Trial Outcomes & Findings for Study of 2 Ribociclib Doses in Combination With Aromatase Inhibitors in Women With HR+, HER2- Advanced Breast Cancer (NCT NCT03822468)
NCT ID: NCT03822468
Last Updated: 2025-10-16
Results Overview
ORR defined as the percentage of participants with best overall response (BOR) of confirmed complete response (CR) or partial response (PR) assessed by local investigators according to RECIST 1.1. CR: Disappearance of all lesions with lymph nodes measuring \< 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.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
376 participants
Primary outcome timeframe
Up to 23.8 months
Results posted on
2025-10-16
Participant Flow
Participants were enrolled in 90 centers across 23 countries.
A total of 558 subjects were screened of which 376 participants were randomized on a 1:1 basis.
Participant milestones
| Measure |
Ribociclib 400 mg
Ribociclib 400 mg QD 3 weeks on/1 week off + letrozole or anastrozole (+goserelin in premenopausal women)
|
Ribociclib 600 mg
Ribociclib 600 mg QD 3 weeks on/1 week off + letrozole or anastrozole (+ goserelin in premenopausal women)
|
|---|---|---|
|
Treatment Period
STARTED
|
188
|
188
|
|
Treatment Period
COMPLETED
|
0
|
0
|
|
Treatment Period
NOT COMPLETED
|
188
|
188
|
|
Post-treatment Efficacy Follow-up
STARTED
|
22
|
26
|
|
Post-treatment Efficacy Follow-up
COMPLETED
|
0
|
0
|
|
Post-treatment Efficacy Follow-up
NOT COMPLETED
|
22
|
26
|
Reasons for withdrawal
| Measure |
Ribociclib 400 mg
Ribociclib 400 mg QD 3 weeks on/1 week off + letrozole or anastrozole (+goserelin in premenopausal women)
|
Ribociclib 600 mg
Ribociclib 600 mg QD 3 weeks on/1 week off + letrozole or anastrozole (+ goserelin in premenopausal women)
|
|---|---|---|
|
Treatment Period
Progressive disease
|
98
|
94
|
|
Treatment Period
Adverse Event
|
21
|
24
|
|
Treatment Period
Withdrawal by Subject
|
9
|
5
|
|
Treatment Period
Physician Decision
|
9
|
7
|
|
Treatment Period
Protocol Violation
|
2
|
1
|
|
Treatment Period
Death
|
2
|
3
|
|
Treatment Period
Lost to Follow-up
|
1
|
1
|
|
Treatment Period
Sponsor decision
|
46
|
53
|
|
Post-treatment Efficacy Follow-up
Progressive disease
|
11
|
14
|
|
Post-treatment Efficacy Follow-up
Withdrawal by Subject
|
4
|
3
|
|
Post-treatment Efficacy Follow-up
Death
|
1
|
0
|
|
Post-treatment Efficacy Follow-up
Physician Decision
|
1
|
2
|
|
Post-treatment Efficacy Follow-up
Adverse Event
|
1
|
0
|
|
Post-treatment Efficacy Follow-up
Lost to Follow-up
|
1
|
0
|
|
Post-treatment Efficacy Follow-up
Sponsor decision
|
3
|
7
|
Baseline Characteristics
Study of 2 Ribociclib Doses in Combination With Aromatase Inhibitors in Women With HR+, HER2- Advanced Breast Cancer
Baseline characteristics by cohort
| Measure |
Ribociclib 400 mg
n=188 Participants
Ribociclib 400 mg QD 3 weeks on/1 week off + letrozole or anastrozole (+goserelin in premenopausal women)
|
Ribociclib 600 mg
n=188 Participants
Ribociclib 600 mg QD 3 weeks on/1 week off + letrozole or anastrozole (+ goserelin in premenopausal women)
|
Total
n=376 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
58.7 Years
STANDARD_DEVIATION 12.96 • n=5 Participants
|
57.0 Years
STANDARD_DEVIATION 12.37 • n=7 Participants
|
57.9 Years
STANDARD_DEVIATION 12.68 • n=5 Participants
|
|
Sex: Female, Male
Female
|
188 Participants
n=5 Participants
|
188 Participants
n=7 Participants
|
376 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
Caucasian
|
147 Participants
n=5 Participants
|
143 Participants
n=7 Participants
|
290 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Native American or Alaska Native
|
14 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
13 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black
|
5 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
1 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Unknown
|
8 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Up to 23.8 monthsPopulation: The Full Analysis Set (FAS) including all randomized participants
ORR defined as the percentage of participants with best overall response (BOR) of confirmed complete response (CR) or partial response (PR) assessed by local investigators according to RECIST 1.1. CR: Disappearance of all lesions with lymph nodes measuring \< 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 |
Ribociclib 400 mg
n=188 Participants
Ribociclib 400 mg QD 3 weeks on/1 week off + letrozole or anastrozole (+goserelin in premenopausal women)
|
Ribociclib 600 mg
n=188 Participants
Ribociclib 600 mg QD 3 weeks on/1 week off + letrozole or anastrozole (+ goserelin in premenopausal women)
|
|---|---|---|
|
Overall Response Rate (ORR)
|
41.5 Percentage of participants
Interval 34.4 to 48.7
|
45.3 Percentage of participants
Interval 38.1 to 52.6
|
SECONDARY outcome
Timeframe: Baseline and Cycle 1 Day 15 at 2 hours post-dose. Cycle = 28 daysPopulation: Participants who received at least one dose of study treatment and had available QT assessments conducted at both baseline and Cycle 1 Day 15 (2 hours post-dose)
Electrocardiogram (ECG) data was collected via 12-lead digital ECG machines. Change from baseline in the QT interval (a segment of the ECG that reflects the time it takes for the heart to repolarize after each heartbeat) was corrected for heart rate using Fridericia's formula (ΔQTcF).
Outcome measures
| Measure |
Ribociclib 400 mg
n=174 Participants
Ribociclib 400 mg QD 3 weeks on/1 week off + letrozole or anastrozole (+goserelin in premenopausal women)
|
Ribociclib 600 mg
n=175 Participants
Ribociclib 600 mg QD 3 weeks on/1 week off + letrozole or anastrozole (+ goserelin in premenopausal women)
|
|---|---|---|
|
Change From Baseline in QTc (With Fridericia's Correction) at Cycle 1 Day 15 (at 2 Hours Post-dose)
|
12.5 milliseconds
Standard Deviation 12.91
|
19.7 milliseconds
Standard Deviation 18.50
|
SECONDARY outcome
Timeframe: Up to approximately 60 monthsPopulation: The Full Analysis Set (FAS) including all randomized participants
Progression free survival (PFS) was defined as the time from the date of randomization to the date of the first documented disease progression or death due to any cause. PFS was censored if no PFS event was observed. The censoring date was the date of the last adequate tumor assessment. Clinical deterioration without objective radiological evidence was not considered as documented disease progression. PFS was assessed via a local radiology assessment as well as Blinded Independent Review Committee (BIRC) according to RECIST 1.1.
Outcome measures
| Measure |
Ribociclib 400 mg
n=188 Participants
Ribociclib 400 mg QD 3 weeks on/1 week off + letrozole or anastrozole (+goserelin in premenopausal women)
|
Ribociclib 600 mg
n=188 Participants
Ribociclib 600 mg QD 3 weeks on/1 week off + letrozole or anastrozole (+ goserelin in premenopausal women)
|
|---|---|---|
|
Progression-free Survival (PFS)
|
26.9 Months
Interval 20.3 to 30.4
|
25.1 Months
Interval 19.4 to 33.4
|
SECONDARY outcome
Timeframe: Up to approximately 60 monthsPopulation: The Full Analysis Set (FAS) including all randomized participants
Clinical benefit rate (CBR) was defined as the proportion of patients with a best overall response of complete response (CR), or partial response (PR), or an overall response of stable disease (SD), lasting for at least 24 weeks. CR, PR, and SD were defined as per local review as well as Blinded Independent Review Committee (BIRC) according to RECIST 1.1. A patient was considered to have SD for 24 weeks or longer if a SD response was recorded at 24-1=23 weeks or later from randomization, allowing for the ±1 week visit window for tumor assessments. CR: Disappearance of all lesions with lymph nodes measuring \< 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 |
Ribociclib 400 mg
n=188 Participants
Ribociclib 400 mg QD 3 weeks on/1 week off + letrozole or anastrozole (+goserelin in premenopausal women)
|
Ribociclib 600 mg
n=188 Participants
Ribociclib 600 mg QD 3 weeks on/1 week off + letrozole or anastrozole (+ goserelin in premenopausal women)
|
|---|---|---|
|
Clinical Benefit Rate (CBR)
|
142 Participants
|
133 Participants
|
SECONDARY outcome
Timeframe: Up to approximately 60 monthsPopulation: Full Analysis Set (FAS) - Only responders included
Time to response (TTR) was defined as the time from the date of randomization to the first documented response of either complete response (CR) or partial response (PR), which had to be subsequently confirmed (although the date of initial response was used, not the date of confirmation). CR and PR were based on tumor response data as per local review and according to RECIST 1.1. CR: Disappearance of all lesions with lymph nodes measuring \< 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 |
Ribociclib 400 mg
n=90 Participants
Ribociclib 400 mg QD 3 weeks on/1 week off + letrozole or anastrozole (+goserelin in premenopausal women)
|
Ribociclib 600 mg
n=103 Participants
Ribociclib 600 mg QD 3 weeks on/1 week off + letrozole or anastrozole (+ goserelin in premenopausal women)
|
|---|---|---|
|
Time to Response (TTR)
|
13.1 Months
Interval 7.4 to
NA: Not estimable due to insufficient number of participants with events
|
9.0 Months
Interval 5.6 to 16.4
|
SECONDARY outcome
Timeframe: Up to approximately 60 monthsPopulation: Full Analysis Set (FAS) - Only responders included
Duration of response (DOR) only applied to patients whose best overall response was complete response (CR) or partial response (PR) according to RECIST 1.1 based on tumor response data per local review. The start date was the date of first documented response of CR or PR (i.e. the start date of response, not the date when response was confirmed), and the end date was defined as the date of the first documented progression or death due to underlying cancer. Patients continuing without progression or death due to underlying cancer were censored at the date of their last adequate tumor assessment. CR: Disappearance of all lesions with lymph nodes measuring \< 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 |
Ribociclib 400 mg
n=90 Participants
Ribociclib 400 mg QD 3 weeks on/1 week off + letrozole or anastrozole (+goserelin in premenopausal women)
|
Ribociclib 600 mg
n=103 Participants
Ribociclib 600 mg QD 3 weeks on/1 week off + letrozole or anastrozole (+ goserelin in premenopausal women)
|
|---|---|---|
|
Duration of Response (DOR)
|
26.5 Months
Interval 16.8 to
NA: Not estimable due to insufficient number of participants with events
|
28.8 Months
Interval 22.6 to
NA: Not estimable due to insufficient number of participants with events
|
SECONDARY outcome
Timeframe: Cycle 1 Day 15 at pre-dose, and 2, 4, 6 and 24 hours post-dose. Cycle = 28 daysPopulation: Participants who provided an evaluable PK parameter (Cmax) and received at least 10 consecutive daily ribociclib doses of 400 mg or 600 mg immediately prior to and on the PK collection day
PK parameters were calculated by non-compartmental analysis. Cmax is the maximum observed plasma drug concentration after single dose administration.
Outcome measures
| Measure |
Ribociclib 400 mg
n=20 Participants
Ribociclib 400 mg QD 3 weeks on/1 week off + letrozole or anastrozole (+goserelin in premenopausal women)
|
Ribociclib 600 mg
n=16 Participants
Ribociclib 600 mg QD 3 weeks on/1 week off + letrozole or anastrozole (+ goserelin in premenopausal women)
|
|---|---|---|
|
Pharmacokinetics (PK) of Ribociclib: Maximum Observed Plasma Concentration (Cmax)
|
1240 nanogram / milliliter (ng / mL)
Standard Deviation 739
|
1740 nanogram / milliliter (ng / mL)
Standard Deviation 918
|
SECONDARY outcome
Timeframe: Cycle 1 Day 15 at pre-dose, and 2, 4, 6 and 24 hours post-dose. Cycle = 28 daysPopulation: Participants who provided an evaluable PK parameter (Tmax) and received at least 10 consecutive daily ribociclib doses of 400 mg or 600 mg immediately prior to and on the PK collection day
PK parameters were calculated by non-compartmental analysis. Tmax is the time to reach maximum observed plasma concentration. Actual recorded sampling times were considered for the calculations.
Outcome measures
| Measure |
Ribociclib 400 mg
n=20 Participants
Ribociclib 400 mg QD 3 weeks on/1 week off + letrozole or anastrozole (+goserelin in premenopausal women)
|
Ribociclib 600 mg
n=16 Participants
Ribociclib 600 mg QD 3 weeks on/1 week off + letrozole or anastrozole (+ goserelin in premenopausal women)
|
|---|---|---|
|
PK of Ribociclib: Time to Reach Observed Maximum Concentration (Tmax)
|
2.08 hours (h)
Interval 1.83 to 4.38
|
4.00 hours (h)
Interval 1.83 to 23.8
|
SECONDARY outcome
Timeframe: Cycle 1 Day 15 at pre-dose, and 2, 4, 6 and 24 hours post-dose. Cycle = 28 daysPopulation: Participants who provided an evaluable PK parameter (AUC0-24) and received at least 10 consecutive daily ribociclib doses of 400 mg or 600 mg immediately prior to and on the PK collection day
PK parameters were calculated by non-compartmental analysis. AUC0-24 is the area under the plasma concentration-time curve from 0 to 24 hours
Outcome measures
| Measure |
Ribociclib 400 mg
n=17 Participants
Ribociclib 400 mg QD 3 weeks on/1 week off + letrozole or anastrozole (+goserelin in premenopausal women)
|
Ribociclib 600 mg
n=13 Participants
Ribociclib 600 mg QD 3 weeks on/1 week off + letrozole or anastrozole (+ goserelin in premenopausal women)
|
|---|---|---|
|
PK of Ribociclib: Area Under the Plasma Concentration-time Curve From 0 to 24 Hours (AUC0-24)
|
18700 ng x h / mL
Standard Deviation 11600
|
31600 ng x h / mL
Standard Deviation 14300
|
Adverse Events
Ribociclib 400mg
Serious events: 38 serious events
Other events: 175 other events
Deaths: 5 deaths
Ribociclib 600mg
Serious events: 37 serious events
Other events: 178 other events
Deaths: 6 deaths
Ribociclib 400mg (Post-treatment Efficacy Follow-up)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 3 deaths
Ribociclib 600 mg (Post-treatment Efficacy Follow-up)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 2 deaths
Serious adverse events
| Measure |
Ribociclib 400mg
n=188 participants at risk
Ribociclib 400 mg QD 3 weeks on/1 week off + letrozole or anastrozole (+goserelin in premenopausal women) - Events up to 30 days safety follow-up
|
Ribociclib 600mg
n=188 participants at risk
Ribociclib 600 mg QD 3 weeks on/1 week off + letrozole or anastrozole (+ goserelin in premenopausal women) - Events up to 30 days safety follow-up
|
Ribociclib 400mg (Post-treatment Efficacy Follow-up)
Ribociclib 400mg (Post-treatment efficacy follow-up) - Deaths in the post-treatment efficacy follow-up period were not considered adverse events.
|
Ribociclib 600 mg (Post-treatment Efficacy Follow-up)
Ribociclib 600 mg (Post-treatment efficacy follow-up) - Deaths in the post-treatment efficacy follow-up period were not considered adverse events.
|
|---|---|---|---|---|
|
General disorders
Asthenia
|
0.00%
0/188 • Adverse events (AEs) were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to 23.8 months. Deaths were collected in the post-treatment efficacy follow-up from 31 days after last dose of study medication until the end of the study, up to 62 months.
Deaths in the post-treatment efficacy follow-up were not considered adverse events. The total number at risk in the post-treatment efficacy follow-up included patients who entered this period.
|
0.53%
1/188 • Adverse events (AEs) were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to 23.8 months. Deaths were collected in the post-treatment efficacy follow-up from 31 days after last dose of study medication until the end of the study, up to 62 months.
Deaths in the post-treatment efficacy follow-up were not considered adverse events. The total number at risk in the post-treatment efficacy follow-up included patients who entered this period.
|
—
0/0 • Adverse events (AEs) were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to 23.8 months. Deaths were collected in the post-treatment efficacy follow-up from 31 days after last dose of study medication until the end of the study, up to 62 months.
Deaths in the post-treatment efficacy follow-up were not considered adverse events. The total number at risk in the post-treatment efficacy follow-up included patients who entered this period.
|
—
0/0 • Adverse events (AEs) were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to 23.8 months. Deaths were collected in the post-treatment efficacy follow-up from 31 days after last dose of study medication until the end of the study, up to 62 months.
Deaths in the post-treatment efficacy follow-up were not considered adverse events. The total number at risk in the post-treatment efficacy follow-up included patients who entered this period.
|
|
Blood and lymphatic system disorders
Anaemia
|
0.53%
1/188 • Adverse events (AEs) were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to 23.8 months. Deaths were collected in the post-treatment efficacy follow-up from 31 days after last dose of study medication until the end of the study, up to 62 months.
Deaths in the post-treatment efficacy follow-up were not considered adverse events. The total number at risk in the post-treatment efficacy follow-up included patients who entered this period.
|
0.00%
0/188 • Adverse events (AEs) were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to 23.8 months. Deaths were collected in the post-treatment efficacy follow-up from 31 days after last dose of study medication until the end of the study, up to 62 months.
Deaths in the post-treatment efficacy follow-up were not considered adverse events. The total number at risk in the post-treatment efficacy follow-up included patients who entered this period.
|
—
0/0 • Adverse events (AEs) were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to 23.8 months. Deaths were collected in the post-treatment efficacy follow-up from 31 days after last dose of study medication until the end of the study, up to 62 months.
Deaths in the post-treatment efficacy follow-up were not considered adverse events. The total number at risk in the post-treatment efficacy follow-up included patients who entered this period.
|
—
0/0 • Adverse events (AEs) were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to 23.8 months. Deaths were collected in the post-treatment efficacy follow-up from 31 days after last dose of study medication until the end of the study, up to 62 months.
Deaths in the post-treatment efficacy follow-up were not considered adverse events. The total number at risk in the post-treatment efficacy follow-up included patients who entered this period.
|
|
Blood and lymphatic system disorders
Leukopenia
|
0.53%
1/188 • Adverse events (AEs) were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to 23.8 months. Deaths were collected in the post-treatment efficacy follow-up from 31 days after last dose of study medication until the end of the study, up to 62 months.
Deaths in the post-treatment efficacy follow-up were not considered adverse events. The total number at risk in the post-treatment efficacy follow-up included patients who entered this period.
|
0.53%
1/188 • Adverse events (AEs) were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to 23.8 months. Deaths were collected in the post-treatment efficacy follow-up from 31 days after last dose of study medication until the end of the study, up to 62 months.
Deaths in the post-treatment efficacy follow-up were not considered adverse events. The total number at risk in the post-treatment efficacy follow-up included patients who entered this period.
|
—
0/0 • Adverse events (AEs) were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to 23.8 months. Deaths were collected in the post-treatment efficacy follow-up from 31 days after last dose of study medication until the end of the study, up to 62 months.
Deaths in the post-treatment efficacy follow-up were not considered adverse events. The total number at risk in the post-treatment efficacy follow-up included patients who entered this period.
|
—
0/0 • Adverse events (AEs) were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to 23.8 months. Deaths were collected in the post-treatment efficacy follow-up from 31 days after last dose of study medication until the end of the study, up to 62 months.
Deaths in the post-treatment efficacy follow-up were not considered adverse events. The total number at risk in the post-treatment efficacy follow-up included patients who entered this period.
|
|
Blood and lymphatic system disorders
Lymphopenia
|
0.53%
1/188 • Adverse events (AEs) were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to 23.8 months. Deaths were collected in the post-treatment efficacy follow-up from 31 days after last dose of study medication until the end of the study, up to 62 months.
Deaths in the post-treatment efficacy follow-up were not considered adverse events. The total number at risk in the post-treatment efficacy follow-up included patients who entered this period.
|
0.53%
1/188 • Adverse events (AEs) were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to 23.8 months. Deaths were collected in the post-treatment efficacy follow-up from 31 days after last dose of study medication until the end of the study, up to 62 months.
Deaths in the post-treatment efficacy follow-up were not considered adverse events. The total number at risk in the post-treatment efficacy follow-up included patients who entered this period.
|
—
0/0 • Adverse events (AEs) were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to 23.8 months. Deaths were collected in the post-treatment efficacy follow-up from 31 days after last dose of study medication until the end of the study, up to 62 months.
Deaths in the post-treatment efficacy follow-up were not considered adverse events. The total number at risk in the post-treatment efficacy follow-up included patients who entered this period.
|
—
0/0 • Adverse events (AEs) were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to 23.8 months. Deaths were collected in the post-treatment efficacy follow-up from 31 days after last dose of study medication until the end of the study, up to 62 months.
Deaths in the post-treatment efficacy follow-up were not considered adverse events. The total number at risk in the post-treatment efficacy follow-up included patients who entered this period.
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/188 • Adverse events (AEs) were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to 23.8 months. Deaths were collected in the post-treatment efficacy follow-up from 31 days after last dose of study medication until the end of the study, up to 62 months.
Deaths in the post-treatment efficacy follow-up were not considered adverse events. The total number at risk in the post-treatment efficacy follow-up included patients who entered this period.
|
0.53%
1/188 • Adverse events (AEs) were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to 23.8 months. Deaths were collected in the post-treatment efficacy follow-up from 31 days after last dose of study medication until the end of the study, up to 62 months.
Deaths in the post-treatment efficacy follow-up were not considered adverse events. The total number at risk in the post-treatment efficacy follow-up included patients who entered this period.
|
—
0/0 • Adverse events (AEs) were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to 23.8 months. Deaths were collected in the post-treatment efficacy follow-up from 31 days after last dose of study medication until the end of the study, up to 62 months.
Deaths in the post-treatment efficacy follow-up were not considered adverse events. The total number at risk in the post-treatment efficacy follow-up included patients who entered this period.
|
—
0/0 • Adverse events (AEs) were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to 23.8 months. Deaths were collected in the post-treatment efficacy follow-up from 31 days after last dose of study medication until the end of the study, up to 62 months.
