Trial Outcomes & Findings for Efficacy and Safety of Lanreotide Autogel® 60, 90 or 120 mg With Lanreotide 40 mg Prolonged Release (PR) in Acromegaly (NCT NCT02493517)
NCT ID: NCT02493517
Last Updated: 2019-01-29
Results Overview
The standardised mean change from Baseline in age-adjusted log-transformed IGF-1 standard deviation score (SDS) at EOST/EW is presented for subjects treated with both lanreotide Autogel and lanreotide PR. Back-transformed results are presented in addition to the results without back-transformation. For each subject the IGF-1 SDS value was calculated based on the z-score derivation: IGF-1 SDS = (IGF-1 - mean)/ standard deviation (SD), with mean and SD derived from the upper limit of normal (ULN) and lower limit of normal (LLN) margins for each age category. ULN = Mean + 2 SD; LLN = Mean - 2 SD. The SDS indicates the number of standard deviations away from the mean. A SDS of 0 is equal to the mean with negative numbers indicating values lower than the mean and positive values higher. A negative change in the SDS indicates a decrease in the mean age-adjusted IGF-1 values.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
128 participants
Primary outcome timeframe
Baseline to EOST/EW Visit (up to Week 33 for the lanreotide Autogel group and up to Week 32 for the lanreotide PR group).
Results posted on
2019-01-29
Participant Flow
Adult subjects with active acromegaly, defined as elevated Insulin-like Growth Factor 1 (IGF-1) and Growth Hormone (GH) levels, were recruited into 10 study sites in China.
170 subjects were screened and 128 eligible subjects were stratified according to surgical history (previous pituitary surgery or no previous pituitary surgery) and randomised in a 1:1 ratio to receive lanreotide Autogel or lanreotide prolonged release (PR). All randomised subjects were treated.
Participant milestones
| Measure |
Lanreotide Autogel
Subjects were randomised to receive lanreotide Autogel. Lanreotide Autogel was administered subcutaneously (s.c.) at a fixed dose of 90 milligrams (mg) every 4 weeks from Day 1, Week 1 to Week 17. At Week 17 the dose was continued at 90 mg or titrated to 60 mg or 120 mg, administered every 4 weeks according to the individual subject's response as determined by the mean value of the GH cycles and IGF-1 measured at the previous Week 13 Visit. The last dose of lanreotide Autogel was given at Week 29, followed by End of Study Treatment (EOST) / Early Withdrawal (EW) Visit at Week 33.
|
Lanreotide PR
Subjects were randomised to receive lanreotide PR. Lanreotide PR was administered intramuscularly (i.m.) every 10 days from Day 1, Week 1 up to Week 16. At Week 16 the injection interval was maintained at 10 days or was adjusted to 7 or 14 days according to the individual subject's response as determined by the mean value of GH cycle and IGF-1 measured at the previous Week 13 Visit. The last dose of lanreotide PR was administered at Week 31. The EOST/EW Visit was at Week 32.
|
|---|---|---|
|
Overall Study
STARTED
|
64
|
64
|
|
Overall Study
COMPLETED
|
62
|
57
|
|
Overall Study
NOT COMPLETED
|
2
|
7
|
Reasons for withdrawal
| Measure |
Lanreotide Autogel
Subjects were randomised to receive lanreotide Autogel. Lanreotide Autogel was administered subcutaneously (s.c.) at a fixed dose of 90 milligrams (mg) every 4 weeks from Day 1, Week 1 to Week 17. At Week 17 the dose was continued at 90 mg or titrated to 60 mg or 120 mg, administered every 4 weeks according to the individual subject's response as determined by the mean value of the GH cycles and IGF-1 measured at the previous Week 13 Visit. The last dose of lanreotide Autogel was given at Week 29, followed by End of Study Treatment (EOST) / Early Withdrawal (EW) Visit at Week 33.
|
Lanreotide PR
Subjects were randomised to receive lanreotide PR. Lanreotide PR was administered intramuscularly (i.m.) every 10 days from Day 1, Week 1 up to Week 16. At Week 16 the injection interval was maintained at 10 days or was adjusted to 7 or 14 days according to the individual subject's response as determined by the mean value of GH cycle and IGF-1 measured at the previous Week 13 Visit. The last dose of lanreotide PR was administered at Week 31. The EOST/EW Visit was at Week 32.
|
|---|---|---|
|
Overall Study
Protocol Violation
|
1
|
2
|
|
Overall Study
Withdrawal by Subject
|
1
|
2
|
|
Overall Study
Adverse Event
|
0
|
2
|
|
Overall Study
Missed study visit
|
0
|
1
|
Baseline Characteristics
Efficacy and Safety of Lanreotide Autogel® 60, 90 or 120 mg With Lanreotide 40 mg Prolonged Release (PR) in Acromegaly
Baseline characteristics by cohort
| Measure |
Lanreotide Autogel
n=64 Participants
Subjects were randomised to receive lanreotide Autogel. Lanreotide Autogel was administered s.c. at a fixed dose of 90 mg every 4 weeks from Day 1, Week 1 to Week 17. At Week 17 the dose was continued at 90 mg or titrated to 60 mg or 120 mg every 4 weeks according to the individual subject's response as determined by the mean value of the GH cycles and IGF-1 measured at the previous Week 13 Visit. The last dose of lanreotide Autogel was given at Week 29, followed by EOST/EW Visit at Week 33.
|
Lanreotide PR
n=64 Participants
Subjects were randomised to receive lanreotide PR. Lanreotide PR was administered i.m. every 10 days from Day 1, Week 1 up to Week 16. At Week 16 the injection interval was maintained at 10 days or was adjusted to 7 or 14 days according to the individual subject's response as determined by the mean value of GH cycle and IGF-1 measured at the previous visit at Week 13. The last dose of lanreotide PR was administered at Week 31. The EOST/EW Visit was at Week 32.
|
Total Title
n=128 Participants
|
|---|---|---|---|
|
Age, Continuous
|
37.9 years
STANDARD_DEVIATION 11.2 • n=5 Participants
|
40.8 years
STANDARD_DEVIATION 12.6 • n=7 Participants
|
39.4 years
STANDARD_DEVIATION 11.9 • n=5 Participants
|
|
Sex: Female, Male
Female
|
38 Participants
n=5 Participants
|
40 Participants
n=7 Participants
|
78 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
26 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
50 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
64 Participants
n=5 Participants
|
64 Participants
n=7 Participants
|
128 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline to EOST/EW Visit (up to Week 33 for the lanreotide Autogel group and up to Week 32 for the lanreotide PR group).Population: The Per Protocol population consisted of all subjects who were randomised and treated with at least one baseline and at least one postbaseline assessment of the primary efficacy parameter and for whom no major protocol deviations occurred with impact on efficacy assessment.
The standardised mean change from Baseline in age-adjusted log-transformed IGF-1 standard deviation score (SDS) at EOST/EW is presented for subjects treated with both lanreotide Autogel and lanreotide PR. Back-transformed results are presented in addition to the results without back-transformation. For each subject the IGF-1 SDS value was calculated based on the z-score derivation: IGF-1 SDS = (IGF-1 - mean)/ standard deviation (SD), with mean and SD derived from the upper limit of normal (ULN) and lower limit of normal (LLN) margins for each age category. ULN = Mean + 2 SD; LLN = Mean - 2 SD. The SDS indicates the number of standard deviations away from the mean. A SDS of 0 is equal to the mean with negative numbers indicating values lower than the mean and positive values higher. A negative change in the SDS indicates a decrease in the mean age-adjusted IGF-1 values.
