Trial Outcomes & Findings for Phase II Study Evaluating Efficacy, Safety and Pharmacokinetics of Pasireotide in Patients With Dumping Syndrome (NCT NCT01637272)
NCT ID: NCT01637272
Last Updated: 2017-05-10
Results Overview
Response rate is defined as percentage of patients with no glucose values \< 60 mg/dL at 90,120, 150 and 180 min during the Oral Glucose Tolerance Test (OGTT) at the end of s.c. dose escalation phase
COMPLETED
PHASE2
43 participants
at Month 3 (M3)
2017-05-10
Participant Flow
43 patients were enrolled as planned; 33 patients completed the core sc phase, 31 patients completed the core LAR phase. Of the 31 patients who completed core LAR phase, 27 patients entered the extension phase. Of the 27 patients who entered the extension phase, 23 patients completed the study.
All patients underwent an OGTT (75g of glucose) and were evaluated at different time points. If the glucose level was \<60 mg/dL at 90, 120, 150 or 180 min during the OGTT and all the other eligibility criteria were met, patients were allowed to start study medication. The study was divided in 2 phases, core phase and extension phase.
Participant milestones
| Measure |
SOM230
Subjects with dumping syndrome treated with pasireotide
|
|---|---|
|
Overall Study
STARTED
|
43
|
|
Overall Study
Completed sc Phase
|
33
|
|
Overall Study
Completed Core Phase (sc + LAR)
|
31
|
|
Overall Study
Entered Extension Phase
|
27
|
|
Overall Study
Completed Core But Did no Enter Ext..
|
4
|
|
Overall Study
COMPLETED
|
23
|
|
Overall Study
NOT COMPLETED
|
20
|
Reasons for withdrawal
| Measure |
SOM230
Subjects with dumping syndrome treated with pasireotide
|
|---|---|
|
Overall Study
Adverse Event
|
6
|
|
Overall Study
Unsatisfactory therapeutic effect
|
2
|
|
Overall Study
Withdrawal by Subject
|
3
|
|
Overall Study
Lost to Follow-up
|
2
|
|
Overall Study
completed core, did not enter ext. phase
|
4
|
|
Overall Study
Administrative problems
|
1
|
|
Overall Study
Protocol Violation
|
2
|
Baseline Characteristics
Phase II Study Evaluating Efficacy, Safety and Pharmacokinetics of Pasireotide in Patients With Dumping Syndrome
Baseline characteristics by cohort
| Measure |
SOM230
n=43 Participants
Subjects with dumping syndrome treated with pasireotide
|
|---|---|
|
Age, Continuous
|
45.9 Years
STANDARD_DEVIATION 9.99 • n=5 Participants
|
|
Sex: Female, Male
Female
|
38 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: at Month 3 (M3)Population: The sc full analysis set (sc FAS) consisted of all patients who received at least one dose of pasireotide sc during core sc phase.
Response rate is defined as percentage of patients with no glucose values \< 60 mg/dL at 90,120, 150 and 180 min during the Oral Glucose Tolerance Test (OGTT) at the end of s.c. dose escalation phase
Outcome measures
| Measure |
SOM230 - 6 Months (LAR)
Subjects with dumping syndrome treated with pasireotide sc (3M) followed by pasireotide LAR (3M) for a total of 6 months
|
SOM230 - 12 Months (Ext)
Subjects with dumping syndrome treated with pasireotide LAR (6 months in Core \& 6 months in Ext. phase)
|
SOM230 - 3 Months (sc)
n=43 Participants
Subjects with dumping syndrome treated with pasireotide sc
|
SOM sc 200 ug t.i.d.
Subjects with dumping syndrome treated with pasireotide sc 200 ug t.i.d.
|
SOM LAR 60mg
Subjects with dumping syndrome treated with pasireotide LAR 60mg
|
|---|---|---|---|---|---|
|
Response Rate in Plasma Glucose Level
|
—
|
—
|
60.5 percentage of participants
Interval 44.41 to 75.02
|
—
|
—
|
SECONDARY outcome
Timeframe: at Month 6 (M6), Month 12 (M12)Population: The LAR full analysis set (LAR FAS) consisted of all patients who received at least one dose of pasireotide LAR during core LAR phase.
Response rate is defined as percentage of patients with no glucose values \< 60 mg/dL at 90,120, 150 and 180 min during the Oral Glucose Tolerance Test (OGTT) at the end of 6 months (end of LAR/Core phase) and at the end of 12 months (extension phase)
Outcome measures
| Measure |
SOM230 - 6 Months (LAR)
n=33 Participants
Subjects with dumping syndrome treated with pasireotide sc (3M) followed by pasireotide LAR (3M) for a total of 6 months
|
SOM230 - 12 Months (Ext)
Subjects with dumping syndrome treated with pasireotide LAR (6 months in Core \& 6 months in Ext. phase)
|
SOM230 - 3 Months (sc)
n=33 Participants
Subjects with dumping syndrome treated with pasireotide sc
|
SOM sc 200 ug t.i.d.
Subjects with dumping syndrome treated with pasireotide sc 200 ug t.i.d.
|
SOM LAR 60mg
Subjects with dumping syndrome treated with pasireotide LAR 60mg
|
|---|---|---|---|---|---|
|
Response Rate in Plasma Glucose Level
|
39.4 percentage of participants
Interval 22.91 to 57.86
|
—
|
36.4 percentage of participants
Interval 20.4 to 54.88
|
—
|
—
|
SECONDARY outcome
Timeframe: at baseline, M3, M6, M12Population: The sc full analysis set (sc FAS) consisted of all patients who received at least one dose of pasireotide sc during core sc phase. The LAR full analysis set (LAR FAS) consisted of all patients who received at least one dose of pasireotide LAR during core LAR phase.
Pulse rate was defined as percentage of patients with change in pulse rate \>=10 bpm from pre-OGTT to 30 minutes post OGTT.
Outcome measures
| Measure |
SOM230 - 6 Months (LAR)
n=33 Participants
Subjects with dumping syndrome treated with pasireotide sc (3M) followed by pasireotide LAR (3M) for a total of 6 months
|
SOM230 - 12 Months (Ext)
n=33 Participants
Subjects with dumping syndrome treated with pasireotide LAR (6 months in Core \& 6 months in Ext. phase)
|
SOM230 - 3 Months (sc)
n=43 Participants
Subjects with dumping syndrome treated with pasireotide sc
|
SOM sc 200 ug t.i.d.
