Trial Outcomes & Findings for Efficacy and Safety of Lanreotide Autogel/ Depot 120 mg vs. Placebo in Subjects With Lung Neuroendocrine Tumours (NCT NCT02683941)
NCT ID: NCT02683941
Last Updated: 2022-07-06
Results Overview
PFS for subjects randomised in the lanreotide group, assessed by central review using Response Evaluation Criteria In Solid Tumours Version 1.1 (RECIST v1.1) criteria every 12 weeks, defined as the time from randomisation to disease progression or death from any causes during either the double-blind phase, or the open-label treatment phase. The distribution of PFS times were estimated using the Kaplan-Meier product limit method.
Recruitment status
TERMINATED
Study phase
PHASE3
Target enrollment
77 participants
Primary outcome timeframe
Up to a maximum of 33 months
Results posted on
2022-07-06
Participant Flow
This study was conducted at 37 investigation sites in 10 countries in North America and Europe between 06 March 2017 and 28 February 2020 in adult subjects with well differentiated, metastatic and/or unresectable, typical or atypical bronchopulmonary (BP) neuroendocrine tumours (NETs) who did not require somatostatin analogue (SSA) treatment for symptom control.
This study consisted of two phases: the double-blind phase, and the open-label phase. 77 subjects were randomised to receive study treatment until disease progression, unacceptable toxicity, withdrawal for any reason, or up to 18 months after the last subject was randomised. Subjects were randomised 2:1 to either lanreotide autogel/depot 120 milligrams (mg) plus best supportive care (BSC) every 28 days (Q4 weeks) or placebo plus BSC Q4 weeks.
Participant milestones
| Measure |
Lanreotide
Subjects received deep subcutaneous (SC) injections of lanreotide autogel/depot 120 mg Q4 weeks plus BSC. Following protocol amendment #5 (28 Jan 2019), all ongoing subjects in the double-blind phase, who had not yet progressed (assessed locally and confirmed centrally) were offered to enter the open-label treatment phase and continue to receive deep SC injections of lanreotide autogel/depot 120 mg Q4 weeks plus BSC. If a subject progressed during the double-blind phase or open-label treatment phase they entered the open-label follow-up phase. The follow-up phase ended at the same time as the open-label treatment phase (18 months after the last subject randomised).
|
Placebo
Subjects received deep SC injections of placebo (saline solution 0.9%) Q4 weeks plus BSC in the double-blind phase. Following protocol amendment #5 (28 Jan 2019), all ongoing subjects in the double-blind phase, who had not yet progressed (assessed locally and confirmed centrally) were offered to enter the open-label treatment phase and receive deep SC injections of lanreotide autogel/depot 120 mg Q4 weeks plus BSC. If a subject progressed during the open-label treatment phase they entered the open-label follow-up phase. The follow-up phase ended at the same time as the open-label treatment phase (18 months after the last subject randomised).
|
|---|---|---|
|
Double-blind Phase
STARTED
|
51
|
26
|
|
Double-blind Phase
COMPLETED
|
41
|
21
|
|
Double-blind Phase
NOT COMPLETED
|
10
|
5
|
|
Open-label Treatment Phase
STARTED
|
21
|
19
|
|
Open-label Treatment Phase
COMPLETED
|
1
|
6
|
|
Open-label Treatment Phase
NOT COMPLETED
|
20
|
13
|
|
Open-label Follow-up Phase
STARTED
|
18
|
8
|
|
Open-label Follow-up Phase
COMPLETED
|
0
|
0
|
|
Open-label Follow-up Phase
NOT COMPLETED
|
18
|
8
|
Reasons for withdrawal
| Measure |
Lanreotide
Subjects received deep subcutaneous (SC) injections of lanreotide autogel/depot 120 mg Q4 weeks plus BSC. Following protocol amendment #5 (28 Jan 2019), all ongoing subjects in the double-blind phase, who had not yet progressed (assessed locally and confirmed centrally) were offered to enter the open-label treatment phase and continue to receive deep SC injections of lanreotide autogel/depot 120 mg Q4 weeks plus BSC. If a subject progressed during the double-blind phase or open-label treatment phase they entered the open-label follow-up phase. The follow-up phase ended at the same time as the open-label treatment phase (18 months after the last subject randomised).
|
Placebo
Subjects received deep SC injections of placebo (saline solution 0.9%) Q4 weeks plus BSC in the double-blind phase. Following protocol amendment #5 (28 Jan 2019), all ongoing subjects in the double-blind phase, who had not yet progressed (assessed locally and confirmed centrally) were offered to enter the open-label treatment phase and receive deep SC injections of lanreotide autogel/depot 120 mg Q4 weeks plus BSC. If a subject progressed during the open-label treatment phase they entered the open-label follow-up phase. The follow-up phase ended at the same time as the open-label treatment phase (18 months after the last subject randomised).
|
|---|---|---|
|
Double-blind Phase
Adverse Event
|
0
|
1
|
|
Double-blind Phase
Withdrawal by Subject
|
4
|
2
|
|
Double-blind Phase
Lost to Follow-up
|
1
|
0
|
|
Double-blind Phase
Disease Progression
|
5
|
2
|
|
Open-label Treatment Phase
Withdrawal by Subject
|
0
|
2
|
|
Open-label Treatment Phase
Disease Progression
|
1
|
2
|
|
Open-label Treatment Phase
Study Termination by the Sponsor
|
18
|
9
|
|
Open-label Treatment Phase
Other
|
1
|
0
|
|
Open-label Follow-up Phase
Withdrawal by Subject
|
3
|
3
|
|
Open-label Follow-up Phase
Lost to Follow-up
|
1
|
0
|
|
Open-label Follow-up Phase
Study Termination by the Sponsor
|
6
|
4
|
|
Open-label Follow-up Phase
Other
|
8
|
1
|
Baseline Characteristics
Efficacy and Safety of Lanreotide Autogel/ Depot 120 mg vs. Placebo in Subjects With Lung Neuroendocrine Tumours
Baseline characteristics by cohort
| Measure |
Lanreotide
n=51 Participants
Subjects received deep SC injections of lanreotide autogel/depot 120 mg Q4 weeks plus BSC. Following protocol amendment #5 (28 Jan 2019), all ongoing subjects in the double-blind phase, who had not yet progressed (assessed locally and confirmed centrally) were offered to enter the open-label treatment phase and receive deep SC injections of lanreotide autogel/depot 120 mg Q4 weeks plus BSC. If a subject progressed during the double-blind phase or open-label treatment phase they entered the open-label follow-up phase. The follow-up phase ended at the same time as the open-label treatment phase (18 months after the last subject randomised).
|
Placebo
n=26 Participants
Subjects received deep SC injections of placebo (saline solution 0.9%) Q4 weeks plus BSC in the double-blind phase. Following protocol amendment #5 (28 Jan 2019), all ongoing subjects in the double-blind phase, who had not yet progressed (assessed locally and confirmed centrally) were offered to enter the open-label treatment phase and receive deep SC injections of lanreotide autogel/depot 120 mg Q4 weeks plus BSC. If a subject progressed during the open-label treatment phase they entered the open-label follow-up phase. The follow-up phase ended at the same time as the open-label treatment phase (18 months after the last subject randomised).
|
Total
n=77 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
66.4 years
STANDARD_DEVIATION 11.94 • n=93 Participants
|
65.8 years
STANDARD_DEVIATION 13.89 • n=4 Participants
|
66.2 years
STANDARD_DEVIATION 12.54 • n=27 Participants
|
|
Sex: Female, Male
Female
|
23 Participants
n=93 Participants
|
12 Participants
n=4 Participants
|
35 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
28 Participants
n=93 Participants
|
14 Participants
n=4 Participants
|
42 Participants
n=27 Participants
|
|
Race/Ethnicity, Customized
Ethnicity · Hispanic or Latino
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race/Ethnicity, Customized
Ethnicity · Not Hispanic or Latino
|
9 Participants
n=93 Participants
|
4 Participants
n=4 Participants
|
13 Participants
n=27 Participants
|
|
Race/Ethnicity, Customized
Ethnicity · Missing
|
42 Participants
n=93 Participants
|
22 Participants
n=4 Participants
|
64 Participants
n=27 Participants
|
|
Race/Ethnicity, Customized
Race · American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race/Ethnicity, Customized
Race · Asian
|
3 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
3 Participants
n=27 Participants
|
|
Race/Ethnicity, Customized
Race · Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race/Ethnicity, Customized
Race · Black or African American
|
1 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
|
Race/Ethnicity, Customized
Race · White
|
35 Participants
n=93 Participants
|
19 Participants
n=4 Participants
|
54 Participants
n=27 Participants
|
|
Race/Ethnicity, Customized
Race · More than one race
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race/Ethnicity, Customized
Race · Missing
|
12 Participants
n=93 Participants
|
7 Participants
n=4 Participants
|
19 Participants
n=27 Participants
|
PRIMARY outcome
Timeframe: Up to a maximum of 33 monthsPopulation: The ITT population included all randomised subjects. Subjects were analysed as randomised, regardless of the treatment received. One subject randomised to lanreotide should have been censored in the PFS analysis treatment for discontinuation for toxicity or other reasons, however the baseline central radiological assessment was performed prior to the randomisation date, therefore the subject was excluded from the analysis.
PFS for subjects randomised in the lanreotide group, assessed by central review using Response Evaluation Criteria In Solid Tumours Version 1.1 (RECIST v1.1) criteria every 12 weeks, defined as the time from randomisation to disease progression or death from any causes during either the double-blind phase, or the open-label treatment phase. The distribution of PFS times were estimated using the Kaplan-Meier product limit method.
Outcome measures
| Measure |
Overall Study: Lanreotide
n=50 Participants
Subjects received deep SC injections of lanreotide autogel/depot 120 mg Q4 weeks plus BSC. Following protocol amendment #5 (28 Jan 2019), all ongoing subjects in the double-blind phase, who had not yet progressed (assessed locally and confirmed centrally) were offered to enter the open-label treatment phase and continue to receive deep SC injections of lanreotide autogel/depot 120 mg Q4 weeks plus BSC. If a subject progressed during the double-blind phase or open-label treatment phase they entered the open-label follow-up phase. The follow-up phase ended at the same time as the open-label treatment phase (18 months after the last subject randomised).
|
Double-Blind Phase: Placebo
Subjects received deep SC injections of placebo (saline solution 0.9%) Q4 weeks plus BSC in the double-blind phase. Following protocol amendment #5 (28 Jan 2019), all ongoing subjects in the double-blind phase, who had not yet progressed (assessed locally and confirmed centrally) were offered to enter the open-label treatment phase and receive deep SC injections of lanreotide autogel/depot 120 mg Q4 weeks plus BSC.
|
Open-Label Treatment Phase: All Subjects
Subjects received deep SC injections of lanreotide autogel/depot 120 mg Q4 weeks plus BSC. Following protocol amendment #5 (28 Jan 2019), all ongoing subjects in the double-blind phase, who had not yet progressed (assessed locally and confirmed centrally) were offered to enter the open-label treatment phase and receive deep SC injections of lanreotide autogel/depot 120 mg Q4 weeks plus BSC. If a subject progressed during the open-label treatment phase they entered the open-label follow-up phase.
|
|---|---|---|---|
|
Median Progression-Free Survival (PFS) Time in Subjects Randomised to Lanreotide in the Double-Blind Phase or Open-Label Treatment Phase, Assessed by Central Review
|
16.6 months
Interval 11.3 to 21.9
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to a maximum of 15 monthsPopulation: The ITT population included all randomised subjects. Subjects were analysed as randomised, regardless of the treatment received. One subject in the double-blind phase: lanreotide arm should have been censored in the PFS analysis for treatment discontinuation for toxicity or other reasons, however the baseline central radiological assessment was performed prior to the randomisation date, therefore the subject was excluded from the analysis.