Outcome measures
| Measure |
Lanreotide Autogel
n=54 Participants
Subjects were randomised to receive lanreotide Autogel. Lanreotide Autogel was administered s.c. at a fixed dose of 90 mg every 4 weeks from Day 1, Week 1 to Week 17. At Week 17 the dose was continued at 90 mg or titrated to 60 mg or 120 mg every 4 weeks according to the individual subject's response as determined by the mean value of the GH cycles and IGF-1 measured at the previous Week 13 Visit. The last dose of lanreotide Autogel was given at Week 29, followed by EOST/EW Visit at Week 33.
|
Lanreotide PR
n=44 Participants
Subjects were randomised to receive lanreotide PR. Lanreotide PR was administered i.m. every 10 days from Day 1, Week 1 up to Week 16. At Week 16 the injection interval was maintained at 10 days or was adjusted to 7 or 14 days according to the individual subject's response as determined by the mean value of GH cycle and IGF-1 measured at the previous visit at Week 13. The last dose of lanreotide PR was administered at Week 31. The EOST/EW Visit was at Week 32.
|
|---|---|---|
|
Standardised Mean Change From Baseline in Age-adjusted IGF-1 Levels at the EOST/EW Visit
Without back-transformation
|
-0.84 SDS
Standard Error 0.15
|
-0.52 SDS
Standard Error 0.17
|
|
Standardised Mean Change From Baseline in Age-adjusted IGF-1 Levels at the EOST/EW Visit
With back transformation
|
0.43 SDS
Standard Error 1.16
|
0.59 SDS
Standard Error 1.19
|
SECONDARY outcome
Timeframe: Baseline to EOST/EW Visit (up to Week 33 for the lanreotide Autogel group and up to Week 32 for the lanreotide PR group).Population: The Intention-To-Treat (ITT) population consisted of all randomised and treated subjects who had at least one baseline and at least one postbaseline assessment of the primary efficacy parameter. The ITT population was analysed using subjects as randomised.
The percentage of subjects with normal age-adjusted IGF-1 levels at the EOST/EW Visit is presented for subjects treated with Lanreotide Autogel and Lanreotide PR. At baseline, all subjects had abnormal IGF-1 levels as per protocol entry criteria.
Outcome measures
| Measure |
Lanreotide Autogel
n=64 Participants
Subjects were randomised to receive lanreotide Autogel. Lanreotide Autogel was administered s.c. at a fixed dose of 90 mg every 4 weeks from Day 1, Week 1 to Week 17. At Week 17 the dose was continued at 90 mg or titrated to 60 mg or 120 mg every 4 weeks according to the individual subject's response as determined by the mean value of the GH cycles and IGF-1 measured at the previous Week 13 Visit. The last dose of lanreotide Autogel was given at Week 29, followed by EOST/EW Visit at Week 33.
|
Lanreotide PR
n=64 Participants
Subjects were randomised to receive lanreotide PR. Lanreotide PR was administered i.m. every 10 days from Day 1, Week 1 up to Week 16. At Week 16 the injection interval was maintained at 10 days or was adjusted to 7 or 14 days according to the individual subject's response as determined by the mean value of GH cycle and IGF-1 measured at the previous visit at Week 13. The last dose of lanreotide PR was administered at Week 31. The EOST/EW Visit was at Week 32.
|
|---|---|---|
|
Percentage of Subjects With Normal Age-adjusted IGF-1 Levels at the EOST/EW Visit
|
15.6 Percentage of Subjects
|
9.4 Percentage of Subjects
|
SECONDARY outcome
Timeframe: Baseline to EOST/EW Visit (up to Week 33 for the lanreotide Autogel group and up to Week 32 for the lanreotide PR group).Population: The ITT population consisted of all randomised and treated subjects who had at least one baseline and at least one postbaseline assessment of the primary efficacy parameter. The ITT population was analysed using subjects as randomised.
The percentage of subjects with GH ≤2.5 mcg/L at the EOST/EW Visit is presented for subjects treated with lanreotide Autogel and lanreotide PR. At baseline, all subjects had GH levels \>2.5 mcg/L as per protocol entry criteria.
Outcome measures
| Measure |
Lanreotide Autogel
n=64 Participants
Subjects were randomised to receive lanreotide Autogel. Lanreotide Autogel was administered s.c. at a fixed dose of 90 mg every 4 weeks from Day 1, Week 1 to Week 17. At Week 17 the dose was continued at 90 mg or titrated to 60 mg or 120 mg every 4 weeks according to the individual subject's response as determined by the mean value of the GH cycles and IGF-1 measured at the previous Week 13 Visit. The last dose of lanreotide Autogel was given at Week 29, followed by EOST/EW Visit at Week 33.
|
Lanreotide PR
n=64 Participants
Subjects were randomised to receive lanreotide PR. Lanreotide PR was administered i.m. every 10 days from Day 1, Week 1 up to Week 16. At Week 16 the injection interval was maintained at 10 days or was adjusted to 7 or 14 days according to the individual subject's response as determined by the mean value of GH cycle and IGF-1 measured at the previous visit at Week 13. The last dose of lanreotide PR was administered at Week 31. The EOST/EW Visit was at Week 32.
|
|---|---|---|
|
Percentage of Subjects With GH ≤2.5 Micrograms Per Litre (mcg/L) at the EOST/EW Visit
|
29.7 Percentage of Subjects
|
31.3 Percentage of Subjects
|
SECONDARY outcome
Timeframe: Baseline to EOST/EW Visit (up to Week 33 for the lanreotide Autogel group and up to Week 32 for the lanreotide PR group).Population: The ITT population consisted of all randomised and treated subjects who had at least one baseline and at least one postbaseline assessment of the primary efficacy parameter. The ITT population was analysed using subjects as randomised.
The percentage of subjects with GH ≤1 mcg/L at the EOST/EW Visit is presented for subjects treated with lanreotide Autogel and lanreotide PR. At baseline, all subjects had GH levels \>2.5 mcg/L as per protocol entry criteria.
Outcome measures
| Measure |
Lanreotide Autogel
n=64 Participants
Subjects were randomised to receive lanreotide Autogel. Lanreotide Autogel was administered s.c. at a fixed dose of 90 mg every 4 weeks from Day 1, Week 1 to Week 17. At Week 17 the dose was continued at 90 mg or titrated to 60 mg or 120 mg every 4 weeks according to the individual subject's response as determined by the mean value of the GH cycles and IGF-1 measured at the previous Week 13 Visit. The last dose of lanreotide Autogel was given at Week 29, followed by EOST/EW Visit at Week 33.
|
Lanreotide PR
n=64 Participants
Subjects were randomised to receive lanreotide PR. Lanreotide PR was administered i.m. every 10 days from Day 1, Week 1 up to Week 16. At Week 16 the injection interval was maintained at 10 days or was adjusted to 7 or 14 days according to the individual subject's response as determined by the mean value of GH cycle and IGF-1 measured at the previous visit at Week 13. The last dose of lanreotide PR was administered at Week 31. The EOST/EW Visit was at Week 32.
|
|---|---|---|
|
The Percentage of Subjects With GH ≤1 mcg/L at the EOST/EW Visit
|
10.9 Percentage of Subjects
|
9.4 Percentage of Subjects
|
SECONDARY outcome
Timeframe: Baseline to EOST/EW Visit (up to Week 33 for the lanreotide Autogel group and up to Week 32 for the lanreotide PR group).Population: The ITT population consisted of all randomised and treated subjects who had at least one baseline and at least one postbaseline assessment of the primary efficacy parameter. The ITT population was analysed using subjects as randomised.
