Trial Outcomes & Findings for Quality of Life in Patients With Inoperable Malignant Bowel Obstruction (NCT NCT02365584)

Last Updated: 2019-11-22

Results Overview

Quality of Life was assessed using ESAS, evaluating 9 common symptoms in cancer patients: pain, activity, nausea, depression, anxiety, drowsiness, appetite, well-being and shortness of breath. Symptom severity is rated 0-10 on a numerical scale (0=symptom absent; 10=worst severity). ESAS total score is sum of the 9 items (min score=0, max score=90). Low scores indicate good quality of life; high scores indicate strong discomfort. Questionnaire assessments by the patient or by nurse/caregiver in case of patient's physical inability. AUC is area under the line which joins the points defined by plotting ESAS total score on vertical axis and time values on horizontal axis, computed using trapezoidal rule. Primary endpoint was analysed using the FAS. LS mean AUC of ESAS total scores during first 7 days is presented.

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

43 participants

Primary outcome timeframe

Baseline (Day 1, before randomisation), Days 2, 3, 4, 5, 6 and 7.

Results posted on

2019-11-22

Participant Flow

Recruitment to this prospective, randomised, parallel arm, open-label study began on 14 Jan 2015. Patients with a documented diagnosis of inoperable malignant bowel obstruction who had a nasogastric tube (NGT) or presented with ≥ 3 vomiting episodes/day in the last consecutive 48 hours at time of enrolment were recruited to 14 centres in Italy.

Overall, 43 patients were enrolled and treated in this phase II study. Planned study period duration was 28 days.

Participant milestones

Participant milestones
Measure	Standard Care Patients received standard care only according to site clinical practice.	Standard Care + Lanreotide Autogel Patients received standard care according to site clinical practice and a single administration of Lanreotide Autogel 120 milligrams (mg) by deep subcutaneous injection on Day 1.
Overall Study STARTED	21	22
Overall Study COMPLETED	9	8
Overall Study NOT COMPLETED	12	14

Reasons for withdrawal

Reasons for withdrawal
Measure	Standard Care Patients received standard care only according to site clinical practice.	Standard Care + Lanreotide Autogel Patients received standard care according to site clinical practice and a single administration of Lanreotide Autogel 120 milligrams (mg) by deep subcutaneous injection on Day 1.
Overall Study Adverse Event	2	2
Overall Study Withdrawal by Subject	1	0
Overall Study Disease Progression	9	12

Baseline Characteristics

Quality of Life in Patients With Inoperable Malignant Bowel Obstruction

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Standard Care n=21 Participants Patients received standard care only according to site clinical practice.	Standard Care + Lanreotide Autogel n=22 Participants Patients received standard care according to site clinical practice and a single administration of Lanreotide Autogel 120 mg by deep subcutaneous injection on Day 1.	Total Title n=43 Participants
Age, Continuous	61.8 Years STANDARD_DEVIATION 9.6 • n=5 Participants	62.8 Years STANDARD_DEVIATION 12.3 • n=7 Participants	62.3 Years STANDARD_DEVIATION 10.9 • n=5 Participants
Sex: Female, Male Female	14 Participants n=5 Participants	19 Participants n=7 Participants	33 Participants n=5 Participants
Sex: Female, Male Male	7 Participants n=5 Participants	3 Participants n=7 Participants	10 Participants n=5 Participants
Race/Ethnicity, Customized Caucasian / White	21 Participants n=5 Participants	22 Participants n=7 Participants	43 Participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline (Day 1, before randomisation), Days 2, 3, 4, 5, 6 and 7.

Population: The FAS included all randomised patients who received study therapy, fulfilled the ESAS questionnaire at baseline and had ≥ 5 post-treatment assessments during the first 7 days of the study.