Subjects with dumping syndrome treated with pasireotide sc 200 ug t.i.d.
|
SOM LAR 60mg
Subjects with dumping syndrome treated with pasireotide LAR 60mg
|
|---|---|---|---|---|---|
|
Response Rate in Pulse Rate
rate ≥ 10 bpm at baseline
|
24.2 Percentage of participants
|
24.2 Percentage of participants
|
60.5 Percentage of participants
|
—
|
—
|
|
Response Rate in Pulse Rate
rate ≥ 10 bpm at post-baseline
|
36.4 Percentage of participants
|
27.3 Percentage of participants
|
18.6 Percentage of participants
|
—
|
—
|
SECONDARY outcome
Timeframe: M3, M6, M12Population: The sc full analysis set (sc FAS) consisted of all patients who received at least one dose of pasireotide sc during core sc phase. The LAR full analysis set (LAR FAS) consisted of all patients who received at least one dose of pasireotide LAR during core LAR phase.
Percentage of patients with change in hematocrit \>= 3% from pre-OGTT to 30 minutes post OGTT.
Outcome measures
| Measure |
SOM230 - 6 Months (LAR)
n=33 Participants
Subjects with dumping syndrome treated with pasireotide sc (3M) followed by pasireotide LAR (3M) for a total of 6 months
|
SOM230 - 12 Months (Ext)
n=33 Participants
Subjects with dumping syndrome treated with pasireotide LAR (6 months in Core \& 6 months in Ext. phase)
|
SOM230 - 3 Months (sc)
n=43 Participants
Subjects with dumping syndrome treated with pasireotide sc
|
SOM sc 200 ug t.i.d.
Subjects with dumping syndrome treated with pasireotide sc 200 ug t.i.d.
|
SOM LAR 60mg
Subjects with dumping syndrome treated with pasireotide LAR 60mg
|
|---|---|---|---|---|---|
|
Response Rate in Hematocrit Levels
hematocrit >= 3% at baseline
|
21.2 Percentage of participants
|
21.2 Percentage of participants
|
27.9 Percentage of participants
|
—
|
—
|
|
Response Rate in Hematocrit Levels
hematocrit >= 3% at post baseline
|
27.3 Percentage of participants
|
24.2 Percentage of participants
|
16.3 Percentage of participants
|
—
|
—
|
SECONDARY outcome
Timeframe: M3, M6, M12Population: The sc full analysis set (sc FAS) consisted of all patients who received at least one dose of pasireotide sc during core sc phase. The LAR full analysis set (LAR FAS) consisted of all patients who received at least one dose of pasireotide LAR during core LAR phase.
Absolute insulin levels at the end of M3, M6, M12
Outcome measures
| Measure |
SOM230 - 6 Months (LAR)
n=33 Participants
Subjects with dumping syndrome treated with pasireotide sc (3M) followed by pasireotide LAR (3M) for a total of 6 months
|
SOM230 - 12 Months (Ext)
n=33 Participants
Subjects with dumping syndrome treated with pasireotide LAR (6 months in Core \& 6 months in Ext. phase)
|
SOM230 - 3 Months (sc)
n=43 Participants
Subjects with dumping syndrome treated with pasireotide sc
|
SOM sc 200 ug t.i.d.
Subjects with dumping syndrome treated with pasireotide sc 200 ug t.i.d.
|
SOM LAR 60mg
Subjects with dumping syndrome treated with pasireotide LAR 60mg
|
|---|---|---|---|---|---|
|
Insulin Levels During OGTT
Pre-OGTT (n= 31, 29, 21)
|
34.7 pmol/L
Standard Deviation 19.73
|
29.0 pmol/L
Standard Deviation 14.43
|
37.0 pmol/L
Standard Deviation 24.55
|
—
|
—
|
|
Insulin Levels During OGTT
30 Minutes (n=30, 29, 23)
|
499.8 pmol/L
Standard Deviation 276.80
|
294.1 pmol/L
Standard Deviation 177.25
|
196.3 pmol/L
Standard Deviation 253.10
|
—
|
—
|
|
Insulin Levels During OGTT
60 Minutes (n= 31, 30, 22)
|
573.2 pmol/L
Standard Deviation 428.46
|
602.1 pmol/L
Standard Deviation 381.6
|
367.5 pmol/L
Standard Deviation 354.73
|
—
|
—
|
|
Insulin Levels During OGTT
90 Minutes (n=31, 30, 22)
|
420.4 pmol/L
Standard Deviation 544.78
|
472.0 pmol/L
Standard Deviation 438.82
|
309.1 pmol/L
Standard Deviation 263.92
|
—
|
—
|
|
Insulin Levels During OGTT
120 Minutes(n=32, 30, 22)
|
205.7 pmol/L
Standard Deviation 514.45
|
195.1 pmol/L
Standard Deviation 247.43
|
183.7 pmol/L
Standard Deviation 209.90
|
—
|
—
|
|
Insulin Levels During OGTT
150 Minutes(n=33, 30, 22)
|
102.8 pmol/L
Standard Deviation 228.92
|
76.0 pmol/L
Standard Deviation 106.05
|
103.2 pmol/L
Standard Deviation 166.67
|
—
|
—
|
|
Insulin Levels During OGTT
180 Minutes (n=32, 29, 22)
|
69.1 pmol/L
Standard Deviation 154.11
|
52.0 pmol/L
Standard Deviation 58.81
|
58.5 pmol/L
Standard Deviation 52.65
|
—
|
—
|
SECONDARY outcome
Timeframe: M3, M6, M12Population: The sc full analysis set (sc FAS) consisted of all patients who received at least one dose of pasireotide sc during core sc phase. The LAR full analysis set (LAR FAS) consisted of all patients who received at least one dose of pasireotide LAR during core LAR phase.
Absolute glucagon levels at the end of Months 3, 6 \& 12
Outcome measures
| Measure |
SOM230 - 6 Months (LAR)
n=33 Participants
Subjects with dumping syndrome treated with pasireotide sc (3M) followed by pasireotide LAR (3M) for a total of 6 months
|
SOM230 - 12 Months (Ext)
n=33 Participants
Subjects with dumping syndrome treated with pasireotide LAR (6 months in Core \& 6 months in Ext. phase)
|
SOM230 - 3 Months (sc)
n=43 Participants
Subjects with dumping syndrome treated with pasireotide sc
|
SOM sc 200 ug t.i.d.