PFS was assessed by central review using RECIST v1.1 criteria every 12 weeks, defined as the time from randomisation to disease progression or death from any causes during the double-blind phase. The distribution of PFS times were estimated using the Kaplan-Meier product limit method.
Outcome measures
| Measure |
Overall Study: Lanreotide
n=50 Participants
Subjects received deep SC injections of lanreotide autogel/depot 120 mg Q4 weeks plus BSC. Following protocol amendment #5 (28 Jan 2019), all ongoing subjects in the double-blind phase, who had not yet progressed (assessed locally and confirmed centrally) were offered to enter the open-label treatment phase and continue to receive deep SC injections of lanreotide autogel/depot 120 mg Q4 weeks plus BSC. If a subject progressed during the double-blind phase or open-label treatment phase they entered the open-label follow-up phase. The follow-up phase ended at the same time as the open-label treatment phase (18 months after the last subject randomised).
|
Double-Blind Phase: Placebo
n=26 Participants
Subjects received deep SC injections of placebo (saline solution 0.9%) Q4 weeks plus BSC in the double-blind phase. Following protocol amendment #5 (28 Jan 2019), all ongoing subjects in the double-blind phase, who had not yet progressed (assessed locally and confirmed centrally) were offered to enter the open-label treatment phase and receive deep SC injections of lanreotide autogel/depot 120 mg Q4 weeks plus BSC.
|
Open-Label Treatment Phase: All Subjects
Subjects received deep SC injections of lanreotide autogel/depot 120 mg Q4 weeks plus BSC. Following protocol amendment #5 (28 Jan 2019), all ongoing subjects in the double-blind phase, who had not yet progressed (assessed locally and confirmed centrally) were offered to enter the open-label treatment phase and receive deep SC injections of lanreotide autogel/depot 120 mg Q4 weeks plus BSC. If a subject progressed during the open-label treatment phase they entered the open-label follow-up phase.
|
|---|---|---|---|
|
Median PFS Time in the Double-Blind Phase, Assessed by Central Review
|
16.6 months
Interval 11.3 to 21.9
|
13.6 months
Interval 8.3 to
Upper confidence interval not calculable due to insufficient progression events.
|
—
|
SECONDARY outcome
Timeframe: Up to a maximum of 15 monthsPopulation: The ITT population included all randomised subjects. Subjects were analysed as randomised, regardless of the treatment received. Two subjects should have been censored in the PFS analysis, however the baseline central radiological assessment was performed prior to the randomisation date, therefore the subjects were excluded from the analysis.
PFS was assessed by local review using RECIST v1.1 criteria every 12 weeks, defined as the time from randomisation to disease progression or death from any causes during the double-blind phase. The distribution of PFS times were estimated using the Kaplan-Meier product limit method.
Outcome measures
| Measure |
Overall Study: Lanreotide
n=50 Participants
Subjects received deep SC injections of lanreotide autogel/depot 120 mg Q4 weeks plus BSC. Following protocol amendment #5 (28 Jan 2019), all ongoing subjects in the double-blind phase, who had not yet progressed (assessed locally and confirmed centrally) were offered to enter the open-label treatment phase and continue to receive deep SC injections of lanreotide autogel/depot 120 mg Q4 weeks plus BSC. If a subject progressed during the double-blind phase or open-label treatment phase they entered the open-label follow-up phase. The follow-up phase ended at the same time as the open-label treatment phase (18 months after the last subject randomised).
|
Double-Blind Phase: Placebo
n=25 Participants
Subjects received deep SC injections of placebo (saline solution 0.9%) Q4 weeks plus BSC in the double-blind phase. Following protocol amendment #5 (28 Jan 2019), all ongoing subjects in the double-blind phase, who had not yet progressed (assessed locally and confirmed centrally) were offered to enter the open-label treatment phase and receive deep SC injections of lanreotide autogel/depot 120 mg Q4 weeks plus BSC.
|
Open-Label Treatment Phase: All Subjects
Subjects received deep SC injections of lanreotide autogel/depot 120 mg Q4 weeks plus BSC. Following protocol amendment #5 (28 Jan 2019), all ongoing subjects in the double-blind phase, who had not yet progressed (assessed locally and confirmed centrally) were offered to enter the open-label treatment phase and receive deep SC injections of lanreotide autogel/depot 120 mg Q4 weeks plus BSC. If a subject progressed during the open-label treatment phase they entered the open-label follow-up phase.
|
|---|---|---|---|
|
Median PFS Time in the Double-Blind Phase, Assessed by Local Review
|
14.1 months
Interval 11.1 to
Upper confidence interval not calculable due to insufficient progression events.
|
13.6 months
Interval 8.3 to
Upper confidence interval not calculable due to insufficient progression events.
|
—
|
SECONDARY outcome
Timeframe: Up to a maximum of 15 monthsPopulation: The ITT population included all randomised subjects. Subjects were analysed as randomised, regardless of the treatment received. Two subjects were excluded from the analysis as they had no best response recorded in the raw data.
ORR was assessed by central review and local review using RECIST v1.1 criteria every 12 weeks, defined as the percentage of subjects who achieved a best overall response of complete response or partial response in the double-blind phase.
Outcome measures
| Measure |
Overall Study: Lanreotide
n=50 Participants
Subjects received deep SC injections of lanreotide autogel/depot 120 mg Q4 weeks plus BSC. Following protocol amendment #5 (28 Jan 2019), all ongoing subjects in the double-blind phase, who had not yet progressed (assessed locally and confirmed centrally) were offered to enter the open-label treatment phase and continue to receive deep SC injections of lanreotide autogel/depot 120 mg Q4 weeks plus BSC. If a subject progressed during the double-blind phase or open-label treatment phase they entered the open-label follow-up phase. The follow-up phase ended at the same time as the open-label treatment phase (18 months after the last subject randomised).
|
Double-Blind Phase: Placebo
n=25 Participants
Subjects received deep SC injections of placebo (saline solution 0.9%) Q4 weeks plus BSC in the double-blind phase. Following protocol amendment #5 (28 Jan 2019), all ongoing subjects in the double-blind phase, who had not yet progressed (assessed locally and confirmed centrally) were offered to enter the open-label treatment phase and receive deep SC injections of lanreotide autogel/depot 120 mg Q4 weeks plus BSC.
|
Open-Label Treatment Phase: All Subjects
Subjects received deep SC injections of lanreotide autogel/depot 120 mg Q4 weeks plus BSC. Following protocol amendment #5 (28 Jan 2019), all ongoing subjects in the double-blind phase, who had not yet progressed (assessed locally and confirmed centrally) were offered to enter the open-label treatment phase and receive deep SC injections of lanreotide autogel/depot 120 mg Q4 weeks plus BSC. If a subject progressed during the open-label treatment phase they entered the open-label follow-up phase.
|
|---|---|---|---|
|
Objective Response Rate (ORR) in the Double-Blind Phase
Central review
|
14.00 Percentage of subjects
Interval 5.82 to 26.74
|
0.00 Percentage of subjects
Interval 0.0 to 13.72
|
—
|
|
Objective Response Rate (ORR) in the Double-Blind Phase
Local review
|
6.00 Percentage of subjects
Interval 1.25 to 16.55
|
4.00 Percentage of subjects
Interval 0.1 to 20.35
|
—
|
SECONDARY outcome
Timeframe: Up to a maximum of 15 monthsPopulation: The ITT population included all randomised subjects. Subjects were analysed as randomised, regardless of the treatment received.
TTF was defined as the time from randomisation to disease progression using RECIST v1.1, death, consent withdrawn, an adverse event, protocol deviations, lost to follow-up, the appearance of carcinoid syndrome or other hormone related syndrome necessitating the initiation of SSAs (rescue octreotide and/or long-acting release SSA), or initiation of anticancer treatment in the double-blind phase. The distribution of TTF times were estimated using the Kaplan-Meier product limit method.
Outcome measures
| Measure |
Overall Study: Lanreotide
n=51 Participants
Subjects received deep SC injections of lanreotide autogel/depot 120 mg Q4 weeks plus BSC. Following protocol amendment #5 (28 Jan 2019), all ongoing subjects in the double-blind phase, who had not yet progressed (assessed locally and confirmed centrally) were offered to enter the open-label treatment phase and continue to receive deep SC injections of lanreotide autogel/depot 120 mg Q4 weeks plus BSC. If a subject progressed during the double-blind phase or open-label treatment phase they entered the open-label follow-up phase. The follow-up phase ended at the same time as the open-label treatment phase (18 months after the last subject randomised).
|
Double-Blind Phase: Placebo
n=26 Participants
Subjects received deep SC injections of placebo (saline solution 0.9%) Q4 weeks plus BSC in the double-blind phase. Following protocol amendment #5 (28 Jan 2019), all ongoing subjects in the double-blind phase, who had not yet progressed (assessed locally and confirmed centrally) were offered to enter the open-label treatment phase and receive deep SC injections of lanreotide autogel/depot 120 mg Q4 weeks plus BSC.
|
Open-Label Treatment Phase: All Subjects
Subjects received deep SC injections of lanreotide autogel/depot 120 mg Q4 weeks plus BSC. Following protocol amendment #5 (28 Jan 2019), all ongoing subjects in the double-blind phase, who had not yet progressed (assessed locally and confirmed centrally) were offered to enter the open-label treatment phase and receive deep SC injections of lanreotide autogel/depot 120 mg Q4 weeks plus BSC. If a subject progressed during the open-label treatment phase they entered the open-label follow-up phase.
|
|---|---|---|---|
|
Time to Treatment Failure (TTF) in the Double-Blind Phase
|
13.3 months
Interval 5.6 to 14.1
|
9.8 months
Interval 5.4 to 13.6
|
—
|
SECONDARY outcome
Timeframe: Baseline, Weeks 8, 12, 24, and 48, and post-treatment in the double-blind phase (a maximum of 15 months); Baseline, Weeks 12, 24, and 48, and post-treatment in the the open-label treatment phase (a maximum of 33 months)Population: Double-blind phase: The ITT population included all randomised subjects with non-missing measurements. Subjects were analysed as randomised, regardless of the treatment received. Open-label phase: The open-label ITT population included all ITT subjects with non-missing measurements entering the open-label phase who received at least one injection of lanreotide autogel/depot in the open-label phase.
