Trial Outcomes & Findings for 3-arm Trial to Evaluate Pasireotide LAR/Everolimus Alone/in Combination in Patients With Lung/Thymus NET - LUNA Trial (NCT NCT01563354)
NCT ID: NCT01563354
Last Updated: 2021-04-02
Results Overview
Patients with Complete Response (CR), Partial Response (PR), or Stable Disease (SD) at Month 9 were to be considered as "progression-free" based on RECIST v1.1. Patients with missing tumor assessment, or with overall lesion response "unknown" at Month 9 were considered as "non progression-free", unless any of the following assessments at Week 48 or Week 52 indicate CR, PR, or SD, in which case the patient was to be considered as progression-free at Month 9. Patients discontinuing the study for any reason prior to the 9 month assessment were to be considered as "non progression-free".
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
124 participants
Primary outcome timeframe
Baseline up to 9 months
Results posted on
2021-04-02
Participant Flow
Two patients completed the core phase of the study but they did not enter the extension phase one due to worsening in clinical conditions and one for Physician decision.
Participant milestones
| Measure |
Pasireotide LAR
Pasireotide long acting release (LAR) 60 mg will be administered as an intra muscular (i.m.) depot injection once every 28 days starting on Day 1
|
Everolimus
Everolimus 10 mg taken orally (p.o) once daily starting on Day 1
|
Pasireotide LAR and Everolimus Combination
Pasireotide LAR 60 mg i.m. injected once every 28 days + Everolimus 10 mg p.o. daily starting on Day 1
|
|---|---|---|---|
|
Core Phase
STARTED
|
41
|
42
|
41
|
|
Core Phase
Entered Extension Phase
|
12
|
14
|
15
|
|
Core Phase
COMPLETED
|
12
|
14
|
15
|
|
Core Phase
NOT COMPLETED
|
29
|
28
|
26
|
|
Extension Phase
STARTED
|
12
|
14
|
15
|
|
Extension Phase
COMPLETED
|
0
|
0
|
0
|
|
Extension Phase
NOT COMPLETED
|
12
|
14
|
15
|
Reasons for withdrawal
| Measure |
Pasireotide LAR
Pasireotide long acting release (LAR) 60 mg will be administered as an intra muscular (i.m.) depot injection once every 28 days starting on Day 1
|
Everolimus
Everolimus 10 mg taken orally (p.o) once daily starting on Day 1
|
Pasireotide LAR and Everolimus Combination
Pasireotide LAR 60 mg i.m. injected once every 28 days + Everolimus 10 mg p.o. daily starting on Day 1
|
|---|---|---|---|
|
Core Phase
Adverse Event
|
5
|
15
|
13
|
|
Core Phase
Withdrawal by Subject
|
1
|
0
|
3
|
|
Core Phase
Lost to Follow-up
|
1
|
0
|
0
|
|
Core Phase
Death
|
1
|
5
|
2
|
|
Core Phase
Diseasse progression
|
18
|
7
|
8
|
|
Core Phase
Protocol deviation
|
2
|
0
|
0
|
|
Core Phase
PI decision - did not enter extension
|
0
|
1
|
0
|
|
Core Phase
Worsening of clinical condition - did not enter extension
|
1
|
0
|
0
|
|
Extension Phase
Adverse Event
|
0
|
3
|
2
|
|
Extension Phase
Withdrawal by Subject
|
0
|
1
|
0
|
|
Extension Phase
Administration problems
|
3
|
2
|
3
|
|
Extension Phase
Disease progression
|
9
|
8
|
10
|
Baseline Characteristics
3-arm Trial to Evaluate Pasireotide LAR/Everolimus Alone/in Combination in Patients With Lung/Thymus NET - LUNA Trial
Baseline characteristics by cohort
| Measure |
Pasireotide LAR
n=41 Participants
Pasireotide long acting release (LAR) 60 mg will be administered as an intra muscular (i.m.) depot injection once every 28 days starting on Day 1
|
Everolimus
n=42 Participants
Everolimus 10 mg taken orally (p.o) once daily starting on Day 1
|
Pasireotide LAR and Everolimus Combination
n=41 Participants
Pasireotide LAR 60 mg i.m. injected once every 28 days + Everolimus 10 mg p.o. daily starting on Day 1
|
Total
n=124 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Customized
18 to <65
|
21 participants
n=99 Participants
|
18 participants
n=107 Participants
|
24 participants
n=206 Participants
|
63 participants
n=7 Participants
|
|
Age, Customized
≥65 to 84
|
20 participants
n=99 Participants
|
24 participants
n=107 Participants
|
17 participants
n=206 Participants
|
61 participants
n=7 Participants
|
|
Sex: Female, Male
Female
|
15 Participants
n=99 Participants
|
19 Participants
n=107 Participants
|
13 Participants
n=206 Participants
|
47 Participants
n=7 Participants
|
|
Sex: Female, Male
Male
|
26 Participants
n=99 Participants
|
23 Participants
n=107 Participants
|
28 Participants
n=206 Participants
|
77 Participants
n=7 Participants
|
|
Race/Ethnicity, Customized
Caucasian
|
40 Participants
n=99 Participants
|
42 Participants
n=107 Participants
|
40 Participants
n=206 Participants
|
122 Participants
n=7 Participants
|
|
Race/Ethnicity, Customized
Black
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
|
Race/Ethnicity, Customized
Asian
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
PRIMARY outcome
Timeframe: Baseline up to 9 monthsPopulation: Full analysis set
Patients with Complete Response (CR), Partial Response (PR), or Stable Disease (SD) at Month 9 were to be considered as "progression-free" based on RECIST v1.1. Patients with missing tumor assessment, or with overall lesion response "unknown" at Month 9 were considered as "non progression-free", unless any of the following assessments at Week 48 or Week 52 indicate CR, PR, or SD, in which case the patient was to be considered as progression-free at Month 9. Patients discontinuing the study for any reason prior to the 9 month assessment were to be considered as "non progression-free".
Outcome measures
| Measure |
Pasireotide LAR and Everolimus Combination
n=41 Participants
Pasireotide LAR 60 mg i.m. injected once every 28 days + Everolimus 10 mg p.o. daily starting on Day 1
|
Pasireotide LAR
n=41 Participants
Pasireotide long acting release (LAR) 60 mg will be administered as an intra muscular (i.m.) depot injection once every 28 days starting on Day 1
|
Everolimus
n=42 Participants
Everolimus 10 mg taken orally (p.o) once daily starting on Day 1
|
|---|---|---|---|
|
Percentage of Participants Progression-free at 9 Months Based on Response Evaluation Criteria In Solid Tumors v1.1 (RECIST v1.1)
Complete response
|
0 percentage of participants
Interval 0.0 to 8.6
|
0 percentage of participants
Interval 0.0 to 8.6
|
0 percentage of participants
Interval 0.0 to 8.4
|
|
Percentage of Participants Progression-free at 9 Months Based on Response Evaluation Criteria In Solid Tumors v1.1 (RECIST v1.1)
Partial response
|
2.4 percentage of participants
Interval 0.1 to 12.9
|
2.4 percentage of participants
Interval 0.1 to 12.9
|
2.4 percentage of participants
Interval 0.1 to 12.6
|
|
Percentage of Participants Progression-free at 9 Months Based on Response Evaluation Criteria In Solid Tumors v1.1 (RECIST v1.1)
Stable disease
|
48.8 percentage of participants
Interval 32.9 to 64.9
|
34.1 percentage of participants
Interval 20.1 to 50.6
|
31.0 percentage of participants
Interval 17.6 to 47.1
|
|
Percentage of Participants Progression-free at 9 Months Based on Response Evaluation Criteria In Solid Tumors v1.1 (RECIST v1.1)
Progression-free (PF) at Month 9
|
58.5 percentage of participants
Interval 42.1 to 73.7
|
39.0 percentage of participants
Interval 24.2 to 55.5
|
33.3 percentage of participants
Interval 19.6 to 49.5
|
SECONDARY outcome
Timeframe: Baseline, every 3 months up to 69 monthsPopulation: Full analysis set
Time from first study drug administration to objective tumor progression or death from any cause according to RECIST v1.1
Outcome measures
| Measure |
Pasireotide LAR and Everolimus Combination
n=41 Participants
Pasireotide LAR 60 mg i.m. injected once every 28 days + Everolimus 10 mg p.o. daily starting on Day 1
|
Pasireotide LAR
n=41 Participants
Pasireotide long acting release (LAR) 60 mg will be administered as an intra muscular (i.m.) depot injection once every 28 days starting on Day 1
|
Everolimus
n=42 Participants
Everolimus 10 mg taken orally (p.o) once daily starting on Day 1
|
|---|---|---|---|
|
Summary of Progression-free Survival (PFS) Based on RECIST v1.1
|
16.53 months
Interval 11.1 to 23.26
|
8.51 months
Interval 5.68 to 14.03
|
12.48 months
Interval 5.55 to 20.21
|
SECONDARY outcome
Timeframe: Baseline, every 3 months up to 69 monthsPopulation: Full analysis set
Percent (%) event-free probability estimate is the estimated probability that a patient will remain event-free up to the specified time point. Percent event-free probability estimates are obtained from the Kaplan-Meier survival estimates. Events are time from first study drug administration to objective tumor progression or death from any cause according to RECIST v1.1.
Outcome measures
| Measure |
Pasireotide LAR and Everolimus Combination
n=41 Participants
Pasireotide LAR 60 mg i.m. injected once every 28 days + Everolimus 10 mg p.o. daily starting on Day 1
|
Pasireotide LAR
n=41 Participants
Pasireotide long acting release (LAR) 60 mg will be administered as an intra muscular (i.m.) depot injection once every 28 days starting on Day 1
|
Everolimus
n=42 Participants
Everolimus 10 mg taken orally (p.o) once daily starting on Day 1
|
|---|---|---|---|
|
Kaplan-Meier Estimates of Progression-free Survival (PFS)
3 months
|
88.6 event free probability estimates
Interval 72.4 to 95.5
|
83.6 event free probability estimates
Interval 67.1 to 92.3
|
91.2 event free probability estimates
Interval 75.1 to 97.1
|
|
Kaplan-Meier Estimates of Progression-free Survival (PFS)
6 months
|
85.5 event free probability estimates
Interval 68.6 to 93.7
|
68.2 event free probability estimates
Interval 49.8 to 81.1
|
63.5 event free probability estimates
Interval 44.7 to 77.4
|
|
Kaplan-Meier Estimates of Progression-free Survival (PFS)
9 months
|
79.2 event free probability estimates
Interval 61.1 to 89.5
|
49.6 event free probability estimates
Interval 31.9 to 65.1
|
56.9 event free probability estimates
Interval 38.1 to 71.9
|
|
Kaplan-Meier Estimates of Progression-free Survival (PFS)
12 months
|
55.5 event free probability estimates
Interval 36.4 to 71.0
|
39.9 event free probability estimates
Interval 23.3 to 56.0
|
50.2 event free probability estimates
Interval 31.9 to 66.0
|
|
Kaplan-Meier Estimates of Progression-free Survival (PFS)
15 months
|
51.2 event free probability estimates
Interval 32.1 to 67.5
|
32.6 event free probability estimates
Interval 17.2 to 49.1
|
46.8 event free probability estimates
Interval 28.9 to 62.9
|
|
Kaplan-Meier Estimates of Progression-free Survival (PFS)
18 months
|
42.7 event free probability estimates
Interval 24.2 to 60.1
|
21.8 event free probability estimates
Interval 9.1 to 37.8
|
38.6 event free probability estimates
Interval 21.4 to 55.6
|
|
Kaplan-Meier Estimates of Progression-free Survival (PFS)
21 months
|
38.0 event free probability estimates
Interval 20.0 to 55.9
|
14.5 event free probability estimates
Interval 4.7 to 29.6
|
29.4 event free probability estimates
Interval 13.6 to 47.2
|
|
Kaplan-Meier Estimates of Progression-free Survival (PFS)
24 months
|
28.5 event free probability estimates
Interval 12.5 to 46.9
|
14.5 event free probability estimates
Interval 4.7 to 29.6
|
19.6 event free probability estimates
Interval 6.7 to 37.4
|
|
Kaplan-Meier Estimates of Progression-free Survival (PFS)
27 months
|
28.5 event free probability estimates
Interval 12.5 to 46.9
|
14.5 event free probability estimates
Interval 4.7 to 29.6
|
19.6 event free probability estimates
Interval 6.7 to 37.4
|
|
Kaplan-Meier Estimates of Progression-free Survival (PFS)
30 months
|
19.0 event free probability estimates
Interval 6.3 to 36.9
|
10.9 event free probability estimates
Interval 2.8 to 25.2
|
9.8 event free probability estimates
Interval 1.8 to 26.2
|
|
Kaplan-Meier Estimates of Progression-free Survival (PFS)
33 months
|
19.0 event free probability estimates
Interval 6.3 to 36.9
|
10.9 event free probability estimates
Interval 2.8 to 25.2
|
9.8 event free probability estimates
Interval 1.8 to 26.2
|
|
Kaplan-Meier Estimates of Progression-free Survival (PFS)
36 months
|
14.2 event free probability estimates
Interval 3.7 to 31.5
|
10.9 event free probability estimates
Interval 2.8 to 25.2
|
9.8 event free probability estimates
Interval 1.8 to 26.2
|
|
Kaplan-Meier Estimates of Progression-free Survival (PFS)
39 months
|
14.2 event free probability estimates
Interval 3.7 to 31.5
|
10.9 event free probability estimates
Interval 2.8 to 25.2
|
9.8 event free probability estimates
Interval 1.8 to 26.2
|
|
Kaplan-Meier Estimates of Progression-free Survival (PFS)
42 months
|
14.2 event free probability estimates
Interval 3.7 to 31.5
|
10.9 event free probability estimates
Interval 2.8 to 25.2
|
9.8 event free probability estimates
Interval 1.8 to 26.2
|
|
Kaplan-Meier Estimates of Progression-free Survival (PFS)
45 months
|
14.2 event free probability estimates
Interval 3.7 to 31.5
|
10.9 event free probability estimates
Interval 2.8 to 25.2
|
9.8 event free probability estimates
Interval 1.8 to 26.2
|
|
Kaplan-Meier Estimates of Progression-free Survival (PFS)
48 months
|
14.2 event free probability estimates
Interval 3.7 to 31.5
|
10.9 event free probability estimates
Interval 2.8 to 25.2
|
9.8 event free probability estimates
Interval 1.8 to 26.2
|
|
Kaplan-Meier Estimates of Progression-free Survival (PFS)
51 months
|
14.2 event free probability estimates
Interval 3.7 to 31.5
|
10.9 event free probability estimates
Interval 2.8 to 25.2
|
NA event free probability estimates
Event-free probability is non-estimable due to insufficient number of participants with events
|
|
Kaplan-Meier Estimates of Progression-free Survival (PFS)
54 months
|
14.2 event free probability estimates
Interval 3.7 to 31.5
|
10.9 event free probability estimates
Interval 2.8 to 25.2
|
NA event free probability estimates
Event-free probability is non-estimable due to insufficient number of participants with events
|
|
Kaplan-Meier Estimates of Progression-free Survival (PFS)
57 months
|
7.1 event free probability estimates
Interval 0.6 to 25.2
|
10.9 event free probability estimates
Interval 2.8 to 25.2
|
NA event free probability estimates
Event-free probability is non-estimable due to insufficient number of participants with events
|
|
Kaplan-Meier Estimates of Progression-free Survival (PFS)
60 months
|
7.1 event free probability estimates
Interval 0.6 to 25.2
|
10.9 event free probability estimates
Interval 2.8 to 25.2
|
NA event free probability estimates
Event-free probability is non-estimable due to insufficient number of participants with events
|
|
Kaplan-Meier Estimates of Progression-free Survival (PFS)
63 months
|
7.1 event free probability estimates
Interval 0.6 to 25.2
|
10.9 event free probability estimates
Interval 2.8 to 25.2
|
NA event free probability estimates
Event-free probability is non-estimable due to insufficient number of participants with events
|
|
Kaplan-Meier Estimates of Progression-free Survival (PFS)
66 months
|
7.1 event free probability estimates
Interval 0.6 to 25.2
|
NA event free probability estimates
Event-free probability is non-estimable due to insufficient number of participants with events
|
NA event free probability estimates
Event-free probability is non-estimable due to insufficient number of participants with events
|
|
Kaplan-Meier Estimates of Progression-free Survival (PFS)
69 months
|
7.1 event free probability estimates
Interval 0.6 to 25.2
|
NA event free probability estimates
Event-free probability is non-estimable due to insufficient number of participants with events
|
NA event free probability estimates
Event-free probability is non-estimable due to insufficient number of participants with events
|
SECONDARY outcome
Timeframe: Every 3 months up to Year 1Population: Full analysis set
Time from start of treatment to the first observed objective tumor response (partial response or complete response) observed according to RECIST v1.1.
