Trial Outcomes & Findings for A Study of Neoadjuvant Letrozole + Taselisib Versus Letrozole + Placebo in Post-Menopausal Women With Breast Cancer (LORELEI) (NCT NCT02273973)
NCT ID: NCT02273973
Last Updated: 2018-05-21
Results Overview
Objective response rate (ORR) was defined as proportion of participants achieving complete response (CR) or partial response (PR). As per modified RECIST v1.1, CR: disappearance of all target lesions, PR: at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
334 participants
Primary outcome timeframe
From Baseline to 16 weeks
Results posted on
2018-05-21
Participant Flow
The study recruited post-menopausal participants with breast cancer in 22 countries from November 2014 to March 2017.
Participant milestones
| Measure |
Experimental: Taselisib + Letrozole
Participants received 2.5 milligrams (mg) letrozole tablets orally once daily (QD) along with taselisib tablets at 4 mg (two 2 mg tablets) orally on a 5 days-on/2 days-off schedule for a total of 16 weeks.
|
Placebo Comparator: Placebo + Letrozole
Participants received 2.5 mg letrozole tablets orally QD along with placebo on a 5-days-on/2-days-off schedule for a total of 16 weeks.
|
|---|---|---|
|
Overall Study
STARTED
|
166
|
168
|
|
Overall Study
COMPLETED
|
157
|
160
|
|
Overall Study
NOT COMPLETED
|
9
|
8
|
Reasons for withdrawal
| Measure |
Experimental: Taselisib + Letrozole
Participants received 2.5 milligrams (mg) letrozole tablets orally once daily (QD) along with taselisib tablets at 4 mg (two 2 mg tablets) orally on a 5 days-on/2 days-off schedule for a total of 16 weeks.
|
Placebo Comparator: Placebo + Letrozole
Participants received 2.5 mg letrozole tablets orally QD along with placebo on a 5-days-on/2-days-off schedule for a total of 16 weeks.
|
|---|---|---|
|
Overall Study
Adverse Event
|
4
|
0
|
|
Overall Study
Withdrawal by Subject
|
2
|
3
|
|
Overall Study
Death
|
1
|
0
|
|
Overall Study
Non-compliance
|
1
|
0
|
|
Overall Study
Protocol Violation
|
1
|
0
|
|
Overall Study
Progression of disease
|
0
|
2
|
|
Overall Study
Lost to Follow-up
|
0
|
1
|
|
Overall Study
Physician Decision
|
0
|
1
|
|
Overall Study
Reason not specified
|
0
|
1
|
Baseline Characteristics
A Study of Neoadjuvant Letrozole + Taselisib Versus Letrozole + Placebo in Post-Menopausal Women With Breast Cancer (LORELEI)
Baseline characteristics by cohort
| Measure |
Experimental: Taselisib + Letrozole
n=166 Participants
Participants received 2.5 milligrams (mg) letrozole tablets orally once daily (QD) along with taselisib tablets at 4 mg (two 2 mg tablets) orally on a 5 days-on/2 days-off schedule for a total of 16 weeks.
|
Placebo Comparator: Placebo + Letrozole
n=168 Participants
Participants received 2.5 mg letrozole tablets orally QD along with placebo on a 5-days-on/2-days-off schedule for a total of 16 weeks.
|
Total
n=334 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
64.6 years
STANDARD_DEVIATION 8.5 • n=99 Participants
|
64.7 years
STANDARD_DEVIATION 8.7 • n=107 Participants
|
64.6 years
STANDARD_DEVIATION 8.6 • n=206 Participants
|
|
Sex: Female, Male
Female
|
166 Participants
n=99 Participants
|
168 Participants
n=107 Participants
|
334 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
White
|
143 Participants
n=99 Participants
|
140 Participants
n=107 Participants
|
283 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaskan Native
|
11 Participants
n=99 Participants
|
11 Participants
n=107 Participants
|
22 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Asian
|
6 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
12 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
1 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Multiple
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Other
|
3 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
9 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Missing
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Hispanic or Latino
|
36 Participants
n=99 Participants
|
48 Participants
n=107 Participants
|
84 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Not Hispanic or Latino
|
114 Participants
n=99 Participants
|
109 Participants
n=107 Participants
|
223 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Not Reported
|
13 Participants
n=99 Participants
|
10 Participants
n=107 Participants
|
23 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Unknown
|
3 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: From Baseline to 16 weeksPopulation: ITT population includes all randomized participants regardless of whether they received any study drug (taselisib or placebo).
Objective response rate (ORR) was defined as proportion of participants achieving complete response (CR) or partial response (PR). As per modified RECIST v1.1, CR: disappearance of all target lesions, 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 |
Experimental: Taselisib + Letrozole
n=166 Participants
Participants received 2.5 milligrams (mg) letrozole tablets orally once daily (QD) along with taselisib tablets at 4 mg (two 2 mg tablets) orally on a 5 days-on/2 days-off schedule for a total of 16 weeks.
|
Placebo Comparator: Placebo + Letrozole
n=168 Participants
Participants received 2.5 mg letrozole tablets orally QD along with placebo on a 5-days-on/2-days-off schedule for a total of 16 weeks.
|
|---|---|---|
|
Percentage of Participants With Objective Response (OR) by Centrally Assessed Breast Magnetic Resonance Imaging (MRI) Via Modified Response Evaluation Criteria in Solid Tumors (mRECIST) Version 1.1
|
50.0 percentage of participants
|
39.3 percentage of participants
|
PRIMARY outcome
Timeframe: From Baseline to 16 weeksPopulation: ITT population includes all randomized participants regardless of whether they received any study drug (taselisib or placebo).
Total pCR was assessed by local pathology review on samples taken at surgery following completion of neoadjuvant therapy. tpCR was defined as the absence of any residual invasive cancer on hematoxylin and eosin evaluation of the resected breast specimen and all sampled ipsilateral lymph nodes ( i.e., ypT0/Tis, ypN0 in the AJCC staging system, 7th edition).
Outcome measures
| Measure |
Experimental: Taselisib + Letrozole
n=166 Participants
Participants received 2.5 milligrams (mg) letrozole tablets orally once daily (QD) along with taselisib tablets at 4 mg (two 2 mg tablets) orally on a 5 days-on/2 days-off schedule for a total of 16 weeks.
|
Placebo Comparator: Placebo + Letrozole
n=168 Participants
Participants received 2.5 mg letrozole tablets orally QD along with placebo on a 5-days-on/2-days-off schedule for a total of 16 weeks.
|
|---|---|---|
|
Percentage of Participants With Total Pathologic Complete Response (Total pCR), Defined as Having pCR in Both Breast and Axilla, Using American Joint Committee on Cancer (AJCC) Staging System
|
1.8 percentage of participants
|
0.6 percentage of participants
|
PRIMARY outcome
Timeframe: From Baseline to 16 weeksPopulation: ITT population includes all randomized participants regardless of whether they received any study drug (taselisib or placebo).
ORR was defined as proportion of participants achieving CR or PR. As per modified RECIST v1.1, CR: disappearance of all target lesions, 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 |
Experimental: Taselisib + Letrozole
n=73 Participants
Participants received 2.5 milligrams (mg) letrozole tablets orally once daily (QD) along with taselisib tablets at 4 mg (two 2 mg tablets) orally on a 5 days-on/2 days-off schedule for a total of 16 weeks.
|
Placebo Comparator: Placebo + Letrozole
n=79 Participants
Participants received 2.5 mg letrozole tablets orally QD along with placebo on a 5-days-on/2-days-off schedule for a total of 16 weeks.
|
|---|---|---|
|
Percentage of Participants With OR by Centrally Assessed Breast MRI Via mRECIST Version 1.1 in Phosphatidylinositol-4,5-Bisphosphate 3-Kinase, Catalytic Subunit Alpha (PIK3CA) Mutant (MT) Participants
|
56.2 percentage of participants
|
38.0 percentage of participants
|
PRIMARY outcome
Timeframe: From Baseline to 16 weeksPopulation: ITT population includes all randomized participants regardless of whether they received any study drug (taselisib or placebo).
Total pCR was assessed by local pathology review on samples taken at surgery following completion of neoadjuvant therapy. tpCR was defined as the absence of any residual invasive cancer on hematoxylin and eosin evaluation of the resected breast specimen and all sampled ipsilateral lymph nodes (i.e., ypT0/Tis, ypN0 in the AJCC staging system, 7th edition).
Outcome measures
| Measure |
Experimental: Taselisib + Letrozole
n=73 Participants
Participants received 2.5 milligrams (mg) letrozole tablets orally once daily (QD) along with taselisib tablets at 4 mg (two 2 mg tablets) orally on a 5 days-on/2 days-off schedule for a total of 16 weeks.
|
Placebo Comparator: Placebo + Letrozole
n=79 Participants
Participants received 2.5 mg letrozole tablets orally QD along with placebo on a 5-days-on/2-days-off schedule for a total of 16 weeks.
|
|---|---|---|
|
Percentage of Participants With Total pCR , Defined as Having pCR in Both Breast and Axilla, Using AJCC Staging System in PIK3CA MT Participants
|
1.4 percentage of participants
|
0 percentage of participants
|
SECONDARY outcome
Timeframe: From Baseline to 16 weeksPopulation: ITT population includes all randomized participants regardless of whether they received any study drug (taselisib or placebo).