Blood samples were collected to determine plasma CgA. Baseline was defined as the last non-missing measurement collected prior to the first dose of study treatment (lanreotide). The x of upper limit of normal (ULN) was calculated as raw value/ULN.
Outcome measures
| Measure |
Overall Study: Lanreotide
n=38 Participants
Subjects received deep SC injections of lanreotide autogel/depot 120 mg Q4 weeks plus BSC. Following protocol amendment #5 (28 Jan 2019), all ongoing subjects in the double-blind phase, who had not yet progressed (assessed locally and confirmed centrally) were offered to enter the open-label treatment phase and continue to receive deep SC injections of lanreotide autogel/depot 120 mg Q4 weeks plus BSC. If a subject progressed during the double-blind phase or open-label treatment phase they entered the open-label follow-up phase. The follow-up phase ended at the same time as the open-label treatment phase (18 months after the last subject randomised).
|
Double-Blind Phase: Placebo
n=22 Participants
Subjects received deep SC injections of placebo (saline solution 0.9%) Q4 weeks plus BSC in the double-blind phase. Following protocol amendment #5 (28 Jan 2019), all ongoing subjects in the double-blind phase, who had not yet progressed (assessed locally and confirmed centrally) were offered to enter the open-label treatment phase and receive deep SC injections of lanreotide autogel/depot 120 mg Q4 weeks plus BSC.
|
Open-Label Treatment Phase: All Subjects
n=33 Participants
Subjects received deep SC injections of lanreotide autogel/depot 120 mg Q4 weeks plus BSC. Following protocol amendment #5 (28 Jan 2019), all ongoing subjects in the double-blind phase, who had not yet progressed (assessed locally and confirmed centrally) were offered to enter the open-label treatment phase and receive deep SC injections of lanreotide autogel/depot 120 mg Q4 weeks plus BSC. If a subject progressed during the open-label treatment phase they entered the open-label follow-up phase.
|
|---|---|---|---|
|
Mean Change From Baseline in the Biomarker Chromogranin A (CgA) in the Double-Blind Phase and Open-Label Treatment Phase
Week 8
|
-213.63 x of ULN
Standard Deviation 1293.111
|
0.09 x of ULN
Standard Deviation 2.578
|
—
|
|
Mean Change From Baseline in the Biomarker Chromogranin A (CgA) in the Double-Blind Phase and Open-Label Treatment Phase
Week 12
|
-214.49 x of ULN
Standard Deviation 1344.401
|
5.73 x of ULN
Standard Deviation 15.519
|
-28.27 x of ULN
Standard Deviation 149.110
|
|
Mean Change From Baseline in the Biomarker Chromogranin A (CgA) in the Double-Blind Phase and Open-Label Treatment Phase
Week 24
|
-3.42 x of ULN
Standard Deviation 14.122
|
60.41 x of ULN
Standard Deviation 193.327
|
-1.42 x of ULN
Standard Deviation 8.338
|
|
Mean Change From Baseline in the Biomarker Chromogranin A (CgA) in the Double-Blind Phase and Open-Label Treatment Phase
Week 48
|
-4.07 x of ULN
Standard Deviation 8.066
|
1.24 x of ULN
Standard Deviation 2.969
|
-1.66 x of ULN
Standard Deviation 0.925
|
|
Mean Change From Baseline in the Biomarker Chromogranin A (CgA) in the Double-Blind Phase and Open-Label Treatment Phase
Post-treatment
|
12.22 x of ULN
Standard Deviation 64.053
|
160.11 x of ULN
Standard Deviation 596.759
|
-31.59 x of ULN
Standard Deviation 167.515
|
SECONDARY outcome
Timeframe: Baseline and Week 8 in the double-blind phase; Baseline and Week 8 in the open-label treatment phasePopulation: Double-blind phase: The ITT population included all randomised subjects with non-missing measurements and elevated CgA at Baseline. Subjects were analysed as randomised, regardless of the treatment received. Open-label phase: The open-label ITT population included all ITT subjects with non-missing measurements and elevated CgA at Baseline entering the open-label phase who received at least one injection of lanreotide autogel/depot in the open-label phase.
Measured in subjects with an elevated CgA at baseline (≥2 x ULN). Blood samples were collected to determine plasma CgA. Baseline was defined as the last non-missing measurement collected prior to the first dose of study treatment (lanreotide).
Outcome measures
| Measure |
Overall Study: Lanreotide
n=30 Participants
Subjects received deep SC injections of lanreotide autogel/depot 120 mg Q4 weeks plus BSC. Following protocol amendment #5 (28 Jan 2019), all ongoing subjects in the double-blind phase, who had not yet progressed (assessed locally and confirmed centrally) were offered to enter the open-label treatment phase and continue to receive deep SC injections of lanreotide autogel/depot 120 mg Q4 weeks plus BSC. If a subject progressed during the double-blind phase or open-label treatment phase they entered the open-label follow-up phase. The follow-up phase ended at the same time as the open-label treatment phase (18 months after the last subject randomised).
|
Double-Blind Phase: Placebo
n=13 Participants
Subjects received deep SC injections of placebo (saline solution 0.9%) Q4 weeks plus BSC in the double-blind phase. Following protocol amendment #5 (28 Jan 2019), all ongoing subjects in the double-blind phase, who had not yet progressed (assessed locally and confirmed centrally) were offered to enter the open-label treatment phase and receive deep SC injections of lanreotide autogel/depot 120 mg Q4 weeks plus BSC.
|
Open-Label Treatment Phase: All Subjects
n=19 Participants
Subjects received deep SC injections of lanreotide autogel/depot 120 mg Q4 weeks plus BSC. Following protocol amendment #5 (28 Jan 2019), all ongoing subjects in the double-blind phase, who had not yet progressed (assessed locally and confirmed centrally) were offered to enter the open-label treatment phase and receive deep SC injections of lanreotide autogel/depot 120 mg Q4 weeks plus BSC. If a subject progressed during the open-label treatment phase they entered the open-label follow-up phase.
|
|---|---|---|---|
|
Percentage of Subjects With a Decrease of CgA ≥30% From Baseline at Week 8 in the Double-Blind Phase and Open-Label Treatment Phase
|
63.3 percentage of subjects
Interval 43.9 to 80.1
|
7.7 percentage of subjects
Interval 0.2 to 36.0
|
73.7 percentage of subjects
Interval 48.8 to 90.9
|
SECONDARY outcome
Timeframe: Baseline and post-treatment in the double-blind phase (a maximum of 15 months); Baseline and post-treatment in the open-label treatment phase (a maximum of 33 months)Population: Double-blind phase: The ITT population included all randomised subjects with non-missing measurements. Subjects were analysed as randomised, regardless of the treatment received. Open-label phase: The open-label ITT population included all ITT subjects with non-missing measurements entering the open-label phase who received at least one injection of lanreotide autogel/depot in the open-label phase.
The EORTC QLQ-C30 (V3.0) consisted of 30 questions. The final 2 questions were related to global health status/QoL, with responses requested on a 7-point scale from 1 ('Very poor') to 7 ('Excellent'). The global health status/QoL scale ranges in score from 0 to 100. A high score for the global health status/QoL scale represents a high QoL, thus, an increase in score represents an increase in QoL. 95% Clopper-Pearson confidence intervals were estimated using the exact method for binomial distributions. Baseline was defined as the last non-missing measurement collected prior to the first dose of study treatment (lanreotide).
Outcome measures
| Measure |
Overall Study: Lanreotide
n=25 Participants
Subjects received deep SC injections of lanreotide autogel/depot 120 mg Q4 weeks plus BSC. Following protocol amendment #5 (28 Jan 2019), all ongoing subjects in the double-blind phase, who had not yet progressed (assessed locally and confirmed centrally) were offered to enter the open-label treatment phase and continue to receive deep SC injections of lanreotide autogel/depot 120 mg Q4 weeks plus BSC. If a subject progressed during the double-blind phase or open-label treatment phase they entered the open-label follow-up phase. The follow-up phase ended at the same time as the open-label treatment phase (18 months after the last subject randomised).
|
Double-Blind Phase: Placebo
n=3 Participants
Subjects received deep SC injections of placebo (saline solution 0.9%) Q4 weeks plus BSC in the double-blind phase. Following protocol amendment #5 (28 Jan 2019), all ongoing subjects in the double-blind phase, who had not yet progressed (assessed locally and confirmed centrally) were offered to enter the open-label treatment phase and receive deep SC injections of lanreotide autogel/depot 120 mg Q4 weeks plus BSC.
|
Open-Label Treatment Phase: All Subjects
n=34 Participants
Subjects received deep SC injections of lanreotide autogel/depot 120 mg Q4 weeks plus BSC. Following protocol amendment #5 (28 Jan 2019), all ongoing subjects in the double-blind phase, who had not yet progressed (assessed locally and confirmed centrally) were offered to enter the open-label treatment phase and receive deep SC injections of lanreotide autogel/depot 120 mg Q4 weeks plus BSC. If a subject progressed during the open-label treatment phase they entered the open-label follow-up phase.
|
|---|---|---|---|
|
Mean Changes From Baseline in Quality of Life (QoL), as Assessed by the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core-30 (EORTC QLQ-C30) Global Health Status/QoL Score
|
-2.7 score on a scale
Standard Deviation 18.27
|
-19.4 score on a scale
Standard Deviation 17.33
|
0.0 score on a scale
Standard Deviation 19.67
|
SECONDARY outcome
Timeframe: Baseline and post-treatment in the double-blind phase (a maximum of 15 months); Baseline and post-treatment in the open-label treatment phase (a maximum of 33 months)Population: Double-blind phase: The ITT population included all randomised subjects with non-missing measurements. Subjects were analysed as randomised, regardless of the treatment received. Open-label phase: The open-label ITT population included all ITT subjects with non-missing measurements entering the open-label phase who received at least one injection of lanreotide autogel/depot in the open-label phase.
QoL deterioration was defined by a decrease from baseline in EORTC QLQ-C30 Global Health Status/QoL Score of at least 10 points. The EORTC QLQ-C30 (V3.0) consisted of 30 questions. The final 2 questions were related to global health status/QoL, with responses requested on a 7-point scale from 1 ('Very poor') to 7 ('Excellent'). The global health status/QoL scale ranges in score from 0 to 100. A high score for the global health status/QoL scale represents a high QoL, thus, an increase in score represents an increase in QoL. 95% Clopper-Pearson confidence intervals were estimated using the exact method for binomial distributions. Baseline was defined as the last non-missing measurement collected prior to the first dose of study treatment (lanreotide).