Outcome measures

Outcome measures
Measure	Standard Care n=19 Participants Patients received standard care only according to site clinical practice.	Standard Care + Lanreotide Autogel n=19 Participants Patients received standard care according to site clinical practice and a single administration of Lanreotide Autogel 120 mg by deep subcutaneous injection on Day 1.
Least Squares (LS) Mean Area Under Curve (AUC) of Edmonton Symptom Assessment System (ESAS) Total Scores Collected for the First 7 Days; Full Analysis Set (FAS)	179 Scores on a scale x time (day) Standard Error 12.4	190 Scores on a scale x time (day) Standard Error 12.4

SECONDARY outcome

Timeframe: Baseline (Day 1, before randomisation) and Days 7, 14 and 28.

Quality of Life was assessed using ESAS, evaluating 9 common symptoms in cancer patients: pain, activity, nausea, depression, anxiety, drowsiness, appetite, well-being and shortness of breath. Symptom severity is rated 0-10 on a numerical scale (0=symptom absent; 10=worst severity). ESAS total score is sum of the 9 items (min score=0, max score=90). Low scores indicate good quality of life; high scores indicate strong discomfort. Questionnaire assessments by the patient or by nurse/caregiver in case of patient's physical inability. Secondary endpoints were analysed using the ITT population but to permit following the FAS which was used for primary endpoint analysis, ESAS total score results are reported for both the ITT and the FAS. Mean change from baseline of ESAS total score at Days 7, 14 and 28 is presented here for the FAS; a positive change indicates a worsening condition.

Outcome measures

Outcome measures
Measure	Standard Care n=19 Participants Patients received standard care only according to site clinical practice.	Standard Care + Lanreotide Autogel n=19 Participants Patients received standard care according to site clinical practice and a single administration of Lanreotide Autogel 120 mg by deep subcutaneous injection on Day 1.
Mean Change From Baseline in ESAS Total Score; FAS Change at Day 7	-5.1 Scores on a scale Standard Deviation 15.7	1.9 Scores on a scale Standard Deviation 18.4
Mean Change From Baseline in ESAS Total Score; FAS Change at Day 14	-1.3 Scores on a scale Standard Deviation 21.4	-7.3 Scores on a scale Standard Deviation 16.7
Mean Change From Baseline in ESAS Total Score; FAS Change at Day 28	-6.8 Scores on a scale Standard Deviation 15.2	-10.3 Scores on a scale Standard Deviation 16.7

SECONDARY outcome

Timeframe: Baseline (Day 1, before randomisation) and Days 7, 14 and 28.

Population: The ITT population included all randomised patients. Only patients with data available for analysis at each time point are presented.

Quality of Life was assessed using ESAS, evaluating 9 common symptoms in cancer patients: pain, activity, nausea, depression, anxiety, drowsiness, appetite, well-being and shortness of breath. Symptom severity is rated 0-10 on a numerical scale (0=symptom absent; 10=worst severity). ESAS total score is sum of the 9 items (min score=0, max score=90). Low scores indicate good quality of life; high scores indicate strong discomfort. Questionnaire assessments by the patient or by nurse/caregiver in case of patient's physical inability. Secondary endpoints were analysed using the ITT population but to permit following the FAS which was used for primary endpoint analysis, ESAS total score results are reported for both the ITT and the FAS. Mean change from baseline of ESAS total score at Days 7, 14 and 28 is presented here for the ITT population; a positive change indicates a worsening condition.

Outcome measures

Outcome measures
Measure	Standard Care n=21 Participants Patients received standard care only according to site clinical practice.	Standard Care + Lanreotide Autogel n=22 Participants Patients received standard care according to site clinical practice and a single administration of Lanreotide Autogel 120 mg by deep subcutaneous injection on Day 1.
Mean Change From Baseline in ESAS Total Score; ITT Population Change at Day 7	-5.1 Scores on a scale Standard Deviation 15.7	1.5 Scores on a scale Standard Deviation 18.1
Mean Change From Baseline in ESAS Total Score; ITT Population Change at Day 14	-1.3 Scores on a scale Standard Deviation 21.4	-7.3 Scores on a scale Standard Deviation 16.7
Mean Change From Baseline in ESAS Total Score; ITT Population Change at Day 28	-6.8 Scores on a scale Standard Deviation 15.2	-10.3 Scores on a scale Standard Deviation 16.7

SECONDARY outcome

Timeframe: Baseline (Day 1, before randomisation) and Days 7, 14 and 28.

