Trial Outcomes & Findings for A Study of Everolimus Plus Exemestane in Chinese Postmenopausal Women With Estrogen Receptor Positive, Locally Advanced, Recurrent, or Metastatic Breast Cancer After Recurrence or Progression on Non-steroidal Aromatase Inhibitor (NCT NCT03312738)

NCT ID: NCT03312738

Last Updated: 2024-01-23

Results Overview

PFS was defined as time from the date of randomization to the date of first documented progression or death due to any cause. A patient who had not progressed or died at the date of the analysis cut-off or received another anticancer therapy had their PFS censored at the time of the last adequate tumor evaluation before the earlier of the cut-off date or the anticancer therapy date. Disease progression was assessed using the local investigator's tumor assessment per Response Evaluation Criteria in Solid Tumours (RECIST) 1.1. The distribution of PFS was estimated using the Kaplan-Meier method. Cox regression model stratified by randomization stratification factors was used to estimate the hazard ratio (HR) of PFS, along with 90% CI. As this was an estimation based approach, no p-value was provided.

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 159 participants
• Primary outcome timeframe: From randomization up to date of first documented progression or death, assessed up to approximately 3.5 years
• Results posted on: 2024-01-23

Participant Flow

Participants took part in 15 investigative sites in China

The screening period began once patients had signed the study informed consent. All screening/baseline evaluations were performed within maximum 21 days prior to the first dose of study treatment

Participant milestones

Measure	Everolimus + Exemestane Participants received everolimus as a continuous oral daily dose of 10 mg and exemestane as a continuous oral daily dose of 25 mg	Placebo + Exemestane Participants received placebo as a continuous oral daily dose and exemestane as a continuous oral daily dose of 25 mg
Overall Study STARTED	80	79
Overall Study COMPLETED	0	0
Overall Study NOT COMPLETED	80	79

Reasons for withdrawal

Measure	Everolimus + Exemestane Participants received everolimus as a continuous oral daily dose of 10 mg and exemestane as a continuous oral daily dose of 25 mg	Placebo + Exemestane Participants received placebo as a continuous oral daily dose and exemestane as a continuous oral daily dose of 25 mg
Overall Study Progressive disease	58	67
Overall Study Patient/guardian decision	13	5
Overall Study Adverse Event	5	3
Overall Study Protocol deviation	2	0
Overall Study Technical problems	0	1
Overall Study Physician Decision	2	3

Baseline Characteristics

A Study of Everolimus Plus Exemestane in Chinese Postmenopausal Women With Estrogen Receptor Positive, Locally Advanced, Recurrent, or Metastatic Breast Cancer After Recurrence or Progression on Non-steroidal Aromatase Inhibitor

Baseline characteristics by cohort

Measure	Everolimus + Exemestane n=80 Participants Participants received everolimus as a continuous oral daily dose of 10 mg and exemestane as a continuous oral daily dose of 25 mg	Placebo + Exemestane n=79 Participants Participants received placebo as a continuous oral daily dose and exemestane as a continuous oral daily dose of 25 mg	Total n=159 Participants Total of all reporting groups
Age, Continuous	56.6 Years STANDARD_DEVIATION 9.14 • n=5 Participants	56.3 Years STANDARD_DEVIATION 8.43 • n=7 Participants	56.4 Years STANDARD_DEVIATION 8.77 • n=5 Participants
Sex: Female, Male Female	80 Participants n=5 Participants	79 Participants n=7 Participants	159 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race/Ethnicity, Customized Asian	80 Participants n=5 Participants	79 Participants n=7 Participants	159 Participants n=5 Participants

PRIMARY outcome

Timeframe: From randomization up to date of first documented progression or death, assessed up to approximately 3.5 years

Population: Full Analysis Set (FAS) including all subjects to whom study treatment was assigned by randomization.

PFS was defined as time from the date of randomization to the date of first documented progression or death due to any cause. A patient who had not progressed or died at the date of the analysis cut-off or received another anticancer therapy had their PFS censored at the time of the last adequate tumor evaluation before the earlier of the cut-off date or the anticancer therapy date. Disease progression was assessed using the local investigator's tumor assessment per Response Evaluation Criteria in Solid Tumours (RECIST) 1.1.

The distribution of PFS was estimated using the Kaplan-Meier method. Cox regression model stratified by randomization stratification factors was used to estimate the hazard ratio (HR) of PFS, along with 90% CI. As this was an estimation based approach, no p-value was provided.

Outcome measures

Measure	Everolimus + Exemestane n=80 Participants Participants received everolimus as a continuous oral daily dose of 10 mg and exemestane as a continuous oral daily dose of 25 mg	Placebo + Exemestane n=79 Participants Participants received placebo as a continuous oral daily dose and exemestane as a continuous oral daily dose of 25 mg
Progression-free Survival (PFS) Based on Local Radiology Review of Tumor Assessment	7.4 Months Interval 5.5 to 9.2	2.0 Months Interval 1.9 to 3.6

SECONDARY outcome

Timeframe: From randomization up to date of first documented progression or death, assessed up to approximately 1.8 years

Population: FAS including all subjects to whom study treatment was assigned by randomization.

PFS was defined as time from the date of randomization to the date of first documented progression or death due to any cause. A patient who had not progressed or died at the date of the analysis cut-off or received another anticancer therapy had their PFS censored at the time of the last adequate tumor evaluation before the earlier of the cut-off date or the anticancer therapy date. Disease progression was assessed using the BIRC tumor assessment per RECIST 1.1.

The distribution of PFS was estimated using the Kaplan-Meier method. Cox regression model stratified by randomization stratification factors was used to estimate the hazard ratio (HR) of PFS, along with 90% CI. As this was an estimation based approach, no p-value was provided.

Outcome measures

Measure	Everolimus + Exemestane n=80 Participants Participants received everolimus as a continuous oral daily dose of 10 mg and exemestane as a continuous oral daily dose of 25 mg	Placebo + Exemestane n=79 Participants Participants received placebo as a continuous oral daily dose and exemestane as a continuous oral daily dose of 25 mg
Progression-free Survival (PFS) Based on Blinded Independent Review Committee (BIRC) Assessment	7.4 Months Interval 5.5 to 9.3	3.1 Months Interval 1.9 to 3.7

SECONDARY outcome

Timeframe: From randomization to date of death, up to approximately 3.8 years

Population: FAS including all subjects to whom study treatment was assigned by randomization.