The percentage of subjects with normal age-adjusted IGF-1 levels and who have GH levels \>1 mcg/L but ≤2.5 mcg/L at the EOST/EW Visit is presented for subjects treated with lanreotide Autogel and lanreotide PR. The calculation of percentages was based on the overall ITT population. At baseline, all subjects had abnormal IGF-1 levels and GH levels \>2.5 mcg/L as per protocol entry criteria.
Outcome measures
| Measure |
Lanreotide Autogel
n=64 Participants
Subjects were randomised to receive lanreotide Autogel. Lanreotide Autogel was administered s.c. at a fixed dose of 90 mg every 4 weeks from Day 1, Week 1 to Week 17. At Week 17 the dose was continued at 90 mg or titrated to 60 mg or 120 mg every 4 weeks according to the individual subject's response as determined by the mean value of the GH cycles and IGF-1 measured at the previous Week 13 Visit. The last dose of lanreotide Autogel was given at Week 29, followed by EOST/EW Visit at Week 33.
|
Lanreotide PR
n=64 Participants
Subjects were randomised to receive lanreotide PR. Lanreotide PR was administered i.m. every 10 days from Day 1, Week 1 up to Week 16. At Week 16 the injection interval was maintained at 10 days or was adjusted to 7 or 14 days according to the individual subject's response as determined by the mean value of GH cycle and IGF-1 measured at the previous visit at Week 13. The last dose of lanreotide PR was administered at Week 31. The EOST/EW Visit was at Week 32.
|
|---|---|---|
|
Percentage of Subjects With Normal Age-adjusted IGF-1 Levels and Who Have GH Levels >1 mcg/L and ≤2.5 mcg/L at the EOST/EW Visit
|
7.8 Percentage of Subjects
|
3.1 Percentage of Subjects
|
SECONDARY outcome
Timeframe: Baseline to EOST/EW Visit (up to Week 33 for the lanreotide Autogel group and up to Week 32 for the lanreotide PR group).Population: The ITT population consisted of all randomised and treated subjects who had at least one baseline and at least one postbaseline assessment of the primary efficacy parameter. The ITT population was analysed using subjects as randomised. Subjects with data available at time of analysis are presented.
The mean change from baseline in GH values at the EOST/EW Visit is presented for subjects treated with lanreotide Autogel and lanreotide PR.
Outcome measures
| Measure |
Lanreotide Autogel
n=64 Participants
Subjects were randomised to receive lanreotide Autogel. Lanreotide Autogel was administered s.c. at a fixed dose of 90 mg every 4 weeks from Day 1, Week 1 to Week 17. At Week 17 the dose was continued at 90 mg or titrated to 60 mg or 120 mg every 4 weeks according to the individual subject's response as determined by the mean value of the GH cycles and IGF-1 measured at the previous Week 13 Visit. The last dose of lanreotide Autogel was given at Week 29, followed by EOST/EW Visit at Week 33.
|
Lanreotide PR
n=62 Participants
Subjects were randomised to receive lanreotide PR. Lanreotide PR was administered i.m. every 10 days from Day 1, Week 1 up to Week 16. At Week 16 the injection interval was maintained at 10 days or was adjusted to 7 or 14 days according to the individual subject's response as determined by the mean value of GH cycle and IGF-1 measured at the previous visit at Week 13. The last dose of lanreotide PR was administered at Week 31. The EOST/EW Visit was at Week 32.
|
|---|---|---|
|
Mean Change From Baseline in GH Values at the EOST/EW Visit
|
-9.548 mcg/L
Standard Deviation 22.852
|
-13.182 mcg/L
Standard Deviation 20.224
|
SECONDARY outcome
Timeframe: Baseline to EOST/EW Visit (up to Week 33 for the lanreotide Autogel group and up to Week 32 for the lanreotide PR group).Population: The ITT population consisted of all randomised and treated subjects who had at least one baseline and at least one postbaseline assessment of the primary efficacy parameter. The ITT population was analysed using subjects as randomised. Data is presented for the subgroup of subjects in the ITT population who had solid tumours at baseline.
The percentage of subjects with at least a 20% reduction in the solid component of the tumour volume at the EOST/EW Visit compared to baseline is presented for the subgroup of subjects who had solid tumours at baseline. The tumour volume was measured by Magnetic Resonance Imaging (MRI) at Screening and at the EOST/EW Visit, and then assessed by two independent blinded readers.
Outcome measures
| Measure |
Lanreotide Autogel
n=55 Participants
Subjects were randomised to receive lanreotide Autogel. Lanreotide Autogel was administered s.c. at a fixed dose of 90 mg every 4 weeks from Day 1, Week 1 to Week 17. At Week 17 the dose was continued at 90 mg or titrated to 60 mg or 120 mg every 4 weeks according to the individual subject's response as determined by the mean value of the GH cycles and IGF-1 measured at the previous Week 13 Visit. The last dose of lanreotide Autogel was given at Week 29, followed by EOST/EW Visit at Week 33.
|
Lanreotide PR
n=53 Participants
Subjects were randomised to receive lanreotide PR. Lanreotide PR was administered i.m. every 10 days from Day 1, Week 1 up to Week 16. At Week 16 the injection interval was maintained at 10 days or was adjusted to 7 or 14 days according to the individual subject's response as determined by the mean value of GH cycle and IGF-1 measured at the previous visit at Week 13. The last dose of lanreotide PR was administered at Week 31. The EOST/EW Visit was at Week 32.
|
|---|---|---|
|
Percentage of Subjects With at Least 20% Reduction in Tumour Volume at EOST/EW Visit Compared to Baseline
|
45.5 Percentage of Subjects
|
50.9 Percentage of Subjects
|
SECONDARY outcome
Timeframe: Baseline to EOST/EW Visit (up to Week 33 for the lanreotide Autogel group and up to Week 32 for the lanreotide PR group).Population: The ITT population consisted of all randomised and treated subjects who had at least one baseline and at least one postbaseline assessment of the primary efficacy parameter. The ITT population was analysed using subjects as randomised. Data is presented for the subgroup of subjects in the ITT population who had solid tumours at baseline.
The median percentage change in the solid component of the tumour volume from baseline to the EOST/EW Visit is presented. The tumour volume was measured by MRI at Screening and at the EOST/EW Visit, and then assessed by two independent blinded readers.
Outcome measures
| Measure |
Lanreotide Autogel
n=55 Participants
Subjects were randomised to receive lanreotide Autogel. Lanreotide Autogel was administered s.c. at a fixed dose of 90 mg every 4 weeks from Day 1, Week 1 to Week 17. At Week 17 the dose was continued at 90 mg or titrated to 60 mg or 120 mg every 4 weeks according to the individual subject's response as determined by the mean value of the GH cycles and IGF-1 measured at the previous Week 13 Visit. The last dose of lanreotide Autogel was given at Week 29, followed by EOST/EW Visit at Week 33.
|
Lanreotide PR
n=53 Participants
Subjects were randomised to receive lanreotide PR. Lanreotide PR was administered i.m. every 10 days from Day 1, Week 1 up to Week 16. At Week 16 the injection interval was maintained at 10 days or was adjusted to 7 or 14 days according to the individual subject's response as determined by the mean value of GH cycle and IGF-1 measured at the previous visit at Week 13. The last dose of lanreotide PR was administered at Week 31. The EOST/EW Visit was at Week 32.
|
|---|---|---|
|
Median Percentage Change From Baseline in Tumour Volume at the EOST/EW Visit
|
-17.870 Percentage change in tumour volume
Interval -75.77 to 95259.11
|
-20.120 Percentage change in tumour volume
Interval -86.41 to 113.03
|
SECONDARY outcome
Timeframe: Baseline, Week 13 Visit and EOST/EW Visit (up to Week 33 for the lanreotide Autogel group and up to Week 32 for the lanreotide PR group).Population: The ITT population consisted of all randomised and treated subjects who had at least one baseline and at least one postbaseline assessment of the primary efficacy parameter. The ITT population was analysed using subjects as randomised.