Population: The ITT population included all randomised patients. Only patients with data available for analysis at each time point are presented.

Outcome measures

Outcome measures
Measure	Standard Care n=21 Participants Patients received standard care only according to site clinical practice.	Standard Care + Lanreotide Autogel n=22 Participants Patients received standard care according to site clinical practice and a single administration of Lanreotide Autogel 120 mg by deep subcutaneous injection on Day 1.
Mean Change From Baseline in Single ESAS Items Symptom Scores; ITT Population Change at Day 7: Pain	-1.8 Scores on a scale Standard Deviation 3.6	0.1 Scores on a scale Standard Deviation 3.4
Mean Change From Baseline in Single ESAS Items Symptom Scores; ITT Population Change at Day 14: Pain	-1.3 Scores on a scale Standard Deviation 3.6	-1.9 Scores on a scale Standard Deviation 2.9
Mean Change From Baseline in Single ESAS Items Symptom Scores; ITT Population Change at Day 28: Pain	-3.0 Scores on a scale Standard Deviation 3.1	-1.3 Scores on a scale Standard Deviation 4.2
Mean Change From Baseline in Single ESAS Items Symptom Scores; ITT Population Change at Day 7: Activity	-0.3 Scores on a scale Standard Deviation 2.6	0.7 Scores on a scale Standard Deviation 2.6
Mean Change From Baseline in Single ESAS Items Symptom Scores; ITT Population Change at Day 14: Activity	-0.3 Scores on a scale Standard Deviation 3.3	-0.7 Scores on a scale Standard Deviation 3.0
Mean Change From Baseline in Single ESAS Items Symptom Scores; ITT Population Change at Day 28: Activity	-1.4 Scores on a scale Standard Deviation 2.8	-0.3 Scores on a scale Standard Deviation 3.2
Mean Change From Baseline in Single ESAS Items Symptom Scores; ITT Population Change at Day 7: Nausea	0.5 Scores on a scale Standard Deviation 3.2	0.9 Scores on a scale Standard Deviation 3.2
Mean Change From Baseline in Single ESAS Items Symptom Scores; ITT Population Change at Day 14: Nausea	0.1 Scores on a scale Standard Deviation 3.8	0.5 Scores on a scale Standard Deviation 4.1
Mean Change From Baseline in Single ESAS Items Symptom Scores; ITT Population Change at Day 28: Nausea	-0.6 Scores on a scale Standard Deviation 4.6	0.0 Scores on a scale Standard Deviation 3.9
Mean Change From Baseline in Single ESAS Items Symptom Scores; ITT Population Change at Day 7: Depression	-1.8 Scores on a scale Standard Deviation 3.5	-1.1 Scores on a scale Standard Deviation 3.7
Mean Change From Baseline in Single ESAS Items Symptom Scores; ITT Population Change at Day 14 Depression	-1.9 Scores on a scale Standard Deviation 3.5	-2.4 Scores on a scale Standard Deviation 3.2
Mean Change From Baseline in Single ESAS Items Symptom Scores; ITT Population Change at Day 28: Depression	-2.6 Scores on a scale Standard Deviation 1.9	-3.7 Scores on a scale Standard Deviation 4.0
