Trial Outcomes & Findings for Study of Letrozole With or Without BYL719 or Buparlisib, for the Neoadjuvant Treatment of Postmenopausal Women (NCT NCT01923168)
NCT ID: NCT01923168
Last Updated: 2018-09-14
Results Overview
Pathologic complete response (pCR) defined as absence of any residual invasive cancer on hematoxylin and eosin evaluation of the resected breast specimen and all sampled ipsilateral lymph nodes following completion of 24 weeks of treatment by local assessment (ypT0/Tis ypN0). Patients who experienced progression of disease while undergoing neoadjuvant therapy, or who did not receive surgery for any reason, or received antineoplastic treatment other than study drug(s) before surgery were considered as non-responders for the calculation of pCR rate.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
340 participants
Primary outcome timeframe
After 24 weeks of treatment
Results posted on
2018-09-14
Participant Flow
A total of approximately 320 patients were planned to be randomized: this was based on 60 patients per arm in each cohort (PIK3CA mutant and PIK3CA wild-type) for the alpelisib+letrozole and placebo+letrozole arms, plus the estimated number of patients randomized to buparlisib+letrozole arm at the time this arm was discontinued.
Participant milestones
| Measure |
Alpelisib + Letrozole
Participants took alpelisib 300 mg once daily plus letrozole 2.5 mg once daily.
|
Buparlisib + Letrozole
Participants took buparlisib 100 mg once daily or 5 days on/2 days off plus letrozole 2.5 mg once daily.
|
Placebo + Letrozole
Participants took matching Placebo (of alpelisib 300 mg once daily/buparlisib 100 mg once daily or 5 days on/2 days off) plus Letrozole 2.5 mg once daily.
|
|---|---|---|---|
|
Overall Study
STARTED
|
131
|
83
|
126
|
|
Overall Study
COMPLETED
|
94
|
44
|
109
|
|
Overall Study
NOT COMPLETED
|
37
|
39
|
17
|
Reasons for withdrawal
| Measure |
Alpelisib + Letrozole
Participants took alpelisib 300 mg once daily plus letrozole 2.5 mg once daily.
|
Buparlisib + Letrozole
Participants took buparlisib 100 mg once daily or 5 days on/2 days off plus letrozole 2.5 mg once daily.
|
Placebo + Letrozole
Participants took matching Placebo (of alpelisib 300 mg once daily/buparlisib 100 mg once daily or 5 days on/2 days off) plus Letrozole 2.5 mg once daily.
|
|---|---|---|---|
|
Overall Study
Protocol Violation
|
1
|
1
|
0
|
|
Overall Study
Subject/guardian decision
|
14
|
14
|
4
|
|
Overall Study
Adverse Event
|
12
|
12
|
0
|
|
Overall Study
Physician Decision
|
6
|
9
|
5
|
|
Overall Study
Progressive disease
|
4
|
3
|
7
|
|
Overall Study
Death
|
0
|
0
|
1
|
Baseline Characteristics
Study of Letrozole With or Without BYL719 or Buparlisib, for the Neoadjuvant Treatment of Postmenopausal Women
Baseline characteristics by cohort
| Measure |
Alpelisib + Letrozole
n=131 Participants
Participants took alpelisib 300 mg once daily plus letrozole 2.5 mg once daily.
|
Buparlisib + Letrozole
n=83 Participants
Participants took buparlisib 100 mg once daily or 5 days on/2 days off plus letrozole 2.5 mg once daily.
|
Placebo + Letrozole
n=126 Participants
Participants took matching Placebo (of alpelisib 300 mg once daily/buparlisib 100 mg once daily or 5 days on/2 days off) plus Letrozole 2.5 mg once daily.
|
Total
n=340 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
64.3 Years
STANDARD_DEVIATION 8.53 • n=5 Participants
|
65.2 Years
STANDARD_DEVIATION 8.61 • n=7 Participants
|
63.1 Years
STANDARD_DEVIATION 8.31 • n=5 Participants
|
64.1 Years
STANDARD_DEVIATION 8.49 • n=4 Participants
|
|
Sex: Female, Male
Female
|
131 Participants
n=5 Participants
|
83 Participants
n=7 Participants
|
126 Participants
n=5 Participants
|
340 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
White
|
117 Participants
n=5 Participants
|
68 Participants
n=7 Participants
|
105 Participants
n=5 Participants
|
290 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Asian
|
7 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
21 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
11 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Other
|
3 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
12 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Unknown
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: After 24 weeks of treatmentPopulation: The Full Analysis Set (FAS) for the PIK3CA mutant cohort comprised all randomized participants who were assigned to the PIK3CA mutant cohort based on tumor tissue for the randomization.
Pathologic complete response (pCR) defined as absence of any residual invasive cancer on hematoxylin and eosin evaluation of the resected breast specimen and all sampled ipsilateral lymph nodes following completion of 24 weeks of treatment by local assessment (ypT0/Tis ypN0). Patients who experienced progression of disease while undergoing neoadjuvant therapy, or who did not receive surgery for any reason, or received antineoplastic treatment other than study drug(s) before surgery were considered as non-responders for the calculation of pCR rate.
Outcome measures
| Measure |
Alpelisib + Letrozole
n=60 Participants
Participants took alpelisib 300 mg once daily plus letrozole 2.5 mg once daily.
|
Placebo + Letrozole
n=67 Participants
Participants took matching Placebo (of alpelisib 300 mg once daily/buparlisib 100 mg once daily or 5 days on/2 days off) plus Letrozole 2.5 mg once daily.
|
|---|---|---|
|
Pathological Complete Response (pCR) Per Investigator Assessment for Alpelisib vs. Placebo for PIK3CA Mutant Cohort
|
1.7 Percentage of Participants
Interval 0.2 to 6.3
|
3.0 Percentage of Participants
Interval 0.8 to 7.7
|
PRIMARY outcome
Timeframe: After 24 weeks of treatmentPopulation: The Full Analysis Set (FAS) for the PIK3CA wild-type cohort comprised all randomized participants who were assigned to the PIK3CA wild-type cohort based on tumor tissue for the randomization.
Pathologic complete response (pCR) defined as absence of any residual invasive cancer on hematoxylin and eosin evaluation of the resected breast specimen and all sampled ipsilateral lymph nodes following completion of 24 weeks of treatment by local assessment (ypT0/Tis ypN0). Patients who experienced progression of disease while undergoing neoadjuvant therapy, or who did not receive surgery for any reason, or received antineoplastic treatment other than study drug(s) before surgery were considered as non-responders for the calculation of pCR rate.
Outcome measures
| Measure |
Alpelisib + Letrozole
n=71 Participants
Participants took alpelisib 300 mg once daily plus letrozole 2.5 mg once daily.
|
Placebo + Letrozole
n=59 Participants
Participants took matching Placebo (of alpelisib 300 mg once daily/buparlisib 100 mg once daily or 5 days on/2 days off) plus Letrozole 2.5 mg once daily.
|
|---|---|---|
|
Pathological Complete Response (pCR) Per Investigator Assessment for Alpelisib vs. Placebo for PIK3CA Wild-type Cohort
|
2.8 Percentage of Participants
Interval 0.8 to 7.3
|
1.7 Percentage of Participants
Interval 0.2 to 6.4
|
PRIMARY outcome
Timeframe: After 24 weeks of treatmentPopulation: The Full Analysis Set (FAS) for the PIK3CA mutant cohort comprised all randomized participants who were assigned to the PIK3CA mutant cohort based on tumor tissue for the randomization.
Objective Response Rate (ORR) defined as the proportion of patients with a Best Overall Response (BOR) of Complete Response (CR) or Partial Response (PR) based on local investigator's assessment according to Response Evaluation Criteria In Solid Tumors Criteria (RECIST) 1.1. BOR was assessed per MRI or Ultrasound and defined as per RECIST 1.1 as CR for a disappearance of all non-nodal target lesions (TL)/non-target lesions (NTL) and a reduction in short axis to \< 10 mm of any pathological lymph nodes assigned as TL/NTL and no new lesion; as PR if not qualifying for CR but with a decrease from baseline ≥ 30% in the sum of diameter of all TL, no progression of NTL and no new lesion.
Outcome measures
| Measure |
Alpelisib + Letrozole
n=60 Participants
Participants took alpelisib 300 mg once daily plus letrozole 2.5 mg once daily.
|
Placebo + Letrozole
n=67 Participants
Participants took matching Placebo (of alpelisib 300 mg once daily/buparlisib 100 mg once daily or 5 days on/2 days off) plus Letrozole 2.5 mg once daily.
|
|---|---|---|
|
Objective Response Rate Per Investigator Assessment According to RECIST 1.1 for Alpelisib vs. Placebo - PIK3CA Mutant Cohort
|
43.3 Percentage of Participants
Interval 34.6 to 52.4
|
44.8 Percentage of Participants
Interval 36.5 to 53.3
|
PRIMARY outcome
Timeframe: After 24 weeks of treatmentPopulation: The Full Analysis Set (FAS) for the PIK3CA wild-type cohort comprised all randomized participants who were assigned to the PIK3CA wild-type cohort based on tumor tissue for the randomization.
Objective Response Rate (ORR) defined as the proportion of patients with a Best Overall Response (BOR) of Complete Response (CR) or Partial Response (PR) based on local investigator's assessment according to Response Evaluation Criteria In Solid Tumors Criteria (RECIST) 1.1. BOR was assessed per MRI or Ultrasound and defined as per RECIST 1.1 as CR for a disappearance of all non-nodal target lesions (TL)/non-target lesions (NTL) and a reduction in short axis to \< 10 mm of any pathological lymph nodes assigned as TL/NTL and no new lesion; as PR if not qualifying for CR but with a decrease from baseline ≥ 30% in the sum of diameter of all TL, no progression of NTL and no new lesion.
Outcome measures
| Measure |
Alpelisib + Letrozole
n=71 Participants
Participants took alpelisib 300 mg once daily plus letrozole 2.5 mg once daily.
|
Placebo + Letrozole
n=59 Participants
Participants took matching Placebo (of alpelisib 300 mg once daily/buparlisib 100 mg once daily or 5 days on/2 days off) plus Letrozole 2.5 mg once daily.
|
|---|---|---|
|
Objective Response Rate According to RECIST 1.1 Per Investigator Assessment for Alpelisib vs. Placebo - PIK3CA Wild-type Cohort
|
63.4 Percentage of Participants
Interval 55.1 to 71.0
|
61.0 Percentage of Participants
Interval 51.8 to 69.6
|
SECONDARY outcome
Timeframe: After 24 weeks of treatmentPopulation: The FAS comprised all randomized participants. This analysis was to be done in patients with PIK3CA mutation based on Circulating tumor DNA (ctDNA). Data could not be reported as the ctDNA analysis was not done after the primary endpoint was negative.
pCR and Objective response rate according to RECIST 1.1 per investigator assessment after 24 weeks of treatment
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: After 24 weeks of treatmentPopulation: The Full Analysis Set (FAS) comprised all randomized participants in the study. This analysis was to be done in PIK3CA wild-type patients based on Circulating tumor DNA (ctDNA). Data could not be reported in this table as the ctDNA analysis was not done after the primary endpoint was negative.
pCR and Objective response rate according to RECIST 1.1 per investigator assessment after 24 weeks of treatment
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: After 24 weeks of treatmentPopulation: The Full Analysis Set (FAS) for the PIK3CA mutant cohort comprised all randomized participants who were assigned to the PIK3CA mutant cohort based on tumor tissue for the randomization. PIK3CA mutation is based on tumor tissue.
Breast conserving surgery is defined for participants who underwent surgery and did not have a mastectomy. The row "no surgery" provides the number of patients who did not undergo surgery at all for various reasons.
Outcome measures
| Measure |
Alpelisib + Letrozole
n=60 Participants
Participants took alpelisib 300 mg once daily plus letrozole 2.5 mg once daily.
|
Placebo + Letrozole
n=67 Participants
Participants took matching Placebo (of alpelisib 300 mg once daily/buparlisib 100 mg once daily or 5 days on/2 days off) plus Letrozole 2.5 mg once daily.
|
|---|---|---|
|
Rate of Breast Conserving Surgery for Alpelisib vs. Placebo - PIK3CA Mutant Cohort
Breast conserving surgery
|
56.7 Percentage of participants
Interval 47.6 to 65.4
|
50.7 Percentage of participants
Interval 42.2 to 59.2
|
|
Rate of Breast Conserving Surgery for Alpelisib vs. Placebo - PIK3CA Mutant Cohort
No Surgery
|
15.0 Percentage of participants
Interval 9.3 to 22.6
|
9.0 Percentage of participants
Interval 4.8 to 15.2
|
SECONDARY outcome
Timeframe: After 24 weeks of treatmentPopulation: The Full Analysis Set (FAS) for the PIK3CA wild-type cohort comprised all randomized participants who were assigned to the PIK3CA wild-type cohort based on tumor tissue for the randomization. PIK3CA mutation is based on tumor tissue.
Breast conserving surgery is defined as the percentage of participants with no mastectomy following completion of 24 weeks of treatment. Breast conserving surgery is defined for participants who underwent surgery and did not have a mastectomy. The row "no surgery" provides the number of patients who did not undergo surgery at all for various reasons.
Outcome measures
| Measure |
Alpelisib + Letrozole
n=71 Participants
Participants took alpelisib 300 mg once daily plus letrozole 2.5 mg once daily.
|
Placebo + Letrozole
n=59 Participants
Participants took matching Placebo (of alpelisib 300 mg once daily/buparlisib 100 mg once daily or 5 days on/2 days off) plus Letrozole 2.5 mg once daily.
|
|---|---|---|
|
Rate of Breast Conserving Surgery for Alpelisib vs. Placebo - PIK3CA Wild-type Cohort
Breast conserving surgery
|
50.7 Percentage of participants
Interval 42.5 to 58.9
|
62.7 Percentage of participants
Interval 53.6 to 71.2
|
|
Rate of Breast Conserving Surgery for Alpelisib vs. Placebo - PIK3CA Wild-type Cohort
No Surgery
|
18.3 Percentage of participants
Interval 12.5 to 25.6
|
8.5 Percentage of participants
Interval 4.5 to 15.2
|
SECONDARY outcome
Timeframe: Baseline, Cycle 1 Day 15 (each cycle is 28 days) and surgery (End of Treatment (EOT) expected after 24 weeks of treatment)Population: The FAS for the PIK3CA mutant cohort comprised all randomized participants who were assigned to the PIK3CA mutant cohort based on tumor tissue for the randomization. Only responders as per pCR were considered for this analysis. No patient had data reported at end of trial (EOT), hence the percent change from baseline at EOT could not be reported.
Association Between pCR and Changes in Ki67 From Baseline for Alpelisib vs. Placebo - PIK3CA Mutant Cohort: Responders as Per pCR
Outcome measures
| Measure |
Alpelisib + Letrozole
n=1 Participants
Participants took alpelisib 300 mg once daily plus letrozole 2.5 mg once daily.
|
Placebo + Letrozole
n=2 Participants
Participants took matching Placebo (of alpelisib 300 mg once daily/buparlisib 100 mg once daily or 5 days on/2 days off) plus Letrozole 2.5 mg once daily.
|
|---|---|---|
|
Association Between pCR and Changes in Ki67 From Baseline for Alpelisib vs. Placebo - PIK3CA Mutant Cohort: Responders as Per pCR
Baseline
|
5.0 Percentage of positive cells
Interval 5.0 to 5.0
|
11.0 Percentage of positive cells
Interval 5.0 to 17.0
|
|
Association Between pCR and Changes in Ki67 From Baseline for Alpelisib vs. Placebo - PIK3CA Mutant Cohort: Responders as Per pCR
C1D15: % change from Baseline
|
-80.0 Percentage of positive cells
Interval -80.0 to -80.0
|
80.0 Percentage of positive cells
Interval 80.0 to 80.0
|
SECONDARY outcome
Timeframe: Baseline, Cycle 1 Day 15 (each cycle is 28 days ) and surgery (End of Treatment (EOT) expected after 24 weeks of treatment)Population: The Full Analysis Set (FAS) for the PIK3CA mutant cohort comprised all randomized participants who were assigned to the PIK3CA mutant cohort based on tumor tissue for the randomization. Only non-responders as per pCR are considered for this analysis.
Association Between pCR and Changes in Ki67 From Baseline for Alpelisib vs. Placebo - PIK3CA Mutant Cohort: Non-responders as Per pCR.
Outcome measures
| Measure |
Alpelisib + Letrozole
n=59 Participants
Participants took alpelisib 300 mg once daily plus letrozole 2.5 mg once daily.
|
Placebo + Letrozole
n=65 Participants
Participants took matching Placebo (of alpelisib 300 mg once daily/buparlisib 100 mg once daily or 5 days on/2 days off) plus Letrozole 2.5 mg once daily.
|
|---|---|---|
|
Association Between pCR and Changes in Ki67 From Baseline for Alpelisib vs. Placebo - PIK3CA Mutant Cohort: Non-responders as Per pCR
Baseline
|
14.0 Percentage of positive cells
Interval 0.0 to 82.0
|
13.0 Percentage of positive cells
Interval 3.0 to 89.0
|
|
Association Between pCR and Changes in Ki67 From Baseline for Alpelisib vs. Placebo - PIK3CA Mutant Cohort: Non-responders as Per pCR
C1D15 % change from Baseline
|
-62.5 Percentage of positive cells
Interval -97.0 to 467.0
|
-60.0 Percentage of positive cells
Interval -96.0 to 733.0
|
|
Association Between pCR and Changes in Ki67 From Baseline for Alpelisib vs. Placebo - PIK3CA Mutant Cohort: Non-responders as Per pCR
EOT % change from Baseline
|
-51.2 Percentage of positive cells
Interval -94.0 to 400.0
|
-60.0 Percentage of positive cells
Interval -97.0 to 223.0
|
SECONDARY outcome
Timeframe: Baseline, Cycle 1 Day 15 (each cycle is 28 days) and surgery (End of Treatment (EOT) expected after 24 weeks of treatment)Population: FAS for PIK3CA wild-type cohort comprised all rand. Parts. assigned to PIK3CA wild-type cohort based on tumor tissue for rand. Only responders as per pCR were considered for this analysis. No patient had data reported at C1D15 \& EOT for Placebo, hence percent change from baseline could not be reported.