Deaths in the post-treatment efficacy follow-up were not considered adverse events. The total number at risk in the post-treatment efficacy follow-up included patients who entered this period.
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/188 • Adverse events (AEs) were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to 23.8 months. Deaths were collected in the post-treatment efficacy follow-up from 31 days after last dose of study medication until the end of the study, up to 62 months.
Deaths in the post-treatment efficacy follow-up were not considered adverse events. The total number at risk in the post-treatment efficacy follow-up included patients who entered this period.
|
1.1%
2/188 • Adverse events (AEs) were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to 23.8 months. Deaths were collected in the post-treatment efficacy follow-up from 31 days after last dose of study medication until the end of the study, up to 62 months.
Deaths in the post-treatment efficacy follow-up were not considered adverse events. The total number at risk in the post-treatment efficacy follow-up included patients who entered this period.
|
—
0/0 • Adverse events (AEs) were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to 23.8 months. Deaths were collected in the post-treatment efficacy follow-up from 31 days after last dose of study medication until the end of the study, up to 62 months.
Deaths in the post-treatment efficacy follow-up were not considered adverse events. The total number at risk in the post-treatment efficacy follow-up included patients who entered this period.
|
—
0/0 • Adverse events (AEs) were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to 23.8 months. Deaths were collected in the post-treatment efficacy follow-up from 31 days after last dose of study medication until the end of the study, up to 62 months.
Deaths in the post-treatment efficacy follow-up were not considered adverse events. The total number at risk in the post-treatment efficacy follow-up included patients who entered this period.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/188 • Adverse events (AEs) were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to 23.8 months. Deaths were collected in the post-treatment efficacy follow-up from 31 days after last dose of study medication until the end of the study, up to 62 months.
Deaths in the post-treatment efficacy follow-up were not considered adverse events. The total number at risk in the post-treatment efficacy follow-up included patients who entered this period.
|
0.53%
1/188 • Adverse events (AEs) were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to 23.8 months. Deaths were collected in the post-treatment efficacy follow-up from 31 days after last dose of study medication until the end of the study, up to 62 months.
Deaths in the post-treatment efficacy follow-up were not considered adverse events. The total number at risk in the post-treatment efficacy follow-up included patients who entered this period.
|
—
0/0 • Adverse events (AEs) were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to 23.8 months. Deaths were collected in the post-treatment efficacy follow-up from 31 days after last dose of study medication until the end of the study, up to 62 months.
Deaths in the post-treatment efficacy follow-up were not considered adverse events. The total number at risk in the post-treatment efficacy follow-up included patients who entered this period.
|
—
0/0 • Adverse events (AEs) were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to 23.8 months. Deaths were collected in the post-treatment efficacy follow-up from 31 days after last dose of study medication until the end of the study, up to 62 months.
Deaths in the post-treatment efficacy follow-up were not considered adverse events. The total number at risk in the post-treatment efficacy follow-up included patients who entered this period.
|
|
Gastrointestinal disorders
Abdominal pain lower
|
0.00%
0/188 • Adverse events (AEs) were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to 23.8 months. Deaths were collected in the post-treatment efficacy follow-up from 31 days after last dose of study medication until the end of the study, up to 62 months.
Deaths in the post-treatment efficacy follow-up were not considered adverse events. The total number at risk in the post-treatment efficacy follow-up included patients who entered this period.
|
0.53%
1/188 • Adverse events (AEs) were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to 23.8 months. Deaths were collected in the post-treatment efficacy follow-up from 31 days after last dose of study medication until the end of the study, up to 62 months.
Deaths in the post-treatment efficacy follow-up were not considered adverse events. The total number at risk in the post-treatment efficacy follow-up included patients who entered this period.
|
—
0/0 • Adverse events (AEs) were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to 23.8 months. Deaths were collected in the post-treatment efficacy follow-up from 31 days after last dose of study medication until the end of the study, up to 62 months.
Deaths in the post-treatment efficacy follow-up were not considered adverse events. The total number at risk in the post-treatment efficacy follow-up included patients who entered this period.
|
—
0/0 • Adverse events (AEs) were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to 23.8 months. Deaths were collected in the post-treatment efficacy follow-up from 31 days after last dose of study medication until the end of the study, up to 62 months.
Deaths in the post-treatment efficacy follow-up were not considered adverse events. The total number at risk in the post-treatment efficacy follow-up included patients who entered this period.
|
|
Gastrointestinal disorders
Colitis
|
1.1%
2/188 • Adverse events (AEs) were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to 23.8 months. Deaths were collected in the post-treatment efficacy follow-up from 31 days after last dose of study medication until the end of the study, up to 62 months.
Deaths in the post-treatment efficacy follow-up were not considered adverse events. The total number at risk in the post-treatment efficacy follow-up included patients who entered this period.
|
0.00%
0/188 • Adverse events (AEs) were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to 23.8 months. Deaths were collected in the post-treatment efficacy follow-up from 31 days after last dose of study medication until the end of the study, up to 62 months.
Deaths in the post-treatment efficacy follow-up were not considered adverse events. The total number at risk in the post-treatment efficacy follow-up included patients who entered this period.
|
—
0/0 • Adverse events (AEs) were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to 23.8 months. Deaths were collected in the post-treatment efficacy follow-up from 31 days after last dose of study medication until the end of the study, up to 62 months.
Deaths in the post-treatment efficacy follow-up were not considered adverse events. The total number at risk in the post-treatment efficacy follow-up included patients who entered this period.
|
—
0/0 • Adverse events (AEs) were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to 23.8 months. Deaths were collected in the post-treatment efficacy follow-up from 31 days after last dose of study medication until the end of the study, up to 62 months.
Deaths in the post-treatment efficacy follow-up were not considered adverse events. The total number at risk in the post-treatment efficacy follow-up included patients who entered this period.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.53%
1/188 • Adverse events (AEs) were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to 23.8 months. Deaths were collected in the post-treatment efficacy follow-up from 31 days after last dose of study medication until the end of the study, up to 62 months.
Deaths in the post-treatment efficacy follow-up were not considered adverse events. The total number at risk in the post-treatment efficacy follow-up included patients who entered this period.
|
0.00%
0/188 • Adverse events (AEs) were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to 23.8 months. Deaths were collected in the post-treatment efficacy follow-up from 31 days after last dose of study medication until the end of the study, up to 62 months.
Deaths in the post-treatment efficacy follow-up were not considered adverse events. The total number at risk in the post-treatment efficacy follow-up included patients who entered this period.
|
—
0/0 • Adverse events (AEs) were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to 23.8 months. Deaths were collected in the post-treatment efficacy follow-up from 31 days after last dose of study medication until the end of the study, up to 62 months.
Deaths in the post-treatment efficacy follow-up were not considered adverse events. The total number at risk in the post-treatment efficacy follow-up included patients who entered this period.
|
—
0/0 • Adverse events (AEs) were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to 23.8 months. Deaths were collected in the post-treatment efficacy follow-up from 31 days after last dose of study medication until the end of the study, up to 62 months.
Deaths in the post-treatment efficacy follow-up were not considered adverse events. The total number at risk in the post-treatment efficacy follow-up included patients who entered this period.
|
|
Gastrointestinal disorders
Enterocolitis
|
0.53%
1/188 • Adverse events (AEs) were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to 23.8 months. Deaths were collected in the post-treatment efficacy follow-up from 31 days after last dose of study medication until the end of the study, up to 62 months.
Deaths in the post-treatment efficacy follow-up were not considered adverse events. The total number at risk in the post-treatment efficacy follow-up included patients who entered this period.
|
0.00%
0/188 • Adverse events (AEs) were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to 23.8 months. Deaths were collected in the post-treatment efficacy follow-up from 31 days after last dose of study medication until the end of the study, up to 62 months.
Deaths in the post-treatment efficacy follow-up were not considered adverse events. The total number at risk in the post-treatment efficacy follow-up included patients who entered this period.
|
—
0/0 • Adverse events (AEs) were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to 23.8 months. Deaths were collected in the post-treatment efficacy follow-up from 31 days after last dose of study medication until the end of the study, up to 62 months.
Deaths in the post-treatment efficacy follow-up were not considered adverse events. The total number at risk in the post-treatment efficacy follow-up included patients who entered this period.
|
—
0/0 • Adverse events (AEs) were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to 23.8 months. Deaths were collected in the post-treatment efficacy follow-up from 31 days after last dose of study medication until the end of the study, up to 62 months.
Deaths in the post-treatment efficacy follow-up were not considered adverse events. The total number at risk in the post-treatment efficacy follow-up included patients who entered this period.
|
|
Gastrointestinal disorders
Ileus
|
0.53%
1/188 • Adverse events (AEs) were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to 23.8 months. Deaths were collected in the post-treatment efficacy follow-up from 31 days after last dose of study medication until the end of the study, up to 62 months.
Deaths in the post-treatment efficacy follow-up were not considered adverse events. The total number at risk in the post-treatment efficacy follow-up included patients who entered this period.
|
0.00%
0/188 • Adverse events (AEs) were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to 23.8 months. Deaths were collected in the post-treatment efficacy follow-up from 31 days after last dose of study medication until the end of the study, up to 62 months.
Deaths in the post-treatment efficacy follow-up were not considered adverse events. The total number at risk in the post-treatment efficacy follow-up included patients who entered this period.
|
—
0/0 • Adverse events (AEs) were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to 23.8 months. Deaths were collected in the post-treatment efficacy follow-up from 31 days after last dose of study medication until the end of the study, up to 62 months.
Deaths in the post-treatment efficacy follow-up were not considered adverse events. The total number at risk in the post-treatment efficacy follow-up included patients who entered this period.
|
—
0/0 • Adverse events (AEs) were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to 23.8 months. Deaths were collected in the post-treatment efficacy follow-up from 31 days after last dose of study medication until the end of the study, up to 62 months.
Deaths in the post-treatment efficacy follow-up were not considered adverse events. The total number at risk in the post-treatment efficacy follow-up included patients who entered this period.
|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.00%
0/188 • Adverse events (AEs) were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to 23.8 months. Deaths were collected in the post-treatment efficacy follow-up from 31 days after last dose of study medication until the end of the study, up to 62 months.
Deaths in the post-treatment efficacy follow-up were not considered adverse events. The total number at risk in the post-treatment efficacy follow-up included patients who entered this period.
|
0.53%
1/188 • Adverse events (AEs) were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to 23.8 months. Deaths were collected in the post-treatment efficacy follow-up from 31 days after last dose of study medication until the end of the study, up to 62 months.
Deaths in the post-treatment efficacy follow-up were not considered adverse events. The total number at risk in the post-treatment efficacy follow-up included patients who entered this period.
|
—
0/0 • Adverse events (AEs) were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to 23.8 months. Deaths were collected in the post-treatment efficacy follow-up from 31 days after last dose of study medication until the end of the study, up to 62 months.
Deaths in the post-treatment efficacy follow-up were not considered adverse events. The total number at risk in the post-treatment efficacy follow-up included patients who entered this period.
|
—
0/0 • Adverse events (AEs) were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to 23.8 months. Deaths were collected in the post-treatment efficacy follow-up from 31 days after last dose of study medication until the end of the study, up to 62 months.
Deaths in the post-treatment efficacy follow-up were not considered adverse events. The total number at risk in the post-treatment efficacy follow-up included patients who entered this period.
|
|
Gastrointestinal disorders
Nausea
|
0.53%
1/188 • Adverse events (AEs) were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to 23.8 months. Deaths were collected in the post-treatment efficacy follow-up from 31 days after last dose of study medication until the end of the study, up to 62 months.
Deaths in the post-treatment efficacy follow-up were not considered adverse events. The total number at risk in the post-treatment efficacy follow-up included patients who entered this period.
|
0.53%
1/188 • Adverse events (AEs) were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to 23.8 months. Deaths were collected in the post-treatment efficacy follow-up from 31 days after last dose of study medication until the end of the study, up to 62 months.
Deaths in the post-treatment efficacy follow-up were not considered adverse events. The total number at risk in the post-treatment efficacy follow-up included patients who entered this period.
|
—
0/0 • Adverse events (AEs) were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to 23.8 months. Deaths were collected in the post-treatment efficacy follow-up from 31 days after last dose of study medication until the end of the study, up to 62 months.
Deaths in the post-treatment efficacy follow-up were not considered adverse events. The total number at risk in the post-treatment efficacy follow-up included patients who entered this period.
|
—
0/0 • Adverse events (AEs) were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to 23.8 months. Deaths were collected in the post-treatment efficacy follow-up from 31 days after last dose of study medication until the end of the study, up to 62 months.
Deaths in the post-treatment efficacy follow-up were not considered adverse events. The total number at risk in the post-treatment efficacy follow-up included patients who entered this period.
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.00%
0/188 • Adverse events (AEs) were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to 23.8 months. Deaths were collected in the post-treatment efficacy follow-up from 31 days after last dose of study medication until the end of the study, up to 62 months.
Deaths in the post-treatment efficacy follow-up were not considered adverse events. The total number at risk in the post-treatment efficacy follow-up included patients who entered this period.
|
0.53%
1/188 • Adverse events (AEs) were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to 23.8 months. Deaths were collected in the post-treatment efficacy follow-up from 31 days after last dose of study medication until the end of the study, up to 62 months.
Deaths in the post-treatment efficacy follow-up were not considered adverse events. The total number at risk in the post-treatment efficacy follow-up included patients who entered this period.
|
—
0/0 • Adverse events (AEs) were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to 23.8 months. Deaths were collected in the post-treatment efficacy follow-up from 31 days after last dose of study medication until the end of the study, up to 62 months.
Deaths in the post-treatment efficacy follow-up were not considered adverse events. The total number at risk in the post-treatment efficacy follow-up included patients who entered this period.
|
—
0/0 • Adverse events (AEs) were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to 23.8 months. Deaths were collected in the post-treatment efficacy follow-up from 31 days after last dose of study medication until the end of the study, up to 62 months.
Deaths in the post-treatment efficacy follow-up were not considered adverse events. The total number at risk in the post-treatment efficacy follow-up included patients who entered this period.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/188 • Adverse events (AEs) were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to 23.8 months. Deaths were collected in the post-treatment efficacy follow-up from 31 days after last dose of study medication until the end of the study, up to 62 months.
Deaths in the post-treatment efficacy follow-up were not considered adverse events. The total number at risk in the post-treatment efficacy follow-up included patients who entered this period.
|
0.53%
1/188 • Adverse events (AEs) were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to 23.8 months. Deaths were collected in the post-treatment efficacy follow-up from 31 days after last dose of study medication until the end of the study, up to 62 months.
Deaths in the post-treatment efficacy follow-up were not considered adverse events. The total number at risk in the post-treatment efficacy follow-up included patients who entered this period.
|
—
0/0 • Adverse events (AEs) were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to 23.8 months. Deaths were collected in the post-treatment efficacy follow-up from 31 days after last dose of study medication until the end of the study, up to 62 months.
Deaths in the post-treatment efficacy follow-up were not considered adverse events. The total number at risk in the post-treatment efficacy follow-up included patients who entered this period.
|
—
0/0 • Adverse events (AEs) were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to 23.8 months. Deaths were collected in the post-treatment efficacy follow-up from 31 days after last dose of study medication until the end of the study, up to 62 months.
Deaths in the post-treatment efficacy follow-up were not considered adverse events. The total number at risk in the post-treatment efficacy follow-up included patients who entered this period.
|
|
General disorders
Ill-defined disorder
|
0.00%
0/188 • Adverse events (AEs) were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to 23.8 months. Deaths were collected in the post-treatment efficacy follow-up from 31 days after last dose of study medication until the end of the study, up to 62 months.
Deaths in the post-treatment efficacy follow-up were not considered adverse events. The total number at risk in the post-treatment efficacy follow-up included patients who entered this period.
|
0.53%
1/188 • Adverse events (AEs) were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to 23.8 months. Deaths were collected in the post-treatment efficacy follow-up from 31 days after last dose of study medication until the end of the study, up to 62 months.
Deaths in the post-treatment efficacy follow-up were not considered adverse events. The total number at risk in the post-treatment efficacy follow-up included patients who entered this period.
|
—
0/0 • Adverse events (AEs) were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to 23.8 months. Deaths were collected in the post-treatment efficacy follow-up from 31 days after last dose of study medication until the end of the study, up to 62 months.
Deaths in the post-treatment efficacy follow-up were not considered adverse events. The total number at risk in the post-treatment efficacy follow-up included patients who entered this period.
|
—
0/0 • Adverse events (AEs) were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to 23.8 months. Deaths were collected in the post-treatment efficacy follow-up from 31 days after last dose of study medication until the end of the study, up to 62 months.
Deaths in the post-treatment efficacy follow-up were not considered adverse events. The total number at risk in the post-treatment efficacy follow-up included patients who entered this period.
|
|
General disorders
Pain
|
0.53%
1/188 • Adverse events (AEs) were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to 23.8 months. Deaths were collected in the post-treatment efficacy follow-up from 31 days after last dose of study medication until the end of the study, up to 62 months.
Deaths in the post-treatment efficacy follow-up were not considered adverse events. The total number at risk in the post-treatment efficacy follow-up included patients who entered this period.
|
0.53%
1/188 • Adverse events (AEs) were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to 23.8 months. Deaths were collected in the post-treatment efficacy follow-up from 31 days after last dose of study medication until the end of the study, up to 62 months.
Deaths in the post-treatment efficacy follow-up were not considered adverse events. The total number at risk in the post-treatment efficacy follow-up included patients who entered this period.
|
—
0/0 • Adverse events (AEs) were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to 23.8 months. Deaths were collected in the post-treatment efficacy follow-up from 31 days after last dose of study medication until the end of the study, up to 62 months.
Deaths in the post-treatment efficacy follow-up were not considered adverse events. The total number at risk in the post-treatment efficacy follow-up included patients who entered this period.
|
—
0/0 • Adverse events (AEs) were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to 23.8 months. Deaths were collected in the post-treatment efficacy follow-up from 31 days after last dose of study medication until the end of the study, up to 62 months.
Deaths in the post-treatment efficacy follow-up were not considered adverse events. The total number at risk in the post-treatment efficacy follow-up included patients who entered this period.
|
|
General disorders
Pyrexia
|
0.53%
1/188 • Adverse events (AEs) were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to 23.8 months. Deaths were collected in the post-treatment efficacy follow-up from 31 days after last dose of study medication until the end of the study, up to 62 months.
Deaths in the post-treatment efficacy follow-up were not considered adverse events. The total number at risk in the post-treatment efficacy follow-up included patients who entered this period.
|
0.00%
0/188 • Adverse events (AEs) were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to 23.8 months. Deaths were collected in the post-treatment efficacy follow-up from 31 days after last dose of study medication until the end of the study, up to 62 months.
Deaths in the post-treatment efficacy follow-up were not considered adverse events. The total number at risk in the post-treatment efficacy follow-up included patients who entered this period.
|
—
0/0 • Adverse events (AEs) were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to 23.8 months. Deaths were collected in the post-treatment efficacy follow-up from 31 days after last dose of study medication until the end of the study, up to 62 months.
Deaths in the post-treatment efficacy follow-up were not considered adverse events. The total number at risk in the post-treatment efficacy follow-up included patients who entered this period.
|
—
0/0 • Adverse events (AEs) were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to 23.8 months. Deaths were collected in the post-treatment efficacy follow-up from 31 days after last dose of study medication until the end of the study, up to 62 months.
Deaths in the post-treatment efficacy follow-up were not considered adverse events. The total number at risk in the post-treatment efficacy follow-up included patients who entered this period.
|
|
Hepatobiliary disorders
Autoimmune hepatitis
|
0.53%
1/188 • Adverse events (AEs) were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to 23.8 months. Deaths were collected in the post-treatment efficacy follow-up from 31 days after last dose of study medication until the end of the study, up to 62 months.
Deaths in the post-treatment efficacy follow-up were not considered adverse events. The total number at risk in the post-treatment efficacy follow-up included patients who entered this period.
|
0.00%
0/188 • Adverse events (AEs) were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to 23.8 months. Deaths were collected in the post-treatment efficacy follow-up from 31 days after last dose of study medication until the end of the study, up to 62 months.
Deaths in the post-treatment efficacy follow-up were not considered adverse events. The total number at risk in the post-treatment efficacy follow-up included patients who entered this period.
|
—
0/0 • Adverse events (AEs) were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to 23.8 months. Deaths were collected in the post-treatment efficacy follow-up from 31 days after last dose of study medication until the end of the study, up to 62 months.
Deaths in the post-treatment efficacy follow-up were not considered adverse events. The total number at risk in the post-treatment efficacy follow-up included patients who entered this period.
|
—
0/0 • Adverse events (AEs) were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to 23.8 months. Deaths were collected in the post-treatment efficacy follow-up from 31 days after last dose of study medication until the end of the study, up to 62 months.
Deaths in the post-treatment efficacy follow-up were not considered adverse events. The total number at risk in the post-treatment efficacy follow-up included patients who entered this period.
|
|
Hepatobiliary disorders
Cholecystitis
|
0.53%
1/188 • Adverse events (AEs) were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to 23.8 months. Deaths were collected in the post-treatment efficacy follow-up from 31 days after last dose of study medication until the end of the study, up to 62 months.
Deaths in the post-treatment efficacy follow-up were not considered adverse events. The total number at risk in the post-treatment efficacy follow-up included patients who entered this period.
|
0.00%
0/188 • Adverse events (AEs) were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to 23.8 months. Deaths were collected in the post-treatment efficacy follow-up from 31 days after last dose of study medication until the end of the study, up to 62 months.
Deaths in the post-treatment efficacy follow-up were not considered adverse events. The total number at risk in the post-treatment efficacy follow-up included patients who entered this period.
|
—
0/0 • Adverse events (AEs) were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to 23.8 months. Deaths were collected in the post-treatment efficacy follow-up from 31 days after last dose of study medication until the end of the study, up to 62 months.
Deaths in the post-treatment efficacy follow-up were not considered adverse events. The total number at risk in the post-treatment efficacy follow-up included patients who entered this period.
|
—
0/0 • Adverse events (AEs) were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to 23.8 months. Deaths were collected in the post-treatment efficacy follow-up from 31 days after last dose of study medication until the end of the study, up to 62 months.