OS was defined as the time from date of randomization to date of death due to any cause. If the participant was alive at the date of the analysis cut-off or lost to follow-up, then OS was censored at the last contact date prior to data cutoff date.

The distribution of OS was estimated using the Kaplan-Meier method. Cox regression model stratified by randomization stratification factors was used to estimate the hazard ratio (HR) of OS, along with 90% CI. As this was an estimation based approach, no p-value was provided.

Outcome measures

Measure	Everolimus + Exemestane n=80 Participants Participants received everolimus as a continuous oral daily dose of 10 mg and exemestane as a continuous oral daily dose of 25 mg	Placebo + Exemestane n=79 Participants Participants received placebo as a continuous oral daily dose and exemestane as a continuous oral daily dose of 25 mg
Overall Survival (OS)	26.1 Months Interval 20.2 to 33.7	22.7 Months Interval 18.6 to 37.8

SECONDARY outcome

Timeframe: Up to approximately 3.5 years

Population: FAS including all subjects to whom study treatment was assigned by randomization.

ORR was defined as the percentage of participants with a best overall response defined as complete response (CR) or partial response (PR) according to RECIST using local radiologist's/investigator's tumor assessment. ORR was estimated and the exact binomial 90% CI was reported by treatment arm.

CR: Disappearance of all non-nodal target lesions. In addition, any pathological lymph nodes assigned as target lesions must have a reduction in short axis to < 10 mm.

PR: At least a 30% decrease in the sum of diameter of all target lesions, taking as reference the baseline sum of diameters.

Outcome measures

Measure	Everolimus + Exemestane n=80 Participants Participants received everolimus as a continuous oral daily dose of 10 mg and exemestane as a continuous oral daily dose of 25 mg	Placebo + Exemestane n=79 Participants Participants received placebo as a continuous oral daily dose and exemestane as a continuous oral daily dose of 25 mg
Overall Response Rate (ORR) Based on Local Radiology Review of Tumor Assessment	10.0 Percentage of participants Interval 5.1 to 17.3	2.5 Percentage of participants Interval 0.5 to 7.8

SECONDARY outcome

Timeframe: Up to approximately 1.8 years

Population: FAS including all subjects to whom study treatment was assigned by randomization.

ORR was defined as the percentage of participants with a best overall response defined as complete response (CR) or partial response (PR) according to RECIST using BIRC assessment. ORR was estimated and the exact binomial 90% CI was reported by treatment arm.

CR: Disappearance of all non-nodal target lesions. In addition, any pathological lymph nodes assigned as target lesions must have a reduction in short axis to < 10 mm.

PR: At least a 30% decrease in the sum of diameter of all target lesions, taking as reference the baseline sum of diameters.

Outcome measures

Measure	Everolimus + Exemestane n=80 Participants Participants received everolimus as a continuous oral daily dose of 10 mg and exemestane as a continuous oral daily dose of 25 mg	Placebo + Exemestane n=79 Participants Participants received placebo as a continuous oral daily dose and exemestane as a continuous oral daily dose of 25 mg
Overall Response Rate (ORR) Based on BIRC Assessment	8.8 Percentage of participants Interval 4.2 to 15.8	2.5 Percentage of participants Interval 0.5 to 7.8

SECONDARY outcome

Timeframe: Up to approximately 3.5 years

Population: FAS including all subjects to whom study treatment was assigned by randomization.

CBR was defined as the percentage of patients with best overall response of CR, PR or an overall lesion response of stable disease (SD) or Non-CR/Non-progressive disease with duration of 24 weeks or longer according to RECIST 1.1 using local radiologist's/investigator's tumor assessment. CBR was estimated and the exact binomial 90% CI was reported by treatment arm.

CR: Disappearance of all non-nodal target lesions. In addition, any pathological lymph nodes assigned as target lesions must have a reduction in short axis to < 10 mm.

PR: At least a 30% decrease in the sum of diameter of all target lesions, taking as reference the baseline sum of diameters.

SD: Neither sufficient shrinkage to qualify for PR or CR nor an increase in lesions which would qualify for progressive disease.

Outcome measures

Measure	Everolimus + Exemestane n=80 Participants Participants received everolimus as a continuous oral daily dose of 10 mg and exemestane as a continuous oral daily dose of 25 mg	Placebo + Exemestane n=79 Participants Participants received placebo as a continuous oral daily dose and exemestane as a continuous oral daily dose of 25 mg
Clinical Benefit Rate (CBR) Based on Local Radiology Review of Tumor Assessment	42.5 Percentage of participants Interval 33.1 to 52.3	16.5 Percentage of participants Interval 10.0 to 24.9

SECONDARY outcome

Timeframe: Up to approximately 1.8 years

Population: FAS including all subjects to whom study treatment was assigned by randomization.

CBR was defined as the percentage of patients with best overall response of CR, PR or an overall lesion response of stable disease (SD) or Non-CR/Non-progressive disease with duration of 24 weeks or longer according to RECIST 1.1 using BIRC assessment. CBR was estimated and the exact binomial 90% CI was reported by treatment arm.

CR: Disappearance of all non-nodal target lesions. In addition, any pathological lymph nodes assigned as target lesions must have a reduction in short axis to < 10 mm.

PR: At least a 30% decrease in the sum of diameter of all target lesions, taking as reference the baseline sum of diameters.

SD: Neither sufficient shrinkage to qualify for PR or CR nor an increase in lesions which would qualify for progressive disease.

Outcome measures

Measure	Everolimus + Exemestane n=80 Participants Participants received everolimus as a continuous oral daily dose of 10 mg and exemestane as a continuous oral daily dose of 25 mg	Placebo + Exemestane n=79 Participants Participants received placebo as a continuous oral daily dose and exemestane as a continuous oral daily dose of 25 mg
Clinical Benefit Rate (CBR) Based on BIRC Assessment	31.3 Percentage of participants Interval 22.7 to 40.8	11.4 Percentage of participants Interval 6.1 to 19.0

SECONDARY outcome

Timeframe: Up to approximately 3.5 years

Population: Participants in the FAS with a confirmed CR or PR as per local radiologist's/investigator's tumor assessment.

TTR was defined as the time between date of randomization until first documented response (CR or PR) according to RECIST 1.1 using local radiologist's/investigator's tumor assessment.

CR: Disappearance of all non-nodal target lesions. In addition, any pathological lymph nodes assigned as target lesions must have a reduction in short axis to < 10 mm.

