Trial Outcomes & Findings for Study Evaluating SOM230 in Patients With Metastatic Carcinoid Tumors (NCT NCT00088595)
NCT ID: NCT00088595
Last Updated: 2012-06-04
Results Overview
Complete Symptom Control: an average of ≤ 3 bowel movements per day for at least 15 consecutive days, with no more than 3 episodes on any given day, and no episodes of flushing over the time interval being studied. Partial Symptom Control: an average of \< 4 bowel movements per day for at least 15 consecutive days, with no more than 6 episodes per given day, and an average of fewer than 2 daily flushing episodes over the same given time interval. Treatment failure: Failure to obtain partial or complete treatment success over a consecutive 15-day period at a constant dose level.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
45 participants
Primary outcome timeframe
15 days
Results posted on
2012-06-04
Participant Flow
Participant milestones
| Measure |
Pasireotide (Any Dose)
SOM230 (Pasireotide), 150µg twice daily dose titration up to 1200µg twice daily, subcutaneous injection.
|
|---|---|
|
Overall Study
STARTED
|
45
|
|
Overall Study
COMPLETED
|
17
|
|
Overall Study
NOT COMPLETED
|
28
|
Reasons for withdrawal
| Measure |
Pasireotide (Any Dose)
SOM230 (Pasireotide), 150µg twice daily dose titration up to 1200µg twice daily, subcutaneous injection.
|
|---|---|
|
Overall Study
Adverse Event
|
11
|
|
Overall Study
Withdrawal by Subject
|
8
|
|
Overall Study
Ongoing (After Core)
|
7
|
|
Overall Study
New Cancer Therapy
|
2
|
Baseline Characteristics
Study Evaluating SOM230 in Patients With Metastatic Carcinoid Tumors
Baseline characteristics by cohort
| Measure |
Pasireotide (Any Dose)
n=45 Participants
SOM230 (Pasireotide), 150µg twice daily dose titration up to 1200µg twice daily, subcutaneous injection.
|
|---|---|
|
Age Continuous
|
61.0 years
STANDARD_DEVIATION 8.72 • n=5 Participants
|
|
Sex: Female, Male
Female
|
20 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
25 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
24 participants
n=5 Participants
|
|
Region of Enrollment
Sweden
|
5 participants
n=5 Participants
|
|
Region of Enrollment
Germany
|
11 participants
n=5 Participants
|
|
Region of Enrollment
Netherlands
|
4 participants
n=5 Participants
|
|
Region of Enrollment
France
|
1 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 15 daysPopulation: The efficacy analysis population (EAP) consisted of 44 patients all of whom had at least one efficacy assessment available after receiving at least one dose of study drug, but excluded 1 patient who had no post-baseline efficacy assessments.
Complete Symptom Control: an average of ≤ 3 bowel movements per day for at least 15 consecutive days, with no more than 3 episodes on any given day, and no episodes of flushing over the time interval being studied. Partial Symptom Control: an average of \< 4 bowel movements per day for at least 15 consecutive days, with no more than 6 episodes per given day, and an average of fewer than 2 daily flushing episodes over the same given time interval. Treatment failure: Failure to obtain partial or complete treatment success over a consecutive 15-day period at a constant dose level.
Outcome measures
| Measure |
Pasireotide (Any Dose)
n=44 Participants
SOM230 (Pasireotide), 150µg twice daily dose titration up to 1200µg twice daily, subcutaneous injection.
|
Pasireotide >900 - ≤1500 μg
SOM230 (Pasireotide), \>900 - ≤1500 μg / day
|
Pasireotide >1500 - ≤2400 μg
SOM230 (Pasireotide), \>1500 - ≤2400 μg / day
|
Pasireotide Any Dose
SOM230 (Pasireotide), 300 ug - 2400 ug / day
|
|---|---|---|---|---|
|
Symptom Control (Diarrhea/Flushing) Using a Patient Symptom Diary
Complete symptom control
|
3 participants
|
—
|
—
|
—
|
|
Symptom Control (Diarrhea/Flushing) Using a Patient Symptom Diary
Partial symptom control
|
9 participants
|
—
|
—
|
—
|
|
Symptom Control (Diarrhea/Flushing) Using a Patient Symptom Diary
No control
|
32 participants
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 15 daysPopulation: The efficacy analysis population (EAP) consisted of 44 patients all of whom had at least one efficacy assessment available after receiving at least one dose of study drug, but excluded 1 patient who had no post-baseline efficacy assessments. n= the number of patients with complete symptom control.
Complete symptom control: an average of three or less bowel movements per day for at least 15 consecutive days, with no more than three episodes on any given day, and no episodes of flushing over the time interval being studied.
Outcome measures
| Measure |
Pasireotide (Any Dose)
SOM230 (Pasireotide), 150µg twice daily dose titration up to 1200µg twice daily, subcutaneous injection.
|
Pasireotide >900 - ≤1500 μg
n=2 Participants
SOM230 (Pasireotide), \>900 - ≤1500 μg / day
|
Pasireotide >1500 - ≤2400 μg
n=1 Participants
SOM230 (Pasireotide), \>1500 - ≤2400 μg / day
|
Pasireotide Any Dose
n=3 Participants
SOM230 (Pasireotide), 300 ug - 2400 ug / day
|
|---|---|---|---|---|
|
Duration of Complete Symptom Control (Days) by Dose Class
|
—
|
42.0 Days
Standard Deviation 22.68
|
47.0 Days
Standard Deviation NA
Upper limit not attained since there is only one observation
|
43.7 Days
Standard Deviation 16.26
|
SECONDARY outcome
Timeframe: up to 15 daysPopulation: The efficacy analysis population (EAP) consisted of 44 patients all of whom had at least one efficacy assessment available after receiving at least one dose of study drug, but excluded 1 patient who had no post-baseline efficacy assessments. n= then number of patients with partial sympton control
Partial symptom control: an average of less than four bowel movements per day for at least 15 consecutive days, with no more than six episodes per any given day, and an average of less than two daily flushing episodes over the same given time interval.
Outcome measures
| Measure |
Pasireotide (Any Dose)
SOM230 (Pasireotide), 150µg twice daily dose titration up to 1200µg twice daily, subcutaneous injection.
|
Pasireotide >900 - ≤1500 μg
n=6 Participants
SOM230 (Pasireotide), \>900 - ≤1500 μg / day
|
Pasireotide >1500 - ≤2400 μg
n=3 Participants
SOM230 (Pasireotide), \>1500 - ≤2400 μg / day
|
Pasireotide Any Dose
n=9 Participants
SOM230 (Pasireotide), 300 ug - 2400 ug / day
|
|---|---|---|---|---|
|
Duration of Partial Symptom Control (Days) by Dose Class
|
—
|
89.8 Days
Standard Deviation 95.77
|
36.3 Days
Standard Deviation 28.73
|
72.0 Days
Standard Deviation 81.58
|
SECONDARY outcome
Timeframe: At least 15 daysPopulation: The efficacy analysis population (EAP) consisted of 44 patients all of whom had at least one efficacy assessment available after receiving at least one dose of study drug, but excluded 1 patient who had no post-baseline efficacy assessments.
The disappearance of all lesions was considered a complete response and at least a 30% decrease in the diameter of lesions was considered a partial response (PR). Progressive disease (PD) required a 20% increase in the sum of the diameters of lesions and changes that did not qualify for PR or PD were considered stable disease. Progression not documented was defined as unknown. No more than a 10% increase in biochemical values, and no clinical signs of DP with complete or adequate control over symptoms were defined as complete treatment success and partial treatment success, respectively.