Subjects with dumping syndrome treated with pasireotide sc 200 ug t.i.d.
|
SOM LAR 60mg
Subjects with dumping syndrome treated with pasireotide LAR 60mg
|
|---|---|---|---|---|---|
|
Glucagon Levels During OGTT
150 Minutes (n= 32 28, 22)
|
23.7 pmol/L
Standard Deviation 6.67
|
21.8 pmol/L
Standard Deviation 7.27
|
19.94 pmol/L
Standard Deviation 7.169
|
—
|
—
|
|
Glucagon Levels During OGTT
Pre-OGTT (n= 31, 30, 23)
|
22.6 pmol/L
Standard Deviation 5.85
|
21.4 pmol/L
Standard Deviation 6.82
|
20.70 pmol/L
Standard Deviation 6.162
|
—
|
—
|
|
Glucagon Levels During OGTT
30 Minutes (n= 33, 29, 22)
|
25.8 pmol/L
Standard Deviation 6.57
|
23.8 pmol/L
Standard Deviation 6.97
|
20.64 pmol/L
Standard Deviation 7.037
|
—
|
—
|
|
Glucagon Levels During OGTT
60 Minutes (n= 33, 28, 22)
|
23.7 pmol/L
Standard Deviation 5.76
|
22.9 pmol/L
Standard Deviation 7.07
|
20.80 pmol/L
Standard Deviation 7.330
|
—
|
—
|
|
Glucagon Levels During OGTT
90 Minutes (n= 32, 29, 22)
|
22.7 pmol/L
Standard Deviation 5.16
|
21.5 pmol/L
Standard Deviation 7.69
|
20.07 pmol/L
Standard Deviation 7.898
|
—
|
—
|
|
Glucagon Levels During OGTT
120 Minutes (n= 32, 29, 22)
|
23.1 pmol/L
Standard Deviation 5.40
|
22.0 pmol/L
Standard Deviation 7.31
|
19.73 pmol/L
Standard Deviation 7.369
|
—
|
—
|
|
Glucagon Levels During OGTT
180 Minutes (n= 32, 29, 22)
|
22.7 pmol/L
Standard Deviation 5.45
|
22.3 pmol/L
Standard Deviation 6.58
|
20.16 pmol/L
Standard Deviation 7.097
|
—
|
—
|
SECONDARY outcome
Timeframe: M3, M6, M12Population: The sc full analysis set (sc FAS) consisted of all patients who received at least one dose of pasireotide sc during core sc phase. The LAR full analysis set (LAR FAS) consisted of all patients who received at least one dose of pasireotide LAR during core LAR phase.
Absolute Glucagon-like peptide 1 (GLP-1) levels at the end of at the end of Months 3, 6 and 12 at different time points.
Outcome measures
| Measure |
SOM230 - 6 Months (LAR)
n=33 Participants
Subjects with dumping syndrome treated with pasireotide sc (3M) followed by pasireotide LAR (3M) for a total of 6 months
|
SOM230 - 12 Months (Ext)
n=33 Participants
Subjects with dumping syndrome treated with pasireotide LAR (6 months in Core \& 6 months in Ext. phase)
|
SOM230 - 3 Months (sc)
n=43 Participants
Subjects with dumping syndrome treated with pasireotide sc
|
SOM sc 200 ug t.i.d.
Subjects with dumping syndrome treated with pasireotide sc 200 ug t.i.d.
|
SOM LAR 60mg
Subjects with dumping syndrome treated with pasireotide LAR 60mg
|
|---|---|---|---|---|---|
|
Glucagon-like Peptide 1 (GLP-1) Levels During OGTT
Pre-OGTT (n=31, 29, 23)
|
2.1 pmol/L
Standard Deviation 1.37
|
1.6 pmol/L
Standard Deviation 1.26
|
3.021 pmol/L
Standard Deviation 2.1936
|
—
|
—
|
|
Glucagon-like Peptide 1 (GLP-1) Levels During OGTT
30 Minutes(n=32, 29, 22)
|
21.0 pmol/L
Standard Deviation 18.01
|
17.4 pmol/L
Standard Deviation 17.64
|
12.811 pmol/L
Standard Deviation 6.6194
|
—
|
—
|
|
Glucagon-like Peptide 1 (GLP-1) Levels During OGTT
60 Minutes (n= 32, 30, 22)
|
14.6 pmol/L
Standard Deviation 18.44
|
12.6 pmol/L
Standard Deviation 8.76
|
11.208 pmol/L
Standard Deviation 11.1218
|
—
|
—
|
|
Glucagon-like Peptide 1 (GLP-1) Levels During OGTT
90 Minutes (n=31, 29, 22)
|
8.2 pmol/L
Standard Deviation 4.96
|
7.2 pmol/L
Standard Deviation 3.71
|
6.986 pmol/L
Standard Deviation 4.9729
|
—
|
—
|
|
Glucagon-like Peptide 1 (GLP-1) Levels During OGTT
120 Minutes (n=31, 29, 22)
|
5.2 pmol/L
Standard Deviation 3.94
|
5.0 pmol/L
Standard Deviation 2.98
|
5.003 pmol/L
Standard Deviation 4.1183
|
—
|
—
|
|
Glucagon-like Peptide 1 (GLP-1) Levels During OGTT
150 Minutes(n=31, 29, 22)
|
4.2 pmol/L
Standard Deviation 4.20
|
3.7 pmol/L
Standard Deviation 2.46
|
3.565 pmol/L
Standard Deviation 2.3879
|
—
|
—
|
|
Glucagon-like Peptide 1 (GLP-1) Levels During OGTT
180 Minutes (n=31, 29, 22)
|
3.3 pmol/L
Standard Deviation 3.49
|
3.2 pmol/L
Standard Deviation 2.44
|
2.974 pmol/L
Standard Deviation 1.9902
|
—
|
—
|
SECONDARY outcome
Timeframe: M3, M6, M12Population: The sc full analysis set (sc FAS) consisted of all patients who received at least one dose of pasireotide sc during core sc phase. The LAR full analysis set (LAR FAS) consisted of all patients who received at least one dose of pasireotide LAR during core LAR phase.
Absolute Gastric Inhibitory Polypeptide (GIP) levels at the end of Months 3, 6 and 12 at different time points.
Outcome measures
| Measure |
SOM230 - 6 Months (LAR)
n=33 Participants
Subjects with dumping syndrome treated with pasireotide sc (3M) followed by pasireotide LAR (3M) for a total of 6 months
|
SOM230 - 12 Months (Ext)
n=33 Participants
Subjects with dumping syndrome treated with pasireotide LAR (6 months in Core \& 6 months in Ext. phase)
|
SOM230 - 3 Months (sc)
n=43 Participants
Subjects with dumping syndrome treated with pasireotide sc
|
SOM sc 200 ug t.i.d.