Association between pCR and changes in Ki67 from baseline for alpelisib vs. placebo - PIK3CA wild-type cohort: responders as per pCR
Outcome measures
| Measure |
Alpelisib + Letrozole
n=2 Participants
Participants took alpelisib 300 mg once daily plus letrozole 2.5 mg once daily.
|
Placebo + Letrozole
n=1 Participants
Participants took matching Placebo (of alpelisib 300 mg once daily/buparlisib 100 mg once daily or 5 days on/2 days off) plus Letrozole 2.5 mg once daily.
|
|---|---|---|
|
Association Between pCR and Changes in Ki67 From Baseline for Alpelisib vs. Placebo - PIK3CA Wild-type Cohort: Responders as Per pCR
Baseline
|
16.5 Percentage of positive cells
Interval 3.0 to 30.0
|
20.0 Percentage of positive cells
Interval 20.0 to 20.0
|
|
Association Between pCR and Changes in Ki67 From Baseline for Alpelisib vs. Placebo - PIK3CA Wild-type Cohort: Responders as Per pCR
C1D15: % change from Baseline
|
-80.0 Percentage of positive cells
Interval -80.0 to -80.0
|
—
|
|
Association Between pCR and Changes in Ki67 From Baseline for Alpelisib vs. Placebo - PIK3CA Wild-type Cohort: Responders as Per pCR
EOT % change from Baseline
|
-45.0 Percentage of positive cells
Interval -90.0 to 0.0
|
—
|
SECONDARY outcome
Timeframe: Baseline, Cycle 1 Day 15 (each cycle is 28 days) and surgery (End of Treatment (EOT) expected after 24 weeks of treatment)Population: The Full Analysis Set (FAS) for the PIK3CA wild-type cohort comprised all randomized participants who were assigned to the PIK3CA wild-type cohort based on tumor tissue for the randomization. Only non-responders as per pCR are considered for this analysis.
Association between pCR and changes in Ki67 from baseline for alpelisib vs. placebo - PIK3CA wild-type cohort: non-responders as per pCR
Outcome measures
| Measure |
Alpelisib + Letrozole
n=69 Participants
Participants took alpelisib 300 mg once daily plus letrozole 2.5 mg once daily.
|
Placebo + Letrozole
n=58 Participants
Participants took matching Placebo (of alpelisib 300 mg once daily/buparlisib 100 mg once daily or 5 days on/2 days off) plus Letrozole 2.5 mg once daily.
|
|---|---|---|
|
Association Between pCR and Changes in Ki67 From Baseline for Alpelisib vs. Placebo - PIK3CA Wild-type Cohort: Non-responders as Per pCR
Baseline
|
16.0 Percentage of positive cells
Interval 3.0 to 60.0
|
18.0 Percentage of positive cells
Interval 4.0 to 85.0
|
|
Association Between pCR and Changes in Ki67 From Baseline for Alpelisib vs. Placebo - PIK3CA Wild-type Cohort: Non-responders as Per pCR
C1D15 % change from Baseline
|
-60.0 Percentage of positive cells
Interval -97.0 to 220.0
|
-52.0 Percentage of positive cells
Interval -93.0 to 50.0
|
|
Association Between pCR and Changes in Ki67 From Baseline for Alpelisib vs. Placebo - PIK3CA Wild-type Cohort: Non-responders as Per pCR
EOT % change from Baseline
|
-60.0 Percentage of positive cells
Interval -90.0 to 190.0
|
-71.1 Percentage of positive cells
Interval -100.0 to 250.0
|
SECONDARY outcome
Timeframe: At the time of surgery (expected after 24 weeks of treatment)Population: The Full Analysis Set (FAS) for the PIK3CA mutant cohort comprised all randomized participants who were assigned to the PIK3CA mutant cohort based on tumor tissue for the randomization.
Preoperative endocrine prognostic index (PEPI) response as per central assessment for alpelisib vs. placebo - PIK3CA mutant cohort. The total PEPI score assigned to each patient is the sum of the risk points derived from the pT stage, pN stage, Ki67 level, and ER status of the surgical specimen (Ellis et al, Contemp Clin Trials 2008). The PEPI score ranges from 0 to to 12, and a higher score means a worse outcome. PEPI response is defined as a PEPI score of 0.
Outcome measures
| Measure |
Alpelisib + Letrozole
n=60 Participants
Participants took alpelisib 300 mg once daily plus letrozole 2.5 mg once daily.
|
Placebo + Letrozole
n=67 Participants
Participants took matching Placebo (of alpelisib 300 mg once daily/buparlisib 100 mg once daily or 5 days on/2 days off) plus Letrozole 2.5 mg once daily.
|
|---|---|---|
|
Preoperative Endocrine Prognostic Index (PEPI) Response as Per Central Assessment for Alpelisib vs. Placebo - PIK3CA Mutant Cohort
|
1 Number of participants
|
0 Number of participants
|
SECONDARY outcome
Timeframe: At the time of surgery (expected after 24 weeks of treatment)Population: The Full Analysis Set (FAS) for the PIK3CA wild-type cohort comprised all randomized participants who were assigned to the PIK3CA wild-type cohort based on tumor tissue for the randomization.
Preoperative endocrine prognostic index (PEPI) response as per central assessment for alpelisib vs. placebo - PIK3CA wild-type cohort. The total PEPI score assigned to each patient is the sum of the risk points derived from the pT stage, pN stage, Ki67 level, and ER status of the surgical specimen (Ellis et al, Contemp Clin Trials 2008). The PEPI score ranges from 0 to to 12, and a higher score means a worse outcome. PEPI response is defined as a PEPI score of 0.
Outcome measures
| Measure |
Alpelisib + Letrozole
n=71 Participants
Participants took alpelisib 300 mg once daily plus letrozole 2.5 mg once daily.
|
Placebo + Letrozole
n=59 Participants
Participants took matching Placebo (of alpelisib 300 mg once daily/buparlisib 100 mg once daily or 5 days on/2 days off) plus Letrozole 2.5 mg once daily.
|
|---|---|---|
|
Preoperative Endocrine Prognostic Index (PEPI) Response as Per Central Assessment for Alpelisib vs. Placebo - PIK3CA Wild-type Cohort
|
1 Number of participants
|
1 Number of participants
|
SECONDARY outcome
Timeframe: 0, 0.5, 1, 3, 6, 9 and 24 hours post-dose at Cycle 1 Day 1 (each cycle is 28 days)Population: The BYL FPAS included participants who received at least 1 dose of alpelisib, had at least 1 evaluable post-treatment alpelisib concentration, received adequate doses of alpelisib and letrozole prior to full PK assessment, did not vomit within 4 hours of alpelisib or letrozole dosing on the day of full PK and had an evaluable full PK profile.
Summary of primary PK parameters for alpelisib plasma concentration
Outcome measures
| Measure |
Alpelisib + Letrozole
n=5 Participants
Participants took alpelisib 300 mg once daily plus letrozole 2.5 mg once daily.
|
Placebo + Letrozole
Participants took matching Placebo (of alpelisib 300 mg once daily/buparlisib 100 mg once daily or 5 days on/2 days off) plus Letrozole 2.5 mg once daily.
|
|---|---|---|
|
Alpelisib PK Parameters: AUC0-24, AUClast at Cycle 1 Day 1
AUC0-24
|
30800 ng*hr/mL
Geometric Coefficient of Variation 20.6
|
—
|
|
Alpelisib PK Parameters: AUC0-24, AUClast at Cycle 1 Day 1
AUClast
|
27300 ng*hr/mL
Geometric Coefficient of Variation 68.6
|
—
|
SECONDARY outcome
Timeframe: Cycle 1 Day 1 (each cycle is 28 days)Population: The BYL FPAS included participants who received at least 1 dose of alpelisib, had at least 1 evaluable post-treatment alpelisib concentration, received adequate doses of alpelisib and letrozole prior to full PK assessment, did not vomit within 4 hours of alpelisib or letrozole dosing on the day of full PK and had an evaluable full PK profile.
Summary of primary PK parameters for alpelisib plasma concentration
Outcome measures
| Measure |
Alpelisib + Letrozole
n=5 Participants
Participants took alpelisib 300 mg once daily plus letrozole 2.5 mg once daily.
|
Placebo + Letrozole
Participants took matching Placebo (of alpelisib 300 mg once daily/buparlisib 100 mg once daily or 5 days on/2 days off) plus Letrozole 2.5 mg once daily.
|
|---|---|---|
|
Alpelisib PK Parameter: Cmax at Cycle 1 Day 1
|
3160 ng/mL
Geometric Coefficient of Variation 25.3
|
—
|
SECONDARY outcome
Timeframe: Cycle 1 Day 1 (each cycle is 28 days)Population: Alpelisib Pharmacokinetic Analysis Set (BYL PAS): The BYL PAS included all participants who received at least one dose of alpelisib and had at least one evaluable post-treatment alpelisib concentration measurement.
Summary of primary PK parameters for alpelisib plasma concentration
Outcome measures
| Measure |
Alpelisib + Letrozole
n=5 Participants
Participants took alpelisib 300 mg once daily plus letrozole 2.5 mg once daily.
|
Placebo + Letrozole
Participants took matching Placebo (of alpelisib 300 mg once daily/buparlisib 100 mg once daily or 5 days on/2 days off) plus Letrozole 2.5 mg once daily.
|
|---|---|---|
|
Alpelisib and PK Parameter: Tmax at Cycle 1 Day 1
|
2.93 HR
Interval 1.0 to 6.0
|
—
|
SECONDARY outcome
Timeframe: 0, 0.5, 1, 3, 6, 9 and 24 hours post-dose at Cycle 4 Day 1 (each cycle is 28 days)Population: The BYL FPAS included participants who received at least 1 dose of alpelisib, had at least 1 evaluable post-treatment alpelisib concentration, received adequate doses of alpelisib and letrozole prior to full PK assessment, did not vomit within 4 hours of alpelisib or letrozole dosing on the day of full PK and had an evaluable full PK profile.
Summary of primary PK parameters for alpelisib plasma concentration
Outcome measures
| Measure |
Alpelisib + Letrozole
n=5 Participants
Participants took alpelisib 300 mg once daily plus letrozole 2.5 mg once daily.
|
Placebo + Letrozole
Participants took matching Placebo (of alpelisib 300 mg once daily/buparlisib 100 mg once daily or 5 days on/2 days off) plus Letrozole 2.5 mg once daily.
|
|---|---|---|
|
Alpelisib PK Parameters: AUC0-24, AUClast at Cycle 4 Day 1
AUC0-24
|
38000 ng*hr/mL
Geometric Coefficient of Variation 13.2
|
—
|
|
Alpelisib PK Parameters: AUC0-24, AUClast at Cycle 4 Day 1
AUClast
|
38000 ng*hr/mL
Geometric Coefficient of Variation 13.1
|
—
|
SECONDARY outcome
Timeframe: Cycle 4 Day 1 (each cycle is 28 days)Population: Alpelisib Pharmacokinetic Analysis Set (BYL PAS): The BYL PAS included all participants who received at least one dose of alpelisib and had at least one evaluable post-treatment alpelisib concentration measurement.
Summary of primary PK parameters for alpelisib plasma concentration
Outcome measures
| Measure |
Alpelisib + Letrozole
n=5 Participants
Participants took alpelisib 300 mg once daily plus letrozole 2.5 mg once daily.
|
Placebo + Letrozole
Participants took matching Placebo (of alpelisib 300 mg once daily/buparlisib 100 mg once daily or 5 days on/2 days off) plus Letrozole 2.5 mg once daily.
|
|---|---|---|
|
Alpelisib PK Parameter: Cmax at Cycle 4 Day 1
|
3260 ng/mL
Geometric Coefficient of Variation 26.7
|
—
|
SECONDARY outcome
Timeframe: Cycle 4 Day 1 (each cycle is 28 days)Population: Alpelisib Pharmacokinetic Analysis Set (BYL PAS): The BYL PAS included all participants who received at least one dose of alpelisib and had at least one evaluable post-treatment alpelisib concentration measurement.
Summary of primary PK parameters for alpelisib plasma concentration
Outcome measures
| Measure |
Alpelisib + Letrozole
n=5 Participants
Participants took alpelisib 300 mg once daily plus letrozole 2.5 mg once daily.
|
Placebo + Letrozole
Participants took matching Placebo (of alpelisib 300 mg once daily/buparlisib 100 mg once daily or 5 days on/2 days off) plus Letrozole 2.5 mg once daily.
|
|---|---|---|
|
Alpelisib PK Parameter: Tmax at Cycle 4 Day 1
|
2.99 hr
Interval 2.98 to 3.0
|
—
|
SECONDARY outcome
Timeframe: 0, 0.5, 1, 3, 6, 9 and 24 hours post-dose at Cycle 1 Day 1 (each cycle is 28 days)Population: The LZ FPAS included participants who received at least 1 dose of letrozole, had at least 1 evaluable post-treatment letrozole concentration, received adequate doses of letrozole prior to full PK assessment, did not vomit within 4 hours of letrozole dosing on the day of full PK and had an evaluable full PK profile.
Summary of primary PK parameters for Letrozole plasma concentration
Outcome measures
| Measure |
Alpelisib + Letrozole
n=5 Participants
Participants took alpelisib 300 mg once daily plus letrozole 2.5 mg once daily.
|
Placebo + Letrozole
n=15 Participants
Participants took matching Placebo (of alpelisib 300 mg once daily/buparlisib 100 mg once daily or 5 days on/2 days off) plus Letrozole 2.5 mg once daily.
|
|---|---|---|
|
Letrozole and PK Parameters: AUC0-24, AUClast at Cycle 1 Day 1
AUC0-24
|
433 ng*hr/mL
Geometric Coefficient of Variation 36.3
|
427 ng*hr/mL
Geometric Coefficient of Variation 28.8
|
|
Letrozole and PK Parameters: AUC0-24, AUClast at Cycle 1 Day 1
AUClast
|
314 ng*hr/mL
Geometric Coefficient of Variation 96.9
|
347 ng*hr/mL
Geometric Coefficient of Variation 49.6
|
SECONDARY outcome
Timeframe: Cycle 1 Day 1 (each cycle is 28 days)Population: The LZ FPAS included participants who received at least 1 dose of letrozole, had at least 1 evaluable post-treatment letrozole concentration, received adequate doses of letrozole prior to full PK assessment, did not vomit within 4 hours of letrozole dosing on the day of full PK and had an evaluable full PK profile.
Summary of primary PK parameters for letrozole plasma concentration
Outcome measures
| Measure |
Alpelisib + Letrozole
n=5 Participants
Participants took alpelisib 300 mg once daily plus letrozole 2.5 mg once daily.
|
Placebo + Letrozole
n=15 Participants
Participants took matching Placebo (of alpelisib 300 mg once daily/buparlisib 100 mg once daily or 5 days on/2 days off) plus Letrozole 2.5 mg once daily.
|
|---|---|---|
|
Letrozole PK Parameter: Cmax at Cycle 1 Day 1
|
30.2 ng/mL
Geometric Coefficient of Variation 33.2
|
28 ng/mL
Geometric Coefficient of Variation 42.3
|
SECONDARY outcome
Timeframe: Cycle 1 Day 1 (each cycle is 28 days)Population: The LZ FPAS included participants who received at least 1 dose of letrozole, had at least 1 evaluable post-treatment letrozole concentration, received adequate doses of letrozole prior to full PK assessment, did not vomit within 4 hours of letrozole dosing on the day of full PK and had an evaluable full PK profile.
Summary of primary PK parameters for letrozole plasma concentration
Outcome measures
| Measure |
Alpelisib + Letrozole
n=5 Participants
Participants took alpelisib 300 mg once daily plus letrozole 2.5 mg once daily.
|
Placebo + Letrozole
n=15 Participants
Participants took matching Placebo (of alpelisib 300 mg once daily/buparlisib 100 mg once daily or 5 days on/2 days off) plus Letrozole 2.5 mg once daily.
|
|---|---|---|
|
Letrozole PK Parameter: Tmax at Cycle 1 Day 1
|
1.03 hr
Interval 1.0 to 3.0
|
2.25 hr
Interval 1.0 to 24.5
|
SECONDARY outcome
Timeframe: 0, 0.5, 1, 3, 6, 9 and 24 hours post-dose at Cycle 4 Day 1 (each cycle is 28 days)Population: Letrozole Pharmacokinetic Analysis Set (LZ PAS): The LZ PAS included all participants who received at least one dose of letrozole and had at least one evaluable post-treatment letrozole concentration measurement.