ORR was defined as proportion of participants achieving CR or PR. As per modified RECIST v1.1, CR: disappearance of all target lesions, 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 |
Experimental: Taselisib + Letrozole
n=92 Participants
Participants received 2.5 milligrams (mg) letrozole tablets orally once daily (QD) along with taselisib tablets at 4 mg (two 2 mg tablets) orally on a 5 days-on/2 days-off schedule for a total of 16 weeks.
|
Placebo Comparator: Placebo + Letrozole
n=89 Participants
Participants received 2.5 mg letrozole tablets orally QD along with placebo on a 5-days-on/2-days-off schedule for a total of 16 weeks.
|
|---|---|---|
|
Percentage of Participants With OR by Centrally Assessed Breast MRI Via mRECIST Version 1.1 in PIK3CA Wildtype (WT) Participants
|
45.7 percentage of participants
|
40.4 percentage of participants
|
SECONDARY outcome
Timeframe: From Baseline to 16 weeksPopulation: ITT population includes all randomized participants regardless of whether they received any study drug (taselisib or placebo).
Total pCR was assessed by local pathology review on samples taken at surgery following completion of neoadjuvant therapy. tpCR was defined as the absence of any residual invasive cancer on hematoxylin and eosin evaluation of the resected breast specimen and all sampled ipsilateral lymph nodes (i.e., ypT0/Tis, ypN0 in the AJCC staging system, 7th edition).
Outcome measures
| Measure |
Experimental: Taselisib + Letrozole
n=92 Participants
Participants received 2.5 milligrams (mg) letrozole tablets orally once daily (QD) along with taselisib tablets at 4 mg (two 2 mg tablets) orally on a 5 days-on/2 days-off schedule for a total of 16 weeks.
|
Placebo Comparator: Placebo + Letrozole
n=89 Participants
Participants received 2.5 mg letrozole tablets orally QD along with placebo on a 5-days-on/2-days-off schedule for a total of 16 weeks.
|
|---|---|---|
|
Percentage of Participants With Total pCR Defined as Having pCR in Both Breast and Axilla, Using AJCC Staging System in PIK3CA WT Participants
|
2.2 percentage of participants
|
1.1 percentage of participants
|
SECONDARY outcome
Timeframe: From Baseline to 16 weeksPopulation: ITT population includes all randomized participants regardless of whether they received any study drug (taselisib or placebo).
ORR was defined as proportion of participants achieving CR or PR. As per modified RECIST v1.1, CR: disappearance of all target lesions, 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 |
Experimental: Taselisib + Letrozole
n=73 Participants
Participants received 2.5 milligrams (mg) letrozole tablets orally once daily (QD) along with taselisib tablets at 4 mg (two 2 mg tablets) orally on a 5 days-on/2 days-off schedule for a total of 16 weeks.
|
Placebo Comparator: Placebo + Letrozole
n=79 Participants
Participants received 2.5 mg letrozole tablets orally QD along with placebo on a 5-days-on/2-days-off schedule for a total of 16 weeks.
|
|---|---|---|
|
Percentage of Participants With OR by Breast Ultrasound Via mRECIST Version 1.1 in PIK3CA MT Participants
|
61.6 percentage of participants
|
40.5 percentage of participants
|
SECONDARY outcome
Timeframe: From Baseline to 16 weeksPopulation: ITT population includes all randomized participants regardless of whether they received any study drug (taselisib or placebo).
ORR was defined as proportion of participants achieving CR or PR. As per modified RECIST v1.1, CR: disappearance of all target lesions, 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 |
Experimental: Taselisib + Letrozole
n=92 Participants
Participants received 2.5 milligrams (mg) letrozole tablets orally once daily (QD) along with taselisib tablets at 4 mg (two 2 mg tablets) orally on a 5 days-on/2 days-off schedule for a total of 16 weeks.
|
Placebo Comparator: Placebo + Letrozole
n=89 Participants
Participants received 2.5 mg letrozole tablets orally QD along with placebo on a 5-days-on/2-days-off schedule for a total of 16 weeks.
|
|---|---|---|
|
Percentage of Participants With OR by Breast Ultrasound Via mRECIST Version 1.1 in PIK3CA WT Participants
|
54.3 percentage of participants
|
51.7 percentage of participants
|
SECONDARY outcome
Timeframe: From Baseline to 16 weeksPopulation: ITT population includes all randomized participants regardless of whether they received any study drug (taselisib or placebo).
ORR was defined as proportion of participants achieving CR or PR. As per modified RECIST v1.1, CR: disappearance of all target lesions, 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 |
Experimental: Taselisib + Letrozole
n=73 Participants
Participants received 2.5 milligrams (mg) letrozole tablets orally once daily (QD) along with taselisib tablets at 4 mg (two 2 mg tablets) orally on a 5 days-on/2 days-off schedule for a total of 16 weeks.
|
Placebo Comparator: Placebo + Letrozole
n=79 Participants
Participants received 2.5 mg letrozole tablets orally QD along with placebo on a 5-days-on/2-days-off schedule for a total of 16 weeks.
|
|---|---|---|
|
Percentage of Participants With OR by Mammography Via mRECIST Version 1.1 in PIK3CA MT Participants
|
41.1 percentage of participants
|
31.6 percentage of participants
|
SECONDARY outcome
Timeframe: From Baseline to 16 weeksPopulation: ITT population includes all randomized participants regardless of whether they received any study drug (taselisib or placebo).
ORR was defined as proportion of participants achieving CR or PR. As per modified RECIST v1.1, CR: disappearance of all target lesions, 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 |
Experimental: Taselisib + Letrozole
n=92 Participants
Participants received 2.5 milligrams (mg) letrozole tablets orally once daily (QD) along with taselisib tablets at 4 mg (two 2 mg tablets) orally on a 5 days-on/2 days-off schedule for a total of 16 weeks.
|
Placebo Comparator: Placebo + Letrozole
n=89 Participants
Participants received 2.5 mg letrozole tablets orally QD along with placebo on a 5-days-on/2-days-off schedule for a total of 16 weeks.
|
|---|---|---|
|
Percentage of Participants With OR by Mammography Via mRECIST Version 1.1 in PIK3CA WT Participants
|
40.2 percentage of participants
|
32.6 percentage of participants
|
SECONDARY outcome
Timeframe: From Baseline to 16 weeksPopulation: ITT population includes all randomized participants regardless of whether they received any study drug (taselisib or placebo).
ORR was defined as proportion of participants achieving CR or PR. As per modified RECIST v1.1, CR: disappearance of all target lesions, 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 |
Experimental: Taselisib + Letrozole
n=73 Participants
Participants received 2.5 milligrams (mg) letrozole tablets orally once daily (QD) along with taselisib tablets at 4 mg (two 2 mg tablets) orally on a 5 days-on/2 days-off schedule for a total of 16 weeks.
|
Placebo Comparator: Placebo + Letrozole
n=79 Participants
Participants received 2.5 mg letrozole tablets orally QD along with placebo on a 5-days-on/2-days-off schedule for a total of 16 weeks.
|
|---|---|---|
|
Percentage of Participants With OR by Clinical Breast Exam (Palpation) Via mRECIST Version 1.1 in PIK3CA MT Participants
|
74.0 percentage of participants
|
63.3 percentage of participants
|
SECONDARY outcome
Timeframe: From Baseline to 16 weeksPopulation: ITT population includes all randomized participants regardless of whether they received any study drug (taselisib or placebo).
ORR was defined as proportion of participants achieving CR or PR. As per modified RECIST v1.1, CR: disappearance of all target lesions, 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 |
Experimental: Taselisib + Letrozole
n=92 Participants
Participants received 2.5 milligrams (mg) letrozole tablets orally once daily (QD) along with taselisib tablets at 4 mg (two 2 mg tablets) orally on a 5 days-on/2 days-off schedule for a total of 16 weeks.
|
Placebo Comparator: Placebo + Letrozole
n=89 Participants
Participants received 2.5 mg letrozole tablets orally QD along with placebo on a 5-days-on/2-days-off schedule for a total of 16 weeks.
|
|---|---|---|
|
Percentage of Participants With OR by Clinical Breast Exam (Palpation) Via mRECIST Version 1.1 in PIK3CA WT Participants
|
62.0 percentage of participants
|
59.6 percentage of participants
|
SECONDARY outcome
Timeframe: From Baseline to Week 3 and Surgery (Weeks 17-18); and Week 3 to Surgery (Weeks 17-18)Population: ITT population includes all randomized participants regardless of whether they received any study drug (taselisib or placebo).
Ki67 is a prognostic marker and is used to evaluate the proliferative activity of breast cancer.
Outcome measures
| Measure |
Experimental: Taselisib + Letrozole
n=166 Participants
Participants received 2.5 milligrams (mg) letrozole tablets orally once daily (QD) along with taselisib tablets at 4 mg (two 2 mg tablets) orally on a 5 days-on/2 days-off schedule for a total of 16 weeks.
|
Placebo Comparator: Placebo + Letrozole
n=168 Participants
Participants received 2.5 mg letrozole tablets orally QD along with placebo on a 5-days-on/2-days-off schedule for a total of 16 weeks.
|
|---|---|---|
|
Central Assessments of Changes in Ki67 Levels
From Baseline to Week 3
|
-83.81 percentage
Interval -86.73 to -80.23
|
-80.44 percentage
Interval -83.93 to -76.19
|
|
Central Assessments of Changes in Ki67 Levels
From Baseline to Surgery
|
-75.58 percentage
Interval -80.45 to -69.49
|
-80.51 percentage
Interval -84.41 to -75.64
|
SECONDARY outcome
Timeframe: Week 16Population: Data were not collected for this outcome measure.
To obtain the PEPI score, risk points for relapse-free survival (RFS) and breast cancer-specific survival (BCSS) are assigned depending on the hazard ratio (HR) from the multivariable analysis. The total PEPI score assigned to each participant is the sum of the risk points derived from the primary tumor (pT) stage, regional lymph nodes (pN) stage, Ki67 level, and estrogen receptor status of the surgical specimen. A HR in the range of 1 to 2 receives one risk point; a HR in the 2 to 2.5 range, two risk points; a HR greater than 2.5, three risk points. The total risk point score for each participant is the sum of all the risk points accumulated from the four factors in the model, ranges from 0 (best possible outcome) to 12 (worst possible outcome).