Deaths in the post-treatment efficacy follow-up were not considered adverse events. The total number at risk in the post-treatment efficacy follow-up included patients who entered this period.
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.00%
0/188 • Adverse events (AEs) were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to 23.8 months. Deaths were collected in the post-treatment efficacy follow-up from 31 days after last dose of study medication until the end of the study, up to 62 months.
Deaths in the post-treatment efficacy follow-up were not considered adverse events. The total number at risk in the post-treatment efficacy follow-up included patients who entered this period.
|
0.53%
1/188 • Adverse events (AEs) were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to 23.8 months. Deaths were collected in the post-treatment efficacy follow-up from 31 days after last dose of study medication until the end of the study, up to 62 months.
Deaths in the post-treatment efficacy follow-up were not considered adverse events. The total number at risk in the post-treatment efficacy follow-up included patients who entered this period.
|
—
0/0 • Adverse events (AEs) were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to 23.8 months. Deaths were collected in the post-treatment efficacy follow-up from 31 days after last dose of study medication until the end of the study, up to 62 months.
Deaths in the post-treatment efficacy follow-up were not considered adverse events. The total number at risk in the post-treatment efficacy follow-up included patients who entered this period.
|
—
0/0 • Adverse events (AEs) were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to 23.8 months. Deaths were collected in the post-treatment efficacy follow-up from 31 days after last dose of study medication until the end of the study, up to 62 months.
Deaths in the post-treatment efficacy follow-up were not considered adverse events. The total number at risk in the post-treatment efficacy follow-up included patients who entered this period.
|
|
Hepatobiliary disorders
Drug-induced liver injury
|
1.1%
2/188 • Adverse events (AEs) were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to 23.8 months. Deaths were collected in the post-treatment efficacy follow-up from 31 days after last dose of study medication until the end of the study, up to 62 months.
Deaths in the post-treatment efficacy follow-up were not considered adverse events. The total number at risk in the post-treatment efficacy follow-up included patients who entered this period.
|
0.53%
1/188 • Adverse events (AEs) were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to 23.8 months. Deaths were collected in the post-treatment efficacy follow-up from 31 days after last dose of study medication until the end of the study, up to 62 months.
Deaths in the post-treatment efficacy follow-up were not considered adverse events. The total number at risk in the post-treatment efficacy follow-up included patients who entered this period.
|
—
0/0 • Adverse events (AEs) were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to 23.8 months. Deaths were collected in the post-treatment efficacy follow-up from 31 days after last dose of study medication until the end of the study, up to 62 months.
Deaths in the post-treatment efficacy follow-up were not considered adverse events. The total number at risk in the post-treatment efficacy follow-up included patients who entered this period.
|
—
0/0 • Adverse events (AEs) were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to 23.8 months. Deaths were collected in the post-treatment efficacy follow-up from 31 days after last dose of study medication until the end of the study, up to 62 months.
Deaths in the post-treatment efficacy follow-up were not considered adverse events. The total number at risk in the post-treatment efficacy follow-up included patients who entered this period.
|
|
Hepatobiliary disorders
Hepatic failure
|
0.53%
1/188 • Adverse events (AEs) were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to 23.8 months. Deaths were collected in the post-treatment efficacy follow-up from 31 days after last dose of study medication until the end of the study, up to 62 months.
Deaths in the post-treatment efficacy follow-up were not considered adverse events. The total number at risk in the post-treatment efficacy follow-up included patients who entered this period.
|
0.00%
0/188 • Adverse events (AEs) were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to 23.8 months. Deaths were collected in the post-treatment efficacy follow-up from 31 days after last dose of study medication until the end of the study, up to 62 months.
Deaths in the post-treatment efficacy follow-up were not considered adverse events. The total number at risk in the post-treatment efficacy follow-up included patients who entered this period.
|
—
0/0 • Adverse events (AEs) were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to 23.8 months. Deaths were collected in the post-treatment efficacy follow-up from 31 days after last dose of study medication until the end of the study, up to 62 months.
Deaths in the post-treatment efficacy follow-up were not considered adverse events. The total number at risk in the post-treatment efficacy follow-up included patients who entered this period.
|
—
0/0 • Adverse events (AEs) were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to 23.8 months. Deaths were collected in the post-treatment efficacy follow-up from 31 days after last dose of study medication until the end of the study, up to 62 months.
Deaths in the post-treatment efficacy follow-up were not considered adverse events. The total number at risk in the post-treatment efficacy follow-up included patients who entered this period.
|
|
Hepatobiliary disorders
Hepatotoxicity
|
1.1%
2/188 • Adverse events (AEs) were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to 23.8 months. Deaths were collected in the post-treatment efficacy follow-up from 31 days after last dose of study medication until the end of the study, up to 62 months.
Deaths in the post-treatment efficacy follow-up were not considered adverse events. The total number at risk in the post-treatment efficacy follow-up included patients who entered this period.
|
0.00%
0/188 • Adverse events (AEs) were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to 23.8 months. Deaths were collected in the post-treatment efficacy follow-up from 31 days after last dose of study medication until the end of the study, up to 62 months.
Deaths in the post-treatment efficacy follow-up were not considered adverse events. The total number at risk in the post-treatment efficacy follow-up included patients who entered this period.
|
—
0/0 • Adverse events (AEs) were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to 23.8 months. Deaths were collected in the post-treatment efficacy follow-up from 31 days after last dose of study medication until the end of the study, up to 62 months.
Deaths in the post-treatment efficacy follow-up were not considered adverse events. The total number at risk in the post-treatment efficacy follow-up included patients who entered this period.
|
—
0/0 • Adverse events (AEs) were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to 23.8 months. Deaths were collected in the post-treatment efficacy follow-up from 31 days after last dose of study medication until the end of the study, up to 62 months.
Deaths in the post-treatment efficacy follow-up were not considered adverse events. The total number at risk in the post-treatment efficacy follow-up included patients who entered this period.
|
|
Immune system disorders
Haemophagocytic lymphohistiocytosis
|
0.53%
1/188 • Adverse events (AEs) were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to 23.8 months. Deaths were collected in the post-treatment efficacy follow-up from 31 days after last dose of study medication until the end of the study, up to 62 months.
Deaths in the post-treatment efficacy follow-up were not considered adverse events. The total number at risk in the post-treatment efficacy follow-up included patients who entered this period.
|
0.00%
0/188 • Adverse events (AEs) were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to 23.8 months. Deaths were collected in the post-treatment efficacy follow-up from 31 days after last dose of study medication until the end of the study, up to 62 months.
Deaths in the post-treatment efficacy follow-up were not considered adverse events. The total number at risk in the post-treatment efficacy follow-up included patients who entered this period.
|
—
0/0 • Adverse events (AEs) were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to 23.8 months. Deaths were collected in the post-treatment efficacy follow-up from 31 days after last dose of study medication until the end of the study, up to 62 months.
Deaths in the post-treatment efficacy follow-up were not considered adverse events. The total number at risk in the post-treatment efficacy follow-up included patients who entered this period.
|
—
0/0 • Adverse events (AEs) were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to 23.8 months. Deaths were collected in the post-treatment efficacy follow-up from 31 days after last dose of study medication until the end of the study, up to 62 months.
Deaths in the post-treatment efficacy follow-up were not considered adverse events. The total number at risk in the post-treatment efficacy follow-up included patients who entered this period.
|
|
Infections and infestations
COVID-19
|
1.1%
2/188 • Adverse events (AEs) were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to 23.8 months. Deaths were collected in the post-treatment efficacy follow-up from 31 days after last dose of study medication until the end of the study, up to 62 months.
Deaths in the post-treatment efficacy follow-up were not considered adverse events. The total number at risk in the post-treatment efficacy follow-up included patients who entered this period.
|
1.1%
2/188 • Adverse events (AEs) were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to 23.8 months. Deaths were collected in the post-treatment efficacy follow-up from 31 days after last dose of study medication until the end of the study, up to 62 months.
Deaths in the post-treatment efficacy follow-up were not considered adverse events. The total number at risk in the post-treatment efficacy follow-up included patients who entered this period.
|
—
0/0 • Adverse events (AEs) were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to 23.8 months. Deaths were collected in the post-treatment efficacy follow-up from 31 days after last dose of study medication until the end of the study, up to 62 months.
Deaths in the post-treatment efficacy follow-up were not considered adverse events. The total number at risk in the post-treatment efficacy follow-up included patients who entered this period.
|
—
0/0 • Adverse events (AEs) were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to 23.8 months. Deaths were collected in the post-treatment efficacy follow-up from 31 days after last dose of study medication until the end of the study, up to 62 months.
Deaths in the post-treatment efficacy follow-up were not considered adverse events. The total number at risk in the post-treatment efficacy follow-up included patients who entered this period.
|
|
Infections and infestations
COVID-19 pneumonia
|
1.6%
3/188 • Adverse events (AEs) were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to 23.8 months. Deaths were collected in the post-treatment efficacy follow-up from 31 days after last dose of study medication until the end of the study, up to 62 months.
Deaths in the post-treatment efficacy follow-up were not considered adverse events. The total number at risk in the post-treatment efficacy follow-up included patients who entered this period.
|
0.53%
1/188 • Adverse events (AEs) were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to 23.8 months. Deaths were collected in the post-treatment efficacy follow-up from 31 days after last dose of study medication until the end of the study, up to 62 months.
Deaths in the post-treatment efficacy follow-up were not considered adverse events. The total number at risk in the post-treatment efficacy follow-up included patients who entered this period.
|
—
0/0 • Adverse events (AEs) were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to 23.8 months. Deaths were collected in the post-treatment efficacy follow-up from 31 days after last dose of study medication until the end of the study, up to 62 months.
Deaths in the post-treatment efficacy follow-up were not considered adverse events. The total number at risk in the post-treatment efficacy follow-up included patients who entered this period.
|
—
0/0 • Adverse events (AEs) were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to 23.8 months. Deaths were collected in the post-treatment efficacy follow-up from 31 days after last dose of study medication until the end of the study, up to 62 months.
Deaths in the post-treatment efficacy follow-up were not considered adverse events. The total number at risk in the post-treatment efficacy follow-up included patients who entered this period.
|
|
Infections and infestations
Cellulitis
|
0.53%
1/188 • Adverse events (AEs) were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to 23.8 months. Deaths were collected in the post-treatment efficacy follow-up from 31 days after last dose of study medication until the end of the study, up to 62 months.
Deaths in the post-treatment efficacy follow-up were not considered adverse events. The total number at risk in the post-treatment efficacy follow-up included patients who entered this period.
|
0.00%
0/188 • Adverse events (AEs) were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to 23.8 months. Deaths were collected in the post-treatment efficacy follow-up from 31 days after last dose of study medication until the end of the study, up to 62 months.
Deaths in the post-treatment efficacy follow-up were not considered adverse events. The total number at risk in the post-treatment efficacy follow-up included patients who entered this period.
|
—
0/0 • Adverse events (AEs) were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to 23.8 months. Deaths were collected in the post-treatment efficacy follow-up from 31 days after last dose of study medication until the end of the study, up to 62 months.
Deaths in the post-treatment efficacy follow-up were not considered adverse events. The total number at risk in the post-treatment efficacy follow-up included patients who entered this period.
|
—
0/0 • Adverse events (AEs) were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to 23.8 months. Deaths were collected in the post-treatment efficacy follow-up from 31 days after last dose of study medication until the end of the study, up to 62 months.
Deaths in the post-treatment efficacy follow-up were not considered adverse events. The total number at risk in the post-treatment efficacy follow-up included patients who entered this period.
|
|
Infections and infestations
Coronavirus pneumonia
|
0.53%
1/188 • Adverse events (AEs) were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to 23.8 months. Deaths were collected in the post-treatment efficacy follow-up from 31 days after last dose of study medication until the end of the study, up to 62 months.
Deaths in the post-treatment efficacy follow-up were not considered adverse events. The total number at risk in the post-treatment efficacy follow-up included patients who entered this period.
|
0.00%
0/188 • Adverse events (AEs) were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to 23.8 months. Deaths were collected in the post-treatment efficacy follow-up from 31 days after last dose of study medication until the end of the study, up to 62 months.
Deaths in the post-treatment efficacy follow-up were not considered adverse events. The total number at risk in the post-treatment efficacy follow-up included patients who entered this period.
|
—
0/0 • Adverse events (AEs) were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to 23.8 months. Deaths were collected in the post-treatment efficacy follow-up from 31 days after last dose of study medication until the end of the study, up to 62 months.
Deaths in the post-treatment efficacy follow-up were not considered adverse events. The total number at risk in the post-treatment efficacy follow-up included patients who entered this period.
|
—
0/0 • Adverse events (AEs) were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to 23.8 months. Deaths were collected in the post-treatment efficacy follow-up from 31 days after last dose of study medication until the end of the study, up to 62 months.
Deaths in the post-treatment efficacy follow-up were not considered adverse events. The total number at risk in the post-treatment efficacy follow-up included patients who entered this period.
|
|
Infections and infestations
Diverticulitis
|
0.53%
1/188 • Adverse events (AEs) were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to 23.8 months. Deaths were collected in the post-treatment efficacy follow-up from 31 days after last dose of study medication until the end of the study, up to 62 months.
Deaths in the post-treatment efficacy follow-up were not considered adverse events. The total number at risk in the post-treatment efficacy follow-up included patients who entered this period.
|
0.53%
1/188 • Adverse events (AEs) were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to 23.8 months. Deaths were collected in the post-treatment efficacy follow-up from 31 days after last dose of study medication until the end of the study, up to 62 months.
Deaths in the post-treatment efficacy follow-up were not considered adverse events. The total number at risk in the post-treatment efficacy follow-up included patients who entered this period.
|
—
0/0 • Adverse events (AEs) were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to 23.8 months. Deaths were collected in the post-treatment efficacy follow-up from 31 days after last dose of study medication until the end of the study, up to 62 months.
Deaths in the post-treatment efficacy follow-up were not considered adverse events. The total number at risk in the post-treatment efficacy follow-up included patients who entered this period.
|
—
0/0 • Adverse events (AEs) were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to 23.8 months. Deaths were collected in the post-treatment efficacy follow-up from 31 days after last dose of study medication until the end of the study, up to 62 months.
Deaths in the post-treatment efficacy follow-up were not considered adverse events. The total number at risk in the post-treatment efficacy follow-up included patients who entered this period.
|
|
Infections and infestations
Lymphangitis
|
0.00%
0/188 • Adverse events (AEs) were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to 23.8 months. Deaths were collected in the post-treatment efficacy follow-up from 31 days after last dose of study medication until the end of the study, up to 62 months.
Deaths in the post-treatment efficacy follow-up were not considered adverse events. The total number at risk in the post-treatment efficacy follow-up included patients who entered this period.
|
1.1%
2/188 • Adverse events (AEs) were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to 23.8 months. Deaths were collected in the post-treatment efficacy follow-up from 31 days after last dose of study medication until the end of the study, up to 62 months.
Deaths in the post-treatment efficacy follow-up were not considered adverse events. The total number at risk in the post-treatment efficacy follow-up included patients who entered this period.
|
—
0/0 • Adverse events (AEs) were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to 23.8 months. Deaths were collected in the post-treatment efficacy follow-up from 31 days after last dose of study medication until the end of the study, up to 62 months.
Deaths in the post-treatment efficacy follow-up were not considered adverse events. The total number at risk in the post-treatment efficacy follow-up included patients who entered this period.
|
—
0/0 • Adverse events (AEs) were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to 23.8 months. Deaths were collected in the post-treatment efficacy follow-up from 31 days after last dose of study medication until the end of the study, up to 62 months.
Deaths in the post-treatment efficacy follow-up were not considered adverse events. The total number at risk in the post-treatment efficacy follow-up included patients who entered this period.
|
|
Infections and infestations
Oesophageal candidiasis
|
0.00%
0/188 • Adverse events (AEs) were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to 23.8 months. Deaths were collected in the post-treatment efficacy follow-up from 31 days after last dose of study medication until the end of the study, up to 62 months.
Deaths in the post-treatment efficacy follow-up were not considered adverse events. The total number at risk in the post-treatment efficacy follow-up included patients who entered this period.
|
0.53%
1/188 • Adverse events (AEs) were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to 23.8 months. Deaths were collected in the post-treatment efficacy follow-up from 31 days after last dose of study medication until the end of the study, up to 62 months.
Deaths in the post-treatment efficacy follow-up were not considered adverse events. The total number at risk in the post-treatment efficacy follow-up included patients who entered this period.
|
—
0/0 • Adverse events (AEs) were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to 23.8 months. Deaths were collected in the post-treatment efficacy follow-up from 31 days after last dose of study medication until the end of the study, up to 62 months.
Deaths in the post-treatment efficacy follow-up were not considered adverse events. The total number at risk in the post-treatment efficacy follow-up included patients who entered this period.
|
—
0/0 • Adverse events (AEs) were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to 23.8 months. Deaths were collected in the post-treatment efficacy follow-up from 31 days after last dose of study medication until the end of the study, up to 62 months.
Deaths in the post-treatment efficacy follow-up were not considered adverse events. The total number at risk in the post-treatment efficacy follow-up included patients who entered this period.
|
|
Infections and infestations
Pneumonia
|
1.1%
2/188 • Adverse events (AEs) were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to 23.8 months. Deaths were collected in the post-treatment efficacy follow-up from 31 days after last dose of study medication until the end of the study, up to 62 months.
Deaths in the post-treatment efficacy follow-up were not considered adverse events. The total number at risk in the post-treatment efficacy follow-up included patients who entered this period.
|
1.6%
3/188 • Adverse events (AEs) were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to 23.8 months. Deaths were collected in the post-treatment efficacy follow-up from 31 days after last dose of study medication until the end of the study, up to 62 months.
Deaths in the post-treatment efficacy follow-up were not considered adverse events. The total number at risk in the post-treatment efficacy follow-up included patients who entered this period.
|
—
0/0 • Adverse events (AEs) were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to 23.8 months. Deaths were collected in the post-treatment efficacy follow-up from 31 days after last dose of study medication until the end of the study, up to 62 months.
Deaths in the post-treatment efficacy follow-up were not considered adverse events. The total number at risk in the post-treatment efficacy follow-up included patients who entered this period.
|
—
0/0 • Adverse events (AEs) were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to 23.8 months. Deaths were collected in the post-treatment efficacy follow-up from 31 days after last dose of study medication until the end of the study, up to 62 months.
Deaths in the post-treatment efficacy follow-up were not considered adverse events. The total number at risk in the post-treatment efficacy follow-up included patients who entered this period.
|
|
Infections and infestations
Postoperative wound infection
|
0.53%
1/188 • Adverse events (AEs) were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to 23.8 months. Deaths were collected in the post-treatment efficacy follow-up from 31 days after last dose of study medication until the end of the study, up to 62 months.
Deaths in the post-treatment efficacy follow-up were not considered adverse events. The total number at risk in the post-treatment efficacy follow-up included patients who entered this period.
|
0.00%
0/188 • Adverse events (AEs) were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to 23.8 months. Deaths were collected in the post-treatment efficacy follow-up from 31 days after last dose of study medication until the end of the study, up to 62 months.
Deaths in the post-treatment efficacy follow-up were not considered adverse events. The total number at risk in the post-treatment efficacy follow-up included patients who entered this period.
|
—
0/0 • Adverse events (AEs) were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to 23.8 months. Deaths were collected in the post-treatment efficacy follow-up from 31 days after last dose of study medication until the end of the study, up to 62 months.
Deaths in the post-treatment efficacy follow-up were not considered adverse events. The total number at risk in the post-treatment efficacy follow-up included patients who entered this period.
|
—
0/0 • Adverse events (AEs) were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to 23.8 months. Deaths were collected in the post-treatment efficacy follow-up from 31 days after last dose of study medication until the end of the study, up to 62 months.
Deaths in the post-treatment efficacy follow-up were not considered adverse events. The total number at risk in the post-treatment efficacy follow-up included patients who entered this period.
|
|
Infections and infestations
Sepsis
|
0.53%
1/188 • Adverse events (AEs) were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to 23.8 months. Deaths were collected in the post-treatment efficacy follow-up from 31 days after last dose of study medication until the end of the study, up to 62 months.
Deaths in the post-treatment efficacy follow-up were not considered adverse events. The total number at risk in the post-treatment efficacy follow-up included patients who entered this period.
|
0.53%
1/188 • Adverse events (AEs) were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to 23.8 months. Deaths were collected in the post-treatment efficacy follow-up from 31 days after last dose of study medication until the end of the study, up to 62 months.
Deaths in the post-treatment efficacy follow-up were not considered adverse events. The total number at risk in the post-treatment efficacy follow-up included patients who entered this period.
|
—
0/0 • Adverse events (AEs) were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to 23.8 months. Deaths were collected in the post-treatment efficacy follow-up from 31 days after last dose of study medication until the end of the study, up to 62 months.
Deaths in the post-treatment efficacy follow-up were not considered adverse events. The total number at risk in the post-treatment efficacy follow-up included patients who entered this period.
|
—
0/0 • Adverse events (AEs) were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to 23.8 months. Deaths were collected in the post-treatment efficacy follow-up from 31 days after last dose of study medication until the end of the study, up to 62 months.
Deaths in the post-treatment efficacy follow-up were not considered adverse events. The total number at risk in the post-treatment efficacy follow-up included patients who entered this period.
|
|
Infections and infestations
Urinary tract infection
|
0.53%
1/188 • Adverse events (AEs) were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to 23.8 months. Deaths were collected in the post-treatment efficacy follow-up from 31 days after last dose of study medication until the end of the study, up to 62 months.
Deaths in the post-treatment efficacy follow-up were not considered adverse events. The total number at risk in the post-treatment efficacy follow-up included patients who entered this period.
|
0.00%
0/188 • Adverse events (AEs) were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to 23.8 months. Deaths were collected in the post-treatment efficacy follow-up from 31 days after last dose of study medication until the end of the study, up to 62 months.
Deaths in the post-treatment efficacy follow-up were not considered adverse events. The total number at risk in the post-treatment efficacy follow-up included patients who entered this period.
|
—
0/0 • Adverse events (AEs) were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to 23.8 months. Deaths were collected in the post-treatment efficacy follow-up from 31 days after last dose of study medication until the end of the study, up to 62 months.