Summary of primary PK parameters for Letrozole plasma concentration
Outcome measures
| Measure |
Alpelisib + Letrozole
n=5 Participants
Participants took alpelisib 300 mg once daily plus letrozole 2.5 mg once daily.
|
Placebo + Letrozole
n=15 Participants
Participants took matching Placebo (of alpelisib 300 mg once daily/buparlisib 100 mg once daily or 5 days on/2 days off) plus Letrozole 2.5 mg once daily.
|
|---|---|---|
|
Letrozole PK Parameters: AUC0-24, AUClast at Cycle 4 Day 1
AUC0-24
|
1280 ng*hr/mL
Geometric Coefficient of Variation 18
|
1810 ng*hr/mL
Geometric Coefficient of Variation 33.1
|
|
Letrozole PK Parameters: AUC0-24, AUClast at Cycle 4 Day 1
AUClast
|
1280 ng*hr/mL
Geometric Coefficient of Variation 17.9
|
1440 ng*hr/mL
Geometric Coefficient of Variation 66.7
|
SECONDARY outcome
Timeframe: Cycle 4 Day 1 (each cycle is 28 days)Population: The LZ FPAS included participants who received at least 1 dose of letrozole, had at least 1 evaluable post-treatment letrozole concentration, received adequate doses of letrozole prior to full PK assessment, did not vomit within 4 hours of letrozole dosing on the day of full PK and had an evaluable full PK profile.
Summary of primary PK parameters for letrozole plasma concentration
Outcome measures
| Measure |
Alpelisib + Letrozole
n=5 Participants
Participants took alpelisib 300 mg once daily plus letrozole 2.5 mg once daily.
|
Placebo + Letrozole
n=15 Participants
Participants took matching Placebo (of alpelisib 300 mg once daily/buparlisib 100 mg once daily or 5 days on/2 days off) plus Letrozole 2.5 mg once daily.
|
|---|---|---|
|
Letrozole PK Parameter: Cmax at Cycle 4 Day 1
|
75.6 ng/mL
Geometric Coefficient of Variation 6.84
|
103 ng/mL
Geometric Coefficient of Variation 30
|
SECONDARY outcome
Timeframe: Cycle 4 Day 1 (each cycle is 28 days)Population: The LZ FPAS included participants who received at least 1 dose of letrozole, had at least 1 evaluable post-treatment letrozole concentration, received adequate doses of letrozole prior to full PK assessment, did not vomit within 4 hours of letrozole dosing on the day of full PK and had an evaluable full PK profile.
Summary of primary PK parameters for letrozole plasma concentration
Outcome measures
| Measure |
Alpelisib + Letrozole
n=5 Participants
Participants took alpelisib 300 mg once daily plus letrozole 2.5 mg once daily.
|
Placebo + Letrozole
n=15 Participants
Participants took matching Placebo (of alpelisib 300 mg once daily/buparlisib 100 mg once daily or 5 days on/2 days off) plus Letrozole 2.5 mg once daily.
|
|---|---|---|
|
Letrozole PK Parameter: Tmax at Cycle 4 Day 1
|
2 hr
Interval 1.0 to 3.0
|
1.17 hr
Interval 1.0 to 6.0
|
SECONDARY outcome
Timeframe: 0, 0.5, 1, 3, 6, 9 and 24 hours post-dose at Cycle 1 Day 1 (each cycle is 28 days)Population: The BKM FPAS included participants who received at least 1 dose of buparlisib, had at least 1 evaluable post-treatment concentration, received adequate doses of buparlisib and letrozole prior to full PK assessment, did not vomit within 4 hours of buparlisib or letrozole dosing on the day of full PK and had an evaluable full PK profile.
Summary of primary PK parameters for Buparlisib plasma concentration
Outcome measures
| Measure |
Alpelisib + Letrozole
n=10 Participants
Participants took alpelisib 300 mg once daily plus letrozole 2.5 mg once daily.
|
Placebo + Letrozole
Participants took matching Placebo (of alpelisib 300 mg once daily/buparlisib 100 mg once daily or 5 days on/2 days off) plus Letrozole 2.5 mg once daily.
|
|---|---|---|
|
Buparlisib PK Parameters: AUC0-24, AUClast at Cycle 1 Day 1
AUC0-24
|
6420 ng*hr/mL
Geometric Coefficient of Variation 60
|
—
|
|
Buparlisib PK Parameters: AUC0-24, AUClast at Cycle 1 Day 1
AUClast
|
4820 ng*hr/mL
Geometric Coefficient of Variation 123
|
—
|
SECONDARY outcome
Timeframe: Cycle 1 Day 1 (each cycle is 28 days)Population: The BKM FPAS included participants who received at least 1 dose of buparlisib, had at least 1 evaluable post-treatment concentration, received adequate doses of buparlisib and letrozole prior to full PK assessment, did not vomit within 4 hours of buparlisib or letrozole dosing on the day of full PK and had an evaluable full PK profile.
Summary of primary PK parameters for buparlisib plasma concentration
Outcome measures
| Measure |
Alpelisib + Letrozole
n=10 Participants
Participants took alpelisib 300 mg once daily plus letrozole 2.5 mg once daily.
|
Placebo + Letrozole
Participants took matching Placebo (of alpelisib 300 mg once daily/buparlisib 100 mg once daily or 5 days on/2 days off) plus Letrozole 2.5 mg once daily.
|
|---|---|---|
|
Buparlisib PK Parameter: Cmax at Cycle 1 Day 1
|
760 ng/mL
Geometric Coefficient of Variation 86.7
|
—
|
SECONDARY outcome
Timeframe: Cycle 1 Day 1 (each cycle is 28 days)Population: Buparlisib Pharmacokinetic Analysis Set (BKM PAS): The BKM PAS included all participants who received at least one dose of buparlisib and had at least one evaluable post-treatment buparlisib concentration measurement.
Summary of primary PK parameters for buparlisib plasma concentration
Outcome measures
| Measure |
Alpelisib + Letrozole
n=10 Participants
Participants took alpelisib 300 mg once daily plus letrozole 2.5 mg once daily.
|
Placebo + Letrozole
Participants took matching Placebo (of alpelisib 300 mg once daily/buparlisib 100 mg once daily or 5 days on/2 days off) plus Letrozole 2.5 mg once daily.
|
|---|---|---|
|
Buparlisib PK Parameter: Tmax at Cycle 1 Day 1
|
1.03 hr
Interval 0.5 to 3.5
|
—
|
SECONDARY outcome
Timeframe: 0, 0.5, 1, 3, 6, 9 and 24 hours post-dose at Cycle 4 Day 1 (each cycle is 28 days)Population: BKM FPAS: The BKM FPAS included participants who received at least 1 dose of buparlisib, had at least 1 evaluable post-treatment concentration, received adequate doses of buparlisib and letrozole prior to full PK assessment, did not vomit within 4 hours of buparlisib or letrozole dosing on the day of full PK and had an evaluable full PK profile.
Summary of primary PK parameters for Buparlisib plasma concentration
Outcome measures
| Measure |
Alpelisib + Letrozole
n=10 Participants
Participants took alpelisib 300 mg once daily plus letrozole 2.5 mg once daily.
|
Placebo + Letrozole
Participants took matching Placebo (of alpelisib 300 mg once daily/buparlisib 100 mg once daily or 5 days on/2 days off) plus Letrozole 2.5 mg once daily.
|
|---|---|---|
|
Buparlisib PK Parameter: AUClast at Cycle 4 Day 1
|
10400 ng*hr/mL
Interval 10400.0 to 10400.0
|
—
|
SECONDARY outcome
Timeframe: Cycle 4 Day 1 (each cycle is 28 days)Population: Buparlisib Pharmacokinetic Analysis Set (BKM PAS): The BKM PAS included all participants who received at least one dose of buparlisib and had at least one evaluable post-treatment buparlisib concentration measurement.
Summary of primary PK parameters for buparlisib plasma concentration
Outcome measures
| Measure |
Alpelisib + Letrozole
n=10 Participants
Participants took alpelisib 300 mg once daily plus letrozole 2.5 mg once daily.
|
Placebo + Letrozole
Participants took matching Placebo (of alpelisib 300 mg once daily/buparlisib 100 mg once daily or 5 days on/2 days off) plus Letrozole 2.5 mg once daily.
|
|---|---|---|
|
Buparlisb PK Parameter: Cmax at Cycle 4 Day 1
|
610 ng/mL
Interval 610.0 to 610.0
|
—
|
SECONDARY outcome
Timeframe: Cycle 4 Day 1 (each cycle is 28 days)Population: Buparlisib Pharmacokinetic Analysis Set (BKM PAS): The BKM PAS included all participants who received at least one dose of buparlisib and had at least one evaluable post-treatment buparlisib concentration measurement.
Summary of primary PK parameters for buparlisib plasma concentration
Outcome measures
| Measure |
Alpelisib + Letrozole
n=10 Participants
Participants took alpelisib 300 mg once daily plus letrozole 2.5 mg once daily.
|
Placebo + Letrozole
Participants took matching Placebo (of alpelisib 300 mg once daily/buparlisib 100 mg once daily or 5 days on/2 days off) plus Letrozole 2.5 mg once daily.
|
|---|---|---|
|
Buparlisib PK Parameter: Tmax at Cycle 4 Day 1
|
3 hr
Interval 3.0 to 3.0
|
—
|
Adverse Events
Alpelisib + Letrozole
Serious events: 21 serious events
Other events: 126 other events
Deaths: 1 deaths
Buparlisib + Letrozole
Serious events: 22 serious events
Other events: 80 other events
Deaths: 0 deaths
Placebo + Letrozole
Serious events: 6 serious events
Other events: 106 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Alpelisib + Letrozole
n=130 participants at risk
Participants took alpelisib 300 mg once daily plus letrozole 2.5 mg once daily.
|
Buparlisib + Letrozole
n=81 participants at risk
Participants took buparlisib 100 mg once daily or 5 days on/2 days off plus letrozole 2.5 mg once daily.
|
Placebo + Letrozole
n=125 participants at risk
Participants took matching Placebo (of alpelisib 300 mg once daily/buparlisib 100 mg once daily or 5 days on/2 days off) plus Letrozole 2.5 mg once daily.
|
|---|---|---|---|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/130 • All Adverse Events reported in this record are on-treatment events (from first dose of study treatment to last dose of study treatment + 30 days, duration expected to be a total of approximately 25 weeks).
Adverse Events, Serious Adverse Events based on Safety Set population defined as all patients who received at least one dose of study treatment
|
2.5%
2/81 • All Adverse Events reported in this record are on-treatment events (from first dose of study treatment to last dose of study treatment + 30 days, duration expected to be a total of approximately 25 weeks).
Adverse Events, Serious Adverse Events based on Safety Set population defined as all patients who received at least one dose of study treatment
|
0.00%
0/125 • All Adverse Events reported in this record are on-treatment events (from first dose of study treatment to last dose of study treatment + 30 days, duration expected to be a total of approximately 25 weeks).
Adverse Events, Serious Adverse Events based on Safety Set population defined as all patients who received at least one dose of study treatment
|
|
Cardiac disorders
Cardiac disorder
|
0.00%
0/130 • All Adverse Events reported in this record are on-treatment events (from first dose of study treatment to last dose of study treatment + 30 days, duration expected to be a total of approximately 25 weeks).
Adverse Events, Serious Adverse Events based on Safety Set population defined as all patients who received at least one dose of study treatment
|
1.2%
1/81 • All Adverse Events reported in this record are on-treatment events (from first dose of study treatment to last dose of study treatment + 30 days, duration expected to be a total of approximately 25 weeks).
Adverse Events, Serious Adverse Events based on Safety Set population defined as all patients who received at least one dose of study treatment
|
0.00%
0/125 • All Adverse Events reported in this record are on-treatment events (from first dose of study treatment to last dose of study treatment + 30 days, duration expected to be a total of approximately 25 weeks).
Adverse Events, Serious Adverse Events based on Safety Set population defined as all patients who received at least one dose of study treatment
|
|
Cardiac disorders
Cardiac failure
|
0.77%
1/130 • All Adverse Events reported in this record are on-treatment events (from first dose of study treatment to last dose of study treatment + 30 days, duration expected to be a total of approximately 25 weeks).
Adverse Events, Serious Adverse Events based on Safety Set population defined as all patients who received at least one dose of study treatment
|
0.00%
0/81 • All Adverse Events reported in this record are on-treatment events (from first dose of study treatment to last dose of study treatment + 30 days, duration expected to be a total of approximately 25 weeks).
Adverse Events, Serious Adverse Events based on Safety Set population defined as all patients who received at least one dose of study treatment
|
0.00%
0/125 • All Adverse Events reported in this record are on-treatment events (from first dose of study treatment to last dose of study treatment + 30 days, duration expected to be a total of approximately 25 weeks).
Adverse Events, Serious Adverse Events based on Safety Set population defined as all patients who received at least one dose of study treatment
|
|
Cardiac disorders
Stress cardiomyopathy
|
0.77%
1/130 • All Adverse Events reported in this record are on-treatment events (from first dose of study treatment to last dose of study treatment + 30 days, duration expected to be a total of approximately 25 weeks).
Adverse Events, Serious Adverse Events based on Safety Set population defined as all patients who received at least one dose of study treatment
|
0.00%
0/81 • All Adverse Events reported in this record are on-treatment events (from first dose of study treatment to last dose of study treatment + 30 days, duration expected to be a total of approximately 25 weeks).
Adverse Events, Serious Adverse Events based on Safety Set population defined as all patients who received at least one dose of study treatment
|
0.00%
0/125 • All Adverse Events reported in this record are on-treatment events (from first dose of study treatment to last dose of study treatment + 30 days, duration expected to be a total of approximately 25 weeks).
Adverse Events, Serious Adverse Events based on Safety Set population defined as all patients who received at least one dose of study treatment
|
|
Eye disorders
Iritis
|
0.00%
0/130 • All Adverse Events reported in this record are on-treatment events (from first dose of study treatment to last dose of study treatment + 30 days, duration expected to be a total of approximately 25 weeks).
Adverse Events, Serious Adverse Events based on Safety Set population defined as all patients who received at least one dose of study treatment
|
1.2%
1/81 • All Adverse Events reported in this record are on-treatment events (from first dose of study treatment to last dose of study treatment + 30 days, duration expected to be a total of approximately 25 weeks).
Adverse Events, Serious Adverse Events based on Safety Set population defined as all patients who received at least one dose of study treatment
|
0.00%
0/125 • All Adverse Events reported in this record are on-treatment events (from first dose of study treatment to last dose of study treatment + 30 days, duration expected to be a total of approximately 25 weeks).
Adverse Events, Serious Adverse Events based on Safety Set population defined as all patients who received at least one dose of study treatment
|
|
Gastrointestinal disorders
Colitis
|
0.77%
1/130 • All Adverse Events reported in this record are on-treatment events (from first dose of study treatment to last dose of study treatment + 30 days, duration expected to be a total of approximately 25 weeks).
Adverse Events, Serious Adverse Events based on Safety Set population defined as all patients who received at least one dose of study treatment
|
2.5%
2/81 • All Adverse Events reported in this record are on-treatment events (from first dose of study treatment to last dose of study treatment + 30 days, duration expected to be a total of approximately 25 weeks).
Adverse Events, Serious Adverse Events based on Safety Set population defined as all patients who received at least one dose of study treatment
|
0.00%
0/125 • All Adverse Events reported in this record are on-treatment events (from first dose of study treatment to last dose of study treatment + 30 days, duration expected to be a total of approximately 25 weeks).
Adverse Events, Serious Adverse Events based on Safety Set population defined as all patients who received at least one dose of study treatment
|
|
Gastrointestinal disorders
Diarrhoea
|
0.77%
1/130 • All Adverse Events reported in this record are on-treatment events (from first dose of study treatment to last dose of study treatment + 30 days, duration expected to be a total of approximately 25 weeks).
Adverse Events, Serious Adverse Events based on Safety Set population defined as all patients who received at least one dose of study treatment
|
1.2%
1/81 • All Adverse Events reported in this record are on-treatment events (from first dose of study treatment to last dose of study treatment + 30 days, duration expected to be a total of approximately 25 weeks).
Adverse Events, Serious Adverse Events based on Safety Set population defined as all patients who received at least one dose of study treatment
|
0.00%
0/125 • All Adverse Events reported in this record are on-treatment events (from first dose of study treatment to last dose of study treatment + 30 days, duration expected to be a total of approximately 25 weeks).
Adverse Events, Serious Adverse Events based on Safety Set population defined as all patients who received at least one dose of study treatment
|
|
Gastrointestinal disorders
Nausea
|
0.77%
1/130 • All Adverse Events reported in this record are on-treatment events (from first dose of study treatment to last dose of study treatment + 30 days, duration expected to be a total of approximately 25 weeks).
Adverse Events, Serious Adverse Events based on Safety Set population defined as all patients who received at least one dose of study treatment
|
0.00%
0/81 • All Adverse Events reported in this record are on-treatment events (from first dose of study treatment to last dose of study treatment + 30 days, duration expected to be a total of approximately 25 weeks).
Adverse Events, Serious Adverse Events based on Safety Set population defined as all patients who received at least one dose of study treatment
|
0.00%
0/125 • All Adverse Events reported in this record are on-treatment events (from first dose of study treatment to last dose of study treatment + 30 days, duration expected to be a total of approximately 25 weeks).
Adverse Events, Serious Adverse Events based on Safety Set population defined as all patients who received at least one dose of study treatment
|
|
Gastrointestinal disorders
Stomatitis
|
0.77%
1/130 • All Adverse Events reported in this record are on-treatment events (from first dose of study treatment to last dose of study treatment + 30 days, duration expected to be a total of approximately 25 weeks).
Adverse Events, Serious Adverse Events based on Safety Set population defined as all patients who received at least one dose of study treatment
|
0.00%
0/81 • All Adverse Events reported in this record are on-treatment events (from first dose of study treatment to last dose of study treatment + 30 days, duration expected to be a total of approximately 25 weeks).
Adverse Events, Serious Adverse Events based on Safety Set population defined as all patients who received at least one dose of study treatment
|
0.00%
0/125 • All Adverse Events reported in this record are on-treatment events (from first dose of study treatment to last dose of study treatment + 30 days, duration expected to be a total of approximately 25 weeks).