Outcome measures
| Measure |
Pasireotide LAR and Everolimus Combination
n=41 Participants
Pasireotide LAR 60 mg i.m. injected once every 28 days + Everolimus 10 mg p.o. daily starting on Day 1
|
Pasireotide LAR
n=41 Participants
Pasireotide long acting release (LAR) 60 mg will be administered as an intra muscular (i.m.) depot injection once every 28 days starting on Day 1
|
Everolimus
n=42 Participants
Everolimus 10 mg taken orally (p.o) once daily starting on Day 1
|
|---|---|---|---|
|
Summary of Time to Response (Months)
25th percentile
|
NA months
Percentile is not available due to due to insufficient number
|
NA months
Percentile is not available due to due to insufficient number
|
NA months
Percentile is not available due to due to insufficient number
|
|
Summary of Time to Response (Months)
Median
|
NA months
Percentile is not available due to due to insufficient number
|
NA months
Percentile is not available due to due to insufficient number
|
NA months
Percentile is not available due to due to insufficient number
|
|
Summary of Time to Response (Months)
75th percentile
|
NA months
Percentile is not available due to due to insufficient number
|
NA months
Percentile is not available due to due to insufficient number
|
NA months
Percentile is not available due to due to insufficient number
|
SECONDARY outcome
Timeframe: Every 3 months up to Year 1Population: Full analysis set
Date of first objective tumor response to date of tumor progression or death due to any cause.
Outcome measures
| Measure |
Pasireotide LAR and Everolimus Combination
n=41 Participants
Pasireotide LAR 60 mg i.m. injected once every 28 days + Everolimus 10 mg p.o. daily starting on Day 1
|
Pasireotide LAR
n=41 Participants
Pasireotide long acting release (LAR) 60 mg will be administered as an intra muscular (i.m.) depot injection once every 28 days starting on Day 1
|
Everolimus
n=42 Participants
Everolimus 10 mg taken orally (p.o) once daily starting on Day 1
|
|---|---|---|---|
|
Summary of Duration of Response (Months)
25th percentile
|
NA months
Percentile is not available due to due to insufficient number
|
NA months
Percentile is not available due to due to insufficient number
|
NA months
Percentile is not available due to due to insufficient number
|
|
Summary of Duration of Response (Months)
Median
|
NA months
Percentile is not available due to due to insufficient number
|
NA months
Percentile is not available due to due to insufficient number
|
NA months
Percentile is not available due to due to insufficient number
|
|
Summary of Duration of Response (Months)
75th percentile
|
NA months
Percentile is not available due to due to insufficient number
|
NA months
Percentile is not available due to due to insufficient number
|
NA months
Percentile is not available due to due to insufficient number
|
SECONDARY outcome
Timeframe: Baseline up to Month 12Population: Full analysis set
Objective response rate (ORR) was defined as the percentage of patients showing a best overall response (BOR) of CR or PR during the core study according to RECIST v1.1 criteria. The best overall response is interpreted as the best response recorded from the start of the treatment until disease progression/recurrence, death from any cause or until the patient withdraws consent, whichever is earliest. DCR was was defined as the percentage of participants with a best overall response of complete response, partial response or stable disease during 12 months of treatment according to RECIST v1.1.
Outcome measures
| Measure |
Pasireotide LAR and Everolimus Combination
n=41 Participants
Pasireotide LAR 60 mg i.m. injected once every 28 days + Everolimus 10 mg p.o. daily starting on Day 1
|
Pasireotide LAR
n=41 Participants
Pasireotide long acting release (LAR) 60 mg will be administered as an intra muscular (i.m.) depot injection once every 28 days starting on Day 1
|
Everolimus
n=42 Participants
Everolimus 10 mg taken orally (p.o) once daily starting on Day 1
|
|---|---|---|---|
|
12-month Disease Control Rate (DCR) and Objective Response Rate (ORR)
Objective response (CR+PR)
|
4.9 percentage of participants
Interval 0.6 to 16.5
|
2.4 percentage of participants
Interval 0.1 to 12.9
|
2.4 percentage of participants
Interval 0.1 to 12.6
|
|
12-month Disease Control Rate (DCR) and Objective Response Rate (ORR)
Disease control rate (CR+PR+SD)
|
78.0 percentage of participants
Interval 62.4 to 89.4
|
80.5 percentage of participants
Interval 65.1 to 91.2
|
73.8 percentage of participants
Interval 58.0 to 86.1
|
|
12-month Disease Control Rate (DCR) and Objective Response Rate (ORR)
Complete response (CR)
|
0 percentage of participants
Interval 0.0 to 8.6
|
0 percentage of participants
Interval 0.0 to 8.6
|
0 percentage of participants
Interval 0.0 to 8.4
|
|
12-month Disease Control Rate (DCR) and Objective Response Rate (ORR)
Partial response (PR)
|
4.9 percentage of participants
Interval 0.6 to 16.5
|
2.4 percentage of participants
Interval 0.1 to 12.9
|
2.4 percentage of participants
Interval 0.1 to 12.6
|
|
12-month Disease Control Rate (DCR) and Objective Response Rate (ORR)
Stable disease
|
73.2 percentage of participants
Interval 57.1 to 85.8
|
78.0 percentage of participants
Interval 62.4 to 89.4
|
71.4 percentage of participants
Interval 55.4 to 84.3
|
|
12-month Disease Control Rate (DCR) and Objective Response Rate (ORR)
Progressive disease
|
7.3 percentage of participants
Event-free probability is non-estimable due to insufficient number of participants with events
|
14.6 percentage of participants
Event-free probability is non-estimable due to insufficient number of participants with events
|
4.8 percentage of participants
Event-free probability is non-estimable due to insufficient number of participants with events
|
|
12-month Disease Control Rate (DCR) and Objective Response Rate (ORR)
Unknown
|
0 percentage of participants
Event-free probability is non-estimable due to insufficient number of participants with events
|
2.4 percentage of participants
Event-free probability is non-estimable due to insufficient number of participants with events
|
4.8 percentage of participants
Event-free probability is non-estimable due to insufficient number of participants with events
|
|
12-month Disease Control Rate (DCR) and Objective Response Rate (ORR)
Not assessed
|
14.6 percentage of participants
Event-free probability is non-estimable due to insufficient number of participants with events
|
2.4 percentage of participants
Event-free probability is non-estimable due to insufficient number of participants with events
|
16.7 percentage of participants
Event-free probability is non-estimable due to insufficient number of participants with events
|
|
12-month Disease Control Rate (DCR) and Objective Response Rate (ORR)
Discontinued before month 12
|
63.4 percentage of participants
Event-free probability is non-estimable due to insufficient number of participants with events
|
68.3 percentage of participants
Event-free probability is non-estimable due to insufficient number of participants with events
|
64.3 percentage of participants
Event-free probability is non-estimable due to insufficient number of participants with events
|
SECONDARY outcome
Timeframe: Baseline up to Week 52Population: Full analysis set participants with CgA levels outside normal range at baseline.
Percentage of patients showing normalization or a decrease of ≥ 30% of serum CgA concentrations compared to baseline.
Outcome measures
| Measure |
Pasireotide LAR and Everolimus Combination
n=35 Participants
Pasireotide LAR 60 mg i.m. injected once every 28 days + Everolimus 10 mg p.o. daily starting on Day 1
|
Pasireotide LAR
n=34 Participants
Pasireotide long acting release (LAR) 60 mg will be administered as an intra muscular (i.m.) depot injection once every 28 days starting on Day 1
|
Everolimus
n=27 Participants
Everolimus 10 mg taken orally (p.o) once daily starting on Day 1
|
|---|---|---|---|
|
Biochemical Response Rate (BRR) for Chromogranin A (CgA) Levels
Week 12
|
17.1 percentage of participants
Interval 6.6 to 33.6
|
20.6 percentage of participants
Interval 8.7 to 37.9
|
7.4 percentage of participants
Interval 0.9 to 24.3
|
|
Biochemical Response Rate (BRR) for Chromogranin A (CgA) Levels
Week 24
|
20.0 percentage of participants
Interval 8.4 to 36.9
|
8.8 percentage of participants
Interval 1.9 to 23.7
|
7.4 percentage of participants
Interval 0.9 to 24.3
|
|
Biochemical Response Rate (BRR) for Chromogranin A (CgA) Levels
Week 36
|
11.4 percentage of participants
Interval 3.2 to 26.7
|
8.8 percentage of participants
Interval 1.9 to 23.7
|
3.7 percentage of participants
Interval 0.1 to 19.0
|
|
Biochemical Response Rate (BRR) for Chromogranin A (CgA) Levels
Week 48
|
11.4 percentage of participants
Interval 3.2 to 26.7
|
8.8 percentage of participants
Interval 1.9 to 23.7
|
0 percentage of participants
Interval 0.0 to 12.8
|
|
Biochemical Response Rate (BRR) for Chromogranin A (CgA) Levels
Week 52
|
5.7 percentage of participants
Interval 0.7 to 19.2
|
5.9 percentage of participants
Interval 0.7 to 19.7
|
0 percentage of participants
Interval 0.0 to 12.8
|
SECONDARY outcome
Timeframe: Baseline up to Month 18Population: Full analysis set - participants who have experienced biochemical response during the study and had CgA levels outside normal range at baseline
Time from the first documentation of biochemical response to the first documentation of biochemical progression or to death due to any cause, whichever occurred first. Biochemical progression is defined as an increase of serum CgA levels ≥ 25% compared to baseline.
Outcome measures
| Measure |
Pasireotide LAR and Everolimus Combination
n=9 Participants
Pasireotide LAR 60 mg i.m. injected once every 28 days + Everolimus 10 mg p.o. daily starting on Day 1
|
Pasireotide LAR
n=8 Participants
Pasireotide long acting release (LAR) 60 mg will be administered as an intra muscular (i.m.) depot injection once every 28 days starting on Day 1
|
Everolimus
n=4 Participants
Everolimus 10 mg taken orally (p.o) once daily starting on Day 1
|
|---|---|---|---|
|
Duration of Biochemical Response (DBR), by Treatment (Full Analysis Set)
|
8.38 months
Interval 0.03 to
Upper-bound of CI is non-estimable due to insufficient number of events
|
14.75 months
Interval 0.03 to
Upper-bound of CI is non-estimable due to insufficient number of events
|
2.00 months
Interval 0.03 to
Upper-bound of CI is non-estimable due to insufficient number of events
|
SECONDARY outcome
Timeframe: Baseline, every 3 months up to Month 18Population: Full analysis set - participants who have experienced biochemical response during the study and had CgA levels outside normal range at baseline
Kaplan Meier estimates are for Duration of biochemical response (DBR) outcome measure. Events are biochemical progressions i.e. an increase of CgA levels \>= 25% compared to baseline or deaths due to any cause. Percent (%) Event-free probability estimate is the estimated probability that a patient will remain event-free up to the specified time point.
Outcome measures
| Measure |
Pasireotide LAR and Everolimus Combination
n=9 Participants
Pasireotide LAR 60 mg i.m. injected once every 28 days + Everolimus 10 mg p.o. daily starting on Day 1
|
Pasireotide LAR
n=8 Participants
Pasireotide long acting release (LAR) 60 mg will be administered as an intra muscular (i.m.) depot injection once every 28 days starting on Day 1
|
Everolimus
n=4 Participants
Everolimus 10 mg taken orally (p.o) once daily starting on Day 1
|
|---|---|---|---|
|
Kaplan-Meier Event-free Probability Estimate Based on CgA Levels
12 months
|
44.4 event free probability estimates
Interval 13.6 to 71.9
|
56.3 event free probability estimates
Interval 14.7 to 84.2
|
NA event free probability estimates
Event-free probability is non-estimable due to insufficient number of participants with events
|
|
Kaplan-Meier Event-free Probability Estimate Based on CgA Levels
3 months
|
77.8 event free probability estimates
Interval 36.5 to 93.9
|
75.0 event free probability estimates
Interval 31.5 to 93.1
|
37.5 event free probability estimates
Interval 1.1 to 80.8
|
|
Kaplan-Meier Event-free Probability Estimate Based on CgA Levels
6 months
|
77.8 event free probability estimates
Interval 36.5 to 93.9
|
56.3 event free probability estimates
Interval 14.7 to 84.2
|
NA event free probability estimates
Event-free probability is non-estimable due to insufficient number of participants with events
|
|
Kaplan-Meier Event-free Probability Estimate Based on CgA Levels
9 months
|
44.4 event free probability estimates
Interval 13.6 to 71.9
|
56.3 event free probability estimates
Interval 14.7 to 84.2
|
NA event free probability estimates
Event-free probability is non-estimable due to insufficient number of participants with events
|
|
Kaplan-Meier Event-free Probability Estimate Based on CgA Levels
15 months
|
44.4 event free probability estimates
Interval 13.6 to 71.9
|
37.5 event free probability estimates
Interval 5.6 to 71.7
|
NA event free probability estimates
Event-free probability is non-estimable due to insufficient number of participants with events
|
|
Kaplan-Meier Event-free Probability Estimate Based on CgA Levels
18 months
|
44.4 event free probability estimates
Interval 13.6 to 71.9
|
37.5 event free probability estimates
Interval 5.6 to 71.7
|
NA event free probability estimates
Event-free probability is non-estimable due to insufficient number of participants with events
|
SECONDARY outcome
Timeframe: Baseline up Month 24Population: Full analysis set
Time from the first documentation of biochemical response to the first documentation of biochemical progression or to death due to any cause, whichever occurred first. Biochemical progression is defined as an increase of serum CgA levels ≥ 25% compared to baseline.