Deaths in the post-treatment efficacy follow-up were not considered adverse events. The total number at risk in the post-treatment efficacy follow-up included patients who entered this period.
|
—
0/0 • Adverse events (AEs) were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to 23.8 months. Deaths were collected in the post-treatment efficacy follow-up from 31 days after last dose of study medication until the end of the study, up to 62 months.
Deaths in the post-treatment efficacy follow-up were not considered adverse events. The total number at risk in the post-treatment efficacy follow-up included patients who entered this period.
|
|
Injury, poisoning and procedural complications
Femur fracture
|
0.53%
1/188 • Adverse events (AEs) were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to 23.8 months. Deaths were collected in the post-treatment efficacy follow-up from 31 days after last dose of study medication until the end of the study, up to 62 months.
Deaths in the post-treatment efficacy follow-up were not considered adverse events. The total number at risk in the post-treatment efficacy follow-up included patients who entered this period.
|
0.00%
0/188 • Adverse events (AEs) were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to 23.8 months. Deaths were collected in the post-treatment efficacy follow-up from 31 days after last dose of study medication until the end of the study, up to 62 months.
Deaths in the post-treatment efficacy follow-up were not considered adverse events. The total number at risk in the post-treatment efficacy follow-up included patients who entered this period.
|
—
0/0 • Adverse events (AEs) were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to 23.8 months. Deaths were collected in the post-treatment efficacy follow-up from 31 days after last dose of study medication until the end of the study, up to 62 months.
Deaths in the post-treatment efficacy follow-up were not considered adverse events. The total number at risk in the post-treatment efficacy follow-up included patients who entered this period.
|
—
0/0 • Adverse events (AEs) were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to 23.8 months. Deaths were collected in the post-treatment efficacy follow-up from 31 days after last dose of study medication until the end of the study, up to 62 months.
Deaths in the post-treatment efficacy follow-up were not considered adverse events. The total number at risk in the post-treatment efficacy follow-up included patients who entered this period.
|
|
Injury, poisoning and procedural complications
Radiation injury
|
0.53%
1/188 • Adverse events (AEs) were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to 23.8 months. Deaths were collected in the post-treatment efficacy follow-up from 31 days after last dose of study medication until the end of the study, up to 62 months.
Deaths in the post-treatment efficacy follow-up were not considered adverse events. The total number at risk in the post-treatment efficacy follow-up included patients who entered this period.
|
0.00%
0/188 • Adverse events (AEs) were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to 23.8 months. Deaths were collected in the post-treatment efficacy follow-up from 31 days after last dose of study medication until the end of the study, up to 62 months.
Deaths in the post-treatment efficacy follow-up were not considered adverse events. The total number at risk in the post-treatment efficacy follow-up included patients who entered this period.
|
—
0/0 • Adverse events (AEs) were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to 23.8 months. Deaths were collected in the post-treatment efficacy follow-up from 31 days after last dose of study medication until the end of the study, up to 62 months.
Deaths in the post-treatment efficacy follow-up were not considered adverse events. The total number at risk in the post-treatment efficacy follow-up included patients who entered this period.
|
—
0/0 • Adverse events (AEs) were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to 23.8 months. Deaths were collected in the post-treatment efficacy follow-up from 31 days after last dose of study medication until the end of the study, up to 62 months.
Deaths in the post-treatment efficacy follow-up were not considered adverse events. The total number at risk in the post-treatment efficacy follow-up included patients who entered this period.
|
|
Injury, poisoning and procedural complications
Spinal column injury
|
0.00%
0/188 • Adverse events (AEs) were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to 23.8 months. Deaths were collected in the post-treatment efficacy follow-up from 31 days after last dose of study medication until the end of the study, up to 62 months.
Deaths in the post-treatment efficacy follow-up were not considered adverse events. The total number at risk in the post-treatment efficacy follow-up included patients who entered this period.
|
0.53%
1/188 • Adverse events (AEs) were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to 23.8 months. Deaths were collected in the post-treatment efficacy follow-up from 31 days after last dose of study medication until the end of the study, up to 62 months.
Deaths in the post-treatment efficacy follow-up were not considered adverse events. The total number at risk in the post-treatment efficacy follow-up included patients who entered this period.
|
—
0/0 • Adverse events (AEs) were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to 23.8 months. Deaths were collected in the post-treatment efficacy follow-up from 31 days after last dose of study medication until the end of the study, up to 62 months.
Deaths in the post-treatment efficacy follow-up were not considered adverse events. The total number at risk in the post-treatment efficacy follow-up included patients who entered this period.
|
—
0/0 • Adverse events (AEs) were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to 23.8 months. Deaths were collected in the post-treatment efficacy follow-up from 31 days after last dose of study medication until the end of the study, up to 62 months.
Deaths in the post-treatment efficacy follow-up were not considered adverse events. The total number at risk in the post-treatment efficacy follow-up included patients who entered this period.
|
|
Injury, poisoning and procedural complications
Ulna fracture
|
0.53%
1/188 • Adverse events (AEs) were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to 23.8 months. Deaths were collected in the post-treatment efficacy follow-up from 31 days after last dose of study medication until the end of the study, up to 62 months.
Deaths in the post-treatment efficacy follow-up were not considered adverse events. The total number at risk in the post-treatment efficacy follow-up included patients who entered this period.
|
0.00%
0/188 • Adverse events (AEs) were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to 23.8 months. Deaths were collected in the post-treatment efficacy follow-up from 31 days after last dose of study medication until the end of the study, up to 62 months.
Deaths in the post-treatment efficacy follow-up were not considered adverse events. The total number at risk in the post-treatment efficacy follow-up included patients who entered this period.
|
—
0/0 • Adverse events (AEs) were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to 23.8 months. Deaths were collected in the post-treatment efficacy follow-up from 31 days after last dose of study medication until the end of the study, up to 62 months.
Deaths in the post-treatment efficacy follow-up were not considered adverse events. The total number at risk in the post-treatment efficacy follow-up included patients who entered this period.
|
—
0/0 • Adverse events (AEs) were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to 23.8 months. Deaths were collected in the post-treatment efficacy follow-up from 31 days after last dose of study medication until the end of the study, up to 62 months.
Deaths in the post-treatment efficacy follow-up were not considered adverse events. The total number at risk in the post-treatment efficacy follow-up included patients who entered this period.
|
|
Investigations
Blood bilirubin increased
|
0.53%
1/188 • Adverse events (AEs) were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to 23.8 months. Deaths were collected in the post-treatment efficacy follow-up from 31 days after last dose of study medication until the end of the study, up to 62 months.
Deaths in the post-treatment efficacy follow-up were not considered adverse events. The total number at risk in the post-treatment efficacy follow-up included patients who entered this period.
|
0.00%
0/188 • Adverse events (AEs) were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to 23.8 months. Deaths were collected in the post-treatment efficacy follow-up from 31 days after last dose of study medication until the end of the study, up to 62 months.
Deaths in the post-treatment efficacy follow-up were not considered adverse events. The total number at risk in the post-treatment efficacy follow-up included patients who entered this period.
|
—
0/0 • Adverse events (AEs) were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to 23.8 months. Deaths were collected in the post-treatment efficacy follow-up from 31 days after last dose of study medication until the end of the study, up to 62 months.
Deaths in the post-treatment efficacy follow-up were not considered adverse events. The total number at risk in the post-treatment efficacy follow-up included patients who entered this period.
|
—
0/0 • Adverse events (AEs) were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to 23.8 months. Deaths were collected in the post-treatment efficacy follow-up from 31 days after last dose of study medication until the end of the study, up to 62 months.
Deaths in the post-treatment efficacy follow-up were not considered adverse events. The total number at risk in the post-treatment efficacy follow-up included patients who entered this period.
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
0.53%
1/188 • Adverse events (AEs) were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to 23.8 months. Deaths were collected in the post-treatment efficacy follow-up from 31 days after last dose of study medication until the end of the study, up to 62 months.
Deaths in the post-treatment efficacy follow-up were not considered adverse events. The total number at risk in the post-treatment efficacy follow-up included patients who entered this period.
|
0.00%
0/188 • Adverse events (AEs) were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to 23.8 months. Deaths were collected in the post-treatment efficacy follow-up from 31 days after last dose of study medication until the end of the study, up to 62 months.
Deaths in the post-treatment efficacy follow-up were not considered adverse events. The total number at risk in the post-treatment efficacy follow-up included patients who entered this period.
|
—
0/0 • Adverse events (AEs) were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to 23.8 months. Deaths were collected in the post-treatment efficacy follow-up from 31 days after last dose of study medication until the end of the study, up to 62 months.
Deaths in the post-treatment efficacy follow-up were not considered adverse events. The total number at risk in the post-treatment efficacy follow-up included patients who entered this period.
|
—
0/0 • Adverse events (AEs) were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to 23.8 months. Deaths were collected in the post-treatment efficacy follow-up from 31 days after last dose of study medication until the end of the study, up to 62 months.
Deaths in the post-treatment efficacy follow-up were not considered adverse events. The total number at risk in the post-treatment efficacy follow-up included patients who entered this period.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.53%
1/188 • Adverse events (AEs) were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to 23.8 months. Deaths were collected in the post-treatment efficacy follow-up from 31 days after last dose of study medication until the end of the study, up to 62 months.
Deaths in the post-treatment efficacy follow-up were not considered adverse events. The total number at risk in the post-treatment efficacy follow-up included patients who entered this period.
|
0.53%
1/188 • Adverse events (AEs) were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to 23.8 months. Deaths were collected in the post-treatment efficacy follow-up from 31 days after last dose of study medication until the end of the study, up to 62 months.
Deaths in the post-treatment efficacy follow-up were not considered adverse events. The total number at risk in the post-treatment efficacy follow-up included patients who entered this period.
|
—
0/0 • Adverse events (AEs) were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to 23.8 months. Deaths were collected in the post-treatment efficacy follow-up from 31 days after last dose of study medication until the end of the study, up to 62 months.
Deaths in the post-treatment efficacy follow-up were not considered adverse events. The total number at risk in the post-treatment efficacy follow-up included patients who entered this period.
|
—
0/0 • Adverse events (AEs) were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to 23.8 months. Deaths were collected in the post-treatment efficacy follow-up from 31 days after last dose of study medication until the end of the study, up to 62 months.
Deaths in the post-treatment efficacy follow-up were not considered adverse events. The total number at risk in the post-treatment efficacy follow-up included patients who entered this period.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
1.1%
2/188 • Adverse events (AEs) were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to 23.8 months. Deaths were collected in the post-treatment efficacy follow-up from 31 days after last dose of study medication until the end of the study, up to 62 months.
Deaths in the post-treatment efficacy follow-up were not considered adverse events. The total number at risk in the post-treatment efficacy follow-up included patients who entered this period.
|
1.1%
2/188 • Adverse events (AEs) were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to 23.8 months. Deaths were collected in the post-treatment efficacy follow-up from 31 days after last dose of study medication until the end of the study, up to 62 months.
Deaths in the post-treatment efficacy follow-up were not considered adverse events. The total number at risk in the post-treatment efficacy follow-up included patients who entered this period.
|
—
0/0 • Adverse events (AEs) were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to 23.8 months. Deaths were collected in the post-treatment efficacy follow-up from 31 days after last dose of study medication until the end of the study, up to 62 months.
Deaths in the post-treatment efficacy follow-up were not considered adverse events. The total number at risk in the post-treatment efficacy follow-up included patients who entered this period.
|
—
0/0 • Adverse events (AEs) were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to 23.8 months. Deaths were collected in the post-treatment efficacy follow-up from 31 days after last dose of study medication until the end of the study, up to 62 months.
Deaths in the post-treatment efficacy follow-up were not considered adverse events. The total number at risk in the post-treatment efficacy follow-up included patients who entered this period.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
0.53%
1/188 • Adverse events (AEs) were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to 23.8 months. Deaths were collected in the post-treatment efficacy follow-up from 31 days after last dose of study medication until the end of the study, up to 62 months.
Deaths in the post-treatment efficacy follow-up were not considered adverse events. The total number at risk in the post-treatment efficacy follow-up included patients who entered this period.
|
0.00%
0/188 • Adverse events (AEs) were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to 23.8 months. Deaths were collected in the post-treatment efficacy follow-up from 31 days after last dose of study medication until the end of the study, up to 62 months.
Deaths in the post-treatment efficacy follow-up were not considered adverse events. The total number at risk in the post-treatment efficacy follow-up included patients who entered this period.
|
—
0/0 • Adverse events (AEs) were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to 23.8 months. Deaths were collected in the post-treatment efficacy follow-up from 31 days after last dose of study medication until the end of the study, up to 62 months.
Deaths in the post-treatment efficacy follow-up were not considered adverse events. The total number at risk in the post-treatment efficacy follow-up included patients who entered this period.
|
—
0/0 • Adverse events (AEs) were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to 23.8 months. Deaths were collected in the post-treatment efficacy follow-up from 31 days after last dose of study medication until the end of the study, up to 62 months.
Deaths in the post-treatment efficacy follow-up were not considered adverse events. The total number at risk in the post-treatment efficacy follow-up included patients who entered this period.
|
|
Musculoskeletal and connective tissue disorders
Fracture pain
|
0.53%
1/188 • Adverse events (AEs) were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to 23.8 months. Deaths were collected in the post-treatment efficacy follow-up from 31 days after last dose of study medication until the end of the study, up to 62 months.
Deaths in the post-treatment efficacy follow-up were not considered adverse events. The total number at risk in the post-treatment efficacy follow-up included patients who entered this period.
|
0.00%
0/188 • Adverse events (AEs) were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to 23.8 months. Deaths were collected in the post-treatment efficacy follow-up from 31 days after last dose of study medication until the end of the study, up to 62 months.
Deaths in the post-treatment efficacy follow-up were not considered adverse events. The total number at risk in the post-treatment efficacy follow-up included patients who entered this period.
|
—
0/0 • Adverse events (AEs) were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to 23.8 months. Deaths were collected in the post-treatment efficacy follow-up from 31 days after last dose of study medication until the end of the study, up to 62 months.
Deaths in the post-treatment efficacy follow-up were not considered adverse events. The total number at risk in the post-treatment efficacy follow-up included patients who entered this period.
|
—
0/0 • Adverse events (AEs) were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to 23.8 months. Deaths were collected in the post-treatment efficacy follow-up from 31 days after last dose of study medication until the end of the study, up to 62 months.
Deaths in the post-treatment efficacy follow-up were not considered adverse events. The total number at risk in the post-treatment efficacy follow-up included patients who entered this period.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/188 • Adverse events (AEs) were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to 23.8 months. Deaths were collected in the post-treatment efficacy follow-up from 31 days after last dose of study medication until the end of the study, up to 62 months.
Deaths in the post-treatment efficacy follow-up were not considered adverse events. The total number at risk in the post-treatment efficacy follow-up included patients who entered this period.
|
0.53%
1/188 • Adverse events (AEs) were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to 23.8 months. Deaths were collected in the post-treatment efficacy follow-up from 31 days after last dose of study medication until the end of the study, up to 62 months.
Deaths in the post-treatment efficacy follow-up were not considered adverse events. The total number at risk in the post-treatment efficacy follow-up included patients who entered this period.
|
—
0/0 • Adverse events (AEs) were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to 23.8 months. Deaths were collected in the post-treatment efficacy follow-up from 31 days after last dose of study medication until the end of the study, up to 62 months.
Deaths in the post-treatment efficacy follow-up were not considered adverse events. The total number at risk in the post-treatment efficacy follow-up included patients who entered this period.
|
—
0/0 • Adverse events (AEs) were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to 23.8 months. Deaths were collected in the post-treatment efficacy follow-up from 31 days after last dose of study medication until the end of the study, up to 62 months.
Deaths in the post-treatment efficacy follow-up were not considered adverse events. The total number at risk in the post-treatment efficacy follow-up included patients who entered this period.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenocarcinoma of colon
|
0.00%
0/188 • Adverse events (AEs) were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to 23.8 months. Deaths were collected in the post-treatment efficacy follow-up from 31 days after last dose of study medication until the end of the study, up to 62 months.
Deaths in the post-treatment efficacy follow-up were not considered adverse events. The total number at risk in the post-treatment efficacy follow-up included patients who entered this period.
|
0.53%
1/188 • Adverse events (AEs) were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to 23.8 months. Deaths were collected in the post-treatment efficacy follow-up from 31 days after last dose of study medication until the end of the study, up to 62 months.
Deaths in the post-treatment efficacy follow-up were not considered adverse events. The total number at risk in the post-treatment efficacy follow-up included patients who entered this period.
|
—
0/0 • Adverse events (AEs) were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to 23.8 months. Deaths were collected in the post-treatment efficacy follow-up from 31 days after last dose of study medication until the end of the study, up to 62 months.
Deaths in the post-treatment efficacy follow-up were not considered adverse events. The total number at risk in the post-treatment efficacy follow-up included patients who entered this period.
|
—
0/0 • Adverse events (AEs) were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to 23.8 months. Deaths were collected in the post-treatment efficacy follow-up from 31 days after last dose of study medication until the end of the study, up to 62 months.
Deaths in the post-treatment efficacy follow-up were not considered adverse events. The total number at risk in the post-treatment efficacy follow-up included patients who entered this period.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant melanoma
|
0.00%
0/188 • Adverse events (AEs) were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to 23.8 months. Deaths were collected in the post-treatment efficacy follow-up from 31 days after last dose of study medication until the end of the study, up to 62 months.
Deaths in the post-treatment efficacy follow-up were not considered adverse events. The total number at risk in the post-treatment efficacy follow-up included patients who entered this period.
|
0.53%
1/188 • Adverse events (AEs) were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to 23.8 months. Deaths were collected in the post-treatment efficacy follow-up from 31 days after last dose of study medication until the end of the study, up to 62 months.
Deaths in the post-treatment efficacy follow-up were not considered adverse events. The total number at risk in the post-treatment efficacy follow-up included patients who entered this period.
|
—
0/0 • Adverse events (AEs) were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to 23.8 months. Deaths were collected in the post-treatment efficacy follow-up from 31 days after last dose of study medication until the end of the study, up to 62 months.
Deaths in the post-treatment efficacy follow-up were not considered adverse events. The total number at risk in the post-treatment efficacy follow-up included patients who entered this period.
|
—
0/0 • Adverse events (AEs) were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to 23.8 months. Deaths were collected in the post-treatment efficacy follow-up from 31 days after last dose of study medication until the end of the study, up to 62 months.
Deaths in the post-treatment efficacy follow-up were not considered adverse events. The total number at risk in the post-treatment efficacy follow-up included patients who entered this period.
|
|
Nervous system disorders
Cerebrovascular accident
|
0.53%
1/188 • Adverse events (AEs) were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to 23.8 months. Deaths were collected in the post-treatment efficacy follow-up from 31 days after last dose of study medication until the end of the study, up to 62 months.
Deaths in the post-treatment efficacy follow-up were not considered adverse events. The total number at risk in the post-treatment efficacy follow-up included patients who entered this period.
|
0.00%
0/188 • Adverse events (AEs) were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to 23.8 months. Deaths were collected in the post-treatment efficacy follow-up from 31 days after last dose of study medication until the end of the study, up to 62 months.
Deaths in the post-treatment efficacy follow-up were not considered adverse events. The total number at risk in the post-treatment efficacy follow-up included patients who entered this period.
|
—
0/0 • Adverse events (AEs) were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to 23.8 months. Deaths were collected in the post-treatment efficacy follow-up from 31 days after last dose of study medication until the end of the study, up to 62 months.
Deaths in the post-treatment efficacy follow-up were not considered adverse events. The total number at risk in the post-treatment efficacy follow-up included patients who entered this period.
|
—
0/0 • Adverse events (AEs) were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to 23.8 months. Deaths were collected in the post-treatment efficacy follow-up from 31 days after last dose of study medication until the end of the study, up to 62 months.
Deaths in the post-treatment efficacy follow-up were not considered adverse events. The total number at risk in the post-treatment efficacy follow-up included patients who entered this period.
|
|
Nervous system disorders
Hydrocephalus
|
0.53%
1/188 • Adverse events (AEs) were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to 23.8 months. Deaths were collected in the post-treatment efficacy follow-up from 31 days after last dose of study medication until the end of the study, up to 62 months.
Deaths in the post-treatment efficacy follow-up were not considered adverse events. The total number at risk in the post-treatment efficacy follow-up included patients who entered this period.
|
0.00%
0/188 • Adverse events (AEs) were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to 23.8 months. Deaths were collected in the post-treatment efficacy follow-up from 31 days after last dose of study medication until the end of the study, up to 62 months.
Deaths in the post-treatment efficacy follow-up were not considered adverse events. The total number at risk in the post-treatment efficacy follow-up included patients who entered this period.
|
—
0/0 • Adverse events (AEs) were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to 23.8 months. Deaths were collected in the post-treatment efficacy follow-up from 31 days after last dose of study medication until the end of the study, up to 62 months.
Deaths in the post-treatment efficacy follow-up were not considered adverse events. The total number at risk in the post-treatment efficacy follow-up included patients who entered this period.
|
—
0/0 • Adverse events (AEs) were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to 23.8 months. Deaths were collected in the post-treatment efficacy follow-up from 31 days after last dose of study medication until the end of the study, up to 62 months.
Deaths in the post-treatment efficacy follow-up were not considered adverse events. The total number at risk in the post-treatment efficacy follow-up included patients who entered this period.
|
|
Nervous system disorders
Seizure
|
0.53%
1/188 • Adverse events (AEs) were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to 23.8 months. Deaths were collected in the post-treatment efficacy follow-up from 31 days after last dose of study medication until the end of the study, up to 62 months.
Deaths in the post-treatment efficacy follow-up were not considered adverse events. The total number at risk in the post-treatment efficacy follow-up included patients who entered this period.
|
0.00%
0/188 • Adverse events (AEs) were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to 23.8 months. Deaths were collected in the post-treatment efficacy follow-up from 31 days after last dose of study medication until the end of the study, up to 62 months.
Deaths in the post-treatment efficacy follow-up were not considered adverse events. The total number at risk in the post-treatment efficacy follow-up included patients who entered this period.
|
—
0/0 • Adverse events (AEs) were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to 23.8 months. Deaths were collected in the post-treatment efficacy follow-up from 31 days after last dose of study medication until the end of the study, up to 62 months.