Adverse Events, Serious Adverse Events based on Safety Set population defined as all patients who received at least one dose of study treatment
|
|
Gastrointestinal disorders
Vomiting
|
0.77%
1/130 • All Adverse Events reported in this record are on-treatment events (from first dose of study treatment to last dose of study treatment + 30 days, duration expected to be a total of approximately 25 weeks).
Adverse Events, Serious Adverse Events based on Safety Set population defined as all patients who received at least one dose of study treatment
|
0.00%
0/81 • All Adverse Events reported in this record are on-treatment events (from first dose of study treatment to last dose of study treatment + 30 days, duration expected to be a total of approximately 25 weeks).
Adverse Events, Serious Adverse Events based on Safety Set population defined as all patients who received at least one dose of study treatment
|
0.00%
0/125 • All Adverse Events reported in this record are on-treatment events (from first dose of study treatment to last dose of study treatment + 30 days, duration expected to be a total of approximately 25 weeks).
Adverse Events, Serious Adverse Events based on Safety Set population defined as all patients who received at least one dose of study treatment
|
|
General disorders
Disease progression
|
0.77%
1/130 • All Adverse Events reported in this record are on-treatment events (from first dose of study treatment to last dose of study treatment + 30 days, duration expected to be a total of approximately 25 weeks).
Adverse Events, Serious Adverse Events based on Safety Set population defined as all patients who received at least one dose of study treatment
|
0.00%
0/81 • All Adverse Events reported in this record are on-treatment events (from first dose of study treatment to last dose of study treatment + 30 days, duration expected to be a total of approximately 25 weeks).
Adverse Events, Serious Adverse Events based on Safety Set population defined as all patients who received at least one dose of study treatment
|
0.00%
0/125 • All Adverse Events reported in this record are on-treatment events (from first dose of study treatment to last dose of study treatment + 30 days, duration expected to be a total of approximately 25 weeks).
Adverse Events, Serious Adverse Events based on Safety Set population defined as all patients who received at least one dose of study treatment
|
|
General disorders
General physical health deterioration
|
1.5%
2/130 • All Adverse Events reported in this record are on-treatment events (from first dose of study treatment to last dose of study treatment + 30 days, duration expected to be a total of approximately 25 weeks).
Adverse Events, Serious Adverse Events based on Safety Set population defined as all patients who received at least one dose of study treatment
|
1.2%
1/81 • All Adverse Events reported in this record are on-treatment events (from first dose of study treatment to last dose of study treatment + 30 days, duration expected to be a total of approximately 25 weeks).
Adverse Events, Serious Adverse Events based on Safety Set population defined as all patients who received at least one dose of study treatment
|
0.00%
0/125 • All Adverse Events reported in this record are on-treatment events (from first dose of study treatment to last dose of study treatment + 30 days, duration expected to be a total of approximately 25 weeks).
Adverse Events, Serious Adverse Events based on Safety Set population defined as all patients who received at least one dose of study treatment
|
|
General disorders
Generalised oedema
|
0.00%
0/130 • All Adverse Events reported in this record are on-treatment events (from first dose of study treatment to last dose of study treatment + 30 days, duration expected to be a total of approximately 25 weeks).
Adverse Events, Serious Adverse Events based on Safety Set population defined as all patients who received at least one dose of study treatment
|
1.2%
1/81 • All Adverse Events reported in this record are on-treatment events (from first dose of study treatment to last dose of study treatment + 30 days, duration expected to be a total of approximately 25 weeks).
Adverse Events, Serious Adverse Events based on Safety Set population defined as all patients who received at least one dose of study treatment
|
0.00%
0/125 • All Adverse Events reported in this record are on-treatment events (from first dose of study treatment to last dose of study treatment + 30 days, duration expected to be a total of approximately 25 weeks).
Adverse Events, Serious Adverse Events based on Safety Set population defined as all patients who received at least one dose of study treatment
|
|
General disorders
Malaise
|
0.00%
0/130 • All Adverse Events reported in this record are on-treatment events (from first dose of study treatment to last dose of study treatment + 30 days, duration expected to be a total of approximately 25 weeks).
Adverse Events, Serious Adverse Events based on Safety Set population defined as all patients who received at least one dose of study treatment
|
1.2%
1/81 • All Adverse Events reported in this record are on-treatment events (from first dose of study treatment to last dose of study treatment + 30 days, duration expected to be a total of approximately 25 weeks).
Adverse Events, Serious Adverse Events based on Safety Set population defined as all patients who received at least one dose of study treatment
|
0.00%
0/125 • All Adverse Events reported in this record are on-treatment events (from first dose of study treatment to last dose of study treatment + 30 days, duration expected to be a total of approximately 25 weeks).
Adverse Events, Serious Adverse Events based on Safety Set population defined as all patients who received at least one dose of study treatment
|
|
General disorders
Oedema peripheral
|
0.77%
1/130 • All Adverse Events reported in this record are on-treatment events (from first dose of study treatment to last dose of study treatment + 30 days, duration expected to be a total of approximately 25 weeks).
Adverse Events, Serious Adverse Events based on Safety Set population defined as all patients who received at least one dose of study treatment
|
0.00%
0/81 • All Adverse Events reported in this record are on-treatment events (from first dose of study treatment to last dose of study treatment + 30 days, duration expected to be a total of approximately 25 weeks).
Adverse Events, Serious Adverse Events based on Safety Set population defined as all patients who received at least one dose of study treatment
|
0.00%
0/125 • All Adverse Events reported in this record are on-treatment events (from first dose of study treatment to last dose of study treatment + 30 days, duration expected to be a total of approximately 25 weeks).
Adverse Events, Serious Adverse Events based on Safety Set population defined as all patients who received at least one dose of study treatment
|
|
General disorders
Pyrexia
|
1.5%
2/130 • All Adverse Events reported in this record are on-treatment events (from first dose of study treatment to last dose of study treatment + 30 days, duration expected to be a total of approximately 25 weeks).
Adverse Events, Serious Adverse Events based on Safety Set population defined as all patients who received at least one dose of study treatment
|
0.00%
0/81 • All Adverse Events reported in this record are on-treatment events (from first dose of study treatment to last dose of study treatment + 30 days, duration expected to be a total of approximately 25 weeks).
Adverse Events, Serious Adverse Events based on Safety Set population defined as all patients who received at least one dose of study treatment
|
0.00%
0/125 • All Adverse Events reported in this record are on-treatment events (from first dose of study treatment to last dose of study treatment + 30 days, duration expected to be a total of approximately 25 weeks).
Adverse Events, Serious Adverse Events based on Safety Set population defined as all patients who received at least one dose of study treatment
|
|
General disorders
Sudden death
|
0.00%
0/130 • All Adverse Events reported in this record are on-treatment events (from first dose of study treatment to last dose of study treatment + 30 days, duration expected to be a total of approximately 25 weeks).
Adverse Events, Serious Adverse Events based on Safety Set population defined as all patients who received at least one dose of study treatment
|
0.00%
0/81 • All Adverse Events reported in this record are on-treatment events (from first dose of study treatment to last dose of study treatment + 30 days, duration expected to be a total of approximately 25 weeks).
Adverse Events, Serious Adverse Events based on Safety Set population defined as all patients who received at least one dose of study treatment
|
0.80%
1/125 • All Adverse Events reported in this record are on-treatment events (from first dose of study treatment to last dose of study treatment + 30 days, duration expected to be a total of approximately 25 weeks).
Adverse Events, Serious Adverse Events based on Safety Set population defined as all patients who received at least one dose of study treatment
|
|
Hepatobiliary disorders
Hepatotoxicity
|
0.00%
0/130 • All Adverse Events reported in this record are on-treatment events (from first dose of study treatment to last dose of study treatment + 30 days, duration expected to be a total of approximately 25 weeks).
Adverse Events, Serious Adverse Events based on Safety Set population defined as all patients who received at least one dose of study treatment
|
3.7%
3/81 • All Adverse Events reported in this record are on-treatment events (from first dose of study treatment to last dose of study treatment + 30 days, duration expected to be a total of approximately 25 weeks).
Adverse Events, Serious Adverse Events based on Safety Set population defined as all patients who received at least one dose of study treatment
|
0.00%
0/125 • All Adverse Events reported in this record are on-treatment events (from first dose of study treatment to last dose of study treatment + 30 days, duration expected to be a total of approximately 25 weeks).
Adverse Events, Serious Adverse Events based on Safety Set population defined as all patients who received at least one dose of study treatment
|
|
Hepatobiliary disorders
Hypertransaminasaemia
|
0.00%
0/130 • All Adverse Events reported in this record are on-treatment events (from first dose of study treatment to last dose of study treatment + 30 days, duration expected to be a total of approximately 25 weeks).
Adverse Events, Serious Adverse Events based on Safety Set population defined as all patients who received at least one dose of study treatment
|
1.2%
1/81 • All Adverse Events reported in this record are on-treatment events (from first dose of study treatment to last dose of study treatment + 30 days, duration expected to be a total of approximately 25 weeks).
Adverse Events, Serious Adverse Events based on Safety Set population defined as all patients who received at least one dose of study treatment
|
0.00%
0/125 • All Adverse Events reported in this record are on-treatment events (from first dose of study treatment to last dose of study treatment + 30 days, duration expected to be a total of approximately 25 weeks).
Adverse Events, Serious Adverse Events based on Safety Set population defined as all patients who received at least one dose of study treatment
|
|
Immune system disorders
Hypersensitivity
|
0.77%
1/130 • All Adverse Events reported in this record are on-treatment events (from first dose of study treatment to last dose of study treatment + 30 days, duration expected to be a total of approximately 25 weeks).
Adverse Events, Serious Adverse Events based on Safety Set population defined as all patients who received at least one dose of study treatment
|
0.00%
0/81 • All Adverse Events reported in this record are on-treatment events (from first dose of study treatment to last dose of study treatment + 30 days, duration expected to be a total of approximately 25 weeks).
Adverse Events, Serious Adverse Events based on Safety Set population defined as all patients who received at least one dose of study treatment
|
0.00%
0/125 • All Adverse Events reported in this record are on-treatment events (from first dose of study treatment to last dose of study treatment + 30 days, duration expected to be a total of approximately 25 weeks).
Adverse Events, Serious Adverse Events based on Safety Set population defined as all patients who received at least one dose of study treatment
|
|
Infections and infestations
Appendicitis
|
0.00%
0/130 • All Adverse Events reported in this record are on-treatment events (from first dose of study treatment to last dose of study treatment + 30 days, duration expected to be a total of approximately 25 weeks).
Adverse Events, Serious Adverse Events based on Safety Set population defined as all patients who received at least one dose of study treatment
|
0.00%
0/81 • All Adverse Events reported in this record are on-treatment events (from first dose of study treatment to last dose of study treatment + 30 days, duration expected to be a total of approximately 25 weeks).
Adverse Events, Serious Adverse Events based on Safety Set population defined as all patients who received at least one dose of study treatment
|
0.80%
1/125 • All Adverse Events reported in this record are on-treatment events (from first dose of study treatment to last dose of study treatment + 30 days, duration expected to be a total of approximately 25 weeks).
Adverse Events, Serious Adverse Events based on Safety Set population defined as all patients who received at least one dose of study treatment
|
|
Infections and infestations
Gastroenteritis
|
0.77%
1/130 • All Adverse Events reported in this record are on-treatment events (from first dose of study treatment to last dose of study treatment + 30 days, duration expected to be a total of approximately 25 weeks).
Adverse Events, Serious Adverse Events based on Safety Set population defined as all patients who received at least one dose of study treatment
|
0.00%
0/81 • All Adverse Events reported in this record are on-treatment events (from first dose of study treatment to last dose of study treatment + 30 days, duration expected to be a total of approximately 25 weeks).
Adverse Events, Serious Adverse Events based on Safety Set population defined as all patients who received at least one dose of study treatment
|
0.00%
0/125 • All Adverse Events reported in this record are on-treatment events (from first dose of study treatment to last dose of study treatment + 30 days, duration expected to be a total of approximately 25 weeks).
Adverse Events, Serious Adverse Events based on Safety Set population defined as all patients who received at least one dose of study treatment
|
|
Infections and infestations
Respiratory tract infection
|
0.77%
1/130 • All Adverse Events reported in this record are on-treatment events (from first dose of study treatment to last dose of study treatment + 30 days, duration expected to be a total of approximately 25 weeks).
Adverse Events, Serious Adverse Events based on Safety Set population defined as all patients who received at least one dose of study treatment
|
0.00%
0/81 • All Adverse Events reported in this record are on-treatment events (from first dose of study treatment to last dose of study treatment + 30 days, duration expected to be a total of approximately 25 weeks).
Adverse Events, Serious Adverse Events based on Safety Set population defined as all patients who received at least one dose of study treatment
|
0.80%
1/125 • All Adverse Events reported in this record are on-treatment events (from first dose of study treatment to last dose of study treatment + 30 days, duration expected to be a total of approximately 25 weeks).
Adverse Events, Serious Adverse Events based on Safety Set population defined as all patients who received at least one dose of study treatment
|
|
Infections and infestations
Sepsis
|
0.77%
1/130 • All Adverse Events reported in this record are on-treatment events (from first dose of study treatment to last dose of study treatment + 30 days, duration expected to be a total of approximately 25 weeks).
Adverse Events, Serious Adverse Events based on Safety Set population defined as all patients who received at least one dose of study treatment
|
1.2%
1/81 • All Adverse Events reported in this record are on-treatment events (from first dose of study treatment to last dose of study treatment + 30 days, duration expected to be a total of approximately 25 weeks).
Adverse Events, Serious Adverse Events based on Safety Set population defined as all patients who received at least one dose of study treatment
|
0.00%
0/125 • All Adverse Events reported in this record are on-treatment events (from first dose of study treatment to last dose of study treatment + 30 days, duration expected to be a total of approximately 25 weeks).
Adverse Events, Serious Adverse Events based on Safety Set population defined as all patients who received at least one dose of study treatment
|
|
Injury, poisoning and procedural complications
Accidental overdose
|
0.77%
1/130 • All Adverse Events reported in this record are on-treatment events (from first dose of study treatment to last dose of study treatment + 30 days, duration expected to be a total of approximately 25 weeks).
Adverse Events, Serious Adverse Events based on Safety Set population defined as all patients who received at least one dose of study treatment
|
0.00%
0/81 • All Adverse Events reported in this record are on-treatment events (from first dose of study treatment to last dose of study treatment + 30 days, duration expected to be a total of approximately 25 weeks).
Adverse Events, Serious Adverse Events based on Safety Set population defined as all patients who received at least one dose of study treatment
|
0.00%
0/125 • All Adverse Events reported in this record are on-treatment events (from first dose of study treatment to last dose of study treatment + 30 days, duration expected to be a total of approximately 25 weeks).
Adverse Events, Serious Adverse Events based on Safety Set population defined as all patients who received at least one dose of study treatment
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/130 • All Adverse Events reported in this record are on-treatment events (from first dose of study treatment to last dose of study treatment + 30 days, duration expected to be a total of approximately 25 weeks).
Adverse Events, Serious Adverse Events based on Safety Set population defined as all patients who received at least one dose of study treatment
|
0.00%
0/81 • All Adverse Events reported in this record are on-treatment events (from first dose of study treatment to last dose of study treatment + 30 days, duration expected to be a total of approximately 25 weeks).
Adverse Events, Serious Adverse Events based on Safety Set population defined as all patients who received at least one dose of study treatment
|
0.80%
1/125 • All Adverse Events reported in this record are on-treatment events (from first dose of study treatment to last dose of study treatment + 30 days, duration expected to be a total of approximately 25 weeks).
Adverse Events, Serious Adverse Events based on Safety Set population defined as all patients who received at least one dose of study treatment
|
|
Injury, poisoning and procedural complications
Post procedural haematoma
|
0.00%
0/130 • All Adverse Events reported in this record are on-treatment events (from first dose of study treatment to last dose of study treatment + 30 days, duration expected to be a total of approximately 25 weeks).
Adverse Events, Serious Adverse Events based on Safety Set population defined as all patients who received at least one dose of study treatment
|
1.2%
1/81 • All Adverse Events reported in this record are on-treatment events (from first dose of study treatment to last dose of study treatment + 30 days, duration expected to be a total of approximately 25 weeks).
Adverse Events, Serious Adverse Events based on Safety Set population defined as all patients who received at least one dose of study treatment
|
0.00%
0/125 • All Adverse Events reported in this record are on-treatment events (from first dose of study treatment to last dose of study treatment + 30 days, duration expected to be a total of approximately 25 weeks).
Adverse Events, Serious Adverse Events based on Safety Set population defined as all patients who received at least one dose of study treatment
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/130 • All Adverse Events reported in this record are on-treatment events (from first dose of study treatment to last dose of study treatment + 30 days, duration expected to be a total of approximately 25 weeks).
Adverse Events, Serious Adverse Events based on Safety Set population defined as all patients who received at least one dose of study treatment
|
8.6%
7/81 • All Adverse Events reported in this record are on-treatment events (from first dose of study treatment to last dose of study treatment + 30 days, duration expected to be a total of approximately 25 weeks).
Adverse Events, Serious Adverse Events based on Safety Set population defined as all patients who received at least one dose of study treatment
|
0.00%
0/125 • All Adverse Events reported in this record are on-treatment events (from first dose of study treatment to last dose of study treatment + 30 days, duration expected to be a total of approximately 25 weeks).