PR: At least a 30% decrease in the sum of diameter of all target lesions, taking as reference the baseline sum of diameters.

Outcome measures

Measure	Everolimus + Exemestane n=8 Participants Participants received everolimus as a continuous oral daily dose of 10 mg and exemestane as a continuous oral daily dose of 25 mg	Placebo + Exemestane n=2 Participants Participants received placebo as a continuous oral daily dose and exemestane as a continuous oral daily dose of 25 mg
Time to Response (TTR) Based on Local Radiology Review of Tumor Assessment	84.5 Days Interval 51.0 to 162.0	53.0 Days Interval 52.0 to 54.0

SECONDARY outcome

Timeframe: Up to approximately 1.8 years

Population: Participants in the FAS with a confirmed CR or PR as per BIRC assessment

TTR was defined as the time between date of randomization until first documented response (CR or PR) according to RECIST 1.1 using BIRC assessment.

CR: Disappearance of all non-nodal target lesions. In addition, any pathological lymph nodes assigned as target lesions must have a reduction in short axis to < 10 mm.

PR: At least a 30% decrease in the sum of diameter of all target lesions, taking as reference the baseline sum of diameters.

Outcome measures

Measure	Everolimus + Exemestane n=7 Participants Participants received everolimus as a continuous oral daily dose of 10 mg and exemestane as a continuous oral daily dose of 25 mg	Placebo + Exemestane n=2 Participants Participants received placebo as a continuous oral daily dose and exemestane as a continuous oral daily dose of 25 mg
Time to Response (TTR) Based on BIRC Assessment	57.0 Days Interval 15.0 to 224.0	81.5 Days Interval 52.0 to 111.0

SECONDARY outcome

Timeframe: From date of first documented response to date of first documented disease progression or death, assessed up to approximately 3.5 years

Population: Participants in the FAS with a confirmed CR or PR as per local radiologist's/investigator's tumor assessment

DOR was defined as the time from date of first documented CR or PR to date of first documented disease progression or death due to any cause, according to RECIST 1.1 using local radiologist's/investigator's tumor assessment.

CR: Disappearance of all non-nodal target lesions. In addition, any pathological lymph nodes assigned as target lesions must have a reduction in short axis to < 10 mm.

PR: At least a 30% decrease in the sum of diameter of all target lesions, taking as reference the baseline sum of diameters.

Outcome measures

Measure	Everolimus + Exemestane n=8 Participants Participants received everolimus as a continuous oral daily dose of 10 mg and exemestane as a continuous oral daily dose of 25 mg	Placebo + Exemestane n=2 Participants Participants received placebo as a continuous oral daily dose and exemestane as a continuous oral daily dose of 25 mg
Duration of Response (DOR) Based on Local Radiology Review of Tumor Assessment	243.5 Days Interval 110.0 to 624.0	561.5 Days Interval 282.0 to 841.0

SECONDARY outcome

Timeframe: From date of first documented response to date of first documented disease progression or death, assessed up to approximately 1.8 years

Population: Participants in the FAS with a confirmed CR or PR as per BIRC assessment

DOR was defined as the time from date of first documented CR or PR to date of first documented disease progression or death due to any cause, according to RECIST 1.1 using BIRC assessment.

CR: Disappearance of all non-nodal target lesions. In addition, any pathological lymph nodes assigned as target lesions must have a reduction in short axis to < 10 mm.

PR: At least a 30% decrease in the sum of diameter of all target lesions, taking as reference the baseline sum of diameters.

Outcome measures

Measure	Everolimus + Exemestane n=7 Participants Participants received everolimus as a continuous oral daily dose of 10 mg and exemestane as a continuous oral daily dose of 25 mg	Placebo + Exemestane n=2 Participants Participants received placebo as a continuous oral daily dose and exemestane as a continuous oral daily dose of 25 mg
Duration of Response (DOR) Based on BIRC Assessment	148.0 Days Interval 57.0 to 281.0	279.0 Days Interval 221.0 to 337.0

SECONDARY outcome

Timeframe: From randomization up to definitive deterioration of the ECOG PS by one categotu of the score, assessed up to approximately 3.5 years

Population: FAS including all subjects to whom study treatment was assigned by randomization

ECOG PS is a measure of functional status with scores ranging from 0 (fully active) to 5 (dead). Deterioration was considered definitive if no improvements in the ECOG PS status were observed after an instance of deterioration. Death was considered as worsening of the ECOG PS if it occurred close to the last assessment, where "close" is defined as twice the planned period between two assessments. Participants who died after more than twice the planned period between two assessments were censored at the date of their last assessment before the cut-off. Participants receiving any further anticancer therapy prior to definitive worsening were censored at their date of last assessment prior to start of therapy. Participants that had not worsened were censored at the date of last assessment prior to cut off. Time to definitive deterioration was estimated using the Kaplan-Meier method.

Outcome measures

Measure	Everolimus + Exemestane n=80 Participants Participants received everolimus as a continuous oral daily dose of 10 mg and exemestane as a continuous oral daily dose of 25 mg	Placebo + Exemestane n=79 Participants Participants received placebo as a continuous oral daily dose and exemestane as a continuous oral daily dose of 25 mg
Time to Definitive Deterioration of the Eastern Cooperative Oncology Group Performance Status (ECOG PS) by at Least One Category of the Score From Baseline	NA Months Not estimable (NA) due to the low number of participants with deterioration of ECOG PS	NA Months Not estimable (NA) due to the low number of participants with deterioration of ECOG PS

SECONDARY outcome

Timeframe: Predose on Cycle 1 Week 4 ( each cycle is defined as 4 weeks)

Population: All subjects with an evaluable everolimus concentration at the specified time point

Blood samples were collected to assess everolimus predose concentration (Cmin) at steady state at Cycle 1 Week 4 (any day during week 4). Steady-state was defined as having no dose adjustment/interruption of everolimus and exemestane in the previous 4 days prior to the day of the pre-dose PK sample collection.

Everolimus concentrations were determined in the whole blood by a liquid chromatography with tandem mass spectrometry (LC-MS/MS) method. The method has a lower limit of quantitation (LLOQ) of 0.3 ng/mL for everolimus. Values below the LLOQ were set to 0.