Deaths in the post-treatment efficacy follow-up were not considered adverse events. The total number at risk in the post-treatment efficacy follow-up included patients who entered this period.
|
—
0/0 • Adverse events (AEs) were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to 23.8 months. Deaths were collected in the post-treatment efficacy follow-up from 31 days after last dose of study medication until the end of the study, up to 62 months.
Deaths in the post-treatment efficacy follow-up were not considered adverse events. The total number at risk in the post-treatment efficacy follow-up included patients who entered this period.
|
|
Nervous system disorders
Syncope
|
0.53%
1/188 • Adverse events (AEs) were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to 23.8 months. Deaths were collected in the post-treatment efficacy follow-up from 31 days after last dose of study medication until the end of the study, up to 62 months.
Deaths in the post-treatment efficacy follow-up were not considered adverse events. The total number at risk in the post-treatment efficacy follow-up included patients who entered this period.
|
0.00%
0/188 • Adverse events (AEs) were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to 23.8 months. Deaths were collected in the post-treatment efficacy follow-up from 31 days after last dose of study medication until the end of the study, up to 62 months.
Deaths in the post-treatment efficacy follow-up were not considered adverse events. The total number at risk in the post-treatment efficacy follow-up included patients who entered this period.
|
—
0/0 • Adverse events (AEs) were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to 23.8 months. Deaths were collected in the post-treatment efficacy follow-up from 31 days after last dose of study medication until the end of the study, up to 62 months.
Deaths in the post-treatment efficacy follow-up were not considered adverse events. The total number at risk in the post-treatment efficacy follow-up included patients who entered this period.
|
—
0/0 • Adverse events (AEs) were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to 23.8 months. Deaths were collected in the post-treatment efficacy follow-up from 31 days after last dose of study medication until the end of the study, up to 62 months.
Deaths in the post-treatment efficacy follow-up were not considered adverse events. The total number at risk in the post-treatment efficacy follow-up included patients who entered this period.
|
|
Nervous system disorders
Transient ischaemic attack
|
0.53%
1/188 • Adverse events (AEs) were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to 23.8 months. Deaths were collected in the post-treatment efficacy follow-up from 31 days after last dose of study medication until the end of the study, up to 62 months.
Deaths in the post-treatment efficacy follow-up were not considered adverse events. The total number at risk in the post-treatment efficacy follow-up included patients who entered this period.
|
0.00%
0/188 • Adverse events (AEs) were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to 23.8 months. Deaths were collected in the post-treatment efficacy follow-up from 31 days after last dose of study medication until the end of the study, up to 62 months.
Deaths in the post-treatment efficacy follow-up were not considered adverse events. The total number at risk in the post-treatment efficacy follow-up included patients who entered this period.
|
—
0/0 • Adverse events (AEs) were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to 23.8 months. Deaths were collected in the post-treatment efficacy follow-up from 31 days after last dose of study medication until the end of the study, up to 62 months.
Deaths in the post-treatment efficacy follow-up were not considered adverse events. The total number at risk in the post-treatment efficacy follow-up included patients who entered this period.
|
—
0/0 • Adverse events (AEs) were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to 23.8 months. Deaths were collected in the post-treatment efficacy follow-up from 31 days after last dose of study medication until the end of the study, up to 62 months.
Deaths in the post-treatment efficacy follow-up were not considered adverse events. The total number at risk in the post-treatment efficacy follow-up included patients who entered this period.
|
|
Psychiatric disorders
Depression
|
1.1%
2/188 • Adverse events (AEs) were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to 23.8 months. Deaths were collected in the post-treatment efficacy follow-up from 31 days after last dose of study medication until the end of the study, up to 62 months.
Deaths in the post-treatment efficacy follow-up were not considered adverse events. The total number at risk in the post-treatment efficacy follow-up included patients who entered this period.
|
0.00%
0/188 • Adverse events (AEs) were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to 23.8 months. Deaths were collected in the post-treatment efficacy follow-up from 31 days after last dose of study medication until the end of the study, up to 62 months.
Deaths in the post-treatment efficacy follow-up were not considered adverse events. The total number at risk in the post-treatment efficacy follow-up included patients who entered this period.
|
—
0/0 • Adverse events (AEs) were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to 23.8 months. Deaths were collected in the post-treatment efficacy follow-up from 31 days after last dose of study medication until the end of the study, up to 62 months.
Deaths in the post-treatment efficacy follow-up were not considered adverse events. The total number at risk in the post-treatment efficacy follow-up included patients who entered this period.
|
—
0/0 • Adverse events (AEs) were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to 23.8 months. Deaths were collected in the post-treatment efficacy follow-up from 31 days after last dose of study medication until the end of the study, up to 62 months.
Deaths in the post-treatment efficacy follow-up were not considered adverse events. The total number at risk in the post-treatment efficacy follow-up included patients who entered this period.
|
|
Psychiatric disorders
Disorientation
|
0.00%
0/188 • Adverse events (AEs) were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to 23.8 months. Deaths were collected in the post-treatment efficacy follow-up from 31 days after last dose of study medication until the end of the study, up to 62 months.
Deaths in the post-treatment efficacy follow-up were not considered adverse events. The total number at risk in the post-treatment efficacy follow-up included patients who entered this period.
|
0.53%
1/188 • Adverse events (AEs) were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to 23.8 months. Deaths were collected in the post-treatment efficacy follow-up from 31 days after last dose of study medication until the end of the study, up to 62 months.
Deaths in the post-treatment efficacy follow-up were not considered adverse events. The total number at risk in the post-treatment efficacy follow-up included patients who entered this period.
|
—
0/0 • Adverse events (AEs) were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to 23.8 months. Deaths were collected in the post-treatment efficacy follow-up from 31 days after last dose of study medication until the end of the study, up to 62 months.
Deaths in the post-treatment efficacy follow-up were not considered adverse events. The total number at risk in the post-treatment efficacy follow-up included patients who entered this period.
|
—
0/0 • Adverse events (AEs) were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to 23.8 months. Deaths were collected in the post-treatment efficacy follow-up from 31 days after last dose of study medication until the end of the study, up to 62 months.
Deaths in the post-treatment efficacy follow-up were not considered adverse events. The total number at risk in the post-treatment efficacy follow-up included patients who entered this period.
|
|
Renal and urinary disorders
Acute kidney injury
|
0.53%
1/188 • Adverse events (AEs) were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to 23.8 months. Deaths were collected in the post-treatment efficacy follow-up from 31 days after last dose of study medication until the end of the study, up to 62 months.
Deaths in the post-treatment efficacy follow-up were not considered adverse events. The total number at risk in the post-treatment efficacy follow-up included patients who entered this period.
|
1.1%
2/188 • Adverse events (AEs) were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to 23.8 months. Deaths were collected in the post-treatment efficacy follow-up from 31 days after last dose of study medication until the end of the study, up to 62 months.
Deaths in the post-treatment efficacy follow-up were not considered adverse events. The total number at risk in the post-treatment efficacy follow-up included patients who entered this period.
|
—
0/0 • Adverse events (AEs) were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to 23.8 months. Deaths were collected in the post-treatment efficacy follow-up from 31 days after last dose of study medication until the end of the study, up to 62 months.
Deaths in the post-treatment efficacy follow-up were not considered adverse events. The total number at risk in the post-treatment efficacy follow-up included patients who entered this period.
|
—
0/0 • Adverse events (AEs) were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to 23.8 months. Deaths were collected in the post-treatment efficacy follow-up from 31 days after last dose of study medication until the end of the study, up to 62 months.
Deaths in the post-treatment efficacy follow-up were not considered adverse events. The total number at risk in the post-treatment efficacy follow-up included patients who entered this period.
|
|
Renal and urinary disorders
Renal impairment
|
0.00%
0/188 • Adverse events (AEs) were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to 23.8 months. Deaths were collected in the post-treatment efficacy follow-up from 31 days after last dose of study medication until the end of the study, up to 62 months.
Deaths in the post-treatment efficacy follow-up were not considered adverse events. The total number at risk in the post-treatment efficacy follow-up included patients who entered this period.
|
0.53%
1/188 • Adverse events (AEs) were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to 23.8 months. Deaths were collected in the post-treatment efficacy follow-up from 31 days after last dose of study medication until the end of the study, up to 62 months.
Deaths in the post-treatment efficacy follow-up were not considered adverse events. The total number at risk in the post-treatment efficacy follow-up included patients who entered this period.
|
—
0/0 • Adverse events (AEs) were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to 23.8 months. Deaths were collected in the post-treatment efficacy follow-up from 31 days after last dose of study medication until the end of the study, up to 62 months.
Deaths in the post-treatment efficacy follow-up were not considered adverse events. The total number at risk in the post-treatment efficacy follow-up included patients who entered this period.
|
—
0/0 • Adverse events (AEs) were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to 23.8 months. Deaths were collected in the post-treatment efficacy follow-up from 31 days after last dose of study medication until the end of the study, up to 62 months.
Deaths in the post-treatment efficacy follow-up were not considered adverse events. The total number at risk in the post-treatment efficacy follow-up included patients who entered this period.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory distress syndrome
|
0.00%
0/188 • Adverse events (AEs) were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to 23.8 months. Deaths were collected in the post-treatment efficacy follow-up from 31 days after last dose of study medication until the end of the study, up to 62 months.
Deaths in the post-treatment efficacy follow-up were not considered adverse events. The total number at risk in the post-treatment efficacy follow-up included patients who entered this period.
|
0.53%
1/188 • Adverse events (AEs) were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to 23.8 months. Deaths were collected in the post-treatment efficacy follow-up from 31 days after last dose of study medication until the end of the study, up to 62 months.
Deaths in the post-treatment efficacy follow-up were not considered adverse events. The total number at risk in the post-treatment efficacy follow-up included patients who entered this period.
|
—
0/0 • Adverse events (AEs) were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to 23.8 months. Deaths were collected in the post-treatment efficacy follow-up from 31 days after last dose of study medication until the end of the study, up to 62 months.
Deaths in the post-treatment efficacy follow-up were not considered adverse events. The total number at risk in the post-treatment efficacy follow-up included patients who entered this period.
|
—
0/0 • Adverse events (AEs) were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to 23.8 months. Deaths were collected in the post-treatment efficacy follow-up from 31 days after last dose of study medication until the end of the study, up to 62 months.
Deaths in the post-treatment efficacy follow-up were not considered adverse events. The total number at risk in the post-treatment efficacy follow-up included patients who entered this period.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.53%
1/188 • Adverse events (AEs) were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to 23.8 months. Deaths were collected in the post-treatment efficacy follow-up from 31 days after last dose of study medication until the end of the study, up to 62 months.
Deaths in the post-treatment efficacy follow-up were not considered adverse events. The total number at risk in the post-treatment efficacy follow-up included patients who entered this period.
|
0.53%
1/188 • Adverse events (AEs) were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to 23.8 months. Deaths were collected in the post-treatment efficacy follow-up from 31 days after last dose of study medication until the end of the study, up to 62 months.
Deaths in the post-treatment efficacy follow-up were not considered adverse events. The total number at risk in the post-treatment efficacy follow-up included patients who entered this period.
|
—
0/0 • Adverse events (AEs) were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to 23.8 months. Deaths were collected in the post-treatment efficacy follow-up from 31 days after last dose of study medication until the end of the study, up to 62 months.
Deaths in the post-treatment efficacy follow-up were not considered adverse events. The total number at risk in the post-treatment efficacy follow-up included patients who entered this period.
|
—
0/0 • Adverse events (AEs) were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to 23.8 months. Deaths were collected in the post-treatment efficacy follow-up from 31 days after last dose of study medication until the end of the study, up to 62 months.
Deaths in the post-treatment efficacy follow-up were not considered adverse events. The total number at risk in the post-treatment efficacy follow-up included patients who entered this period.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/188 • Adverse events (AEs) were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to 23.8 months. Deaths were collected in the post-treatment efficacy follow-up from 31 days after last dose of study medication until the end of the study, up to 62 months.
Deaths in the post-treatment efficacy follow-up were not considered adverse events. The total number at risk in the post-treatment efficacy follow-up included patients who entered this period.
|
2.1%
4/188 • Adverse events (AEs) were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to 23.8 months. Deaths were collected in the post-treatment efficacy follow-up from 31 days after last dose of study medication until the end of the study, up to 62 months.
Deaths in the post-treatment efficacy follow-up were not considered adverse events. The total number at risk in the post-treatment efficacy follow-up included patients who entered this period.
|
—
0/0 • Adverse events (AEs) were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to 23.8 months. Deaths were collected in the post-treatment efficacy follow-up from 31 days after last dose of study medication until the end of the study, up to 62 months.
Deaths in the post-treatment efficacy follow-up were not considered adverse events. The total number at risk in the post-treatment efficacy follow-up included patients who entered this period.
|
—
0/0 • Adverse events (AEs) were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to 23.8 months. Deaths were collected in the post-treatment efficacy follow-up from 31 days after last dose of study medication until the end of the study, up to 62 months.
Deaths in the post-treatment efficacy follow-up were not considered adverse events. The total number at risk in the post-treatment efficacy follow-up included patients who entered this period.
|
|
Respiratory, thoracic and mediastinal disorders
Interstitial lung disease
|
0.53%
1/188 • Adverse events (AEs) were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to 23.8 months. Deaths were collected in the post-treatment efficacy follow-up from 31 days after last dose of study medication until the end of the study, up to 62 months.
Deaths in the post-treatment efficacy follow-up were not considered adverse events. The total number at risk in the post-treatment efficacy follow-up included patients who entered this period.
|
0.53%
1/188 • Adverse events (AEs) were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to 23.8 months. Deaths were collected in the post-treatment efficacy follow-up from 31 days after last dose of study medication until the end of the study, up to 62 months.
Deaths in the post-treatment efficacy follow-up were not considered adverse events. The total number at risk in the post-treatment efficacy follow-up included patients who entered this period.
|
—
0/0 • Adverse events (AEs) were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to 23.8 months. Deaths were collected in the post-treatment efficacy follow-up from 31 days after last dose of study medication until the end of the study, up to 62 months.
Deaths in the post-treatment efficacy follow-up were not considered adverse events. The total number at risk in the post-treatment efficacy follow-up included patients who entered this period.
|
—
0/0 • Adverse events (AEs) were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to 23.8 months. Deaths were collected in the post-treatment efficacy follow-up from 31 days after last dose of study medication until the end of the study, up to 62 months.
Deaths in the post-treatment efficacy follow-up were not considered adverse events. The total number at risk in the post-treatment efficacy follow-up included patients who entered this period.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
1.1%
2/188 • Adverse events (AEs) were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to 23.8 months. Deaths were collected in the post-treatment efficacy follow-up from 31 days after last dose of study medication until the end of the study, up to 62 months.
Deaths in the post-treatment efficacy follow-up were not considered adverse events. The total number at risk in the post-treatment efficacy follow-up included patients who entered this period.
|
1.1%
2/188 • Adverse events (AEs) were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to 23.8 months. Deaths were collected in the post-treatment efficacy follow-up from 31 days after last dose of study medication until the end of the study, up to 62 months.
Deaths in the post-treatment efficacy follow-up were not considered adverse events. The total number at risk in the post-treatment efficacy follow-up included patients who entered this period.
|
—
0/0 • Adverse events (AEs) were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to 23.8 months. Deaths were collected in the post-treatment efficacy follow-up from 31 days after last dose of study medication until the end of the study, up to 62 months.
Deaths in the post-treatment efficacy follow-up were not considered adverse events. The total number at risk in the post-treatment efficacy follow-up included patients who entered this period.
|
—
0/0 • Adverse events (AEs) were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to 23.8 months. Deaths were collected in the post-treatment efficacy follow-up from 31 days after last dose of study medication until the end of the study, up to 62 months.
Deaths in the post-treatment efficacy follow-up were not considered adverse events. The total number at risk in the post-treatment efficacy follow-up included patients who entered this period.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.53%
1/188 • Adverse events (AEs) were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to 23.8 months. Deaths were collected in the post-treatment efficacy follow-up from 31 days after last dose of study medication until the end of the study, up to 62 months.
Deaths in the post-treatment efficacy follow-up were not considered adverse events. The total number at risk in the post-treatment efficacy follow-up included patients who entered this period.
|
0.00%
0/188 • Adverse events (AEs) were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to 23.8 months. Deaths were collected in the post-treatment efficacy follow-up from 31 days after last dose of study medication until the end of the study, up to 62 months.
Deaths in the post-treatment efficacy follow-up were not considered adverse events. The total number at risk in the post-treatment efficacy follow-up included patients who entered this period.
|
—
0/0 • Adverse events (AEs) were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to 23.8 months. Deaths were collected in the post-treatment efficacy follow-up from 31 days after last dose of study medication until the end of the study, up to 62 months.
Deaths in the post-treatment efficacy follow-up were not considered adverse events. The total number at risk in the post-treatment efficacy follow-up included patients who entered this period.
|
—
0/0 • Adverse events (AEs) were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to 23.8 months. Deaths were collected in the post-treatment efficacy follow-up from 31 days after last dose of study medication until the end of the study, up to 62 months.
Deaths in the post-treatment efficacy follow-up were not considered adverse events. The total number at risk in the post-treatment efficacy follow-up included patients who entered this period.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary thrombosis
|
0.53%
1/188 • Adverse events (AEs) were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to 23.8 months. Deaths were collected in the post-treatment efficacy follow-up from 31 days after last dose of study medication until the end of the study, up to 62 months.
Deaths in the post-treatment efficacy follow-up were not considered adverse events. The total number at risk in the post-treatment efficacy follow-up included patients who entered this period.
|
0.00%
0/188 • Adverse events (AEs) were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to 23.8 months. Deaths were collected in the post-treatment efficacy follow-up from 31 days after last dose of study medication until the end of the study, up to 62 months.
Deaths in the post-treatment efficacy follow-up were not considered adverse events. The total number at risk in the post-treatment efficacy follow-up included patients who entered this period.
|
—
0/0 • Adverse events (AEs) were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to 23.8 months. Deaths were collected in the post-treatment efficacy follow-up from 31 days after last dose of study medication until the end of the study, up to 62 months.
Deaths in the post-treatment efficacy follow-up were not considered adverse events. The total number at risk in the post-treatment efficacy follow-up included patients who entered this period.
|
—
0/0 • Adverse events (AEs) were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to 23.8 months. Deaths were collected in the post-treatment efficacy follow-up from 31 days after last dose of study medication until the end of the study, up to 62 months.
Deaths in the post-treatment efficacy follow-up were not considered adverse events. The total number at risk in the post-treatment efficacy follow-up included patients who entered this period.
|
|
Vascular disorders
Deep vein thrombosis
|
0.00%
0/188 • Adverse events (AEs) were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to 23.8 months. Deaths were collected in the post-treatment efficacy follow-up from 31 days after last dose of study medication until the end of the study, up to 62 months.
Deaths in the post-treatment efficacy follow-up were not considered adverse events. The total number at risk in the post-treatment efficacy follow-up included patients who entered this period.
|
0.53%
1/188 • Adverse events (AEs) were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to 23.8 months. Deaths were collected in the post-treatment efficacy follow-up from 31 days after last dose of study medication until the end of the study, up to 62 months.
Deaths in the post-treatment efficacy follow-up were not considered adverse events. The total number at risk in the post-treatment efficacy follow-up included patients who entered this period.
|
—
0/0 • Adverse events (AEs) were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to 23.8 months. Deaths were collected in the post-treatment efficacy follow-up from 31 days after last dose of study medication until the end of the study, up to 62 months.
Deaths in the post-treatment efficacy follow-up were not considered adverse events. The total number at risk in the post-treatment efficacy follow-up included patients who entered this period.
|
—
0/0 • Adverse events (AEs) were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to 23.8 months. Deaths were collected in the post-treatment efficacy follow-up from 31 days after last dose of study medication until the end of the study, up to 62 months.
Deaths in the post-treatment efficacy follow-up were not considered adverse events. The total number at risk in the post-treatment efficacy follow-up included patients who entered this period.
|
|
Vascular disorders
Embolism
|
0.53%
1/188 • Adverse events (AEs) were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to 23.8 months. Deaths were collected in the post-treatment efficacy follow-up from 31 days after last dose of study medication until the end of the study, up to 62 months.
Deaths in the post-treatment efficacy follow-up were not considered adverse events. The total number at risk in the post-treatment efficacy follow-up included patients who entered this period.
|
0.00%
0/188 • Adverse events (AEs) were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to 23.8 months. Deaths were collected in the post-treatment efficacy follow-up from 31 days after last dose of study medication until the end of the study, up to 62 months.
Deaths in the post-treatment efficacy follow-up were not considered adverse events. The total number at risk in the post-treatment efficacy follow-up included patients who entered this period.
|
—
0/0 • Adverse events (AEs) were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to 23.8 months. Deaths were collected in the post-treatment efficacy follow-up from 31 days after last dose of study medication until the end of the study, up to 62 months.
Deaths in the post-treatment efficacy follow-up were not considered adverse events. The total number at risk in the post-treatment efficacy follow-up included patients who entered this period.
|
—
0/0 • Adverse events (AEs) were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to 23.8 months. Deaths were collected in the post-treatment efficacy follow-up from 31 days after last dose of study medication until the end of the study, up to 62 months.
Deaths in the post-treatment efficacy follow-up were not considered adverse events. The total number at risk in the post-treatment efficacy follow-up included patients who entered this period.
|
|
Vascular disorders
Peripheral embolism
|
0.53%
1/188 • Adverse events (AEs) were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to 23.8 months. Deaths were collected in the post-treatment efficacy follow-up from 31 days after last dose of study medication until the end of the study, up to 62 months.
Deaths in the post-treatment efficacy follow-up were not considered adverse events. The total number at risk in the post-treatment efficacy follow-up included patients who entered this period.
|
0.00%
0/188 • Adverse events (AEs) were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to 23.8 months. Deaths were collected in the post-treatment efficacy follow-up from 31 days after last dose of study medication until the end of the study, up to 62 months.
Deaths in the post-treatment efficacy follow-up were not considered adverse events. The total number at risk in the post-treatment efficacy follow-up included patients who entered this period.
|
—
0/0 • Adverse events (AEs) were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to 23.8 months. Deaths were collected in the post-treatment efficacy follow-up from 31 days after last dose of study medication until the end of the study, up to 62 months.