Outcome measures
| Measure |
Pasireotide LAR and Everolimus Combination
n=41 Participants
Pasireotide LAR 60 mg i.m. injected once every 28 days + Everolimus 10 mg p.o. daily starting on Day 1
|
Pasireotide LAR
n=41 Participants
Pasireotide long acting release (LAR) 60 mg will be administered as an intra muscular (i.m.) depot injection once every 28 days starting on Day 1
|
Everolimus
n=42 Participants
Everolimus 10 mg taken orally (p.o) once daily starting on Day 1
|
|---|---|---|---|
|
Summary of Biochemical Progression-free Survival Based on CgA Levels by Treatment
|
5.62 months
Interval 3.9 to 8.31
|
2.89 months
Interval 2.79 to 5.49
|
2.86 months
Interval 2.79 to 3.52
|
SECONDARY outcome
Timeframe: Baseline, every 3 months up to Month 24Population: Full analysis set
Percent (%) Event-free probability estimate is the estimated probability that a patient will remain event-free up to the specified time point. Percent event-free probability estimates are obtained from the Kaplan-Meier survival estimates. Events are biochemical progressions, i.e., an increase of CgA levels \>= 25% compared to baseline or deaths due to any cause.
Outcome measures
| Measure |
Pasireotide LAR and Everolimus Combination
n=41 Participants
Pasireotide LAR 60 mg i.m. injected once every 28 days + Everolimus 10 mg p.o. daily starting on Day 1
|
Pasireotide LAR
n=41 Participants
Pasireotide long acting release (LAR) 60 mg will be administered as an intra muscular (i.m.) depot injection once every 28 days starting on Day 1
|
Everolimus
n=42 Participants
Everolimus 10 mg taken orally (p.o) once daily starting on Day 1
|
|---|---|---|---|
|
Kaplan-Meier Event-free Probability Estimate for Biochemical Progression-free Survival Based on CgA Levels
15 months
|
18.1 event free probability estimates
Interval 6.7 to 33.8
|
18.5 event free probability estimates
Interval 7.1 to 34.0
|
NA event free probability estimates
Event-free probability is non-estimable due to insufficient number of participants with events
|
|
Kaplan-Meier Event-free Probability Estimate for Biochemical Progression-free Survival Based on CgA Levels
3 months
|
77.1 event free probability estimates
Interval 59.4 to 87.8
|
43.1 event free probability estimates
Interval 26.4 to 58.6
|
35.4 event free probability estimates
Interval 20.0 to 51.1
|
|
Kaplan-Meier Event-free Probability Estimate for Biochemical Progression-free Survival Based on CgA Levels
6 months
|
44.5 event free probability estimates
Interval 27.6 to 60.0
|
29.5 event free probability estimates
Interval 15.0 to 45.6
|
17.7 event free probability estimates
Interval 7.2 to 32.0
|
|
Kaplan-Meier Event-free Probability Estimate for Biochemical Progression-free Survival Based on CgA Levels
9 months
|
29.7 event free probability estimates
Interval 15.5 to 45.2
|
18.5 event free probability estimates
Interval 7.1 to 34.0
|
11.0 event free probability estimates
Interval 3.2 to 24.5
|
|
Kaplan-Meier Event-free Probability Estimate for Biochemical Progression-free Survival Based on CgA Levels
12 months
|
26.4 event free probability estimates
Interval 13.0 to 41.9
|
18.5 event free probability estimates
Interval 7.1 to 34.0
|
7.4 event free probability estimates
Interval 1.4 to 20.0
|
|
Kaplan-Meier Event-free Probability Estimate for Biochemical Progression-free Survival Based on CgA Levels
18 months
|
18.1 event free probability estimates
Interval 6.7 to 33.8
|
13.8 event free probability estimates
Interval 4.1 to 29.4
|
NA event free probability estimates
Event-free probability is non-estimable due to insufficient number of participants with events
|
|
Kaplan-Meier Event-free Probability Estimate for Biochemical Progression-free Survival Based on CgA Levels
21 months
|
18.1 event free probability estimates
Interval 6.7 to 33.8
|
13.8 event free probability estimates
Interval 4.1 to 29.4
|
NA event free probability estimates
Event-free probability is non-estimable due to insufficient number of participants with events
|
|
Kaplan-Meier Event-free Probability Estimate for Biochemical Progression-free Survival Based on CgA Levels
24 months
|
18.1 event free probability estimates
Interval 6.7 to 33.8
|
NA event free probability estimates
Event-free probability is non-estimable due to insufficient number of participants with events
|
NA event free probability estimates
Event-free probability is non-estimable due to insufficient number of participants with events
|
SECONDARY outcome
Timeframe: Baseline up Week 52Population: Full analysis set - participants with 5HIAA levels within normal range at baseline are excluded from the table, therefore 'n' stands for the number of patients with 5-HIAA levels outside normal range at baseline.
The percentages are the biochemical response rates i.e. percentage of patients showing normalization i.e. return to within normal ranges, or a decrease of \>= 50% from baseline of 5HIAA concentrations.
Outcome measures
| Measure |
Pasireotide LAR and Everolimus Combination
n=20 Participants
Pasireotide LAR 60 mg i.m. injected once every 28 days + Everolimus 10 mg p.o. daily starting on Day 1
|
Pasireotide LAR
n=20 Participants
Pasireotide long acting release (LAR) 60 mg will be administered as an intra muscular (i.m.) depot injection once every 28 days starting on Day 1
|
Everolimus
n=18 Participants
Everolimus 10 mg taken orally (p.o) once daily starting on Day 1
|
|---|---|---|---|
|
Biochemical Response Rate (BRR) for 5HIAA Levels
Week 48
|
5.0 percentage of participants
Interval 0.1 to 24.9
|
5.0 percentage of participants
Interval 0.1 to 24.9
|
0 percentage of participants
Interval 0.0 to 18.5
|
|
Biochemical Response Rate (BRR) for 5HIAA Levels
Week 52
|
10.0 percentage of participants
Interval 1.2 to 31.7
|
5.0 percentage of participants
Interval 0.1 to 24.9
|
0 percentage of participants
Interval 0.0 to 18.5
|
|
Biochemical Response Rate (BRR) for 5HIAA Levels
Week 12
|
10.0 percentage of participants
Interval 1.2 to 31.7
|
20.0 percentage of participants
Interval 5.7 to 43.7
|
11.1 percentage of participants
Interval 1.4 to 34.7
|
|
Biochemical Response Rate (BRR) for 5HIAA Levels
Week 24
|
20.0 percentage of participants
Interval 5.7 to 43.7
|
5.0 percentage of participants
Interval 0.1 to 24.9
|
11.1 percentage of participants
Interval 1.4 to 34.7
|
|
Biochemical Response Rate (BRR) for 5HIAA Levels
Week 36
|
5.0 percentage of participants
Interval 0.1 to 24.9
|
5.0 percentage of participants
Interval 0.1 to 24.9
|
11.1 percentage of participants
Interval 1.4 to 34.7
|
Adverse Events
Pasireotide LAR
Serious events: 17 serious events
Other events: 40 other events
Deaths: 2 deaths
Everolimus
Serious events: 20 serious events
Other events: 42 other events
Deaths: 7 deaths
Pasireotide LAR and Everolimus Combination
Serious events: 16 serious events
Other events: 40 other events
Deaths: 3 deaths
Serious adverse events
| Measure |
Pasireotide LAR
n=41 participants at risk
Pasireotide LAR
|
Everolimus
n=42 participants at risk
Everolimus
|
Pasireotide LAR and Everolimus Combination
n=41 participants at risk
Pasireotide LAR and Everolimus Combination
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/41 • Adverse events were reported from first dose of study treatment until end of study treatment plus 8 weeks post treatment up to maximum duration of 316 weeks
|
2.4%
1/42 • Adverse events were reported from first dose of study treatment until end of study treatment plus 8 weeks post treatment up to maximum duration of 316 weeks
|
2.4%
1/41 • Adverse events were reported from first dose of study treatment until end of study treatment plus 8 weeks post treatment up to maximum duration of 316 weeks
|
|
Cardiac disorders
Atrial flutter
|
0.00%
0/41 • Adverse events were reported from first dose of study treatment until end of study treatment plus 8 weeks post treatment up to maximum duration of 316 weeks
|
0.00%
0/42 • Adverse events were reported from first dose of study treatment until end of study treatment plus 8 weeks post treatment up to maximum duration of 316 weeks
|
2.4%
1/41 • Adverse events were reported from first dose of study treatment until end of study treatment plus 8 weeks post treatment up to maximum duration of 316 weeks
|
|
Cardiac disorders
Cardiac failure
|
2.4%
1/41 • Adverse events were reported from first dose of study treatment until end of study treatment plus 8 weeks post treatment up to maximum duration of 316 weeks
|
2.4%
1/42 • Adverse events were reported from first dose of study treatment until end of study treatment plus 8 weeks post treatment up to maximum duration of 316 weeks
|
0.00%
0/41 • Adverse events were reported from first dose of study treatment until end of study treatment plus 8 weeks post treatment up to maximum duration of 316 weeks
|
|
Cardiac disorders
Tachycardia paroxysmal
|
2.4%
1/41 • Adverse events were reported from first dose of study treatment until end of study treatment plus 8 weeks post treatment up to maximum duration of 316 weeks
|
0.00%
0/42 • Adverse events were reported from first dose of study treatment until end of study treatment plus 8 weeks post treatment up to maximum duration of 316 weeks
|
0.00%
0/41 • Adverse events were reported from first dose of study treatment until end of study treatment plus 8 weeks post treatment up to maximum duration of 316 weeks
|
|
Endocrine disorders
Carcinoid crisis
|
0.00%
0/41 • Adverse events were reported from first dose of study treatment until end of study treatment plus 8 weeks post treatment up to maximum duration of 316 weeks
|
0.00%
0/42 • Adverse events were reported from first dose of study treatment until end of study treatment plus 8 weeks post treatment up to maximum duration of 316 weeks
|
2.4%
1/41 • Adverse events were reported from first dose of study treatment until end of study treatment plus 8 weeks post treatment up to maximum duration of 316 weeks
|
|
Endocrine disorders
Carcinoid syndrome
|
0.00%
0/41 • Adverse events were reported from first dose of study treatment until end of study treatment plus 8 weeks post treatment up to maximum duration of 316 weeks
|
2.4%
1/42 • Adverse events were reported from first dose of study treatment until end of study treatment plus 8 weeks post treatment up to maximum duration of 316 weeks
|
0.00%
0/41 • Adverse events were reported from first dose of study treatment until end of study treatment plus 8 weeks post treatment up to maximum duration of 316 weeks
|
|
Endocrine disorders
Cushing's syndrome
|
0.00%
0/41 • Adverse events were reported from first dose of study treatment until end of study treatment plus 8 weeks post treatment up to maximum duration of 316 weeks
|
2.4%
1/42 • Adverse events were reported from first dose of study treatment until end of study treatment plus 8 weeks post treatment up to maximum duration of 316 weeks
|
0.00%
0/41 • Adverse events were reported from first dose of study treatment until end of study treatment plus 8 weeks post treatment up to maximum duration of 316 weeks
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/41 • Adverse events were reported from first dose of study treatment until end of study treatment plus 8 weeks post treatment up to maximum duration of 316 weeks
|
4.8%
2/42 • Adverse events were reported from first dose of study treatment until end of study treatment plus 8 weeks post treatment up to maximum duration of 316 weeks
|
0.00%
0/41 • Adverse events were reported from first dose of study treatment until end of study treatment plus 8 weeks post treatment up to maximum duration of 316 weeks
|
|
Gastrointestinal disorders
Abdominal pain upper
|
2.4%
1/41 • Adverse events were reported from first dose of study treatment until end of study treatment plus 8 weeks post treatment up to maximum duration of 316 weeks
|
0.00%
0/42 • Adverse events were reported from first dose of study treatment until end of study treatment plus 8 weeks post treatment up to maximum duration of 316 weeks
|
0.00%
0/41 • Adverse events were reported from first dose of study treatment until end of study treatment plus 8 weeks post treatment up to maximum duration of 316 weeks
|
|
Gastrointestinal disorders
Ascites
|
0.00%
0/41 • Adverse events were reported from first dose of study treatment until end of study treatment plus 8 weeks post treatment up to maximum duration of 316 weeks
|
0.00%
0/42 • Adverse events were reported from first dose of study treatment until end of study treatment plus 8 weeks post treatment up to maximum duration of 316 weeks
|
2.4%
1/41 • Adverse events were reported from first dose of study treatment until end of study treatment plus 8 weeks post treatment up to maximum duration of 316 weeks
|
|
Gastrointestinal disorders
Constipation
|
4.9%
2/41 • Adverse events were reported from first dose of study treatment until end of study treatment plus 8 weeks post treatment up to maximum duration of 316 weeks
|
0.00%
0/42 • Adverse events were reported from first dose of study treatment until end of study treatment plus 8 weeks post treatment up to maximum duration of 316 weeks
|
0.00%
0/41 • Adverse events were reported from first dose of study treatment until end of study treatment plus 8 weeks post treatment up to maximum duration of 316 weeks
|
|
Gastrointestinal disorders
Diarrhoea
|
2.4%
1/41 • Adverse events were reported from first dose of study treatment until end of study treatment plus 8 weeks post treatment up to maximum duration of 316 weeks
|
7.1%
3/42 • Adverse events were reported from first dose of study treatment until end of study treatment plus 8 weeks post treatment up to maximum duration of 316 weeks
|
4.9%
2/41 • Adverse events were reported from first dose of study treatment until end of study treatment plus 8 weeks post treatment up to maximum duration of 316 weeks
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/41 • Adverse events were reported from first dose of study treatment until end of study treatment plus 8 weeks post treatment up to maximum duration of 316 weeks
|
4.8%
2/42 • Adverse events were reported from first dose of study treatment until end of study treatment plus 8 weeks post treatment up to maximum duration of 316 weeks
|
0.00%
0/41 • Adverse events were reported from first dose of study treatment until end of study treatment plus 8 weeks post treatment up to maximum duration of 316 weeks
|
|
Gastrointestinal disorders
Ileus
|
0.00%
0/41 • Adverse events were reported from first dose of study treatment until end of study treatment plus 8 weeks post treatment up to maximum duration of 316 weeks
|
0.00%
0/42 • Adverse events were reported from first dose of study treatment until end of study treatment plus 8 weeks post treatment up to maximum duration of 316 weeks
|
2.4%
1/41 • Adverse events were reported from first dose of study treatment until end of study treatment plus 8 weeks post treatment up to maximum duration of 316 weeks
|
|
Gastrointestinal disorders
Intestinal obstruction
|
2.4%
1/41 • Adverse events were reported from first dose of study treatment until end of study treatment plus 8 weeks post treatment up to maximum duration of 316 weeks
|
0.00%
0/42 • Adverse events were reported from first dose of study treatment until end of study treatment plus 8 weeks post treatment up to maximum duration of 316 weeks
|
2.4%
1/41 • Adverse events were reported from first dose of study treatment until end of study treatment plus 8 weeks post treatment up to maximum duration of 316 weeks
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/41 • Adverse events were reported from first dose of study treatment until end of study treatment plus 8 weeks post treatment up to maximum duration of 316 weeks
|
4.8%
2/42 • Adverse events were reported from first dose of study treatment until end of study treatment plus 8 weeks post treatment up to maximum duration of 316 weeks
|
0.00%
0/41 • Adverse events were reported from first dose of study treatment until end of study treatment plus 8 weeks post treatment up to maximum duration of 316 weeks
|
|
Gastrointestinal disorders
Salivary gland pain
|
0.00%
0/41 • Adverse events were reported from first dose of study treatment until end of study treatment plus 8 weeks post treatment up to maximum duration of 316 weeks
|
2.4%
1/42 • Adverse events were reported from first dose of study treatment until end of study treatment plus 8 weeks post treatment up to maximum duration of 316 weeks
|
0.00%
0/41 • Adverse events were reported from first dose of study treatment until end of study treatment plus 8 weeks post treatment up to maximum duration of 316 weeks
|
|
Gastrointestinal disorders
Stomatitis
|
0.00%
0/41 • Adverse events were reported from first dose of study treatment until end of study treatment plus 8 weeks post treatment up to maximum duration of 316 weeks
|
2.4%
1/42 • Adverse events were reported from first dose of study treatment until end of study treatment plus 8 weeks post treatment up to maximum duration of 316 weeks
|
0.00%
0/41 • Adverse events were reported from first dose of study treatment until end of study treatment plus 8 weeks post treatment up to maximum duration of 316 weeks
|
|
Gastrointestinal disorders
Vomiting
|
2.4%
1/41 • Adverse events were reported from first dose of study treatment until end of study treatment plus 8 weeks post treatment up to maximum duration of 316 weeks