Outcome measures

Measure	Everolimus + Exemestane n=70 Participants Participants received everolimus as a continuous oral daily dose of 10 mg and exemestane as a continuous oral daily dose of 25 mg	Placebo + Exemestane Participants received placebo as a continuous oral daily dose and exemestane as a continuous oral daily dose of 25 mg
Everolimus Predose Concentration (Cmin)	16.5 nanogram/mililiter (ng/mL) Geometric Coefficient of Variation 59.1	—

SECONDARY outcome

Timeframe: Two hours post everolimus administration on Cycle 1 Week 4 ( each cycle is defined as 4 weeks)

Population: All subjects with an evaluable everolimus concentration at the specified time point

Blood samples were collected to assess everolimus concentration at 2 hours post dose (C2h) at steady state at Cycle 1 Week 4 (any day during week 4) Steady-state was defined as having no dose adjustment/interruption of everolimus and exemestane in the previous 4 days prior to the day of the pre-dose PK sample collection.

Everolimus concentrations were determined in the whole blood by a liquid chromatography with tandem mass spectrometry (LC-MS/MS) method. The method has a LLOQ of 0.3 ng/mL for everolimus. Values below the LLOQ were set to 0.

Outcome measures

Measure	Everolimus + Exemestane n=71 Participants Participants received everolimus as a continuous oral daily dose of 10 mg and exemestane as a continuous oral daily dose of 25 mg	Placebo + Exemestane Participants received placebo as a continuous oral daily dose and exemestane as a continuous oral daily dose of 25 mg
Everolimus Concentration at 2 Hours Post Dose (C2h)	44.2 ng/mL Geometric Coefficient of Variation 57.8	—

SECONDARY outcome

Timeframe: Predose of exemestane on Cycle 1 Week 4 ( each cycle is defined as 4 weeks)

Population: All subjects with an evaluable exemestane concentration at the specified time point

Blood samples were collected to assess exemestane predose concentration (Cmin) at steady state at Cycle 1 Week 4 (any day during week 4). Steady-state was defined as having no dose adjustment/interruption of everolimus and exemestane in the previous 4 days prior to the day of the pre-dose PK sample collection.

Exemestane concentrations were determined in the whole blood by a liquid chromatography with LC-MS/MS method. The method has a LLOQ of 20 pg/mL for exemestane. Values below the LLOQ were set to 0.

Outcome measures

Measure	Everolimus + Exemestane n=71 Participants Participants received everolimus as a continuous oral daily dose of 10 mg and exemestane as a continuous oral daily dose of 25 mg	Placebo + Exemestane n=71 Participants Participants received placebo as a continuous oral daily dose and exemestane as a continuous oral daily dose of 25 mg
Exemestane Predose Concentration (Cmin)	737 picogram/mililiter (pg/mL) Geometric Coefficient of Variation 74.2	502 picogram/mililiter (pg/mL) Geometric Coefficient of Variation 48.7

SECONDARY outcome

Timeframe: Two hours post exemestane administration on Cycle 1 Week 4 ( each cycle is defined as 4 weeks)

Population: All subjects with an evaluable exemestane concentration at the specified time point

Blood samples were collected to assess exemestane concentration at 2 hours post dose (C2h) at steady state at Cycle 1 Week 4 (any day during week 4) Steady-state was defined as having no dose adjustment/interruption of everolimus and exemestane in the previous 4 days prior to the day of the pre-dose PK sample collection.

Exemestane concentrations were determined in the whole blood by a liquid chromatography with LC-MS/MS method. The method has a LLOQ of 20 pg/mL for exemestane. Values below the LLOQ were set to 0.

Outcome measures

Measure	Everolimus + Exemestane n=72 Participants Participants received everolimus as a continuous oral daily dose of 10 mg and exemestane as a continuous oral daily dose of 25 mg	Placebo + Exemestane n=73 Participants Participants received placebo as a continuous oral daily dose and exemestane as a continuous oral daily dose of 25 mg
Exemestane Concentration at 2 Hours Post Dose (C2h)	20500 pg/mL Geometric Coefficient of Variation 97.1	14300 pg/mL Geometric Coefficient of Variation 71.6

SECONDARY outcome

Timeframe: Baseline, and at Cycle 1 Week 4 prior to any study drug (each cycle is defined as 4 weeks)

Population: All subjects with evaluable estradiol concentrations at the specified time points

Blood samples were collected to assess estradiol levels after 4 weeks of study treatment. Estradiol was determined in plasma using competitive immunoassay. The method has a LLOQ of 1.952 pg/mL for estradiol. Values below the LLOQ were set to 0.

Outcome measures

Measure	Everolimus + Exemestane n=72 Participants Participants received everolimus as a continuous oral daily dose of 10 mg and exemestane as a continuous oral daily dose of 25 mg	Placebo + Exemestane n=70 Participants Participants received placebo as a continuous oral daily dose and exemestane as a continuous oral daily dose of 25 mg
Estradiol Levels After 4 Weeks of Study Treatment Baseline	5.98 pg/mL Geometric Coefficient of Variation 10.5	5.38 pg/mL Geometric Coefficient of Variation 10.4
Estradiol Levels After 4 Weeks of Study Treatment Week 4	3.98 pg/mL Geometric Coefficient of Variation 7.77	3.77 pg/mL Geometric Coefficient of Variation 6.80

POST_HOC outcome

Timeframe: On-treatment deaths: Up to 3.5 years. Post-treatment survival follow-up deaths: Up to 3.8 years

Population: Safety set including all subjects who received at least one dose of study treatment.

On-treatment deaths were collected from first dose of study medication to 30 days after the last dose of study medication for a maximum duration of approximately 3.5 years Post-treatment survival follow-up deaths were collected after 30 days post-treatment, for a maximum duration of approximately 3.8 years All deaths refer to the sum of on-treatment and post-treatment deaths

Outcome measures

Measure	Everolimus + Exemestane n=80 Participants Participants received everolimus as a continuous oral daily dose of 10 mg and exemestane as a continuous oral daily dose of 25 mg	Placebo + Exemestane n=79 Participants Participants received placebo as a continuous oral daily dose and exemestane as a continuous oral daily dose of 25 mg
All Collected Deaths On-treatment deaths	3 Participants	2 Participants
All Collected Deaths Post-treatment survival follow-up deaths	41 Participants	43 Participants
All Collected Deaths All deaths	44 Participants	45 Participants

Adverse Events

Everolimus + Exemestane (On-treatment)

Serious events: 18 serious events

Other events: 79 other events

Deaths: 3 deaths

Placebo + Exemestane (On-treatment)