Subjects with dumping syndrome treated with pasireotide sc 200 ug t.i.d.
|
SOM LAR 60mg
Subjects with dumping syndrome treated with pasireotide LAR 60mg
|
|---|---|---|---|---|---|
|
Gastric Inhibitory Polypeptide (GIP) Levels at During OGTT
Pre-OGTT (n=31, 29, 23)
|
1.5 pmol/L
Standard Deviation 1.00
|
1.7 pmol/L
Standard Deviation 1.51
|
2.608 pmol/L
Standard Deviation 1.7441
|
—
|
—
|
|
Gastric Inhibitory Polypeptide (GIP) Levels at During OGTT
30 Minutes (n=32, 29, 22)
|
30.3 pmol/L
Standard Deviation 19.73
|
24.8 pmol/L
Standard Deviation 18.88
|
15.704 pmol/L
Standard Deviation 10.6395
|
—
|
—
|
|
Gastric Inhibitory Polypeptide (GIP) Levels at During OGTT
60 Minutes (n= 32, 30, 22)
|
14.3 pmol/L
Standard Deviation 13.37
|
11.6 pmol/L
Standard Deviation 9.05
|
9.471 pmol/L
Standard Deviation 6.1861
|
—
|
—
|
|
Gastric Inhibitory Polypeptide (GIP) Levels at During OGTT
90 Minutes(n=31, 29, 22)
|
6.5 pmol/L
Standard Deviation 7.32
|
5.2 pmol/L
Standard Deviation 5.18
|
4.141 pmol/L
Standard Deviation 2.8978
|
—
|
—
|
|
Gastric Inhibitory Polypeptide (GIP) Levels at During OGTT
120 Minutes (n=31, 29, 22)
|
2.4 pmol/L
Standard Deviation 1.73
|
3.0 pmol/L
Standard Deviation 2.81
|
2.089 pmol/L
Standard Deviation 1.4681
|
—
|
—
|
|
Gastric Inhibitory Polypeptide (GIP) Levels at During OGTT
150 Minutes (n=30, 29, 22)
|
2.1 pmol/L
Standard Deviation 3.22
|
1.9 pmol/L
Standard Deviation 1.44
|
1.376 pmol/L
Standard Deviation 1.2049
|
—
|
—
|
|
Gastric Inhibitory Polypeptide (GIP) Levels at During OGTT
180 Minutes (n=31, 29, 22)
|
3.8 pmol/L
Standard Deviation 12.77
|
2.5 pmol/L
Standard Deviation 3.72
|
1.260 pmol/L
Standard Deviation 1.2218
|
—
|
—
|
SECONDARY outcome
Timeframe: M3, M6, M12Population: The sc full analysis set (sc FAS) consisted of all patients who received at least one dose of pasireotide sc during core sc phase. The LAR full analysis set (LAR FAS) consisted of all patients who received at least one dose of pasireotide LAR during core LAR phase.
Absolute HRQoL SF-36 Scores at end of the Months 3, 6 and 12 from s.c. baseline. SF-36, a 36-Item Short Form Health Survey (SF-36) is a set of generic, coherent, and easily administered quality-of-life measures. These measures rely upon patient self-reporting. Items are scored so that a high score defines a more favorable health state. In addition, each item is scored on a 0 to 100 range so that the lowest and highest possible scores are 0 and 100, respectively.
Outcome measures
| Measure |
SOM230 - 6 Months (LAR)
n=33 Participants
Subjects with dumping syndrome treated with pasireotide sc (3M) followed by pasireotide LAR (3M) for a total of 6 months
|
SOM230 - 12 Months (Ext)
n=33 Participants
Subjects with dumping syndrome treated with pasireotide LAR (6 months in Core \& 6 months in Ext. phase)
|
SOM230 - 3 Months (sc)
n=43 Participants
Subjects with dumping syndrome treated with pasireotide sc
|
SOM sc 200 ug t.i.d.
Subjects with dumping syndrome treated with pasireotide sc 200 ug t.i.d.
|
SOM LAR 60mg
Subjects with dumping syndrome treated with pasireotide LAR 60mg
|
|---|---|---|---|---|---|
|
Health-related Quality of Live (HRQoL) Short Form- 36 (SF-36) Score(s)
Physical Component Summary (n=35, 29, 23)
|
45.306 scores on a scale
Standard Deviation 9.5622
|
46.505 scores on a scale
Standard Deviation 8.5105
|
44.801 scores on a scale
Standard Deviation 8.3378
|
—
|
—
|
|
Health-related Quality of Live (HRQoL) Short Form- 36 (SF-36) Score(s)
Mental Component Summary (n=35, 29, 23)
|
44.838 scores on a scale
Standard Deviation 11.6573
|
47.021 scores on a scale
Standard Deviation 11.5053
|
44.093 scores on a scale
Standard Deviation 12.2144
|
—
|
—
|
SECONDARY outcome
Timeframe: M3, M6, M8Population: The sc full analysis set (sc FAS) consisted of all patients who received at least one dose of pasireotide sc during core sc phase. The LAR full analysis set (LAR FAS) consisted of all patients who received at least one dose of pasireotide LAR during core LAR phase.
Absolute Dumping Severity Score (DSS) scores at end of M3, M6 \& M8. At study start patients were assessed using DSS (older version of DSQ); however after the implementation of protocol amendment 2, all patients were expected to use DSQ. No results available for M12 as last patient that answered the DSS was at M8. DSS = disease-specific patient (Pt.) reported outcome (PRO) questionnaire uses a 4-point Likert scale (0, absent; 1, mild; 2, relevant; 3, severe; 4) to ask Pt. to evaluate intensity of early dumping symptoms (within 30 minutes (\<30 minutes) after food ingestion). The questionnaire also evaluates 65 late dumping symptoms (more than 1.5 hours (\>90 minutes) after food ingestion). Early \& late dumping score calculated by adding the scores of the respective questions. Cumulative dumping score is obtained by adding early \& late scores. DSS Range (min (absent) - max (severe)): Early dumping: 0-24; Late Dumping: 0-18; Cumulative: 0-42. Lower scores represent a better outcome.
Outcome measures
| Measure |
SOM230 - 6 Months (LAR)
n=33 Participants
Subjects with dumping syndrome treated with pasireotide sc (3M) followed by pasireotide LAR (3M) for a total of 6 months
|
SOM230 - 12 Months (Ext)
n=33 Participants
Subjects with dumping syndrome treated with pasireotide LAR (6 months in Core \& 6 months in Ext. phase)
|
SOM230 - 3 Months (sc)
n=43 Participants
Subjects with dumping syndrome treated with pasireotide sc
|
SOM sc 200 ug t.i.d.
Subjects with dumping syndrome treated with pasireotide sc 200 ug t.i.d.
|
SOM LAR 60mg
Subjects with dumping syndrome treated with pasireotide LAR 60mg
|
|---|---|---|---|---|---|
|
Dumping Severity Score (DSS) at the End of Months 3, 6 and 8
Early symptoms (n=20, 9, 2)
|
6.8 scores on a scale
Standard Deviation 6.46
|
9.0 scores on a scale
Standard Deviation 8.49
|
7.1 scores on a scale
Standard Deviation 6.38
|
—
|
—
|
|
Dumping Severity Score (DSS) at the End of Months 3, 6 and 8
Late symptoms (n=20, 9, 2)
|
6.4 scores on a scale
Standard Deviation 5.27
|
6.0 scores on a scale
Standard Deviation 4.24
|
6.7 scores on a scale
Standard Deviation 5.42
|
—
|
—
|
|
Dumping Severity Score (DSS) at the End of Months 3, 6 and 8
Overall score (n=20, 9, 2)
|
13.2 scores on a scale
Standard Deviation 10.65
|
15.0 scores on a scale
Standard Deviation 12.73
|
13.7 scores on a scale
Standard Deviation 11.11
|
—
|
—
|
SECONDARY outcome
Timeframe: M3, M6, M12Population: The sc full analysis set (sc FAS) consisted of all patients who received at least one dose of pasireotide sc during core sc phase. The LAR full analysis set (LAR FAS) consisted of all patients who received at least one dose of pasireotide LAR during core LAR phase.