Mean Change From Baseline in Single ESAS Items Symptom Scores; ITT Population Change at Day 7: Anxiety	0.0 Scores on a scale Standard Deviation 2.7	-0.2 Scores on a scale Standard Deviation 3.2
Mean Change From Baseline in Single ESAS Items Symptom Scores; ITT Population Change at Day 14: Anxiety	0.4 Scores on a scale Standard Deviation 3.3	-2.7 Scores on a scale Standard Deviation 3.8
Mean Change From Baseline in Single ESAS Items Symptom Scores; ITT Population Change at Day 28: Anxiety	-1.1 Scores on a scale Standard Deviation 1.9	-1.5 Scores on a scale Standard Deviation 1.0
Mean Change From Baseline in Single ESAS Items Symptom Scores; ITT Population Change at Day 7: Drowsiness	-0.7 Scores on a scale Standard Deviation 2.7	0.4 Scores on a scale Standard Deviation 3.1
Mean Change From Baseline in Single ESAS Items Symptom Scores; ITT Population Change at Day 14: Drowsiness	-0.1 Scores on a scale Standard Deviation 3.5	-0.6 Scores on a scale Standard Deviation 2.6
Mean Change From Baseline in Single ESAS Items Symptom Scores; ITT Population Change at Day 28: Drowsiness	-1.9 Scores on a scale Standard Deviation 3.1	-1.5 Scores on a scale Standard Deviation 1.5
Mean Change From Baseline in Single ESAS Items Symptom Scores; ITT Population Change at Day 7: Appetite	-0.2 Scores on a scale Standard Deviation 3.1	0.5 Scores on a scale Standard Deviation 3.2
Mean Change From Baseline in Single ESAS Items Symptom Scores; ITT Population Change at Day 14: Appetite	0.9 Scores on a scale Standard Deviation 3.0	0.4 Scores on a scale Standard Deviation 3.9
Mean Change From Baseline in Single ESAS Items Symptom Scores; ITT Population Change at Day 28: Appetite	0.4 Scores on a scale Standard Deviation 3.1	-2.0 Scores on a scale Standard Deviation 2.3
Mean Change From Baseline in Single ESAS Items Symptom Scores; ITT Population Change at Day 7: Well-being	-0.8 Scores on a scale Standard Deviation 2.6	-0.4 Scores on a scale Standard Deviation 3.1
Mean Change From Baseline in Single ESAS Items Symptom Scores; ITT Population Change at Day 14: Well-being	0.4 Scores on a scale Standard Deviation 2.5	-0.5 Scores on a scale Standard Deviation 4.3
Mean Change From Baseline in Single ESAS Items Symptom Scores; ITT Population Change at Day 28: Well-being	0.4 Scores on a scale Standard Deviation 2.4	-2.3 Scores on a scale Standard Deviation 2.9
Mean Change From Baseline in Single ESAS Items Symptom Scores; ITT Population Change at Day 7: Shortness of breath	-0.1 Scores on a scale Standard Deviation 2.3	0.7 Scores on a scale Standard Deviation 2.6
Mean Change From Baseline in Single ESAS Items Symptom Scores; ITT Population Change at Day 14: Shortness of breath	0.6 Scores on a scale Standard Deviation 3.4	0.7 Scores on a scale Standard Deviation 2.9
Mean Change From Baseline in Single ESAS Items Symptom Scores; ITT Population Change at Day 28: Shortness of breath	-0.4 Scores on a scale Standard Deviation 2.0	-0.2 Scores on a scale Standard Deviation 3.8