|
2.4%
1/42 • Adverse events were reported from first dose of study treatment until end of study treatment plus 8 weeks post treatment up to maximum duration of 316 weeks
|
2.4%
1/41 • Adverse events were reported from first dose of study treatment until end of study treatment plus 8 weeks post treatment up to maximum duration of 316 weeks
|
|
General disorders
Asthenia
|
0.00%
0/41 • Adverse events were reported from first dose of study treatment until end of study treatment plus 8 weeks post treatment up to maximum duration of 316 weeks
|
2.4%
1/42 • Adverse events were reported from first dose of study treatment until end of study treatment plus 8 weeks post treatment up to maximum duration of 316 weeks
|
0.00%
0/41 • Adverse events were reported from first dose of study treatment until end of study treatment plus 8 weeks post treatment up to maximum duration of 316 weeks
|
|
General disorders
Axillary pain
|
2.4%
1/41 • Adverse events were reported from first dose of study treatment until end of study treatment plus 8 weeks post treatment up to maximum duration of 316 weeks
|
0.00%
0/42 • Adverse events were reported from first dose of study treatment until end of study treatment plus 8 weeks post treatment up to maximum duration of 316 weeks
|
0.00%
0/41 • Adverse events were reported from first dose of study treatment until end of study treatment plus 8 weeks post treatment up to maximum duration of 316 weeks
|
|
General disorders
Chest pain
|
0.00%
0/41 • Adverse events were reported from first dose of study treatment until end of study treatment plus 8 weeks post treatment up to maximum duration of 316 weeks
|
0.00%
0/42 • Adverse events were reported from first dose of study treatment until end of study treatment plus 8 weeks post treatment up to maximum duration of 316 weeks
|
2.4%
1/41 • Adverse events were reported from first dose of study treatment until end of study treatment plus 8 weeks post treatment up to maximum duration of 316 weeks
|
|
General disorders
Disease progression
|
2.4%
1/41 • Adverse events were reported from first dose of study treatment until end of study treatment plus 8 weeks post treatment up to maximum duration of 316 weeks
|
2.4%
1/42 • Adverse events were reported from first dose of study treatment until end of study treatment plus 8 weeks post treatment up to maximum duration of 316 weeks
|
0.00%
0/41 • Adverse events were reported from first dose of study treatment until end of study treatment plus 8 weeks post treatment up to maximum duration of 316 weeks
|
|
General disorders
Face oedema
|
2.4%
1/41 • Adverse events were reported from first dose of study treatment until end of study treatment plus 8 weeks post treatment up to maximum duration of 316 weeks
|
0.00%
0/42 • Adverse events were reported from first dose of study treatment until end of study treatment plus 8 weeks post treatment up to maximum duration of 316 weeks
|
0.00%
0/41 • Adverse events were reported from first dose of study treatment until end of study treatment plus 8 weeks post treatment up to maximum duration of 316 weeks
|
|
General disorders
General physical health deterioration
|
7.3%
3/41 • Adverse events were reported from first dose of study treatment until end of study treatment plus 8 weeks post treatment up to maximum duration of 316 weeks
|
4.8%
2/42 • Adverse events were reported from first dose of study treatment until end of study treatment plus 8 weeks post treatment up to maximum duration of 316 weeks
|
0.00%
0/41 • Adverse events were reported from first dose of study treatment until end of study treatment plus 8 weeks post treatment up to maximum duration of 316 weeks
|
|
General disorders
Multiple organ dysfunction syndrome
|
2.4%
1/41 • Adverse events were reported from first dose of study treatment until end of study treatment plus 8 weeks post treatment up to maximum duration of 316 weeks
|
0.00%
0/42 • Adverse events were reported from first dose of study treatment until end of study treatment plus 8 weeks post treatment up to maximum duration of 316 weeks
|
0.00%
0/41 • Adverse events were reported from first dose of study treatment until end of study treatment plus 8 weeks post treatment up to maximum duration of 316 weeks
|
|
General disorders
Non-cardiac chest pain
|
2.4%
1/41 • Adverse events were reported from first dose of study treatment until end of study treatment plus 8 weeks post treatment up to maximum duration of 316 weeks
|
2.4%
1/42 • Adverse events were reported from first dose of study treatment until end of study treatment plus 8 weeks post treatment up to maximum duration of 316 weeks
|
0.00%
0/41 • Adverse events were reported from first dose of study treatment until end of study treatment plus 8 weeks post treatment up to maximum duration of 316 weeks
|
|
General disorders
Oedema peripheral
|
0.00%
0/41 • Adverse events were reported from first dose of study treatment until end of study treatment plus 8 weeks post treatment up to maximum duration of 316 weeks
|
2.4%
1/42 • Adverse events were reported from first dose of study treatment until end of study treatment plus 8 weeks post treatment up to maximum duration of 316 weeks
|
0.00%
0/41 • Adverse events were reported from first dose of study treatment until end of study treatment plus 8 weeks post treatment up to maximum duration of 316 weeks
|
|
General disorders
Pyrexia
|
2.4%
1/41 • Adverse events were reported from first dose of study treatment until end of study treatment plus 8 weeks post treatment up to maximum duration of 316 weeks
|
7.1%
3/42 • Adverse events were reported from first dose of study treatment until end of study treatment plus 8 weeks post treatment up to maximum duration of 316 weeks
|
2.4%
1/41 • Adverse events were reported from first dose of study treatment until end of study treatment plus 8 weeks post treatment up to maximum duration of 316 weeks
|
|
Hepatobiliary disorders
Cholecystocholangitis
|
0.00%
0/41 • Adverse events were reported from first dose of study treatment until end of study treatment plus 8 weeks post treatment up to maximum duration of 316 weeks
|
0.00%
0/42 • Adverse events were reported from first dose of study treatment until end of study treatment plus 8 weeks post treatment up to maximum duration of 316 weeks
|
2.4%
1/41 • Adverse events were reported from first dose of study treatment until end of study treatment plus 8 weeks post treatment up to maximum duration of 316 weeks
|
|
Hepatobiliary disorders
Hepatic failure
|
0.00%
0/41 • Adverse events were reported from first dose of study treatment until end of study treatment plus 8 weeks post treatment up to maximum duration of 316 weeks
|
2.4%
1/42 • Adverse events were reported from first dose of study treatment until end of study treatment plus 8 weeks post treatment up to maximum duration of 316 weeks
|
0.00%
0/41 • Adverse events were reported from first dose of study treatment until end of study treatment plus 8 weeks post treatment up to maximum duration of 316 weeks
|
|
Hepatobiliary disorders
Jaundice
|
0.00%
0/41 • Adverse events were reported from first dose of study treatment until end of study treatment plus 8 weeks post treatment up to maximum duration of 316 weeks
|
2.4%
1/42 • Adverse events were reported from first dose of study treatment until end of study treatment plus 8 weeks post treatment up to maximum duration of 316 weeks
|
0.00%
0/41 • Adverse events were reported from first dose of study treatment until end of study treatment plus 8 weeks post treatment up to maximum duration of 316 weeks
|
|
Infections and infestations
Aspergillus infection
|
0.00%
0/41 • Adverse events were reported from first dose of study treatment until end of study treatment plus 8 weeks post treatment up to maximum duration of 316 weeks
|
0.00%
0/42 • Adverse events were reported from first dose of study treatment until end of study treatment plus 8 weeks post treatment up to maximum duration of 316 weeks
|
2.4%
1/41 • Adverse events were reported from first dose of study treatment until end of study treatment plus 8 weeks post treatment up to maximum duration of 316 weeks
|
|
Infections and infestations
Febrile infection
|
0.00%
0/41 • Adverse events were reported from first dose of study treatment until end of study treatment plus 8 weeks post treatment up to maximum duration of 316 weeks
|
2.4%
1/42 • Adverse events were reported from first dose of study treatment until end of study treatment plus 8 weeks post treatment up to maximum duration of 316 weeks
|
0.00%
0/41 • Adverse events were reported from first dose of study treatment until end of study treatment plus 8 weeks post treatment up to maximum duration of 316 weeks
|
|
Infections and infestations
Gastroenteritis
|
2.4%
1/41 • Adverse events were reported from first dose of study treatment until end of study treatment plus 8 weeks post treatment up to maximum duration of 316 weeks
|
2.4%
1/42 • Adverse events were reported from first dose of study treatment until end of study treatment plus 8 weeks post treatment up to maximum duration of 316 weeks
|
0.00%
0/41 • Adverse events were reported from first dose of study treatment until end of study treatment plus 8 weeks post treatment up to maximum duration of 316 weeks
|
|
Infections and infestations
Lower respiratory tract infection
|
2.4%
1/41 • Adverse events were reported from first dose of study treatment until end of study treatment plus 8 weeks post treatment up to maximum duration of 316 weeks
|
2.4%
1/42 • Adverse events were reported from first dose of study treatment until end of study treatment plus 8 weeks post treatment up to maximum duration of 316 weeks
|
0.00%
0/41 • Adverse events were reported from first dose of study treatment until end of study treatment plus 8 weeks post treatment up to maximum duration of 316 weeks
|
|
Infections and infestations
Oesophageal candidiasis
|
0.00%
0/41 • Adverse events were reported from first dose of study treatment until end of study treatment plus 8 weeks post treatment up to maximum duration of 316 weeks
|
2.4%
1/42 • Adverse events were reported from first dose of study treatment until end of study treatment plus 8 weeks post treatment up to maximum duration of 316 weeks
|
0.00%
0/41 • Adverse events were reported from first dose of study treatment until end of study treatment plus 8 weeks post treatment up to maximum duration of 316 weeks
|
|
Infections and infestations
Pneumonia
|
12.2%
5/41 • Adverse events were reported from first dose of study treatment until end of study treatment plus 8 weeks post treatment up to maximum duration of 316 weeks
|
4.8%
2/42 • Adverse events were reported from first dose of study treatment until end of study treatment plus 8 weeks post treatment up to maximum duration of 316 weeks
|
0.00%
0/41 • Adverse events were reported from first dose of study treatment until end of study treatment plus 8 weeks post treatment up to maximum duration of 316 weeks
|
|
Infections and infestations
Sepsis
|
2.4%
1/41 • Adverse events were reported from first dose of study treatment until end of study treatment plus 8 weeks post treatment up to maximum duration of 316 weeks
|
2.4%
1/42 • Adverse events were reported from first dose of study treatment until end of study treatment plus 8 weeks post treatment up to maximum duration of 316 weeks
|
0.00%
0/41 • Adverse events were reported from first dose of study treatment until end of study treatment plus 8 weeks post treatment up to maximum duration of 316 weeks
|
|
Infections and infestations
Urinary tract infection
|
4.9%
2/41 • Adverse events were reported from first dose of study treatment until end of study treatment plus 8 weeks post treatment up to maximum duration of 316 weeks
|
2.4%
1/42 • Adverse events were reported from first dose of study treatment until end of study treatment plus 8 weeks post treatment up to maximum duration of 316 weeks
|
0.00%
0/41 • Adverse events were reported from first dose of study treatment until end of study treatment plus 8 weeks post treatment up to maximum duration of 316 weeks
|
|
Infections and infestations
Urosepsis
|
0.00%
0/41 • Adverse events were reported from first dose of study treatment until end of study treatment plus 8 weeks post treatment up to maximum duration of 316 weeks
|
0.00%
0/42 • Adverse events were reported from first dose of study treatment until end of study treatment plus 8 weeks post treatment up to maximum duration of 316 weeks
|
2.4%
1/41 • Adverse events were reported from first dose of study treatment until end of study treatment plus 8 weeks post treatment up to maximum duration of 316 weeks
|
|
Injury, poisoning and procedural complications
Contusion
|
2.4%
1/41 • Adverse events were reported from first dose of study treatment until end of study treatment plus 8 weeks post treatment up to maximum duration of 316 weeks
|
0.00%
0/42 • Adverse events were reported from first dose of study treatment until end of study treatment plus 8 weeks post treatment up to maximum duration of 316 weeks
|
0.00%
0/41 • Adverse events were reported from first dose of study treatment until end of study treatment plus 8 weeks post treatment up to maximum duration of 316 weeks
|
|
Injury, poisoning and procedural complications
Haematuria traumatic
|
2.4%
1/41 • Adverse events were reported from first dose of study treatment until end of study treatment plus 8 weeks post treatment up to maximum duration of 316 weeks
|
0.00%
0/42 • Adverse events were reported from first dose of study treatment until end of study treatment plus 8 weeks post treatment up to maximum duration of 316 weeks
|
0.00%
0/41 • Adverse events were reported from first dose of study treatment until end of study treatment plus 8 weeks post treatment up to maximum duration of 316 weeks
|
|
Injury, poisoning and procedural complications
Radiation oesophagitis
|
0.00%
0/41 • Adverse events were reported from first dose of study treatment until end of study treatment plus 8 weeks post treatment up to maximum duration of 316 weeks
|
2.4%
1/42 • Adverse events were reported from first dose of study treatment until end of study treatment plus 8 weeks post treatment up to maximum duration of 316 weeks
|
0.00%
0/41 • Adverse events were reported from first dose of study treatment until end of study treatment plus 8 weeks post treatment up to maximum duration of 316 weeks
|
|
Investigations
Blood creatinine increased
|
0.00%
0/41 • Adverse events were reported from first dose of study treatment until end of study treatment plus 8 weeks post treatment up to maximum duration of 316 weeks
|
0.00%
0/42 • Adverse events were reported from first dose of study treatment until end of study treatment plus 8 weeks post treatment up to maximum duration of 316 weeks
|
2.4%
1/41 • Adverse events were reported from first dose of study treatment until end of study treatment plus 8 weeks post treatment up to maximum duration of 316 weeks
|
|
Investigations
C-reactive protein increased
|
2.4%
1/41 • Adverse events were reported from first dose of study treatment until end of study treatment plus 8 weeks post treatment up to maximum duration of 316 weeks
|
0.00%
0/42 • Adverse events were reported from first dose of study treatment until end of study treatment plus 8 weeks post treatment up to maximum duration of 316 weeks
|
0.00%
0/41 • Adverse events were reported from first dose of study treatment until end of study treatment plus 8 weeks post treatment up to maximum duration of 316 weeks
|
|
Investigations
Liver function test increased
|
0.00%
0/41 • Adverse events were reported from first dose of study treatment until end of study treatment plus 8 weeks post treatment up to maximum duration of 316 weeks
|
0.00%
0/42 • Adverse events were reported from first dose of study treatment until end of study treatment plus 8 weeks post treatment up to maximum duration of 316 weeks
|
2.4%
1/41 • Adverse events were reported from first dose of study treatment until end of study treatment plus 8 weeks post treatment up to maximum duration of 316 weeks
|
|
Investigations
Weight decreased
|
0.00%
0/41 • Adverse events were reported from first dose of study treatment until end of study treatment plus 8 weeks post treatment up to maximum duration of 316 weeks
|
4.8%
2/42 • Adverse events were reported from first dose of study treatment until end of study treatment plus 8 weeks post treatment up to maximum duration of 316 weeks
|
0.00%
0/41 • Adverse events were reported from first dose of study treatment until end of study treatment plus 8 weeks post treatment up to maximum duration of 316 weeks
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/41 • Adverse events were reported from first dose of study treatment until end of study treatment plus 8 weeks post treatment up to maximum duration of 316 weeks
|
0.00%
0/42 • Adverse events were reported from first dose of study treatment until end of study treatment plus 8 weeks post treatment up to maximum duration of 316 weeks
|
2.4%
1/41 • Adverse events were reported from first dose of study treatment until end of study treatment plus 8 weeks post treatment up to maximum duration of 316 weeks
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
0.00%
0/41 • Adverse events were reported from first dose of study treatment until end of study treatment plus 8 weeks post treatment up to maximum duration of 316 weeks