Outcome measures
| Measure |
Pasireotide (Any Dose)
n=44 Participants
SOM230 (Pasireotide), 150µg twice daily dose titration up to 1200µg twice daily, subcutaneous injection.
|
Pasireotide >900 - ≤1500 μg
SOM230 (Pasireotide), \>900 - ≤1500 μg / day
|
Pasireotide >1500 - ≤2400 μg
SOM230 (Pasireotide), \>1500 - ≤2400 μg / day
|
Pasireotide Any Dose
SOM230 (Pasireotide), 300 ug - 2400 ug / day
|
|---|---|---|---|---|
|
The Number of Patients (Participants) With Overall Tumor Response
Complete response for complete treatment success
|
0 Participants
|
—
|
—
|
—
|
|
The Number of Patients (Participants) With Overall Tumor Response
Partial response for complete treatment success
|
0 Participants
|
—
|
—
|
—
|
|
The Number of Patients (Participants) With Overall Tumor Response
Stable disease for complete treatment success
|
1 Participants
|
—
|
—
|
—
|
|
The Number of Patients (Participants) With Overall Tumor Response
Progressive disease for complete treatment success
|
0 Participants
|
—
|
—
|
—
|
|
The Number of Patients (Participants) With Overall Tumor Response
Unknown for complete treatment success
|
0 Participants
|
—
|
—
|
—
|
|
The Number of Patients (Participants) With Overall Tumor Response
Missing for complete treatment success
|
0 Participants
|
—
|
—
|
—
|
|
The Number of Patients (Participants) With Overall Tumor Response
Complete response for partial treatment success
|
0 Participants
|
—
|
—
|
—
|
|
The Number of Patients (Participants) With Overall Tumor Response
Partial response for partial treatment success
|
0 Participants
|
—
|
—
|
—
|
|
The Number of Patients (Participants) With Overall Tumor Response
Stable disease for partial treatment success
|
4 Participants
|
—
|
—
|
—
|
|
The Number of Patients (Participants) With Overall Tumor Response
Progressive disease for partial treatment success
|
0 Participants
|
—
|
—
|
—
|
|
The Number of Patients (Participants) With Overall Tumor Response
Unknown for partial treatment success
|
0 Participants
|
—
|
—
|
—
|
|
The Number of Patients (Participants) With Overall Tumor Response
Missing for partial treatment success
|
0 Participants
|
—
|
—
|
—
|
|
The Number of Patients (Participants) With Overall Tumor Response
Complete response for treatment failure
|
0 Participants
|
—
|
—
|
—
|
|
The Number of Patients (Participants) With Overall Tumor Response
Partial response for treatment failure
|
0 Participants
|
—
|
—
|
—
|
|
The Number of Patients (Participants) With Overall Tumor Response
Stable disease for treatment failure
|
8 Participants
|
—
|
—
|
—
|
|
The Number of Patients (Participants) With Overall Tumor Response
Progressive disease for treatment failure
|
10 Participants
|
—
|
—
|
—
|
|
The Number of Patients (Participants) With Overall Tumor Response
Unknown for treatment failure
|
1 Participants
|
—
|
—
|
—
|
|
The Number of Patients (Participants) With Overall Tumor Response
Missing for treatment failure
|
20 Participants
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: At least 15 daysPopulation: The safety population consisted of all patients who received study drug (i.e. who started the pasireotide injections) and was thus identical to the Intent to treat (ITT) population.
Safety assessments consisted of recording all AEs and serious adverse events (SAEs), the regular monitoring of hematology, blood chemistry, vital signs, physical condition and body weight.
Outcome measures
| Measure |
Pasireotide (Any Dose)
n=44 Participants
SOM230 (Pasireotide), 150µg twice daily dose titration up to 1200µg twice daily, subcutaneous injection.
|
Pasireotide >900 - ≤1500 μg
SOM230 (Pasireotide), \>900 - ≤1500 μg / day
|
Pasireotide >1500 - ≤2400 μg
SOM230 (Pasireotide), \>1500 - ≤2400 μg / day
|
Pasireotide Any Dose
SOM230 (Pasireotide), 300 ug - 2400 ug / day
|
|---|---|---|---|---|
|
The Overall Safety and Tolerability of Pasireotide
Death
|
1 Participants
|
—
|
—
|
—
|
|
The Overall Safety and Tolerability of Pasireotide
Serious or Significant Events
|
23 Participants
|
—
|
—
|
—
|
|
The Overall Safety and Tolerability of Pasireotide
Serious Adverse Events (SAEs)
|
14 Participants
|
—
|
—
|
—
|
|
The Overall Safety and Tolerability of Pasireotide
Discontinued due to Adverse Events (AEs)
|
12 Participants
|
—
|
—
|
—
|
Adverse Events
Pasireotide 300 ≤ 900 μg
Serious events: 3 serious events
Other events: 24 other events
Deaths: 0 deaths
Pasireotide > 900 ≤ 1500 μg
Serious events: 3 serious events
Other events: 20 other events
Deaths: 0 deaths
Pasireotide > 1500 ≤ 2400 μg
Serious events: 10 serious events
Other events: 21 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Pasireotide 300 ≤ 900 μg
n=45 participants at risk
Pasireotide 300 ≤ 900 μg / day
|
Pasireotide > 900 ≤ 1500 μg
n=43 participants at risk
Pasireotide \> 900 ≤ 1500 μg / day
|
Pasireotide > 1500 ≤ 2400 μg
n=31 participants at risk
Pasireotide \> 1500 ≤ 2400 μg / day
|
|---|---|---|---|
|
Cardiac disorders
Tricuspid valve incompetence
|
0.00%
0/45 • Up to 2 years
The safety population consisted of all patients who received study drug. Dosing began at 150μg twice daily (300μg daily) and went up to 1200μg twice daily (2400μg daily). Through the duration of the study the 45 patients started at 300μg-≤900μg /day, 43 patients proceeded to \>900μg-≤1500μg/day and 31 patients proceeded to \>1500μg -≤2400μg/day.
|
2.3%
1/43 • Up to 2 years
The safety population consisted of all patients who received study drug. Dosing began at 150μg twice daily (300μg daily) and went up to 1200μg twice daily (2400μg daily). Through the duration of the study the 45 patients started at 300μg-≤900μg /day, 43 patients proceeded to \>900μg-≤1500μg/day and 31 patients proceeded to \>1500μg -≤2400μg/day.
|
0.00%
0/31 • Up to 2 years
The safety population consisted of all patients who received study drug. Dosing began at 150μg twice daily (300μg daily) and went up to 1200μg twice daily (2400μg daily). Through the duration of the study the 45 patients started at 300μg-≤900μg /day, 43 patients proceeded to \>900μg-≤1500μg/day and 31 patients proceeded to \>1500μg -≤2400μg/day.
|
|
Gastrointestinal disorders
Duodenal stenosis
|
2.2%
1/45 • Up to 2 years
The safety population consisted of all patients who received study drug. Dosing began at 150μg twice daily (300μg daily) and went up to 1200μg twice daily (2400μg daily). Through the duration of the study the 45 patients started at 300μg-≤900μg /day, 43 patients proceeded to \>900μg-≤1500μg/day and 31 patients proceeded to \>1500μg -≤2400μg/day.