The percentage of subjects with at least one symptom of acromegaly at Week 13 and at the EOST/EW Visit compared with baseline is presented for subjects treated with lanreotide Autogel and lanreotide PR. The symptoms of acromegaly monitored included: headache, excessive perspiration, fatigue, soft tissue swelling and arthralgia.
Outcome measures
| Measure |
Lanreotide Autogel
n=64 Participants
Subjects were randomised to receive lanreotide Autogel. Lanreotide Autogel was administered s.c. at a fixed dose of 90 mg every 4 weeks from Day 1, Week 1 to Week 17. At Week 17 the dose was continued at 90 mg or titrated to 60 mg or 120 mg every 4 weeks according to the individual subject's response as determined by the mean value of the GH cycles and IGF-1 measured at the previous Week 13 Visit. The last dose of lanreotide Autogel was given at Week 29, followed by EOST/EW Visit at Week 33.
|
Lanreotide PR
n=64 Participants
Subjects were randomised to receive lanreotide PR. Lanreotide PR was administered i.m. every 10 days from Day 1, Week 1 up to Week 16. At Week 16 the injection interval was maintained at 10 days or was adjusted to 7 or 14 days according to the individual subject's response as determined by the mean value of GH cycle and IGF-1 measured at the previous visit at Week 13. The last dose of lanreotide PR was administered at Week 31. The EOST/EW Visit was at Week 32.
|
|---|---|---|
|
Percentage of Subjects With at Least One Symptom of Acromegaly at Week 13 and at the EOST/EW Visit Compared to Baseline
Week 13 Visit
|
70.3 Percentage of Subjects
|
59.4 Percentage of Subjects
|
|
Percentage of Subjects With at Least One Symptom of Acromegaly at Week 13 and at the EOST/EW Visit Compared to Baseline
EOST/EW Visit
|
75.0 Percentage of Subjects
|
59.4 Percentage of Subjects
|
Adverse Events
Lanreotide Autogel
Serious events: 1 serious events
Other events: 59 other events
Deaths: 0 deaths
Lanreotide PR
Serious events: 2 serious events
Other events: 62 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Lanreotide Autogel
n=64 participants at risk
Subjects were randomised to receive lanreotide Autogel. Lanreotide Autogel was administered s.c. at a fixed dose of 90 mg every 4 weeks from Day 1, Week 1 to Week 17. At Week 17 the dose was continued at 90 mg or titrated to 60 mg or 120 mg every 4 weeks according to the individual subject's response as determined by the mean value of the GH cycles and IGF-1 measured at the previous Week 13 Visit. The last dose of lanreotide Autogel was given at Week 29, followed by EOST/EW Visit at Week 33.
|
Lanreotide PR
n=64 participants at risk
Subjects were randomised to receive lanreotide PR. Lanreotide PR was administered i.m. every 10 days from Day 1, Week 1 up to Week 16. At Week 16 the injection interval was maintained at 10 days or was adjusted to 7 or 14 days according to the individual subject's response as determined by the mean value of GH cycle and IGF-1 measured at the previous visit at Week 13. The last dose of lanreotide PR was administered at Week 31. The EOST/EW Visit was at Week 32.
|
|---|---|---|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pituitary tumour
|
1.6%
1/64 • Number of events 1 • Treatment emergent adverse events (TEAEs) were collected from the first dose of study treatment up to the EOST/EW Visit (up to approximately 33 weeks).
TEAEs were reported for the Safety population which consisted of all randomised subjects who received at least one dose of study treatment. The Safety population was analysed using subjects as treated.
|
0.00%
0/64 • Treatment emergent adverse events (TEAEs) were collected from the first dose of study treatment up to the EOST/EW Visit (up to approximately 33 weeks).
TEAEs were reported for the Safety population which consisted of all randomised subjects who received at least one dose of study treatment. The Safety population was analysed using subjects as treated.
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/64 • Treatment emergent adverse events (TEAEs) were collected from the first dose of study treatment up to the EOST/EW Visit (up to approximately 33 weeks).
TEAEs were reported for the Safety population which consisted of all randomised subjects who received at least one dose of study treatment. The Safety population was analysed using subjects as treated.
|
1.6%
1/64 • Number of events 1 • Treatment emergent adverse events (TEAEs) were collected from the first dose of study treatment up to the EOST/EW Visit (up to approximately 33 weeks).
TEAEs were reported for the Safety population which consisted of all randomised subjects who received at least one dose of study treatment. The Safety population was analysed using subjects as treated.
|
|
Nervous system disorders
Cerebral infarction
|
0.00%
0/64 • Treatment emergent adverse events (TEAEs) were collected from the first dose of study treatment up to the EOST/EW Visit (up to approximately 33 weeks).
TEAEs were reported for the Safety population which consisted of all randomised subjects who received at least one dose of study treatment. The Safety population was analysed using subjects as treated.
|
1.6%
1/64 • Number of events 1 • Treatment emergent adverse events (TEAEs) were collected from the first dose of study treatment up to the EOST/EW Visit (up to approximately 33 weeks).
TEAEs were reported for the Safety population which consisted of all randomised subjects who received at least one dose of study treatment. The Safety population was analysed using subjects as treated.
|
Other adverse events
| Measure |
Lanreotide Autogel
n=64 participants at risk
Subjects were randomised to receive lanreotide Autogel. Lanreotide Autogel was administered s.c. at a fixed dose of 90 mg every 4 weeks from Day 1, Week 1 to Week 17. At Week 17 the dose was continued at 90 mg or titrated to 60 mg or 120 mg every 4 weeks according to the individual subject's response as determined by the mean value of the GH cycles and IGF-1 measured at the previous Week 13 Visit. The last dose of lanreotide Autogel was given at Week 29, followed by EOST/EW Visit at Week 33.
|
Lanreotide PR
n=64 participants at risk
Subjects were randomised to receive lanreotide PR. Lanreotide PR was administered i.m. every 10 days from Day 1, Week 1 up to Week 16. At Week 16 the injection interval was maintained at 10 days or was adjusted to 7 or 14 days according to the individual subject's response as determined by the mean value of GH cycle and IGF-1 measured at the previous visit at Week 13. The last dose of lanreotide PR was administered at Week 31. The EOST/EW Visit was at Week 32.
|
|---|---|---|
|
General disorders
Chest discomfort
|
4.7%
3/64 • Number of events 9 • Treatment emergent adverse events (TEAEs) were collected from the first dose of study treatment up to the EOST/EW Visit (up to approximately 33 weeks).
TEAEs were reported for the Safety population which consisted of all randomised subjects who received at least one dose of study treatment. The Safety population was analysed using subjects as treated.
|
7.8%
5/64 • Number of events 10 • Treatment emergent adverse events (TEAEs) were collected from the first dose of study treatment up to the EOST/EW Visit (up to approximately 33 weeks).
TEAEs were reported for the Safety population which consisted of all randomised subjects who received at least one dose of study treatment. The Safety population was analysed using subjects as treated.
|
|
General disorders
Pyrexia
|
4.7%
3/64 • Number of events 4 • Treatment emergent adverse events (TEAEs) were collected from the first dose of study treatment up to the EOST/EW Visit (up to approximately 33 weeks).