|
0.00%
0/42 • Adverse events were reported from first dose of study treatment until end of study treatment plus 8 weeks post treatment up to maximum duration of 316 weeks
|
2.4%
1/41 • Adverse events were reported from first dose of study treatment until end of study treatment plus 8 weeks post treatment up to maximum duration of 316 weeks
|
|
Metabolism and nutrition disorders
Hyperammonaemia
|
2.4%
1/41 • Adverse events were reported from first dose of study treatment until end of study treatment plus 8 weeks post treatment up to maximum duration of 316 weeks
|
0.00%
0/42 • Adverse events were reported from first dose of study treatment until end of study treatment plus 8 weeks post treatment up to maximum duration of 316 weeks
|
0.00%
0/41 • Adverse events were reported from first dose of study treatment until end of study treatment plus 8 weeks post treatment up to maximum duration of 316 weeks
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
2.4%
1/41 • Adverse events were reported from first dose of study treatment until end of study treatment plus 8 weeks post treatment up to maximum duration of 316 weeks
|
0.00%
0/42 • Adverse events were reported from first dose of study treatment until end of study treatment plus 8 weeks post treatment up to maximum duration of 316 weeks
|
0.00%
0/41 • Adverse events were reported from first dose of study treatment until end of study treatment plus 8 weeks post treatment up to maximum duration of 316 weeks
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/41 • Adverse events were reported from first dose of study treatment until end of study treatment plus 8 weeks post treatment up to maximum duration of 316 weeks
|
2.4%
1/42 • Adverse events were reported from first dose of study treatment until end of study treatment plus 8 weeks post treatment up to maximum duration of 316 weeks
|
2.4%
1/41 • Adverse events were reported from first dose of study treatment until end of study treatment plus 8 weeks post treatment up to maximum duration of 316 weeks
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.00%
0/41 • Adverse events were reported from first dose of study treatment until end of study treatment plus 8 weeks post treatment up to maximum duration of 316 weeks
|
0.00%
0/42 • Adverse events were reported from first dose of study treatment until end of study treatment plus 8 weeks post treatment up to maximum duration of 316 weeks
|
2.4%
1/41 • Adverse events were reported from first dose of study treatment until end of study treatment plus 8 weeks post treatment up to maximum duration of 316 weeks
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/41 • Adverse events were reported from first dose of study treatment until end of study treatment plus 8 weeks post treatment up to maximum duration of 316 weeks
|
0.00%
0/42 • Adverse events were reported from first dose of study treatment until end of study treatment plus 8 weeks post treatment up to maximum duration of 316 weeks
|
2.4%
1/41 • Adverse events were reported from first dose of study treatment until end of study treatment plus 8 weeks post treatment up to maximum duration of 316 weeks
|
|
Metabolism and nutrition disorders
Metabolic acidosis
|
2.4%
1/41 • Adverse events were reported from first dose of study treatment until end of study treatment plus 8 weeks post treatment up to maximum duration of 316 weeks
|
0.00%
0/42 • Adverse events were reported from first dose of study treatment until end of study treatment plus 8 weeks post treatment up to maximum duration of 316 weeks
|
0.00%
0/41 • Adverse events were reported from first dose of study treatment until end of study treatment plus 8 weeks post treatment up to maximum duration of 316 weeks
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
2.4%
1/41 • Adverse events were reported from first dose of study treatment until end of study treatment plus 8 weeks post treatment up to maximum duration of 316 weeks
|
0.00%
0/42 • Adverse events were reported from first dose of study treatment until end of study treatment plus 8 weeks post treatment up to maximum duration of 316 weeks
|
0.00%
0/41 • Adverse events were reported from first dose of study treatment until end of study treatment plus 8 weeks post treatment up to maximum duration of 316 weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cancer pain
|
2.4%
1/41 • Adverse events were reported from first dose of study treatment until end of study treatment plus 8 weeks post treatment up to maximum duration of 316 weeks
|
0.00%
0/42 • Adverse events were reported from first dose of study treatment until end of study treatment plus 8 weeks post treatment up to maximum duration of 316 weeks
|
0.00%
0/41 • Adverse events were reported from first dose of study treatment until end of study treatment plus 8 weeks post treatment up to maximum duration of 316 weeks
|
|
Nervous system disorders
Altered state of consciousness
|
0.00%
0/41 • Adverse events were reported from first dose of study treatment until end of study treatment plus 8 weeks post treatment up to maximum duration of 316 weeks
|
2.4%
1/42 • Adverse events were reported from first dose of study treatment until end of study treatment plus 8 weeks post treatment up to maximum duration of 316 weeks
|
0.00%
0/41 • Adverse events were reported from first dose of study treatment until end of study treatment plus 8 weeks post treatment up to maximum duration of 316 weeks
|
|
Nervous system disorders
Brain compression
|
2.4%
1/41 • Adverse events were reported from first dose of study treatment until end of study treatment plus 8 weeks post treatment up to maximum duration of 316 weeks
|
0.00%
0/42 • Adverse events were reported from first dose of study treatment until end of study treatment plus 8 weeks post treatment up to maximum duration of 316 weeks
|
0.00%
0/41 • Adverse events were reported from first dose of study treatment until end of study treatment plus 8 weeks post treatment up to maximum duration of 316 weeks
|
|
Nervous system disorders
Headache
|
0.00%
0/41 • Adverse events were reported from first dose of study treatment until end of study treatment plus 8 weeks post treatment up to maximum duration of 316 weeks
|
2.4%
1/42 • Adverse events were reported from first dose of study treatment until end of study treatment plus 8 weeks post treatment up to maximum duration of 316 weeks
|
0.00%
0/41 • Adverse events were reported from first dose of study treatment until end of study treatment plus 8 weeks post treatment up to maximum duration of 316 weeks
|
|
Nervous system disorders
Loss of consciousness
|
0.00%
0/41 • Adverse events were reported from first dose of study treatment until end of study treatment plus 8 weeks post treatment up to maximum duration of 316 weeks
|
0.00%
0/42 • Adverse events were reported from first dose of study treatment until end of study treatment plus 8 weeks post treatment up to maximum duration of 316 weeks
|
2.4%
1/41 • Adverse events were reported from first dose of study treatment until end of study treatment plus 8 weeks post treatment up to maximum duration of 316 weeks
|
|
Nervous system disorders
Spinal cord compression
|
4.9%
2/41 • Adverse events were reported from first dose of study treatment until end of study treatment plus 8 weeks post treatment up to maximum duration of 316 weeks
|
0.00%
0/42 • Adverse events were reported from first dose of study treatment until end of study treatment plus 8 weeks post treatment up to maximum duration of 316 weeks
|
0.00%
0/41 • Adverse events were reported from first dose of study treatment until end of study treatment plus 8 weeks post treatment up to maximum duration of 316 weeks
|
|
Nervous system disorders
Syncope
|
4.9%
2/41 • Adverse events were reported from first dose of study treatment until end of study treatment plus 8 weeks post treatment up to maximum duration of 316 weeks
|
0.00%
0/42 • Adverse events were reported from first dose of study treatment until end of study treatment plus 8 weeks post treatment up to maximum duration of 316 weeks
|
0.00%
0/41 • Adverse events were reported from first dose of study treatment until end of study treatment plus 8 weeks post treatment up to maximum duration of 316 weeks
|
|
Psychiatric disorders
Confusional state
|
2.4%
1/41 • Adverse events were reported from first dose of study treatment until end of study treatment plus 8 weeks post treatment up to maximum duration of 316 weeks
|
0.00%
0/42 • Adverse events were reported from first dose of study treatment until end of study treatment plus 8 weeks post treatment up to maximum duration of 316 weeks
|
0.00%
0/41 • Adverse events were reported from first dose of study treatment until end of study treatment plus 8 weeks post treatment up to maximum duration of 316 weeks
|
|
Psychiatric disorders
Delirium
|
2.4%
1/41 • Adverse events were reported from first dose of study treatment until end of study treatment plus 8 weeks post treatment up to maximum duration of 316 weeks
|
0.00%
0/42 • Adverse events were reported from first dose of study treatment until end of study treatment plus 8 weeks post treatment up to maximum duration of 316 weeks
|
0.00%
0/41 • Adverse events were reported from first dose of study treatment until end of study treatment plus 8 weeks post treatment up to maximum duration of 316 weeks
|
|
Psychiatric disorders
Depression
|
0.00%
0/41 • Adverse events were reported from first dose of study treatment until end of study treatment plus 8 weeks post treatment up to maximum duration of 316 weeks
|
0.00%
0/42 • Adverse events were reported from first dose of study treatment until end of study treatment plus 8 weeks post treatment up to maximum duration of 316 weeks
|
2.4%
1/41 • Adverse events were reported from first dose of study treatment until end of study treatment plus 8 weeks post treatment up to maximum duration of 316 weeks
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/41 • Adverse events were reported from first dose of study treatment until end of study treatment plus 8 weeks post treatment up to maximum duration of 316 weeks
|
4.8%
2/42 • Adverse events were reported from first dose of study treatment until end of study treatment plus 8 weeks post treatment up to maximum duration of 316 weeks
|
2.4%
1/41 • Adverse events were reported from first dose of study treatment until end of study treatment plus 8 weeks post treatment up to maximum duration of 316 weeks
|
|
Renal and urinary disorders
Anuria
|
0.00%
0/41 • Adverse events were reported from first dose of study treatment until end of study treatment plus 8 weeks post treatment up to maximum duration of 316 weeks
|
2.4%
1/42 • Adverse events were reported from first dose of study treatment until end of study treatment plus 8 weeks post treatment up to maximum duration of 316 weeks
|
0.00%
0/41 • Adverse events were reported from first dose of study treatment until end of study treatment plus 8 weeks post treatment up to maximum duration of 316 weeks
|
|
Renal and urinary disorders
Dysuria
|
2.4%
1/41 • Adverse events were reported from first dose of study treatment until end of study treatment plus 8 weeks post treatment up to maximum duration of 316 weeks
|
0.00%
0/42 • Adverse events were reported from first dose of study treatment until end of study treatment plus 8 weeks post treatment up to maximum duration of 316 weeks
|
0.00%
0/41 • Adverse events were reported from first dose of study treatment until end of study treatment plus 8 weeks post treatment up to maximum duration of 316 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Bronchial obstruction
|
0.00%
0/41 • Adverse events were reported from first dose of study treatment until end of study treatment plus 8 weeks post treatment up to maximum duration of 316 weeks
|
2.4%
1/42 • Adverse events were reported from first dose of study treatment until end of study treatment plus 8 weeks post treatment up to maximum duration of 316 weeks
|
0.00%
0/41 • Adverse events were reported from first dose of study treatment until end of study treatment plus 8 weeks post treatment up to maximum duration of 316 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Bronchospasm
|
2.4%
1/41 • Adverse events were reported from first dose of study treatment until end of study treatment plus 8 weeks post treatment up to maximum duration of 316 weeks
|
0.00%
0/42 • Adverse events were reported from first dose of study treatment until end of study treatment plus 8 weeks post treatment up to maximum duration of 316 weeks
|
0.00%
0/41 • Adverse events were reported from first dose of study treatment until end of study treatment plus 8 weeks post treatment up to maximum duration of 316 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
2.4%
1/41 • Adverse events were reported from first dose of study treatment until end of study treatment plus 8 weeks post treatment up to maximum duration of 316 weeks
|
0.00%
0/42 • Adverse events were reported from first dose of study treatment until end of study treatment plus 8 weeks post treatment up to maximum duration of 316 weeks
|
0.00%
0/41 • Adverse events were reported from first dose of study treatment until end of study treatment plus 8 weeks post treatment up to maximum duration of 316 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
7.3%
3/41 • Adverse events were reported from first dose of study treatment until end of study treatment plus 8 weeks post treatment up to maximum duration of 316 weeks
|
7.1%
3/42 • Adverse events were reported from first dose of study treatment until end of study treatment plus 8 weeks post treatment up to maximum duration of 316 weeks
|
2.4%
1/41 • Adverse events were reported from first dose of study treatment until end of study treatment plus 8 weeks post treatment up to maximum duration of 316 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Hydrothorax
|
2.4%
1/41 • Adverse events were reported from first dose of study treatment until end of study treatment plus 8 weeks post treatment up to maximum duration of 316 weeks
|
0.00%
0/42 • Adverse events were reported from first dose of study treatment until end of study treatment plus 8 weeks post treatment up to maximum duration of 316 weeks
|
0.00%
0/41 • Adverse events were reported from first dose of study treatment until end of study treatment plus 8 weeks post treatment up to maximum duration of 316 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Lung disorder
|
0.00%
0/41 • Adverse events were reported from first dose of study treatment until end of study treatment plus 8 weeks post treatment up to maximum duration of 316 weeks
|
2.4%
1/42 • Adverse events were reported from first dose of study treatment until end of study treatment plus 8 weeks post treatment up to maximum duration of 316 weeks
|
0.00%
0/41 • Adverse events were reported from first dose of study treatment until end of study treatment plus 8 weeks post treatment up to maximum duration of 316 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
7.3%
3/41 • Adverse events were reported from first dose of study treatment until end of study treatment plus 8 weeks post treatment up to maximum duration of 316 weeks
|
2.4%
1/42 • Adverse events were reported from first dose of study treatment until end of study treatment plus 8 weeks post treatment up to maximum duration of 316 weeks
|
0.00%
0/41 • Adverse events were reported from first dose of study treatment until end of study treatment plus 8 weeks post treatment up to maximum duration of 316 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia aspiration
|
0.00%
0/41 • Adverse events were reported from first dose of study treatment until end of study treatment plus 8 weeks post treatment up to maximum duration of 316 weeks
|
0.00%
0/42 • Adverse events were reported from first dose of study treatment until end of study treatment plus 8 weeks post treatment up to maximum duration of 316 weeks
|
2.4%
1/41 • Adverse events were reported from first dose of study treatment until end of study treatment plus 8 weeks post treatment up to maximum duration of 316 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.00%
0/41 • Adverse events were reported from first dose of study treatment until end of study treatment plus 8 weeks post treatment up to maximum duration of 316 weeks
|
4.8%
2/42 • Adverse events were reported from first dose of study treatment until end of study treatment plus 8 weeks post treatment up to maximum duration of 316 weeks
|
4.9%
2/41 • Adverse events were reported from first dose of study treatment until end of study treatment plus 8 weeks post treatment up to maximum duration of 316 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
2.4%
1/41 • Adverse events were reported from first dose of study treatment until end of study treatment plus 8 weeks post treatment up to maximum duration of 316 weeks
|
4.8%
2/42 • Adverse events were reported from first dose of study treatment until end of study treatment plus 8 weeks post treatment up to maximum duration of 316 weeks
|
2.4%
1/41 • Adverse events were reported from first dose of study treatment until end of study treatment plus 8 weeks post treatment up to maximum duration of 316 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory distress