Deaths in the post-treatment efficacy follow-up were not considered adverse events. The total number at risk in the post-treatment efficacy follow-up included patients who entered this period.
|
—
0/0 • Adverse events (AEs) were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to 23.8 months. Deaths were collected in the post-treatment efficacy follow-up from 31 days after last dose of study medication until the end of the study, up to 62 months.
Deaths in the post-treatment efficacy follow-up were not considered adverse events. The total number at risk in the post-treatment efficacy follow-up included patients who entered this period.
|
|
Vascular disorders
Venous thrombosis
|
0.53%
1/188 • Adverse events (AEs) were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to 23.8 months. Deaths were collected in the post-treatment efficacy follow-up from 31 days after last dose of study medication until the end of the study, up to 62 months.
Deaths in the post-treatment efficacy follow-up were not considered adverse events. The total number at risk in the post-treatment efficacy follow-up included patients who entered this period.
|
0.00%
0/188 • Adverse events (AEs) were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to 23.8 months. Deaths were collected in the post-treatment efficacy follow-up from 31 days after last dose of study medication until the end of the study, up to 62 months.
Deaths in the post-treatment efficacy follow-up were not considered adverse events. The total number at risk in the post-treatment efficacy follow-up included patients who entered this period.
|
—
0/0 • Adverse events (AEs) were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to 23.8 months. Deaths were collected in the post-treatment efficacy follow-up from 31 days after last dose of study medication until the end of the study, up to 62 months.
Deaths in the post-treatment efficacy follow-up were not considered adverse events. The total number at risk in the post-treatment efficacy follow-up included patients who entered this period.
|
—
0/0 • Adverse events (AEs) were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to 23.8 months. Deaths were collected in the post-treatment efficacy follow-up from 31 days after last dose of study medication until the end of the study, up to 62 months.
Deaths in the post-treatment efficacy follow-up were not considered adverse events. The total number at risk in the post-treatment efficacy follow-up included patients who entered this period.
|
Other adverse events
| Measure |
Ribociclib 400mg
n=188 participants at risk
Ribociclib 400 mg QD 3 weeks on/1 week off + letrozole or anastrozole (+goserelin in premenopausal women) - Events up to 30 days safety follow-up
|
Ribociclib 600mg
n=188 participants at risk
Ribociclib 600 mg QD 3 weeks on/1 week off + letrozole or anastrozole (+ goserelin in premenopausal women) - Events up to 30 days safety follow-up
|
Ribociclib 400mg (Post-treatment Efficacy Follow-up)
Ribociclib 400mg (Post-treatment efficacy follow-up) - Deaths in the post-treatment efficacy follow-up period were not considered adverse events.
|
Ribociclib 600 mg (Post-treatment Efficacy Follow-up)
Ribociclib 600 mg (Post-treatment efficacy follow-up) - Deaths in the post-treatment efficacy follow-up period were not considered adverse events.
|
|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
16.5%
31/188 • Adverse events (AEs) were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to 23.8 months. Deaths were collected in the post-treatment efficacy follow-up from 31 days after last dose of study medication until the end of the study, up to 62 months.
Deaths in the post-treatment efficacy follow-up were not considered adverse events. The total number at risk in the post-treatment efficacy follow-up included patients who entered this period.
|
26.1%
49/188 • Adverse events (AEs) were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to 23.8 months. Deaths were collected in the post-treatment efficacy follow-up from 31 days after last dose of study medication until the end of the study, up to 62 months.
Deaths in the post-treatment efficacy follow-up were not considered adverse events. The total number at risk in the post-treatment efficacy follow-up included patients who entered this period.
|
—
0/0 • Adverse events (AEs) were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to 23.8 months. Deaths were collected in the post-treatment efficacy follow-up from 31 days after last dose of study medication until the end of the study, up to 62 months.
Deaths in the post-treatment efficacy follow-up were not considered adverse events. The total number at risk in the post-treatment efficacy follow-up included patients who entered this period.
|
—
0/0 • Adverse events (AEs) were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to 23.8 months. Deaths were collected in the post-treatment efficacy follow-up from 31 days after last dose of study medication until the end of the study, up to 62 months.
Deaths in the post-treatment efficacy follow-up were not considered adverse events. The total number at risk in the post-treatment efficacy follow-up included patients who entered this period.
|
|
Blood and lymphatic system disorders
Leukopenia
|
21.3%
40/188 • Adverse events (AEs) were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to 23.8 months. Deaths were collected in the post-treatment efficacy follow-up from 31 days after last dose of study medication until the end of the study, up to 62 months.
Deaths in the post-treatment efficacy follow-up were not considered adverse events. The total number at risk in the post-treatment efficacy follow-up included patients who entered this period.
|
27.7%
52/188 • Adverse events (AEs) were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to 23.8 months. Deaths were collected in the post-treatment efficacy follow-up from 31 days after last dose of study medication until the end of the study, up to 62 months.
Deaths in the post-treatment efficacy follow-up were not considered adverse events. The total number at risk in the post-treatment efficacy follow-up included patients who entered this period.
|
—
0/0 • Adverse events (AEs) were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to 23.8 months. Deaths were collected in the post-treatment efficacy follow-up from 31 days after last dose of study medication until the end of the study, up to 62 months.
Deaths in the post-treatment efficacy follow-up were not considered adverse events. The total number at risk in the post-treatment efficacy follow-up included patients who entered this period.
|
—
0/0 • Adverse events (AEs) were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to 23.8 months. Deaths were collected in the post-treatment efficacy follow-up from 31 days after last dose of study medication until the end of the study, up to 62 months.
Deaths in the post-treatment efficacy follow-up were not considered adverse events. The total number at risk in the post-treatment efficacy follow-up included patients who entered this period.
|
|
Blood and lymphatic system disorders
Lymphopenia
|
9.0%
17/188 • Adverse events (AEs) were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to 23.8 months. Deaths were collected in the post-treatment efficacy follow-up from 31 days after last dose of study medication until the end of the study, up to 62 months.
Deaths in the post-treatment efficacy follow-up were not considered adverse events. The total number at risk in the post-treatment efficacy follow-up included patients who entered this period.
|
9.6%
18/188 • Adverse events (AEs) were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to 23.8 months. Deaths were collected in the post-treatment efficacy follow-up from 31 days after last dose of study medication until the end of the study, up to 62 months.
Deaths in the post-treatment efficacy follow-up were not considered adverse events. The total number at risk in the post-treatment efficacy follow-up included patients who entered this period.
|
—
0/0 • Adverse events (AEs) were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to 23.8 months. Deaths were collected in the post-treatment efficacy follow-up from 31 days after last dose of study medication until the end of the study, up to 62 months.
Deaths in the post-treatment efficacy follow-up were not considered adverse events. The total number at risk in the post-treatment efficacy follow-up included patients who entered this period.
|
—
0/0 • Adverse events (AEs) were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to 23.8 months. Deaths were collected in the post-treatment efficacy follow-up from 31 days after last dose of study medication until the end of the study, up to 62 months.
Deaths in the post-treatment efficacy follow-up were not considered adverse events. The total number at risk in the post-treatment efficacy follow-up included patients who entered this period.
|
|
Blood and lymphatic system disorders
Neutropenia
|
53.2%
100/188 • Adverse events (AEs) were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to 23.8 months. Deaths were collected in the post-treatment efficacy follow-up from 31 days after last dose of study medication until the end of the study, up to 62 months.
Deaths in the post-treatment efficacy follow-up were not considered adverse events. The total number at risk in the post-treatment efficacy follow-up included patients who entered this period.
|
66.5%
125/188 • Adverse events (AEs) were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to 23.8 months. Deaths were collected in the post-treatment efficacy follow-up from 31 days after last dose of study medication until the end of the study, up to 62 months.
Deaths in the post-treatment efficacy follow-up were not considered adverse events. The total number at risk in the post-treatment efficacy follow-up included patients who entered this period.
|
—
0/0 • Adverse events (AEs) were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to 23.8 months. Deaths were collected in the post-treatment efficacy follow-up from 31 days after last dose of study medication until the end of the study, up to 62 months.
Deaths in the post-treatment efficacy follow-up were not considered adverse events. The total number at risk in the post-treatment efficacy follow-up included patients who entered this period.
|
—
0/0 • Adverse events (AEs) were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to 23.8 months. Deaths were collected in the post-treatment efficacy follow-up from 31 days after last dose of study medication until the end of the study, up to 62 months.
Deaths in the post-treatment efficacy follow-up were not considered adverse events. The total number at risk in the post-treatment efficacy follow-up included patients who entered this period.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
6.9%
13/188 • Adverse events (AEs) were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to 23.8 months. Deaths were collected in the post-treatment efficacy follow-up from 31 days after last dose of study medication until the end of the study, up to 62 months.
Deaths in the post-treatment efficacy follow-up were not considered adverse events. The total number at risk in the post-treatment efficacy follow-up included patients who entered this period.
|
10.1%
19/188 • Adverse events (AEs) were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to 23.8 months. Deaths were collected in the post-treatment efficacy follow-up from 31 days after last dose of study medication until the end of the study, up to 62 months.
Deaths in the post-treatment efficacy follow-up were not considered adverse events. The total number at risk in the post-treatment efficacy follow-up included patients who entered this period.
|
—
0/0 • Adverse events (AEs) were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to 23.8 months. Deaths were collected in the post-treatment efficacy follow-up from 31 days after last dose of study medication until the end of the study, up to 62 months.
Deaths in the post-treatment efficacy follow-up were not considered adverse events. The total number at risk in the post-treatment efficacy follow-up included patients who entered this period.
|
—
0/0 • Adverse events (AEs) were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to 23.8 months. Deaths were collected in the post-treatment efficacy follow-up from 31 days after last dose of study medication until the end of the study, up to 62 months.
Deaths in the post-treatment efficacy follow-up were not considered adverse events. The total number at risk in the post-treatment efficacy follow-up included patients who entered this period.
|
|
Gastrointestinal disorders
Abdominal pain
|
5.3%
10/188 • Adverse events (AEs) were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to 23.8 months. Deaths were collected in the post-treatment efficacy follow-up from 31 days after last dose of study medication until the end of the study, up to 62 months.
Deaths in the post-treatment efficacy follow-up were not considered adverse events. The total number at risk in the post-treatment efficacy follow-up included patients who entered this period.
|
6.4%
12/188 • Adverse events (AEs) were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to 23.8 months. Deaths were collected in the post-treatment efficacy follow-up from 31 days after last dose of study medication until the end of the study, up to 62 months.
Deaths in the post-treatment efficacy follow-up were not considered adverse events. The total number at risk in the post-treatment efficacy follow-up included patients who entered this period.
|
—
0/0 • Adverse events (AEs) were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to 23.8 months. Deaths were collected in the post-treatment efficacy follow-up from 31 days after last dose of study medication until the end of the study, up to 62 months.
Deaths in the post-treatment efficacy follow-up were not considered adverse events. The total number at risk in the post-treatment efficacy follow-up included patients who entered this period.
|
—
0/0 • Adverse events (AEs) were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to 23.8 months. Deaths were collected in the post-treatment efficacy follow-up from 31 days after last dose of study medication until the end of the study, up to 62 months.
Deaths in the post-treatment efficacy follow-up were not considered adverse events. The total number at risk in the post-treatment efficacy follow-up included patients who entered this period.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
2.7%
5/188 • Adverse events (AEs) were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to 23.8 months. Deaths were collected in the post-treatment efficacy follow-up from 31 days after last dose of study medication until the end of the study, up to 62 months.
Deaths in the post-treatment efficacy follow-up were not considered adverse events. The total number at risk in the post-treatment efficacy follow-up included patients who entered this period.
|
6.4%
12/188 • Adverse events (AEs) were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to 23.8 months. Deaths were collected in the post-treatment efficacy follow-up from 31 days after last dose of study medication until the end of the study, up to 62 months.
Deaths in the post-treatment efficacy follow-up were not considered adverse events. The total number at risk in the post-treatment efficacy follow-up included patients who entered this period.
|
—
0/0 • Adverse events (AEs) were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to 23.8 months. Deaths were collected in the post-treatment efficacy follow-up from 31 days after last dose of study medication until the end of the study, up to 62 months.
Deaths in the post-treatment efficacy follow-up were not considered adverse events. The total number at risk in the post-treatment efficacy follow-up included patients who entered this period.
|
—
0/0 • Adverse events (AEs) were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to 23.8 months. Deaths were collected in the post-treatment efficacy follow-up from 31 days after last dose of study medication until the end of the study, up to 62 months.
Deaths in the post-treatment efficacy follow-up were not considered adverse events. The total number at risk in the post-treatment efficacy follow-up included patients who entered this period.
|
|
Gastrointestinal disorders
Constipation
|
9.0%
17/188 • Adverse events (AEs) were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to 23.8 months. Deaths were collected in the post-treatment efficacy follow-up from 31 days after last dose of study medication until the end of the study, up to 62 months.
Deaths in the post-treatment efficacy follow-up were not considered adverse events. The total number at risk in the post-treatment efficacy follow-up included patients who entered this period.
|
11.2%
21/188 • Adverse events (AEs) were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to 23.8 months. Deaths were collected in the post-treatment efficacy follow-up from 31 days after last dose of study medication until the end of the study, up to 62 months.
Deaths in the post-treatment efficacy follow-up were not considered adverse events. The total number at risk in the post-treatment efficacy follow-up included patients who entered this period.
|
—
0/0 • Adverse events (AEs) were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to 23.8 months. Deaths were collected in the post-treatment efficacy follow-up from 31 days after last dose of study medication until the end of the study, up to 62 months.
Deaths in the post-treatment efficacy follow-up were not considered adverse events. The total number at risk in the post-treatment efficacy follow-up included patients who entered this period.
|
—
0/0 • Adverse events (AEs) were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to 23.8 months. Deaths were collected in the post-treatment efficacy follow-up from 31 days after last dose of study medication until the end of the study, up to 62 months.
Deaths in the post-treatment efficacy follow-up were not considered adverse events. The total number at risk in the post-treatment efficacy follow-up included patients who entered this period.
|
|
Gastrointestinal disorders
Diarrhoea
|
11.7%
22/188 • Adverse events (AEs) were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to 23.8 months. Deaths were collected in the post-treatment efficacy follow-up from 31 days after last dose of study medication until the end of the study, up to 62 months.
Deaths in the post-treatment efficacy follow-up were not considered adverse events. The total number at risk in the post-treatment efficacy follow-up included patients who entered this period.
|
13.3%
25/188 • Adverse events (AEs) were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to 23.8 months. Deaths were collected in the post-treatment efficacy follow-up from 31 days after last dose of study medication until the end of the study, up to 62 months.
Deaths in the post-treatment efficacy follow-up were not considered adverse events. The total number at risk in the post-treatment efficacy follow-up included patients who entered this period.
|
—
0/0 • Adverse events (AEs) were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to 23.8 months. Deaths were collected in the post-treatment efficacy follow-up from 31 days after last dose of study medication until the end of the study, up to 62 months.
Deaths in the post-treatment efficacy follow-up were not considered adverse events. The total number at risk in the post-treatment efficacy follow-up included patients who entered this period.
|
—
0/0 • Adverse events (AEs) were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to 23.8 months. Deaths were collected in the post-treatment efficacy follow-up from 31 days after last dose of study medication until the end of the study, up to 62 months.
Deaths in the post-treatment efficacy follow-up were not considered adverse events. The total number at risk in the post-treatment efficacy follow-up included patients who entered this period.
|
|
Gastrointestinal disorders
Nausea
|
16.5%
31/188 • Adverse events (AEs) were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to 23.8 months. Deaths were collected in the post-treatment efficacy follow-up from 31 days after last dose of study medication until the end of the study, up to 62 months.
Deaths in the post-treatment efficacy follow-up were not considered adverse events. The total number at risk in the post-treatment efficacy follow-up included patients who entered this period.
|
23.4%
44/188 • Adverse events (AEs) were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to 23.8 months. Deaths were collected in the post-treatment efficacy follow-up from 31 days after last dose of study medication until the end of the study, up to 62 months.
Deaths in the post-treatment efficacy follow-up were not considered adverse events. The total number at risk in the post-treatment efficacy follow-up included patients who entered this period.
|
—
0/0 • Adverse events (AEs) were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to 23.8 months. Deaths were collected in the post-treatment efficacy follow-up from 31 days after last dose of study medication until the end of the study, up to 62 months.
Deaths in the post-treatment efficacy follow-up were not considered adverse events. The total number at risk in the post-treatment efficacy follow-up included patients who entered this period.
|
—
0/0 • Adverse events (AEs) were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to 23.8 months. Deaths were collected in the post-treatment efficacy follow-up from 31 days after last dose of study medication until the end of the study, up to 62 months.
Deaths in the post-treatment efficacy follow-up were not considered adverse events. The total number at risk in the post-treatment efficacy follow-up included patients who entered this period.
|
|
Gastrointestinal disorders
Vomiting
|
8.0%
15/188 • Adverse events (AEs) were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to 23.8 months. Deaths were collected in the post-treatment efficacy follow-up from 31 days after last dose of study medication until the end of the study, up to 62 months.
Deaths in the post-treatment efficacy follow-up were not considered adverse events. The total number at risk in the post-treatment efficacy follow-up included patients who entered this period.
|
11.7%
22/188 • Adverse events (AEs) were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to 23.8 months. Deaths were collected in the post-treatment efficacy follow-up from 31 days after last dose of study medication until the end of the study, up to 62 months.
Deaths in the post-treatment efficacy follow-up were not considered adverse events. The total number at risk in the post-treatment efficacy follow-up included patients who entered this period.
|
—
0/0 • Adverse events (AEs) were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to 23.8 months. Deaths were collected in the post-treatment efficacy follow-up from 31 days after last dose of study medication until the end of the study, up to 62 months.
Deaths in the post-treatment efficacy follow-up were not considered adverse events. The total number at risk in the post-treatment efficacy follow-up included patients who entered this period.
|
—
0/0 • Adverse events (AEs) were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to 23.8 months. Deaths were collected in the post-treatment efficacy follow-up from 31 days after last dose of study medication until the end of the study, up to 62 months.
Deaths in the post-treatment efficacy follow-up were not considered adverse events. The total number at risk in the post-treatment efficacy follow-up included patients who entered this period.
|
|
General disorders
Asthenia
|
12.8%
24/188 • Adverse events (AEs) were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to 23.8 months. Deaths were collected in the post-treatment efficacy follow-up from 31 days after last dose of study medication until the end of the study, up to 62 months.
Deaths in the post-treatment efficacy follow-up were not considered adverse events. The total number at risk in the post-treatment efficacy follow-up included patients who entered this period.
|
12.2%
23/188 • Adverse events (AEs) were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to 23.8 months. Deaths were collected in the post-treatment efficacy follow-up from 31 days after last dose of study medication until the end of the study, up to 62 months.
Deaths in the post-treatment efficacy follow-up were not considered adverse events. The total number at risk in the post-treatment efficacy follow-up included patients who entered this period.
|
—
0/0 • Adverse events (AEs) were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to 23.8 months. Deaths were collected in the post-treatment efficacy follow-up from 31 days after last dose of study medication until the end of the study, up to 62 months.
Deaths in the post-treatment efficacy follow-up were not considered adverse events. The total number at risk in the post-treatment efficacy follow-up included patients who entered this period.
|
—
0/0 • Adverse events (AEs) were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to 23.8 months. Deaths were collected in the post-treatment efficacy follow-up from 31 days after last dose of study medication until the end of the study, up to 62 months.
Deaths in the post-treatment efficacy follow-up were not considered adverse events. The total number at risk in the post-treatment efficacy follow-up included patients who entered this period.
|
|
General disorders
Fatigue
|
11.7%
22/188 • Adverse events (AEs) were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to 23.8 months. Deaths were collected in the post-treatment efficacy follow-up from 31 days after last dose of study medication until the end of the study, up to 62 months.
Deaths in the post-treatment efficacy follow-up were not considered adverse events. The total number at risk in the post-treatment efficacy follow-up included patients who entered this period.
|
21.3%
40/188 • Adverse events (AEs) were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to 23.8 months. Deaths were collected in the post-treatment efficacy follow-up from 31 days after last dose of study medication until the end of the study, up to 62 months.
Deaths in the post-treatment efficacy follow-up were not considered adverse events. The total number at risk in the post-treatment efficacy follow-up included patients who entered this period.
|
—
0/0 • Adverse events (AEs) were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to 23.8 months. Deaths were collected in the post-treatment efficacy follow-up from 31 days after last dose of study medication until the end of the study, up to 62 months.
Deaths in the post-treatment efficacy follow-up were not considered adverse events. The total number at risk in the post-treatment efficacy follow-up included patients who entered this period.
|
—
0/0 • Adverse events (AEs) were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to 23.8 months. Deaths were collected in the post-treatment efficacy follow-up from 31 days after last dose of study medication until the end of the study, up to 62 months.
Deaths in the post-treatment efficacy follow-up were not considered adverse events. The total number at risk in the post-treatment efficacy follow-up included patients who entered this period.
|
|
General disorders
Oedema peripheral
|
4.3%
8/188 • Adverse events (AEs) were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to 23.8 months. Deaths were collected in the post-treatment efficacy follow-up from 31 days after last dose of study medication until the end of the study, up to 62 months.
Deaths in the post-treatment efficacy follow-up were not considered adverse events. The total number at risk in the post-treatment efficacy follow-up included patients who entered this period.
|
6.4%
12/188 • Adverse events (AEs) were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to 23.8 months. Deaths were collected in the post-treatment efficacy follow-up from 31 days after last dose of study medication until the end of the study, up to 62 months.
Deaths in the post-treatment efficacy follow-up were not considered adverse events. The total number at risk in the post-treatment efficacy follow-up included patients who entered this period.
|
—
0/0 • Adverse events (AEs) were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to 23.8 months. Deaths were collected in the post-treatment efficacy follow-up from 31 days after last dose of study medication until the end of the study, up to 62 months.
Deaths in the post-treatment efficacy follow-up were not considered adverse events. The total number at risk in the post-treatment efficacy follow-up included patients who entered this period.
|
—
0/0 • Adverse events (AEs) were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to 23.8 months. Deaths were collected in the post-treatment efficacy follow-up from 31 days after last dose of study medication until the end of the study, up to 62 months.