TEAEs were reported for the Safety population which consisted of all randomised subjects who received at least one dose of study treatment. The Safety population was analysed using subjects as treated.
|
6.2%
4/64 • Number of events 4 • Treatment emergent adverse events (TEAEs) were collected from the first dose of study treatment up to the EOST/EW Visit (up to approximately 33 weeks).
TEAEs were reported for the Safety population which consisted of all randomised subjects who received at least one dose of study treatment. The Safety population was analysed using subjects as treated.
|
|
General disorders
Injection site pain
|
3.1%
2/64 • Number of events 2 • Treatment emergent adverse events (TEAEs) were collected from the first dose of study treatment up to the EOST/EW Visit (up to approximately 33 weeks).
TEAEs were reported for the Safety population which consisted of all randomised subjects who received at least one dose of study treatment. The Safety population was analysed using subjects as treated.
|
14.1%
9/64 • Number of events 38 • Treatment emergent adverse events (TEAEs) were collected from the first dose of study treatment up to the EOST/EW Visit (up to approximately 33 weeks).
TEAEs were reported for the Safety population which consisted of all randomised subjects who received at least one dose of study treatment. The Safety population was analysed using subjects as treated.
|
|
General disorders
Injection site swelling
|
0.00%
0/64 • Treatment emergent adverse events (TEAEs) were collected from the first dose of study treatment up to the EOST/EW Visit (up to approximately 33 weeks).
TEAEs were reported for the Safety population which consisted of all randomised subjects who received at least one dose of study treatment. The Safety population was analysed using subjects as treated.
|
9.4%
6/64 • Number of events 24 • Treatment emergent adverse events (TEAEs) were collected from the first dose of study treatment up to the EOST/EW Visit (up to approximately 33 weeks).
TEAEs were reported for the Safety population which consisted of all randomised subjects who received at least one dose of study treatment. The Safety population was analysed using subjects as treated.
|
|
Nervous system disorders
Headache
|
15.6%
10/64 • Number of events 17 • Treatment emergent adverse events (TEAEs) were collected from the first dose of study treatment up to the EOST/EW Visit (up to approximately 33 weeks).
TEAEs were reported for the Safety population which consisted of all randomised subjects who received at least one dose of study treatment. The Safety population was analysed using subjects as treated.
|
26.6%
17/64 • Number of events 61 • Treatment emergent adverse events (TEAEs) were collected from the first dose of study treatment up to the EOST/EW Visit (up to approximately 33 weeks).
TEAEs were reported for the Safety population which consisted of all randomised subjects who received at least one dose of study treatment. The Safety population was analysed using subjects as treated.
|
|
Nervous system disorders
Dizziness
|
9.4%
6/64 • Number of events 11 • Treatment emergent adverse events (TEAEs) were collected from the first dose of study treatment up to the EOST/EW Visit (up to approximately 33 weeks).
TEAEs were reported for the Safety population which consisted of all randomised subjects who received at least one dose of study treatment. The Safety population was analysed using subjects as treated.
|
15.6%
10/64 • Number of events 19 • Treatment emergent adverse events (TEAEs) were collected from the first dose of study treatment up to the EOST/EW Visit (up to approximately 33 weeks).
TEAEs were reported for the Safety population which consisted of all randomised subjects who received at least one dose of study treatment. The Safety population was analysed using subjects as treated.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
7.8%
5/64 • Number of events 5 • Treatment emergent adverse events (TEAEs) were collected from the first dose of study treatment up to the EOST/EW Visit (up to approximately 33 weeks).
TEAEs were reported for the Safety population which consisted of all randomised subjects who received at least one dose of study treatment. The Safety population was analysed using subjects as treated.
|
14.1%
9/64 • Number of events 9 • Treatment emergent adverse events (TEAEs) were collected from the first dose of study treatment up to the EOST/EW Visit (up to approximately 33 weeks).
TEAEs were reported for the Safety population which consisted of all randomised subjects who received at least one dose of study treatment. The Safety population was analysed using subjects as treated.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
6.2%
4/64 • Number of events 5 • Treatment emergent adverse events (TEAEs) were collected from the first dose of study treatment up to the EOST/EW Visit (up to approximately 33 weeks).
TEAEs were reported for the Safety population which consisted of all randomised subjects who received at least one dose of study treatment. The Safety population was analysed using subjects as treated.
|
7.8%
5/64 • Number of events 8 • Treatment emergent adverse events (TEAEs) were collected from the first dose of study treatment up to the EOST/EW Visit (up to approximately 33 weeks).
TEAEs were reported for the Safety population which consisted of all randomised subjects who received at least one dose of study treatment. The Safety population was analysed using subjects as treated.
|
|
Gastrointestinal disorders
Diarrhoea
|
79.7%
51/64 • Number of events 194 • Treatment emergent adverse events (TEAEs) were collected from the first dose of study treatment up to the EOST/EW Visit (up to approximately 33 weeks).
TEAEs were reported for the Safety population which consisted of all randomised subjects who received at least one dose of study treatment. The Safety population was analysed using subjects as treated.
|
71.9%
46/64 • Number of events 337 • Treatment emergent adverse events (TEAEs) were collected from the first dose of study treatment up to the EOST/EW Visit (up to approximately 33 weeks).
TEAEs were reported for the Safety population which consisted of all randomised subjects who received at least one dose of study treatment. The Safety population was analysed using subjects as treated.
|
|
Gastrointestinal disorders
Abdominal distension
|
34.4%
22/64 • Number of events 67 • Treatment emergent adverse events (TEAEs) were collected from the first dose of study treatment up to the EOST/EW Visit (up to approximately 33 weeks).
TEAEs were reported for the Safety population which consisted of all randomised subjects who received at least one dose of study treatment. The Safety population was analysed using subjects as treated.
|
42.2%
27/64 • Number of events 146 • Treatment emergent adverse events (TEAEs) were collected from the first dose of study treatment up to the EOST/EW Visit (up to approximately 33 weeks).
TEAEs were reported for the Safety population which consisted of all randomised subjects who received at least one dose of study treatment. The Safety population was analysed using subjects as treated.
|
|
Gastrointestinal disorders
Abdominal pain
|
28.1%
18/64 • Number of events 40 • Treatment emergent adverse events (TEAEs) were collected from the first dose of study treatment up to the EOST/EW Visit (up to approximately 33 weeks).
TEAEs were reported for the Safety population which consisted of all randomised subjects who received at least one dose of study treatment. The Safety population was analysed using subjects as treated.
|
31.2%
20/64 • Number of events 114 • Treatment emergent adverse events (TEAEs) were collected from the first dose of study treatment up to the EOST/EW Visit (up to approximately 33 weeks).
TEAEs were reported for the Safety population which consisted of all randomised subjects who received at least one dose of study treatment. The Safety population was analysed using subjects as treated.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
20.3%
13/64 • Number of events 32 • Treatment emergent adverse events (TEAEs) were collected from the first dose of study treatment up to the EOST/EW Visit (up to approximately 33 weeks).
TEAEs were reported for the Safety population which consisted of all randomised subjects who received at least one dose of study treatment. The Safety population was analysed using subjects as treated.
|
25.0%
16/64 • Number of events 37 • Treatment emergent adverse events (TEAEs) were collected from the first dose of study treatment up to the EOST/EW Visit (up to approximately 33 weeks).
TEAEs were reported for the Safety population which consisted of all randomised subjects who received at least one dose of study treatment. The Safety population was analysed using subjects as treated.
|
|
Gastrointestinal disorders
Nausea
|
10.9%
7/64 • Number of events 7 • Treatment emergent adverse events (TEAEs) were collected from the first dose of study treatment up to the EOST/EW Visit (up to approximately 33 weeks).