Outcome measures
| Measure |
Overall Study: Lanreotide
n=25 Participants
Subjects received deep SC injections of lanreotide autogel/depot 120 mg Q4 weeks plus BSC. Following protocol amendment #5 (28 Jan 2019), all ongoing subjects in the double-blind phase, who had not yet progressed (assessed locally and confirmed centrally) were offered to enter the open-label treatment phase and continue to receive deep SC injections of lanreotide autogel/depot 120 mg Q4 weeks plus BSC. If a subject progressed during the double-blind phase or open-label treatment phase they entered the open-label follow-up phase. The follow-up phase ended at the same time as the open-label treatment phase (18 months after the last subject randomised).
|
Double-Blind Phase: Placebo
n=3 Participants
Subjects received deep SC injections of placebo (saline solution 0.9%) Q4 weeks plus BSC in the double-blind phase. Following protocol amendment #5 (28 Jan 2019), all ongoing subjects in the double-blind phase, who had not yet progressed (assessed locally and confirmed centrally) were offered to enter the open-label treatment phase and receive deep SC injections of lanreotide autogel/depot 120 mg Q4 weeks plus BSC.
|
Open-Label Treatment Phase: All Subjects
n=34 Participants
Subjects received deep SC injections of lanreotide autogel/depot 120 mg Q4 weeks plus BSC. Following protocol amendment #5 (28 Jan 2019), all ongoing subjects in the double-blind phase, who had not yet progressed (assessed locally and confirmed centrally) were offered to enter the open-label treatment phase and receive deep SC injections of lanreotide autogel/depot 120 mg Q4 weeks plus BSC. If a subject progressed during the open-label treatment phase they entered the open-label follow-up phase.
|
|---|---|---|---|
|
Percentage of Subjects Who Experienced QoL Deterioration
|
32.0 percentage of subjects
Interval 14.9 to 53.5
|
66.7 percentage of subjects
Interval 9.4 to 99.2
|
23.5 percentage of subjects
Interval 10.7 to 41.2
|
SECONDARY outcome
Timeframe: Baseline, Weeks 8, 12, 24, and 48, and post-treatment in the double-blind phase (a maximum of 15 months); Baseline, Weeks 12, 24, and 48, and post-treatment in the the open-label treatment phase (a maximum of 33 months)Population: Double-blind phase: The ITT population included all randomised subjects with non-missing measurements and elevated 5-HIAA at baseline. Subjects were analysed as randomised, regardless of the treatment received. Open-label phase: The open-label ITT population included all ITT subjects with non-missing measurements and elevated 5-HIAA at baseline entering the open-label phase who received at least one injection of lanreotide autogel/depot in the open-label phase.
Measured in subjects with an elevated 5-HIAA at baseline (≥2 x ULN). The assessment of urinary 5-HIAA required subjects to collect their urine for the 24 hour period prior to the study visit. Baseline was defined as the last non-missing measurement collected prior to the first dose of study treatment (lanreotide). The x of ULN was calculated as raw value/ULN.
Outcome measures
| Measure |
Overall Study: Lanreotide
n=7 Participants
Subjects received deep SC injections of lanreotide autogel/depot 120 mg Q4 weeks plus BSC. Following protocol amendment #5 (28 Jan 2019), all ongoing subjects in the double-blind phase, who had not yet progressed (assessed locally and confirmed centrally) were offered to enter the open-label treatment phase and continue to receive deep SC injections of lanreotide autogel/depot 120 mg Q4 weeks plus BSC. If a subject progressed during the double-blind phase or open-label treatment phase they entered the open-label follow-up phase. The follow-up phase ended at the same time as the open-label treatment phase (18 months after the last subject randomised).
|
Double-Blind Phase: Placebo
n=4 Participants
Subjects received deep SC injections of placebo (saline solution 0.9%) Q4 weeks plus BSC in the double-blind phase. Following protocol amendment #5 (28 Jan 2019), all ongoing subjects in the double-blind phase, who had not yet progressed (assessed locally and confirmed centrally) were offered to enter the open-label treatment phase and receive deep SC injections of lanreotide autogel/depot 120 mg Q4 weeks plus BSC.
|
Open-Label Treatment Phase: All Subjects
n=3 Participants
Subjects received deep SC injections of lanreotide autogel/depot 120 mg Q4 weeks plus BSC. Following protocol amendment #5 (28 Jan 2019), all ongoing subjects in the double-blind phase, who had not yet progressed (assessed locally and confirmed centrally) were offered to enter the open-label treatment phase and receive deep SC injections of lanreotide autogel/depot 120 mg Q4 weeks plus BSC. If a subject progressed during the open-label treatment phase they entered the open-label follow-up phase.
|
|---|---|---|---|
|
Mean Changes From Baseline in Urinary 5-hydroxyindoleacetic Acid (5-HIAA) Levels in the Double-Blind Phase and Open-Label Treatment Phase
Week 24
|
0.15 x of ULN
Standard Deviation 3.041
|
-1.40 x of ULN
Standard Deviation 2.734
|
-4.84 x of ULN
Standard Deviation 10.019
|
|
Mean Changes From Baseline in Urinary 5-hydroxyindoleacetic Acid (5-HIAA) Levels in the Double-Blind Phase and Open-Label Treatment Phase
Week 48
|
-3.00 x of ULN
Standard Deviation 8.900
|
1.13 x of ULN
Standard Deviation NA
Standard deviation was not calculable as only 1 subject was analysed.
|
-2.47 x of ULN
Standard Deviation NA
Standard deviation was not calculable as only 1 subject was analysed.
|
|
Mean Changes From Baseline in Urinary 5-hydroxyindoleacetic Acid (5-HIAA) Levels in the Double-Blind Phase and Open-Label Treatment Phase
Week 8
|
-2.90 x of ULN
Standard Deviation 5.368
|
2.78 x of ULN
Standard Deviation 4.215
|
—
|
|
Mean Changes From Baseline in Urinary 5-hydroxyindoleacetic Acid (5-HIAA) Levels in the Double-Blind Phase and Open-Label Treatment Phase
Week 12
|
0.21 x of ULN
Standard Deviation 1.904
|
5.38 x of ULN
Standard Deviation 4.342
|
-0.47 x of ULN
Standard Deviation 1.886
|
|
Mean Changes From Baseline in Urinary 5-hydroxyindoleacetic Acid (5-HIAA) Levels in the Double-Blind Phase and Open-Label Treatment Phase
Post-treatment
|
-1.27 x of ULN
Standard Deviation 7.007
|
-5.13 x of ULN
Standard Deviation 11.597
|
0.60 x of ULN
Standard Deviation 3.583
|
Adverse Events
Double-Blind Phase: Lanreotide
Serious events: 10 serious events
Other events: 48 other events
Deaths: 2 deaths
Double-Blind Phase: Placebo
Serious events: 7 serious events
Other events: 25 other events
Deaths: 0 deaths
Open-Label Treatment Phase
Serious events: 1 serious events
Other events: 26 other events
Deaths: 0 deaths
Open-Label Follow-Up Phase
Serious events: 0 serious events
Other events: 0 other events
Deaths: 7 deaths
Serious adverse events
| Measure |
Double-Blind Phase: Lanreotide
n=51 participants at risk
Subjects received deep SC injections of lanreotide autogel/depot 120 mg Q4 weeks plus BSC. Following protocol amendment #5 (28 Jan 2019), all ongoing subjects in the double-blind phase, who had not yet progressed (assessed locally and confirmed centrally) were offered to enter the open-label treatment phase and continue to receive deep SC injections of lanreotide autogel/depot 120 mg Q4 weeks plus BSC. If a subject progressed during the double-blind phase they entered the open-label follow-up phase.
|
Double-Blind Phase: Placebo
n=26 participants at risk
Subjects received deep SC injections of placebo (saline solution 0.9%) Q4 weeks plus BSC in the double-blind phase. Following protocol amendment #5 (28 Jan 2019), all ongoing subjects in the double-blind phase, who had not yet progressed (assessed locally and confirmed centrally) were offered to enter the open-label treatment phase and receive deep SC injections of lanreotide autogel/depot 120 mg Q4 weeks plus BSC.
|
Open-Label Treatment Phase
n=40 participants at risk
Subjects received deep SC injections of lanreotide autogel/depot 120 mg Q4 weeks plus BSC. Following protocol amendment #5 (28 Jan 2019), all ongoing subjects in the double-blind phase, who had not yet progressed (assessed locally and confirmed centrally) were offered to enter the open-label treatment phase and receive deep SC injections of lanreotide autogel/depot 120 mg Q4 weeks plus BSC. If a subject progressed during the open-label treatment phase they entered the open-label follow-up phase.
|
Open-Label Follow-Up Phase
n=26 participants at risk
If the subject received lanreotide autogel/depot and progressed during the double-blind phase or open-label treatment phase, the subject entered the follow-up phase of the open-label treatment phase and was followed for QoL/survival and all subsequent anticancer treatments received. No intervention was received in the open-label follow-up phase.
|
|---|---|---|---|---|
|
Cardiac disorders
Atrial fibrillation
|
2.0%
1/51 • Number of events 1 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
0.00%
0/26 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
0.00%
0/40 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
0.00%
0/26 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
|
Cardiac disorders
Atrioventricular block complete
|
2.0%
1/51 • Number of events 1 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
0.00%
0/26 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
0.00%
0/40 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
0.00%
0/26 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
|
Cardiac disorders
Myocardial infarction
|
2.0%
1/51 • Number of events 1 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
0.00%
0/26 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
0.00%
0/40 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
0.00%
0/26 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
|
Gastrointestinal disorders
Abdominal pain
|
2.0%
1/51 • Number of events 1 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
0.00%
0/26 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
0.00%
0/40 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
0.00%
0/26 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/51 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
3.8%
1/26 • Number of events 1 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
0.00%
0/40 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
0.00%
0/26 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/51 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
3.8%
1/26 • Number of events 1 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
0.00%
0/40 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
0.00%
0/26 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
|
Gastrointestinal disorders
Inguinal hernia
|
0.00%
0/51 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
3.8%
1/26 • Number of events 1 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
0.00%
0/40 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
0.00%
0/26 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
|
Gastrointestinal disorders
Pancreatitis acute
|
2.0%
1/51 • Number of events 1 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
0.00%
0/26 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
0.00%
0/40 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
0.00%
0/26 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
|
Gastrointestinal disorders
Subileus
|
0.00%
0/51 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
3.8%
1/26 • Number of events 1 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
0.00%
0/40 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
0.00%
0/26 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
|
General disorders
Asthenia
|
0.00%
0/51 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
3.8%
1/26 • Number of events 1 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
0.00%
0/40 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
0.00%
0/26 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
|
Hepatobiliary disorders
Biliary dilatation
|
2.0%
1/51 • Number of events 1 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
0.00%
0/26 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
0.00%
0/40 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
0.00%
0/26 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
|
Hepatobiliary disorders
Cholecystitis
|
2.0%
1/51 • Number of events 1 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
0.00%
0/26 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
0.00%
0/40 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
0.00%
0/26 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
|
Infections and infestations
Pneumocystis jirovecii infection
|
2.0%
1/51 • Number of events 1 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
0.00%
0/26 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
0.00%
0/40 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
0.00%
0/26 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
|
Infections and infestations
Pneumonia
|
2.0%
1/51 • Number of events 1 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
7.7%
2/26 • Number of events 2 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
0.00%
0/40 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
0.00%
0/26 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
|
Injury, poisoning and procedural complications
Femoral neck fracture
|
2.0%
1/51 • Number of events 1 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
0.00%
0/26 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
0.00%
0/40 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
0.00%
0/26 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.00%
0/51 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
3.8%
1/26 • Number of events 1 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
0.00%
0/40 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
0.00%
0/26 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
|
Nervous system disorders
Vagus nerve disorder
|
2.0%
1/51 • Number of events 1 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
0.00%
0/26 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
0.00%
0/40 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
0.00%
0/26 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
|
Psychiatric disorders
Alcohol withdrawal syndrome
|
2.0%
1/51 • Number of events 1 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
0.00%
0/26 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
0.00%
0/40 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
0.00%
0/26 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
|
Psychiatric disorders
Confusional state
|
0.00%
0/51 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
3.8%
1/26 • Number of events 1 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
0.00%
0/40 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
0.00%
0/26 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
|
Psychiatric disorders
Mental status changes
|
0.00%
0/51 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
3.8%
1/26 • Number of events 2 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
0.00%
0/40 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
0.00%
0/26 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
2.0%
1/51 • Number of events 1 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
0.00%
0/26 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
0.00%
0/40 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
0.00%
0/26 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
2.0%
1/51 • Number of events 1 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
0.00%
0/26 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
0.00%
0/40 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
0.00%
0/26 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.00%
0/51 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
3.8%
1/26 • Number of events 1 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
0.00%
0/40 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
0.00%
0/26 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory distress
|
2.0%
1/51 • Number of events 1 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
0.00%
0/26 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
0.00%
0/40 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
0.00%
0/26 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/51 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
0.00%
0/26 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
2.5%
1/40 • Number of events 1 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
0.00%
0/26 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
Other adverse events
| Measure |
Double-Blind Phase: Lanreotide
n=51 participants at risk
Subjects received deep SC injections of lanreotide autogel/depot 120 mg Q4 weeks plus BSC. Following protocol amendment #5 (28 Jan 2019), all ongoing subjects in the double-blind phase, who had not yet progressed (assessed locally and confirmed centrally) were offered to enter the open-label treatment phase and continue to receive deep SC injections of lanreotide autogel/depot 120 mg Q4 weeks plus BSC. If a subject progressed during the double-blind phase they entered the open-label follow-up phase.