Adverse Events, Serious Adverse Events based on Safety Set population defined as all patients who received at least one dose of study treatment
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/130 • All Adverse Events reported in this record are on-treatment events (from first dose of study treatment to last dose of study treatment + 30 days, duration expected to be a total of approximately 25 weeks).
Adverse Events, Serious Adverse Events based on Safety Set population defined as all patients who received at least one dose of study treatment
|
7.4%
6/81 • All Adverse Events reported in this record are on-treatment events (from first dose of study treatment to last dose of study treatment + 30 days, duration expected to be a total of approximately 25 weeks).
Adverse Events, Serious Adverse Events based on Safety Set population defined as all patients who received at least one dose of study treatment
|
0.00%
0/125 • All Adverse Events reported in this record are on-treatment events (from first dose of study treatment to last dose of study treatment + 30 days, duration expected to be a total of approximately 25 weeks).
Adverse Events, Serious Adverse Events based on Safety Set population defined as all patients who received at least one dose of study treatment
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/130 • All Adverse Events reported in this record are on-treatment events (from first dose of study treatment to last dose of study treatment + 30 days, duration expected to be a total of approximately 25 weeks).
Adverse Events, Serious Adverse Events based on Safety Set population defined as all patients who received at least one dose of study treatment
|
1.2%
1/81 • All Adverse Events reported in this record are on-treatment events (from first dose of study treatment to last dose of study treatment + 30 days, duration expected to be a total of approximately 25 weeks).
Adverse Events, Serious Adverse Events based on Safety Set population defined as all patients who received at least one dose of study treatment
|
0.00%
0/125 • All Adverse Events reported in this record are on-treatment events (from first dose of study treatment to last dose of study treatment + 30 days, duration expected to be a total of approximately 25 weeks).
Adverse Events, Serious Adverse Events based on Safety Set population defined as all patients who received at least one dose of study treatment
|
|
Investigations
Ejection fraction decreased
|
0.77%
1/130 • All Adverse Events reported in this record are on-treatment events (from first dose of study treatment to last dose of study treatment + 30 days, duration expected to be a total of approximately 25 weeks).
Adverse Events, Serious Adverse Events based on Safety Set population defined as all patients who received at least one dose of study treatment
|
0.00%
0/81 • All Adverse Events reported in this record are on-treatment events (from first dose of study treatment to last dose of study treatment + 30 days, duration expected to be a total of approximately 25 weeks).
Adverse Events, Serious Adverse Events based on Safety Set population defined as all patients who received at least one dose of study treatment
|
0.00%
0/125 • All Adverse Events reported in this record are on-treatment events (from first dose of study treatment to last dose of study treatment + 30 days, duration expected to be a total of approximately 25 weeks).
Adverse Events, Serious Adverse Events based on Safety Set population defined as all patients who received at least one dose of study treatment
|
|
Metabolism and nutrition disorders
Dehydration
|
1.5%
2/130 • All Adverse Events reported in this record are on-treatment events (from first dose of study treatment to last dose of study treatment + 30 days, duration expected to be a total of approximately 25 weeks).
Adverse Events, Serious Adverse Events based on Safety Set population defined as all patients who received at least one dose of study treatment
|
0.00%
0/81 • All Adverse Events reported in this record are on-treatment events (from first dose of study treatment to last dose of study treatment + 30 days, duration expected to be a total of approximately 25 weeks).
Adverse Events, Serious Adverse Events based on Safety Set population defined as all patients who received at least one dose of study treatment
|
0.00%
0/125 • All Adverse Events reported in this record are on-treatment events (from first dose of study treatment to last dose of study treatment + 30 days, duration expected to be a total of approximately 25 weeks).
Adverse Events, Serious Adverse Events based on Safety Set population defined as all patients who received at least one dose of study treatment
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
0.77%
1/130 • All Adverse Events reported in this record are on-treatment events (from first dose of study treatment to last dose of study treatment + 30 days, duration expected to be a total of approximately 25 weeks).
Adverse Events, Serious Adverse Events based on Safety Set population defined as all patients who received at least one dose of study treatment
|
0.00%
0/81 • All Adverse Events reported in this record are on-treatment events (from first dose of study treatment to last dose of study treatment + 30 days, duration expected to be a total of approximately 25 weeks).
Adverse Events, Serious Adverse Events based on Safety Set population defined as all patients who received at least one dose of study treatment
|
0.00%
0/125 • All Adverse Events reported in this record are on-treatment events (from first dose of study treatment to last dose of study treatment + 30 days, duration expected to be a total of approximately 25 weeks).
Adverse Events, Serious Adverse Events based on Safety Set population defined as all patients who received at least one dose of study treatment
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
5.4%
7/130 • All Adverse Events reported in this record are on-treatment events (from first dose of study treatment to last dose of study treatment + 30 days, duration expected to be a total of approximately 25 weeks).
Adverse Events, Serious Adverse Events based on Safety Set population defined as all patients who received at least one dose of study treatment
|
0.00%
0/81 • All Adverse Events reported in this record are on-treatment events (from first dose of study treatment to last dose of study treatment + 30 days, duration expected to be a total of approximately 25 weeks).
Adverse Events, Serious Adverse Events based on Safety Set population defined as all patients who received at least one dose of study treatment
|
0.00%
0/125 • All Adverse Events reported in this record are on-treatment events (from first dose of study treatment to last dose of study treatment + 30 days, duration expected to be a total of approximately 25 weeks).
Adverse Events, Serious Adverse Events based on Safety Set population defined as all patients who received at least one dose of study treatment
|
|
Metabolism and nutrition disorders
Hyperuricaemia
|
0.77%
1/130 • All Adverse Events reported in this record are on-treatment events (from first dose of study treatment to last dose of study treatment + 30 days, duration expected to be a total of approximately 25 weeks).
Adverse Events, Serious Adverse Events based on Safety Set population defined as all patients who received at least one dose of study treatment
|
0.00%
0/81 • All Adverse Events reported in this record are on-treatment events (from first dose of study treatment to last dose of study treatment + 30 days, duration expected to be a total of approximately 25 weeks).
Adverse Events, Serious Adverse Events based on Safety Set population defined as all patients who received at least one dose of study treatment
|
0.00%
0/125 • All Adverse Events reported in this record are on-treatment events (from first dose of study treatment to last dose of study treatment + 30 days, duration expected to be a total of approximately 25 weeks).
Adverse Events, Serious Adverse Events based on Safety Set population defined as all patients who received at least one dose of study treatment
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.77%
1/130 • All Adverse Events reported in this record are on-treatment events (from first dose of study treatment to last dose of study treatment + 30 days, duration expected to be a total of approximately 25 weeks).
Adverse Events, Serious Adverse Events based on Safety Set population defined as all patients who received at least one dose of study treatment
|
0.00%
0/81 • All Adverse Events reported in this record are on-treatment events (from first dose of study treatment to last dose of study treatment + 30 days, duration expected to be a total of approximately 25 weeks).
Adverse Events, Serious Adverse Events based on Safety Set population defined as all patients who received at least one dose of study treatment
|
0.00%
0/125 • All Adverse Events reported in this record are on-treatment events (from first dose of study treatment to last dose of study treatment + 30 days, duration expected to be a total of approximately 25 weeks).
Adverse Events, Serious Adverse Events based on Safety Set population defined as all patients who received at least one dose of study treatment
|
|
Nervous system disorders
Syncope
|
0.00%
0/130 • All Adverse Events reported in this record are on-treatment events (from first dose of study treatment to last dose of study treatment + 30 days, duration expected to be a total of approximately 25 weeks).
Adverse Events, Serious Adverse Events based on Safety Set population defined as all patients who received at least one dose of study treatment
|
1.2%
1/81 • All Adverse Events reported in this record are on-treatment events (from first dose of study treatment to last dose of study treatment + 30 days, duration expected to be a total of approximately 25 weeks).
Adverse Events, Serious Adverse Events based on Safety Set population defined as all patients who received at least one dose of study treatment
|
0.00%
0/125 • All Adverse Events reported in this record are on-treatment events (from first dose of study treatment to last dose of study treatment + 30 days, duration expected to be a total of approximately 25 weeks).
Adverse Events, Serious Adverse Events based on Safety Set population defined as all patients who received at least one dose of study treatment
|
|
Nervous system disorders
Transient ischaemic attack
|
0.00%
0/130 • All Adverse Events reported in this record are on-treatment events (from first dose of study treatment to last dose of study treatment + 30 days, duration expected to be a total of approximately 25 weeks).
Adverse Events, Serious Adverse Events based on Safety Set population defined as all patients who received at least one dose of study treatment
|
0.00%
0/81 • All Adverse Events reported in this record are on-treatment events (from first dose of study treatment to last dose of study treatment + 30 days, duration expected to be a total of approximately 25 weeks).
Adverse Events, Serious Adverse Events based on Safety Set population defined as all patients who received at least one dose of study treatment
|
0.80%
1/125 • All Adverse Events reported in this record are on-treatment events (from first dose of study treatment to last dose of study treatment + 30 days, duration expected to be a total of approximately 25 weeks).
Adverse Events, Serious Adverse Events based on Safety Set population defined as all patients who received at least one dose of study treatment
|
|
Renal and urinary disorders
Ureterolithiasis
|
0.77%
1/130 • All Adverse Events reported in this record are on-treatment events (from first dose of study treatment to last dose of study treatment + 30 days, duration expected to be a total of approximately 25 weeks).
Adverse Events, Serious Adverse Events based on Safety Set population defined as all patients who received at least one dose of study treatment
|
0.00%
0/81 • All Adverse Events reported in this record are on-treatment events (from first dose of study treatment to last dose of study treatment + 30 days, duration expected to be a total of approximately 25 weeks).
Adverse Events, Serious Adverse Events based on Safety Set population defined as all patients who received at least one dose of study treatment
|
0.00%
0/125 • All Adverse Events reported in this record are on-treatment events (from first dose of study treatment to last dose of study treatment + 30 days, duration expected to be a total of approximately 25 weeks).
Adverse Events, Serious Adverse Events based on Safety Set population defined as all patients who received at least one dose of study treatment
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
1.5%
2/130 • All Adverse Events reported in this record are on-treatment events (from first dose of study treatment to last dose of study treatment + 30 days, duration expected to be a total of approximately 25 weeks).
Adverse Events, Serious Adverse Events based on Safety Set population defined as all patients who received at least one dose of study treatment
|
0.00%
0/81 • All Adverse Events reported in this record are on-treatment events (from first dose of study treatment to last dose of study treatment + 30 days, duration expected to be a total of approximately 25 weeks).
Adverse Events, Serious Adverse Events based on Safety Set population defined as all patients who received at least one dose of study treatment
|
0.00%
0/125 • All Adverse Events reported in this record are on-treatment events (from first dose of study treatment to last dose of study treatment + 30 days, duration expected to be a total of approximately 25 weeks).
Adverse Events, Serious Adverse Events based on Safety Set population defined as all patients who received at least one dose of study treatment
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/130 • All Adverse Events reported in this record are on-treatment events (from first dose of study treatment to last dose of study treatment + 30 days, duration expected to be a total of approximately 25 weeks).
Adverse Events, Serious Adverse Events based on Safety Set population defined as all patients who received at least one dose of study treatment
|
1.2%
1/81 • All Adverse Events reported in this record are on-treatment events (from first dose of study treatment to last dose of study treatment + 30 days, duration expected to be a total of approximately 25 weeks).
Adverse Events, Serious Adverse Events based on Safety Set population defined as all patients who received at least one dose of study treatment
|
0.00%
0/125 • All Adverse Events reported in this record are on-treatment events (from first dose of study treatment to last dose of study treatment + 30 days, duration expected to be a total of approximately 25 weeks).
Adverse Events, Serious Adverse Events based on Safety Set population defined as all patients who received at least one dose of study treatment
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/130 • All Adverse Events reported in this record are on-treatment events (from first dose of study treatment to last dose of study treatment + 30 days, duration expected to be a total of approximately 25 weeks).
Adverse Events, Serious Adverse Events based on Safety Set population defined as all patients who received at least one dose of study treatment
|
0.00%
0/81 • All Adverse Events reported in this record are on-treatment events (from first dose of study treatment to last dose of study treatment + 30 days, duration expected to be a total of approximately 25 weeks).
Adverse Events, Serious Adverse Events based on Safety Set population defined as all patients who received at least one dose of study treatment
|
0.80%
1/125 • All Adverse Events reported in this record are on-treatment events (from first dose of study treatment to last dose of study treatment + 30 days, duration expected to be a total of approximately 25 weeks).
Adverse Events, Serious Adverse Events based on Safety Set population defined as all patients who received at least one dose of study treatment
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
1.5%
2/130 • All Adverse Events reported in this record are on-treatment events (from first dose of study treatment to last dose of study treatment + 30 days, duration expected to be a total of approximately 25 weeks).
Adverse Events, Serious Adverse Events based on Safety Set population defined as all patients who received at least one dose of study treatment
|
0.00%
0/81 • All Adverse Events reported in this record are on-treatment events (from first dose of study treatment to last dose of study treatment + 30 days, duration expected to be a total of approximately 25 weeks).
Adverse Events, Serious Adverse Events based on Safety Set population defined as all patients who received at least one dose of study treatment
|
0.00%
0/125 • All Adverse Events reported in this record are on-treatment events (from first dose of study treatment to last dose of study treatment + 30 days, duration expected to be a total of approximately 25 weeks).
Adverse Events, Serious Adverse Events based on Safety Set population defined as all patients who received at least one dose of study treatment
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/130 • All Adverse Events reported in this record are on-treatment events (from first dose of study treatment to last dose of study treatment + 30 days, duration expected to be a total of approximately 25 weeks).
Adverse Events, Serious Adverse Events based on Safety Set population defined as all patients who received at least one dose of study treatment
|
0.00%
0/81 • All Adverse Events reported in this record are on-treatment events (from first dose of study treatment to last dose of study treatment + 30 days, duration expected to be a total of approximately 25 weeks).
Adverse Events, Serious Adverse Events based on Safety Set population defined as all patients who received at least one dose of study treatment
|
0.80%
1/125 • All Adverse Events reported in this record are on-treatment events (from first dose of study treatment to last dose of study treatment + 30 days, duration expected to be a total of approximately 25 weeks).
Adverse Events, Serious Adverse Events based on Safety Set population defined as all patients who received at least one dose of study treatment
|
|
Skin and subcutaneous tissue disorders
Angioedema
|
0.00%
0/130 • All Adverse Events reported in this record are on-treatment events (from first dose of study treatment to last dose of study treatment + 30 days, duration expected to be a total of approximately 25 weeks).
Adverse Events, Serious Adverse Events based on Safety Set population defined as all patients who received at least one dose of study treatment
|
1.2%
1/81 • All Adverse Events reported in this record are on-treatment events (from first dose of study treatment to last dose of study treatment + 30 days, duration expected to be a total of approximately 25 weeks).
Adverse Events, Serious Adverse Events based on Safety Set population defined as all patients who received at least one dose of study treatment
|
0.00%
0/125 • All Adverse Events reported in this record are on-treatment events (from first dose of study treatment to last dose of study treatment + 30 days, duration expected to be a total of approximately 25 weeks).
Adverse Events, Serious Adverse Events based on Safety Set population defined as all patients who received at least one dose of study treatment
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
1.5%
2/130 • All Adverse Events reported in this record are on-treatment events (from first dose of study treatment to last dose of study treatment + 30 days, duration expected to be a total of approximately 25 weeks).
Adverse Events, Serious Adverse Events based on Safety Set population defined as all patients who received at least one dose of study treatment
|
0.00%
0/81 • All Adverse Events reported in this record are on-treatment events (from first dose of study treatment to last dose of study treatment + 30 days, duration expected to be a total of approximately 25 weeks).
Adverse Events, Serious Adverse Events based on Safety Set population defined as all patients who received at least one dose of study treatment
|
0.00%
0/125 • All Adverse Events reported in this record are on-treatment events (from first dose of study treatment to last dose of study treatment + 30 days, duration expected to be a total of approximately 25 weeks).
Adverse Events, Serious Adverse Events based on Safety Set population defined as all patients who received at least one dose of study treatment
|
|
Skin and subcutaneous tissue disorders
Rash
|
2.3%
3/130 • All Adverse Events reported in this record are on-treatment events (from first dose of study treatment to last dose of study treatment + 30 days, duration expected to be a total of approximately 25 weeks).
Adverse Events, Serious Adverse Events based on Safety Set population defined as all patients who received at least one dose of study treatment
|
2.5%
2/81 • All Adverse Events reported in this record are on-treatment events (from first dose of study treatment to last dose of study treatment + 30 days, duration expected to be a total of approximately 25 weeks).
Adverse Events, Serious Adverse Events based on Safety Set population defined as all patients who received at least one dose of study treatment
|
0.00%
0/125 • All Adverse Events reported in this record are on-treatment events (from first dose of study treatment to last dose of study treatment + 30 days, duration expected to be a total of approximately 25 weeks).
Adverse Events, Serious Adverse Events based on Safety Set population defined as all patients who received at least one dose of study treatment
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
1.5%
2/130 • All Adverse Events reported in this record are on-treatment events (from first dose of study treatment to last dose of study treatment + 30 days, duration expected to be a total of approximately 25 weeks).
Adverse Events, Serious Adverse Events based on Safety Set population defined as all patients who received at least one dose of study treatment
|
2.5%
2/81 • All Adverse Events reported in this record are on-treatment events (from first dose of study treatment to last dose of study treatment + 30 days, duration expected to be a total of approximately 25 weeks).
Adverse Events, Serious Adverse Events based on Safety Set population defined as all patients who received at least one dose of study treatment
|
0.00%
0/125 • All Adverse Events reported in this record are on-treatment events (from first dose of study treatment to last dose of study treatment + 30 days, duration expected to be a total of approximately 25 weeks).