|
0.00%
0/43 • Up to 2 years
The safety population consisted of all patients who received study drug. Dosing began at 150μg twice daily (300μg daily) and went up to 1200μg twice daily (2400μg daily). Through the duration of the study the 45 patients started at 300μg-≤900μg /day, 43 patients proceeded to \>900μg-≤1500μg/day and 31 patients proceeded to \>1500μg -≤2400μg/day.
|
0.00%
0/31 • Up to 2 years
The safety population consisted of all patients who received study drug. Dosing began at 150μg twice daily (300μg daily) and went up to 1200μg twice daily (2400μg daily). Through the duration of the study the 45 patients started at 300μg-≤900μg /day, 43 patients proceeded to \>900μg-≤1500μg/day and 31 patients proceeded to \>1500μg -≤2400μg/day.
|
|
Gastrointestinal disorders
Erosive duodenitis
|
0.00%
0/45 • Up to 2 years
The safety population consisted of all patients who received study drug. Dosing began at 150μg twice daily (300μg daily) and went up to 1200μg twice daily (2400μg daily). Through the duration of the study the 45 patients started at 300μg-≤900μg /day, 43 patients proceeded to \>900μg-≤1500μg/day and 31 patients proceeded to \>1500μg -≤2400μg/day.
|
0.00%
0/43 • Up to 2 years
The safety population consisted of all patients who received study drug. Dosing began at 150μg twice daily (300μg daily) and went up to 1200μg twice daily (2400μg daily). Through the duration of the study the 45 patients started at 300μg-≤900μg /day, 43 patients proceeded to \>900μg-≤1500μg/day and 31 patients proceeded to \>1500μg -≤2400μg/day.
|
3.2%
1/31 • Up to 2 years
The safety population consisted of all patients who received study drug. Dosing began at 150μg twice daily (300μg daily) and went up to 1200μg twice daily (2400μg daily). Through the duration of the study the 45 patients started at 300μg-≤900μg /day, 43 patients proceeded to \>900μg-≤1500μg/day and 31 patients proceeded to \>1500μg -≤2400μg/day.
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/45 • Up to 2 years
The safety population consisted of all patients who received study drug. Dosing began at 150μg twice daily (300μg daily) and went up to 1200μg twice daily (2400μg daily). Through the duration of the study the 45 patients started at 300μg-≤900μg /day, 43 patients proceeded to \>900μg-≤1500μg/day and 31 patients proceeded to \>1500μg -≤2400μg/day.
|
0.00%
0/43 • Up to 2 years
The safety population consisted of all patients who received study drug. Dosing began at 150μg twice daily (300μg daily) and went up to 1200μg twice daily (2400μg daily). Through the duration of the study the 45 patients started at 300μg-≤900μg /day, 43 patients proceeded to \>900μg-≤1500μg/day and 31 patients proceeded to \>1500μg -≤2400μg/day.
|
3.2%
1/31 • Up to 2 years
The safety population consisted of all patients who received study drug. Dosing began at 150μg twice daily (300μg daily) and went up to 1200μg twice daily (2400μg daily). Through the duration of the study the 45 patients started at 300μg-≤900μg /day, 43 patients proceeded to \>900μg-≤1500μg/day and 31 patients proceeded to \>1500μg -≤2400μg/day.
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
2.2%
1/45 • Up to 2 years
The safety population consisted of all patients who received study drug. Dosing began at 150μg twice daily (300μg daily) and went up to 1200μg twice daily (2400μg daily). Through the duration of the study the 45 patients started at 300μg-≤900μg /day, 43 patients proceeded to \>900μg-≤1500μg/day and 31 patients proceeded to \>1500μg -≤2400μg/day.
|
0.00%
0/43 • Up to 2 years
The safety population consisted of all patients who received study drug. Dosing began at 150μg twice daily (300μg daily) and went up to 1200μg twice daily (2400μg daily). Through the duration of the study the 45 patients started at 300μg-≤900μg /day, 43 patients proceeded to \>900μg-≤1500μg/day and 31 patients proceeded to \>1500μg -≤2400μg/day.
|
0.00%
0/31 • Up to 2 years
The safety population consisted of all patients who received study drug. Dosing began at 150μg twice daily (300μg daily) and went up to 1200μg twice daily (2400μg daily). Through the duration of the study the 45 patients started at 300μg-≤900μg /day, 43 patients proceeded to \>900μg-≤1500μg/day and 31 patients proceeded to \>1500μg -≤2400μg/day.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/45 • Up to 2 years
The safety population consisted of all patients who received study drug. Dosing began at 150μg twice daily (300μg daily) and went up to 1200μg twice daily (2400μg daily). Through the duration of the study the 45 patients started at 300μg-≤900μg /day, 43 patients proceeded to \>900μg-≤1500μg/day and 31 patients proceeded to \>1500μg -≤2400μg/day.
|
0.00%
0/43 • Up to 2 years
The safety population consisted of all patients who received study drug. Dosing began at 150μg twice daily (300μg daily) and went up to 1200μg twice daily (2400μg daily). Through the duration of the study the 45 patients started at 300μg-≤900μg /day, 43 patients proceeded to \>900μg-≤1500μg/day and 31 patients proceeded to \>1500μg -≤2400μg/day.
|
3.2%
1/31 • Up to 2 years
The safety population consisted of all patients who received study drug. Dosing began at 150μg twice daily (300μg daily) and went up to 1200μg twice daily (2400μg daily). Through the duration of the study the 45 patients started at 300μg-≤900μg /day, 43 patients proceeded to \>900μg-≤1500μg/day and 31 patients proceeded to \>1500μg -≤2400μg/day.
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
0.00%
0/45 • Up to 2 years
The safety population consisted of all patients who received study drug. Dosing began at 150μg twice daily (300μg daily) and went up to 1200μg twice daily (2400μg daily). Through the duration of the study the 45 patients started at 300μg-≤900μg /day, 43 patients proceeded to \>900μg-≤1500μg/day and 31 patients proceeded to \>1500μg -≤2400μg/day.
|
0.00%
0/43 • Up to 2 years
The safety population consisted of all patients who received study drug. Dosing began at 150μg twice daily (300μg daily) and went up to 1200μg twice daily (2400μg daily). Through the duration of the study the 45 patients started at 300μg-≤900μg /day, 43 patients proceeded to \>900μg-≤1500μg/day and 31 patients proceeded to \>1500μg -≤2400μg/day.
|
3.2%
1/31 • Up to 2 years
The safety population consisted of all patients who received study drug. Dosing began at 150μg twice daily (300μg daily) and went up to 1200μg twice daily (2400μg daily). Through the duration of the study the 45 patients started at 300μg-≤900μg /day, 43 patients proceeded to \>900μg-≤1500μg/day and 31 patients proceeded to \>1500μg -≤2400μg/day.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/45 • Up to 2 years
The safety population consisted of all patients who received study drug. Dosing began at 150μg twice daily (300μg daily) and went up to 1200μg twice daily (2400μg daily). Through the duration of the study the 45 patients started at 300μg-≤900μg /day, 43 patients proceeded to \>900μg-≤1500μg/day and 31 patients proceeded to \>1500μg -≤2400μg/day.
|
0.00%
0/43 • Up to 2 years
The safety population consisted of all patients who received study drug. Dosing began at 150μg twice daily (300μg daily) and went up to 1200μg twice daily (2400μg daily). Through the duration of the study the 45 patients started at 300μg-≤900μg /day, 43 patients proceeded to \>900μg-≤1500μg/day and 31 patients proceeded to \>1500μg -≤2400μg/day.