Absolute Dumping Score Questionnaire (DSQ) scores at end of Months 3, 6 \& 12 from s.c. baseline. DSQ = disease-specific PRO scale. The questionnaire uses a 5-point Likert scale (0, none; 1, mild; 2, moderate; 3, severe; 4, very severe) to ask Pt. to evaluate intensity of 10 early dumping symptoms (within 30 minutes (\<30 minutes) after food ingestion). The questionnaire also evaluates 5 late dumping symptoms (more than 1.5 hours (\>90 minutes) after food ingestion). Early \& late dumping score calculated by adding the scores of respective questions. A cumulative dumping score is obtained by adding early \& late scores. At study start patients were assessed using DSS (older version of DSQ); however after the implementation of protocol amendment 2, all patients used DSQ. DSQ Range: (min (None) - max (Very severe)): Early dumping: 0-40; Late Dumping: 0-20; Cumulative: 0-60. Lower scores represent a better outcome.
Outcome measures
| Measure |
SOM230 - 6 Months (LAR)
n=33 Participants
Subjects with dumping syndrome treated with pasireotide sc (3M) followed by pasireotide LAR (3M) for a total of 6 months
|
SOM230 - 12 Months (Ext)
n=33 Participants
Subjects with dumping syndrome treated with pasireotide LAR (6 months in Core \& 6 months in Ext. phase)
|
SOM230 - 3 Months (sc)
n=43 Participants
Subjects with dumping syndrome treated with pasireotide sc
|
SOM sc 200 ug t.i.d.
Subjects with dumping syndrome treated with pasireotide sc 200 ug t.i.d.
|
SOM LAR 60mg
Subjects with dumping syndrome treated with pasireotide LAR 60mg
|
|---|---|---|---|---|---|
|
Dumping Score Questionnaire (DSQ) at the End of Months 3, 6 and 12
Early symptoms (n=15, 20, 23)
|
9.2 scores on a scale
Standard Deviation 10.05
|
10.7 scores on a scale
Standard Deviation 10.94
|
9.6 scores on a scale
Standard Deviation 10.27
|
—
|
—
|
|
Dumping Score Questionnaire (DSQ) at the End of Months 3, 6 and 12
Late symptoms (n=15, 20, 23)
|
5.6 scores on a scale
Standard Deviation 6.57
|
5.7 scores on a scale
Standard Deviation 5.93
|
4.9 scores on a scale
Standard Deviation 5.37
|
—
|
—
|
|
Dumping Score Questionnaire (DSQ) at the End of Months 3, 6 and 12
Overall score (n=15, 20, 23)
|
14.8 scores on a scale
Standard Deviation 14.65
|
16.3 scores on a scale
Standard Deviation 16.23
|
14.5 scores on a scale
Standard Deviation 15.26
|
—
|
—
|
SECONDARY outcome
Timeframe: M3, M6, M12Population: The sc full analysis set (sc FAS) consisted of all patients who received at least one dose of pasireotide sc during core sc phase. The LAR full analysis set (LAR FAS) consisted of all patients who received at least one dose of pasireotide LAR during core LAR phase.
Treatment with pasireotide LAR (both early and late dumping scores), was assessed by patient global assessment. Patient Global Assessment served as an additional approach to symptom based measurement by DSQ. It incorporated a patient global assessment question: "Considering all the ways that your disease affects you, rate how you are feeling during the last 7 days compared with your situation before starting the study" .Patients Global Assessment was measured utilizing a 7 point scale (from 1=a lot worse to 7= a lot better).
Outcome measures
| Measure |
SOM230 - 6 Months (LAR)
n=29 Participants
Subjects with dumping syndrome treated with pasireotide sc (3M) followed by pasireotide LAR (3M) for a total of 6 months
|
SOM230 - 12 Months (Ext)
n=23 Participants
Subjects with dumping syndrome treated with pasireotide LAR (6 months in Core \& 6 months in Ext. phase)
|
SOM230 - 3 Months (sc)
n=35 Participants
Subjects with dumping syndrome treated with pasireotide sc
|
SOM sc 200 ug t.i.d.
Subjects with dumping syndrome treated with pasireotide sc 200 ug t.i.d.
|
SOM LAR 60mg
Subjects with dumping syndrome treated with pasireotide LAR 60mg
|
|---|---|---|---|---|---|
|
Patient Global Assessment at the End of Months 3, 6 and 12
|
5.1 scores on a scale
Standard Deviation 1.27
|
5.9 scores on a scale
Standard Deviation 0.95
|
5.1 scores on a scale
Standard Deviation 1.19
|
—
|
—
|
SECONDARY outcome
Timeframe: M1 to M3Population: The sc PK analysis set consisted of all patients who received at least one of the scheduled full daily sc dose (3 injections) and had evaluable PK data (concentration) in the sc dose escalation phase of the study (Visit 2 through Visit 8).
A pre-dose PK blood sample was collected before the morning pasireotide s.c. dose of 50 μg, 100 ug, 150 ug and 200 ug. OGTT was performed right after the morning s.c. dose (Time point zero); additional PK blood samples were collected at the same time points as the OGTT evaluation at 30, 60, 90, 120, 150 and 180 minutes. 'n' = number of subjects with non-missing values
Outcome measures
| Measure |
SOM230 - 6 Months (LAR)
n=31 Participants
Subjects with dumping syndrome treated with pasireotide sc (3M) followed by pasireotide LAR (3M) for a total of 6 months
|
SOM230 - 12 Months (Ext)
n=23 Participants
Subjects with dumping syndrome treated with pasireotide LAR (6 months in Core \& 6 months in Ext. phase)
|
SOM230 - 3 Months (sc)
n=40 Participants
Subjects with dumping syndrome treated with pasireotide sc
|
SOM sc 200 ug t.i.d.
n=14 Participants
Subjects with dumping syndrome treated with pasireotide sc 200 ug t.i.d.