SECONDARY outcome

Timeframe: Baseline (Day 1, before randomisation) and Days 7, 14 and 28.

Population: The ITT population included all randomised patients. Only patients with data available for analysis at each time point are presented.

The KPS allows patients to be classified as to their functional impairment and was used to assess general activity. KPS scores range from 0 (dead) to 100 (normal/no disease) and are classified as 0-40 = unable to care for self; 50-70 = unable to work; 80-100 = able to work. The lower the KPS score, the worse the survival for most serious illnesses. Scores were recorded on the patient's medical file at each study visit (Days 1, 7, 14 and 28). Mean change from baseline of KPS score at Days 7, 14 and 28 is presented for the ITT population (all randomised patients); a negative change indicates a worsening condition.

Outcome measures

Outcome measures
Measure	Standard Care n=21 Participants Patients received standard care only according to site clinical practice.	Standard Care + Lanreotide Autogel n=22 Participants Patients received standard care according to site clinical practice and a single administration of Lanreotide Autogel 120 mg by deep subcutaneous injection on Day 1.
Mean Change From Baseline in Performing General Activity (Karnofsky Performance Status [KPS]); ITT Population Change at Day 7	-2.8 Scores on a scale Standard Deviation 12.3	-3.7 Scores on a scale Standard Deviation 6.8
Mean Change From Baseline in Performing General Activity (Karnofsky Performance Status [KPS]); ITT Population Change at Day 14	-5.6 Scores on a scale Standard Deviation 11.5	-5.4 Scores on a scale Standard Deviation 12.7
Mean Change From Baseline in Performing General Activity (Karnofsky Performance Status [KPS]); ITT Population Change at Day 28	-5.0 Scores on a scale Standard Deviation 16.0	-7.1 Scores on a scale Standard Deviation 20.6

SECONDARY outcome

Timeframe: Baseline (Day 1, before randomisation) and Days 7, 14 and 28.

Population: The ITT population included all randomised patients. Only patients with data available for analysis at each time point are presented.

Abdominal pain was assessed using the VAS numeric pain distress scale which is a 100-millimetre (10-centimetre) scoring scale on which patients mark their perceived level of pain. Scores range from 0 to 100 where 0=no pain and 100=unbearable pain. Higher scores indicate a worse outcome. Scores were recorded on the Patient Diary daily until the end of study (Day 28), by the patient or filled in by the nurse/caregiver in case of patient's physical inability. Mean change from baseline of VAS for abdominal pain at Days 7, 14 and 28 is presented for the ITT population; a positive change indicates a worsening condition.

Outcome measures

Outcome measures
Measure	Standard Care n=21 Participants Patients received standard care only according to site clinical practice.	Standard Care + Lanreotide Autogel n=22 Participants Patients received standard care according to site clinical practice and a single administration of Lanreotide Autogel 120 mg by deep subcutaneous injection on Day 1.
Mean Change From Baseline in Daily Intensity of Abdominal Pain Score (Visual Analogue Scale [VAS]); ITT Population Change at Day 7	-22.0 Scores on a scale Standard Deviation 32.5	-9.6 Scores on a scale Standard Deviation 30.8
Mean Change From Baseline in Daily Intensity of Abdominal Pain Score (Visual Analogue Scale [VAS]); ITT Population Change at Day 14	-15.6 Scores on a scale Standard Deviation 34.9	-27.7 Scores on a scale Standard Deviation 28.8
Mean Change From Baseline in Daily Intensity of Abdominal Pain Score (Visual Analogue Scale [VAS]); ITT Population Change at Day 28	-32.0 Scores on a scale Standard Deviation 31.5	-17.0 Scores on a scale Standard Deviation 34.9

SECONDARY outcome

Timeframe: From Baseline (Day 1, before randomisation) to Days 7, 14 and 28.

Population: Patients without NGT were defined as patients without the insertion of NGT for the whole study period. Only patients in the ITT population without NGT and with data available for analysis at each time point are presented.

Vomiting episodes and NGT presence were recorded on the Patient Diary daily until the end of study (Day 28), by the patient or filled in by the nurse/caregiver in case of patient's physical inability. Number of patients experiencing ≤ 2 vomiting episodes/day during at least 3 consecutive days, in patients without NGT, is presented.