|
3.2%
1/31 • Up to 2 years
The safety population consisted of all patients who received study drug. Dosing began at 150μg twice daily (300μg daily) and went up to 1200μg twice daily (2400μg daily). Through the duration of the study the 45 patients started at 300μg-≤900μg /day, 43 patients proceeded to \>900μg-≤1500μg/day and 31 patients proceeded to \>1500μg -≤2400μg/day.
|
|
General disorders
Oedema peripheral
|
2.2%
1/45 • Up to 2 years
The safety population consisted of all patients who received study drug. Dosing began at 150μg twice daily (300μg daily) and went up to 1200μg twice daily (2400μg daily). Through the duration of the study the 45 patients started at 300μg-≤900μg /day, 43 patients proceeded to \>900μg-≤1500μg/day and 31 patients proceeded to \>1500μg -≤2400μg/day.
|
0.00%
0/43 • Up to 2 years
The safety population consisted of all patients who received study drug. Dosing began at 150μg twice daily (300μg daily) and went up to 1200μg twice daily (2400μg daily). Through the duration of the study the 45 patients started at 300μg-≤900μg /day, 43 patients proceeded to \>900μg-≤1500μg/day and 31 patients proceeded to \>1500μg -≤2400μg/day.
|
0.00%
0/31 • Up to 2 years
The safety population consisted of all patients who received study drug. Dosing began at 150μg twice daily (300μg daily) and went up to 1200μg twice daily (2400μg daily). Through the duration of the study the 45 patients started at 300μg-≤900μg /day, 43 patients proceeded to \>900μg-≤1500μg/day and 31 patients proceeded to \>1500μg -≤2400μg/day.
|
|
Hepatobiliary disorders
Hepatic artery embolism
|
0.00%
0/45 • Up to 2 years
The safety population consisted of all patients who received study drug. Dosing began at 150μg twice daily (300μg daily) and went up to 1200μg twice daily (2400μg daily). Through the duration of the study the 45 patients started at 300μg-≤900μg /day, 43 patients proceeded to \>900μg-≤1500μg/day and 31 patients proceeded to \>1500μg -≤2400μg/day.
|
0.00%
0/43 • Up to 2 years
The safety population consisted of all patients who received study drug. Dosing began at 150μg twice daily (300μg daily) and went up to 1200μg twice daily (2400μg daily). Through the duration of the study the 45 patients started at 300μg-≤900μg /day, 43 patients proceeded to \>900μg-≤1500μg/day and 31 patients proceeded to \>1500μg -≤2400μg/day.
|
6.5%
2/31 • Up to 2 years
The safety population consisted of all patients who received study drug. Dosing began at 150μg twice daily (300μg daily) and went up to 1200μg twice daily (2400μg daily). Through the duration of the study the 45 patients started at 300μg-≤900μg /day, 43 patients proceeded to \>900μg-≤1500μg/day and 31 patients proceeded to \>1500μg -≤2400μg/day.
|
|
Infections and infestations
Abdominal infection
|
0.00%
0/45 • Up to 2 years
The safety population consisted of all patients who received study drug. Dosing began at 150μg twice daily (300μg daily) and went up to 1200μg twice daily (2400μg daily). Through the duration of the study the 45 patients started at 300μg-≤900μg /day, 43 patients proceeded to \>900μg-≤1500μg/day and 31 patients proceeded to \>1500μg -≤2400μg/day.
|
0.00%
0/43 • Up to 2 years
The safety population consisted of all patients who received study drug. Dosing began at 150μg twice daily (300μg daily) and went up to 1200μg twice daily (2400μg daily). Through the duration of the study the 45 patients started at 300μg-≤900μg /day, 43 patients proceeded to \>900μg-≤1500μg/day and 31 patients proceeded to \>1500μg -≤2400μg/day.
|
3.2%
1/31 • Up to 2 years
The safety population consisted of all patients who received study drug. Dosing began at 150μg twice daily (300μg daily) and went up to 1200μg twice daily (2400μg daily). Through the duration of the study the 45 patients started at 300μg-≤900μg /day, 43 patients proceeded to \>900μg-≤1500μg/day and 31 patients proceeded to \>1500μg -≤2400μg/day.
|
|
Investigations
Lipase increased
|
0.00%
0/45 • Up to 2 years
The safety population consisted of all patients who received study drug. Dosing began at 150μg twice daily (300μg daily) and went up to 1200μg twice daily (2400μg daily). Through the duration of the study the 45 patients started at 300μg-≤900μg /day, 43 patients proceeded to \>900μg-≤1500μg/day and 31 patients proceeded to \>1500μg -≤2400μg/day.
|
0.00%
0/43 • Up to 2 years
The safety population consisted of all patients who received study drug. Dosing began at 150μg twice daily (300μg daily) and went up to 1200μg twice daily (2400μg daily). Through the duration of the study the 45 patients started at 300μg-≤900μg /day, 43 patients proceeded to \>900μg-≤1500μg/day and 31 patients proceeded to \>1500μg -≤2400μg/day.
|
3.2%
1/31 • Up to 2 years
The safety population consisted of all patients who received study drug. Dosing began at 150μg twice daily (300μg daily) and went up to 1200μg twice daily (2400μg daily). Through the duration of the study the 45 patients started at 300μg-≤900μg /day, 43 patients proceeded to \>900μg-≤1500μg/day and 31 patients proceeded to \>1500μg -≤2400μg/day.
|
|
Metabolism and nutrition disorders
Vitamin K deficiency
|
0.00%
0/45 • Up to 2 years
The safety population consisted of all patients who received study drug. Dosing began at 150μg twice daily (300μg daily) and went up to 1200μg twice daily (2400μg daily). Through the duration of the study the 45 patients started at 300μg-≤900μg /day, 43 patients proceeded to \>900μg-≤1500μg/day and 31 patients proceeded to \>1500μg -≤2400μg/day.
|
0.00%
0/43 • Up to 2 years
The safety population consisted of all patients who received study drug. Dosing began at 150μg twice daily (300μg daily) and went up to 1200μg twice daily (2400μg daily). Through the duration of the study the 45 patients started at 300μg-≤900μg /day, 43 patients proceeded to \>900μg-≤1500μg/day and 31 patients proceeded to \>1500μg -≤2400μg/day.
|
3.2%
1/31 • Up to 2 years
The safety population consisted of all patients who received study drug. Dosing began at 150μg twice daily (300μg daily) and went up to 1200μg twice daily (2400μg daily). Through the duration of the study the 45 patients started at 300μg-≤900μg /day, 43 patients proceeded to \>900μg-≤1500μg/day and 31 patients proceeded to \>1500μg -≤2400μg/day.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
0.00%
0/45 • Up to 2 years
The safety population consisted of all patients who received study drug. Dosing began at 150μg twice daily (300μg daily) and went up to 1200μg twice daily (2400μg daily). Through the duration of the study the 45 patients started at 300μg-≤900μg /day, 43 patients proceeded to \>900μg-≤1500μg/day and 31 patients proceeded to \>1500μg -≤2400μg/day.
|
0.00%
0/43 • Up to 2 years
The safety population consisted of all patients who received study drug. Dosing began at 150μg twice daily (300μg daily) and went up to 1200μg twice daily (2400μg daily). Through the duration of the study the 45 patients started at 300μg-≤900μg /day, 43 patients proceeded to \>900μg-≤1500μg/day and 31 patients proceeded to \>1500μg -≤2400μg/day.
