
General disorders
Pyrexia
|
18.0%
11/61 • Number of events 13 • Baseline up to 30 days after the last dose of study drug or until initiation of another anti-cancer therapy, whichever occurs first (up to 3 years, 3 months)
|
11.3%
7/62 • Number of events 9 • Baseline up to 30 days after the last dose of study drug or until initiation of another anti-cancer therapy, whichever occurs first (up to 3 years, 3 months)
|
|
Eye disorders
Dry Eye
|
6.6%
4/61 • Number of events 5 • Baseline up to 30 days after the last dose of study drug or until initiation of another anti-cancer therapy, whichever occurs first (up to 3 years, 3 months)
|
4.8%
3/62 • Number of events 3 • Baseline up to 30 days after the last dose of study drug or until initiation of another anti-cancer therapy, whichever occurs first (up to 3 years, 3 months)
|
|
Infections and infestations
Influenza
|
6.6%
4/61 • Number of events 6 • Baseline up to 30 days after the last dose of study drug or until initiation of another anti-cancer therapy, whichever occurs first (up to 3 years, 3 months)
|
1.6%
1/62 • Number of events 1 • Baseline up to 30 days after the last dose of study drug or until initiation of another anti-cancer therapy, whichever occurs first (up to 3 years, 3 months)
|
|
Infections and infestations
Rhinitis
|
6.6%
4/61 • Number of events 5 • Baseline up to 30 days after the last dose of study drug or until initiation of another anti-cancer therapy, whichever occurs first (up to 3 years, 3 months)
|
1.6%
1/62 • Number of events 1 • Baseline up to 30 days after the last dose of study drug or until initiation of another anti-cancer therapy, whichever occurs first (up to 3 years, 3 months)
|
|
Metabolism and nutrition disorders
Decreased appetite
|
19.7%
12/61 • Number of events 15 • Baseline up to 30 days after the last dose of study drug or until initiation of another anti-cancer therapy, whichever occurs first (up to 3 years, 3 months)
|
17.7%
11/62 • Number of events 15 • Baseline up to 30 days after the last dose of study drug or until initiation of another anti-cancer therapy, whichever occurs first (up to 3 years, 3 months)
|
|
Metabolism and nutrition disorders
Hypercholesterolaemia
|
9.8%
6/61 • Number of events 6 • Baseline up to 30 days after the last dose of study drug or until initiation of another anti-cancer therapy, whichever occurs first (up to 3 years, 3 months)
|
1.6%
1/62 • Number of events 2 • Baseline up to 30 days after the last dose of study drug or until initiation of another anti-cancer therapy, whichever occurs first (up to 3 years, 3 months)
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
8.2%
5/61 • Number of events 10 • Baseline up to 30 days after the last dose of study drug or until initiation of another anti-cancer therapy, whichever occurs first (up to 3 years, 3 months)
|
3.2%
2/62 • Number of events 3 • Baseline up to 30 days after the last dose of study drug or until initiation of another anti-cancer therapy, whichever occurs first (up to 3 years, 3 months)
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
6.6%
4/61 • Number of events 7 • Baseline up to 30 days after the last dose of study drug or until initiation of another anti-cancer therapy, whichever occurs first (up to 3 years, 3 months)
|
3.2%
2/62 • Number of events 2 • Baseline up to 30 days after the last dose of study drug or until initiation of another anti-cancer therapy, whichever occurs first (up to 3 years, 3 months)
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
6.6%
4/61 • Number of events 6 • Baseline up to 30 days after the last dose of study drug or until initiation of another anti-cancer therapy, whichever occurs first (up to 3 years, 3 months)
|
1.6%
1/62 • Number of events 1 • Baseline up to 30 days after the last dose of study drug or until initiation of another anti-cancer therapy, whichever occurs first (up to 3 years, 3 months)
|
|
Psychiatric disorders
Depression
|
6.6%
4/61 • Number of events 4 • Baseline up to 30 days after the last dose of study drug or until initiation of another anti-cancer therapy, whichever occurs first (up to 3 years, 3 months)
|
3.2%
2/62 • Number of events 2 • Baseline up to 30 days after the last dose of study drug or until initiation of another anti-cancer therapy, whichever occurs first (up to 3 years, 3 months)
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
6.6%
4/61 • Number of events 4 • Baseline up to 30 days after the last dose of study drug or until initiation of another anti-cancer therapy, whichever occurs first (up to 3 years, 3 months)
|
3.2%
2/62 • Number of events 2 • Baseline up to 30 days after the last dose of study drug or until initiation of another anti-cancer therapy, whichever occurs first (up to 3 years, 3 months)
|
|
Vascular disorders
Hypertension
|
4.9%
3/61 • Number of events 3 • Baseline up to 30 days after the last dose of study drug or until initiation of another anti-cancer therapy, whichever occurs first (up to 3 years, 3 months)
|
6.5%
4/62 • Number of events 4 • Baseline up to 30 days after the last dose of study drug or until initiation of another anti-cancer therapy, whichever occurs first (up to 3 years, 3 months)
|
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