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: From Baseline to Surgery (Weeks 17-18)Population: ITT population includes all randomized participants regardless of whether they received any study drug (taselisib or placebo).
Outcome measures
| Measure |
Experimental: Taselisib + Letrozole
n=166 Participants
Participants received 2.5 milligrams (mg) letrozole tablets orally once daily (QD) along with taselisib tablets at 4 mg (two 2 mg tablets) orally on a 5 days-on/2 days-off schedule for a total of 16 weeks.
|
Placebo Comparator: Placebo + Letrozole
n=168 Participants
Participants received 2.5 mg letrozole tablets orally QD along with placebo on a 5-days-on/2-days-off schedule for a total of 16 weeks.
|
|---|---|---|
|
Percent Change From Baseline to Surgery in Enhancing Tumor Volume as Measured by Breast MRI
|
-70.60 percent change
Interval -77.53 to -63.66
|
-57.28 percent change
Interval -64.21 to -50.35
|
SECONDARY outcome
Timeframe: Weeks 1, 5, 9, 13, 16, 4-week Post-SurgeryPopulation: ITT population includes all randomized participants regardless of whether they received any study drug (taselisib or placebo).
EORTC QLQ-C30 is a cancer-specific instrument with 30 questions used to assess the overall quality of life (QOL) in cancer participants. The first 28 questions used a 4-point scale (1=not at all, 2=a little, 3=quite a bit, 4=very much) for evaluating 5 functional scales (physical, role, social, cognitive, emotional), 8 symptom scales/items (diarrhea, fatigue, dyspnea, appetite loss, insomnia, nausea and vomiting \[N/V\], constipation, and pain) and a single item (financial difficulties). The last 2 questions represented the participant's assessment of overall health and quality of life, used 7-point scale (1=very poor to 7=excellent). EORTC QLQ-C30 global scores were linearly transformed on a scale of 0 to 100, with a high score indicating better QOL. Negative change from Baseline values indicated deterioration in QOL or functioning and positive values indicated improvement. Here, Post surgery= PS.
Outcome measures
| Measure |
Experimental: Taselisib + Letrozole
n=166 Participants
Participants received 2.5 milligrams (mg) letrozole tablets orally once daily (QD) along with taselisib tablets at 4 mg (two 2 mg tablets) orally on a 5 days-on/2 days-off schedule for a total of 16 weeks.
|
Placebo Comparator: Placebo + Letrozole
n=168 Participants
Participants received 2.5 mg letrozole tablets orally QD along with placebo on a 5-days-on/2-days-off schedule for a total of 16 weeks.
|
|---|---|---|
|
Mean Score for Health-Related Quality of Life Measured by the European Organization for Research C30 (EORTC QLQ-C30)
Appetite Loss: Change at Week 5
|
3.0 score on a scale
Standard Deviation 18.4
|
1.9 score on a scale
Standard Deviation 18.8
|
|
Mean Score for Health-Related Quality of Life Measured by the European Organization for Research C30 (EORTC QLQ-C30)
Appetite Loss: Change at Week 9
|
5.3 score on a scale
Standard Deviation 21.4
|
3.0 score on a scale
Standard Deviation 17.8
|
|
Mean Score for Health-Related Quality of Life Measured by the European Organization for Research C30 (EORTC QLQ-C30)
Appetite Loss: Change at Week 16
|
6.8 score on a scale
Standard Deviation 24.1
|
0.9 score on a scale
Standard Deviation 16.3
|
|
Mean Score for Health-Related Quality of Life Measured by the European Organization for Research C30 (EORTC QLQ-C30)
Appetite Loss: Change at PS Visit
|
5.0 score on a scale
Standard Deviation 24.9
|
5.0 score on a scale
Standard Deviation 23.3
|
|
Mean Score for Health-Related Quality of Life Measured by the European Organization for Research C30 (EORTC QLQ-C30)
Cognitive functioning: Baseline
|
90.8 score on a scale
Standard Deviation 15.8
|
90.9 score on a scale
Standard Deviation 16.6
|
|
Mean Score for Health-Related Quality of Life Measured by the European Organization for Research C30 (EORTC QLQ-C30)
Cognitive functioning: Change at Week 5
|
0.4 score on a scale
Standard Deviation 12.8
|
-2.5 score on a scale
Standard Deviation 12.3
|
|
Mean Score for Health-Related Quality of Life Measured by the European Organization for Research C30 (EORTC QLQ-C30)
Cognitive functioning: Change at Week 9
|
-1.1 score on a scale
Standard Deviation 14.4
|
-4.2 score on a scale
Standard Deviation 14.7
|
|
Mean Score for Health-Related Quality of Life Measured by the European Organization for Research C30 (EORTC QLQ-C30)
Cognitive functioning: Change at Week 13
|
-3.4 score on a scale
Standard Deviation 15.8
|
-5.1 score on a scale
Standard Deviation 15.7
|
|
Mean Score for Health-Related Quality of Life Measured by the European Organization for Research C30 (EORTC QLQ-C30)
Cognitive functioning: Change at Week 16
|
-4.2 score on a scale
Standard Deviation 15.2
|
-4.1 score on a scale
Standard Deviation 17.5
|
|
Mean Score for Health-Related Quality of Life Measured by the European Organization for Research C30 (EORTC QLQ-C30)
Cognitive functioning: Change at PS Visit
|
-3.1 score on a scale
Standard Deviation 18.9
|
-5.4 score on a scale
Standard Deviation 16.8
|
|
Mean Score for Health-Related Quality of Life Measured by the European Organization for Research C30 (EORTC QLQ-C30)
Constipation: Change at Week 5
|
0.0 score on a scale
Standard Deviation 16.1
|
3.1 score on a scale
Standard Deviation 22.1
|
|
Mean Score for Health-Related Quality of Life Measured by the European Organization for Research C30 (EORTC QLQ-C30)
Constipation: Change at Week 9
|
0.2 score on a scale
Standard Deviation 17.0
|
0.2 score on a scale
Standard Deviation 18.6
|
|
Mean Score for Health-Related Quality of Life Measured by the European Organization for Research C30 (EORTC QLQ-C30)
Constipation: Change at Week 16
|
-1.1 score on a scale
Standard Deviation 17.2
|
1.6 score on a scale
Standard Deviation 20.3
|
|
Mean Score for Health-Related Quality of Life Measured by the European Organization for Research C30 (EORTC QLQ-C30)
Diarrhoea: Baseline
|
5.9 score on a scale
Standard Deviation 14.9
|
4.3 score on a scale
Standard Deviation 11.8
|
|
Mean Score for Health-Related Quality of Life Measured by the European Organization for Research C30 (EORTC QLQ-C30)
Diarrhoea: Change at Week 5
|
6.7 score on a scale
Standard Deviation 21.7
|
-0.2 score on a scale
Standard Deviation 13.4
|
|
Mean Score for Health-Related Quality of Life Measured by the European Organization for Research C30 (EORTC QLQ-C30)
Diarrhoea: Change at Week 9
|
6.4 score on a scale
Standard Deviation 24.3
|
0.8 score on a scale
Standard Deviation 15.1
|
|
Mean Score for Health-Related Quality of Life Measured by the European Organization for Research C30 (EORTC QLQ-C30)
Diarrhoea: Change at Week 13
|
7.9 score on a scale
Standard Deviation 22.3
|
-0.4 score on a scale
Standard Deviation 14.7
|
|
Mean Score for Health-Related Quality of Life Measured by the European Organization for Research C30 (EORTC QLQ-C30)
Diarrhoea: Change at PS Visit
|
0.2 score on a scale
Standard Deviation 17.7
|
-0.9 score on a scale
Standard Deviation 15.7
|
|
Mean Score for Health-Related Quality of Life Measured by the European Organization for Research C30 (EORTC QLQ-C30)
Dyspnoea: Baseline
|
7.4 score on a scale
Standard Deviation 15.8
|
8.5 score on a scale
Standard Deviation 17.5
|
|
Mean Score for Health-Related Quality of Life Measured by the European Organization for Research C30 (EORTC QLQ-C30)
Dyspnoea: Change at Week 5
|
-0.2 score on a scale
Standard Deviation 14.0
|
0.6 score on a scale
Standard Deviation 18.1
|
|
Mean Score for Health-Related Quality of Life Measured by the European Organization for Research C30 (EORTC QLQ-C30)
Dyspnoea: Change at Week 9
|
2.0 score on a scale
Standard Deviation 17.4
|
1.9 score on a scale
Standard Deviation 19.9
|
|
Mean Score for Health-Related Quality of Life Measured by the European Organization for Research C30 (EORTC QLQ-C30)
Dyspnoea: Change at Week 13
|
3.5 score on a scale
Standard Deviation 21.1
|
1.7 score on a scale
Standard Deviation 22.3
|
|
Mean Score for Health-Related Quality of Life Measured by the European Organization for Research C30 (EORTC QLQ-C30)
Emotional functioning: Baseline
|
77.0 score on a scale
Standard Deviation 20.4
|
78.2 score on a scale
Standard Deviation 19.9
|
|
Mean Score for Health-Related Quality of Life Measured by the European Organization for Research C30 (EORTC QLQ-C30)
Emotional functioning: Change at Week 5
|
4.2 score on a scale
Standard Deviation 15.2
|
2.4 score on a scale
Standard Deviation 17.0
|
|
Mean Score for Health-Related Quality of Life Measured by the European Organization for Research C30 (EORTC QLQ-C30)