|
3.2%
1/31 • Up to 2 years
The safety population consisted of all patients who received study drug. Dosing began at 150μg twice daily (300μg daily) and went up to 1200μg twice daily (2400μg daily). Through the duration of the study the 45 patients started at 300μg-≤900μg /day, 43 patients proceeded to \>900μg-≤1500μg/day and 31 patients proceeded to \>1500μg -≤2400μg/day.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastatic carcinoid tumour
|
0.00%
0/45 • Up to 2 years
The safety population consisted of all patients who received study drug. Dosing began at 150μg twice daily (300μg daily) and went up to 1200μg twice daily (2400μg daily). Through the duration of the study the 45 patients started at 300μg-≤900μg /day, 43 patients proceeded to \>900μg-≤1500μg/day and 31 patients proceeded to \>1500μg -≤2400μg/day.
|
0.00%
0/43 • Up to 2 years
The safety population consisted of all patients who received study drug. Dosing began at 150μg twice daily (300μg daily) and went up to 1200μg twice daily (2400μg daily). Through the duration of the study the 45 patients started at 300μg-≤900μg /day, 43 patients proceeded to \>900μg-≤1500μg/day and 31 patients proceeded to \>1500μg -≤2400μg/day.
|
3.2%
1/31 • Up to 2 years
The safety population consisted of all patients who received study drug. Dosing began at 150μg twice daily (300μg daily) and went up to 1200μg twice daily (2400μg daily). Through the duration of the study the 45 patients started at 300μg-≤900μg /day, 43 patients proceeded to \>900μg-≤1500μg/day and 31 patients proceeded to \>1500μg -≤2400μg/day.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastatic pain
|
0.00%
0/45 • Up to 2 years
The safety population consisted of all patients who received study drug. Dosing began at 150μg twice daily (300μg daily) and went up to 1200μg twice daily (2400μg daily). Through the duration of the study the 45 patients started at 300μg-≤900μg /day, 43 patients proceeded to \>900μg-≤1500μg/day and 31 patients proceeded to \>1500μg -≤2400μg/day.
|
0.00%
0/43 • Up to 2 years
The safety population consisted of all patients who received study drug. Dosing began at 150μg twice daily (300μg daily) and went up to 1200μg twice daily (2400μg daily). Through the duration of the study the 45 patients started at 300μg-≤900μg /day, 43 patients proceeded to \>900μg-≤1500μg/day and 31 patients proceeded to \>1500μg -≤2400μg/day.
|
3.2%
1/31 • Up to 2 years
The safety population consisted of all patients who received study drug. Dosing began at 150μg twice daily (300μg daily) and went up to 1200μg twice daily (2400μg daily). Through the duration of the study the 45 patients started at 300μg-≤900μg /day, 43 patients proceeded to \>900μg-≤1500μg/day and 31 patients proceeded to \>1500μg -≤2400μg/day.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasm progression
|
0.00%
0/45 • Up to 2 years
The safety population consisted of all patients who received study drug. Dosing began at 150μg twice daily (300μg daily) and went up to 1200μg twice daily (2400μg daily). Through the duration of the study the 45 patients started at 300μg-≤900μg /day, 43 patients proceeded to \>900μg-≤1500μg/day and 31 patients proceeded to \>1500μg -≤2400μg/day.
|
0.00%
0/43 • Up to 2 years
The safety population consisted of all patients who received study drug. Dosing began at 150μg twice daily (300μg daily) and went up to 1200μg twice daily (2400μg daily). Through the duration of the study the 45 patients started at 300μg-≤900μg /day, 43 patients proceeded to \>900μg-≤1500μg/day and 31 patients proceeded to \>1500μg -≤2400μg/day.
|
3.2%
1/31 • Up to 2 years
The safety population consisted of all patients who received study drug. Dosing began at 150μg twice daily (300μg daily) and went up to 1200μg twice daily (2400μg daily). Through the duration of the study the 45 patients started at 300μg-≤900μg /day, 43 patients proceeded to \>900μg-≤1500μg/day and 31 patients proceeded to \>1500μg -≤2400μg/day.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma
|
0.00%
0/45 • Up to 2 years
The safety population consisted of all patients who received study drug. Dosing began at 150μg twice daily (300μg daily) and went up to 1200μg twice daily (2400μg daily). Through the duration of the study the 45 patients started at 300μg-≤900μg /day, 43 patients proceeded to \>900μg-≤1500μg/day and 31 patients proceeded to \>1500μg -≤2400μg/day.
|
2.3%
1/43 • Up to 2 years
The safety population consisted of all patients who received study drug. Dosing began at 150μg twice daily (300μg daily) and went up to 1200μg twice daily (2400μg daily). Through the duration of the study the 45 patients started at 300μg-≤900μg /day, 43 patients proceeded to \>900μg-≤1500μg/day and 31 patients proceeded to \>1500μg -≤2400μg/day.
|
0.00%
0/31 • Up to 2 years
The safety population consisted of all patients who received study drug. Dosing began at 150μg twice daily (300μg daily) and went up to 1200μg twice daily (2400μg daily). Through the duration of the study the 45 patients started at 300μg-≤900μg /day, 43 patients proceeded to \>900μg-≤1500μg/day and 31 patients proceeded to \>1500μg -≤2400μg/day.
|
|
Vascular disorders
Hypotension
|
0.00%
0/45 • Up to 2 years
The safety population consisted of all patients who received study drug. Dosing began at 150μg twice daily (300μg daily) and went up to 1200μg twice daily (2400μg daily). Through the duration of the study the 45 patients started at 300μg-≤900μg /day, 43 patients proceeded to \>900μg-≤1500μg/day and 31 patients proceeded to \>1500μg -≤2400μg/day.
|
0.00%
0/43 • Up to 2 years
The safety population consisted of all patients who received study drug. Dosing began at 150μg twice daily (300μg daily) and went up to 1200μg twice daily (2400μg daily). Through the duration of the study the 45 patients started at 300μg-≤900μg /day, 43 patients proceeded to \>900μg-≤1500μg/day and 31 patients proceeded to \>1500μg -≤2400μg/day.
|
3.2%
1/31 • Up to 2 years
The safety population consisted of all patients who received study drug. Dosing began at 150μg twice daily (300μg daily) and went up to 1200μg twice daily (2400μg daily). Through the duration of the study the 45 patients started at 300μg-≤900μg /day, 43 patients proceeded to \>900μg-≤1500μg/day and 31 patients proceeded to \>1500μg -≤2400μg/day.
|
|
Vascular disorders
Venous insufficiency
|
0.00%
0/45 • Up to 2 years
The safety population consisted of all patients who received study drug. Dosing began at 150μg twice daily (300μg daily) and went up to 1200μg twice daily (2400μg daily). Through the duration of the study the 45 patients started at 300μg-≤900μg /day, 43 patients proceeded to \>900μg-≤1500μg/day and 31 patients proceeded to \>1500μg -≤2400μg/day.
|
2.3%
1/43 • Up to 2 years
The safety population consisted of all patients who received study drug. Dosing began at 150μg twice daily (300μg daily) and went up to 1200μg twice daily (2400μg daily). Through the duration of the study the 45 patients started at 300μg-≤900μg /day, 43 patients proceeded to \>900μg-≤1500μg/day and 31 patients proceeded to \>1500μg -≤2400μg/day.