|
Double-Blind Phase: Placebo
n=26 participants at risk
Subjects received deep SC injections of placebo (saline solution 0.9%) Q4 weeks plus BSC in the double-blind phase. Following protocol amendment #5 (28 Jan 2019), all ongoing subjects in the double-blind phase, who had not yet progressed (assessed locally and confirmed centrally) were offered to enter the open-label treatment phase and receive deep SC injections of lanreotide autogel/depot 120 mg Q4 weeks plus BSC.
|
Open-Label Treatment Phase
n=40 participants at risk
Subjects received deep SC injections of lanreotide autogel/depot 120 mg Q4 weeks plus BSC. Following protocol amendment #5 (28 Jan 2019), all ongoing subjects in the double-blind phase, who had not yet progressed (assessed locally and confirmed centrally) were offered to enter the open-label treatment phase and receive deep SC injections of lanreotide autogel/depot 120 mg Q4 weeks plus BSC. If a subject progressed during the open-label treatment phase they entered the open-label follow-up phase.
|
Open-Label Follow-Up Phase
n=26 participants at risk
If the subject received lanreotide autogel/depot and progressed during the double-blind phase or open-label treatment phase, the subject entered the follow-up phase of the open-label treatment phase and was followed for QoL/survival and all subsequent anticancer treatments received. No intervention was received in the open-label follow-up phase.
|
|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/51 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
3.8%
1/26 • Number of events 1 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
0.00%
0/40 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
0.00%
0/26 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
|
Blood and lymphatic system disorders
Hyperleukocytosis
|
0.00%
0/51 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
3.8%
1/26 • Number of events 1 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
0.00%
0/40 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
0.00%
0/26 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
|
Blood and lymphatic system disorders
Iron deficiency anaemia
|
2.0%
1/51 • Number of events 1 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
0.00%
0/26 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
0.00%
0/40 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
0.00%
0/26 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
|
Blood and lymphatic system disorders
Leukocytosis
|
0.00%
0/51 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
3.8%
1/26 • Number of events 1 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
0.00%
0/40 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
0.00%
0/26 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
2.0%
1/51 • Number of events 1 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
0.00%
0/26 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
0.00%
0/40 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
0.00%
0/26 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
|
Cardiac disorders
Aortic valve incompetence
|
0.00%
0/51 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
3.8%
1/26 • Number of events 1 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
0.00%
0/40 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
0.00%
0/26 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
|
Cardiac disorders
Atrial fibrillation
|
2.0%
1/51 • Number of events 1 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
0.00%
0/26 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
0.00%
0/40 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
0.00%
0/26 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
|
Cardiac disorders
Atrioventricular block second degree
|
0.00%
0/51 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
3.8%
1/26 • Number of events 1 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
0.00%
0/40 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
0.00%
0/26 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
|
Cardiac disorders
Bradycardia
|
2.0%
1/51 • Number of events 2 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
0.00%
0/26 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
0.00%
0/40 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
0.00%
0/26 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
|
Cardiac disorders
Cardiac failure
|
0.00%
0/51 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
3.8%
1/26 • Number of events 1 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
0.00%
0/40 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
0.00%
0/26 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
|
Cardiac disorders
Cardiovascular disorder
|
0.00%
0/51 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
3.8%
1/26 • Number of events 1 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
0.00%
0/40 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
0.00%
0/26 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
|
Cardiac disorders
Left ventricular hypertrophy
|
0.00%
0/51 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
3.8%
1/26 • Number of events 1 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
0.00%
0/40 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
0.00%
0/26 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
|
Cardiac disorders
Tachycardia
|
3.9%
2/51 • Number of events 4 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
0.00%
0/26 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
0.00%
0/40 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
0.00%
0/26 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
|
Ear and labyrinth disorders
Tinnitus
|
2.0%
1/51 • Number of events 1 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
0.00%
0/26 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
0.00%
0/40 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
0.00%
0/26 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
|
Ear and labyrinth disorders
Vertigo
|
2.0%
1/51 • Number of events 3 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
7.7%
2/26 • Number of events 3 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
7.5%
3/40 • Number of events 4 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
0.00%
0/26 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
|
Endocrine disorders
Carcinoid syndrome
|
3.9%
2/51 • Number of events 2 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
0.00%
0/26 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
0.00%
0/40 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
0.00%
0/26 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
|
Endocrine disorders
Hyperthyroidism
|
2.0%
1/51 • Number of events 1 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
3.8%
1/26 • Number of events 1 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
0.00%
0/40 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
0.00%
0/26 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
|
Eye disorders
Eye haemorrhage
|
2.0%
1/51 • Number of events 1 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
0.00%
0/26 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
0.00%
0/40 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
0.00%
0/26 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
|
Eye disorders
Glaucoma
|
2.0%
1/51 • Number of events 1 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
0.00%
0/26 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
0.00%
0/40 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
0.00%
0/26 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
|
Eye disorders
Lacrimation increased
|
2.0%
1/51 • Number of events 1 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
3.8%
1/26 • Number of events 1 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
0.00%
0/40 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
0.00%
0/26 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
|
Eye disorders
Vision blurred
|
2.0%
1/51 • Number of events 1 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
3.8%
1/26 • Number of events 1 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
0.00%
0/40 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
0.00%
0/26 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
|
Gastrointestinal disorders
Abdominal discomfort
|
2.0%
1/51 • Number of events 1 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
3.8%
1/26 • Number of events 1 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
0.00%
0/40 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
0.00%
0/26 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
|
Gastrointestinal disorders
Abdominal distension
|
9.8%
5/51 • Number of events 14 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
3.8%
1/26 • Number of events 1 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
2.5%
1/40 • Number of events 1 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
0.00%
0/26 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
|
Gastrointestinal disorders
Abdominal pain
|
19.6%
10/51 • Number of events 21 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
19.2%
5/26 • Number of events 8 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
10.0%
4/40 • Number of events 4 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
0.00%
0/26 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
9.8%
5/51 • Number of events 5 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
7.7%
2/26 • Number of events 4 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
0.00%
0/40 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
0.00%
0/26 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
|
Gastrointestinal disorders
Ascites
|
2.0%
1/51 • Number of events 1 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
0.00%
0/26 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
0.00%
0/40 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
0.00%
0/26 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
|
Gastrointestinal disorders
Constipation
|
15.7%
8/51 • Number of events 9 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
15.4%
4/26 • Number of events 4 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
2.5%
1/40 • Number of events 1 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
0.00%
0/26 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
|
Gastrointestinal disorders
Diarrhoea
|
62.7%
32/51 • Number of events 61 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
30.8%
8/26 • Number of events 12 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
22.5%
9/40 • Number of events 13 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
0.00%
0/26 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
|
Gastrointestinal disorders
Dry mouth
|
2.0%
1/51 • Number of events 1 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
3.8%
1/26 • Number of events 1 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
0.00%
0/40 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
0.00%
0/26 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
|
Gastrointestinal disorders
Dyschezia
|
2.0%
1/51 • Number of events 1 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
0.00%
0/26 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
0.00%
0/40 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
0.00%
0/26 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
|
Gastrointestinal disorders
Dyspepsia
|
2.0%
1/51 • Number of events 1 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
0.00%
0/26 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
0.00%
0/40 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
0.00%
0/26 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
|
Gastrointestinal disorders
Dysphagia
|
2.0%
1/51 • Number of events 1 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
0.00%
0/26 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
0.00%
0/40 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
0.00%
0/26 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
|
Gastrointestinal disorders
Erosive duodenitis
|
0.00%
0/51 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
3.8%
1/26 • Number of events 1 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
0.00%
0/40 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
0.00%
0/26 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
|
Gastrointestinal disorders
Flatulence
|
13.7%
7/51 • Number of events 12 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
7.7%
2/26 • Number of events 2 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
5.0%
2/40 • Number of events 2 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
0.00%
0/26 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/51 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
3.8%
1/26 • Number of events 1 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
0.00%
0/40 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
0.00%
0/26 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
|
Gastrointestinal disorders
Glycogenic acanthosis
|
0.00%
0/51 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
3.8%
1/26 • Number of events 1 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
0.00%
0/40 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
0.00%
0/26 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
|
Gastrointestinal disorders
Haemorrhoids
|
3.9%
2/51 • Number of events 2 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
0.00%
0/26 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
0.00%
0/40 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
0.00%
0/26 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
|
Gastrointestinal disorders
Hiatus hernia
|
0.00%
0/51 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
3.8%
1/26 • Number of events 1 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
0.00%
0/40 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
0.00%
0/26 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
|
Gastrointestinal disorders
Impaired gastric emptying
|
0.00%
0/51 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
3.8%
1/26 • Number of events 1 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
0.00%
0/40 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
0.00%
0/26 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
|
Gastrointestinal disorders
Nausea
|
11.8%
6/51 • Number of events 17 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
15.4%
4/26 • Number of events 4 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
7.5%
3/40 • Number of events 5 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
0.00%
0/26 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
|
Gastrointestinal disorders
Pancreatic failure
|
0.00%
0/51 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
3.8%
1/26 • Number of events 1 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
0.00%
0/40 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
0.00%
0/26 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
|
Gastrointestinal disorders
Paraesthesia oral
|
2.0%
1/51 • Number of events 1 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
0.00%
0/26 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
0.00%
0/40 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
0.00%
0/26 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
|
Gastrointestinal disorders
Rectal tenesmus
|
0.00%
0/51 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
3.8%
1/26 • Number of events 1 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
0.00%
0/40 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
0.00%
0/26 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
|
Gastrointestinal disorders
Steatorrhoea
|
2.0%
1/51 • Number of events 1 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
0.00%
0/26 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
2.5%
1/40 • Number of events 1 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
0.00%
0/26 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
|
Gastrointestinal disorders
Stomatitis
|
0.00%
0/51 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
3.8%
1/26 • Number of events 1 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
0.00%
0/40 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
0.00%
0/26 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
|
Gastrointestinal disorders
Vomiting
|
13.7%
7/51 • Number of events 8 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
7.7%
2/26 • Number of events 2 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
0.00%
0/40 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
0.00%
0/26 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
|
General disorders
Asthenia
|
21.6%
11/51 • Number of events 19 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
19.2%
5/26 • Number of events 11 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
5.0%
2/40 • Number of events 10 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
0.00%
0/26 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
|
General disorders
Chest pain
|
3.9%
2/51 • Number of events 5 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
3.8%
1/26 • Number of events 1 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
2.5%
1/40 • Number of events 1 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
0.00%
0/26 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
|
General disorders
Fatigue
|
25.5%
13/51 • Number of events 20 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
38.5%
10/26 • Number of events 10 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
2.5%
1/40 • Number of events 1 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
0.00%
0/26 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
|
General disorders
General physical health deterioration
|
0.00%
0/51 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
3.8%
1/26 • Number of events 1 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
0.00%
0/40 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
0.00%
0/26 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
|
General disorders
Influenza like illness
|
7.8%
4/51 • Number of events 5 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
3.8%
1/26 • Number of events 1 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
5.0%
2/40 • Number of events 2 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
0.00%
0/26 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
|
General disorders
Injection site reaction
|
5.9%
3/51 • Number of events 5 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
0.00%
0/26 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
0.00%