Emotional functioning: Change at Week 13
|
2.5 score on a scale
Standard Deviation 15.2
|
-1.4 score on a scale
Standard Deviation 18.6
|
|
Mean Score for Health-Related Quality of Life Measured by the European Organization for Research C30 (EORTC QLQ-C30)
Emotional functioning: Change at Week 16
|
1.0 score on a scale
Standard Deviation 17.0
|
-3.5 score on a scale
Standard Deviation 20.2
|
|
Mean Score for Health-Related Quality of Life Measured by the European Organization for Research C30 (EORTC QLQ-C30)
Fatigue: Change at Week 5
|
4.7 score on a scale
Standard Deviation 13.9
|
4.9 score on a scale
Standard Deviation 17.9
|
|
Mean Score for Health-Related Quality of Life Measured by the European Organization for Research C30 (EORTC QLQ-C30)
Fatigue: Change at Week 16
|
6.8 score on a scale
Standard Deviation 17.5
|
8.0 score on a scale
Standard Deviation 20.4
|
|
Mean Score for Health-Related Quality of Life Measured by the European Organization for Research C30 (EORTC QLQ-C30)
Fatigue: Change at PS Visit
|
12.3 score on a scale
Standard Deviation 19.5
|
12.4 score on a scale
Standard Deviation 22.6
|
|
Mean Score for Health-Related Quality of Life Measured by the European Organization for Research C30 (EORTC QLQ-C30)
Financial difficulties: Baseline
|
9.0 score on a scale
Standard Deviation 20.9
|
10.0 score on a scale
Standard Deviation 20.4
|
|
Mean Score for Health-Related Quality of Life Measured by the European Organization for Research C30 (EORTC QLQ-C30)
Financial difficulties: Change at Week 5
|
-2.6 score on a scale
Standard Deviation 14.6
|
-0.4 score on a scale
Standard Deviation 20.2
|
|
Mean Score for Health-Related Quality of Life Measured by the European Organization for Research C30 (EORTC QLQ-C30)
Financial difficulties: Change at Week 9
|
-2.6 score on a scale
Standard Deviation 17.9
|
0.7 score on a scale
Standard Deviation 20.4
|
|
Mean Score for Health-Related Quality of Life Measured by the European Organization for Research C30 (EORTC QLQ-C30)
Global health status / QoL: Change at Week 5
|
1.5 score on a scale
Standard Deviation 15.2
|
-1.1 score on a scale
Standard Deviation 18.5
|
|
Mean Score for Health-Related Quality of Life Measured by the European Organization for Research C30 (EORTC QLQ-C30)
Global health status / QoL: Change at Week 9
|
-1.1 score on a scale
Standard Deviation 15.9
|
-3.2 score on a scale
Standard Deviation 22.7
|
|
Mean Score for Health-Related Quality of Life Measured by the European Organization for Research C30 (EORTC QLQ-C30)
Global health status / QoL: Change at Week 16
|
-2.2 score on a scale
Standard Deviation 18.4
|
-2.9 score on a scale
Standard Deviation 22.6
|
|
Mean Score for Health-Related Quality of Life Measured by the European Organization for Research C30 (EORTC QLQ-C30)
Insomnia: Change at Week 5
|
-2.4 score on a scale
Standard Deviation 24.1
|
-0.4 score on a scale
Standard Deviation 27.6
|
|
Mean Score for Health-Related Quality of Life Measured by the European Organization for Research C30 (EORTC QLQ-C30)
Insomnia: Change at Week 9
|
-1.8 score on a scale
Standard Deviation 24.9
|
-0.6 score on a scale
Standard Deviation 26.9
|
|
Mean Score for Health-Related Quality of Life Measured by the European Organization for Research C30 (EORTC QLQ-C30)
Insomnia: Change at Week 13
|
-1.1 score on a scale
Standard Deviation 27.7
|
2.1 score on a scale
Standard Deviation 29.5
|
|
Mean Score for Health-Related Quality of Life Measured by the European Organization for Research C30 (EORTC QLQ-C30)
Insomnia: Change at Week 16
|
-0.7 score on a scale
Standard Deviation 26.1
|
-2.2 score on a scale
Standard Deviation 27.6
|
|
Mean Score for Health-Related Quality of Life Measured by the European Organization for Research C30 (EORTC QLQ-C30)
Insomnia: Change at PS Visit
|
-1.4 score on a scale
Standard Deviation 26.8
|
3.2 score on a scale
Standard Deviation 34.4
|
|
Mean Score for Health-Related Quality of Life Measured by the European Organization for Research C30 (EORTC QLQ-C30)
Nausea and vomiting: Baseline
|
1.9 score on a scale
Standard Deviation 7.5
|
1.6 score on a scale
Standard Deviation 6.2
|
|
Mean Score for Health-Related Quality of Life Measured by the European Organization for Research C30 (EORTC QLQ-C30)
Nausea and vomiting: Change at Week 5
|
3.7 score on a scale
Standard Deviation 11.3
|
1.9 score on a scale
Standard Deviation 9.9
|
|
Mean Score for Health-Related Quality of Life Measured by the European Organization for Research C30 (EORTC QLQ-C30)
Nausea and vomiting: Change at Week 13
|
3.7 score on a scale
Standard Deviation 12.9
|
0.7 score on a scale
Standard Deviation 8.5
|
|
Mean Score for Health-Related Quality of Life Measured by the European Organization for Research C30 (EORTC QLQ-C30)
Nausea and vomiting: Change at Week 16
|
2.5 score on a scale
Standard Deviation 14.0
|
0.6 score on a scale
Standard Deviation 8.0
|
|
Mean Score for Health-Related Quality of Life Measured by the European Organization for Research C30 (EORTC QLQ-C30)
Nausea and vomiting: Change at PS Visit
|
2.1 score on a scale
Standard Deviation 14.8
|
1.0 score on a scale
Standard Deviation 8.6
|
|
Mean Score for Health-Related Quality of Life Measured by the European Organization for Research C30 (EORTC QLQ-C30)
Pain: Baseline
|
13.1 score on a scale
Standard Deviation 20.4
|
12.3 score on a scale
Standard Deviation 19.6
|
|
Mean Score for Health-Related Quality of Life Measured by the European Organization for Research C30 (EORTC QLQ-C30)
Pain: Change at Week 5
|
-0.6 score on a scale
Standard Deviation 18.8
|
2.6 score on a scale
Standard Deviation 17.5
|
|
Mean Score for Health-Related Quality of Life Measured by the European Organization for Research C30 (EORTC QLQ-C30)
Pain: Change at Week 13
|
-1.4 score on a scale
Standard Deviation 18.4
|
4.7 score on a scale
Standard Deviation 23.4
|
|
Mean Score for Health-Related Quality of Life Measured by the European Organization for Research C30 (EORTC QLQ-C30)
Pain: Change at Week 16
|
-0.9 score on a scale
Standard Deviation 19.1
|
1.8 score on a scale
Standard Deviation 22.0
|
|
Mean Score for Health-Related Quality of Life Measured by the European Organization for Research C30 (EORTC QLQ-C30)
Physical functioning: Change at Week 5
|
0.5 score on a scale
Standard Deviation 9.6
|
-1.2 score on a scale
Standard Deviation 11.5
|
|
Mean Score for Health-Related Quality of Life Measured by the European Organization for Research C30 (EORTC QLQ-C30)
Physical functioning: Change at Week 9
|
0.2 score on a scale
Standard Deviation 10.1
|
-2.0 score on a scale
Standard Deviation 13.1
|
|
Mean Score for Health-Related Quality of Life Measured by the European Organization for Research C30 (EORTC QLQ-C30)
Physical functioning: Change at Week 13
|
-0.3 score on a scale
Standard Deviation 12.4
|
-1.9 score on a scale
Standard Deviation 14.0
|
|
Mean Score for Health-Related Quality of Life Measured by the European Organization for Research C30 (EORTC QLQ-C30)
Physical functioning: Change at Week 16
|
-0.5 score on a scale
Standard Deviation 10.9
|
-3.4 score on a scale
Standard Deviation 15.1
|
|
Mean Score for Health-Related Quality of Life Measured by the European Organization for Research C30 (EORTC QLQ-C30)
Physical functioning: Change at PS Visit
|
-5.2 score on a scale
Standard Deviation 16.0
|
-7.5 score on a scale
Standard Deviation 15.7
|
|
Mean Score for Health-Related Quality of Life Measured by the European Organization for Research C30 (EORTC QLQ-C30)
Role functioning: Baseline
|
90.7 score on a scale
Standard Deviation 20.1
|
93.1 score on a scale
Standard Deviation 16.5
|
|
Mean Score for Health-Related Quality of Life Measured by the European Organization for Research C30 (EORTC QLQ-C30)
Role functioning:Change at Week 5
|
1.3 score on a scale
Standard Deviation 14.3
|
-2.5 score on a scale
Standard Deviation 17.1
|
|
Mean Score for Health-Related Quality of Life Measured by the European Organization for Research C30 (EORTC QLQ-C30)
Role functioning:Change at Week 9
|
-0.2 score on a scale
Standard Deviation 12.8
|
-4.9 score on a scale
Standard Deviation 18.9
|
|
Mean Score for Health-Related Quality of Life Measured by the European Organization for Research C30 (EORTC QLQ-C30)
Role functioning:Change at Week 13
|
-2.3 score on a scale
Standard Deviation 17.4
|
-5.6 score on a scale
Standard Deviation 19.8
|
|
Mean Score for Health-Related Quality of Life Measured by the European Organization for Research C30 (EORTC QLQ-C30)
Social functioning: Baseline
|
91.2 score on a scale
Standard Deviation 17.6
|
94.9 score on a scale
Standard Deviation 14.3
|
|