|
0.00%
0/31 • Up to 2 years
The safety population consisted of all patients who received study drug. Dosing began at 150μg twice daily (300μg daily) and went up to 1200μg twice daily (2400μg daily). Through the duration of the study the 45 patients started at 300μg-≤900μg /day, 43 patients proceeded to \>900μg-≤1500μg/day and 31 patients proceeded to \>1500μg -≤2400μg/day.
|
Other adverse events
| Measure |
Pasireotide 300 ≤ 900 μg
n=45 participants at risk
Pasireotide 300 ≤ 900 μg / day
|
Pasireotide > 900 ≤ 1500 μg
n=43 participants at risk
Pasireotide \> 900 ≤ 1500 μg / day
|
Pasireotide > 1500 ≤ 2400 μg
n=31 participants at risk
Pasireotide \> 1500 ≤ 2400 μg / day
|
|---|---|---|---|
|
Ear and labyrinth disorders
Vertigo
|
6.7%
3/45 • Up to 2 years
The safety population consisted of all patients who received study drug. Dosing began at 150μg twice daily (300μg daily) and went up to 1200μg twice daily (2400μg daily). Through the duration of the study the 45 patients started at 300μg-≤900μg /day, 43 patients proceeded to \>900μg-≤1500μg/day and 31 patients proceeded to \>1500μg -≤2400μg/day.
|
0.00%
0/43 • Up to 2 years
The safety population consisted of all patients who received study drug. Dosing began at 150μg twice daily (300μg daily) and went up to 1200μg twice daily (2400μg daily). Through the duration of the study the 45 patients started at 300μg-≤900μg /day, 43 patients proceeded to \>900μg-≤1500μg/day and 31 patients proceeded to \>1500μg -≤2400μg/day.
|
3.2%
1/31 • Up to 2 years
The safety population consisted of all patients who received study drug. Dosing began at 150μg twice daily (300μg daily) and went up to 1200μg twice daily (2400μg daily). Through the duration of the study the 45 patients started at 300μg-≤900μg /day, 43 patients proceeded to \>900μg-≤1500μg/day and 31 patients proceeded to \>1500μg -≤2400μg/day.
|
|
Gastrointestinal disorders
Abdominal pain
|
17.8%
8/45 • Up to 2 years
The safety population consisted of all patients who received study drug. Dosing began at 150μg twice daily (300μg daily) and went up to 1200μg twice daily (2400μg daily). Through the duration of the study the 45 patients started at 300μg-≤900μg /day, 43 patients proceeded to \>900μg-≤1500μg/day and 31 patients proceeded to \>1500μg -≤2400μg/day.
|
16.3%
7/43 • Up to 2 years
The safety population consisted of all patients who received study drug. Dosing began at 150μg twice daily (300μg daily) and went up to 1200μg twice daily (2400μg daily). Through the duration of the study the 45 patients started at 300μg-≤900μg /day, 43 patients proceeded to \>900μg-≤1500μg/day and 31 patients proceeded to \>1500μg -≤2400μg/day.
|
6.5%
2/31 • Up to 2 years
The safety population consisted of all patients who received study drug. Dosing began at 150μg twice daily (300μg daily) and went up to 1200μg twice daily (2400μg daily). Through the duration of the study the 45 patients started at 300μg-≤900μg /day, 43 patients proceeded to \>900μg-≤1500μg/day and 31 patients proceeded to \>1500μg -≤2400μg/day.
|
|
Gastrointestinal disorders
Defaecation urgency
|
0.00%
0/45 • Up to 2 years
The safety population consisted of all patients who received study drug. Dosing began at 150μg twice daily (300μg daily) and went up to 1200μg twice daily (2400μg daily). Through the duration of the study the 45 patients started at 300μg-≤900μg /day, 43 patients proceeded to \>900μg-≤1500μg/day and 31 patients proceeded to \>1500μg -≤2400μg/day.
|
0.00%
0/43 • Up to 2 years
The safety population consisted of all patients who received study drug. Dosing began at 150μg twice daily (300μg daily) and went up to 1200μg twice daily (2400μg daily). Through the duration of the study the 45 patients started at 300μg-≤900μg /day, 43 patients proceeded to \>900μg-≤1500μg/day and 31 patients proceeded to \>1500μg -≤2400μg/day.
|
6.5%
2/31 • Up to 2 years
The safety population consisted of all patients who received study drug. Dosing began at 150μg twice daily (300μg daily) and went up to 1200μg twice daily (2400μg daily). Through the duration of the study the 45 patients started at 300μg-≤900μg /day, 43 patients proceeded to \>900μg-≤1500μg/day and 31 patients proceeded to \>1500μg -≤2400μg/day.
|
|
Gastrointestinal disorders
Diarrhoea
|
4.4%
2/45 • Up to 2 years
The safety population consisted of all patients who received study drug. Dosing began at 150μg twice daily (300μg daily) and went up to 1200μg twice daily (2400μg daily). Through the duration of the study the 45 patients started at 300μg-≤900μg /day, 43 patients proceeded to \>900μg-≤1500μg/day and 31 patients proceeded to \>1500μg -≤2400μg/day.
|
7.0%
3/43 • Up to 2 years
The safety population consisted of all patients who received study drug. Dosing began at 150μg twice daily (300μg daily) and went up to 1200μg twice daily (2400μg daily). Through the duration of the study the 45 patients started at 300μg-≤900μg /day, 43 patients proceeded to \>900μg-≤1500μg/day and 31 patients proceeded to \>1500μg -≤2400μg/day.
|
19.4%
6/31 • Up to 2 years
The safety population consisted of all patients who received study drug. Dosing began at 150μg twice daily (300μg daily) and went up to 1200μg twice daily (2400μg daily). Through the duration of the study the 45 patients started at 300μg-≤900μg /day, 43 patients proceeded to \>900μg-≤1500μg/day and 31 patients proceeded to \>1500μg -≤2400μg/day.
|
|
Gastrointestinal disorders
Flatulence
|
6.7%
3/45 • Up to 2 years
The safety population consisted of all patients who received study drug. Dosing began at 150μg twice daily (300μg daily) and went up to 1200μg twice daily (2400μg daily). Through the duration of the study the 45 patients started at 300μg-≤900μg /day, 43 patients proceeded to \>900μg-≤1500μg/day and 31 patients proceeded to \>1500μg -≤2400μg/day.
|
4.7%
2/43 • Up to 2 years
The safety population consisted of all patients who received study drug. Dosing began at 150μg twice daily (300μg daily) and went up to 1200μg twice daily (2400μg daily). Through the duration of the study the 45 patients started at 300μg-≤900μg /day, 43 patients proceeded to \>900μg-≤1500μg/day and 31 patients proceeded to \>1500μg -≤2400μg/day.
|
3.2%
1/31 • Up to 2 years
The safety population consisted of all patients who received study drug. Dosing began at 150μg twice daily (300μg daily) and went up to 1200μg twice daily (2400μg daily). Through the duration of the study the 45 patients started at 300μg-≤900μg /day, 43 patients proceeded to \>900μg-≤1500μg/day and 31 patients proceeded to \>1500μg -≤2400μg/day.