TEAEs were reported for the Safety population which consisted of all randomised subjects who received at least one dose of study treatment. The Safety population was analysed using subjects as treated.
|
25.0%
16/64 • Number of events 69 • Treatment emergent adverse events (TEAEs) were collected from the first dose of study treatment up to the EOST/EW Visit (up to approximately 33 weeks).
TEAEs were reported for the Safety population which consisted of all randomised subjects who received at least one dose of study treatment. The Safety population was analysed using subjects as treated.
|
|
Gastrointestinal disorders
Constipation
|
10.9%
7/64 • Number of events 14 • Treatment emergent adverse events (TEAEs) were collected from the first dose of study treatment up to the EOST/EW Visit (up to approximately 33 weeks).
TEAEs were reported for the Safety population which consisted of all randomised subjects who received at least one dose of study treatment. The Safety population was analysed using subjects as treated.
|
15.6%
10/64 • Number of events 14 • Treatment emergent adverse events (TEAEs) were collected from the first dose of study treatment up to the EOST/EW Visit (up to approximately 33 weeks).
TEAEs were reported for the Safety population which consisted of all randomised subjects who received at least one dose of study treatment. The Safety population was analysed using subjects as treated.
|
|
Gastrointestinal disorders
Flatulence
|
10.9%
7/64 • Number of events 8 • Treatment emergent adverse events (TEAEs) were collected from the first dose of study treatment up to the EOST/EW Visit (up to approximately 33 weeks).
TEAEs were reported for the Safety population which consisted of all randomised subjects who received at least one dose of study treatment. The Safety population was analysed using subjects as treated.
|
4.7%
3/64 • Number of events 5 • Treatment emergent adverse events (TEAEs) were collected from the first dose of study treatment up to the EOST/EW Visit (up to approximately 33 weeks).
TEAEs were reported for the Safety population which consisted of all randomised subjects who received at least one dose of study treatment. The Safety population was analysed using subjects as treated.
|
|
Gastrointestinal disorders
Toothache
|
6.2%
4/64 • Number of events 4 • Treatment emergent adverse events (TEAEs) were collected from the first dose of study treatment up to the EOST/EW Visit (up to approximately 33 weeks).
TEAEs were reported for the Safety population which consisted of all randomised subjects who received at least one dose of study treatment. The Safety population was analysed using subjects as treated.
|
7.8%
5/64 • Number of events 8 • Treatment emergent adverse events (TEAEs) were collected from the first dose of study treatment up to the EOST/EW Visit (up to approximately 33 weeks).
TEAEs were reported for the Safety population which consisted of all randomised subjects who received at least one dose of study treatment. The Safety population was analysed using subjects as treated.
|
|
Gastrointestinal disorders
Abdominal discomfort
|
6.2%
4/64 • Number of events 4 • Treatment emergent adverse events (TEAEs) were collected from the first dose of study treatment up to the EOST/EW Visit (up to approximately 33 weeks).
TEAEs were reported for the Safety population which consisted of all randomised subjects who received at least one dose of study treatment. The Safety population was analysed using subjects as treated.
|
4.7%
3/64 • Number of events 5 • Treatment emergent adverse events (TEAEs) were collected from the first dose of study treatment up to the EOST/EW Visit (up to approximately 33 weeks).
TEAEs were reported for the Safety population which consisted of all randomised subjects who received at least one dose of study treatment. The Safety population was analysed using subjects as treated.
|
|
Gastrointestinal disorders
Gastrointestinal sounds abnormal
|
4.7%
3/64 • Number of events 7 • Treatment emergent adverse events (TEAEs) were collected from the first dose of study treatment up to the EOST/EW Visit (up to approximately 33 weeks).
TEAEs were reported for the Safety population which consisted of all randomised subjects who received at least one dose of study treatment. The Safety population was analysed using subjects as treated.
|
14.1%
9/64 • Number of events 32 • Treatment emergent adverse events (TEAEs) were collected from the first dose of study treatment up to the EOST/EW Visit (up to approximately 33 weeks).
TEAEs were reported for the Safety population which consisted of all randomised subjects who received at least one dose of study treatment. The Safety population was analysed using subjects as treated.
|
|
Gastrointestinal disorders
Gastric dilatation
|
3.1%
2/64 • Number of events 2 • Treatment emergent adverse events (TEAEs) were collected from the first dose of study treatment up to the EOST/EW Visit (up to approximately 33 weeks).
TEAEs were reported for the Safety population which consisted of all randomised subjects who received at least one dose of study treatment. The Safety population was analysed using subjects as treated.
|
6.2%
4/64 • Number of events 7 • Treatment emergent adverse events (TEAEs) were collected from the first dose of study treatment up to the EOST/EW Visit (up to approximately 33 weeks).
TEAEs were reported for the Safety population which consisted of all randomised subjects who received at least one dose of study treatment. The Safety population was analysed using subjects as treated.
|
|
Gastrointestinal disorders
Rectal tenesmus
|
1.6%
1/64 • Number of events 1 • Treatment emergent adverse events (TEAEs) were collected from the first dose of study treatment up to the EOST/EW Visit (up to approximately 33 weeks).
TEAEs were reported for the Safety population which consisted of all randomised subjects who received at least one dose of study treatment. The Safety population was analysed using subjects as treated.
|
14.1%
9/64 • Number of events 37 • Treatment emergent adverse events (TEAEs) were collected from the first dose of study treatment up to the EOST/EW Visit (up to approximately 33 weeks).
TEAEs were reported for the Safety population which consisted of all randomised subjects who received at least one dose of study treatment. The Safety population was analysed using subjects as treated.
|
|
Gastrointestinal disorders
Vomiting
|
1.6%
1/64 • Number of events 1 • Treatment emergent adverse events (TEAEs) were collected from the first dose of study treatment up to the EOST/EW Visit (up to approximately 33 weeks).
TEAEs were reported for the Safety population which consisted of all randomised subjects who received at least one dose of study treatment. The Safety population was analysed using subjects as treated.
|
10.9%
7/64 • Number of events 9 • Treatment emergent adverse events (TEAEs) were collected from the first dose of study treatment up to the EOST/EW Visit (up to approximately 33 weeks).
TEAEs were reported for the Safety population which consisted of all randomised subjects who received at least one dose of study treatment. The Safety population was analysed using subjects as treated.
|
|
Hepatobiliary disorders
Cholelithiasis
|
35.9%
23/64 • Number of events 27 • Treatment emergent adverse events (TEAEs) were collected from the first dose of study treatment up to the EOST/EW Visit (up to approximately 33 weeks).
TEAEs were reported for the Safety population which consisted of all randomised subjects who received at least one dose of study treatment. The Safety population was analysed using subjects as treated.
|
28.1%
18/64 • Number of events 19 • Treatment emergent adverse events (TEAEs) were collected from the first dose of study treatment up to the EOST/EW Visit (up to approximately 33 weeks).
TEAEs were reported for the Safety population which consisted of all randomised subjects who received at least one dose of study treatment. The Safety population was analysed using subjects as treated.
|
|
Hepatobiliary disorders
Gallbladder enlargement
|
6.2%
4/64 • Number of events 4 • Treatment emergent adverse events (TEAEs) were collected from the first dose of study treatment up to the EOST/EW Visit (up to approximately 33 weeks).
TEAEs were reported for the Safety population which consisted of all randomised subjects who received at least one dose of study treatment. The Safety population was analysed using subjects as treated.
|
4.7%
3/64 • Number of events 3 • Treatment emergent adverse events (TEAEs) were collected from the first dose of study treatment up to the EOST/EW Visit (up to approximately 33 weeks).