Mean Score for Health-Related Quality of Life Measured by the European Organization for Research C30 (EORTC QLQ-C30)
Social functioning: Change at Week 5
|
3.1 score on a scale
Standard Deviation 12.8
|
-2.0 score on a scale
Standard Deviation 15.7
|
|
Mean Score for Health-Related Quality of Life Measured by the European Organization for Research C30 (EORTC QLQ-C30)
Social functioning: Change at Week 9
|
2.0 score on a scale
Standard Deviation 13.4
|
-4.0 score on a scale
Standard Deviation 18.1
|
|
Mean Score for Health-Related Quality of Life Measured by the European Organization for Research C30 (EORTC QLQ-C30)
Social functioning: Change at Week 16
|
-0.5 score on a scale
Standard Deviation 13.7
|
-3.1 score on a scale
Standard Deviation 19.3
|
|
Mean Score for Health-Related Quality of Life Measured by the European Organization for Research C30 (EORTC QLQ-C30)
Social functioning: Change at PS Visit
|
-6.4 score on a scale
Standard Deviation 20.3
|
-10.1 score on a scale
Standard Deviation 24.2
|
|
Mean Score for Health-Related Quality of Life Measured by the European Organization for Research C30 (EORTC QLQ-C30)
Appetite Loss: Baseline
|
6.2 score on a scale
Standard Deviation 16.4
|
5.9 score on a scale
Standard Deviation 14.2
|
|
Mean Score for Health-Related Quality of Life Measured by the European Organization for Research C30 (EORTC QLQ-C30)
Appetite Loss: Change at Week 13
|
5.5 score on a scale
Standard Deviation 23.8
|
2.1 score on a scale
Standard Deviation 16.3
|
|
Mean Score for Health-Related Quality of Life Measured by the European Organization for Research C30 (EORTC QLQ-C30)
Constipation: Baseline
|
6.8 score on a scale
Standard Deviation 15.9
|
8.3 score on a scale
Standard Deviation 18.2
|
|
Mean Score for Health-Related Quality of Life Measured by the European Organization for Research C30 (EORTC QLQ-C30)
Constipation: Change at Week 13
|
-0.4 score on a scale
Standard Deviation 18.5
|
-0.6 score on a scale
Standard Deviation 19.5
|
|
Mean Score for Health-Related Quality of Life Measured by the European Organization for Research C30 (EORTC QLQ-C30)
Constipation: Change at PS Visit
|
4.8 score on a scale
Standard Deviation 23.2
|
1.1 score on a scale
Standard Deviation 16.9
|
|
Mean Score for Health-Related Quality of Life Measured by the European Organization for Research C30 (EORTC QLQ-C30)
Diarrhoea: Change at Week 16
|
8.4 score on a scale
Standard Deviation 23.1
|
0.2 score on a scale
Standard Deviation 16.4
|
|
Mean Score for Health-Related Quality of Life Measured by the European Organization for Research C30 (EORTC QLQ-C30)
Pain: Change at PS Visit
|
11.1 score on a scale
Standard Deviation 26.0
|
13.8 score on a scale
Standard Deviation 26.6
|
|
Mean Score for Health-Related Quality of Life Measured by the European Organization for Research C30 (EORTC QLQ-C30)
Physical functioning: Baseline
|
89.6 score on a scale
Standard Deviation 13.7
|
90.8 score on a scale
Standard Deviation 13.4
|
|
Mean Score for Health-Related Quality of Life Measured by the European Organization for Research C30 (EORTC QLQ-C30)
Dyspnoea: Change at Week 16
|
3.4 score on a scale
Standard Deviation 20.2
|
2.6 score on a scale
Standard Deviation 22.6
|
|
Mean Score for Health-Related Quality of Life Measured by the European Organization for Research C30 (EORTC QLQ-C30)
Dyspnoea: Change at PS Visit
|
3.1 score on a scale
Standard Deviation 24.8
|
2.1 score on a scale
Standard Deviation 21.5
|
|
Mean Score for Health-Related Quality of Life Measured by the European Organization for Research C30 (EORTC QLQ-C30)
Emotional functioning: Change at Week 9
|
3.8 score on a scale
Standard Deviation 14.7
|
1.3 score on a scale
Standard Deviation 20.7
|
|
Mean Score for Health-Related Quality of Life Measured by the European Organization for Research C30 (EORTC QLQ-C30)
Emotional functioning: Change at PS Visit
|
-0.8 score on a scale
Standard Deviation 19.0
|
-3.6 score on a scale
Standard Deviation 20.9
|
|
Mean Score for Health-Related Quality of Life Measured by the European Organization for Research C30 (EORTC QLQ-C30)
Fatigue: Baseline
|
14.8 score on a scale
Standard Deviation 18.7
|
15.6 score on a scale
Standard Deviation 18.5
|
|
Mean Score for Health-Related Quality of Life Measured by the European Organization for Research C30 (EORTC QLQ-C30)
Fatigue: Change at Week 9
|
5.0 score on a scale
Standard Deviation 15.9
|
7.5 score on a scale
Standard Deviation 20.3
|
|
Mean Score for Health-Related Quality of Life Measured by the European Organization for Research C30 (EORTC QLQ-C30)
Fatigue: Change at Week 13
|
7.9 score on a scale
Standard Deviation 18.1
|
8.8 score on a scale
Standard Deviation 21.4
|
|
Mean Score for Health-Related Quality of Life Measured by the European Organization for Research C30 (EORTC QLQ-C30)
Financial difficulties: Change at Week 13
|
-1.1 score on a scale
Standard Deviation 17.9
|
0.0 score on a scale
Standard Deviation 19.9
|
|
Mean Score for Health-Related Quality of Life Measured by the European Organization for Research C30 (EORTC QLQ-C30)
Financial difficulties: Change at Week 16
|
-1.1 score on a scale
Standard Deviation 15.9
|
2.1 score on a scale
Standard Deviation 24.4
|
|
Mean Score for Health-Related Quality of Life Measured by the European Organization for Research C30 (EORTC QLQ-C30)
Financial difficulties: Change at PS Visit
|
1.9 score on a scale
Standard Deviation 20.0
|
3.8 score on a scale
Standard Deviation 23.6
|
|
Mean Score for Health-Related Quality of Life Measured by the European Organization for Research C30 (EORTC QLQ-C30)
Global health status / QoL: Baseline
|
75.3 score on a scale
Standard Deviation 19.7
|
74.6 score on a scale
Standard Deviation 21.2
|
|
Mean Score for Health-Related Quality of Life Measured by the European Organization for Research C30 (EORTC QLQ-C30)
Global health status / QoL: Change at Week 13
|
-2.4 score on a scale
Standard Deviation 19.5
|
-3.7 score on a scale
Standard Deviation 20.7
|
|
Mean Score for Health-Related Quality of Life Measured by the European Organization for Research C30 (EORTC QLQ-C30)
Global health status / QoL: Change at PS Visit
|
-5.9 score on a scale
Standard Deviation 19.7
|
-7.0 score on a scale
Standard Deviation 22.2
|
|
Mean Score for Health-Related Quality of Life Measured by the European Organization for Research C30 (EORTC QLQ-C30)
Insomnia: Baseline
|
23.0 score on a scale
Standard Deviation 27.1
|
22.4 score on a scale
Standard Deviation 28.1
|
|
Mean Score for Health-Related Quality of Life Measured by the European Organization for Research C30 (EORTC QLQ-C30)
Role functioning:Change at Week 16
|
-4.6 score on a scale
Standard Deviation 16.3
|
-4.4 score on a scale
Standard Deviation 18.9
|
|
Mean Score for Health-Related Quality of Life Measured by the European Organization for Research C30 (EORTC QLQ-C30)
Role functioning:Change at PS Visit
|
-15.1 score on a scale
Standard Deviation 24.7
|
-20.1 score on a scale
Standard Deviation 28.1
|
|
Mean Score for Health-Related Quality of Life Measured by the European Organization for Research C30 (EORTC QLQ-C30)
Social functioning: Change at Week 13
|
0.0 score on a scale
Standard Deviation 13.7
|
-4.0 score on a scale
Standard Deviation 19.0
|
|
Mean Score for Health-Related Quality of Life Measured by the European Organization for Research C30 (EORTC QLQ-C30)
Nausea and vomiting: Change at Week 9
|
3.4 score on a scale
Standard Deviation 10.9
|
1.7 score on a scale
Standard Deviation 10.3
|
|
Mean Score for Health-Related Quality of Life Measured by the European Organization for Research C30 (EORTC QLQ-C30)
Pain: Change at Week 9
|
-1.8 score on a scale
Standard Deviation 16.5
|
3.8 score on a scale
Standard Deviation 22.9
|
SECONDARY outcome
Timeframe: Weeks 1, 5, 9, 13, 16, 4-week Post-SurgeryPopulation: ITT population includes all randomized participants regardless of whether they received any study drug (taselisib or placebo).
EORTC-QLQ-BR23 is a 23-item breast cancer-specific companion module to the EORTC-QLQ-C30 and consists of four functional scales (body image, sexual enjoyment, sexual functioning, future perspective \[FP\]) and four symptom scales (systemic side effects \[SE\], upset by hair loss, arm symptoms, breast symptoms). Questions used 4-point scale (1=not at all, 2=a little, 3=quite a bit, 4=very much). Scores were averaged and transformed to 0-100 scale. High score for functional scale indicated high/better level of functioning/healthy functioning. Negative change from Baseline indicated deterioration in QOL and positive change from Baseline indicated an improvement in QOL. Here, Post surgery= PS.