Adverse Events, Serious Adverse Events based on Safety Set population defined as all patients who received at least one dose of study treatment
|
|
Skin and subcutaneous tissue disorders
Skin necrosis
|
0.00%
0/130 • All Adverse Events reported in this record are on-treatment events (from first dose of study treatment to last dose of study treatment + 30 days, duration expected to be a total of approximately 25 weeks).
Adverse Events, Serious Adverse Events based on Safety Set population defined as all patients who received at least one dose of study treatment
|
1.2%
1/81 • All Adverse Events reported in this record are on-treatment events (from first dose of study treatment to last dose of study treatment + 30 days, duration expected to be a total of approximately 25 weeks).
Adverse Events, Serious Adverse Events based on Safety Set population defined as all patients who received at least one dose of study treatment
|
0.00%
0/125 • All Adverse Events reported in this record are on-treatment events (from first dose of study treatment to last dose of study treatment + 30 days, duration expected to be a total of approximately 25 weeks).
Adverse Events, Serious Adverse Events based on Safety Set population defined as all patients who received at least one dose of study treatment
|
|
Vascular disorders
Deep vein thrombosis
|
0.77%
1/130 • All Adverse Events reported in this record are on-treatment events (from first dose of study treatment to last dose of study treatment + 30 days, duration expected to be a total of approximately 25 weeks).
Adverse Events, Serious Adverse Events based on Safety Set population defined as all patients who received at least one dose of study treatment
|
0.00%
0/81 • All Adverse Events reported in this record are on-treatment events (from first dose of study treatment to last dose of study treatment + 30 days, duration expected to be a total of approximately 25 weeks).
Adverse Events, Serious Adverse Events based on Safety Set population defined as all patients who received at least one dose of study treatment
|
0.00%
0/125 • All Adverse Events reported in this record are on-treatment events (from first dose of study treatment to last dose of study treatment + 30 days, duration expected to be a total of approximately 25 weeks).
Adverse Events, Serious Adverse Events based on Safety Set population defined as all patients who received at least one dose of study treatment
|
Other adverse events
| Measure |
Alpelisib + Letrozole
n=130 participants at risk
Participants took alpelisib 300 mg once daily plus letrozole 2.5 mg once daily.
|
Buparlisib + Letrozole
n=81 participants at risk
Participants took buparlisib 100 mg once daily or 5 days on/2 days off plus letrozole 2.5 mg once daily.
|
Placebo + Letrozole
n=125 participants at risk
Participants took matching Placebo (of alpelisib 300 mg once daily/buparlisib 100 mg once daily or 5 days on/2 days off) plus Letrozole 2.5 mg once daily.
|
|---|---|---|---|
|
Cardiac disorders
Tachycardia
|
2.3%
3/130 • All Adverse Events reported in this record are on-treatment events (from first dose of study treatment to last dose of study treatment + 30 days, duration expected to be a total of approximately 25 weeks).
Adverse Events, Serious Adverse Events based on Safety Set population defined as all patients who received at least one dose of study treatment
|
6.2%
5/81 • All Adverse Events reported in this record are on-treatment events (from first dose of study treatment to last dose of study treatment + 30 days, duration expected to be a total of approximately 25 weeks).
Adverse Events, Serious Adverse Events based on Safety Set population defined as all patients who received at least one dose of study treatment
|
0.80%
1/125 • All Adverse Events reported in this record are on-treatment events (from first dose of study treatment to last dose of study treatment + 30 days, duration expected to be a total of approximately 25 weeks).
Adverse Events, Serious Adverse Events based on Safety Set population defined as all patients who received at least one dose of study treatment
|
|
Ear and labyrinth disorders
Vertigo
|
3.8%
5/130 • All Adverse Events reported in this record are on-treatment events (from first dose of study treatment to last dose of study treatment + 30 days, duration expected to be a total of approximately 25 weeks).
Adverse Events, Serious Adverse Events based on Safety Set population defined as all patients who received at least one dose of study treatment
|
6.2%
5/81 • All Adverse Events reported in this record are on-treatment events (from first dose of study treatment to last dose of study treatment + 30 days, duration expected to be a total of approximately 25 weeks).
Adverse Events, Serious Adverse Events based on Safety Set population defined as all patients who received at least one dose of study treatment
|
4.8%
6/125 • All Adverse Events reported in this record are on-treatment events (from first dose of study treatment to last dose of study treatment + 30 days, duration expected to be a total of approximately 25 weeks).
Adverse Events, Serious Adverse Events based on Safety Set population defined as all patients who received at least one dose of study treatment
|
|
Eye disorders
Vision blurred
|
6.9%
9/130 • All Adverse Events reported in this record are on-treatment events (from first dose of study treatment to last dose of study treatment + 30 days, duration expected to be a total of approximately 25 weeks).
Adverse Events, Serious Adverse Events based on Safety Set population defined as all patients who received at least one dose of study treatment
|
3.7%
3/81 • All Adverse Events reported in this record are on-treatment events (from first dose of study treatment to last dose of study treatment + 30 days, duration expected to be a total of approximately 25 weeks).
Adverse Events, Serious Adverse Events based on Safety Set population defined as all patients who received at least one dose of study treatment
|
0.00%
0/125 • All Adverse Events reported in this record are on-treatment events (from first dose of study treatment to last dose of study treatment + 30 days, duration expected to be a total of approximately 25 weeks).
Adverse Events, Serious Adverse Events based on Safety Set population defined as all patients who received at least one dose of study treatment
|
|
Gastrointestinal disorders
Abdominal distension
|
2.3%
3/130 • All Adverse Events reported in this record are on-treatment events (from first dose of study treatment to last dose of study treatment + 30 days, duration expected to be a total of approximately 25 weeks).
Adverse Events, Serious Adverse Events based on Safety Set population defined as all patients who received at least one dose of study treatment
|
7.4%
6/81 • All Adverse Events reported in this record are on-treatment events (from first dose of study treatment to last dose of study treatment + 30 days, duration expected to be a total of approximately 25 weeks).
Adverse Events, Serious Adverse Events based on Safety Set population defined as all patients who received at least one dose of study treatment
|
3.2%
4/125 • All Adverse Events reported in this record are on-treatment events (from first dose of study treatment to last dose of study treatment + 30 days, duration expected to be a total of approximately 25 weeks).
Adverse Events, Serious Adverse Events based on Safety Set population defined as all patients who received at least one dose of study treatment
|
|
Gastrointestinal disorders
Abdominal pain
|
5.4%
7/130 • All Adverse Events reported in this record are on-treatment events (from first dose of study treatment to last dose of study treatment + 30 days, duration expected to be a total of approximately 25 weeks).
Adverse Events, Serious Adverse Events based on Safety Set population defined as all patients who received at least one dose of study treatment
|
6.2%
5/81 • All Adverse Events reported in this record are on-treatment events (from first dose of study treatment to last dose of study treatment + 30 days, duration expected to be a total of approximately 25 weeks).
Adverse Events, Serious Adverse Events based on Safety Set population defined as all patients who received at least one dose of study treatment
|
3.2%
4/125 • All Adverse Events reported in this record are on-treatment events (from first dose of study treatment to last dose of study treatment + 30 days, duration expected to be a total of approximately 25 weeks).
Adverse Events, Serious Adverse Events based on Safety Set population defined as all patients who received at least one dose of study treatment
|
|
Gastrointestinal disorders
Abdominal pain upper
|
3.8%
5/130 • All Adverse Events reported in this record are on-treatment events (from first dose of study treatment to last dose of study treatment + 30 days, duration expected to be a total of approximately 25 weeks).
Adverse Events, Serious Adverse Events based on Safety Set population defined as all patients who received at least one dose of study treatment
|
8.6%
7/81 • All Adverse Events reported in this record are on-treatment events (from first dose of study treatment to last dose of study treatment + 30 days, duration expected to be a total of approximately 25 weeks).
Adverse Events, Serious Adverse Events based on Safety Set population defined as all patients who received at least one dose of study treatment
|
3.2%
4/125 • All Adverse Events reported in this record are on-treatment events (from first dose of study treatment to last dose of study treatment + 30 days, duration expected to be a total of approximately 25 weeks).
Adverse Events, Serious Adverse Events based on Safety Set population defined as all patients who received at least one dose of study treatment
|
|
Gastrointestinal disorders
Constipation
|
3.8%
5/130 • All Adverse Events reported in this record are on-treatment events (from first dose of study treatment to last dose of study treatment + 30 days, duration expected to be a total of approximately 25 weeks).
Adverse Events, Serious Adverse Events based on Safety Set population defined as all patients who received at least one dose of study treatment
|
8.6%
7/81 • All Adverse Events reported in this record are on-treatment events (from first dose of study treatment to last dose of study treatment + 30 days, duration expected to be a total of approximately 25 weeks).
Adverse Events, Serious Adverse Events based on Safety Set population defined as all patients who received at least one dose of study treatment
|
10.4%
13/125 • All Adverse Events reported in this record are on-treatment events (from first dose of study treatment to last dose of study treatment + 30 days, duration expected to be a total of approximately 25 weeks).
Adverse Events, Serious Adverse Events based on Safety Set population defined as all patients who received at least one dose of study treatment
|
|
Gastrointestinal disorders
Diarrhoea
|
50.8%
66/130 • All Adverse Events reported in this record are on-treatment events (from first dose of study treatment to last dose of study treatment + 30 days, duration expected to be a total of approximately 25 weeks).
Adverse Events, Serious Adverse Events based on Safety Set population defined as all patients who received at least one dose of study treatment
|
35.8%
29/81 • All Adverse Events reported in this record are on-treatment events (from first dose of study treatment to last dose of study treatment + 30 days, duration expected to be a total of approximately 25 weeks).
Adverse Events, Serious Adverse Events based on Safety Set population defined as all patients who received at least one dose of study treatment
|
15.2%
19/125 • All Adverse Events reported in this record are on-treatment events (from first dose of study treatment to last dose of study treatment + 30 days, duration expected to be a total of approximately 25 weeks).
Adverse Events, Serious Adverse Events based on Safety Set population defined as all patients who received at least one dose of study treatment
|
|
Gastrointestinal disorders
Dry mouth
|
10.8%
14/130 • All Adverse Events reported in this record are on-treatment events (from first dose of study treatment to last dose of study treatment + 30 days, duration expected to be a total of approximately 25 weeks).
Adverse Events, Serious Adverse Events based on Safety Set population defined as all patients who received at least one dose of study treatment
|
6.2%
5/81 • All Adverse Events reported in this record are on-treatment events (from first dose of study treatment to last dose of study treatment + 30 days, duration expected to be a total of approximately 25 weeks).
Adverse Events, Serious Adverse Events based on Safety Set population defined as all patients who received at least one dose of study treatment
|
3.2%
4/125 • All Adverse Events reported in this record are on-treatment events (from first dose of study treatment to last dose of study treatment + 30 days, duration expected to be a total of approximately 25 weeks).
Adverse Events, Serious Adverse Events based on Safety Set population defined as all patients who received at least one dose of study treatment
|
|
Gastrointestinal disorders
Dyspepsia
|
8.5%
11/130 • All Adverse Events reported in this record are on-treatment events (from first dose of study treatment to last dose of study treatment + 30 days, duration expected to be a total of approximately 25 weeks).
Adverse Events, Serious Adverse Events based on Safety Set population defined as all patients who received at least one dose of study treatment
|
13.6%
11/81 • All Adverse Events reported in this record are on-treatment events (from first dose of study treatment to last dose of study treatment + 30 days, duration expected to be a total of approximately 25 weeks).
Adverse Events, Serious Adverse Events based on Safety Set population defined as all patients who received at least one dose of study treatment
|
4.8%
6/125 • All Adverse Events reported in this record are on-treatment events (from first dose of study treatment to last dose of study treatment + 30 days, duration expected to be a total of approximately 25 weeks).
Adverse Events, Serious Adverse Events based on Safety Set population defined as all patients who received at least one dose of study treatment
|
|
Gastrointestinal disorders
Nausea
|
43.8%
57/130 • All Adverse Events reported in this record are on-treatment events (from first dose of study treatment to last dose of study treatment + 30 days, duration expected to be a total of approximately 25 weeks).
Adverse Events, Serious Adverse Events based on Safety Set population defined as all patients who received at least one dose of study treatment
|
45.7%
37/81 • All Adverse Events reported in this record are on-treatment events (from first dose of study treatment to last dose of study treatment + 30 days, duration expected to be a total of approximately 25 weeks).
Adverse Events, Serious Adverse Events based on Safety Set population defined as all patients who received at least one dose of study treatment
|
18.4%
23/125 • All Adverse Events reported in this record are on-treatment events (from first dose of study treatment to last dose of study treatment + 30 days, duration expected to be a total of approximately 25 weeks).
Adverse Events, Serious Adverse Events based on Safety Set population defined as all patients who received at least one dose of study treatment
|
|
Gastrointestinal disorders
Stomatitis
|
32.3%
42/130 • All Adverse Events reported in this record are on-treatment events (from first dose of study treatment to last dose of study treatment + 30 days, duration expected to be a total of approximately 25 weeks).
Adverse Events, Serious Adverse Events based on Safety Set population defined as all patients who received at least one dose of study treatment
|
22.2%
18/81 • All Adverse Events reported in this record are on-treatment events (from first dose of study treatment to last dose of study treatment + 30 days, duration expected to be a total of approximately 25 weeks).
Adverse Events, Serious Adverse Events based on Safety Set population defined as all patients who received at least one dose of study treatment
|
4.0%
5/125 • All Adverse Events reported in this record are on-treatment events (from first dose of study treatment to last dose of study treatment + 30 days, duration expected to be a total of approximately 25 weeks).
Adverse Events, Serious Adverse Events based on Safety Set population defined as all patients who received at least one dose of study treatment
|
|
Gastrointestinal disorders
Vomiting
|
17.7%
23/130 • All Adverse Events reported in this record are on-treatment events (from first dose of study treatment to last dose of study treatment + 30 days, duration expected to be a total of approximately 25 weeks).
Adverse Events, Serious Adverse Events based on Safety Set population defined as all patients who received at least one dose of study treatment
|
7.4%
6/81 • All Adverse Events reported in this record are on-treatment events (from first dose of study treatment to last dose of study treatment + 30 days, duration expected to be a total of approximately 25 weeks).
Adverse Events, Serious Adverse Events based on Safety Set population defined as all patients who received at least one dose of study treatment
|
4.8%
6/125 • All Adverse Events reported in this record are on-treatment events (from first dose of study treatment to last dose of study treatment + 30 days, duration expected to be a total of approximately 25 weeks).
Adverse Events, Serious Adverse Events based on Safety Set population defined as all patients who received at least one dose of study treatment
|
|
General disorders
Asthenia
|
16.2%
21/130 • All Adverse Events reported in this record are on-treatment events (from first dose of study treatment to last dose of study treatment + 30 days, duration expected to be a total of approximately 25 weeks).
Adverse Events, Serious Adverse Events based on Safety Set population defined as all patients who received at least one dose of study treatment
|
19.8%
16/81 • All Adverse Events reported in this record are on-treatment events (from first dose of study treatment to last dose of study treatment + 30 days, duration expected to be a total of approximately 25 weeks).
Adverse Events, Serious Adverse Events based on Safety Set population defined as all patients who received at least one dose of study treatment
|
13.6%
17/125 • All Adverse Events reported in this record are on-treatment events (from first dose of study treatment to last dose of study treatment + 30 days, duration expected to be a total of approximately 25 weeks).
Adverse Events, Serious Adverse Events based on Safety Set population defined as all patients who received at least one dose of study treatment
|
|
General disorders
Chills
|
5.4%
7/130 • All Adverse Events reported in this record are on-treatment events (from first dose of study treatment to last dose of study treatment + 30 days, duration expected to be a total of approximately 25 weeks).
Adverse Events, Serious Adverse Events based on Safety Set population defined as all patients who received at least one dose of study treatment
|
9.9%
8/81 • All Adverse Events reported in this record are on-treatment events (from first dose of study treatment to last dose of study treatment + 30 days, duration expected to be a total of approximately 25 weeks).
Adverse Events, Serious Adverse Events based on Safety Set population defined as all patients who received at least one dose of study treatment
|
4.0%
5/125 • All Adverse Events reported in this record are on-treatment events (from first dose of study treatment to last dose of study treatment + 30 days, duration expected to be a total of approximately 25 weeks).
Adverse Events, Serious Adverse Events based on Safety Set population defined as all patients who received at least one dose of study treatment
|
|
General disorders
Fatigue
|
40.8%
53/130 • All Adverse Events reported in this record are on-treatment events (from first dose of study treatment to last dose of study treatment + 30 days, duration expected to be a total of approximately 25 weeks).
Adverse Events, Serious Adverse Events based on Safety Set population defined as all patients who received at least one dose of study treatment
|
37.0%
30/81 • All Adverse Events reported in this record are on-treatment events (from first dose of study treatment to last dose of study treatment + 30 days, duration expected to be a total of approximately 25 weeks).
Adverse Events, Serious Adverse Events based on Safety Set population defined as all patients who received at least one dose of study treatment
|
33.6%
42/125 • All Adverse Events reported in this record are on-treatment events (from first dose of study treatment to last dose of study treatment + 30 days, duration expected to be a total of approximately 25 weeks).
Adverse Events, Serious Adverse Events based on Safety Set population defined as all patients who received at least one dose of study treatment
|
|
General disorders
Mucosal dryness
|
5.4%
7/130 • All Adverse Events reported in this record are on-treatment events (from first dose of study treatment to last dose of study treatment + 30 days, duration expected to be a total of approximately 25 weeks).