|
SOM LAR 60mg
Subjects with dumping syndrome treated with pasireotide LAR 60mg
|
|---|---|---|---|---|---|
|
Plasma Pharmacokinetic (PK) Parameter of Pasireotide: Cmax, ss (Steady State) and Ctrough, ss, After s.c. Injection
Cmax, ss (n=35, 28, 18, 10)
|
3.31 ng/mL
Standard Deviation 1.78
|
4.56 ng/mL
Standard Deviation 2.22
|
1.49 ng/mL
Standard Deviation 0.613
|
5.62 ng/mL
Standard Deviation 3.18
|
—
|
|
Plasma Pharmacokinetic (PK) Parameter of Pasireotide: Cmax, ss (Steady State) and Ctrough, ss, After s.c. Injection
Ctrough, ss (n=37, 30, 22, 12)
|
1.11 ng/mL
Standard Deviation 0.909
|
1.5 ng/mL
Standard Deviation 0.798
|
0.574 ng/mL
Standard Deviation 0.436
|
2.03 ng/mL
Standard Deviation 1.54
|
—
|
SECONDARY outcome
Timeframe: M1 to M3Population: The sc PK analysis set consisted of all patients who received at least one of the scheduled full daily sc dose (3 injections) and had evaluable PK data (concentration) in the sc dose escalation phase of the study (Visit 2 through Visit 8).
A pre-dose PK blood sample was collected before the morning pasireotide s.c. dose of 50 μg, 100 ug, 150 ug and 200 ug. OGTT was performed right after the morning s.c. dose (Time point zero); additional PK blood samples were collected at the same time points as the OGTT evaluation at 30, 60, 90, 120, 150 and 180 minutes.
Outcome measures
| Measure |
SOM230 - 6 Months (LAR)
n=28 Participants
Subjects with dumping syndrome treated with pasireotide sc (3M) followed by pasireotide LAR (3M) for a total of 6 months
|
SOM230 - 12 Months (Ext)
n=18 Participants
Subjects with dumping syndrome treated with pasireotide LAR (6 months in Core \& 6 months in Ext. phase)
|
SOM230 - 3 Months (sc)
n=36 Participants
Subjects with dumping syndrome treated with pasireotide sc
|
SOM sc 200 ug t.i.d.
n=10 Participants
Subjects with dumping syndrome treated with pasireotide sc 200 ug t.i.d.
|
SOM LAR 60mg
Subjects with dumping syndrome treated with pasireotide LAR 60mg
|
|---|---|---|---|---|---|
|
Plasma Pharmacokinetic (PK) Parameter of Pasireotide: AUC0-3h, ss, After s.c. Injection
|
6.53 hr*ng/mL
Standard Deviation 3.45
|
8.84 hr*ng/mL
Standard Deviation 3.89
|
3.04 hr*ng/mL
Standard Deviation 1.13
|
11.5 hr*ng/mL
Standard Deviation 6.23
|
—
|
SECONDARY outcome
Timeframe: M1 to M3Population: The sc PK analysis set consisted of all patients who received at least one of the scheduled full daily sc dose (3 injections) and had evaluable PK data (concentration) in the sc dose escalation phase of the study (Visit 2 through Visit 8).
A pre-dose PK blood sample was collected before the morning pasireotide s.c. dose of 50 μg, 100 ug, 150 ug and 200 ug. OGTT was performed right after the morning s.c. dose (Time point zero); additional PK blood samples were collected at the same time points as the OGTT evaluation at 30, 60, 90, 120, 150 and 180 minutes.
Outcome measures
| Measure |
SOM230 - 6 Months (LAR)
n=28 Participants
Subjects with dumping syndrome treated with pasireotide sc (3M) followed by pasireotide LAR (3M) for a total of 6 months
|
SOM230 - 12 Months (Ext)
n=20 Participants
Subjects with dumping syndrome treated with pasireotide LAR (6 months in Core \& 6 months in Ext. phase)
|
SOM230 - 3 Months (sc)
n=36 Participants
Subjects with dumping syndrome treated with pasireotide sc
|
SOM sc 200 ug t.i.d.
n=11 Participants
Subjects with dumping syndrome treated with pasireotide sc 200 ug t.i.d.
|
SOM LAR 60mg
Subjects with dumping syndrome treated with pasireotide LAR 60mg
|
|---|---|---|---|---|---|
|
Plasma Pharmacokinetic (PK) Parameter of Pasireotide: Tmax, ss, After s.c. Injection
|
0.6 hr
Full Range NA • Interval 0.0 to 2.1
|
0.583 hr
Full Range NA • Interval 0.5 to 2.6
|
0.583 hr
Full Range NA • Interval 0.0 to 1.58
|
0.633 hr
Full Range NA • Interval 0.5 to 1.22
|
—
|
SECONDARY outcome
Timeframe: M4 to M6Population: The LAR PK analysis set consisted of all patients who received at least one of the scheduled full monthly im LAR injections and had evaluable PK data (concentration) in the LAR phase of the study (Visit 9 through end of LAR phase visit).
Outcome measures
| Measure |
SOM230 - 6 Months (LAR)
n=19 Participants
Subjects with dumping syndrome treated with pasireotide sc (3M) followed by pasireotide LAR (3M) for a total of 6 months
|
SOM230 - 12 Months (Ext)
Subjects with dumping syndrome treated with pasireotide LAR (6 months in Core \& 6 months in Ext. phase)
|
SOM230 - 3 Months (sc)
n=14 Participants
Subjects with dumping syndrome treated with pasireotide sc
|
SOM sc 200 ug t.i.d.
Subjects with dumping syndrome treated with pasireotide sc 200 ug t.i.d.
|
SOM LAR 60mg
Subjects with dumping syndrome treated with pasireotide LAR 60mg
|
|---|---|---|---|---|---|
|
Plasma PK Parameter of AUC0-3h, d21, End _inj and AUC0-3h, d28, 3rd_inj Associated With LAR (LAR Core Phase)
AUC0-3h,d21, 2nd injection (n = 12, 14)
|
14.9 hr*ng/mL
Standard Deviation 6.71
|
—
|
6.92 hr*ng/mL
Standard Deviation 4.12
|
—
|
—
|
|
Plasma PK Parameter of AUC0-3h, d21, End _inj and AUC0-3h, d28, 3rd_inj Associated With LAR (LAR Core Phase)
AUC0-3h,d28, 3rd_injection (n = 9, 16)
|
9.3 hr*ng/mL
Standard Deviation 4.11
|
—
|
5.97 hr*ng/mL
Standard Deviation 2.41
|
—
|
—
|
SECONDARY outcome
Timeframe: M4 to M6Population: The LAR PK analysis set consisted of all patients who received at least one of the scheduled full monthly im LAR injections and had evaluable PK data (concentration) in the LAR phase of the study (Visit 9 through end of LAR phase visit).