Outcome measures
| Measure |
Experimental: Taselisib + Letrozole
n=166 Participants
Participants received 2.5 milligrams (mg) letrozole tablets orally once daily (QD) along with taselisib tablets at 4 mg (two 2 mg tablets) orally on a 5 days-on/2 days-off schedule for a total of 16 weeks.
|
Placebo Comparator: Placebo + Letrozole
n=168 Participants
Participants received 2.5 mg letrozole tablets orally QD along with placebo on a 5-days-on/2-days-off schedule for a total of 16 weeks.
|
|---|---|---|
|
Mean Score for Treatment of Cancer Quality of Life Questionnaire BR23 (QLQ-BR23)
Sexual enjoyment: Change at Week 5
|
3.3 score on a scale
Standard Deviation 18.2
|
11.1 score on a scale
Standard Deviation 23.4
|
|
Mean Score for Treatment of Cancer Quality of Life Questionnaire BR23 (QLQ-BR23)
Body image: Baseline
|
91.8 score on a scale
Standard Deviation 15.7
|
94.0 score on a scale
Standard Deviation 14.6
|
|
Mean Score for Treatment of Cancer Quality of Life Questionnaire BR23 (QLQ-BR23)
Body image: Change at Week 5
|
2.8 score on a scale
Standard Deviation 8.8
|
0.6 score on a scale
Standard Deviation 11.4
|
|
Mean Score for Treatment of Cancer Quality of Life Questionnaire BR23 (QLQ-BR23)
Body image: Change at Week 9
|
1.2 score on a scale
Standard Deviation 9.8
|
-0.2 score on a scale
Standard Deviation 10.3
|
|
Mean Score for Treatment of Cancer Quality of Life Questionnaire BR23 (QLQ-BR23)
Body image: Change at Week 13
|
1.2 score on a scale
Standard Deviation 11.6
|
-1.6 score on a scale
Standard Deviation 13.8
|
|
Mean Score for Treatment of Cancer Quality of Life Questionnaire BR23 (QLQ-BR23)
Body image: Change at Week 16
|
0.1 score on a scale
Standard Deviation 10.8
|
-1.2 score on a scale
Standard Deviation 12.8
|
|
Mean Score for Treatment of Cancer Quality of Life Questionnaire BR23 (QLQ-BR23)
Body image: Change at PS Visit
|
-6.5 score on a scale
Standard Deviation 22.3
|
-8.3 score on a scale
Standard Deviation 19.2
|
|
Mean Score for Treatment of Cancer Quality of Life Questionnaire BR23 (QLQ-BR23)
Breast symptoms: Baseline
|
5.3 score on a scale
Standard Deviation 9.8
|
6.9 score on a scale
Standard Deviation 12.7
|
|
Mean Score for Treatment of Cancer Quality of Life Questionnaire BR23 (QLQ-BR23)
Breast symptoms: Change at Week 5
|
2.3 score on a scale
Standard Deviation 14.6
|
1.0 score on a scale
Standard Deviation 13.0
|
|
Mean Score for Treatment of Cancer Quality of Life Questionnaire BR23 (QLQ-BR23)
Breast symptoms: Change at Week 9
|
4.5 score on a scale
Standard Deviation 15.1
|
1.8 score on a scale
Standard Deviation 11.7
|
|
Mean Score for Treatment of Cancer Quality of Life Questionnaire BR23 (QLQ-BR23)
Breast symptoms: Change at Week 13
|
5.8 score on a scale
Standard Deviation 16.0
|
2.3 score on a scale
Standard Deviation 13.3
|
|
Mean Score for Treatment of Cancer Quality of Life Questionnaire BR23 (QLQ-BR23)
Breast symptoms: Change at Week 16
|
7.9 score on a scale
Standard Deviation 18.6
|
3.9 score on a scale
Standard Deviation 14.9
|
|
Mean Score for Treatment of Cancer Quality of Life Questionnaire BR23 (QLQ-BR23)
Breast symptoms: Change at PS Visit
|
6.6 score on a scale
Standard Deviation 17.9
|
4.3 score on a scale
Standard Deviation 14.2
|
|
Mean Score for Treatment of Cancer Quality of Life Questionnaire BR23 (QLQ-BR23)
Future perspective: Baseline
|
57.7 score on a scale
Standard Deviation 31.0
|
58.7 score on a scale
Standard Deviation 29.9
|
|
Mean Score for Treatment of Cancer Quality of Life Questionnaire BR23 (QLQ-BR23)
Future perspective: Change at Week 5
|
6.5 score on a scale
Standard Deviation 26.7
|
9.3 score on a scale
Standard Deviation 28.1
|
|
Mean Score for Treatment of Cancer Quality of Life Questionnaire BR23 (QLQ-BR23)
Future perspective: Change at Week 9
|
10.2 score on a scale
Standard Deviation 25.0
|
9.7 score on a scale
Standard Deviation 26.6
|
|
Mean Score for Treatment of Cancer Quality of Life Questionnaire BR23 (QLQ-BR23)
Future perspective: Change at Week 16
|
10.2 score on a scale
Standard Deviation 26.1
|
5.1 score on a scale
Standard Deviation 29.2
|
|
Mean Score for Treatment of Cancer Quality of Life Questionnaire BR23 (QLQ-BR23)
Future perspective: Change at PS Visit
|
6.5 score on a scale
Standard Deviation 29.7
|
3.4 score on a scale
Standard Deviation 34.8
|
|
Mean Score for Treatment of Cancer Quality of Life Questionnaire BR23 (QLQ-BR23)
Sexual enjoyment: Baseline
|
41.7 score on a scale
Standard Deviation 22.3
|
47.1 score on a scale
Standard Deviation 28.9
|
|
Mean Score for Treatment of Cancer Quality of Life Questionnaire BR23 (QLQ-BR23)
Sexual enjoyment: Change at Week 13
|
6.1 score on a scale
Standard Deviation 19.5
|
1.6 score on a scale
Standard Deviation 22.3
|
|
Mean Score for Treatment of Cancer Quality of Life Questionnaire BR23 (QLQ-BR23)
Sexual enjoyment: Change at Week 16
|
9.8 score on a scale
Standard Deviation 19.3
|
7.6 score on a scale
Standard Deviation 22.8
|
|
Mean Score for Treatment of Cancer Quality of Life Questionnaire BR23 (QLQ-BR23)
Sexual enjoyment: Change at PS Visit
|
14.3 score on a scale
Standard Deviation 27.0
|
2.2 score on a scale
Standard Deviation 23.5
|
|
Mean Score for Treatment of Cancer Quality of Life Questionnaire BR23 (QLQ-BR23)
Sexual functioning: Baseline
|
81.2 score on a scale
Standard Deviation 23.4
|
85.1 score on a scale
Standard Deviation 20.2
|
|
Mean Score for Treatment of Cancer Quality of Life Questionnaire BR23 (QLQ-BR23)
Sexual functioning: Change at Week 5
|
1.2 score on a scale
Standard Deviation 13.6
|
1.0 score on a scale
Standard Deviation 15.0
|
|
Mean Score for Treatment of Cancer Quality of Life Questionnaire BR23 (QLQ-BR23)
Sexual functioning: Change at Week 9
|
1.3 score on a scale
Standard Deviation 14.5
|
0.3 score on a scale
Standard Deviation 16.5
|
|
Mean Score for Treatment of Cancer Quality of Life Questionnaire BR23 (QLQ-BR23)
Sexual functioning: Change at Week 13
|
4.1 score on a scale
Standard Deviation 16.1
|
1.6 score on a scale
Standard Deviation 17.7
|
|
Mean Score for Treatment of Cancer Quality of Life Questionnaire BR23 (QLQ-BR23)
Systematic therapy side effects: Baseline
|
8.7 score on a scale
Standard Deviation 10.8
|
9.5 score on a scale
Standard Deviation 11.5
|
|
Mean Score for Treatment of Cancer Quality of Life Questionnaire BR23 (QLQ-BR23)
Systematic therapy side effects: Change at Week 5
|
4.3 score on a scale
Standard Deviation 10.0
|
3.9 score on a scale
Standard Deviation 10.5
|
|
Mean Score for Treatment of Cancer Quality of Life Questionnaire BR23 (QLQ-BR23)
Systematic therapy side effects: Change at Week 9
|
6.7 score on a scale
Standard Deviation 10.8
|
5.9 score on a scale
Standard Deviation 12.1
|
|
Mean Score for Treatment of Cancer Quality of Life Questionnaire BR23 (QLQ-BR23)
Systematic therapy side effects: Change at Week 13
|
7.3 score on a scale
Standard Deviation 11.0
|
6.2 score on a scale
Standard Deviation 13.1
|
|
Mean Score for Treatment of Cancer Quality of Life Questionnaire BR23 (QLQ-BR23)
Systematic therapy side effects: Change at Week 16
|
7.5 score on a scale
Standard Deviation 12.9
|
7.1 score on a scale
Standard Deviation 12.6
|
|
Mean Score for Treatment of Cancer Quality of Life Questionnaire BR23 (QLQ-BR23)
Systematic therapy side effects:Change at PS Visit
|
7.0 score on a scale
Standard Deviation 12.0
|
5.9 score on a scale
Standard Deviation 12.1
|
|
Mean Score for Treatment of Cancer Quality of Life Questionnaire BR23 (QLQ-BR23)
Upset by hair loss: Baseline
|
24.6 score on a scale
Standard Deviation 26.9
|
35.2 score on a scale
Standard Deviation 31.3
|
|
Mean Score for Treatment of Cancer Quality of Life Questionnaire BR23 (QLQ-BR23)
Upset by hair loss: Change at Week 5
|
11.1 score on a scale
Standard Deviation 32.8
|
-3.3 score on a scale
Standard Deviation 18.9
|
|
Mean Score for Treatment of Cancer Quality of Life Questionnaire BR23 (QLQ-BR23)
Upset by hair loss: Change at Week 9
|
9.1 score on a scale
Standard Deviation 44.9
|
-9.1 score on a scale
Standard Deviation 26.2
|
|
Mean Score for Treatment of Cancer Quality of Life Questionnaire BR23 (QLQ-BR23)
Future perspective: Change at Week 13
|
7.7 score on a scale
Standard Deviation 28.4
|
4.4 score on a scale
Standard Deviation 29.1
|
|
Mean Score for Treatment of Cancer Quality of Life Questionnaire BR23 (QLQ-BR23)
Sexual enjoyment: Change at Week 9
|
8.3 score on a scale
Standard Deviation 23.6
|
10.6 score on a scale
Standard Deviation 23.9
|
|
Mean Score for Treatment of Cancer Quality of Life Questionnaire BR23 (QLQ-BR23)
Sexual functioning: Change at Week 16
|
4.8 score on a scale
Standard Deviation 15.9
|
1.1 score on a scale
Standard Deviation 18.1
|
|
Mean Score for Treatment of Cancer Quality of Life Questionnaire BR23 (QLQ-BR23)
Sexual functioning: Change at PS Visit
|
9.6 score on a scale
Standard Deviation 19.2
|
4.1 score on a scale
Standard Deviation 21.8
|
|
Mean Score for Treatment of Cancer Quality of Life Questionnaire BR23 (QLQ-BR23)
Upset by hair loss: Change at Week 13
|
16.7 score on a scale
Standard Deviation 36.0
|
-3.0 score on a scale
Standard Deviation 34.8
|
|
Mean Score for Treatment of Cancer Quality of Life Questionnaire BR23 (QLQ-BR23)
Upset by hair loss: Change at Week 16
|
21.2 score on a scale
Standard Deviation 34.2
|
-7.1 score on a scale
Standard Deviation 23.3
|
|
Mean Score for Treatment of Cancer Quality of Life Questionnaire BR23 (QLQ-BR23)
Upset by hair loss: Change at PS Visit
|
30.8 score on a scale
Standard Deviation 37.2
|
-2.6 score on a scale
Standard Deviation 34.6
|
SECONDARY outcome
Timeframe: Baseline up to 22 weeksPopulation: The safety population includes all randomized participants who received at least one dose of taselisib or placebo.