Serious events: 10 serious events

Other events: 62 other events

Deaths: 2 deaths

Everolimus + Exemestane (Post-treatment Survival Follow-up)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 41 deaths

Placebo + Exemestane (Post-treatment Survival Follow-up)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 43 deaths

Serious adverse events

Measure	Everolimus + Exemestane (On-treatment) n=80 participants at risk AEs collected during on-treatment period (up to 30 days post-treatment)	Placebo + Exemestane (On-treatment) n=79 participants at risk AEs collected during on-treatment period (up to 30 days post- treatment)	Everolimus + Exemestane (Post-treatment Survival Follow-up) Deaths collected in the post- treatment survival follow-up period (starting from day 31 post- treatment). No AEs were collected during this period	Placebo + Exemestane (Post-treatment Survival Follow-up) Deaths collected in the post- treatment survival follow-up period (starting from day 31 post- treatment). No AEs were collected during this period
Blood and lymphatic system disorders Thrombocytopenia	0.00% 0/80 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 3.5 years. Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 3.8 years. These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.	1.3% 1/79 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 3.5 years. Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 3.8 years. These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 3.5 years. Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 3.8 years. These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 3.5 years. Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 3.8 years. These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
Cardiac disorders Cardiac failure	1.2% 1/80 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 3.5 years. Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 3.8 years. These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.	0.00% 0/79 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 3.5 years. Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 3.8 years. These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 3.5 years. Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 3.8 years. These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 3.5 years. Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 3.8 years. These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
Gastrointestinal disorders Vomiting	1.2% 1/80 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 3.5 years. Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 3.8 years. These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.	0.00% 0/79 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 3.5 years. Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 3.8 years. These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 3.5 years. Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 3.8 years. These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 3.5 years. Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 3.8 years. These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
General disorders Multiple organ dysfunction syndrome	1.2% 1/80 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 3.5 years. Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 3.8 years. These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.	0.00% 0/79 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 3.5 years. Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 3.8 years. These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 3.5 years. Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 3.8 years. These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 3.5 years. Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 3.8 years. These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
General disorders Pyrexia	1.2% 1/80 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 3.5 years. Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 3.8 years. These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.	0.00% 0/79 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 3.5 years. Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 3.8 years. These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 3.5 years. Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 3.8 years. These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 3.5 years. Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 3.8 years. These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
Hepatobiliary disorders Cholecystitis	0.00% 0/80 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 3.5 years. Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 3.8 years. These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.	1.3% 1/79 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 3.5 years. Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 3.8 years. These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 3.5 years. Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 3.8 years. These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 3.5 years. Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 3.8 years. These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
Hepatobiliary disorders Hepatic function abnormal	0.00% 0/80 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 3.5 years. Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 3.8 years. These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.	1.3% 1/79 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 3.5 years. Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 3.8 years. These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 3.5 years. Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 3.8 years. These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 3.5 years. Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 3.8 years. These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
Infections and infestations Herpes virus infection	1.2% 1/80 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 3.5 years. Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 3.8 years. These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.	0.00% 0/79 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 3.5 years. Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 3.8 years. These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 3.5 years. Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 3.8 years. These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 3.5 years. Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 3.8 years. These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
Infections and infestations Pneumonia	7.5% 6/80 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 3.5 years. Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 3.8 years. These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.	0.00% 0/79 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 3.5 years. Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 3.8 years. These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 3.5 years. Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 3.8 years. These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 3.5 years. Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 3.8 years. These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
Infections and infestations Subcutaneous abscess	1.2% 1/80 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 3.5 years. Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 3.8 years. These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.	0.00% 0/79 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 3.5 years. Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 3.8 years. These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 3.5 years. Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 3.8 years. These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 3.5 years. Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 3.8 years. These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
Injury, poisoning and procedural complications Spinal compression fracture	1.2% 1/80 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 3.5 years. Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 3.8 years. These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.	0.00% 0/79 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 3.5 years. Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 3.8 years. These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 3.5 years. Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 3.8 years. These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 3.5 years. Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 3.8 years. These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
Investigations Neutrophil count decreased	1.2% 1/80 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 3.5 years. Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 3.8 years. These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.	0.00% 0/79 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 3.5 years. Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 3.8 years. These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 3.5 years. Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 3.8 years. These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 3.5 years. Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 3.8 years. These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
Metabolism and nutrition disorders Diabetic ketosis	1.2% 1/80 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 3.5 years. Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 3.8 years. These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.	0.00% 0/79 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 3.5 years. Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 3.8 years. These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 3.5 years. Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 3.8 years. These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 3.5 years. Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 3.8 years. These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
Metabolism and nutrition disorders Electrolyte imbalance	1.2% 1/80 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 3.5 years. Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 3.8 years. These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.	0.00% 0/79 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 3.5 years. Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 3.8 years. These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 3.5 years. Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 3.8 years. These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 3.5 years. Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 3.8 years. These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
Metabolism and nutrition disorders Hypercalcaemia	1.2% 1/80 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 3.5 years. Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 3.8 years. These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.	0.00% 0/79 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 3.5 years. Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 3.8 years. These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 3.5 years. Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 3.8 years. These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 3.5 years. Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 3.8 years. These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
Metabolism and nutrition disorders Hyperglycaemia	1.2% 1/80 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 3.5 years. Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 3.8 years. These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.	0.00% 0/79 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 3.5 years. Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 3.8 years. These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 3.5 years. Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 3.8 years. These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 3.5 years. Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 3.8 years. These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
Musculoskeletal and connective tissue disorders Back pain	1.2% 1/80 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 3.5 years. Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 3.8 years. These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.	0.00% 0/79 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 3.5 years. Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 3.8 years. These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 3.5 years. Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 3.8 years. These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 3.5 years. Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 3.8 years. These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
Musculoskeletal and connective tissue disorders Bone pain	0.00% 0/80 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 3.5 years. Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 3.8 years. These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.	2.5% 2/79 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 3.5 years. Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 3.8 years. These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 3.5 years. Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 3.8 years. These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 3.5 years. Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 3.8 years. These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
Musculoskeletal and connective tissue disorders Pain in extremity	0.00% 0/80 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 3.5 years. Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 3.8 years. These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.	1.3% 1/79 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 3.5 years. Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 3.8 years. These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 3.5 years. Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 3.8 years. These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 3.5 years. Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 3.8 years. These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
Musculoskeletal and connective tissue disorders Pathological fracture	0.00% 0/80 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 3.5 years. Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 3.8 years. These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.	1.3% 1/79 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 3.5 years. Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 3.8 years. These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 3.5 years. Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 3.8 years. These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 3.5 years. Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 3.8 years. These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
Renal and urinary disorders Renal failure	1.2% 1/80 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 3.5 years. Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 3.8 years. These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.	0.00% 0/79 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 3.5 years. Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 3.8 years. These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 3.5 years. Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 3.8 years. These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 3.5 years. Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 3.8 years. These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
Respiratory, thoracic and mediastinal disorders Cough	1.2% 1/80 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 3.5 years. Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 3.8 years. These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.	1.3% 1/79 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 3.5 years. Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 3.8 years. These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 3.5 years. Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 3.8 years. These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 3.5 years. Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 3.8 years. These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
Respiratory, thoracic and mediastinal disorders Interstitial lung disease	2.5% 2/80 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 3.5 years. Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 3.8 years. These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.	0.00% 0/79 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 3.5 years. Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 3.8 years. These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 3.5 years. Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 3.8 years. These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 3.5 years. Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 3.8 years. These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
Respiratory, thoracic and mediastinal disorders Pleural effusion	0.00% 0/80 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 3.5 years. Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 3.8 years. These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.	1.3% 1/79 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 3.5 years. Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 3.8 years. These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 3.5 years. Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 3.8 years. These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 3.5 years. Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 3.8 years. These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
Respiratory, thoracic and mediastinal disorders Respiratory failure	0.00% 0/80 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 3.5 years. Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 3.8 years. These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.	1.3% 1/79 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 3.5 years. Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 3.8 years. These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 3.5 years. Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 3.8 years. These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 3.5 years. Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 3.8 years. These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
Vascular disorders Hypotension	0.00% 0/80 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 3.5 years. Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 3.8 years. These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.	1.3% 1/79 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 3.5 years. Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 3.8 years. These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 3.5 years. Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 3.8 years. These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 3.5 years. Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 3.8 years. These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.