Summary of plasma PK parameter Cmax, p2 , 2nd injection and Ctrough, d28 associated with LAR injection (LAR Core phase)
Outcome measures
| Measure |
SOM230 - 6 Months (LAR)
n=19 Participants
Subjects with dumping syndrome treated with pasireotide sc (3M) followed by pasireotide LAR (3M) for a total of 6 months
|
SOM230 - 12 Months (Ext)
Subjects with dumping syndrome treated with pasireotide LAR (6 months in Core \& 6 months in Ext. phase)
|
SOM230 - 3 Months (sc)
n=14 Participants
Subjects with dumping syndrome treated with pasireotide sc
|
SOM sc 200 ug t.i.d.
Subjects with dumping syndrome treated with pasireotide sc 200 ug t.i.d.
|
SOM LAR 60mg
Subjects with dumping syndrome treated with pasireotide LAR 60mg
|
|---|---|---|---|---|---|
|
Summary of LAR PK Parameters by Dose
Cmax, p2, 2nd_inj (n = 10, 13)
|
6.2 ng/mL
Standard Deviation 2.6
|
—
|
3.2 ng/mL
Standard Deviation 1.55
|
—
|
—
|
|
Summary of LAR PK Parameters by Dose
Ctrough (n= 14, 19)
|
3.33 ng/mL
Standard Deviation 1.34
|
—
|
2.29 ng/mL
Standard Deviation 1.05
|
—
|
—
|
SECONDARY outcome
Timeframe: M7 to M12Population: The LAR PK analysis set consisted of all patients who received at least one of the scheduled full monthly im LAR injections and had evaluable PK data (concentration) in the LAR phase of the study (Visit 9 through end of LAR phase visit).
Summary of pasireotide concentrations following monthly i.m. injections of pasireotide LAR by incident dose (LAR Pharmacokinetic set)
Outcome measures
| Measure |
SOM230 - 6 Months (LAR)
n=12 Participants
Subjects with dumping syndrome treated with pasireotide sc (3M) followed by pasireotide LAR (3M) for a total of 6 months
|
SOM230 - 12 Months (Ext)
n=17 Participants
Subjects with dumping syndrome treated with pasireotide LAR (6 months in Core \& 6 months in Ext. phase)
|
SOM230 - 3 Months (sc)
n=6 Participants
Subjects with dumping syndrome treated with pasireotide sc
|
SOM sc 200 ug t.i.d.
n=9 Participants
Subjects with dumping syndrome treated with pasireotide sc 200 ug t.i.d.
|
SOM LAR 60mg
n=3 Participants
Subjects with dumping syndrome treated with pasireotide LAR 60mg
|
|---|---|---|---|---|---|
|
Pasireotide Concentrations in LAR Phase
M11 - 0hr (pre-dose) (n = 5, 4, 8, 4, 3)
|
3.48 ng/mL
Standard Deviation 0.772
|
7.99 ng/mL
Standard Deviation 3.54
|
3.45 ng/mL
Standard Deviation 1.98
|
6.53 ng/mL
Standard Deviation 1.83
|
17.9 ng/mL
Standard Deviation 7.15
|
|
Pasireotide Concentrations in LAR Phase
M7 - 0hr (pre-dose) (n = 4, 11, 11, 0, 0)
|
4.3 ng/mL
Standard Deviation 2.19
|
7.76 ng/mL
Standard Deviation 4.31
|
2.25 ng/mL
Standard Deviation 1.56
|
NA ng/mL
Standard Deviation NA
N/A = No participants took this dose hence no data
|
NA ng/mL
Standard Deviation NA
N/A =No participants took this dose hence no data
|
|
Pasireotide Concentrations in LAR Phase
M8 - 0hr (pre-dose) (n = 5, 7, 11, 0, 0)
|
3.77 ng/mL
Standard Deviation 1.57
|
6.5 ng/mL
Standard Deviation 2.91
|
2.91 ng/mL
Standard Deviation 2.42
|
NA ng/mL
Standard Deviation NA
N/A = No participants took this dose hence no data
|
NA ng/mL
Standard Deviation NA
N/A = No participants took this dose hence no data
|
|
Pasireotide Concentrations in LAR Phase
M9 - 0hr (pre-dose) (n = 5, 6, 9, 6, 0)
|
4.01 ng/mL
Standard Deviation 2.27
|
6.38 ng/mL
Standard Deviation 3.15
|
2.97 ng/mL
Standard Deviation 1.68
|
7.53 ng/mL
Standard Deviation 4.45
|
NA ng/mL
Standard Deviation NA
N/A = No participants took this dose hence no data
|
|
Pasireotide Concentrations in LAR Phase
M10 - 0hr (pre-dose) (n = 5, 6, 8, 5, 0)
|
5.48 ng/mL
Standard Deviation 3.62
|
8.38 ng/mL
Standard Deviation 2.81
|
3.53 ng/mL
Standard Deviation 1.75
|
11.8 ng/mL
Standard Deviation 8.26
|
NA ng/mL
Standard Deviation NA
N/A = No participants took this dose hence no data
|
|
Pasireotide Concentrations in LAR Phase
M12 - 0hr (pre-dose) (n = 5, 3, 8, 4, 3)
|
4.63 ng/mL
Standard Deviation 1.04
|
10.3 ng/mL
Standard Deviation 6.05
|
3.27 ng/mL
Standard Deviation 2.02
|
6.55 ng/mL
Standard Deviation 2.05
|
18.1 ng/mL
Standard Deviation 13.8
|
SECONDARY outcome
Timeframe: M4 to M12Population: The LAR PK analysis set consisted of all patients who received at least one of the scheduled full monthly im LAR injections and had evaluable PK data (concentration) in the LAR phase of the study (Visit 9 through end of LAR phase visit).
In the LAR treatment phase, monthly injections of pasireotide LAR 10, 20, 30 and 40 mg were given to participants and trough concentration at steady state (Ctrough,ss) were obtained but due to only 1 participant in the 40mg arm, standard deviation could not be calculated.