An adverse event (AE) is any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Outcome measures
| Measure |
Experimental: Taselisib + Letrozole
n=167 Participants
Participants received 2.5 milligrams (mg) letrozole tablets orally once daily (QD) along with taselisib tablets at 4 mg (two 2 mg tablets) orally on a 5 days-on/2 days-off schedule for a total of 16 weeks.
|
Placebo Comparator: Placebo + Letrozole
n=167 Participants
Participants received 2.5 mg letrozole tablets orally QD along with placebo on a 5-days-on/2-days-off schedule for a total of 16 weeks.
|
|---|---|---|
|
Percentage of Participants With Adverse Events
|
91.0 percentage of participants
|
83.2 percentage of participants
|
Adverse Events
Experimental: Taselisib + Letrozole
Serious events: 20 serious events
Other events: 130 other events
Deaths: 1 deaths
Placebo Comparator: Placebo + Letrozole
Serious events: 4 serious events
Other events: 126 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Experimental: Taselisib + Letrozole
n=167 participants at risk
Participants received 2.5 milligrams (mg) letrozole tablets orally once daily (QD) along with taselisib tablets at 4 mg (two 2 mg tablets) orally on a 5 days-on/2 days-off schedule for a total of 16 weeks.
|
Placebo Comparator: Placebo + Letrozole
n=167 participants at risk
Participants received 2.5 mg letrozole tablets orally QD along with placebo on a 5-days-on/2-days-off schedule for a total of 16 weeks.
|
|---|---|---|
|
Infections and infestations
Postoperative wound infection
|
1.2%
2/167 • Baseline up to 22 weeks
The safety population includes all randomized participants who received at least one dose of taselisib or placebo.
|
0.60%
1/167 • Baseline up to 22 weeks
The safety population includes all randomized participants who received at least one dose of taselisib or placebo.
|
|
Infections and infestations
Erysipelas
|
1.2%
2/167 • Baseline up to 22 weeks
The safety population includes all randomized participants who received at least one dose of taselisib or placebo.
|
0.00%
0/167 • Baseline up to 22 weeks
The safety population includes all randomized participants who received at least one dose of taselisib or placebo.
|
|
Infections and infestations
Bacterial diarrhoea
|
0.60%
1/167 • Baseline up to 22 weeks
The safety population includes all randomized participants who received at least one dose of taselisib or placebo.
|
0.00%
0/167 • Baseline up to 22 weeks
The safety population includes all randomized participants who received at least one dose of taselisib or placebo.
|
|
Infections and infestations
Cytomegalovirus infection
|
0.60%
1/167 • Baseline up to 22 weeks
The safety population includes all randomized participants who received at least one dose of taselisib or placebo.
|
0.00%
0/167 • Baseline up to 22 weeks
The safety population includes all randomized participants who received at least one dose of taselisib or placebo.
|
|
Infections and infestations
Diarrhoea infectious
|
0.60%
1/167 • Baseline up to 22 weeks
The safety population includes all randomized participants who received at least one dose of taselisib or placebo.
|
0.00%
0/167 • Baseline up to 22 weeks
The safety population includes all randomized participants who received at least one dose of taselisib or placebo.
|
|
Infections and infestations
Gastroenteritis
|
0.60%
1/167 • Baseline up to 22 weeks
The safety population includes all randomized participants who received at least one dose of taselisib or placebo.
|
0.00%
0/167 • Baseline up to 22 weeks
The safety population includes all randomized participants who received at least one dose of taselisib or placebo.
|
|
Infections and infestations
Haematoma infection
|
0.00%
0/167 • Baseline up to 22 weeks
The safety population includes all randomized participants who received at least one dose of taselisib or placebo.
|
0.60%
1/167 • Baseline up to 22 weeks
The safety population includes all randomized participants who received at least one dose of taselisib or placebo.
|
|
Infections and infestations
Pneumonia
|
0.60%
1/167 • Baseline up to 22 weeks
The safety population includes all randomized participants who received at least one dose of taselisib or placebo.
|
0.00%
0/167 • Baseline up to 22 weeks
The safety population includes all randomized participants who received at least one dose of taselisib or placebo.
|
|
Infections and infestations
Urinary tract infection
|
0.60%
1/167 • Baseline up to 22 weeks
The safety population includes all randomized participants who received at least one dose of taselisib or placebo.
|
0.00%
0/167 • Baseline up to 22 weeks
The safety population includes all randomized participants who received at least one dose of taselisib or placebo.
|
|
Gastrointestinal disorders
Diarrhoea
|
3.0%
5/167 • Baseline up to 22 weeks
The safety population includes all randomized participants who received at least one dose of taselisib or placebo.
|
0.00%
0/167 • Baseline up to 22 weeks
The safety population includes all randomized participants who received at least one dose of taselisib or placebo.
|
|
Gastrointestinal disorders
Colitis
|
1.2%
2/167 • Baseline up to 22 weeks
The safety population includes all randomized participants who received at least one dose of taselisib or placebo.
|
0.00%
0/167 • Baseline up to 22 weeks
The safety population includes all randomized participants who received at least one dose of taselisib or placebo.
|
|
Gastrointestinal disorders
Enterocolitis
|
0.60%
1/167 • Baseline up to 22 weeks
The safety population includes all randomized participants who received at least one dose of taselisib or placebo.
|
0.00%
0/167 • Baseline up to 22 weeks
The safety population includes all randomized participants who received at least one dose of taselisib or placebo.
|
|
Gastrointestinal disorders
Enterocolitis haemorrhagic
|
0.60%
1/167 • Baseline up to 22 weeks
The safety population includes all randomized participants who received at least one dose of taselisib or placebo.
|
0.00%
0/167 • Baseline up to 22 weeks
The safety population includes all randomized participants who received at least one dose of taselisib or placebo.
|
|
Gastrointestinal disorders
Stomatitis
|
0.60%
1/167 • Baseline up to 22 weeks
The safety population includes all randomized participants who received at least one dose of taselisib or placebo.
|
0.00%
0/167 • Baseline up to 22 weeks
The safety population includes all randomized participants who received at least one dose of taselisib or placebo.
|
|
General disorders
Impaired healing
|
0.60%
1/167 • Baseline up to 22 weeks
The safety population includes all randomized participants who received at least one dose of taselisib or placebo.
|
0.00%
0/167 • Baseline up to 22 weeks
The safety population includes all randomized participants who received at least one dose of taselisib or placebo.
|
|
General disorders
Sudden death
|
0.60%
1/167 • Baseline up to 22 weeks
The safety population includes all randomized participants who received at least one dose of taselisib or placebo.
|
0.00%
0/167 • Baseline up to 22 weeks
The safety population includes all randomized participants who received at least one dose of taselisib or placebo.
|
|
Nervous system disorders
Hypertensive encephalopathy
|
0.00%
0/167 • Baseline up to 22 weeks
The safety population includes all randomized participants who received at least one dose of taselisib or placebo.
|
0.60%
1/167 • Baseline up to 22 weeks
The safety population includes all randomized participants who received at least one dose of taselisib or placebo.
|
|
Nervous system disorders
Memory impairment
|
0.60%
1/167 • Baseline up to 22 weeks
The safety population includes all randomized participants who received at least one dose of taselisib or placebo.
|
0.00%
0/167 • Baseline up to 22 weeks
The safety population includes all randomized participants who received at least one dose of taselisib or placebo.
|
|
Skin and subcutaneous tissue disorders
Erythema multiforme
|
0.60%
1/167 • Baseline up to 22 weeks
The safety population includes all randomized participants who received at least one dose of taselisib or placebo.
|
0.00%
0/167 • Baseline up to 22 weeks
The safety population includes all randomized participants who received at least one dose of taselisib or placebo.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.60%
1/167 • Baseline up to 22 weeks
The safety population includes all randomized participants who received at least one dose of taselisib or placebo.
|
0.00%
0/167 • Baseline up to 22 weeks
The safety population includes all randomized participants who received at least one dose of taselisib or placebo.