Other adverse events

Measure	Everolimus + Exemestane (On-treatment) n=80 participants at risk AEs collected during on-treatment period (up to 30 days post-treatment)	Placebo + Exemestane (On-treatment) n=79 participants at risk AEs collected during on-treatment period (up to 30 days post- treatment)	Everolimus + Exemestane (Post-treatment Survival Follow-up) Deaths collected in the post- treatment survival follow-up period (starting from day 31 post- treatment). No AEs were collected during this period	Placebo + Exemestane (Post-treatment Survival Follow-up) Deaths collected in the post- treatment survival follow-up period (starting from day 31 post- treatment). No AEs were collected during this period
Blood and lymphatic system disorders Anaemia	32.5% 26/80 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 3.5 years. Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 3.8 years. These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.	12.7% 10/79 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 3.5 years. Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 3.8 years. These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 3.5 years. Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 3.8 years. These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 3.5 years. Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 3.8 years. These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
Blood and lymphatic system disorders Leukopenia	12.5% 10/80 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 3.5 years. Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 3.8 years. These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.	3.8% 3/79 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 3.5 years. Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 3.8 years. These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 3.5 years. Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 3.8 years. These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 3.5 years. Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 3.8 years. These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
Blood and lymphatic system disorders Neutropenia	6.2% 5/80 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 3.5 years. Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 3.8 years. These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.	0.00% 0/79 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 3.5 years. Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 3.8 years. These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 3.5 years. Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 3.8 years. These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 3.5 years. Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 3.8 years. These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
Blood and lymphatic system disorders Thrombocytopenia	8.8% 7/80 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 3.5 years. Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 3.8 years. These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.	0.00% 0/79 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 3.5 years. Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 3.8 years. These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 3.5 years. Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 3.8 years. These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 3.5 years. Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 3.8 years. These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
Gastrointestinal disorders Abdominal pain upper	7.5% 6/80 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 3.5 years. Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 3.8 years. These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.	0.00% 0/79 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 3.5 years. Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 3.8 years. These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 3.5 years. Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 3.8 years. These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 3.5 years. Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 3.8 years. These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
Gastrointestinal disorders Aphthous ulcer	15.0% 12/80 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 3.5 years. Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 3.8 years. These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.	2.5% 2/79 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 3.5 years. Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 3.8 years. These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 3.5 years. Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 3.8 years. These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 3.5 years. Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 3.8 years. These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
Gastrointestinal disorders Diarrhoea	12.5% 10/80 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 3.5 years. Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 3.8 years. These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.	3.8% 3/79 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 3.5 years. Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 3.8 years. These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 3.5 years. Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 3.8 years. These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 3.5 years. Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 3.8 years. These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
Gastrointestinal disorders Mouth ulceration	23.8% 19/80 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 3.5 years. Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 3.8 years. These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.	3.8% 3/79 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 3.5 years. Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 3.8 years. These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 3.5 years. Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 3.8 years. These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 3.5 years. Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 3.8 years. These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
Gastrointestinal disorders Nausea	12.5% 10/80 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 3.5 years. Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 3.8 years. These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.	7.6% 6/79 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 3.5 years. Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 3.8 years. These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 3.5 years. Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 3.8 years. These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 3.5 years. Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 3.8 years. These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
Gastrointestinal disorders Stomatitis	35.0% 28/80 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 3.5 years. Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 3.8 years. These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.	6.3% 5/79 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 3.5 years. Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 3.8 years. These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 3.5 years. Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 3.8 years. These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 3.5 years. Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 3.8 years. These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
Gastrointestinal disorders Toothache	7.5% 6/80 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 3.5 years. Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 3.8 years. These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.	1.3% 1/79 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 3.5 years. Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 3.8 years. These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 3.5 years. Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 3.8 years. These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 3.5 years. Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 3.8 years. These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
Gastrointestinal disorders Vomiting	12.5% 10/80 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 3.5 years. Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 3.8 years. These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.	5.1% 4/79 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 3.5 years. Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 3.8 years. These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 3.5 years. Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 3.8 years. These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 3.5 years. Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 3.8 years. These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
General disorders Asthenia	6.2% 5/80 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 3.5 years. Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 3.8 years. These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.	3.8% 3/79 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 3.5 years. Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 3.8 years. These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 3.5 years. Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 3.8 years. These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 3.5 years. Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 3.8 years. These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
General disorders Chest discomfort	2.5% 2/80 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 3.5 years. Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 3.8 years. These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.	5.1% 4/79 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 3.5 years. Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 3.8 years. These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 3.5 years. Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 3.8 years. These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 3.5 years. Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 3.8 years. These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
General disorders Malaise	11.2% 9/80 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 3.5 years. Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 3.8 years. These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.	0.00% 0/79 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 3.5 years. Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 3.8 years. These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 3.5 years. Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 3.8 years. These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 3.5 years. Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 3.8 years. These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
General disorders Oedema peripheral	12.5% 10/80 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 3.5 years. Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 3.8 years. These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.	0.00% 0/79 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 3.5 years. Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 3.8 years. These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 3.5 years. Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 3.8 years. These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 3.5 years. Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 3.8 years. These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
General disorders Pyrexia	7.5% 6/80 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 3.5 years. Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 3.8 years. These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.	3.8% 3/79 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 3.5 years. Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 3.8 years. These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 3.5 years. Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 3.8 years. These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 3.5 years. Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 3.8 years. These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
Infections and infestations Pneumonia	13.8% 11/80 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 3.5 years. Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 3.8 years. These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.	3.8% 3/79 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 3.5 years. Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 3.8 years. These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 3.5 years. Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 3.8 years. These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 3.5 years. Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 3.8 years. These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
Infections and infestations Upper respiratory tract infection	10.0% 8/80 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 3.5 years. Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 3.8 years. These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.	7.6% 6/79 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 3.5 years. Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 3.8 years. These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 3.5 years. Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 3.8 years. These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 3.5 years. Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 3.8 years. These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
Infections and infestations Urinary tract infection	10.0% 8/80 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 3.5 years. Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 3.8 years. These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.	0.00% 0/79 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 3.5 years. Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 3.8 years. These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 3.5 years. Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 3.8 years. These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 3.5 years. Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 3.8 years. These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