0/40 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
0.00%
0/26 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
|
General disorders
Non-cardiac chest pain
|
3.9%
2/51 • Number of events 3 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
0.00%
0/26 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
2.5%
1/40 • Number of events 1 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
0.00%
0/26 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
|
General disorders
Oedema
|
2.0%
1/51 • Number of events 1 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
3.8%
1/26 • Number of events 1 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
0.00%
0/40 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
0.00%
0/26 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
|
General disorders
Oedema peripheral
|
9.8%
5/51 • Number of events 10 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
3.8%
1/26 • Number of events 1 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
2.5%
1/40 • Number of events 1 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
0.00%
0/26 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
|
General disorders
Pyrexia
|
3.9%
2/51 • Number of events 2 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
3.8%
1/26 • Number of events 1 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
2.5%
1/40 • Number of events 2 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
0.00%
0/26 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
|
General disorders
Xerosis
|
0.00%
0/51 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
3.8%
1/26 • Number of events 2 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
0.00%
0/40 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
0.00%
0/26 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
|
Hepatobiliary disorders
Cholelithiasis
|
2.0%
1/51 • Number of events 1 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
0.00%
0/26 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
0.00%
0/40 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
0.00%
0/26 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
|
Hepatobiliary disorders
Hepatomegaly
|
2.0%
1/51 • Number of events 1 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
3.8%
1/26 • Number of events 1 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
0.00%
0/40 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
0.00%
0/26 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
|
Hepatobiliary disorders
Hyperbilirubinaemia
|
2.0%
1/51 • Number of events 1 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
0.00%
0/26 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
0.00%
0/40 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
0.00%
0/26 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
|
Immune system disorders
Drug hypersensitivity
|
0.00%
0/51 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
3.8%
1/26 • Number of events 3 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
0.00%
0/40 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
0.00%
0/26 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
|
Infections and infestations
Bronchitis
|
9.8%
5/51 • Number of events 6 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
0.00%
0/26 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
0.00%
0/40 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
0.00%
0/26 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
|
Infections and infestations
Candida infection
|
2.0%
1/51 • Number of events 1 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
0.00%
0/26 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
0.00%
0/40 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
0.00%
0/26 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
|
Infections and infestations
Conjunctivitis
|
0.00%
0/51 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
3.8%
1/26 • Number of events 1 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
0.00%
0/40 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
0.00%
0/26 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
|
Infections and infestations
Conjunctivitis bacterial
|
0.00%
0/51 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
3.8%
1/26 • Number of events 1 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
0.00%
0/40 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
0.00%
0/26 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
|
Infections and infestations
Cystitis
|
3.9%
2/51 • Number of events 2 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
3.8%
1/26 • Number of events 1 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
0.00%
0/40 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
0.00%
0/26 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/51 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
7.7%
2/26 • Number of events 2 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
0.00%
0/40 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
0.00%
0/26 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
|
Infections and infestations
Nasopharyngitis
|
7.8%
4/51 • Number of events 6 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
15.4%
4/26 • Number of events 4 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
5.0%
2/40 • Number of events 4 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
0.00%
0/26 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
|
Infections and infestations
Paronychia
|
2.0%
1/51 • Number of events 1 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
0.00%
0/26 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
0.00%
0/40 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
0.00%
0/26 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
|
Infections and infestations
Pneumonia
|
3.9%
2/51 • Number of events 4 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
3.8%
1/26 • Number of events 1 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
0.00%
0/40 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
0.00%
0/26 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
|
Infections and infestations
Postoperative wound infection
|
2.0%
1/51 • Number of events 1 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
0.00%
0/26 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
0.00%
0/40 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
0.00%
0/26 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
|
Infections and infestations
Tinea pedis
|
2.0%
1/51 • Number of events 1 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
0.00%
0/26 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
0.00%
0/40 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
0.00%
0/26 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
|
Infections and infestations
Tooth abscess
|
2.0%
1/51 • Number of events 1 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
0.00%
0/26 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
0.00%
0/40 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
0.00%
0/26 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
|
Infections and infestations
Tooth infection
|
2.0%
1/51 • Number of events 1 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
0.00%
0/26 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
0.00%
0/40 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
0.00%
0/26 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
|
Infections and infestations
Upper respiratory tract infection
|
2.0%
1/51 • Number of events 1 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
7.7%
2/26 • Number of events 2 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
0.00%
0/40 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
0.00%
0/26 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
|
Infections and infestations
Urinary tract infection
|
5.9%
3/51 • Number of events 3 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
0.00%
0/26 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
7.5%
3/40 • Number of events 6 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
0.00%
0/26 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
|
Injury, poisoning and procedural complications
Contusion
|
2.0%
1/51 • Number of events 1 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
0.00%
0/26 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
2.5%
1/40 • Number of events 1 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
0.00%
0/26 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
|
Injury, poisoning and procedural complications
Fall
|
3.9%
2/51 • Number of events 2 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
0.00%
0/26 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
2.5%
1/40 • Number of events 1 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
0.00%
0/26 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
|
Injury, poisoning and procedural complications
Joint dislocation
|
2.0%
1/51 • Number of events 1 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
0.00%
0/26 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
0.00%
0/40 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
0.00%
0/26 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
|
Injury, poisoning and procedural complications
Ligament sprain
|
0.00%
0/51 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
3.8%
1/26 • Number of events 1 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
0.00%
0/40 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
0.00%
0/26 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
|
Injury, poisoning and procedural complications
Procedural pain
|
3.9%
2/51 • Number of events 2 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
0.00%
0/26 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
0.00%
0/40 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
0.00%
0/26 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
|
Injury, poisoning and procedural complications
Scar
|
0.00%
0/51 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
3.8%
1/26 • Number of events 1 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
0.00%
0/40 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
0.00%
0/26 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
|
Investigations
Amylase increased
|
2.0%
1/51 • Number of events 2 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
0.00%
0/26 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
0.00%
0/40 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
0.00%
0/26 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
|
Investigations
Aspartate aminotransferase increased
|
2.0%
1/51 • Number of events 1 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
0.00%
0/26 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
0.00%
0/40 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
0.00%
0/26 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
|
Investigations
Blood albumin increased
|
0.00%
0/51 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
3.8%
1/26 • Number of events 1 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
0.00%
0/40 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
0.00%
0/26 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
|
Investigations
Blood alkaline phosphatase increased
|
5.9%
3/51 • Number of events 3 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
0.00%
0/26 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
2.5%
1/40 • Number of events 2 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
0.00%
0/26 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
|
Investigations
Blood bilirubin increased
|
3.9%
2/51 • Number of events 3 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
0.00%
0/26 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
0.00%
0/40 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
0.00%
0/26 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
|
Investigations
Blood cholesterol increased
|
3.9%
2/51 • Number of events 2 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
0.00%
0/26 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
2.5%
1/40 • Number of events 1 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
0.00%
0/26 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
|
Investigations
Blood creatine phosphokinase increased
|
0.00%
0/51 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
3.8%
1/26 • Number of events 1 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
0.00%
0/40 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
0.00%
0/26 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
|
Investigations
Blood creatinine increased
|
2.0%
1/51 • Number of events 2 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
0.00%
0/26 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
0.00%
0/40 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
0.00%
0/26 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
|
Investigations
Blood glucose increased
|
7.8%
4/51 • Number of events 4 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
0.00%
0/26 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
0.00%
0/40 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
0.00%
0/26 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
|
Investigations
Blood lactate dehydrogenase increased
|
0.00%
0/51 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
3.8%
1/26 • Number of events 1 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
0.00%
0/40 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
0.00%
0/26 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
|
Investigations
Blood potassium increased
|
2.0%
1/51 • Number of events 1 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
0.00%
0/26 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
0.00%
0/40 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
0.00%
0/26 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
|
Investigations
Blood sodium decreased
|
0.00%
0/51 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
3.8%
1/26 • Number of events 2 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
0.00%
0/40 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
0.00%
0/26 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
|
Investigations
Blood triglycerides increased
|
2.0%
1/51 • Number of events 1 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
0.00%
0/26 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
0.00%
0/40 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
0.00%
0/26 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
|
Investigations
Gamma-glutamyltransferase increased
|
5.9%
3/51 • Number of events 3 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
0.00%
0/26 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
2.5%
1/40 • Number of events 1 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
0.00%
0/26 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
|
Investigations
Intestinal transit time increased
|
2.0%
1/51 • Number of events 1 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
0.00%
0/26 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
0.00%
0/40 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
0.00%
0/26 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
|
Investigations
Lipase increased
|
2.0%
1/51 • Number of events 1 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
3.8%
1/26 • Number of events 1 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
0.00%
0/40 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
0.00%
0/26 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
|
Investigations
Weight decreased
|
7.8%
4/51 • Number of events 5 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
11.5%
3/26 • Number of events 3 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
2.5%
1/40 • Number of events 1 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
0.00%
0/26 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
|
Investigations
Weight increased
|
2.0%
1/51 • Number of events 1 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
3.8%
1/26 • Number of events 1 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
0.00%
0/40 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
0.00%
0/26 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
|
Metabolism and nutrition disorders
Cachexia
|
0.00%
0/51 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
3.8%
1/26 • Number of events 1 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
0.00%
0/40 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
0.00%
0/26 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
11.8%
6/51 • Number of events 7 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
23.1%
6/26 • Number of events 7 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
7.5%
3/40 • Number of events 4 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
0.00%
0/26 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
|
Metabolism and nutrition disorders
Dehydration
|
2.0%
1/51 • Number of events 1 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
0.00%
0/26 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
0.00%
0/40 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
0.00%
0/26 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
2.0%
1/51 • Number of events 2 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
0.00%
0/26 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
0.00%
0/40 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
0.00%
0/26 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
7.8%
4/51 • Number of events 5 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
15.4%
4/26 • Number of events 11 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
2.5%
1/40 • Number of events 3 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
0.00%
0/26 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
3.9%
2/51 • Number of events 3 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
0.00%
0/26 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
0.00%
0/40 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
0.00%
0/26 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
|
Metabolism and nutrition disorders
Hypernatraemia
|
2.0%
1/51 • Number of events 1 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
0.00%
0/26 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
0.00%
0/40 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
0.00%
0/26 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
|
Metabolism and nutrition disorders
Hypertriglyceridaemia
|
2.0%
1/51 • Number of events 1 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
0.00%
0/26 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
2.5%