|
|
Cardiac disorders
Cardiac failure acute
|
0.00%
0/167 • Baseline up to 22 weeks
The safety population includes all randomized participants who received at least one dose of taselisib or placebo.
|
0.60%
1/167 • Baseline up to 22 weeks
The safety population includes all randomized participants who received at least one dose of taselisib or placebo.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.60%
1/167 • Baseline up to 22 weeks
The safety population includes all randomized participants who received at least one dose of taselisib or placebo.
|
0.00%
0/167 • Baseline up to 22 weeks
The safety population includes all randomized participants who received at least one dose of taselisib or placebo.
|
|
Reproductive system and breast disorders
Breast pain
|
0.00%
0/167 • Baseline up to 22 weeks
The safety population includes all randomized participants who received at least one dose of taselisib or placebo.
|
0.60%
1/167 • Baseline up to 22 weeks
The safety population includes all randomized participants who received at least one dose of taselisib or placebo.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.60%
1/167 • Baseline up to 22 weeks
The safety population includes all randomized participants who received at least one dose of taselisib or placebo.
|
0.00%
0/167 • Baseline up to 22 weeks
The safety population includes all randomized participants who received at least one dose of taselisib or placebo.
|
Other adverse events
| Measure |
Experimental: Taselisib + Letrozole
n=167 participants at risk
Participants received 2.5 milligrams (mg) letrozole tablets orally once daily (QD) along with taselisib tablets at 4 mg (two 2 mg tablets) orally on a 5 days-on/2 days-off schedule for a total of 16 weeks.
|
Placebo Comparator: Placebo + Letrozole
n=167 participants at risk
Participants received 2.5 mg letrozole tablets orally QD along with placebo on a 5-days-on/2-days-off schedule for a total of 16 weeks.
|
|---|---|---|
|
Gastrointestinal disorders
Diarrhoea
|
29.3%
49/167 • Baseline up to 22 weeks
The safety population includes all randomized participants who received at least one dose of taselisib or placebo.
|
12.0%
20/167 • Baseline up to 22 weeks
The safety population includes all randomized participants who received at least one dose of taselisib or placebo.
|
|
Gastrointestinal disorders
Nausea
|
21.0%
35/167 • Baseline up to 22 weeks
The safety population includes all randomized participants who received at least one dose of taselisib or placebo.
|
11.4%
19/167 • Baseline up to 22 weeks
The safety population includes all randomized participants who received at least one dose of taselisib or placebo.
|
|
Gastrointestinal disorders
Stomatitis
|
13.2%
22/167 • Baseline up to 22 weeks
The safety population includes all randomized participants who received at least one dose of taselisib or placebo.
|
3.0%
5/167 • Baseline up to 22 weeks
The safety population includes all randomized participants who received at least one dose of taselisib or placebo.
|
|
Gastrointestinal disorders
Dry mouth
|
3.6%
6/167 • Baseline up to 22 weeks
The safety population includes all randomized participants who received at least one dose of taselisib or placebo.
|
8.4%
14/167 • Baseline up to 22 weeks
The safety population includes all randomized participants who received at least one dose of taselisib or placebo.
|
|
Gastrointestinal disorders
Constipation
|
6.0%
10/167 • Baseline up to 22 weeks
The safety population includes all randomized participants who received at least one dose of taselisib or placebo.
|
4.2%
7/167 • Baseline up to 22 weeks
The safety population includes all randomized participants who received at least one dose of taselisib or placebo.
|
|
Gastrointestinal disorders
Vomiting
|
6.0%
10/167 • Baseline up to 22 weeks
The safety population includes all randomized participants who received at least one dose of taselisib or placebo.
|
3.6%
6/167 • Baseline up to 22 weeks
The safety population includes all randomized participants who received at least one dose of taselisib or placebo.
|
|
Gastrointestinal disorders
Dyspepsia
|
5.4%
9/167 • Baseline up to 22 weeks
The safety population includes all randomized participants who received at least one dose of taselisib or placebo.
|
0.60%
1/167 • Baseline up to 22 weeks
The safety population includes all randomized participants who received at least one dose of taselisib or placebo.
|
|
General disorders
Fatigue
|
19.8%
33/167 • Baseline up to 22 weeks
The safety population includes all randomized participants who received at least one dose of taselisib or placebo.
|
24.0%
40/167 • Baseline up to 22 weeks
The safety population includes all randomized participants who received at least one dose of taselisib or placebo.
|
|
General disorders
Asthenia
|
10.2%
17/167 • Baseline up to 22 weeks
The safety population includes all randomized participants who received at least one dose of taselisib or placebo.
|
9.6%
16/167 • Baseline up to 22 weeks
The safety population includes all randomized participants who received at least one dose of taselisib or placebo.
|
|
Infections and infestations
Viral upper respiratory tract infection
|
3.6%
6/167 • Baseline up to 22 weeks
The safety population includes all randomized participants who received at least one dose of taselisib or placebo.
|
7.8%
13/167 • Baseline up to 22 weeks
The safety population includes all randomized participants who received at least one dose of taselisib or placebo.
|
|
Infections and infestations
Urinary tract infection
|
4.2%
7/167 • Baseline up to 22 weeks
The safety population includes all randomized participants who received at least one dose of taselisib or placebo.
|
5.4%
9/167 • Baseline up to 22 weeks
The safety population includes all randomized participants who received at least one dose of taselisib or placebo.
|
|
Investigations
Alanine aminotransferase increased
|
5.4%
9/167 • Baseline up to 22 weeks
The safety population includes all randomized participants who received at least one dose of taselisib or placebo.
|
2.4%
4/167 • Baseline up to 22 weeks
The safety population includes all randomized participants who received at least one dose of taselisib or placebo.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
15.6%
26/167 • Baseline up to 22 weeks
The safety population includes all randomized participants who received at least one dose of taselisib or placebo.
|
7.2%
12/167 • Baseline up to 22 weeks
The safety population includes all randomized participants who received at least one dose of taselisib or placebo.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
6.6%
11/167 • Baseline up to 22 weeks
The safety population includes all randomized participants who received at least one dose of taselisib or placebo.
|
3.6%
6/167 • Baseline up to 22 weeks
The safety population includes all randomized participants who received at least one dose of taselisib or placebo.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
11.4%
19/167 • Baseline up to 22 weeks
The safety population includes all randomized participants who received at least one dose of taselisib or placebo.
|
21.6%
36/167 • Baseline up to 22 weeks
The safety population includes all randomized participants who received at least one dose of taselisib or placebo.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
3.6%
6/167 • Baseline up to 22 weeks
The safety population includes all randomized participants who received at least one dose of taselisib or placebo.
|
6.0%
10/167 • Baseline up to 22 weeks
The safety population includes all randomized participants who received at least one dose of taselisib or placebo.
|
|
Nervous system disorders
Headache
|
9.6%
16/167 • Baseline up to 22 weeks
The safety population includes all randomized participants who received at least one dose of taselisib or placebo.
|
10.8%
18/167 • Baseline up to 22 weeks
The safety population includes all randomized participants who received at least one dose of taselisib or placebo.
|
|
Nervous system disorders
Dizziness
|
5.4%
9/167 • Baseline up to 22 weeks
The safety population includes all randomized participants who received at least one dose of taselisib or placebo.
|
5.4%
9/167 • Baseline up to 22 weeks
The safety population includes all randomized participants who received at least one dose of taselisib or placebo.
|
|
Psychiatric disorders
Insomnia
|
3.6%
6/167 • Baseline up to 22 weeks
The safety population includes all randomized participants who received at least one dose of taselisib or placebo.
|
6.6%
11/167 • Baseline up to 22 weeks
The safety population includes all randomized participants who received at least one dose of taselisib or placebo.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
5.4%
9/167 • Baseline up to 22 weeks
The safety population includes all randomized participants who received at least one dose of taselisib or placebo.
|
4.8%
8/167 • Baseline up to 22 weeks
The safety population includes all randomized participants who received at least one dose of taselisib or placebo.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
8.4%
14/167 • Baseline up to 22 weeks
The safety population includes all randomized participants who received at least one dose of taselisib or placebo.
|
4.8%
8/167 • Baseline up to 22 weeks
The safety population includes all randomized participants who received at least one dose of taselisib or placebo.
|
|
Skin and subcutaneous tissue disorders
Rash
|
9.0%
15/167 • Baseline up to 22 weeks
The safety population includes all randomized participants who received at least one dose of taselisib or placebo.
|
3.0%
5/167 • Baseline up to 22 weeks
The safety population includes all randomized participants who received at least one dose of taselisib or placebo.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
3.6%
6/167 • Baseline up to 22 weeks
The safety population includes all randomized participants who received at least one dose of taselisib or placebo.
|
5.4%
9/167 • Baseline up to 22 weeks
The safety population includes all randomized participants who received at least one dose of taselisib or placebo.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
6.0%
10/167 • Baseline up to 22 weeks
The safety population includes all randomized participants who received at least one dose of taselisib or placebo.
|
1.8%
3/167 • Baseline up to 22 weeks
The safety population includes all randomized participants who received at least one dose of taselisib or placebo.
|
|
Vascular disorders
Hot flush
|
15.0%
25/167 • Baseline up to 22 weeks
The safety population includes all randomized participants who received at least one dose of taselisib or placebo.
|
19.8%
33/167 • Baseline up to 22 weeks
The safety population includes all randomized participants who received at least one dose of taselisib or placebo.
|
|
Vascular disorders
Hypertension
|
6.0%
10/167 • Baseline up to 22 weeks
The safety population includes all randomized participants who received at least one dose of taselisib or placebo.
|
6.6%
11/167 • Baseline up to 22 weeks
The safety population includes all randomized participants who received at least one dose of taselisib or placebo.
|
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