Investigations Alanine aminotransferase increased	35.0% 28/80 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 3.5 years. Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 3.8 years. These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.	17.7% 14/79 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 3.5 years. Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 3.8 years. These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 3.5 years. Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 3.8 years. These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 3.5 years. Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 3.8 years. These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
Investigations Aspartate aminotransferase increased	47.5% 38/80 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 3.5 years. Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 3.8 years. These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.	19.0% 15/79 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 3.5 years. Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 3.8 years. These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 3.5 years. Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 3.8 years. These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 3.5 years. Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 3.8 years. These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
Investigations Bilirubin conjugated increased	0.00% 0/80 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 3.5 years. Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 3.8 years. These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.	5.1% 4/79 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 3.5 years. Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 3.8 years. These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 3.5 years. Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 3.8 years. These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 3.5 years. Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 3.8 years. These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
Investigations Blood albumin decreased	6.2% 5/80 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 3.5 years. Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 3.8 years. These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.	0.00% 0/79 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 3.5 years. Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 3.8 years. These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 3.5 years. Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 3.8 years. These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 3.5 years. Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 3.8 years. These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
Investigations Blood alkaline phosphatase increased	6.2% 5/80 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 3.5 years. Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 3.8 years. These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.	5.1% 4/79 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 3.5 years. Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 3.8 years. These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 3.5 years. Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 3.8 years. These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 3.5 years. Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 3.8 years. These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
Investigations Blood bilirubin increased	3.8% 3/80 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 3.5 years. Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 3.8 years. These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.	6.3% 5/79 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 3.5 years. Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 3.8 years. These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 3.5 years. Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 3.8 years. These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 3.5 years. Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 3.8 years. These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
Investigations Blood cholesterol increased	12.5% 10/80 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 3.5 years. Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 3.8 years. These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.	2.5% 2/79 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 3.5 years. Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 3.8 years. These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 3.5 years. Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 3.8 years. These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 3.5 years. Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 3.8 years. These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
Investigations Blood creatine phosphokinase increased	16.2% 13/80 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 3.5 years. Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 3.8 years. These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.	3.8% 3/79 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 3.5 years. Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 3.8 years. These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 3.5 years. Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 3.8 years. These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 3.5 years. Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 3.8 years. These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
Investigations Blood creatinine increased	7.5% 6/80 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 3.5 years. Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 3.8 years. These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.	5.1% 4/79 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 3.5 years. Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 3.8 years. These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 3.5 years. Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 3.8 years. These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 3.5 years. Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 3.8 years. These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
Investigations Blood glucose increased	6.2% 5/80 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 3.5 years. Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 3.8 years. These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.	1.3% 1/79 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 3.5 years. Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 3.8 years. These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 3.5 years. Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 3.8 years. These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 3.5 years. Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 3.8 years. These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
Investigations Blood lactate dehydrogenase increased	10.0% 8/80 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 3.5 years. Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 3.8 years. These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.	3.8% 3/79 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 3.5 years. Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 3.8 years. These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 3.5 years. Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 3.8 years. These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 3.5 years. Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 3.8 years. These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
Investigations Blood triglycerides increased	6.2% 5/80 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 3.5 years. Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 3.8 years. These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.	0.00% 0/79 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 3.5 years. Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 3.8 years. These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 3.5 years. Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 3.8 years. These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 3.5 years. Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 3.8 years. These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
Investigations Gamma-glutamyltransferase increased	17.5% 14/80 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 3.5 years. Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 3.8 years. These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.	7.6% 6/79 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 3.5 years. Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 3.8 years. These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 3.5 years. Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 3.8 years. These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 3.5 years. Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 3.8 years. These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
Investigations Low density lipoprotein increased	11.2% 9/80 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 3.5 years. Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 3.8 years. These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.	1.3% 1/79 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 3.5 years. Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 3.8 years. These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 3.5 years. Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 3.8 years. These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 3.5 years. Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 3.8 years. These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
Investigations Neutrophil count decreased	16.2% 13/80 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 3.5 years. Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 3.8 years. These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.	10.1% 8/79 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 3.5 years. Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 3.8 years. These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 3.5 years. Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 3.8 years. These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 3.5 years. Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 3.8 years. These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
Investigations Platelet count decreased	17.5% 14/80 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 3.5 years. Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 3.8 years. These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.	6.3% 5/79 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 3.5 years. Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 3.8 years. These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 3.5 years. Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 3.8 years. These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 3.5 years. Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 3.8 years. These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
Investigations Weight decreased	28.7% 23/80 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 3.5 years. Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 3.8 years. These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.	3.8% 3/79 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 3.5 years. Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 3.8 years. These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 3.5 years. Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 3.8 years. These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 3.5 years. Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 3.8 years. These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
Investigations Weight increased	1.2% 1/80 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 3.5 years. Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 3.8 years. These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.	5.1% 4/79 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 3.5 years. Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 3.8 years. These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 3.5 years. Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 3.8 years. These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 3.5 years. Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 3.8 years. These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
Investigations White blood cell count decreased	20.0% 16/80 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 3.5 years. Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 3.8 years. These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.	6.3% 5/79 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 3.5 years. Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 3.8 years. These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 3.5 years. Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 3.8 years. These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 3.5 years. Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 3.8 years. These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
Metabolism and nutrition disorders Decreased appetite	21.2% 17/80 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 3.5 years. Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 3.8 years. These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.	5.1% 4/79 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 3.5 years. Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 3.8 years. These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 3.5 years. Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 3.8 years. These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 3.5 years. Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 3.8 years. These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
Metabolism and nutrition disorders Hypercholesterolaemia	26.2% 21/80 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 3.5 years. Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 3.8 years. These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.	0.00% 0/79 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 3.5 years. Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 3.8 years. These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 3.5 years. Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 3.8 years. These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 3.5 years. Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 3.8 years. These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