Deaths in the post-treatment efficacy follow-up were not considered adverse events. The total number at risk in the post-treatment efficacy follow-up included patients who entered this period.
|
|
General disorders
Pain
|
0.53%
1/188 • Adverse events (AEs) were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to 23.8 months. Deaths were collected in the post-treatment efficacy follow-up from 31 days after last dose of study medication until the end of the study, up to 62 months.
Deaths in the post-treatment efficacy follow-up were not considered adverse events. The total number at risk in the post-treatment efficacy follow-up included patients who entered this period.
|
7.4%
14/188 • Adverse events (AEs) were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to 23.8 months. Deaths were collected in the post-treatment efficacy follow-up from 31 days after last dose of study medication until the end of the study, up to 62 months.
Deaths in the post-treatment efficacy follow-up were not considered adverse events. The total number at risk in the post-treatment efficacy follow-up included patients who entered this period.
|
—
0/0 • Adverse events (AEs) were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to 23.8 months. Deaths were collected in the post-treatment efficacy follow-up from 31 days after last dose of study medication until the end of the study, up to 62 months.
Deaths in the post-treatment efficacy follow-up were not considered adverse events. The total number at risk in the post-treatment efficacy follow-up included patients who entered this period.
|
—
0/0 • Adverse events (AEs) were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to 23.8 months. Deaths were collected in the post-treatment efficacy follow-up from 31 days after last dose of study medication until the end of the study, up to 62 months.
Deaths in the post-treatment efficacy follow-up were not considered adverse events. The total number at risk in the post-treatment efficacy follow-up included patients who entered this period.
|
|
General disorders
Pyrexia
|
5.9%
11/188 • Adverse events (AEs) were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to 23.8 months. Deaths were collected in the post-treatment efficacy follow-up from 31 days after last dose of study medication until the end of the study, up to 62 months.
Deaths in the post-treatment efficacy follow-up were not considered adverse events. The total number at risk in the post-treatment efficacy follow-up included patients who entered this period.
|
6.4%
12/188 • Adverse events (AEs) were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to 23.8 months. Deaths were collected in the post-treatment efficacy follow-up from 31 days after last dose of study medication until the end of the study, up to 62 months.
Deaths in the post-treatment efficacy follow-up were not considered adverse events. The total number at risk in the post-treatment efficacy follow-up included patients who entered this period.
|
—
0/0 • Adverse events (AEs) were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to 23.8 months. Deaths were collected in the post-treatment efficacy follow-up from 31 days after last dose of study medication until the end of the study, up to 62 months.
Deaths in the post-treatment efficacy follow-up were not considered adverse events. The total number at risk in the post-treatment efficacy follow-up included patients who entered this period.
|
—
0/0 • Adverse events (AEs) were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to 23.8 months. Deaths were collected in the post-treatment efficacy follow-up from 31 days after last dose of study medication until the end of the study, up to 62 months.
Deaths in the post-treatment efficacy follow-up were not considered adverse events. The total number at risk in the post-treatment efficacy follow-up included patients who entered this period.
|
|
Infections and infestations
COVID-19
|
9.0%
17/188 • Adverse events (AEs) were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to 23.8 months. Deaths were collected in the post-treatment efficacy follow-up from 31 days after last dose of study medication until the end of the study, up to 62 months.
Deaths in the post-treatment efficacy follow-up were not considered adverse events. The total number at risk in the post-treatment efficacy follow-up included patients who entered this period.
|
14.4%
27/188 • Adverse events (AEs) were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to 23.8 months. Deaths were collected in the post-treatment efficacy follow-up from 31 days after last dose of study medication until the end of the study, up to 62 months.
Deaths in the post-treatment efficacy follow-up were not considered adverse events. The total number at risk in the post-treatment efficacy follow-up included patients who entered this period.
|
—
0/0 • Adverse events (AEs) were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to 23.8 months. Deaths were collected in the post-treatment efficacy follow-up from 31 days after last dose of study medication until the end of the study, up to 62 months.
Deaths in the post-treatment efficacy follow-up were not considered adverse events. The total number at risk in the post-treatment efficacy follow-up included patients who entered this period.
|
—
0/0 • Adverse events (AEs) were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to 23.8 months. Deaths were collected in the post-treatment efficacy follow-up from 31 days after last dose of study medication until the end of the study, up to 62 months.
Deaths in the post-treatment efficacy follow-up were not considered adverse events. The total number at risk in the post-treatment efficacy follow-up included patients who entered this period.
|
|
Infections and infestations
Nasopharyngitis
|
3.2%
6/188 • Adverse events (AEs) were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to 23.8 months. Deaths were collected in the post-treatment efficacy follow-up from 31 days after last dose of study medication until the end of the study, up to 62 months.
Deaths in the post-treatment efficacy follow-up were not considered adverse events. The total number at risk in the post-treatment efficacy follow-up included patients who entered this period.
|
6.4%
12/188 • Adverse events (AEs) were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to 23.8 months. Deaths were collected in the post-treatment efficacy follow-up from 31 days after last dose of study medication until the end of the study, up to 62 months.
Deaths in the post-treatment efficacy follow-up were not considered adverse events. The total number at risk in the post-treatment efficacy follow-up included patients who entered this period.
|
—
0/0 • Adverse events (AEs) were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to 23.8 months. Deaths were collected in the post-treatment efficacy follow-up from 31 days after last dose of study medication until the end of the study, up to 62 months.
Deaths in the post-treatment efficacy follow-up were not considered adverse events. The total number at risk in the post-treatment efficacy follow-up included patients who entered this period.
|
—
0/0 • Adverse events (AEs) were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to 23.8 months. Deaths were collected in the post-treatment efficacy follow-up from 31 days after last dose of study medication until the end of the study, up to 62 months.
Deaths in the post-treatment efficacy follow-up were not considered adverse events. The total number at risk in the post-treatment efficacy follow-up included patients who entered this period.
|
|
Infections and infestations
Urinary tract infection
|
8.0%
15/188 • Adverse events (AEs) were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to 23.8 months. Deaths were collected in the post-treatment efficacy follow-up from 31 days after last dose of study medication until the end of the study, up to 62 months.
Deaths in the post-treatment efficacy follow-up were not considered adverse events. The total number at risk in the post-treatment efficacy follow-up included patients who entered this period.
|
9.0%
17/188 • Adverse events (AEs) were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to 23.8 months. Deaths were collected in the post-treatment efficacy follow-up from 31 days after last dose of study medication until the end of the study, up to 62 months.
Deaths in the post-treatment efficacy follow-up were not considered adverse events. The total number at risk in the post-treatment efficacy follow-up included patients who entered this period.
|
—
0/0 • Adverse events (AEs) were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to 23.8 months. Deaths were collected in the post-treatment efficacy follow-up from 31 days after last dose of study medication until the end of the study, up to 62 months.
Deaths in the post-treatment efficacy follow-up were not considered adverse events. The total number at risk in the post-treatment efficacy follow-up included patients who entered this period.
|
—
0/0 • Adverse events (AEs) were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to 23.8 months. Deaths were collected in the post-treatment efficacy follow-up from 31 days after last dose of study medication until the end of the study, up to 62 months.
Deaths in the post-treatment efficacy follow-up were not considered adverse events. The total number at risk in the post-treatment efficacy follow-up included patients who entered this period.
|
|
Investigations
Alanine aminotransferase increased
|
26.1%
49/188 • Adverse events (AEs) were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to 23.8 months. Deaths were collected in the post-treatment efficacy follow-up from 31 days after last dose of study medication until the end of the study, up to 62 months.
Deaths in the post-treatment efficacy follow-up were not considered adverse events. The total number at risk in the post-treatment efficacy follow-up included patients who entered this period.
|
25.0%
47/188 • Adverse events (AEs) were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to 23.8 months. Deaths were collected in the post-treatment efficacy follow-up from 31 days after last dose of study medication until the end of the study, up to 62 months.
Deaths in the post-treatment efficacy follow-up were not considered adverse events. The total number at risk in the post-treatment efficacy follow-up included patients who entered this period.
|
—
0/0 • Adverse events (AEs) were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to 23.8 months. Deaths were collected in the post-treatment efficacy follow-up from 31 days after last dose of study medication until the end of the study, up to 62 months.
Deaths in the post-treatment efficacy follow-up were not considered adverse events. The total number at risk in the post-treatment efficacy follow-up included patients who entered this period.
|
—
0/0 • Adverse events (AEs) were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to 23.8 months. Deaths were collected in the post-treatment efficacy follow-up from 31 days after last dose of study medication until the end of the study, up to 62 months.
Deaths in the post-treatment efficacy follow-up were not considered adverse events. The total number at risk in the post-treatment efficacy follow-up included patients who entered this period.
|
|
Investigations
Aspartate aminotransferase increased
|
21.8%
41/188 • Adverse events (AEs) were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to 23.8 months. Deaths were collected in the post-treatment efficacy follow-up from 31 days after last dose of study medication until the end of the study, up to 62 months.
Deaths in the post-treatment efficacy follow-up were not considered adverse events. The total number at risk in the post-treatment efficacy follow-up included patients who entered this period.
|
21.3%
40/188 • Adverse events (AEs) were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to 23.8 months. Deaths were collected in the post-treatment efficacy follow-up from 31 days after last dose of study medication until the end of the study, up to 62 months.
Deaths in the post-treatment efficacy follow-up were not considered adverse events. The total number at risk in the post-treatment efficacy follow-up included patients who entered this period.
|
—
0/0 • Adverse events (AEs) were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to 23.8 months. Deaths were collected in the post-treatment efficacy follow-up from 31 days after last dose of study medication until the end of the study, up to 62 months.
Deaths in the post-treatment efficacy follow-up were not considered adverse events. The total number at risk in the post-treatment efficacy follow-up included patients who entered this period.
|
—
0/0 • Adverse events (AEs) were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to 23.8 months. Deaths were collected in the post-treatment efficacy follow-up from 31 days after last dose of study medication until the end of the study, up to 62 months.
Deaths in the post-treatment efficacy follow-up were not considered adverse events. The total number at risk in the post-treatment efficacy follow-up included patients who entered this period.
|
|
Investigations
Blood alkaline phosphatase increased
|
5.9%
11/188 • Adverse events (AEs) were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to 23.8 months. Deaths were collected in the post-treatment efficacy follow-up from 31 days after last dose of study medication until the end of the study, up to 62 months.
Deaths in the post-treatment efficacy follow-up were not considered adverse events. The total number at risk in the post-treatment efficacy follow-up included patients who entered this period.
|
9.0%
17/188 • Adverse events (AEs) were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to 23.8 months. Deaths were collected in the post-treatment efficacy follow-up from 31 days after last dose of study medication until the end of the study, up to 62 months.
Deaths in the post-treatment efficacy follow-up were not considered adverse events. The total number at risk in the post-treatment efficacy follow-up included patients who entered this period.
|
—
0/0 • Adverse events (AEs) were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to 23.8 months. Deaths were collected in the post-treatment efficacy follow-up from 31 days after last dose of study medication until the end of the study, up to 62 months.
Deaths in the post-treatment efficacy follow-up were not considered adverse events. The total number at risk in the post-treatment efficacy follow-up included patients who entered this period.
|
—
0/0 • Adverse events (AEs) were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to 23.8 months. Deaths were collected in the post-treatment efficacy follow-up from 31 days after last dose of study medication until the end of the study, up to 62 months.
Deaths in the post-treatment efficacy follow-up were not considered adverse events. The total number at risk in the post-treatment efficacy follow-up included patients who entered this period.
|
|
Investigations
Blood creatinine increased
|
6.4%
12/188 • Adverse events (AEs) were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to 23.8 months. Deaths were collected in the post-treatment efficacy follow-up from 31 days after last dose of study medication until the end of the study, up to 62 months.
Deaths in the post-treatment efficacy follow-up were not considered adverse events. The total number at risk in the post-treatment efficacy follow-up included patients who entered this period.
|
8.0%
15/188 • Adverse events (AEs) were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to 23.8 months. Deaths were collected in the post-treatment efficacy follow-up from 31 days after last dose of study medication until the end of the study, up to 62 months.
Deaths in the post-treatment efficacy follow-up were not considered adverse events. The total number at risk in the post-treatment efficacy follow-up included patients who entered this period.
|
—
0/0 • Adverse events (AEs) were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to 23.8 months. Deaths were collected in the post-treatment efficacy follow-up from 31 days after last dose of study medication until the end of the study, up to 62 months.
Deaths in the post-treatment efficacy follow-up were not considered adverse events. The total number at risk in the post-treatment efficacy follow-up included patients who entered this period.
|
—
0/0 • Adverse events (AEs) were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to 23.8 months. Deaths were collected in the post-treatment efficacy follow-up from 31 days after last dose of study medication until the end of the study, up to 62 months.
Deaths in the post-treatment efficacy follow-up were not considered adverse events. The total number at risk in the post-treatment efficacy follow-up included patients who entered this period.
|
|
Investigations
Electrocardiogram QT prolonged
|
7.4%
14/188 • Adverse events (AEs) were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to 23.8 months. Deaths were collected in the post-treatment efficacy follow-up from 31 days after last dose of study medication until the end of the study, up to 62 months.
Deaths in the post-treatment efficacy follow-up were not considered adverse events. The total number at risk in the post-treatment efficacy follow-up included patients who entered this period.
|
13.8%
26/188 • Adverse events (AEs) were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to 23.8 months. Deaths were collected in the post-treatment efficacy follow-up from 31 days after last dose of study medication until the end of the study, up to 62 months.
Deaths in the post-treatment efficacy follow-up were not considered adverse events. The total number at risk in the post-treatment efficacy follow-up included patients who entered this period.
|
—
0/0 • Adverse events (AEs) were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to 23.8 months. Deaths were collected in the post-treatment efficacy follow-up from 31 days after last dose of study medication until the end of the study, up to 62 months.
Deaths in the post-treatment efficacy follow-up were not considered adverse events. The total number at risk in the post-treatment efficacy follow-up included patients who entered this period.
|
—
0/0 • Adverse events (AEs) were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to 23.8 months. Deaths were collected in the post-treatment efficacy follow-up from 31 days after last dose of study medication until the end of the study, up to 62 months.
Deaths in the post-treatment efficacy follow-up were not considered adverse events. The total number at risk in the post-treatment efficacy follow-up included patients who entered this period.
|
|
Investigations
Gamma-glutamyltransferase increased
|
9.0%
17/188 • Adverse events (AEs) were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to 23.8 months. Deaths were collected in the post-treatment efficacy follow-up from 31 days after last dose of study medication until the end of the study, up to 62 months.
Deaths in the post-treatment efficacy follow-up were not considered adverse events. The total number at risk in the post-treatment efficacy follow-up included patients who entered this period.
|
8.5%
16/188 • Adverse events (AEs) were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to 23.8 months. Deaths were collected in the post-treatment efficacy follow-up from 31 days after last dose of study medication until the end of the study, up to 62 months.
Deaths in the post-treatment efficacy follow-up were not considered adverse events. The total number at risk in the post-treatment efficacy follow-up included patients who entered this period.
|
—
0/0 • Adverse events (AEs) were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to 23.8 months. Deaths were collected in the post-treatment efficacy follow-up from 31 days after last dose of study medication until the end of the study, up to 62 months.
Deaths in the post-treatment efficacy follow-up were not considered adverse events. The total number at risk in the post-treatment efficacy follow-up included patients who entered this period.
|
—
0/0 • Adverse events (AEs) were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to 23.8 months. Deaths were collected in the post-treatment efficacy follow-up from 31 days after last dose of study medication until the end of the study, up to 62 months.
Deaths in the post-treatment efficacy follow-up were not considered adverse events. The total number at risk in the post-treatment efficacy follow-up included patients who entered this period.
|
|
Investigations
Lipase increased
|
4.8%
9/188 • Adverse events (AEs) were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to 23.8 months. Deaths were collected in the post-treatment efficacy follow-up from 31 days after last dose of study medication until the end of the study, up to 62 months.
Deaths in the post-treatment efficacy follow-up were not considered adverse events. The total number at risk in the post-treatment efficacy follow-up included patients who entered this period.
|
6.4%
12/188 • Adverse events (AEs) were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to 23.8 months. Deaths were collected in the post-treatment efficacy follow-up from 31 days after last dose of study medication until the end of the study, up to 62 months.
Deaths in the post-treatment efficacy follow-up were not considered adverse events. The total number at risk in the post-treatment efficacy follow-up included patients who entered this period.
|
—
0/0 • Adverse events (AEs) were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to 23.8 months. Deaths were collected in the post-treatment efficacy follow-up from 31 days after last dose of study medication until the end of the study, up to 62 months.
Deaths in the post-treatment efficacy follow-up were not considered adverse events. The total number at risk in the post-treatment efficacy follow-up included patients who entered this period.
|
—
0/0 • Adverse events (AEs) were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to 23.8 months. Deaths were collected in the post-treatment efficacy follow-up from 31 days after last dose of study medication until the end of the study, up to 62 months.
Deaths in the post-treatment efficacy follow-up were not considered adverse events. The total number at risk in the post-treatment efficacy follow-up included patients who entered this period.
|
|
Investigations
Neutrophil count decreased
|
13.3%
25/188 • Adverse events (AEs) were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to 23.8 months. Deaths were collected in the post-treatment efficacy follow-up from 31 days after last dose of study medication until the end of the study, up to 62 months.
Deaths in the post-treatment efficacy follow-up were not considered adverse events. The total number at risk in the post-treatment efficacy follow-up included patients who entered this period.
|
12.8%
24/188 • Adverse events (AEs) were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to 23.8 months. Deaths were collected in the post-treatment efficacy follow-up from 31 days after last dose of study medication until the end of the study, up to 62 months.
Deaths in the post-treatment efficacy follow-up were not considered adverse events. The total number at risk in the post-treatment efficacy follow-up included patients who entered this period.
|
—
0/0 • Adverse events (AEs) were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to 23.8 months. Deaths were collected in the post-treatment efficacy follow-up from 31 days after last dose of study medication until the end of the study, up to 62 months.
Deaths in the post-treatment efficacy follow-up were not considered adverse events. The total number at risk in the post-treatment efficacy follow-up included patients who entered this period.
|
—
0/0 • Adverse events (AEs) were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to 23.8 months. Deaths were collected in the post-treatment efficacy follow-up from 31 days after last dose of study medication until the end of the study, up to 62 months.
Deaths in the post-treatment efficacy follow-up were not considered adverse events. The total number at risk in the post-treatment efficacy follow-up included patients who entered this period.
|
|
Investigations
Weight decreased
|
5.9%
11/188 • Adverse events (AEs) were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to 23.8 months. Deaths were collected in the post-treatment efficacy follow-up from 31 days after last dose of study medication until the end of the study, up to 62 months.
Deaths in the post-treatment efficacy follow-up were not considered adverse events. The total number at risk in the post-treatment efficacy follow-up included patients who entered this period.
|
5.9%
11/188 • Adverse events (AEs) were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to 23.8 months. Deaths were collected in the post-treatment efficacy follow-up from 31 days after last dose of study medication until the end of the study, up to 62 months.
Deaths in the post-treatment efficacy follow-up were not considered adverse events. The total number at risk in the post-treatment efficacy follow-up included patients who entered this period.
|
—
0/0 • Adverse events (AEs) were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to 23.8 months. Deaths were collected in the post-treatment efficacy follow-up from 31 days after last dose of study medication until the end of the study, up to 62 months.
Deaths in the post-treatment efficacy follow-up were not considered adverse events. The total number at risk in the post-treatment efficacy follow-up included patients who entered this period.
|
—
0/0 • Adverse events (AEs) were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to 23.8 months. Deaths were collected in the post-treatment efficacy follow-up from 31 days after last dose of study medication until the end of the study, up to 62 months.
Deaths in the post-treatment efficacy follow-up were not considered adverse events. The total number at risk in the post-treatment efficacy follow-up included patients who entered this period.
|
|
Investigations
White blood cell count decreased
|
6.9%
13/188 • Adverse events (AEs) were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to 23.8 months. Deaths were collected in the post-treatment efficacy follow-up from 31 days after last dose of study medication until the end of the study, up to 62 months.
Deaths in the post-treatment efficacy follow-up were not considered adverse events. The total number at risk in the post-treatment efficacy follow-up included patients who entered this period.
|
11.7%
22/188 • Adverse events (AEs) were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to 23.8 months. Deaths were collected in the post-treatment efficacy follow-up from 31 days after last dose of study medication until the end of the study, up to 62 months.
Deaths in the post-treatment efficacy follow-up were not considered adverse events. The total number at risk in the post-treatment efficacy follow-up included patients who entered this period.
|
—
0/0 • Adverse events (AEs) were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to 23.8 months. Deaths were collected in the post-treatment efficacy follow-up from 31 days after last dose of study medication until the end of the study, up to 62 months.
Deaths in the post-treatment efficacy follow-up were not considered adverse events. The total number at risk in the post-treatment efficacy follow-up included patients who entered this period.
|
—
0/0 • Adverse events (AEs) were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to 23.8 months. Deaths were collected in the post-treatment efficacy follow-up from 31 days after last dose of study medication until the end of the study, up to 62 months.
Deaths in the post-treatment efficacy follow-up were not considered adverse events. The total number at risk in the post-treatment efficacy follow-up included patients who entered this period.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
5.9%
11/188 • Adverse events (AEs) were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to 23.8 months. Deaths were collected in the post-treatment efficacy follow-up from 31 days after last dose of study medication until the end of the study, up to 62 months.
Deaths in the post-treatment efficacy follow-up were not considered adverse events. The total number at risk in the post-treatment efficacy follow-up included patients who entered this period.
|
6.9%
13/188 • Adverse events (AEs) were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to 23.8 months. Deaths were collected in the post-treatment efficacy follow-up from 31 days after last dose of study medication until the end of the study, up to 62 months.
Deaths in the post-treatment efficacy follow-up were not considered adverse events. The total number at risk in the post-treatment efficacy follow-up included patients who entered this period.
|
—
0/0 • Adverse events (AEs) were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to 23.8 months. Deaths were collected in the post-treatment efficacy follow-up from 31 days after last dose of study medication until the end of the study, up to 62 months.
Deaths in the post-treatment efficacy follow-up were not considered adverse events. The total number at risk in the post-treatment efficacy follow-up included patients who entered this period.
|
—
0/0 • Adverse events (AEs) were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to 23.8 months. Deaths were collected in the post-treatment efficacy follow-up from 31 days after last dose of study medication until the end of the study, up to 62 months.