1/40 • Number of events 2 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
0.00%
0/26 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
2.0%
1/51 • Number of events 1 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
0.00%
0/26 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
0.00%
0/40 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
0.00%
0/26 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
2.0%
1/51 • Number of events 1 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
0.00%
0/26 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
0.00%
0/40 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
0.00%
0/26 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
2.0%
1/51 • Number of events 1 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
0.00%
0/26 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
0.00%
0/40 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
0.00%
0/26 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
|
Metabolism and nutrition disorders
Iron deficiency
|
0.00%
0/51 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
3.8%
1/26 • Number of events 1 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
0.00%
0/40 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
0.00%
0/26 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
|
Metabolism and nutrition disorders
Type 2 diabetes mellitus
|
2.0%
1/51 • Number of events 1 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
0.00%
0/26 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
7.5%
3/40 • Number of events 3 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
0.00%
0/26 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
|
Metabolism and nutrition disorders
Vitamin D deficiency
|
2.0%
1/51 • Number of events 1 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
0.00%
0/26 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
0.00%
0/40 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
0.00%
0/26 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
11.8%
6/51 • Number of events 8 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
7.7%
2/26 • Number of events 2 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
5.0%
2/40 • Number of events 2 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
0.00%
0/26 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
|
Nervous system disorders
Carotid arteriosclerosis
|
0.00%
0/51 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
3.8%
1/26 • Number of events 1 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
0.00%
0/40 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
0.00%
0/26 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
|
Nervous system disorders
Coordination abnormal
|
0.00%
0/51 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
3.8%
1/26 • Number of events 1 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
0.00%
0/40 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
0.00%
0/26 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
|
Nervous system disorders
Dementia Alzheimer's type
|
2.0%
1/51 • Number of events 1 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
0.00%
0/26 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
0.00%
0/40 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
0.00%
0/26 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
|
Nervous system disorders
Dizziness
|
15.7%
8/51 • Number of events 15 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
7.7%
2/26 • Number of events 2 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
5.0%
2/40 • Number of events 2 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
0.00%
0/26 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
|
Nervous system disorders
Dysgeusia
|
2.0%
1/51 • Number of events 2 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
3.8%
1/26 • Number of events 1 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
0.00%
0/40 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
0.00%
0/26 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
|
Nervous system disorders
Head discomfort
|
2.0%
1/51 • Number of events 1 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
0.00%
0/26 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
0.00%
0/40 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
0.00%
0/26 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
|
Nervous system disorders
Headache
|
7.8%
4/51 • Number of events 5 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
15.4%
4/26 • Number of events 4 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
10.0%
4/40 • Number of events 5 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
0.00%
0/26 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
|
Nervous system disorders
Hypoaesthesia
|
2.0%
1/51 • Number of events 1 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
0.00%
0/26 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
0.00%
0/40 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
0.00%
0/26 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
|
Nervous system disorders
Lacunar infarction
|
0.00%
0/51 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
3.8%
1/26 • Number of events 1 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
0.00%
0/40 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
0.00%
0/26 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
|
Nervous system disorders
Memory impairment
|
2.0%
1/51 • Number of events 1 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
0.00%
0/26 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
0.00%
0/40 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
0.00%
0/26 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
|
Nervous system disorders
Neuralgia
|
0.00%
0/51 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
3.8%
1/26 • Number of events 1 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
0.00%
0/40 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
0.00%
0/26 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
|
Nervous system disorders
Neuropathy peripheral
|
2.0%
1/51 • Number of events 1 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
0.00%
0/26 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
0.00%
0/40 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
0.00%
0/26 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
|
Nervous system disorders
Parkinsonism
|
2.0%
1/51 • Number of events 1 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
0.00%
0/26 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
0.00%
0/40 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
0.00%
0/26 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
|
Nervous system disorders
Sciatica
|
3.9%
2/51 • Number of events 2 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
3.8%
1/26 • Number of events 1 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
0.00%
0/40 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
0.00%
0/26 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
|
Nervous system disorders
Syncope
|
2.0%
1/51 • Number of events 1 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
3.8%
1/26 • Number of events 1 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
0.00%
0/40 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
0.00%
0/26 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
|
Psychiatric disorders
Anxiety
|
3.9%
2/51 • Number of events 2 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
0.00%
0/26 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
2.5%
1/40 • Number of events 1 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
0.00%
0/26 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
|
Psychiatric disorders
Confusional state
|
0.00%
0/51 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
3.8%
1/26 • Number of events 1 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
2.5%
1/40 • Number of events 1 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
0.00%
0/26 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
|
Psychiatric disorders
Depression
|
5.9%
3/51 • Number of events 3 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
0.00%
0/26 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
0.00%
0/40 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
0.00%
0/26 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
|
Psychiatric disorders
Insomnia
|
7.8%
4/51 • Number of events 5 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
7.7%
2/26 • Number of events 2 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
0.00%
0/40 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
0.00%
0/26 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
|
Psychiatric disorders
Irritability
|
2.0%
1/51 • Number of events 1 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
0.00%
0/26 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
0.00%
0/40 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
0.00%
0/26 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
|
Renal and urinary disorders
Chronic kidney disease
|
2.0%
1/51 • Number of events 1 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
0.00%
0/26 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
0.00%
0/40 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
0.00%
0/26 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
|
Renal and urinary disorders
Haematuria
|
2.0%
1/51 • Number of events 1 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
0.00%
0/26 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
0.00%
0/40 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
0.00%
0/26 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
|
Renal and urinary disorders
Nocturia
|
2.0%
1/51 • Number of events 1 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
0.00%
0/26 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
0.00%
0/40 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
0.00%
0/26 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
|
Renal and urinary disorders
Pollakiuria
|
3.9%
2/51 • Number of events 2 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
0.00%
0/26 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
0.00%
0/40 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
0.00%
0/26 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
|
Renal and urinary disorders
Polyuria
|
0.00%
0/51 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
3.8%
1/26 • Number of events 1 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
0.00%
0/40 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
0.00%
0/26 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
|
Renal and urinary disorders
Proteinuria
|
2.0%
1/51 • Number of events 1 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
0.00%
0/26 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
0.00%
0/40 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
0.00%
0/26 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
|
Renal and urinary disorders
Renal mass
|
0.00%
0/51 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
3.8%
1/26 • Number of events 1 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
0.00%
0/40 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
0.00%
0/26 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
|
Renal and urinary disorders
Urinary tract discomfort
|
0.00%
0/51 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
3.8%
1/26 • Number of events 1 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
0.00%
0/40 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
0.00%
0/26 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
|
Reproductive system and breast disorders
Breast tenderness
|
2.0%
1/51 • Number of events 1 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
0.00%
0/26 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
0.00%
0/40 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
0.00%
0/26 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
|
Reproductive system and breast disorders
Vaginal discharge
|
2.0%
1/51 • Number of events 1 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
0.00%
0/26 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
0.00%
0/40 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
0.00%
0/26 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
|
Reproductive system and breast disorders
Vulvovaginal dryness
|
2.0%
1/51 • Number of events 1 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
0.00%
0/26 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
0.00%
0/40 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
0.00%
0/26 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
|
Respiratory, thoracic and mediastinal disorders
Aphonia
|
2.0%
1/51 • Number of events 1 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
0.00%
0/26 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
0.00%
0/40 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
0.00%
0/26 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
2.0%
1/51 • Number of events 1 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
0.00%
0/26 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
0.00%
0/40 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
0.00%
0/26 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma-chronic obstructive pulmonary disease overlap syndrome
|
2.0%
1/51 • Number of events 1 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
0.00%
0/26 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
0.00%
0/40 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
0.00%
0/26 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
0.00%
0/51 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
3.8%
1/26 • Number of events 1 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
0.00%
0/40 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
0.00%
0/26 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
5.9%
3/51 • Number of events 4 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
11.5%
3/26 • Number of events 3 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
5.0%
2/40 • Number of events 4 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
0.00%
0/26 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
2.0%
1/51 • Number of events 1 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
0.00%
0/26 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
0.00%
0/40 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
0.00%
0/26 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
11.8%
6/51 • Number of events 8 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
15.4%
4/26 • Number of events 4 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
5.0%
2/40 • Number of events 3 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
0.00%
0/26 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
9.8%
5/51 • Number of events 6 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
7.7%
2/26 • Number of events 2 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
2.5%
1/40 • Number of events 2 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
0.00%
0/26 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
|
Respiratory, thoracic and mediastinal disorders
Emphysema
|
0.00%
0/51 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
3.8%
1/26 • Number of events 1 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
0.00%
0/40 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
0.00%
0/26 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
2.0%
1/51 • Number of events 1 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
3.8%
1/26 • Number of events 1 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
0.00%
0/40 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
0.00%
0/26 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
|
Respiratory, thoracic and mediastinal disorders
Interstitial lung disease
|
0.00%
0/51 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
3.8%
1/26 • Number of events 1 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
0.00%
0/40 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
0.00%
0/26 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
2.0%
1/51 • Number of events 3 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
0.00%
0/26 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
0.00%
0/40 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
0.00%
0/26 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/51 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
11.5%
3/26 • Number of events 3 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
2.5%
1/40 • Number of events 1 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
0.00%
0/26 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
3.9%
2/51 • Number of events 3 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
11.5%
3/26 • Number of events 3 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
2.5%
1/40 • Number of events 1 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
0.00%
0/26 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.00%
0/51 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
3.8%
1/26 • Number of events 1 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
0.00%
0/40 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
0.00%
0/26 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
|
Respiratory, thoracic and mediastinal disorders
Sleep apnoea syndrome
|
0.00%
0/51 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
3.8%
1/26 • Number of events 1 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
0.00%
0/40 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
0.00%
0/26 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
|
Respiratory, thoracic and mediastinal disorders
Upper-airway cough syndrome
|
2.0%
1/51 • Number of events 1 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
0.00%
0/26 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
0.00%
0/40 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
0.00%
0/26 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
|
Skin and subcutaneous tissue disorders
Actinic keratosis
|
2.0%
1/51 • Number of events 1 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
0.00%
0/26 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
0.00%
0/40 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
0.00%
0/26 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
5.9%
3/51 • Number of events 3 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
3.8%
1/26 • Number of events 1 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
5.0%
2/40 • Number of events 2 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
0.00%
0/26 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.00%
0/51 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