Metabolism and nutrition disorders Hyperglycaemia	45.0% 36/80 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 3.5 years. Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 3.8 years. These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.	7.6% 6/79 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 3.5 years. Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 3.8 years. These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 3.5 years. Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 3.8 years. These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 3.5 years. Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 3.8 years. These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
Metabolism and nutrition disorders Hyperlipidaemia	7.5% 6/80 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 3.5 years. Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 3.8 years. These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.	3.8% 3/79 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 3.5 years. Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 3.8 years. These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 3.5 years. Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 3.8 years. These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 3.5 years. Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 3.8 years. These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
Metabolism and nutrition disorders Hypertriglyceridaemia	16.2% 13/80 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 3.5 years. Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 3.8 years. These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.	3.8% 3/79 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 3.5 years. Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 3.8 years. These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 3.5 years. Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 3.8 years. These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 3.5 years. Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 3.8 years. These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
Metabolism and nutrition disorders Hyperuricaemia	1.2% 1/80 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 3.5 years. Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 3.8 years. These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.	6.3% 5/79 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 3.5 years. Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 3.8 years. These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 3.5 years. Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 3.8 years. These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 3.5 years. Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 3.8 years. These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
Metabolism and nutrition disorders Hypokalaemia	15.0% 12/80 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 3.5 years. Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 3.8 years. These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.	1.3% 1/79 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 3.5 years. Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 3.8 years. These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 3.5 years. Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 3.8 years. These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 3.5 years. Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 3.8 years. These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
Metabolism and nutrition disorders Hyponatraemia	6.2% 5/80 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 3.5 years. Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 3.8 years. These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.	2.5% 2/79 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 3.5 years. Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 3.8 years. These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 3.5 years. Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 3.8 years. These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 3.5 years. Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 3.8 years. These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
Metabolism and nutrition disorders Hypophosphataemia	11.2% 9/80 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 3.5 years. Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 3.8 years. These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.	0.00% 0/79 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 3.5 years. Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 3.8 years. These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 3.5 years. Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 3.8 years. These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 3.5 years. Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 3.8 years. These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
Musculoskeletal and connective tissue disorders Arthralgia	7.5% 6/80 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 3.5 years. Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 3.8 years. These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.	8.9% 7/79 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 3.5 years. Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 3.8 years. These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 3.5 years. Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 3.8 years. These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 3.5 years. Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 3.8 years. These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
Musculoskeletal and connective tissue disorders Back pain	10.0% 8/80 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 3.5 years. Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 3.8 years. These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.	7.6% 6/79 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 3.5 years. Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 3.8 years. These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 3.5 years. Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 3.8 years. These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 3.5 years. Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 3.8 years. These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
Musculoskeletal and connective tissue disorders Pain in extremity	7.5% 6/80 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 3.5 years. Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 3.8 years. These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.	6.3% 5/79 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 3.5 years. Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 3.8 years. These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 3.5 years. Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 3.8 years. These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 3.5 years. Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 3.8 years. These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
Nervous system disorders Headache	2.5% 2/80 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 3.5 years. Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 3.8 years. These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.	6.3% 5/79 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 3.5 years. Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 3.8 years. These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 3.5 years. Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 3.8 years. These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 3.5 years. Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 3.8 years. These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
Psychiatric disorders Insomnia	10.0% 8/80 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 3.5 years. Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 3.8 years. These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.	2.5% 2/79 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 3.5 years. Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 3.8 years. These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 3.5 years. Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 3.8 years. These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 3.5 years. Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 3.8 years. These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
Respiratory, thoracic and mediastinal disorders Cough	20.0% 16/80 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 3.5 years. Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 3.8 years. These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.	7.6% 6/79 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 3.5 years. Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 3.8 years. These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 3.5 years. Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 3.8 years. These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 3.5 years. Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 3.8 years. These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
Respiratory, thoracic and mediastinal disorders Epistaxis	6.2% 5/80 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 3.5 years. Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 3.8 years. These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.	0.00% 0/79 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 3.5 years. Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 3.8 years. These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 3.5 years. Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 3.8 years. These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 3.5 years. Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 3.8 years. These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
Respiratory, thoracic and mediastinal disorders Interstitial lung disease	17.5% 14/80 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 3.5 years. Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 3.8 years. These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.	0.00% 0/79 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 3.5 years. Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 3.8 years. These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 3.5 years. Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 3.8 years. These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 3.5 years. Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 3.8 years. These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
Respiratory, thoracic and mediastinal disorders Pneumonitis	6.2% 5/80 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 3.5 years. Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 3.8 years. These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.	0.00% 0/79 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 3.5 years. Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 3.8 years. These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 3.5 years. Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 3.8 years. These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 3.5 years. Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 3.8 years. These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
Skin and subcutaneous tissue disorders Dermatitis acneiform	6.2% 5/80 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 3.5 years. Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 3.8 years. These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.	1.3% 1/79 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 3.5 years. Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 3.8 years. These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 3.5 years. Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 3.8 years. These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 3.5 years. Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 3.8 years. These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
Skin and subcutaneous tissue disorders Pruritus	8.8% 7/80 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 3.5 years. Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 3.8 years. These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.	3.8% 3/79 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 3.5 years. Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 3.8 years. These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 3.5 years. Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 3.8 years. These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 3.5 years. Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 3.8 years. These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
Skin and subcutaneous tissue disorders Rash	13.8% 11/80 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 3.5 years. Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 3.8 years. These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.	1.3% 1/79 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 3.5 years. Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 3.8 years. These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 3.5 years. Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 3.8 years. These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 3.5 years. Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 3.8 years. These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
Vascular disorders Hypertension	7.5% 6/80 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 3.5 years. Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 3.8 years. These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.	2.5% 2/79 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 3.5 years. Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 3.8 years. These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 3.5 years. Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 3.8 years. These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.	— 0/0 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 3.5 years. Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approx. 3.8 years. These are not considered AEs Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.

Additional Information

Study director

Novartis Pharmaceuticals

Phone: 862-778-8300

Email: Novartis.email@novartis.com

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 the pooled data (ie, data from all sites) in the clinical trial.
• Publication restrictions are in place

Restriction type: OTHER