|
0.00%
0/41 • Adverse events were reported from first dose of study treatment until end of study treatment plus 8 weeks post treatment up to maximum duration of 316 weeks
|
2.4%
1/42 • Adverse events were reported from first dose of study treatment until end of study treatment plus 8 weeks post treatment up to maximum duration of 316 weeks
|
0.00%
0/41 • Adverse events were reported from first dose of study treatment until end of study treatment plus 8 weeks post treatment up to maximum duration of 316 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.00%
0/41 • Adverse events were reported from first dose of study treatment until end of study treatment plus 8 weeks post treatment up to maximum duration of 316 weeks
|
2.4%
1/42 • Adverse events were reported from first dose of study treatment until end of study treatment plus 8 weeks post treatment up to maximum duration of 316 weeks
|
2.4%
1/41 • Adverse events were reported from first dose of study treatment until end of study treatment plus 8 weeks post treatment up to maximum duration of 316 weeks
|
|
Skin and subcutaneous tissue disorders
Angioedema
|
0.00%
0/41 • Adverse events were reported from first dose of study treatment until end of study treatment plus 8 weeks post treatment up to maximum duration of 316 weeks
|
0.00%
0/42 • Adverse events were reported from first dose of study treatment until end of study treatment plus 8 weeks post treatment up to maximum duration of 316 weeks
|
2.4%
1/41 • Adverse events were reported from first dose of study treatment until end of study treatment plus 8 weeks post treatment up to maximum duration of 316 weeks
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/41 • Adverse events were reported from first dose of study treatment until end of study treatment plus 8 weeks post treatment up to maximum duration of 316 weeks
|
2.4%
1/42 • Adverse events were reported from first dose of study treatment until end of study treatment plus 8 weeks post treatment up to maximum duration of 316 weeks
|
0.00%
0/41 • Adverse events were reported from first dose of study treatment until end of study treatment plus 8 weeks post treatment up to maximum duration of 316 weeks
|
|
Skin and subcutaneous tissue disorders
Skin haemorrhage
|
2.4%
1/41 • Adverse events were reported from first dose of study treatment until end of study treatment plus 8 weeks post treatment up to maximum duration of 316 weeks
|
0.00%
0/42 • Adverse events were reported from first dose of study treatment until end of study treatment plus 8 weeks post treatment up to maximum duration of 316 weeks
|
0.00%
0/41 • Adverse events were reported from first dose of study treatment until end of study treatment plus 8 weeks post treatment up to maximum duration of 316 weeks
|
|
Vascular disorders
Deep vein thrombosis
|
0.00%
0/41 • Adverse events were reported from first dose of study treatment until end of study treatment plus 8 weeks post treatment up to maximum duration of 316 weeks
|
0.00%
0/42 • Adverse events were reported from first dose of study treatment until end of study treatment plus 8 weeks post treatment up to maximum duration of 316 weeks
|
2.4%
1/41 • Adverse events were reported from first dose of study treatment until end of study treatment plus 8 weeks post treatment up to maximum duration of 316 weeks
|
|
Vascular disorders
Hypotension
|
4.9%
2/41 • Adverse events were reported from first dose of study treatment until end of study treatment plus 8 weeks post treatment up to maximum duration of 316 weeks
|
0.00%
0/42 • Adverse events were reported from first dose of study treatment until end of study treatment plus 8 weeks post treatment up to maximum duration of 316 weeks
|
0.00%
0/41 • Adverse events were reported from first dose of study treatment until end of study treatment plus 8 weeks post treatment up to maximum duration of 316 weeks
|
Other adverse events
| Measure |
Pasireotide LAR
n=41 participants at risk
Pasireotide LAR
|
Everolimus
n=42 participants at risk
Everolimus
|
Pasireotide LAR and Everolimus Combination
n=41 participants at risk
Pasireotide LAR and Everolimus Combination
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
22.0%
9/41 • Adverse events were reported from first dose of study treatment until end of study treatment plus 8 weeks post treatment up to maximum duration of 316 weeks
|
33.3%
14/42 • Adverse events were reported from first dose of study treatment until end of study treatment plus 8 weeks post treatment up to maximum duration of 316 weeks
|
24.4%
10/41 • Adverse events were reported from first dose of study treatment until end of study treatment plus 8 weeks post treatment up to maximum duration of 316 weeks
|
|
Blood and lymphatic system disorders
Leukopenia
|
0.00%
0/41 • Adverse events were reported from first dose of study treatment until end of study treatment plus 8 weeks post treatment up to maximum duration of 316 weeks
|
7.1%
3/42 • Adverse events were reported from first dose of study treatment until end of study treatment plus 8 weeks post treatment up to maximum duration of 316 weeks
|
7.3%
3/41 • Adverse events were reported from first dose of study treatment until end of study treatment plus 8 weeks post treatment up to maximum duration of 316 weeks
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/41 • Adverse events were reported from first dose of study treatment until end of study treatment plus 8 weeks post treatment up to maximum duration of 316 weeks
|
21.4%
9/42 • Adverse events were reported from first dose of study treatment until end of study treatment plus 8 weeks post treatment up to maximum duration of 316 weeks
|
17.1%
7/41 • Adverse events were reported from first dose of study treatment until end of study treatment plus 8 weeks post treatment up to maximum duration of 316 weeks
|
|
Cardiac disorders
Palpitations
|
9.8%
4/41 • Adverse events were reported from first dose of study treatment until end of study treatment plus 8 weeks post treatment up to maximum duration of 316 weeks
|
2.4%
1/42 • Adverse events were reported from first dose of study treatment until end of study treatment plus 8 weeks post treatment up to maximum duration of 316 weeks
|
2.4%
1/41 • Adverse events were reported from first dose of study treatment until end of study treatment plus 8 weeks post treatment up to maximum duration of 316 weeks
|
|
Ear and labyrinth disorders
Vertigo
|
7.3%
3/41 • Adverse events were reported from first dose of study treatment until end of study treatment plus 8 weeks post treatment up to maximum duration of 316 weeks
|
0.00%
0/42 • Adverse events were reported from first dose of study treatment until end of study treatment plus 8 weeks post treatment up to maximum duration of 316 weeks
|
0.00%
0/41 • Adverse events were reported from first dose of study treatment until end of study treatment plus 8 weeks post treatment up to maximum duration of 316 weeks
|
|
Gastrointestinal disorders
Abdominal pain
|
36.6%
15/41 • Adverse events were reported from first dose of study treatment until end of study treatment plus 8 weeks post treatment up to maximum duration of 316 weeks
|
14.3%
6/42 • Adverse events were reported from first dose of study treatment until end of study treatment plus 8 weeks post treatment up to maximum duration of 316 weeks
|
14.6%
6/41 • Adverse events were reported from first dose of study treatment until end of study treatment plus 8 weeks post treatment up to maximum duration of 316 weeks
|
|
Gastrointestinal disorders
Abdominal pain upper
|
12.2%
5/41 • Adverse events were reported from first dose of study treatment until end of study treatment plus 8 weeks post treatment up to maximum duration of 316 weeks
|
11.9%
5/42 • Adverse events were reported from first dose of study treatment until end of study treatment plus 8 weeks post treatment up to maximum duration of 316 weeks
|
7.3%
3/41 • Adverse events were reported from first dose of study treatment until end of study treatment plus 8 weeks post treatment up to maximum duration of 316 weeks
|
|
Gastrointestinal disorders
Aphthous ulcer
|
0.00%
0/41 • Adverse events were reported from first dose of study treatment until end of study treatment plus 8 weeks post treatment up to maximum duration of 316 weeks
|
7.1%
3/42 • Adverse events were reported from first dose of study treatment until end of study treatment plus 8 weeks post treatment up to maximum duration of 316 weeks
|
0.00%
0/41 • Adverse events were reported from first dose of study treatment until end of study treatment plus 8 weeks post treatment up to maximum duration of 316 weeks
|
|
Gastrointestinal disorders
Constipation
|
22.0%
9/41 • Adverse events were reported from first dose of study treatment until end of study treatment plus 8 weeks post treatment up to maximum duration of 316 weeks
|
14.3%
6/42 • Adverse events were reported from first dose of study treatment until end of study treatment plus 8 weeks post treatment up to maximum duration of 316 weeks
|
0.00%
0/41 • Adverse events were reported from first dose of study treatment until end of study treatment plus 8 weeks post treatment up to maximum duration of 316 weeks
|
|
Gastrointestinal disorders
Diarrhoea
|
41.5%
17/41 • Adverse events were reported from first dose of study treatment until end of study treatment plus 8 weeks post treatment up to maximum duration of 316 weeks
|
50.0%
21/42 • Adverse events were reported from first dose of study treatment until end of study treatment plus 8 weeks post treatment up to maximum duration of 316 weeks
|
80.5%
33/41 • Adverse events were reported from first dose of study treatment until end of study treatment plus 8 weeks post treatment up to maximum duration of 316 weeks
|
|
Gastrointestinal disorders
Dyspepsia
|
2.4%
1/41 • Adverse events were reported from first dose of study treatment until end of study treatment plus 8 weeks post treatment up to maximum duration of 316 weeks
|
0.00%
0/42 • Adverse events were reported from first dose of study treatment until end of study treatment plus 8 weeks post treatment up to maximum duration of 316 weeks
|
7.3%
3/41 • Adverse events were reported from first dose of study treatment until end of study treatment plus 8 weeks post treatment up to maximum duration of 316 weeks
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/41 • Adverse events were reported from first dose of study treatment until end of study treatment plus 8 weeks post treatment up to maximum duration of 316 weeks
|
9.5%
4/42 • Adverse events were reported from first dose of study treatment until end of study treatment plus 8 weeks post treatment up to maximum duration of 316 weeks
|
0.00%
0/41 • Adverse events were reported from first dose of study treatment until end of study treatment plus 8 weeks post treatment up to maximum duration of 316 weeks
|
|
Gastrointestinal disorders
Flatulence
|
4.9%
2/41 • Adverse events were reported from first dose of study treatment until end of study treatment plus 8 weeks post treatment up to maximum duration of 316 weeks
|
0.00%
0/42 • Adverse events were reported from first dose of study treatment until end of study treatment plus 8 weeks post treatment up to maximum duration of 316 weeks
|
9.8%
4/41 • Adverse events were reported from first dose of study treatment until end of study treatment plus 8 weeks post treatment up to maximum duration of 316 weeks
|
|
Gastrointestinal disorders
Haemorrhoids
|
7.3%
3/41 • Adverse events were reported from first dose of study treatment until end of study treatment plus 8 weeks post treatment up to maximum duration of 316 weeks
|
2.4%
1/42 • Adverse events were reported from first dose of study treatment until end of study treatment plus 8 weeks post treatment up to maximum duration of 316 weeks
|
9.8%
4/41 • Adverse events were reported from first dose of study treatment until end of study treatment plus 8 weeks post treatment up to maximum duration of 316 weeks
|
|
Gastrointestinal disorders
Mouth ulceration
|
0.00%
0/41 • Adverse events were reported from first dose of study treatment until end of study treatment plus 8 weeks post treatment up to maximum duration of 316 weeks
|
7.1%
3/42 • Adverse events were reported from first dose of study treatment until end of study treatment plus 8 weeks post treatment up to maximum duration of 316 weeks
|
14.6%
6/41 • Adverse events were reported from first dose of study treatment until end of study treatment plus 8 weeks post treatment up to maximum duration of 316 weeks
|
|
Gastrointestinal disorders
Nausea
|
26.8%
11/41 • Adverse events were reported from first dose of study treatment until end of study treatment plus 8 weeks post treatment up to maximum duration of 316 weeks
|
23.8%
10/42 • Adverse events were reported from first dose of study treatment until end of study treatment plus 8 weeks post treatment up to maximum duration of 316 weeks
|
19.5%
8/41 • Adverse events were reported from first dose of study treatment until end of study treatment plus 8 weeks post treatment up to maximum duration of 316 weeks
|
|
Gastrointestinal disorders
Steatorrhoea
|
9.8%
4/41 • Adverse events were reported from first dose of study treatment until end of study treatment plus 8 weeks post treatment up to maximum duration of 316 weeks
|
0.00%
0/42 • Adverse events were reported from first dose of study treatment until end of study treatment plus 8 weeks post treatment up to maximum duration of 316 weeks
|
4.9%
2/41 • Adverse events were reported from first dose of study treatment until end of study treatment plus 8 weeks post treatment up to maximum duration of 316 weeks
|
|
Gastrointestinal disorders
Stomatitis
|
4.9%
2/41 • Adverse events were reported from first dose of study treatment until end of study treatment plus 8 weeks post treatment up to maximum duration of 316 weeks
|
61.9%
26/42 • Adverse events were reported from first dose of study treatment until end of study treatment plus 8 weeks post treatment up to maximum duration of 316 weeks
|
34.1%
14/41 • Adverse events were reported from first dose of study treatment until end of study treatment plus 8 weeks post treatment up to maximum duration of 316 weeks
|
|
Gastrointestinal disorders
Toothache
|
4.9%
2/41 • Adverse events were reported from first dose of study treatment until end of study treatment plus 8 weeks post treatment up to maximum duration of 316 weeks
|
2.4%
1/42 • Adverse events were reported from first dose of study treatment until end of study treatment plus 8 weeks post treatment up to maximum duration of 316 weeks
|
9.8%
4/41 • Adverse events were reported from first dose of study treatment until end of study treatment plus 8 weeks post treatment up to maximum duration of 316 weeks
|
|
Gastrointestinal disorders
Vomiting
|
12.2%
5/41 • Adverse events were reported from first dose of study treatment until end of study treatment plus 8 weeks post treatment up to maximum duration of 316 weeks
|
11.9%
5/42 • Adverse events were reported from first dose of study treatment until end of study treatment plus 8 weeks post treatment up to maximum duration of 316 weeks
|
9.8%
4/41 • Adverse events were reported from first dose of study treatment until end of study treatment plus 8 weeks post treatment up to maximum duration of 316 weeks
|
|
General disorders
Asthenia
|
26.8%
11/41 • Adverse events were reported from first dose of study treatment until end of study treatment plus 8 weeks post treatment up to maximum duration of 316 weeks
|
28.6%
12/42 • Adverse events were reported from first dose of study treatment until end of study treatment plus 8 weeks post treatment up to maximum duration of 316 weeks
|
39.0%
16/41 • Adverse events were reported from first dose of study treatment until end of study treatment plus 8 weeks post treatment up to maximum duration of 316 weeks
|
|
General disorders
Chills
|
9.8%
4/41 • Adverse events were reported from first dose of study treatment until end of study treatment plus 8 weeks post treatment up to maximum duration of 316 weeks
|
0.00%
0/42 • Adverse events were reported from first dose of study treatment until end of study treatment plus 8 weeks post treatment up to maximum duration of 316 weeks
|
0.00%
0/41 • Adverse events were reported from first dose of study treatment until end of study treatment plus 8 weeks post treatment up to maximum duration of 316 weeks
|
|
General disorders
Fatigue
|
14.6%
6/41 • Adverse events were reported from first dose of study treatment until end of study treatment plus 8 weeks post treatment up to maximum duration of 316 weeks
|
21.4%
9/42 • Adverse events were reported from first dose of study treatment until end of study treatment plus 8 weeks post treatment up to maximum duration of 316 weeks
|
39.0%
16/41 • Adverse events were reported from first dose of study treatment until end of study treatment plus 8 weeks post treatment up to maximum duration of 316 weeks
|
|
General disorders
Non-cardiac chest pain
|
7.3%
3/41 • Adverse events were reported from first dose of study treatment until end of study treatment plus 8 weeks post treatment up to maximum duration of 316 weeks
|
9.5%
4/42 • Adverse events were reported from first dose of study treatment until end of study treatment plus 8 weeks post treatment up to maximum duration of 316 weeks