TEAEs were reported for the Safety population which consisted of all randomised subjects who received at least one dose of study treatment. The Safety population was analysed using subjects as treated.
|
|
Hepatobiliary disorders
Cholestasis
|
6.2%
4/64 • Number of events 4 • Treatment emergent adverse events (TEAEs) were collected from the first dose of study treatment up to the EOST/EW Visit (up to approximately 33 weeks).
TEAEs were reported for the Safety population which consisted of all randomised subjects who received at least one dose of study treatment. The Safety population was analysed using subjects as treated.
|
1.6%
1/64 • Number of events 1 • Treatment emergent adverse events (TEAEs) were collected from the first dose of study treatment up to the EOST/EW Visit (up to approximately 33 weeks).
TEAEs were reported for the Safety population which consisted of all randomised subjects who received at least one dose of study treatment. The Safety population was analysed using subjects as treated.
|
|
Hepatobiliary disorders
Hepatic cyst
|
4.7%
3/64 • Number of events 3 • Treatment emergent adverse events (TEAEs) were collected from the first dose of study treatment up to the EOST/EW Visit (up to approximately 33 weeks).
TEAEs were reported for the Safety population which consisted of all randomised subjects who received at least one dose of study treatment. The Safety population was analysed using subjects as treated.
|
9.4%
6/64 • Number of events 6 • Treatment emergent adverse events (TEAEs) were collected from the first dose of study treatment up to the EOST/EW Visit (up to approximately 33 weeks).
TEAEs were reported for the Safety population which consisted of all randomised subjects who received at least one dose of study treatment. The Safety population was analysed using subjects as treated.
|
|
Infections and infestations
Upper respiratory tract infection
|
32.8%
21/64 • Number of events 28 • Treatment emergent adverse events (TEAEs) were collected from the first dose of study treatment up to the EOST/EW Visit (up to approximately 33 weeks).
TEAEs were reported for the Safety population which consisted of all randomised subjects who received at least one dose of study treatment. The Safety population was analysed using subjects as treated.
|
28.1%
18/64 • Number of events 31 • Treatment emergent adverse events (TEAEs) were collected from the first dose of study treatment up to the EOST/EW Visit (up to approximately 33 weeks).
TEAEs were reported for the Safety population which consisted of all randomised subjects who received at least one dose of study treatment. The Safety population was analysed using subjects as treated.
|
|
Infections and infestations
Nasopharyngitis
|
10.9%
7/64 • Number of events 17 • Treatment emergent adverse events (TEAEs) were collected from the first dose of study treatment up to the EOST/EW Visit (up to approximately 33 weeks).
TEAEs were reported for the Safety population which consisted of all randomised subjects who received at least one dose of study treatment. The Safety population was analysed using subjects as treated.
|
15.6%
10/64 • Number of events 12 • Treatment emergent adverse events (TEAEs) were collected from the first dose of study treatment up to the EOST/EW Visit (up to approximately 33 weeks).
TEAEs were reported for the Safety population which consisted of all randomised subjects who received at least one dose of study treatment. The Safety population was analysed using subjects as treated.
|
|
Infections and infestations
Urinary tract infection
|
6.2%
4/64 • Number of events 4 • Treatment emergent adverse events (TEAEs) were collected from the first dose of study treatment up to the EOST/EW Visit (up to approximately 33 weeks).
TEAEs were reported for the Safety population which consisted of all randomised subjects who received at least one dose of study treatment. The Safety population was analysed using subjects as treated.
|
7.8%
5/64 • Number of events 5 • Treatment emergent adverse events (TEAEs) were collected from the first dose of study treatment up to the EOST/EW Visit (up to approximately 33 weeks).
TEAEs were reported for the Safety population which consisted of all randomised subjects who received at least one dose of study treatment. The Safety population was analysed using subjects as treated.
|
|
Infections and infestations
Gastroenteritis
|
6.2%
4/64 • Number of events 4 • Treatment emergent adverse events (TEAEs) were collected from the first dose of study treatment up to the EOST/EW Visit (up to approximately 33 weeks).
TEAEs were reported for the Safety population which consisted of all randomised subjects who received at least one dose of study treatment. The Safety population was analysed using subjects as treated.
|
3.1%
2/64 • Number of events 2 • Treatment emergent adverse events (TEAEs) were collected from the first dose of study treatment up to the EOST/EW Visit (up to approximately 33 weeks).
TEAEs were reported for the Safety population which consisted of all randomised subjects who received at least one dose of study treatment. The Safety population was analysed using subjects as treated.
|
|
Investigations
Weight decreased
|
12.5%
8/64 • Number of events 9 • Treatment emergent adverse events (TEAEs) were collected from the first dose of study treatment up to the EOST/EW Visit (up to approximately 33 weeks).
TEAEs were reported for the Safety population which consisted of all randomised subjects who received at least one dose of study treatment. The Safety population was analysed using subjects as treated.
|
6.2%
4/64 • Number of events 4 • Treatment emergent adverse events (TEAEs) were collected from the first dose of study treatment up to the EOST/EW Visit (up to approximately 33 weeks).
TEAEs were reported for the Safety population which consisted of all randomised subjects who received at least one dose of study treatment. The Safety population was analysed using subjects as treated.
|
|
Investigations
Blood glucose increased
|
10.9%
7/64 • Number of events 7 • Treatment emergent adverse events (TEAEs) were collected from the first dose of study treatment up to the EOST/EW Visit (up to approximately 33 weeks).
TEAEs were reported for the Safety population which consisted of all randomised subjects who received at least one dose of study treatment. The Safety population was analysed using subjects as treated.
|
9.4%
6/64 • Number of events 6 • Treatment emergent adverse events (TEAEs) were collected from the first dose of study treatment up to the EOST/EW Visit (up to approximately 33 weeks).
TEAEs were reported for the Safety population which consisted of all randomised subjects who received at least one dose of study treatment. The Safety population was analysed using subjects as treated.
|
|
Investigations
Protein urine present
|
4.7%
3/64 • Number of events 3 • Treatment emergent adverse events (TEAEs) were collected from the first dose of study treatment up to the EOST/EW Visit (up to approximately 33 weeks).
TEAEs were reported for the Safety population which consisted of all randomised subjects who received at least one dose of study treatment. The Safety population was analysed using subjects as treated.
|
6.2%
4/64 • Number of events 4 • Treatment emergent adverse events (TEAEs) were collected from the first dose of study treatment up to the EOST/EW Visit (up to approximately 33 weeks).
TEAEs were reported for the Safety population which consisted of all randomised subjects who received at least one dose of study treatment. The Safety population was analysed using subjects as treated.
|
|
Investigations
Blood parathyroid hormone increased
|
1.6%
1/64 • Number of events 1 • Treatment emergent adverse events (TEAEs) were collected from the first dose of study treatment up to the EOST/EW Visit (up to approximately 33 weeks).
TEAEs were reported for the Safety population which consisted of all randomised subjects who received at least one dose of study treatment. The Safety population was analysed using subjects as treated.
|
7.8%
5/64 • Number of events 5 • Treatment emergent adverse events (TEAEs) were collected from the first dose of study treatment up to the EOST/EW Visit (up to approximately 33 weeks).
TEAEs were reported for the Safety population which consisted of all randomised subjects who received at least one dose of study treatment. The Safety population was analysed using subjects as treated.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
18.8%
12/64 • Number of events 12 • Treatment emergent adverse events (TEAEs) were collected from the first dose of study treatment up to the EOST/EW Visit (up to approximately 33 weeks).