Outcome measures

Outcome measures
Measure	Standard Care n=6 Participants Patients received standard care only according to site clinical practice.	Standard Care + Lanreotide Autogel n=8 Participants Patients received standard care according to site clinical practice and a single administration of Lanreotide Autogel 120 mg by deep subcutaneous injection on Day 1.
Number of Patients Experiencing ≤ 2 Vomiting Episodes/Day During at Least 3 Consecutive Days, in Patients Without NGT From Day 1 to Day 7	5 Participants	4 Participants
Number of Patients Experiencing ≤ 2 Vomiting Episodes/Day During at Least 3 Consecutive Days, in Patients Without NGT From Day 1 to Day 14	4 Participants	4 Participants
Number of Patients Experiencing ≤ 2 Vomiting Episodes/Day During at Least 3 Consecutive Days, in Patients Without NGT From Day 1 to Day 28	4 Participants	4 Participants

SECONDARY outcome

Timeframe: Baseline (Day 1, before randomisation) and Days 7, 14 and 28.

Population: Only patients with NGT and with data available for analysis at each time point are presented.

NGT presence and related secretion volume were recorded on the Patient Diary daily until the end of study (Day 28), by the patient or filled in by the nurse/caregiver in case of patient's physical inability. Mean daily secretion volumes, in patients with NGT, is presented.

Outcome measures

Outcome measures
Measure	Standard Care n=10 Participants Patients received standard care only according to site clinical practice.	Standard Care + Lanreotide Autogel n=7 Participants Patients received standard care according to site clinical practice and a single administration of Lanreotide Autogel 120 mg by deep subcutaneous injection on Day 1.
Mean Daily NGT Secretion Volume, in Patients With a NGT Baseline	200.0 millilitres Standard Deviation NA Not calculable as only 1 patient had data available for analysis at this time point.	700.0 millilitres Standard Deviation 141.4
Mean Daily NGT Secretion Volume, in Patients With a NGT Day 7	4875.0 millilitres Standard Deviation 4023.6	1025.0 millilitres Standard Deviation 813.2
Mean Daily NGT Secretion Volume, in Patients With a NGT Day 14	12675.0 millilitres Standard Deviation 2863.8	7090.8 millilitres Standard Deviation 2433.9
Mean Daily NGT Secretion Volume, in Patients With a NGT Day 28	27501.0 millilitres Standard Deviation 27081.8	18301.4 millilitres Standard Deviation 11657.9

SECONDARY outcome

Timeframe: Baseline (Day 1, before randomisation) and Days 7, 14 and 28.

Population: The ITT population included all randomised patients. Only patients with data available at each time point are presented.

Vomiting episodes were recorded on the Patient Diary daily until the end of study (Day 28), by the patient or filled in by the nurse/caregiver in case of patient's physical inability. Mean change from baseline in number of daily vomiting episodes is presented for the ITT population.

Outcome measures

Outcome measures
Measure	Standard Care n=21 Participants Patients received standard care only according to site clinical practice.	Standard Care + Lanreotide Autogel n=22 Participants Patients received standard care according to site clinical practice and a single administration of Lanreotide Autogel 120 mg by deep subcutaneous injection on Day 1.
Mean Change From Baseline in Number of Daily Vomiting Episodes; ITT Population Change at Day 7	5.7 Episodes (daily) Standard Deviation 6.2	6.0 Episodes (daily) Standard Deviation 9.9
Mean Change From Baseline in Number of Daily Vomiting Episodes; ITT Population Change at Day 14	10.6 Episodes (daily) Standard Deviation 12.7	10.4 Episodes (daily) Standard Deviation 15.8
Mean Change From Baseline in Number of Daily Vomiting Episodes; ITT Population Change at Day 28	16.5 Episodes (daily) Standard Deviation 19.9	14.1 Episodes (daily) Standard Deviation 20.2

SECONDARY outcome

Timeframe: From Baseline (Day 1, before randomisation) to Day 28.

Population: The ITT population included all randomised patients. Only patients with data available for analysis at each time point are presented.

Passage of stools assessments (Yes/No) were recorded on the Patient Diary daily until the end of study (Day 28), by the patient or filled in by the nurse/caregiver in case of patient's physical inability.