Deaths in the post-treatment efficacy follow-up were not considered adverse events. The total number at risk in the post-treatment efficacy follow-up included patients who entered this period.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
4.8%
9/188 • Adverse events (AEs) were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to 23.8 months. Deaths were collected in the post-treatment efficacy follow-up from 31 days after last dose of study medication until the end of the study, up to 62 months.
Deaths in the post-treatment efficacy follow-up were not considered adverse events. The total number at risk in the post-treatment efficacy follow-up included patients who entered this period.
|
6.4%
12/188 • Adverse events (AEs) were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to 23.8 months. Deaths were collected in the post-treatment efficacy follow-up from 31 days after last dose of study medication until the end of the study, up to 62 months.
Deaths in the post-treatment efficacy follow-up were not considered adverse events. The total number at risk in the post-treatment efficacy follow-up included patients who entered this period.
|
—
0/0 • Adverse events (AEs) were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to 23.8 months. Deaths were collected in the post-treatment efficacy follow-up from 31 days after last dose of study medication until the end of the study, up to 62 months.
Deaths in the post-treatment efficacy follow-up were not considered adverse events. The total number at risk in the post-treatment efficacy follow-up included patients who entered this period.
|
—
0/0 • Adverse events (AEs) were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to 23.8 months. Deaths were collected in the post-treatment efficacy follow-up from 31 days after last dose of study medication until the end of the study, up to 62 months.
Deaths in the post-treatment efficacy follow-up were not considered adverse events. The total number at risk in the post-treatment efficacy follow-up included patients who entered this period.
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
6.4%
12/188 • Adverse events (AEs) were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to 23.8 months. Deaths were collected in the post-treatment efficacy follow-up from 31 days after last dose of study medication until the end of the study, up to 62 months.
Deaths in the post-treatment efficacy follow-up were not considered adverse events. The total number at risk in the post-treatment efficacy follow-up included patients who entered this period.
|
8.0%
15/188 • Adverse events (AEs) were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to 23.8 months. Deaths were collected in the post-treatment efficacy follow-up from 31 days after last dose of study medication until the end of the study, up to 62 months.
Deaths in the post-treatment efficacy follow-up were not considered adverse events. The total number at risk in the post-treatment efficacy follow-up included patients who entered this period.
|
—
0/0 • Adverse events (AEs) were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to 23.8 months. Deaths were collected in the post-treatment efficacy follow-up from 31 days after last dose of study medication until the end of the study, up to 62 months.
Deaths in the post-treatment efficacy follow-up were not considered adverse events. The total number at risk in the post-treatment efficacy follow-up included patients who entered this period.
|
—
0/0 • Adverse events (AEs) were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to 23.8 months. Deaths were collected in the post-treatment efficacy follow-up from 31 days after last dose of study medication until the end of the study, up to 62 months.
Deaths in the post-treatment efficacy follow-up were not considered adverse events. The total number at risk in the post-treatment efficacy follow-up included patients who entered this period.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
4.8%
9/188 • Adverse events (AEs) were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to 23.8 months. Deaths were collected in the post-treatment efficacy follow-up from 31 days after last dose of study medication until the end of the study, up to 62 months.
Deaths in the post-treatment efficacy follow-up were not considered adverse events. The total number at risk in the post-treatment efficacy follow-up included patients who entered this period.
|
5.3%
10/188 • Adverse events (AEs) were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to 23.8 months. Deaths were collected in the post-treatment efficacy follow-up from 31 days after last dose of study medication until the end of the study, up to 62 months.
Deaths in the post-treatment efficacy follow-up were not considered adverse events. The total number at risk in the post-treatment efficacy follow-up included patients who entered this period.
|
—
0/0 • Adverse events (AEs) were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to 23.8 months. Deaths were collected in the post-treatment efficacy follow-up from 31 days after last dose of study medication until the end of the study, up to 62 months.
Deaths in the post-treatment efficacy follow-up were not considered adverse events. The total number at risk in the post-treatment efficacy follow-up included patients who entered this period.
|
—
0/0 • Adverse events (AEs) were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to 23.8 months. Deaths were collected in the post-treatment efficacy follow-up from 31 days after last dose of study medication until the end of the study, up to 62 months.
Deaths in the post-treatment efficacy follow-up were not considered adverse events. The total number at risk in the post-treatment efficacy follow-up included patients who entered this period.
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
2.1%
4/188 • Adverse events (AEs) were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to 23.8 months. Deaths were collected in the post-treatment efficacy follow-up from 31 days after last dose of study medication until the end of the study, up to 62 months.
Deaths in the post-treatment efficacy follow-up were not considered adverse events. The total number at risk in the post-treatment efficacy follow-up included patients who entered this period.
|
5.3%
10/188 • Adverse events (AEs) were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to 23.8 months. Deaths were collected in the post-treatment efficacy follow-up from 31 days after last dose of study medication until the end of the study, up to 62 months.
Deaths in the post-treatment efficacy follow-up were not considered adverse events. The total number at risk in the post-treatment efficacy follow-up included patients who entered this period.
|
—
0/0 • Adverse events (AEs) were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to 23.8 months. Deaths were collected in the post-treatment efficacy follow-up from 31 days after last dose of study medication until the end of the study, up to 62 months.
Deaths in the post-treatment efficacy follow-up were not considered adverse events. The total number at risk in the post-treatment efficacy follow-up included patients who entered this period.
|
—
0/0 • Adverse events (AEs) were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to 23.8 months. Deaths were collected in the post-treatment efficacy follow-up from 31 days after last dose of study medication until the end of the study, up to 62 months.
Deaths in the post-treatment efficacy follow-up were not considered adverse events. The total number at risk in the post-treatment efficacy follow-up included patients who entered this period.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
16.5%
31/188 • Adverse events (AEs) were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to 23.8 months. Deaths were collected in the post-treatment efficacy follow-up from 31 days after last dose of study medication until the end of the study, up to 62 months.
Deaths in the post-treatment efficacy follow-up were not considered adverse events. The total number at risk in the post-treatment efficacy follow-up included patients who entered this period.
|
14.9%
28/188 • Adverse events (AEs) were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to 23.8 months. Deaths were collected in the post-treatment efficacy follow-up from 31 days after last dose of study medication until the end of the study, up to 62 months.
Deaths in the post-treatment efficacy follow-up were not considered adverse events. The total number at risk in the post-treatment efficacy follow-up included patients who entered this period.
|
—
0/0 • Adverse events (AEs) were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to 23.8 months. Deaths were collected in the post-treatment efficacy follow-up from 31 days after last dose of study medication until the end of the study, up to 62 months.
Deaths in the post-treatment efficacy follow-up were not considered adverse events. The total number at risk in the post-treatment efficacy follow-up included patients who entered this period.
|
—
0/0 • Adverse events (AEs) were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to 23.8 months. Deaths were collected in the post-treatment efficacy follow-up from 31 days after last dose of study medication until the end of the study, up to 62 months.
Deaths in the post-treatment efficacy follow-up were not considered adverse events. The total number at risk in the post-treatment efficacy follow-up included patients who entered this period.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
10.6%
20/188 • Adverse events (AEs) were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to 23.8 months. Deaths were collected in the post-treatment efficacy follow-up from 31 days after last dose of study medication until the end of the study, up to 62 months.
Deaths in the post-treatment efficacy follow-up were not considered adverse events. The total number at risk in the post-treatment efficacy follow-up included patients who entered this period.
|
12.2%
23/188 • Adverse events (AEs) were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to 23.8 months. Deaths were collected in the post-treatment efficacy follow-up from 31 days after last dose of study medication until the end of the study, up to 62 months.
Deaths in the post-treatment efficacy follow-up were not considered adverse events. The total number at risk in the post-treatment efficacy follow-up included patients who entered this period.
|
—
0/0 • Adverse events (AEs) were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to 23.8 months. Deaths were collected in the post-treatment efficacy follow-up from 31 days after last dose of study medication until the end of the study, up to 62 months.
Deaths in the post-treatment efficacy follow-up were not considered adverse events. The total number at risk in the post-treatment efficacy follow-up included patients who entered this period.
|
—
0/0 • Adverse events (AEs) were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to 23.8 months. Deaths were collected in the post-treatment efficacy follow-up from 31 days after last dose of study medication until the end of the study, up to 62 months.
Deaths in the post-treatment efficacy follow-up were not considered adverse events. The total number at risk in the post-treatment efficacy follow-up included patients who entered this period.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
6.4%
12/188 • Adverse events (AEs) were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to 23.8 months. Deaths were collected in the post-treatment efficacy follow-up from 31 days after last dose of study medication until the end of the study, up to 62 months.
Deaths in the post-treatment efficacy follow-up were not considered adverse events. The total number at risk in the post-treatment efficacy follow-up included patients who entered this period.
|
9.0%
17/188 • Adverse events (AEs) were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to 23.8 months. Deaths were collected in the post-treatment efficacy follow-up from 31 days after last dose of study medication until the end of the study, up to 62 months.
Deaths in the post-treatment efficacy follow-up were not considered adverse events. The total number at risk in the post-treatment efficacy follow-up included patients who entered this period.
|
—
0/0 • Adverse events (AEs) were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to 23.8 months. Deaths were collected in the post-treatment efficacy follow-up from 31 days after last dose of study medication until the end of the study, up to 62 months.
Deaths in the post-treatment efficacy follow-up were not considered adverse events. The total number at risk in the post-treatment efficacy follow-up included patients who entered this period.
|
—
0/0 • Adverse events (AEs) were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to 23.8 months. Deaths were collected in the post-treatment efficacy follow-up from 31 days after last dose of study medication until the end of the study, up to 62 months.
Deaths in the post-treatment efficacy follow-up were not considered adverse events. The total number at risk in the post-treatment efficacy follow-up included patients who entered this period.
|
|
Nervous system disorders
Headache
|
9.6%
18/188 • Adverse events (AEs) were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to 23.8 months. Deaths were collected in the post-treatment efficacy follow-up from 31 days after last dose of study medication until the end of the study, up to 62 months.
Deaths in the post-treatment efficacy follow-up were not considered adverse events. The total number at risk in the post-treatment efficacy follow-up included patients who entered this period.
|
16.5%
31/188 • Adverse events (AEs) were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to 23.8 months. Deaths were collected in the post-treatment efficacy follow-up from 31 days after last dose of study medication until the end of the study, up to 62 months.
Deaths in the post-treatment efficacy follow-up were not considered adverse events. The total number at risk in the post-treatment efficacy follow-up included patients who entered this period.
|
—
0/0 • Adverse events (AEs) were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to 23.8 months. Deaths were collected in the post-treatment efficacy follow-up from 31 days after last dose of study medication until the end of the study, up to 62 months.
Deaths in the post-treatment efficacy follow-up were not considered adverse events. The total number at risk in the post-treatment efficacy follow-up included patients who entered this period.
|
—
0/0 • Adverse events (AEs) were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to 23.8 months. Deaths were collected in the post-treatment efficacy follow-up from 31 days after last dose of study medication until the end of the study, up to 62 months.
Deaths in the post-treatment efficacy follow-up were not considered adverse events. The total number at risk in the post-treatment efficacy follow-up included patients who entered this period.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
9.0%
17/188 • Adverse events (AEs) were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to 23.8 months. Deaths were collected in the post-treatment efficacy follow-up from 31 days after last dose of study medication until the end of the study, up to 62 months.
Deaths in the post-treatment efficacy follow-up were not considered adverse events. The total number at risk in the post-treatment efficacy follow-up included patients who entered this period.
|
12.2%
23/188 • Adverse events (AEs) were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to 23.8 months. Deaths were collected in the post-treatment efficacy follow-up from 31 days after last dose of study medication until the end of the study, up to 62 months.
Deaths in the post-treatment efficacy follow-up were not considered adverse events. The total number at risk in the post-treatment efficacy follow-up included patients who entered this period.
|
—
0/0 • Adverse events (AEs) were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to 23.8 months. Deaths were collected in the post-treatment efficacy follow-up from 31 days after last dose of study medication until the end of the study, up to 62 months.
Deaths in the post-treatment efficacy follow-up were not considered adverse events. The total number at risk in the post-treatment efficacy follow-up included patients who entered this period.
|
—
0/0 • Adverse events (AEs) were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to 23.8 months. Deaths were collected in the post-treatment efficacy follow-up from 31 days after last dose of study medication until the end of the study, up to 62 months.
Deaths in the post-treatment efficacy follow-up were not considered adverse events. The total number at risk in the post-treatment efficacy follow-up included patients who entered this period.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
4.3%
8/188 • Adverse events (AEs) were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to 23.8 months. Deaths were collected in the post-treatment efficacy follow-up from 31 days after last dose of study medication until the end of the study, up to 62 months.
Deaths in the post-treatment efficacy follow-up were not considered adverse events. The total number at risk in the post-treatment efficacy follow-up included patients who entered this period.
|
8.0%
15/188 • Adverse events (AEs) were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to 23.8 months. Deaths were collected in the post-treatment efficacy follow-up from 31 days after last dose of study medication until the end of the study, up to 62 months.
Deaths in the post-treatment efficacy follow-up were not considered adverse events. The total number at risk in the post-treatment efficacy follow-up included patients who entered this period.
|
—
0/0 • Adverse events (AEs) were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to 23.8 months. Deaths were collected in the post-treatment efficacy follow-up from 31 days after last dose of study medication until the end of the study, up to 62 months.
Deaths in the post-treatment efficacy follow-up were not considered adverse events. The total number at risk in the post-treatment efficacy follow-up included patients who entered this period.
|
—
0/0 • Adverse events (AEs) were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to 23.8 months. Deaths were collected in the post-treatment efficacy follow-up from 31 days after last dose of study medication until the end of the study, up to 62 months.
Deaths in the post-treatment efficacy follow-up were not considered adverse events. The total number at risk in the post-treatment efficacy follow-up included patients who entered this period.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
10.1%
19/188 • Adverse events (AEs) were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to 23.8 months. Deaths were collected in the post-treatment efficacy follow-up from 31 days after last dose of study medication until the end of the study, up to 62 months.
Deaths in the post-treatment efficacy follow-up were not considered adverse events. The total number at risk in the post-treatment efficacy follow-up included patients who entered this period.
|
12.8%
24/188 • Adverse events (AEs) were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to 23.8 months. Deaths were collected in the post-treatment efficacy follow-up from 31 days after last dose of study medication until the end of the study, up to 62 months.
Deaths in the post-treatment efficacy follow-up were not considered adverse events. The total number at risk in the post-treatment efficacy follow-up included patients who entered this period.
|
—
0/0 • Adverse events (AEs) were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to 23.8 months. Deaths were collected in the post-treatment efficacy follow-up from 31 days after last dose of study medication until the end of the study, up to 62 months.
Deaths in the post-treatment efficacy follow-up were not considered adverse events. The total number at risk in the post-treatment efficacy follow-up included patients who entered this period.
|
—
0/0 • Adverse events (AEs) were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to 23.8 months. Deaths were collected in the post-treatment efficacy follow-up from 31 days after last dose of study medication until the end of the study, up to 62 months.
Deaths in the post-treatment efficacy follow-up were not considered adverse events. The total number at risk in the post-treatment efficacy follow-up included patients who entered this period.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
3.2%
6/188 • Adverse events (AEs) were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to 23.8 months. Deaths were collected in the post-treatment efficacy follow-up from 31 days after last dose of study medication until the end of the study, up to 62 months.
Deaths in the post-treatment efficacy follow-up were not considered adverse events. The total number at risk in the post-treatment efficacy follow-up included patients who entered this period.
|
8.0%
15/188 • Adverse events (AEs) were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to 23.8 months. Deaths were collected in the post-treatment efficacy follow-up from 31 days after last dose of study medication until the end of the study, up to 62 months.
Deaths in the post-treatment efficacy follow-up were not considered adverse events. The total number at risk in the post-treatment efficacy follow-up included patients who entered this period.
|
—
0/0 • Adverse events (AEs) were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to 23.8 months. Deaths were collected in the post-treatment efficacy follow-up from 31 days after last dose of study medication until the end of the study, up to 62 months.
Deaths in the post-treatment efficacy follow-up were not considered adverse events. The total number at risk in the post-treatment efficacy follow-up included patients who entered this period.
|
—
0/0 • Adverse events (AEs) were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to 23.8 months. Deaths were collected in the post-treatment efficacy follow-up from 31 days after last dose of study medication until the end of the study, up to 62 months.
Deaths in the post-treatment efficacy follow-up were not considered adverse events. The total number at risk in the post-treatment efficacy follow-up included patients who entered this period.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
2.1%
4/188 • Adverse events (AEs) were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to 23.8 months. Deaths were collected in the post-treatment efficacy follow-up from 31 days after last dose of study medication until the end of the study, up to 62 months.
Deaths in the post-treatment efficacy follow-up were not considered adverse events. The total number at risk in the post-treatment efficacy follow-up included patients who entered this period.
|
9.0%
17/188 • Adverse events (AEs) were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to 23.8 months. Deaths were collected in the post-treatment efficacy follow-up from 31 days after last dose of study medication until the end of the study, up to 62 months.
Deaths in the post-treatment efficacy follow-up were not considered adverse events. The total number at risk in the post-treatment efficacy follow-up included patients who entered this period.
|
—
0/0 • Adverse events (AEs) were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to 23.8 months. Deaths were collected in the post-treatment efficacy follow-up from 31 days after last dose of study medication until the end of the study, up to 62 months.
Deaths in the post-treatment efficacy follow-up were not considered adverse events. The total number at risk in the post-treatment efficacy follow-up included patients who entered this period.
|
—
0/0 • Adverse events (AEs) were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to 23.8 months. Deaths were collected in the post-treatment efficacy follow-up from 31 days after last dose of study medication until the end of the study, up to 62 months.
Deaths in the post-treatment efficacy follow-up were not considered adverse events. The total number at risk in the post-treatment efficacy follow-up included patients who entered this period.
|
|
Skin and subcutaneous tissue disorders
Rash
|
3.7%
7/188 • Adverse events (AEs) were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to 23.8 months. Deaths were collected in the post-treatment efficacy follow-up from 31 days after last dose of study medication until the end of the study, up to 62 months.
Deaths in the post-treatment efficacy follow-up were not considered adverse events. The total number at risk in the post-treatment efficacy follow-up included patients who entered this period.
|
8.5%
16/188 • Adverse events (AEs) were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to 23.8 months. Deaths were collected in the post-treatment efficacy follow-up from 31 days after last dose of study medication until the end of the study, up to 62 months.
Deaths in the post-treatment efficacy follow-up were not considered adverse events. The total number at risk in the post-treatment efficacy follow-up included patients who entered this period.
|
—
0/0 • Adverse events (AEs) were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to 23.8 months. Deaths were collected in the post-treatment efficacy follow-up from 31 days after last dose of study medication until the end of the study, up to 62 months.
Deaths in the post-treatment efficacy follow-up were not considered adverse events. The total number at risk in the post-treatment efficacy follow-up included patients who entered this period.
|
—
0/0 • Adverse events (AEs) were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to 23.8 months. Deaths were collected in the post-treatment efficacy follow-up from 31 days after last dose of study medication until the end of the study, up to 62 months.
Deaths in the post-treatment efficacy follow-up were not considered adverse events. The total number at risk in the post-treatment efficacy follow-up included patients who entered this period.
|
|
Vascular disorders
Hot flush
|
12.8%
24/188 • Adverse events (AEs) were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to 23.8 months. Deaths were collected in the post-treatment efficacy follow-up from 31 days after last dose of study medication until the end of the study, up to 62 months.
Deaths in the post-treatment efficacy follow-up were not considered adverse events. The total number at risk in the post-treatment efficacy follow-up included patients who entered this period.
|
7.4%
14/188 • Adverse events (AEs) were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to 23.8 months. Deaths were collected in the post-treatment efficacy follow-up from 31 days after last dose of study medication until the end of the study, up to 62 months.
Deaths in the post-treatment efficacy follow-up were not considered adverse events. The total number at risk in the post-treatment efficacy follow-up included patients who entered this period.
|
—
0/0 • Adverse events (AEs) were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to 23.8 months. Deaths were collected in the post-treatment efficacy follow-up from 31 days after last dose of study medication until the end of the study, up to 62 months.
Deaths in the post-treatment efficacy follow-up were not considered adverse events. The total number at risk in the post-treatment efficacy follow-up included patients who entered this period.
|
—
0/0 • Adverse events (AEs) were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to 23.8 months. Deaths were collected in the post-treatment efficacy follow-up from 31 days after last dose of study medication until the end of the study, up to 62 months.
Deaths in the post-treatment efficacy follow-up were not considered adverse events. The total number at risk in the post-treatment efficacy follow-up included patients who entered this period.
|
|
Vascular disorders
Hypertension
|
3.2%
6/188 • Adverse events (AEs) were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to 23.8 months. Deaths were collected in the post-treatment efficacy follow-up from 31 days after last dose of study medication until the end of the study, up to 62 months.
Deaths in the post-treatment efficacy follow-up were not considered adverse events. The total number at risk in the post-treatment efficacy follow-up included patients who entered this period.
|
5.3%
10/188 • Adverse events (AEs) were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to 23.8 months. Deaths were collected in the post-treatment efficacy follow-up from 31 days after last dose of study medication until the end of the study, up to 62 months.
Deaths in the post-treatment efficacy follow-up were not considered adverse events. The total number at risk in the post-treatment efficacy follow-up included patients who entered this period.
|
—
0/0 • Adverse events (AEs) were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to 23.8 months. Deaths were collected in the post-treatment efficacy follow-up from 31 days after last dose of study medication until the end of the study, up to 62 months.
Deaths in the post-treatment efficacy follow-up were not considered adverse events. The total number at risk in the post-treatment efficacy follow-up included patients who entered this period.
|
—
0/0 • Adverse events (AEs) were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to 23.8 months. Deaths were collected in the post-treatment efficacy follow-up from 31 days after last dose of study medication until the end of the study, up to 62 months.
Deaths in the post-treatment efficacy follow-up were not considered adverse events. The total number at risk in the post-treatment efficacy follow-up included patients who entered this period.
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Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (ie, data from all sites) in the clinical trial.
- Publication restrictions are in place
Restriction type: OTHER