|
7.3%
3/41 • Adverse events were reported from first dose of study treatment until end of study treatment plus 8 weeks post treatment up to maximum duration of 316 weeks
|
|
General disorders
Oedema peripheral
|
19.5%
8/41 • Adverse events were reported from first dose of study treatment until end of study treatment plus 8 weeks post treatment up to maximum duration of 316 weeks
|
31.0%
13/42 • Adverse events were reported from first dose of study treatment until end of study treatment plus 8 weeks post treatment up to maximum duration of 316 weeks
|
29.3%
12/41 • Adverse events were reported from first dose of study treatment until end of study treatment plus 8 weeks post treatment up to maximum duration of 316 weeks
|
|
General disorders
Pyrexia
|
17.1%
7/41 • Adverse events were reported from first dose of study treatment until end of study treatment plus 8 weeks post treatment up to maximum duration of 316 weeks
|
16.7%
7/42 • Adverse events were reported from first dose of study treatment until end of study treatment plus 8 weeks post treatment up to maximum duration of 316 weeks
|
14.6%
6/41 • Adverse events were reported from first dose of study treatment until end of study treatment plus 8 weeks post treatment up to maximum duration of 316 weeks
|
|
Infections and infestations
Bronchitis
|
4.9%
2/41 • Adverse events were reported from first dose of study treatment until end of study treatment plus 8 weeks post treatment up to maximum duration of 316 weeks
|
7.1%
3/42 • Adverse events were reported from first dose of study treatment until end of study treatment plus 8 weeks post treatment up to maximum duration of 316 weeks
|
2.4%
1/41 • Adverse events were reported from first dose of study treatment until end of study treatment plus 8 weeks post treatment up to maximum duration of 316 weeks
|
|
Infections and infestations
Cystitis
|
2.4%
1/41 • Adverse events were reported from first dose of study treatment until end of study treatment plus 8 weeks post treatment up to maximum duration of 316 weeks
|
9.5%
4/42 • Adverse events were reported from first dose of study treatment until end of study treatment plus 8 weeks post treatment up to maximum duration of 316 weeks
|
0.00%
0/41 • Adverse events were reported from first dose of study treatment until end of study treatment plus 8 weeks post treatment up to maximum duration of 316 weeks
|
|
Infections and infestations
Folliculitis
|
0.00%
0/41 • Adverse events were reported from first dose of study treatment until end of study treatment plus 8 weeks post treatment up to maximum duration of 316 weeks
|
2.4%
1/42 • Adverse events were reported from first dose of study treatment until end of study treatment plus 8 weeks post treatment up to maximum duration of 316 weeks
|
9.8%
4/41 • Adverse events were reported from first dose of study treatment until end of study treatment plus 8 weeks post treatment up to maximum duration of 316 weeks
|
|
Infections and infestations
Influenza
|
12.2%
5/41 • Adverse events were reported from first dose of study treatment until end of study treatment plus 8 weeks post treatment up to maximum duration of 316 weeks
|
4.8%
2/42 • Adverse events were reported from first dose of study treatment until end of study treatment plus 8 weeks post treatment up to maximum duration of 316 weeks
|
4.9%
2/41 • Adverse events were reported from first dose of study treatment until end of study treatment plus 8 weeks post treatment up to maximum duration of 316 weeks
|
|
Infections and infestations
Lower respiratory tract infection
|
0.00%
0/41 • Adverse events were reported from first dose of study treatment until end of study treatment plus 8 weeks post treatment up to maximum duration of 316 weeks
|
2.4%
1/42 • Adverse events were reported from first dose of study treatment until end of study treatment plus 8 weeks post treatment up to maximum duration of 316 weeks
|
9.8%
4/41 • Adverse events were reported from first dose of study treatment until end of study treatment plus 8 weeks post treatment up to maximum duration of 316 weeks
|
|
Infections and infestations
Rhinitis
|
7.3%
3/41 • Adverse events were reported from first dose of study treatment until end of study treatment plus 8 weeks post treatment up to maximum duration of 316 weeks
|
2.4%
1/42 • Adverse events were reported from first dose of study treatment until end of study treatment plus 8 weeks post treatment up to maximum duration of 316 weeks
|
0.00%
0/41 • Adverse events were reported from first dose of study treatment until end of study treatment plus 8 weeks post treatment up to maximum duration of 316 weeks
|
|
Infections and infestations
Urinary tract infection
|
9.8%
4/41 • Adverse events were reported from first dose of study treatment until end of study treatment plus 8 weeks post treatment up to maximum duration of 316 weeks
|
4.8%
2/42 • Adverse events were reported from first dose of study treatment until end of study treatment plus 8 weeks post treatment up to maximum duration of 316 weeks
|
17.1%
7/41 • Adverse events were reported from first dose of study treatment until end of study treatment plus 8 weeks post treatment up to maximum duration of 316 weeks
|
|
Investigations
Alanine aminotransferase increased
|
7.3%
3/41 • Adverse events were reported from first dose of study treatment until end of study treatment plus 8 weeks post treatment up to maximum duration of 316 weeks
|
7.1%
3/42 • Adverse events were reported from first dose of study treatment until end of study treatment plus 8 weeks post treatment up to maximum duration of 316 weeks
|
7.3%
3/41 • Adverse events were reported from first dose of study treatment until end of study treatment plus 8 weeks post treatment up to maximum duration of 316 weeks
|
|
Investigations
Aspartate aminotransferase increased
|
9.8%
4/41 • Adverse events were reported from first dose of study treatment until end of study treatment plus 8 weeks post treatment up to maximum duration of 316 weeks
|
7.1%
3/42 • Adverse events were reported from first dose of study treatment until end of study treatment plus 8 weeks post treatment up to maximum duration of 316 weeks
|
2.4%
1/41 • Adverse events were reported from first dose of study treatment until end of study treatment plus 8 weeks post treatment up to maximum duration of 316 weeks
|
|
Investigations
Blood alkaline phosphatase increased
|
17.1%
7/41 • Adverse events were reported from first dose of study treatment until end of study treatment plus 8 weeks post treatment up to maximum duration of 316 weeks
|
4.8%
2/42 • Adverse events were reported from first dose of study treatment until end of study treatment plus 8 weeks post treatment up to maximum duration of 316 weeks
|
4.9%
2/41 • Adverse events were reported from first dose of study treatment until end of study treatment plus 8 weeks post treatment up to maximum duration of 316 weeks
|
|
Investigations
Blood creatinine increased
|
4.9%
2/41 • Adverse events were reported from first dose of study treatment until end of study treatment plus 8 weeks post treatment up to maximum duration of 316 weeks
|
2.4%
1/42 • Adverse events were reported from first dose of study treatment until end of study treatment plus 8 weeks post treatment up to maximum duration of 316 weeks
|
7.3%
3/41 • Adverse events were reported from first dose of study treatment until end of study treatment plus 8 weeks post treatment up to maximum duration of 316 weeks
|
|
Investigations
Gamma-glutamyltransferase increased
|
24.4%
10/41 • Adverse events were reported from first dose of study treatment until end of study treatment plus 8 weeks post treatment up to maximum duration of 316 weeks
|
9.5%
4/42 • Adverse events were reported from first dose of study treatment until end of study treatment plus 8 weeks post treatment up to maximum duration of 316 weeks
|
9.8%
4/41 • Adverse events were reported from first dose of study treatment until end of study treatment plus 8 weeks post treatment up to maximum duration of 316 weeks
|
|
Investigations
Glycosylated haemoglobin increased
|
7.3%
3/41 • Adverse events were reported from first dose of study treatment until end of study treatment plus 8 weeks post treatment up to maximum duration of 316 weeks
|
2.4%
1/42 • Adverse events were reported from first dose of study treatment until end of study treatment plus 8 weeks post treatment up to maximum duration of 316 weeks
|
7.3%
3/41 • Adverse events were reported from first dose of study treatment until end of study treatment plus 8 weeks post treatment up to maximum duration of 316 weeks
|
|
Investigations
Platelet count decreased
|
0.00%
0/41 • Adverse events were reported from first dose of study treatment until end of study treatment plus 8 weeks post treatment up to maximum duration of 316 weeks
|
2.4%
1/42 • Adverse events were reported from first dose of study treatment until end of study treatment plus 8 weeks post treatment up to maximum duration of 316 weeks
|
7.3%
3/41 • Adverse events were reported from first dose of study treatment until end of study treatment plus 8 weeks post treatment up to maximum duration of 316 weeks
|
|
Investigations
Weight decreased
|
43.9%
18/41 • Adverse events were reported from first dose of study treatment until end of study treatment plus 8 weeks post treatment up to maximum duration of 316 weeks
|
42.9%
18/42 • Adverse events were reported from first dose of study treatment until end of study treatment plus 8 weeks post treatment up to maximum duration of 316 weeks
|
58.5%
24/41 • Adverse events were reported from first dose of study treatment until end of study treatment plus 8 weeks post treatment up to maximum duration of 316 weeks
|
|
Metabolism and nutrition disorders
Decreased appetite
|
24.4%
10/41 • Adverse events were reported from first dose of study treatment until end of study treatment plus 8 weeks post treatment up to maximum duration of 316 weeks
|
38.1%
16/42 • Adverse events were reported from first dose of study treatment until end of study treatment plus 8 weeks post treatment up to maximum duration of 316 weeks
|
31.7%
13/41 • Adverse events were reported from first dose of study treatment until end of study treatment plus 8 weeks post treatment up to maximum duration of 316 weeks
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
22.0%
9/41 • Adverse events were reported from first dose of study treatment until end of study treatment plus 8 weeks post treatment up to maximum duration of 316 weeks
|
9.5%
4/42 • Adverse events were reported from first dose of study treatment until end of study treatment plus 8 weeks post treatment up to maximum duration of 316 weeks
|
19.5%
8/41 • Adverse events were reported from first dose of study treatment until end of study treatment plus 8 weeks post treatment up to maximum duration of 316 weeks
|
|
Metabolism and nutrition disorders
Hypercholesterolaemia
|
2.4%
1/41 • Adverse events were reported from first dose of study treatment until end of study treatment plus 8 weeks post treatment up to maximum duration of 316 weeks
|
16.7%
7/42 • Adverse events were reported from first dose of study treatment until end of study treatment plus 8 weeks post treatment up to maximum duration of 316 weeks
|
12.2%
5/41 • Adverse events were reported from first dose of study treatment until end of study treatment plus 8 weeks post treatment up to maximum duration of 316 weeks
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
43.9%
18/41 • Adverse events were reported from first dose of study treatment until end of study treatment plus 8 weeks post treatment up to maximum duration of 316 weeks
|
33.3%
14/42 • Adverse events were reported from first dose of study treatment until end of study treatment plus 8 weeks post treatment up to maximum duration of 316 weeks
|
87.8%
36/41 • Adverse events were reported from first dose of study treatment until end of study treatment plus 8 weeks post treatment up to maximum duration of 316 weeks
|
|
Metabolism and nutrition disorders
Hypertriglyceridaemia
|
7.3%
3/41 • Adverse events were reported from first dose of study treatment until end of study treatment plus 8 weeks post treatment up to maximum duration of 316 weeks
|
21.4%
9/42 • Adverse events were reported from first dose of study treatment until end of study treatment plus 8 weeks post treatment up to maximum duration of 316 weeks
|
12.2%
5/41 • Adverse events were reported from first dose of study treatment until end of study treatment plus 8 weeks post treatment up to maximum duration of 316 weeks
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
4.9%
2/41 • Adverse events were reported from first dose of study treatment until end of study treatment plus 8 weeks post treatment up to maximum duration of 316 weeks
|
4.8%
2/42 • Adverse events were reported from first dose of study treatment until end of study treatment plus 8 weeks post treatment up to maximum duration of 316 weeks
|
7.3%
3/41 • Adverse events were reported from first dose of study treatment until end of study treatment plus 8 weeks post treatment up to maximum duration of 316 weeks
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
4.9%
2/41 • Adverse events were reported from first dose of study treatment until end of study treatment plus 8 weeks post treatment up to maximum duration of 316 weeks
|
7.1%
3/42 • Adverse events were reported from first dose of study treatment until end of study treatment plus 8 weeks post treatment up to maximum duration of 316 weeks
|
12.2%
5/41 • Adverse events were reported from first dose of study treatment until end of study treatment plus 8 weeks post treatment up to maximum duration of 316 weeks
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
9.8%
4/41 • Adverse events were reported from first dose of study treatment until end of study treatment plus 8 weeks post treatment up to maximum duration of 316 weeks
|
4.8%
2/42 • Adverse events were reported from first dose of study treatment until end of study treatment plus 8 weeks post treatment up to maximum duration of 316 weeks
|
7.3%
3/41 • Adverse events were reported from first dose of study treatment until end of study treatment plus 8 weeks post treatment up to maximum duration of 316 weeks
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
4.9%
2/41 • Adverse events were reported from first dose of study treatment until end of study treatment plus 8 weeks post treatment up to maximum duration of 316 weeks
|
0.00%
0/42 • Adverse events were reported from first dose of study treatment until end of study treatment plus 8 weeks post treatment up to maximum duration of 316 weeks
|
7.3%
3/41 • Adverse events were reported from first dose of study treatment until end of study treatment plus 8 weeks post treatment up to maximum duration of 316 weeks
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
2.4%
1/41 • Adverse events were reported from first dose of study treatment until end of study treatment plus 8 weeks post treatment up to maximum duration of 316 weeks
|
7.1%
3/42 • Adverse events were reported from first dose of study treatment until end of study treatment plus 8 weeks post treatment up to maximum duration of 316 weeks
|
12.2%
5/41 • Adverse events were reported from first dose of study treatment until end of study treatment plus 8 weeks post treatment up to maximum duration of 316 weeks
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
7.3%
3/41 • Adverse events were reported from first dose of study treatment until end of study treatment plus 8 weeks post treatment up to maximum duration of 316 weeks
|
2.4%
1/42 • Adverse events were reported from first dose of study treatment until end of study treatment plus 8 weeks post treatment up to maximum duration of 316 weeks
|
7.3%
3/41 • Adverse events were reported from first dose of study treatment until end of study treatment plus 8 weeks post treatment up to maximum duration of 316 weeks
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
24.4%
10/41 • Adverse events were reported from first dose of study treatment until end of study treatment plus 8 weeks post treatment up to maximum duration of 316 weeks
|
14.3%
6/42 • Adverse events were reported from first dose of study treatment until end of study treatment plus 8 weeks post treatment up to maximum duration of 316 weeks
|
17.1%
7/41 • Adverse events were reported from first dose of study treatment until end of study treatment plus 8 weeks post treatment up to maximum duration of 316 weeks
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
4.9%
2/41 • Adverse events were reported from first dose of study treatment until end of study treatment plus 8 weeks post treatment up to maximum duration of 316 weeks
|
4.8%
2/42 • Adverse events were reported from first dose of study treatment until end of study treatment plus 8 weeks post treatment up to maximum duration of 316 weeks
|
7.3%
3/41 • Adverse events were reported from first dose of study treatment until end of study treatment plus 8 weeks post treatment up to maximum duration of 316 weeks
|
|
Musculoskeletal and connective tissue disorders
Joint swelling
|
4.9%
2/41 • Adverse events were reported from first dose of study treatment until end of study treatment plus 8 weeks post treatment up to maximum duration of 316 weeks