|
|
Gastrointestinal disorders
Nausea
|
15.6%
7/45 • Up to 2 years
The safety population consisted of all patients who received study drug. Dosing began at 150μg twice daily (300μg daily) and went up to 1200μg twice daily (2400μg daily). Through the duration of the study the 45 patients started at 300μg-≤900μg /day, 43 patients proceeded to \>900μg-≤1500μg/day and 31 patients proceeded to \>1500μg -≤2400μg/day.
|
18.6%
8/43 • Up to 2 years
The safety population consisted of all patients who received study drug. Dosing began at 150μg twice daily (300μg daily) and went up to 1200μg twice daily (2400μg daily). Through the duration of the study the 45 patients started at 300μg-≤900μg /day, 43 patients proceeded to \>900μg-≤1500μg/day and 31 patients proceeded to \>1500μg -≤2400μg/day.
|
6.5%
2/31 • Up to 2 years
The safety population consisted of all patients who received study drug. Dosing began at 150μg twice daily (300μg daily) and went up to 1200μg twice daily (2400μg daily). Through the duration of the study the 45 patients started at 300μg-≤900μg /day, 43 patients proceeded to \>900μg-≤1500μg/day and 31 patients proceeded to \>1500μg -≤2400μg/day.
|
|
Gastrointestinal disorders
Steatorrhoea
|
0.00%
0/45 • Up to 2 years
The safety population consisted of all patients who received study drug. Dosing began at 150μg twice daily (300μg daily) and went up to 1200μg twice daily (2400μg daily). Through the duration of the study the 45 patients started at 300μg-≤900μg /day, 43 patients proceeded to \>900μg-≤1500μg/day and 31 patients proceeded to \>1500μg -≤2400μg/day.
|
0.00%
0/43 • Up to 2 years
The safety population consisted of all patients who received study drug. Dosing began at 150μg twice daily (300μg daily) and went up to 1200μg twice daily (2400μg daily). Through the duration of the study the 45 patients started at 300μg-≤900μg /day, 43 patients proceeded to \>900μg-≤1500μg/day and 31 patients proceeded to \>1500μg -≤2400μg/day.
|
6.5%
2/31 • Up to 2 years
The safety population consisted of all patients who received study drug. Dosing began at 150μg twice daily (300μg daily) and went up to 1200μg twice daily (2400μg daily). Through the duration of the study the 45 patients started at 300μg-≤900μg /day, 43 patients proceeded to \>900μg-≤1500μg/day and 31 patients proceeded to \>1500μg -≤2400μg/day.
|
|
Gastrointestinal disorders
Vomiting
|
4.4%
2/45 • Up to 2 years
The safety population consisted of all patients who received study drug. Dosing began at 150μg twice daily (300μg daily) and went up to 1200μg twice daily (2400μg daily). Through the duration of the study the 45 patients started at 300μg-≤900μg /day, 43 patients proceeded to \>900μg-≤1500μg/day and 31 patients proceeded to \>1500μg -≤2400μg/day.
|
4.7%
2/43 • Up to 2 years
The safety population consisted of all patients who received study drug. Dosing began at 150μg twice daily (300μg daily) and went up to 1200μg twice daily (2400μg daily). Through the duration of the study the 45 patients started at 300μg-≤900μg /day, 43 patients proceeded to \>900μg-≤1500μg/day and 31 patients proceeded to \>1500μg -≤2400μg/day.
|
6.5%
2/31 • Up to 2 years
The safety population consisted of all patients who received study drug. Dosing began at 150μg twice daily (300μg daily) and went up to 1200μg twice daily (2400μg daily). Through the duration of the study the 45 patients started at 300μg-≤900μg /day, 43 patients proceeded to \>900μg-≤1500μg/day and 31 patients proceeded to \>1500μg -≤2400μg/day.
|
|
General disorders
Fatigue
|
13.3%
6/45 • Up to 2 years
The safety population consisted of all patients who received study drug. Dosing began at 150μg twice daily (300μg daily) and went up to 1200μg twice daily (2400μg daily). Through the duration of the study the 45 patients started at 300μg-≤900μg /day, 43 patients proceeded to \>900μg-≤1500μg/day and 31 patients proceeded to \>1500μg -≤2400μg/day.
|
4.7%
2/43 • Up to 2 years
The safety population consisted of all patients who received study drug. Dosing began at 150μg twice daily (300μg daily) and went up to 1200μg twice daily (2400μg daily). Through the duration of the study the 45 patients started at 300μg-≤900μg /day, 43 patients proceeded to \>900μg-≤1500μg/day and 31 patients proceeded to \>1500μg -≤2400μg/day.
|
22.6%
7/31 • Up to 2 years
The safety population consisted of all patients who received study drug. Dosing began at 150μg twice daily (300μg daily) and went up to 1200μg twice daily (2400μg daily). Through the duration of the study the 45 patients started at 300μg-≤900μg /day, 43 patients proceeded to \>900μg-≤1500μg/day and 31 patients proceeded to \>1500μg -≤2400μg/day.
|
|
General disorders
Oedema peripheral
|
2.2%
1/45 • Up to 2 years
The safety population consisted of all patients who received study drug. Dosing began at 150μg twice daily (300μg daily) and went up to 1200μg twice daily (2400μg daily). Through the duration of the study the 45 patients started at 300μg-≤900μg /day, 43 patients proceeded to \>900μg-≤1500μg/day and 31 patients proceeded to \>1500μg -≤2400μg/day.
|
7.0%
3/43 • Up to 2 years
The safety population consisted of all patients who received study drug. Dosing began at 150μg twice daily (300μg daily) and went up to 1200μg twice daily (2400μg daily). Through the duration of the study the 45 patients started at 300μg-≤900μg /day, 43 patients proceeded to \>900μg-≤1500μg/day and 31 patients proceeded to \>1500μg -≤2400μg/day.
|
9.7%
3/31 • Up to 2 years
The safety population consisted of all patients who received study drug. Dosing began at 150μg twice daily (300μg daily) and went up to 1200μg twice daily (2400μg daily). Through the duration of the study the 45 patients started at 300μg-≤900μg /day, 43 patients proceeded to \>900μg-≤1500μg/day and 31 patients proceeded to \>1500μg -≤2400μg/day.
|
|
Infections and infestations
Cystitis
|
0.00%
0/45 • Up to 2 years
The safety population consisted of all patients who received study drug. Dosing began at 150μg twice daily (300μg daily) and went up to 1200μg twice daily (2400μg daily). Through the duration of the study the 45 patients started at 300μg-≤900μg /day, 43 patients proceeded to \>900μg-≤1500μg/day and 31 patients proceeded to \>1500μg -≤2400μg/day.
|
0.00%
0/43 • Up to 2 years
The safety population consisted of all patients who received study drug. Dosing began at 150μg twice daily (300μg daily) and went up to 1200μg twice daily (2400μg daily). Through the duration of the study the 45 patients started at 300μg-≤900μg /day, 43 patients proceeded to \>900μg-≤1500μg/day and 31 patients proceeded to \>1500μg -≤2400μg/day.
|
6.5%
2/31 • Up to 2 years
The safety population consisted of all patients who received study drug. Dosing began at 150μg twice daily (300μg daily) and went up to 1200μg twice daily (2400μg daily). Through the duration of the study the 45 patients started at 300μg-≤900μg /day, 43 patients proceeded to \>900μg-≤1500μg/day and 31 patients proceeded to \>1500μg -≤2400μg/day.