Adverse Events, Serious Adverse Events based on Safety Set population defined as all patients who received at least one dose of study treatment
|
2.5%
2/81 • All Adverse Events reported in this record are on-treatment events (from first dose of study treatment to last dose of study treatment + 30 days, duration expected to be a total of approximately 25 weeks).
Adverse Events, Serious Adverse Events based on Safety Set population defined as all patients who received at least one dose of study treatment
|
0.00%
0/125 • All Adverse Events reported in this record are on-treatment events (from first dose of study treatment to last dose of study treatment + 30 days, duration expected to be a total of approximately 25 weeks).
Adverse Events, Serious Adverse Events based on Safety Set population defined as all patients who received at least one dose of study treatment
|
|
General disorders
Oedema peripheral
|
6.9%
9/130 • All Adverse Events reported in this record are on-treatment events (from first dose of study treatment to last dose of study treatment + 30 days, duration expected to be a total of approximately 25 weeks).
Adverse Events, Serious Adverse Events based on Safety Set population defined as all patients who received at least one dose of study treatment
|
4.9%
4/81 • All Adverse Events reported in this record are on-treatment events (from first dose of study treatment to last dose of study treatment + 30 days, duration expected to be a total of approximately 25 weeks).
Adverse Events, Serious Adverse Events based on Safety Set population defined as all patients who received at least one dose of study treatment
|
3.2%
4/125 • All Adverse Events reported in this record are on-treatment events (from first dose of study treatment to last dose of study treatment + 30 days, duration expected to be a total of approximately 25 weeks).
Adverse Events, Serious Adverse Events based on Safety Set population defined as all patients who received at least one dose of study treatment
|
|
General disorders
Pyrexia
|
9.2%
12/130 • All Adverse Events reported in this record are on-treatment events (from first dose of study treatment to last dose of study treatment + 30 days, duration expected to be a total of approximately 25 weeks).
Adverse Events, Serious Adverse Events based on Safety Set population defined as all patients who received at least one dose of study treatment
|
1.2%
1/81 • All Adverse Events reported in this record are on-treatment events (from first dose of study treatment to last dose of study treatment + 30 days, duration expected to be a total of approximately 25 weeks).
Adverse Events, Serious Adverse Events based on Safety Set population defined as all patients who received at least one dose of study treatment
|
2.4%
3/125 • All Adverse Events reported in this record are on-treatment events (from first dose of study treatment to last dose of study treatment + 30 days, duration expected to be a total of approximately 25 weeks).
Adverse Events, Serious Adverse Events based on Safety Set population defined as all patients who received at least one dose of study treatment
|
|
Infections and infestations
Urinary tract infection
|
11.5%
15/130 • All Adverse Events reported in this record are on-treatment events (from first dose of study treatment to last dose of study treatment + 30 days, duration expected to be a total of approximately 25 weeks).
Adverse Events, Serious Adverse Events based on Safety Set population defined as all patients who received at least one dose of study treatment
|
8.6%
7/81 • All Adverse Events reported in this record are on-treatment events (from first dose of study treatment to last dose of study treatment + 30 days, duration expected to be a total of approximately 25 weeks).
Adverse Events, Serious Adverse Events based on Safety Set population defined as all patients who received at least one dose of study treatment
|
5.6%
7/125 • All Adverse Events reported in this record are on-treatment events (from first dose of study treatment to last dose of study treatment + 30 days, duration expected to be a total of approximately 25 weeks).
Adverse Events, Serious Adverse Events based on Safety Set population defined as all patients who received at least one dose of study treatment
|
|
Infections and infestations
Viral upper respiratory tract infection
|
3.8%
5/130 • All Adverse Events reported in this record are on-treatment events (from first dose of study treatment to last dose of study treatment + 30 days, duration expected to be a total of approximately 25 weeks).
Adverse Events, Serious Adverse Events based on Safety Set population defined as all patients who received at least one dose of study treatment
|
6.2%
5/81 • All Adverse Events reported in this record are on-treatment events (from first dose of study treatment to last dose of study treatment + 30 days, duration expected to be a total of approximately 25 weeks).
Adverse Events, Serious Adverse Events based on Safety Set population defined as all patients who received at least one dose of study treatment
|
10.4%
13/125 • All Adverse Events reported in this record are on-treatment events (from first dose of study treatment to last dose of study treatment + 30 days, duration expected to be a total of approximately 25 weeks).
Adverse Events, Serious Adverse Events based on Safety Set population defined as all patients who received at least one dose of study treatment
|
|
Injury, poisoning and procedural complications
Procedural pain
|
1.5%
2/130 • All Adverse Events reported in this record are on-treatment events (from first dose of study treatment to last dose of study treatment + 30 days, duration expected to be a total of approximately 25 weeks).
Adverse Events, Serious Adverse Events based on Safety Set population defined as all patients who received at least one dose of study treatment
|
6.2%
5/81 • All Adverse Events reported in this record are on-treatment events (from first dose of study treatment to last dose of study treatment + 30 days, duration expected to be a total of approximately 25 weeks).
Adverse Events, Serious Adverse Events based on Safety Set population defined as all patients who received at least one dose of study treatment
|
7.2%
9/125 • All Adverse Events reported in this record are on-treatment events (from first dose of study treatment to last dose of study treatment + 30 days, duration expected to be a total of approximately 25 weeks).
Adverse Events, Serious Adverse Events based on Safety Set population defined as all patients who received at least one dose of study treatment
|
|
Investigations
Alanine aminotransferase increased
|
10.8%
14/130 • All Adverse Events reported in this record are on-treatment events (from first dose of study treatment to last dose of study treatment + 30 days, duration expected to be a total of approximately 25 weeks).
Adverse Events, Serious Adverse Events based on Safety Set population defined as all patients who received at least one dose of study treatment
|
60.5%
49/81 • All Adverse Events reported in this record are on-treatment events (from first dose of study treatment to last dose of study treatment + 30 days, duration expected to be a total of approximately 25 weeks).
Adverse Events, Serious Adverse Events based on Safety Set population defined as all patients who received at least one dose of study treatment
|
2.4%
3/125 • All Adverse Events reported in this record are on-treatment events (from first dose of study treatment to last dose of study treatment + 30 days, duration expected to be a total of approximately 25 weeks).
Adverse Events, Serious Adverse Events based on Safety Set population defined as all patients who received at least one dose of study treatment
|
|
Investigations
Aspartate aminotransferase increased
|
8.5%
11/130 • All Adverse Events reported in this record are on-treatment events (from first dose of study treatment to last dose of study treatment + 30 days, duration expected to be a total of approximately 25 weeks).
Adverse Events, Serious Adverse Events based on Safety Set population defined as all patients who received at least one dose of study treatment
|
54.3%
44/81 • All Adverse Events reported in this record are on-treatment events (from first dose of study treatment to last dose of study treatment + 30 days, duration expected to be a total of approximately 25 weeks).
Adverse Events, Serious Adverse Events based on Safety Set population defined as all patients who received at least one dose of study treatment
|
1.6%
2/125 • All Adverse Events reported in this record are on-treatment events (from first dose of study treatment to last dose of study treatment + 30 days, duration expected to be a total of approximately 25 weeks).
Adverse Events, Serious Adverse Events based on Safety Set population defined as all patients who received at least one dose of study treatment
|
|
Investigations
Blood bilirubin increased
|
1.5%
2/130 • All Adverse Events reported in this record are on-treatment events (from first dose of study treatment to last dose of study treatment + 30 days, duration expected to be a total of approximately 25 weeks).
Adverse Events, Serious Adverse Events based on Safety Set population defined as all patients who received at least one dose of study treatment
|
7.4%
6/81 • All Adverse Events reported in this record are on-treatment events (from first dose of study treatment to last dose of study treatment + 30 days, duration expected to be a total of approximately 25 weeks).
Adverse Events, Serious Adverse Events based on Safety Set population defined as all patients who received at least one dose of study treatment
|
0.80%
1/125 • All Adverse Events reported in this record are on-treatment events (from first dose of study treatment to last dose of study treatment + 30 days, duration expected to be a total of approximately 25 weeks).
Adverse Events, Serious Adverse Events based on Safety Set population defined as all patients who received at least one dose of study treatment
|
|
Investigations
Blood creatinine increased
|
9.2%
12/130 • All Adverse Events reported in this record are on-treatment events (from first dose of study treatment to last dose of study treatment + 30 days, duration expected to be a total of approximately 25 weeks).
Adverse Events, Serious Adverse Events based on Safety Set population defined as all patients who received at least one dose of study treatment
|
1.2%
1/81 • All Adverse Events reported in this record are on-treatment events (from first dose of study treatment to last dose of study treatment + 30 days, duration expected to be a total of approximately 25 weeks).
Adverse Events, Serious Adverse Events based on Safety Set population defined as all patients who received at least one dose of study treatment
|
3.2%
4/125 • All Adverse Events reported in this record are on-treatment events (from first dose of study treatment to last dose of study treatment + 30 days, duration expected to be a total of approximately 25 weeks).
Adverse Events, Serious Adverse Events based on Safety Set population defined as all patients who received at least one dose of study treatment
|
|
Investigations
Blood glucose increased
|
9.2%
12/130 • All Adverse Events reported in this record are on-treatment events (from first dose of study treatment to last dose of study treatment + 30 days, duration expected to be a total of approximately 25 weeks).
Adverse Events, Serious Adverse Events based on Safety Set population defined as all patients who received at least one dose of study treatment
|
3.7%
3/81 • All Adverse Events reported in this record are on-treatment events (from first dose of study treatment to last dose of study treatment + 30 days, duration expected to be a total of approximately 25 weeks).
Adverse Events, Serious Adverse Events based on Safety Set population defined as all patients who received at least one dose of study treatment
|
1.6%
2/125 • All Adverse Events reported in this record are on-treatment events (from first dose of study treatment to last dose of study treatment + 30 days, duration expected to be a total of approximately 25 weeks).
Adverse Events, Serious Adverse Events based on Safety Set population defined as all patients who received at least one dose of study treatment
|
|
Investigations
Gamma-glutamyltransferase increased
|
3.8%
5/130 • All Adverse Events reported in this record are on-treatment events (from first dose of study treatment to last dose of study treatment + 30 days, duration expected to be a total of approximately 25 weeks).
Adverse Events, Serious Adverse Events based on Safety Set population defined as all patients who received at least one dose of study treatment
|
7.4%
6/81 • All Adverse Events reported in this record are on-treatment events (from first dose of study treatment to last dose of study treatment + 30 days, duration expected to be a total of approximately 25 weeks).
Adverse Events, Serious Adverse Events based on Safety Set population defined as all patients who received at least one dose of study treatment
|
0.80%
1/125 • All Adverse Events reported in this record are on-treatment events (from first dose of study treatment to last dose of study treatment + 30 days, duration expected to be a total of approximately 25 weeks).
Adverse Events, Serious Adverse Events based on Safety Set population defined as all patients who received at least one dose of study treatment
|
|
Investigations
Weight decreased
|
12.3%
16/130 • All Adverse Events reported in this record are on-treatment events (from first dose of study treatment to last dose of study treatment + 30 days, duration expected to be a total of approximately 25 weeks).
Adverse Events, Serious Adverse Events based on Safety Set population defined as all patients who received at least one dose of study treatment
|
12.3%
10/81 • All Adverse Events reported in this record are on-treatment events (from first dose of study treatment to last dose of study treatment + 30 days, duration expected to be a total of approximately 25 weeks).
Adverse Events, Serious Adverse Events based on Safety Set population defined as all patients who received at least one dose of study treatment
|
2.4%
3/125 • All Adverse Events reported in this record are on-treatment events (from first dose of study treatment to last dose of study treatment + 30 days, duration expected to be a total of approximately 25 weeks).
Adverse Events, Serious Adverse Events based on Safety Set population defined as all patients who received at least one dose of study treatment
|
|
Metabolism and nutrition disorders
Decreased appetite
|
30.8%
40/130 • All Adverse Events reported in this record are on-treatment events (from first dose of study treatment to last dose of study treatment + 30 days, duration expected to be a total of approximately 25 weeks).
Adverse Events, Serious Adverse Events based on Safety Set population defined as all patients who received at least one dose of study treatment
|
30.9%
25/81 • All Adverse Events reported in this record are on-treatment events (from first dose of study treatment to last dose of study treatment + 30 days, duration expected to be a total of approximately 25 weeks).
Adverse Events, Serious Adverse Events based on Safety Set population defined as all patients who received at least one dose of study treatment
|
8.0%
10/125 • All Adverse Events reported in this record are on-treatment events (from first dose of study treatment to last dose of study treatment + 30 days, duration expected to be a total of approximately 25 weeks).
Adverse Events, Serious Adverse Events based on Safety Set population defined as all patients who received at least one dose of study treatment
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
53.1%
69/130 • All Adverse Events reported in this record are on-treatment events (from first dose of study treatment to last dose of study treatment + 30 days, duration expected to be a total of approximately 25 weeks).
Adverse Events, Serious Adverse Events based on Safety Set population defined as all patients who received at least one dose of study treatment
|
46.9%
38/81 • All Adverse Events reported in this record are on-treatment events (from first dose of study treatment to last dose of study treatment + 30 days, duration expected to be a total of approximately 25 weeks).
Adverse Events, Serious Adverse Events based on Safety Set population defined as all patients who received at least one dose of study treatment
|
6.4%
8/125 • All Adverse Events reported in this record are on-treatment events (from first dose of study treatment to last dose of study treatment + 30 days, duration expected to be a total of approximately 25 weeks).
Adverse Events, Serious Adverse Events based on Safety Set population defined as all patients who received at least one dose of study treatment
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
6.9%
9/130 • All Adverse Events reported in this record are on-treatment events (from first dose of study treatment to last dose of study treatment + 30 days, duration expected to be a total of approximately 25 weeks).
Adverse Events, Serious Adverse Events based on Safety Set population defined as all patients who received at least one dose of study treatment
|
1.2%
1/81 • All Adverse Events reported in this record are on-treatment events (from first dose of study treatment to last dose of study treatment + 30 days, duration expected to be a total of approximately 25 weeks).
Adverse Events, Serious Adverse Events based on Safety Set population defined as all patients who received at least one dose of study treatment
|
0.00%
0/125 • All Adverse Events reported in this record are on-treatment events (from first dose of study treatment to last dose of study treatment + 30 days, duration expected to be a total of approximately 25 weeks).
Adverse Events, Serious Adverse Events based on Safety Set population defined as all patients who received at least one dose of study treatment
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
8.5%
11/130 • All Adverse Events reported in this record are on-treatment events (from first dose of study treatment to last dose of study treatment + 30 days, duration expected to be a total of approximately 25 weeks).
Adverse Events, Serious Adverse Events based on Safety Set population defined as all patients who received at least one dose of study treatment
|
16.0%
13/81 • All Adverse Events reported in this record are on-treatment events (from first dose of study treatment to last dose of study treatment + 30 days, duration expected to be a total of approximately 25 weeks).
Adverse Events, Serious Adverse Events based on Safety Set population defined as all patients who received at least one dose of study treatment
|
27.2%
34/125 • All Adverse Events reported in this record are on-treatment events (from first dose of study treatment to last dose of study treatment + 30 days, duration expected to be a total of approximately 25 weeks).
Adverse Events, Serious Adverse Events based on Safety Set population defined as all patients who received at least one dose of study treatment
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.77%
1/130 • All Adverse Events reported in this record are on-treatment events (from first dose of study treatment to last dose of study treatment + 30 days, duration expected to be a total of approximately 25 weeks).
Adverse Events, Serious Adverse Events based on Safety Set population defined as all patients who received at least one dose of study treatment
|
8.6%
7/81 • All Adverse Events reported in this record are on-treatment events (from first dose of study treatment to last dose of study treatment + 30 days, duration expected to be a total of approximately 25 weeks).
Adverse Events, Serious Adverse Events based on Safety Set population defined as all patients who received at least one dose of study treatment
|
8.8%
11/125 • All Adverse Events reported in this record are on-treatment events (from first dose of study treatment to last dose of study treatment + 30 days, duration expected to be a total of approximately 25 weeks).
Adverse Events, Serious Adverse Events based on Safety Set population defined as all patients who received at least one dose of study treatment
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
10.0%
13/130 • All Adverse Events reported in this record are on-treatment events (from first dose of study treatment to last dose of study treatment + 30 days, duration expected to be a total of approximately 25 weeks).
Adverse Events, Serious Adverse Events based on Safety Set population defined as all patients who received at least one dose of study treatment
|
6.2%
5/81 • All Adverse Events reported in this record are on-treatment events (from first dose of study treatment to last dose of study treatment + 30 days, duration expected to be a total of approximately 25 weeks).
Adverse Events, Serious Adverse Events based on Safety Set population defined as all patients who received at least one dose of study treatment
|
4.0%
5/125 • All Adverse Events reported in this record are on-treatment events (from first dose of study treatment to last dose of study treatment + 30 days, duration expected to be a total of approximately 25 weeks).
Adverse Events, Serious Adverse Events based on Safety Set population defined as all patients who received at least one dose of study treatment
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
1.5%
2/130 • All Adverse Events reported in this record are on-treatment events (from first dose of study treatment to last dose of study treatment + 30 days, duration expected to be a total of approximately 25 weeks).
Adverse Events, Serious Adverse Events based on Safety Set population defined as all patients who received at least one dose of study treatment
|
4.9%
4/81 • All Adverse Events reported in this record are on-treatment events (from first dose of study treatment to last dose of study treatment + 30 days, duration expected to be a total of approximately 25 weeks).