3.8%
1/26 • Number of events 2 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
0.00%
0/40 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
0.00%
0/26 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.00%
0/51 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
3.8%
1/26 • Number of events 1 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
0.00%
0/40 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
0.00%
0/26 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
2.0%
1/51 • Number of events 1 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
0.00%
0/26 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
2.5%
1/40 • Number of events 1 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
0.00%
0/26 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
|
Skin and subcutaneous tissue disorders
Melanoderma
|
0.00%
0/51 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
3.8%
1/26 • Number of events 1 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
0.00%
0/40 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
0.00%
0/26 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
|
Skin and subcutaneous tissue disorders
Night sweats
|
0.00%
0/51 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
3.8%
1/26 • Number of events 1 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
0.00%
0/40 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
0.00%
0/26 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
|
Skin and subcutaneous tissue disorders
Pain of skin
|
2.0%
1/51 • Number of events 1 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
0.00%
0/26 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
0.00%
0/40 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
0.00%
0/26 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
2.0%
1/51 • Number of events 1 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
3.8%
1/26 • Number of events 2 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
2.5%
1/40 • Number of events 1 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
0.00%
0/26 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
|
Skin and subcutaneous tissue disorders
Rash
|
5.9%
3/51 • Number of events 3 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
7.7%
2/26 • Number of events 3 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
0.00%
0/40 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
0.00%
0/26 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
2.0%
1/51 • Number of events 3 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
0.00%
0/26 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
0.00%
0/40 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
0.00%
0/26 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
|
Skin and subcutaneous tissue disorders
Seborrhoeic dermatitis
|
2.0%
1/51 • Number of events 1 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
0.00%
0/26 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
0.00%
0/40 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
0.00%
0/26 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
|
Skin and subcutaneous tissue disorders
Skin induration
|
2.0%
1/51 • Number of events 1 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
0.00%
0/26 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
0.00%
0/40 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
0.00%
0/26 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
|
Skin and subcutaneous tissue disorders
Skin lesion
|
2.0%
1/51 • Number of events 1 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
0.00%
0/26 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
0.00%
0/40 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
0.00%
0/26 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
|
Vascular disorders
Deep vein thrombosis
|
2.0%
1/51 • Number of events 1 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
0.00%
0/26 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
0.00%
0/40 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
0.00%
0/26 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
|
Vascular disorders
Flushing
|
2.0%
1/51 • Number of events 1 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
3.8%
1/26 • Number of events 1 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
0.00%
0/40 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
0.00%
0/26 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
|
Vascular disorders
Hot flush
|
0.00%
0/51 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
3.8%
1/26 • Number of events 2 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
2.5%
1/40 • Number of events 2 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
0.00%
0/26 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
|
Vascular disorders
Hypertension
|
9.8%
5/51 • Number of events 14 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
7.7%
2/26 • Number of events 2 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
0.00%
0/40 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
0.00%
0/26 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
|
Vascular disorders
Hypotension
|
3.9%
2/51 • Number of events 3 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
3.8%
1/26 • Number of events 1 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
0.00%
0/40 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
0.00%
0/26 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
|
Vascular disorders
Varicose vein
|
2.0%
1/51 • Number of events 1 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
0.00%
0/26 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
0.00%
0/40 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
0.00%
0/26 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
|
Cardiac disorders
Atrioventricular block
|
0.00%
0/51 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
0.00%
0/26 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
2.5%
1/40 • Number of events 1 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
0.00%
0/26 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
|
Cardiac disorders
Palpitations
|
0.00%
0/51 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
0.00%
0/26 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
2.5%
1/40 • Number of events 1 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
0.00%
0/26 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
|
Eye disorders
Blepharospasm
|
0.00%
0/51 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
0.00%
0/26 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
2.5%
1/40 • Number of events 1 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
0.00%
0/26 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
|
Eye disorders
Swelling of eyelid
|
0.00%
0/51 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
0.00%
0/26 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
2.5%
1/40 • Number of events 1 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
0.00%
0/26 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
|
Gastrointestinal disorders
Anal incontinence
|
0.00%
0/51 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
0.00%
0/26 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
2.5%
1/40 • Number of events 1 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
0.00%
0/26 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
|
Gastrointestinal disorders
Frequent bowel movements
|
0.00%
0/51 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
0.00%
0/26 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
2.5%
1/40 • Number of events 1 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
0.00%
0/26 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
|
General disorders
Chest discomfort
|
0.00%
0/51 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
0.00%
0/26 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
2.5%
1/40 • Number of events 2 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
0.00%
0/26 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
|
General disorders
Chills
|
0.00%
0/51 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
0.00%
0/26 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
2.5%
1/40 • Number of events 1 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
0.00%
0/26 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
|
General disorders
Injection site pain
|
0.00%
0/51 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
0.00%
0/26 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
2.5%
1/40 • Number of events 1 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
0.00%
0/26 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
|
Immune system disorders
Contrast media reaction
|
0.00%
0/51 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
0.00%
0/26 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
2.5%
1/40 • Number of events 1 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
0.00%
0/26 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
|
Infections and infestations
Respiratory tract infection
|
0.00%
0/51 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
0.00%
0/26 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
5.0%
2/40 • Number of events 2 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
0.00%
0/26 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
|
Infections and infestations
Skin infection
|
0.00%
0/51 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
0.00%
0/26 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
2.5%
1/40 • Number of events 1 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
0.00%
0/26 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
|
Injury, poisoning and procedural complications
Procedural nausea
|
0.00%
0/51 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
0.00%
0/26 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
2.5%
1/40 • Number of events 1 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
0.00%
0/26 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
9.8%
5/51 • Number of events 6 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
11.5%
3/26 • Number of events 3 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
7.5%
3/40 • Number of events 3 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
0.00%
0/26 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
0.00%
0/51 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
0.00%
0/26 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
2.5%
1/40 • Number of events 1 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
0.00%
0/26 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
|
Musculoskeletal and connective tissue disorders
Joint swelling
|
0.00%
0/51 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
0.00%
0/26 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
2.5%
1/40 • Number of events 1 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
0.00%
0/26 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
3.9%
2/51 • Number of events 2 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
0.00%
0/26 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
2.5%
1/40 • Number of events 1 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
0.00%
0/26 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
3.9%
2/51 • Number of events 2 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
7.7%
2/26 • Number of events 2 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
2.5%
1/40 • Number of events 1 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
0.00%
0/26 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
3.9%
2/51 • Number of events 4 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
3.8%
1/26 • Number of events 1 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
2.5%
1/40 • Number of events 2 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
0.00%
0/26 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/51 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
3.8%
1/26 • Number of events 1 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
2.5%
1/40 • Number of events 1 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
0.00%
0/26 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
2.0%
1/51 • Number of events 1 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
7.7%
2/26 • Number of events 2 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
2.5%
1/40 • Number of events 1 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
0.00%
0/26 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cancer pain
|
0.00%
0/51 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
0.00%
0/26 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
2.5%
1/40 • Number of events 1 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
0.00%
0/26 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour pain
|
0.00%
0/51 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
0.00%
0/26 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
5.0%
2/40 • Number of events 2 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
0.00%
0/26 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
|
Nervous system disorders
Cervicobrachial syndrome
|
0.00%
0/51 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
0.00%
0/26 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
2.5%
1/40 • Number of events 1 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
0.00%
0/26 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
|
Nervous system disorders
Cognitive disorder
|
0.00%
0/51 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
0.00%
0/26 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
2.5%
1/40 • Number of events 1 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
0.00%
0/26 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
|
Renal and urinary disorders
Renal failure
|
0.00%
0/51 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
0.00%
0/26 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
2.5%
1/40 • Number of events 1 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
0.00%
0/26 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
|
Renal and urinary disorders
Renal pain
|
0.00%
0/51 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
0.00%
0/26 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
2.5%
1/40 • Number of events 1 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
0.00%
0/26 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
|
Respiratory, thoracic and mediastinal disorders
Mediastinal fibrosis
|
0.00%
0/51 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
0.00%
0/26 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
2.5%
1/40 • Number of events 1 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
0.00%
0/26 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
|
Skin and subcutaneous tissue disorders
Acne
|
0.00%
0/51 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
0.00%
0/26 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
2.5%
1/40 • Number of events 1 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
0.00%
0/26 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.00%
0/51 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
3.8%
1/26 • Number of events 1 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
0.00%
0/40 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
0.00%
0/26 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
|
Musculoskeletal and connective tissue disorders
Bursitis
|
0.00%
0/51 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
3.8%
1/26 • Number of events 2 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
0.00%
0/40 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
0.00%
0/26 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.00%
0/51 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
7.7%
2/26 • Number of events 2 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
0.00%
0/40 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
0.00%
0/26 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
2.0%
1/51 • Number of events 1 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
0.00%
0/26 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
0.00%
0/40 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
0.00%
0/26 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.00%
0/51 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
7.7%
2/26 • Number of events 2 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
0.00%
0/40 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
0.00%
0/26 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
|
Musculoskeletal and connective tissue disorders
Osteoporosis
|
0.00%
0/51 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
3.8%
1/26 • Number of events 1 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
0.00%
0/40 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
0.00%
0/26 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
|
Musculoskeletal and connective tissue disorders
Rotator cuff syndrome
|
0.00%
0/51 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
3.8%
1/26 • Number of events 1 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
0.00%
0/40 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
0.00%
0/26 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
|
Musculoskeletal and connective tissue disorders
Synovial cyst
|
0.00%
0/51 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
3.8%
1/26 • Number of events 1 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
0.00%
0/40 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
0.00%
0/26 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
2.0%
1/51 • Number of events 4 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
0.00%
0/26 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
0.00%
0/40 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
0.00%
0/26 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma
|
2.0%
1/51 • Number of events 1 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
0.00%
0/26 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
0.00%
0/40 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
0.00%
0/26 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma of skin
|
2.0%
1/51 • Number of events 1 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
0.00%
0/26 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
0.00%
0/40 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
0.00%
0/26 • Up to 30 days after the last study treatment administration/early termination, approximately 33 months
The safety population included all subjects who received at least one injection of study treatment. Subjects were analysed as treated.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place