Outcome measures
| Measure |
SOM230 - 6 Months (LAR)
n=6 Participants
Subjects with dumping syndrome treated with pasireotide sc (3M) followed by pasireotide LAR (3M) for a total of 6 months
|
SOM230 - 12 Months (Ext)
n=6 Participants
Subjects with dumping syndrome treated with pasireotide LAR (6 months in Core \& 6 months in Ext. phase)
|
SOM230 - 3 Months (sc)
n=6 Participants
Subjects with dumping syndrome treated with pasireotide sc
|
SOM sc 200 ug t.i.d.
n=1 Participants
Subjects with dumping syndrome treated with pasireotide sc 200 ug t.i.d.
|
SOM LAR 60mg
Subjects with dumping syndrome treated with pasireotide LAR 60mg
|
|---|---|---|---|---|---|
|
LAR PK Parameter: Ctrough - at Steady State (ss) by Dose
|
3.76 ng/mL
Standard Deviation 1.48
|
8.19 ng/mL
Standard Deviation 3.22
|
3.34 ng/mL
Standard Deviation 1.52
|
4.63 ng/mL
Standard Deviation NA
N/A - due to only one participant at LAR 40 mg, Ctrough,ss for this arm was not enough to a standard deviation
|
—
|
Adverse Events
s.c. Phase
LAR Phase
Serious adverse events
| Measure |
s.c. Phase
n=43 participants at risk
s.c. phase was made up of subjects with dumping syndrome who entered the study and were treated with pasireotide s.c.
|
LAR Phase
n=33 participants at risk
LAR phase was made up of subjects with dumping syndrome who completed the s.c. phase, entered the LAR phase and were treated with pasireotide LAR
|
|---|---|---|
|
Blood and lymphatic system disorders
Haemorrhagic anaemia
|
0.00%
0/43
|
3.0%
1/33
|
|
Gastrointestinal disorders
Abdominal adhesions
|
0.00%
0/43
|
6.1%
2/33
|
|
Gastrointestinal disorders
Abdominal pain
|
2.3%
1/43
|
3.0%
1/33
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/43
|
3.0%
1/33
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/43
|
3.0%
1/33
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
4.7%
2/43
|
0.00%
0/33
|
|
General disorders
Asthenia
|
0.00%
0/43
|
3.0%
1/33
|
|
Immune system disorders
Anaphylactic reaction
|
2.3%
1/43
|
0.00%
0/33
|
|
Infections and infestations
Subdiaphragmatic abscess
|
0.00%
0/43
|
3.0%
1/33
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
4.7%
2/43
|
3.0%
1/33
|
|
Metabolism and nutrition disorders
Malnutrition
|
0.00%
0/43
|
3.0%
1/33
|
|
Nervous system disorders
Headache
|
0.00%
0/43
|
3.0%
1/33
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/43
|
3.0%
1/33
|
|
Nervous system disorders
Sciatica
|
0.00%
0/43
|
3.0%
1/33
|
|
Nervous system disorders
Visual field defect
|
0.00%
0/43
|
3.0%
1/33
|
|
Psychiatric disorders
Depression
|
0.00%
0/43
|
3.0%
1/33
|
|
Psychiatric disorders
Mental status changes
|
0.00%
0/43
|
3.0%
1/33
|
|
Renal and urinary disorders
Acute kidney injury
|
2.3%
1/43
|
0.00%
0/33
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.00%
0/43
|
3.0%
1/33
|
Other adverse events
| Measure |
s.c. Phase
n=43 participants at risk
s.c. phase was made up of subjects with dumping syndrome who entered the study and were treated with pasireotide s.c.
|
LAR Phase
n=33 participants at risk
LAR phase was made up of subjects with dumping syndrome who completed the s.c. phase, entered the LAR phase and were treated with pasireotide LAR
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/43
|
6.1%
2/33
|
|
Cardiac disorders
Angina pectoris
|
7.0%
3/43
|
0.00%
0/33
|
|
Cardiac disorders
Palpitations
|
7.0%
3/43
|
0.00%
0/33
|
|
Gastrointestinal disorders
Abdominal distension
|
9.3%
4/43
|
3.0%
1/33
|
|
Gastrointestinal disorders
Abdominal pain
|
16.3%
7/43
|
21.2%
7/33
|
|
Gastrointestinal disorders
Abdominal pain upper
|
11.6%
5/43
|
9.1%
3/33
|
|
Gastrointestinal disorders
Constipation
|
7.0%
3/43
|
0.00%
0/33
|
|
Gastrointestinal disorders
Diarrhoea
|
20.9%
9/43
|
24.2%
8/33
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/43
|
6.1%
2/33
|
|
Gastrointestinal disorders
Nausea
|
14.0%
6/43
|
18.2%
6/33
|
|
Gastrointestinal disorders
Steatorrhoea
|
9.3%
4/43
|
0.00%
0/33
|
|
Gastrointestinal disorders
Vomiting
|
7.0%
3/43
|
9.1%
3/33
|
|
General disorders
Asthenia
|
11.6%
5/43
|
12.1%
4/33
|
|
General disorders
Chills
|
2.3%
1/43
|
6.1%
2/33
|
|
General disorders
Fatigue
|
7.0%
3/43
|
24.2%
8/33
|
|
General disorders
Injection site pain
|
9.3%
4/43
|
3.0%
1/33
|
|
General disorders
Injection site reaction
|
7.0%
3/43
|
0.00%
0/33
|
|
General disorders
Oedema peripheral
|
0.00%
0/43
|
6.1%
2/33
|
|
General disorders
Thirst
|
7.0%
3/43
|
0.00%
0/33
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.00%
0/43
|
15.2%
5/33
|
|
Infections and infestations
Bronchitis
|
2.3%
1/43
|
6.1%
2/33
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/43
|
6.1%
2/33
|
|
Infections and infestations
Nasopharyngitis
|
7.0%
3/43
|
18.2%
6/33
|
|
Infections and infestations
Sinusitis
|
0.00%
0/43
|
6.1%
2/33
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/43
|
9.1%
3/33
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/43
|
6.1%
2/33
|
|
Injury, poisoning and procedural complications
Post-traumatic pain
|
0.00%
0/43
|
6.1%
2/33
|
|
Injury, poisoning and procedural complications
Rib fracture
|
0.00%
0/43
|
6.1%
2/33
|
|
Investigations
Weight increased
|
7.0%
3/43
|
6.1%
2/33
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
4.7%
2/43
|
9.1%
3/33
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
11.6%
5/43
|
27.3%
9/33
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
0.00%
0/43
|
6.1%
2/33
|
|
Metabolism and nutrition disorders
Iron deficiency
|
4.7%
2/43
|
15.2%
5/33
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
7.0%
3/43
|
12.1%
4/33
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
4.7%
2/43
|
12.1%
4/33
|
|
Nervous system disorders
Dizziness
|
9.3%
4/43
|
0.00%
0/33
|
|
Nervous system disorders
Headache
|
23.3%
10/43
|
27.3%
9/33
|
|
Nervous system disorders
Syncope
|
0.00%
0/43
|
6.1%
2/33
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/43
|
6.1%
2/33
|
|
Psychiatric disorders
Depressed mood
|
2.3%
1/43
|
6.1%
2/33
|
|
Psychiatric disorders
Depression
|
7.0%
3/43
|
3.0%
1/33
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/43
|
9.1%
3/33
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
0.00%
0/43
|
6.1%
2/33
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
7.0%
3/43
|
6.1%
2/33
|
|
Vascular disorders
Haematoma
|
2.3%
1/43
|
6.1%
2/33
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of pooled data (i.e.,data from all sites) in clinical trial or disclosure of trial results in their entirety.
- Publication restrictions are in place
Restriction type: OTHER