|
2.4%
1/42 • Adverse events were reported from first dose of study treatment until end of study treatment plus 8 weeks post treatment up to maximum duration of 316 weeks
|
7.3%
3/41 • Adverse events were reported from first dose of study treatment until end of study treatment plus 8 weeks post treatment up to maximum duration of 316 weeks
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
12.2%
5/41 • Adverse events were reported from first dose of study treatment until end of study treatment plus 8 weeks post treatment up to maximum duration of 316 weeks
|
4.8%
2/42 • Adverse events were reported from first dose of study treatment until end of study treatment plus 8 weeks post treatment up to maximum duration of 316 weeks
|
2.4%
1/41 • Adverse events were reported from first dose of study treatment until end of study treatment plus 8 weeks post treatment up to maximum duration of 316 weeks
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
9.8%
4/41 • Adverse events were reported from first dose of study treatment until end of study treatment plus 8 weeks post treatment up to maximum duration of 316 weeks
|
4.8%
2/42 • Adverse events were reported from first dose of study treatment until end of study treatment plus 8 weeks post treatment up to maximum duration of 316 weeks
|
4.9%
2/41 • Adverse events were reported from first dose of study treatment until end of study treatment plus 8 weeks post treatment up to maximum duration of 316 weeks
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
9.8%
4/41 • Adverse events were reported from first dose of study treatment until end of study treatment plus 8 weeks post treatment up to maximum duration of 316 weeks
|
2.4%
1/42 • Adverse events were reported from first dose of study treatment until end of study treatment plus 8 weeks post treatment up to maximum duration of 316 weeks
|
4.9%
2/41 • Adverse events were reported from first dose of study treatment until end of study treatment plus 8 weeks post treatment up to maximum duration of 316 weeks
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
7.3%
3/41 • Adverse events were reported from first dose of study treatment until end of study treatment plus 8 weeks post treatment up to maximum duration of 316 weeks
|
2.4%
1/42 • Adverse events were reported from first dose of study treatment until end of study treatment plus 8 weeks post treatment up to maximum duration of 316 weeks
|
0.00%
0/41 • Adverse events were reported from first dose of study treatment until end of study treatment plus 8 weeks post treatment up to maximum duration of 316 weeks
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
7.3%
3/41 • Adverse events were reported from first dose of study treatment until end of study treatment plus 8 weeks post treatment up to maximum duration of 316 weeks
|
2.4%
1/42 • Adverse events were reported from first dose of study treatment until end of study treatment plus 8 weeks post treatment up to maximum duration of 316 weeks
|
9.8%
4/41 • Adverse events were reported from first dose of study treatment until end of study treatment plus 8 weeks post treatment up to maximum duration of 316 weeks
|
|
Nervous system disorders
Dizziness
|
14.6%
6/41 • Adverse events were reported from first dose of study treatment until end of study treatment plus 8 weeks post treatment up to maximum duration of 316 weeks
|
4.8%
2/42 • Adverse events were reported from first dose of study treatment until end of study treatment plus 8 weeks post treatment up to maximum duration of 316 weeks
|
4.9%
2/41 • Adverse events were reported from first dose of study treatment until end of study treatment plus 8 weeks post treatment up to maximum duration of 316 weeks
|
|
Nervous system disorders
Dysgeusia
|
9.8%
4/41 • Adverse events were reported from first dose of study treatment until end of study treatment plus 8 weeks post treatment up to maximum duration of 316 weeks
|
11.9%
5/42 • Adverse events were reported from first dose of study treatment until end of study treatment plus 8 weeks post treatment up to maximum duration of 316 weeks
|
9.8%
4/41 • Adverse events were reported from first dose of study treatment until end of study treatment plus 8 weeks post treatment up to maximum duration of 316 weeks
|
|
Nervous system disorders
Headache
|
17.1%
7/41 • Adverse events were reported from first dose of study treatment until end of study treatment plus 8 weeks post treatment up to maximum duration of 316 weeks
|
9.5%
4/42 • Adverse events were reported from first dose of study treatment until end of study treatment plus 8 weeks post treatment up to maximum duration of 316 weeks
|
14.6%
6/41 • Adverse events were reported from first dose of study treatment until end of study treatment plus 8 weeks post treatment up to maximum duration of 316 weeks
|
|
Nervous system disorders
Presyncope
|
7.3%
3/41 • Adverse events were reported from first dose of study treatment until end of study treatment plus 8 weeks post treatment up to maximum duration of 316 weeks
|
0.00%
0/42 • Adverse events were reported from first dose of study treatment until end of study treatment plus 8 weeks post treatment up to maximum duration of 316 weeks
|
0.00%
0/41 • Adverse events were reported from first dose of study treatment until end of study treatment plus 8 weeks post treatment up to maximum duration of 316 weeks
|
|
Nervous system disorders
Taste disorder
|
0.00%
0/41 • Adverse events were reported from first dose of study treatment until end of study treatment plus 8 weeks post treatment up to maximum duration of 316 weeks
|
0.00%
0/42 • Adverse events were reported from first dose of study treatment until end of study treatment plus 8 weeks post treatment up to maximum duration of 316 weeks
|
7.3%
3/41 • Adverse events were reported from first dose of study treatment until end of study treatment plus 8 weeks post treatment up to maximum duration of 316 weeks
|
|
Psychiatric disorders
Insomnia
|
4.9%
2/41 • Adverse events were reported from first dose of study treatment until end of study treatment plus 8 weeks post treatment up to maximum duration of 316 weeks
|
9.5%
4/42 • Adverse events were reported from first dose of study treatment until end of study treatment plus 8 weeks post treatment up to maximum duration of 316 weeks
|
7.3%
3/41 • Adverse events were reported from first dose of study treatment until end of study treatment plus 8 weeks post treatment up to maximum duration of 316 weeks
|
|
Renal and urinary disorders
Dysuria
|
7.3%
3/41 • Adverse events were reported from first dose of study treatment until end of study treatment plus 8 weeks post treatment up to maximum duration of 316 weeks
|
4.8%
2/42 • Adverse events were reported from first dose of study treatment until end of study treatment plus 8 weeks post treatment up to maximum duration of 316 weeks
|
2.4%
1/41 • Adverse events were reported from first dose of study treatment until end of study treatment plus 8 weeks post treatment up to maximum duration of 316 weeks
|
|
Renal and urinary disorders
Polyuria
|
2.4%
1/41 • Adverse events were reported from first dose of study treatment until end of study treatment plus 8 weeks post treatment up to maximum duration of 316 weeks
|
0.00%
0/42 • Adverse events were reported from first dose of study treatment until end of study treatment plus 8 weeks post treatment up to maximum duration of 316 weeks
|
7.3%
3/41 • Adverse events were reported from first dose of study treatment until end of study treatment plus 8 weeks post treatment up to maximum duration of 316 weeks
|
|
Renal and urinary disorders
Renal failure
|
4.9%
2/41 • Adverse events were reported from first dose of study treatment until end of study treatment plus 8 weeks post treatment up to maximum duration of 316 weeks
|
9.5%
4/42 • Adverse events were reported from first dose of study treatment until end of study treatment plus 8 weeks post treatment up to maximum duration of 316 weeks
|
0.00%
0/41 • Adverse events were reported from first dose of study treatment until end of study treatment plus 8 weeks post treatment up to maximum duration of 316 weeks
|
|
Renal and urinary disorders
Urinary incontinence
|
0.00%
0/41 • Adverse events were reported from first dose of study treatment until end of study treatment plus 8 weeks post treatment up to maximum duration of 316 weeks
|
0.00%
0/42 • Adverse events were reported from first dose of study treatment until end of study treatment plus 8 weeks post treatment up to maximum duration of 316 weeks
|
7.3%
3/41 • Adverse events were reported from first dose of study treatment until end of study treatment plus 8 weeks post treatment up to maximum duration of 316 weeks
|
|
Reproductive system and breast disorders
Erectile dysfunction
|
0.00%
0/41 • Adverse events were reported from first dose of study treatment until end of study treatment plus 8 weeks post treatment up to maximum duration of 316 weeks
|
0.00%
0/42 • Adverse events were reported from first dose of study treatment until end of study treatment plus 8 weeks post treatment up to maximum duration of 316 weeks
|
7.3%
3/41 • Adverse events were reported from first dose of study treatment until end of study treatment plus 8 weeks post treatment up to maximum duration of 316 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
22.0%
9/41 • Adverse events were reported from first dose of study treatment until end of study treatment plus 8 weeks post treatment up to maximum duration of 316 weeks
|
28.6%
12/42 • Adverse events were reported from first dose of study treatment until end of study treatment plus 8 weeks post treatment up to maximum duration of 316 weeks
|
34.1%
14/41 • Adverse events were reported from first dose of study treatment until end of study treatment plus 8 weeks post treatment up to maximum duration of 316 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
19.5%
8/41 • Adverse events were reported from first dose of study treatment until end of study treatment plus 8 weeks post treatment up to maximum duration of 316 weeks
|
26.2%
11/42 • Adverse events were reported from first dose of study treatment until end of study treatment plus 8 weeks post treatment up to maximum duration of 316 weeks
|
14.6%
6/41 • Adverse events were reported from first dose of study treatment until end of study treatment plus 8 weeks post treatment up to maximum duration of 316 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/41 • Adverse events were reported from first dose of study treatment until end of study treatment plus 8 weeks post treatment up to maximum duration of 316 weeks
|
11.9%
5/42 • Adverse events were reported from first dose of study treatment until end of study treatment plus 8 weeks post treatment up to maximum duration of 316 weeks
|
7.3%
3/41 • Adverse events were reported from first dose of study treatment until end of study treatment plus 8 weeks post treatment up to maximum duration of 316 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.00%
0/41 • Adverse events were reported from first dose of study treatment until end of study treatment plus 8 weeks post treatment up to maximum duration of 316 weeks
|
2.4%
1/42 • Adverse events were reported from first dose of study treatment until end of study treatment plus 8 weeks post treatment up to maximum duration of 316 weeks
|
7.3%
3/41 • Adverse events were reported from first dose of study treatment until end of study treatment plus 8 weeks post treatment up to maximum duration of 316 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.00%
0/41 • Adverse events were reported from first dose of study treatment until end of study treatment plus 8 weeks post treatment up to maximum duration of 316 weeks
|
4.8%
2/42 • Adverse events were reported from first dose of study treatment until end of study treatment plus 8 weeks post treatment up to maximum duration of 316 weeks
|
9.8%
4/41 • Adverse events were reported from first dose of study treatment until end of study treatment plus 8 weeks post treatment up to maximum duration of 316 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
0.00%
0/41 • Adverse events were reported from first dose of study treatment until end of study treatment plus 8 weeks post treatment up to maximum duration of 316 weeks
|
4.8%
2/42 • Adverse events were reported from first dose of study treatment until end of study treatment plus 8 weeks post treatment up to maximum duration of 316 weeks
|
17.1%
7/41 • Adverse events were reported from first dose of study treatment until end of study treatment plus 8 weeks post treatment up to maximum duration of 316 weeks
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.00%
0/41 • Adverse events were reported from first dose of study treatment until end of study treatment plus 8 weeks post treatment up to maximum duration of 316 weeks
|
7.1%
3/42 • Adverse events were reported from first dose of study treatment until end of study treatment plus 8 weeks post treatment up to maximum duration of 316 weeks
|
9.8%
4/41 • Adverse events were reported from first dose of study treatment until end of study treatment plus 8 weeks post treatment up to maximum duration of 316 weeks
|
|
Skin and subcutaneous tissue disorders
Onychoclasis
|
0.00%
0/41 • Adverse events were reported from first dose of study treatment until end of study treatment plus 8 weeks post treatment up to maximum duration of 316 weeks
|
7.1%
3/42 • Adverse events were reported from first dose of study treatment until end of study treatment plus 8 weeks post treatment up to maximum duration of 316 weeks
|
7.3%
3/41 • Adverse events were reported from first dose of study treatment until end of study treatment plus 8 weeks post treatment up to maximum duration of 316 weeks
|
|
Skin and subcutaneous tissue disorders
Palmar-plantar erythrodysaesthesia syndrome
|
0.00%
0/41 • Adverse events were reported from first dose of study treatment until end of study treatment plus 8 weeks post treatment up to maximum duration of 316 weeks
|
7.1%
3/42 • Adverse events were reported from first dose of study treatment until end of study treatment plus 8 weeks post treatment up to maximum duration of 316 weeks
|
4.9%
2/41 • Adverse events were reported from first dose of study treatment until end of study treatment plus 8 weeks post treatment up to maximum duration of 316 weeks
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
4.9%
2/41 • Adverse events were reported from first dose of study treatment until end of study treatment plus 8 weeks post treatment up to maximum duration of 316 weeks
|
4.8%
2/42 • Adverse events were reported from first dose of study treatment until end of study treatment plus 8 weeks post treatment up to maximum duration of 316 weeks
|
17.1%
7/41 • Adverse events were reported from first dose of study treatment until end of study treatment plus 8 weeks post treatment up to maximum duration of 316 weeks
|
|
Skin and subcutaneous tissue disorders
Rash
|
7.3%
3/41 • Adverse events were reported from first dose of study treatment until end of study treatment plus 8 weeks post treatment up to maximum duration of 316 weeks
|
28.6%
12/42 • Adverse events were reported from first dose of study treatment until end of study treatment plus 8 weeks post treatment up to maximum duration of 316 weeks
|
14.6%
6/41 • Adverse events were reported from first dose of study treatment until end of study treatment plus 8 weeks post treatment up to maximum duration of 316 weeks
|
|
Vascular disorders
Flushing
|
2.4%
1/41 • Adverse events were reported from first dose of study treatment until end of study treatment plus 8 weeks post treatment up to maximum duration of 316 weeks
|
4.8%
2/42 • Adverse events were reported from first dose of study treatment until end of study treatment plus 8 weeks post treatment up to maximum duration of 316 weeks
|
9.8%
4/41 • Adverse events were reported from first dose of study treatment until end of study treatment plus 8 weeks post treatment up to maximum duration of 316 weeks
|
|
Vascular disorders
Hypertension
|
4.9%
2/41 • Adverse events were reported from first dose of study treatment until end of study treatment plus 8 weeks post treatment up to maximum duration of 316 weeks
|
4.8%
2/42 • Adverse events were reported from first dose of study treatment until end of study treatment plus 8 weeks post treatment up to maximum duration of 316 weeks
|
7.3%
3/41 • Adverse events were reported from first dose of study treatment until end of study treatment plus 8 weeks post treatment up to maximum duration of 316 weeks
|
|
Vascular disorders
Hypotension
|
7.3%
3/41 • Adverse events were reported from first dose of study treatment until end of study treatment plus 8 weeks post treatment up to maximum duration of 316 weeks
|
4.8%
2/42 • Adverse events were reported from first dose of study treatment until end of study treatment plus 8 weeks post treatment up to maximum duration of 316 weeks
|
2.4%
1/41 • Adverse events were reported from first dose of study treatment until end of study treatment plus 8 weeks post treatment up to maximum duration of 316 weeks
|
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 (i.e., data from all sites) in the clinical trial.
- Publication restrictions are in place
Restriction type: OTHER