|
|
Investigations
Weight decreased
|
15.6%
7/45 • Up to 2 years
The safety population consisted of all patients who received study drug. Dosing began at 150μg twice daily (300μg daily) and went up to 1200μg twice daily (2400μg daily). Through the duration of the study the 45 patients started at 300μg-≤900μg /day, 43 patients proceeded to \>900μg-≤1500μg/day and 31 patients proceeded to \>1500μg -≤2400μg/day.
|
14.0%
6/43 • Up to 2 years
The safety population consisted of all patients who received study drug. Dosing began at 150μg twice daily (300μg daily) and went up to 1200μg twice daily (2400μg daily). Through the duration of the study the 45 patients started at 300μg-≤900μg /day, 43 patients proceeded to \>900μg-≤1500μg/day and 31 patients proceeded to \>1500μg -≤2400μg/day.
|
19.4%
6/31 • Up to 2 years
The safety population consisted of all patients who received study drug. Dosing began at 150μg twice daily (300μg daily) and went up to 1200μg twice daily (2400μg daily). Through the duration of the study the 45 patients started at 300μg-≤900μg /day, 43 patients proceeded to \>900μg-≤1500μg/day and 31 patients proceeded to \>1500μg -≤2400μg/day.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
4.4%
2/45 • Up to 2 years
The safety population consisted of all patients who received study drug. Dosing began at 150μg twice daily (300μg daily) and went up to 1200μg twice daily (2400μg daily). Through the duration of the study the 45 patients started at 300μg-≤900μg /day, 43 patients proceeded to \>900μg-≤1500μg/day and 31 patients proceeded to \>1500μg -≤2400μg/day.
|
7.0%
3/43 • Up to 2 years
The safety population consisted of all patients who received study drug. Dosing began at 150μg twice daily (300μg daily) and went up to 1200μg twice daily (2400μg daily). Through the duration of the study the 45 patients started at 300μg-≤900μg /day, 43 patients proceeded to \>900μg-≤1500μg/day and 31 patients proceeded to \>1500μg -≤2400μg/day.
|
9.7%
3/31 • Up to 2 years
The safety population consisted of all patients who received study drug. Dosing began at 150μg twice daily (300μg daily) and went up to 1200μg twice daily (2400μg daily). Through the duration of the study the 45 patients started at 300μg-≤900μg /day, 43 patients proceeded to \>900μg-≤1500μg/day and 31 patients proceeded to \>1500μg -≤2400μg/day.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/45 • Up to 2 years
The safety population consisted of all patients who received study drug. Dosing began at 150μg twice daily (300μg daily) and went up to 1200μg twice daily (2400μg daily). Through the duration of the study the 45 patients started at 300μg-≤900μg /day, 43 patients proceeded to \>900μg-≤1500μg/day and 31 patients proceeded to \>1500μg -≤2400μg/day.
|
4.7%
2/43 • Up to 2 years
The safety population consisted of all patients who received study drug. Dosing began at 150μg twice daily (300μg daily) and went up to 1200μg twice daily (2400μg daily). Through the duration of the study the 45 patients started at 300μg-≤900μg /day, 43 patients proceeded to \>900μg-≤1500μg/day and 31 patients proceeded to \>1500μg -≤2400μg/day.
|
6.5%
2/31 • Up to 2 years
The safety population consisted of all patients who received study drug. Dosing began at 150μg twice daily (300μg daily) and went up to 1200μg twice daily (2400μg daily). Through the duration of the study the 45 patients started at 300μg-≤900μg /day, 43 patients proceeded to \>900μg-≤1500μg/day and 31 patients proceeded to \>1500μg -≤2400μg/day.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/45 • Up to 2 years
The safety population consisted of all patients who received study drug. Dosing began at 150μg twice daily (300μg daily) and went up to 1200μg twice daily (2400μg daily). Through the duration of the study the 45 patients started at 300μg-≤900μg /day, 43 patients proceeded to \>900μg-≤1500μg/day and 31 patients proceeded to \>1500μg -≤2400μg/day.
|
7.0%
3/43 • Up to 2 years
The safety population consisted of all patients who received study drug. Dosing began at 150μg twice daily (300μg daily) and went up to 1200μg twice daily (2400μg daily). Through the duration of the study the 45 patients started at 300μg-≤900μg /day, 43 patients proceeded to \>900μg-≤1500μg/day and 31 patients proceeded to \>1500μg -≤2400μg/day.
|
0.00%
0/31 • Up to 2 years
The safety population consisted of all patients who received study drug. Dosing began at 150μg twice daily (300μg daily) and went up to 1200μg twice daily (2400μg daily). Through the duration of the study the 45 patients started at 300μg-≤900μg /day, 43 patients proceeded to \>900μg-≤1500μg/day and 31 patients proceeded to \>1500μg -≤2400μg/day.
|
|
Nervous system disorders
Dizziness
|
6.7%
3/45 • Up to 2 years
The safety population consisted of all patients who received study drug. Dosing began at 150μg twice daily (300μg daily) and went up to 1200μg twice daily (2400μg daily). Through the duration of the study the 45 patients started at 300μg-≤900μg /day, 43 patients proceeded to \>900μg-≤1500μg/day and 31 patients proceeded to \>1500μg -≤2400μg/day.
|
2.3%
1/43 • Up to 2 years
The safety population consisted of all patients who received study drug. Dosing began at 150μg twice daily (300μg daily) and went up to 1200μg twice daily (2400μg daily). Through the duration of the study the 45 patients started at 300μg-≤900μg /day, 43 patients proceeded to \>900μg-≤1500μg/day and 31 patients proceeded to \>1500μg -≤2400μg/day.
|
0.00%
0/31 • Up to 2 years
The safety population consisted of all patients who received study drug. Dosing began at 150μg twice daily (300μg daily) and went up to 1200μg twice daily (2400μg daily). Through the duration of the study the 45 patients started at 300μg-≤900μg /day, 43 patients proceeded to \>900μg-≤1500μg/day and 31 patients proceeded to \>1500μg -≤2400μg/day.
|
|
Nervous system disorders
Dysgeusia
|
2.2%
1/45 • Up to 2 years
The safety population consisted of all patients who received study drug. Dosing began at 150μg twice daily (300μg daily) and went up to 1200μg twice daily (2400μg daily). Through the duration of the study the 45 patients started at 300μg-≤900μg /day, 43 patients proceeded to \>900μg-≤1500μg/day and 31 patients proceeded to \>1500μg -≤2400μg/day.
|
2.3%
1/43 • Up to 2 years
The safety population consisted of all patients who received study drug. Dosing began at 150μg twice daily (300μg daily) and went up to 1200μg twice daily (2400μg daily). Through the duration of the study the 45 patients started at 300μg-≤900μg /day, 43 patients proceeded to \>900μg-≤1500μg/day and 31 patients proceeded to \>1500μg -≤2400μg/day.
|
6.5%
2/31 • Up to 2 years
The safety population consisted of all patients who received study drug. Dosing began at 150μg twice daily (300μg daily) and went up to 1200μg twice daily (2400μg daily). Through the duration of the study the 45 patients started at 300μg-≤900μg /day, 43 patients proceeded to \>900μg-≤1500μg/day and 31 patients proceeded to \>1500μg -≤2400μg/day.
|
Additional Information
Study Director
Novartis Pharmaceuticals
Phone: 862-778-8300
Results disclosure agreements
- Principal investigator is a sponsor employee The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (i.e., data from all sites) in the clinical trial.
- Publication restrictions are in place
Restriction type: OTHER