Adverse Events, Serious Adverse Events based on Safety Set population defined as all patients who received at least one dose of study treatment
|
5.6%
7/125 • All Adverse Events reported in this record are on-treatment events (from first dose of study treatment to last dose of study treatment + 30 days, duration expected to be a total of approximately 25 weeks).
Adverse Events, Serious Adverse Events based on Safety Set population defined as all patients who received at least one dose of study treatment
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
4.6%
6/130 • All Adverse Events reported in this record are on-treatment events (from first dose of study treatment to last dose of study treatment + 30 days, duration expected to be a total of approximately 25 weeks).
Adverse Events, Serious Adverse Events based on Safety Set population defined as all patients who received at least one dose of study treatment
|
4.9%
4/81 • All Adverse Events reported in this record are on-treatment events (from first dose of study treatment to last dose of study treatment + 30 days, duration expected to be a total of approximately 25 weeks).
Adverse Events, Serious Adverse Events based on Safety Set population defined as all patients who received at least one dose of study treatment
|
10.4%
13/125 • All Adverse Events reported in this record are on-treatment events (from first dose of study treatment to last dose of study treatment + 30 days, duration expected to be a total of approximately 25 weeks).
Adverse Events, Serious Adverse Events based on Safety Set population defined as all patients who received at least one dose of study treatment
|
|
Nervous system disorders
Dizziness
|
5.4%
7/130 • All Adverse Events reported in this record are on-treatment events (from first dose of study treatment to last dose of study treatment + 30 days, duration expected to be a total of approximately 25 weeks).
Adverse Events, Serious Adverse Events based on Safety Set population defined as all patients who received at least one dose of study treatment
|
27.2%
22/81 • All Adverse Events reported in this record are on-treatment events (from first dose of study treatment to last dose of study treatment + 30 days, duration expected to be a total of approximately 25 weeks).
Adverse Events, Serious Adverse Events based on Safety Set population defined as all patients who received at least one dose of study treatment
|
15.2%
19/125 • All Adverse Events reported in this record are on-treatment events (from first dose of study treatment to last dose of study treatment + 30 days, duration expected to be a total of approximately 25 weeks).
Adverse Events, Serious Adverse Events based on Safety Set population defined as all patients who received at least one dose of study treatment
|
|
Nervous system disorders
Dysgeusia
|
18.5%
24/130 • All Adverse Events reported in this record are on-treatment events (from first dose of study treatment to last dose of study treatment + 30 days, duration expected to be a total of approximately 25 weeks).
Adverse Events, Serious Adverse Events based on Safety Set population defined as all patients who received at least one dose of study treatment
|
13.6%
11/81 • All Adverse Events reported in this record are on-treatment events (from first dose of study treatment to last dose of study treatment + 30 days, duration expected to be a total of approximately 25 weeks).
Adverse Events, Serious Adverse Events based on Safety Set population defined as all patients who received at least one dose of study treatment
|
5.6%
7/125 • All Adverse Events reported in this record are on-treatment events (from first dose of study treatment to last dose of study treatment + 30 days, duration expected to be a total of approximately 25 weeks).
Adverse Events, Serious Adverse Events based on Safety Set population defined as all patients who received at least one dose of study treatment
|
|
Nervous system disorders
Headache
|
20.0%
26/130 • All Adverse Events reported in this record are on-treatment events (from first dose of study treatment to last dose of study treatment + 30 days, duration expected to be a total of approximately 25 weeks).
Adverse Events, Serious Adverse Events based on Safety Set population defined as all patients who received at least one dose of study treatment
|
12.3%
10/81 • All Adverse Events reported in this record are on-treatment events (from first dose of study treatment to last dose of study treatment + 30 days, duration expected to be a total of approximately 25 weeks).
Adverse Events, Serious Adverse Events based on Safety Set population defined as all patients who received at least one dose of study treatment
|
12.8%
16/125 • All Adverse Events reported in this record are on-treatment events (from first dose of study treatment to last dose of study treatment + 30 days, duration expected to be a total of approximately 25 weeks).
Adverse Events, Serious Adverse Events based on Safety Set population defined as all patients who received at least one dose of study treatment
|
|
Nervous system disorders
Memory impairment
|
1.5%
2/130 • All Adverse Events reported in this record are on-treatment events (from first dose of study treatment to last dose of study treatment + 30 days, duration expected to be a total of approximately 25 weeks).
Adverse Events, Serious Adverse Events based on Safety Set population defined as all patients who received at least one dose of study treatment
|
6.2%
5/81 • All Adverse Events reported in this record are on-treatment events (from first dose of study treatment to last dose of study treatment + 30 days, duration expected to be a total of approximately 25 weeks).
Adverse Events, Serious Adverse Events based on Safety Set population defined as all patients who received at least one dose of study treatment
|
1.6%
2/125 • All Adverse Events reported in this record are on-treatment events (from first dose of study treatment to last dose of study treatment + 30 days, duration expected to be a total of approximately 25 weeks).
Adverse Events, Serious Adverse Events based on Safety Set population defined as all patients who received at least one dose of study treatment
|
|
Nervous system disorders
Paraesthesia
|
6.2%
8/130 • All Adverse Events reported in this record are on-treatment events (from first dose of study treatment to last dose of study treatment + 30 days, duration expected to be a total of approximately 25 weeks).
Adverse Events, Serious Adverse Events based on Safety Set population defined as all patients who received at least one dose of study treatment
|
2.5%
2/81 • All Adverse Events reported in this record are on-treatment events (from first dose of study treatment to last dose of study treatment + 30 days, duration expected to be a total of approximately 25 weeks).
Adverse Events, Serious Adverse Events based on Safety Set population defined as all patients who received at least one dose of study treatment
|
3.2%
4/125 • All Adverse Events reported in this record are on-treatment events (from first dose of study treatment to last dose of study treatment + 30 days, duration expected to be a total of approximately 25 weeks).
Adverse Events, Serious Adverse Events based on Safety Set population defined as all patients who received at least one dose of study treatment
|
|
Nervous system disorders
Tremor
|
0.00%
0/130 • All Adverse Events reported in this record are on-treatment events (from first dose of study treatment to last dose of study treatment + 30 days, duration expected to be a total of approximately 25 weeks).
Adverse Events, Serious Adverse Events based on Safety Set population defined as all patients who received at least one dose of study treatment
|
9.9%
8/81 • All Adverse Events reported in this record are on-treatment events (from first dose of study treatment to last dose of study treatment + 30 days, duration expected to be a total of approximately 25 weeks).
Adverse Events, Serious Adverse Events based on Safety Set population defined as all patients who received at least one dose of study treatment
|
0.80%
1/125 • All Adverse Events reported in this record are on-treatment events (from first dose of study treatment to last dose of study treatment + 30 days, duration expected to be a total of approximately 25 weeks).
Adverse Events, Serious Adverse Events based on Safety Set population defined as all patients who received at least one dose of study treatment
|
|
Psychiatric disorders
Anxiety
|
7.7%
10/130 • All Adverse Events reported in this record are on-treatment events (from first dose of study treatment to last dose of study treatment + 30 days, duration expected to be a total of approximately 25 weeks).
Adverse Events, Serious Adverse Events based on Safety Set population defined as all patients who received at least one dose of study treatment
|
19.8%
16/81 • All Adverse Events reported in this record are on-treatment events (from first dose of study treatment to last dose of study treatment + 30 days, duration expected to be a total of approximately 25 weeks).
Adverse Events, Serious Adverse Events based on Safety Set population defined as all patients who received at least one dose of study treatment
|
8.0%
10/125 • All Adverse Events reported in this record are on-treatment events (from first dose of study treatment to last dose of study treatment + 30 days, duration expected to be a total of approximately 25 weeks).
Adverse Events, Serious Adverse Events based on Safety Set population defined as all patients who received at least one dose of study treatment
|
|
Psychiatric disorders
Depression
|
3.8%
5/130 • All Adverse Events reported in this record are on-treatment events (from first dose of study treatment to last dose of study treatment + 30 days, duration expected to be a total of approximately 25 weeks).
Adverse Events, Serious Adverse Events based on Safety Set population defined as all patients who received at least one dose of study treatment
|
14.8%
12/81 • All Adverse Events reported in this record are on-treatment events (from first dose of study treatment to last dose of study treatment + 30 days, duration expected to be a total of approximately 25 weeks).
Adverse Events, Serious Adverse Events based on Safety Set population defined as all patients who received at least one dose of study treatment
|
2.4%
3/125 • All Adverse Events reported in this record are on-treatment events (from first dose of study treatment to last dose of study treatment + 30 days, duration expected to be a total of approximately 25 weeks).
Adverse Events, Serious Adverse Events based on Safety Set population defined as all patients who received at least one dose of study treatment
|
|
Psychiatric disorders
Insomnia
|
11.5%
15/130 • All Adverse Events reported in this record are on-treatment events (from first dose of study treatment to last dose of study treatment + 30 days, duration expected to be a total of approximately 25 weeks).
Adverse Events, Serious Adverse Events based on Safety Set population defined as all patients who received at least one dose of study treatment
|
9.9%
8/81 • All Adverse Events reported in this record are on-treatment events (from first dose of study treatment to last dose of study treatment + 30 days, duration expected to be a total of approximately 25 weeks).
Adverse Events, Serious Adverse Events based on Safety Set population defined as all patients who received at least one dose of study treatment
|
13.6%
17/125 • All Adverse Events reported in this record are on-treatment events (from first dose of study treatment to last dose of study treatment + 30 days, duration expected to be a total of approximately 25 weeks).
Adverse Events, Serious Adverse Events based on Safety Set population defined as all patients who received at least one dose of study treatment
|
|
Reproductive system and breast disorders
Breast pain
|
3.1%
4/130 • All Adverse Events reported in this record are on-treatment events (from first dose of study treatment to last dose of study treatment + 30 days, duration expected to be a total of approximately 25 weeks).
Adverse Events, Serious Adverse Events based on Safety Set population defined as all patients who received at least one dose of study treatment
|
9.9%
8/81 • All Adverse Events reported in this record are on-treatment events (from first dose of study treatment to last dose of study treatment + 30 days, duration expected to be a total of approximately 25 weeks).
Adverse Events, Serious Adverse Events based on Safety Set population defined as all patients who received at least one dose of study treatment
|
8.0%
10/125 • All Adverse Events reported in this record are on-treatment events (from first dose of study treatment to last dose of study treatment + 30 days, duration expected to be a total of approximately 25 weeks).
Adverse Events, Serious Adverse Events based on Safety Set population defined as all patients who received at least one dose of study treatment
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
6.9%
9/130 • All Adverse Events reported in this record are on-treatment events (from first dose of study treatment to last dose of study treatment + 30 days, duration expected to be a total of approximately 25 weeks).
Adverse Events, Serious Adverse Events based on Safety Set population defined as all patients who received at least one dose of study treatment
|
9.9%
8/81 • All Adverse Events reported in this record are on-treatment events (from first dose of study treatment to last dose of study treatment + 30 days, duration expected to be a total of approximately 25 weeks).
Adverse Events, Serious Adverse Events based on Safety Set population defined as all patients who received at least one dose of study treatment
|
7.2%
9/125 • All Adverse Events reported in this record are on-treatment events (from first dose of study treatment to last dose of study treatment + 30 days, duration expected to be a total of approximately 25 weeks).
Adverse Events, Serious Adverse Events based on Safety Set population defined as all patients who received at least one dose of study treatment
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
21.5%
28/130 • All Adverse Events reported in this record are on-treatment events (from first dose of study treatment to last dose of study treatment + 30 days, duration expected to be a total of approximately 25 weeks).
Adverse Events, Serious Adverse Events based on Safety Set population defined as all patients who received at least one dose of study treatment
|
3.7%
3/81 • All Adverse Events reported in this record are on-treatment events (from first dose of study treatment to last dose of study treatment + 30 days, duration expected to be a total of approximately 25 weeks).
Adverse Events, Serious Adverse Events based on Safety Set population defined as all patients who received at least one dose of study treatment
|
5.6%
7/125 • All Adverse Events reported in this record are on-treatment events (from first dose of study treatment to last dose of study treatment + 30 days, duration expected to be a total of approximately 25 weeks).
Adverse Events, Serious Adverse Events based on Safety Set population defined as all patients who received at least one dose of study treatment
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
14.6%
19/130 • All Adverse Events reported in this record are on-treatment events (from first dose of study treatment to last dose of study treatment + 30 days, duration expected to be a total of approximately 25 weeks).
Adverse Events, Serious Adverse Events based on Safety Set population defined as all patients who received at least one dose of study treatment
|
17.3%
14/81 • All Adverse Events reported in this record are on-treatment events (from first dose of study treatment to last dose of study treatment + 30 days, duration expected to be a total of approximately 25 weeks).
Adverse Events, Serious Adverse Events based on Safety Set population defined as all patients who received at least one dose of study treatment
|
3.2%
4/125 • All Adverse Events reported in this record are on-treatment events (from first dose of study treatment to last dose of study treatment + 30 days, duration expected to be a total of approximately 25 weeks).
Adverse Events, Serious Adverse Events based on Safety Set population defined as all patients who received at least one dose of study treatment
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
16.9%
22/130 • All Adverse Events reported in this record are on-treatment events (from first dose of study treatment to last dose of study treatment + 30 days, duration expected to be a total of approximately 25 weeks).
Adverse Events, Serious Adverse Events based on Safety Set population defined as all patients who received at least one dose of study treatment
|
22.2%
18/81 • All Adverse Events reported in this record are on-treatment events (from first dose of study treatment to last dose of study treatment + 30 days, duration expected to be a total of approximately 25 weeks).
Adverse Events, Serious Adverse Events based on Safety Set population defined as all patients who received at least one dose of study treatment
|
7.2%
9/125 • All Adverse Events reported in this record are on-treatment events (from first dose of study treatment to last dose of study treatment + 30 days, duration expected to be a total of approximately 25 weeks).
Adverse Events, Serious Adverse Events based on Safety Set population defined as all patients who received at least one dose of study treatment
|
|
Skin and subcutaneous tissue disorders
Rash
|
44.6%
58/130 • All Adverse Events reported in this record are on-treatment events (from first dose of study treatment to last dose of study treatment + 30 days, duration expected to be a total of approximately 25 weeks).
Adverse Events, Serious Adverse Events based on Safety Set population defined as all patients who received at least one dose of study treatment
|
38.3%
31/81 • All Adverse Events reported in this record are on-treatment events (from first dose of study treatment to last dose of study treatment + 30 days, duration expected to be a total of approximately 25 weeks).
Adverse Events, Serious Adverse Events based on Safety Set population defined as all patients who received at least one dose of study treatment
|
8.0%
10/125 • All Adverse Events reported in this record are on-treatment events (from first dose of study treatment to last dose of study treatment + 30 days, duration expected to be a total of approximately 25 weeks).
Adverse Events, Serious Adverse Events based on Safety Set population defined as all patients who received at least one dose of study treatment
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
16.9%
22/130 • All Adverse Events reported in this record are on-treatment events (from first dose of study treatment to last dose of study treatment + 30 days, duration expected to be a total of approximately 25 weeks).
Adverse Events, Serious Adverse Events based on Safety Set population defined as all patients who received at least one dose of study treatment
|
11.1%
9/81 • All Adverse Events reported in this record are on-treatment events (from first dose of study treatment to last dose of study treatment + 30 days, duration expected to be a total of approximately 25 weeks).
Adverse Events, Serious Adverse Events based on Safety Set population defined as all patients who received at least one dose of study treatment
|
2.4%
3/125 • All Adverse Events reported in this record are on-treatment events (from first dose of study treatment to last dose of study treatment + 30 days, duration expected to be a total of approximately 25 weeks).
Adverse Events, Serious Adverse Events based on Safety Set population defined as all patients who received at least one dose of study treatment
|
|
Vascular disorders
Hot flush
|
6.2%
8/130 • All Adverse Events reported in this record are on-treatment events (from first dose of study treatment to last dose of study treatment + 30 days, duration expected to be a total of approximately 25 weeks).
Adverse Events, Serious Adverse Events based on Safety Set population defined as all patients who received at least one dose of study treatment
|
14.8%
12/81 • All Adverse Events reported in this record are on-treatment events (from first dose of study treatment to last dose of study treatment + 30 days, duration expected to be a total of approximately 25 weeks).
Adverse Events, Serious Adverse Events based on Safety Set population defined as all patients who received at least one dose of study treatment
|
24.8%
31/125 • All Adverse Events reported in this record are on-treatment events (from first dose of study treatment to last dose of study treatment + 30 days, duration expected to be a total of approximately 25 weeks).
Adverse Events, Serious Adverse Events based on Safety Set population defined as all patients who received at least one dose of study treatment
|
|
Vascular disorders
Hypertension
|
12.3%
16/130 • All Adverse Events reported in this record are on-treatment events (from first dose of study treatment to last dose of study treatment + 30 days, duration expected to be a total of approximately 25 weeks).
Adverse Events, Serious Adverse Events based on Safety Set population defined as all patients who received at least one dose of study treatment
|
12.3%
10/81 • All Adverse Events reported in this record are on-treatment events (from first dose of study treatment to last dose of study treatment + 30 days, duration expected to be a total of approximately 25 weeks).
Adverse Events, Serious Adverse Events based on Safety Set population defined as all patients who received at least one dose of study treatment
|
6.4%
8/125 • All Adverse Events reported in this record are on-treatment events (from first dose of study treatment to last dose of study treatment + 30 days, duration expected to be a total of approximately 25 weeks).
Adverse Events, Serious Adverse Events based on Safety Set population defined as all patients who received at least one dose of study treatment
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of pooled data (i.e.,data from all sites) in clinical trial or disclosure of trial results in their entirety.
- Publication restrictions are in place
Restriction type: OTHER