TEAEs were reported for the Safety population which consisted of all randomised subjects who received at least one dose of study treatment. The Safety population was analysed using subjects as treated.
|
18.8%
12/64 • Number of events 12 • Treatment emergent adverse events (TEAEs) were collected from the first dose of study treatment up to the EOST/EW Visit (up to approximately 33 weeks).
TEAEs were reported for the Safety population which consisted of all randomised subjects who received at least one dose of study treatment. The Safety population was analysed using subjects as treated.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
15.6%
10/64 • Number of events 15 • Treatment emergent adverse events (TEAEs) were collected from the first dose of study treatment up to the EOST/EW Visit (up to approximately 33 weeks).
TEAEs were reported for the Safety population which consisted of all randomised subjects who received at least one dose of study treatment. The Safety population was analysed using subjects as treated.
|
0.00%
0/64 • Treatment emergent adverse events (TEAEs) were collected from the first dose of study treatment up to the EOST/EW Visit (up to approximately 33 weeks).
TEAEs were reported for the Safety population which consisted of all randomised subjects who received at least one dose of study treatment. The Safety population was analysed using subjects as treated.
|
|
General disorders
Injection site induration
|
9.4%
6/64 • Number of events 8 • Treatment emergent adverse events (TEAEs) were collected from the first dose of study treatment up to the EOST/EW Visit (up to approximately 33 weeks).
TEAEs were reported for the Safety population which consisted of all randomised subjects who received at least one dose of study treatment. The Safety population was analysed using subjects as treated.
|
21.9%
14/64 • Number of events 33 • Treatment emergent adverse events (TEAEs) were collected from the first dose of study treatment up to the EOST/EW Visit (up to approximately 33 weeks).
TEAEs were reported for the Safety population which consisted of all randomised subjects who received at least one dose of study treatment. The Safety population was analysed using subjects as treated.
|
|
Renal and urinary disorders
Renal cyst
|
6.2%
4/64 • Number of events 4 • Treatment emergent adverse events (TEAEs) were collected from the first dose of study treatment up to the EOST/EW Visit (up to approximately 33 weeks).
TEAEs were reported for the Safety population which consisted of all randomised subjects who received at least one dose of study treatment. The Safety population was analysed using subjects as treated.
|
9.4%
6/64 • Number of events 6 • Treatment emergent adverse events (TEAEs) were collected from the first dose of study treatment up to the EOST/EW Visit (up to approximately 33 weeks).
TEAEs were reported for the Safety population which consisted of all randomised subjects who received at least one dose of study treatment. The Safety population was analysed using subjects as treated.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
7.8%
5/64 • Number of events 8 • Treatment emergent adverse events (TEAEs) were collected from the first dose of study treatment up to the EOST/EW Visit (up to approximately 33 weeks).
TEAEs were reported for the Safety population which consisted of all randomised subjects who received at least one dose of study treatment. The Safety population was analysed using subjects as treated.
|
4.7%
3/64 • Number of events 5 • Treatment emergent adverse events (TEAEs) were collected from the first dose of study treatment up to the EOST/EW Visit (up to approximately 33 weeks).
TEAEs were reported for the Safety population which consisted of all randomised subjects who received at least one dose of study treatment. The Safety population was analysed using subjects as treated.
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
3.1%
2/64 • Number of events 2 • Treatment emergent adverse events (TEAEs) were collected from the first dose of study treatment up to the EOST/EW Visit (up to approximately 33 weeks).
TEAEs were reported for the Safety population which consisted of all randomised subjects who received at least one dose of study treatment. The Safety population was analysed using subjects as treated.
|
6.2%
4/64 • Number of events 5 • Treatment emergent adverse events (TEAEs) were collected from the first dose of study treatment up to the EOST/EW Visit (up to approximately 33 weeks).
TEAEs were reported for the Safety population which consisted of all randomised subjects who received at least one dose of study treatment. The Safety population was analysed using subjects as treated.
|
|
Cardiac disorders
Sinus bradycardia
|
14.1%
9/64 • Number of events 9 • Treatment emergent adverse events (TEAEs) were collected from the first dose of study treatment up to the EOST/EW Visit (up to approximately 33 weeks).
TEAEs were reported for the Safety population which consisted of all randomised subjects who received at least one dose of study treatment. The Safety population was analysed using subjects as treated.
|
18.8%
12/64 • Number of events 12 • Treatment emergent adverse events (TEAEs) were collected from the first dose of study treatment up to the EOST/EW Visit (up to approximately 33 weeks).
TEAEs were reported for the Safety population which consisted of all randomised subjects who received at least one dose of study treatment. The Safety population was analysed using subjects as treated.
|
|
Endocrine disorders
Thyroid mass
|
6.2%
4/64 • Number of events 4 • Treatment emergent adverse events (TEAEs) were collected from the first dose of study treatment up to the EOST/EW Visit (up to approximately 33 weeks).
TEAEs were reported for the Safety population which consisted of all randomised subjects who received at least one dose of study treatment. The Safety population was analysed using subjects as treated.
|
10.9%
7/64 • Number of events 7 • Treatment emergent adverse events (TEAEs) were collected from the first dose of study treatment up to the EOST/EW Visit (up to approximately 33 weeks).
TEAEs were reported for the Safety population which consisted of all randomised subjects who received at least one dose of study treatment. The Safety population was analysed using subjects as treated.
|
|
Endocrine disorders
Hypothyroidism
|
1.6%
1/64 • Number of events 1 • Treatment emergent adverse events (TEAEs) were collected from the first dose of study treatment up to the EOST/EW Visit (up to approximately 33 weeks).
TEAEs were reported for the Safety population which consisted of all randomised subjects who received at least one dose of study treatment. The Safety population was analysed using subjects as treated.
|
7.8%
5/64 • Number of events 5 • Treatment emergent adverse events (TEAEs) were collected from the first dose of study treatment up to the EOST/EW Visit (up to approximately 33 weeks).
TEAEs were reported for the Safety population which consisted of all randomised subjects who received at least one dose of study treatment. The Safety population was analysed using subjects as treated.
|
|
Blood and lymphatic system disorders
Anaemia
|
6.2%
4/64 • Number of events 4 • Treatment emergent adverse events (TEAEs) were collected from the first dose of study treatment up to the EOST/EW Visit (up to approximately 33 weeks).
TEAEs were reported for the Safety population which consisted of all randomised subjects who received at least one dose of study treatment. The Safety population was analysed using subjects as treated.
|
7.8%
5/64 • Number of events 5 • Treatment emergent adverse events (TEAEs) were collected from the first dose of study treatment up to the EOST/EW Visit (up to approximately 33 weeks).
TEAEs were reported for the Safety population which consisted of all randomised subjects who received at least one dose of study treatment. The Safety population was analysed using subjects as treated.
|
|
Vascular disorders
Hypertension
|
3.1%
2/64 • Number of events 2 • Treatment emergent adverse events (TEAEs) were collected from the first dose of study treatment up to the EOST/EW Visit (up to approximately 33 weeks).
TEAEs were reported for the Safety population which consisted of all randomised subjects who received at least one dose of study treatment. The Safety population was analysed using subjects as treated.
|
7.8%
5/64 • Number of events 5 • Treatment emergent adverse events (TEAEs) were collected from the first dose of study treatment up to the EOST/EW Visit (up to approximately 33 weeks).
TEAEs were reported for the Safety population which consisted of all randomised subjects who received at least one dose of study treatment. The Safety population was analysed using subjects as treated.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: OTHER