Outcome measures

Outcome measures
Measure	Standard Care n=21 Participants Patients received standard care only according to site clinical practice.	Standard Care + Lanreotide Autogel n=22 Participants Patients received standard care according to site clinical practice and a single administration of Lanreotide Autogel 120 mg by deep subcutaneous injection on Day 1.
Assessment of Passage of Stools; ITT Population Day 1 · Yes	2 Participants	2 Participants
Assessment of Passage of Stools; ITT Population Day 1 · No	19 Participants	20 Participants
Assessment of Passage of Stools; ITT Population Day 2 · Yes	6 Participants	3 Participants
Assessment of Passage of Stools; ITT Population Day 2 · No	13 Participants	16 Participants
Assessment of Passage of Stools; ITT Population Day 3 · Yes	4 Participants	3 Participants
Assessment of Passage of Stools; ITT Population Day 3 · No	15 Participants	17 Participants
Assessment of Passage of Stools; ITT Population Day 4 · Yes	4 Participants	2 Participants
Assessment of Passage of Stools; ITT Population Day 4 · No	15 Participants	18 Participants
Assessment of Passage of Stools; ITT Population Day 5 · Yes	6 Participants	3 Participants
Assessment of Passage of Stools; ITT Population Day 5 · No	13 Participants	17 Participants
Assessment of Passage of Stools; ITT Population Day 6 · Yes	4 Participants	2 Participants
Assessment of Passage of Stools; ITT Population Day 6 · No	15 Participants	17 Participants
Assessment of Passage of Stools; ITT Population Day 7 · Yes	3 Participants	3 Participants
Assessment of Passage of Stools; ITT Population Day 7 · No	16 Participants	16 Participants
Assessment of Passage of Stools; ITT Population Day 8 · Yes	6 Participants	3 Participants
Assessment of Passage of Stools; ITT Population Day 8 · No	12 Participants	17 Participants
Assessment of Passage of Stools; ITT Population Day 9 · Yes	4 Participants	5 Participants
Assessment of Passage of Stools; ITT Population Day 9 · No	13 Participants	14 Participants
Assessment of Passage of Stools; ITT Population Day 10 · Yes	3 Participants	1 Participants
Assessment of Passage of Stools; ITT Population Day 10 · No	13 Participants	15 Participants
Assessment of Passage of Stools; ITT Population Day 11 · Yes	5 Participants	1 Participants
Assessment of Passage of Stools; ITT Population Day 11 · No	10 Participants	14 Participants
Assessment of Passage of Stools; ITT Population Day 12 · Yes	4 Participants	1 Participants
Assessment of Passage of Stools; ITT Population Day 12 · No	11 Participants	11 Participants
Assessment of Passage of Stools; ITT Population Day 13 · Yes	3 Participants	1 Participants
Assessment of Passage of Stools; ITT Population Day 13 · No	12 Participants	13 Participants
Assessment of Passage of Stools; ITT Population Day 14 · Yes	5 Participants	1 Participants
Assessment of Passage of Stools; ITT Population Day 14 · No	10 Participants	14 Participants
Assessment of Passage of Stools; ITT Population Day 15 · Yes	2 Participants	2 Participants
Assessment of Passage of Stools; ITT Population Day 15 · No	12 Participants	10 Participants
Assessment of Passage of Stools; ITT Population Day 16 · Yes	3 Participants	2 Participants
Assessment of Passage of Stools; ITT Population Day 16 · No	11 Participants	9 Participants
Assessment of Passage of Stools; ITT Population Day 17 · Yes	2 Participants	3 Participants
Assessment of Passage of Stools; ITT Population Day 17 · No	12 Participants	9 Participants
Assessment of Passage of Stools; ITT Population Day 18 · Yes	3 Participants	2 Participants
Assessment of Passage of Stools; ITT Population Day 18 · No	11 Participants	8 Participants
Assessment of Passage of Stools; ITT Population Day 19 · Yes	3 Participants	2 Participants
Assessment of Passage of Stools; ITT Population Day 19 · No	8 Participants	8 Participants
Assessment of Passage of Stools; ITT Population Day 20 · Yes	2 Participants	2 Participants
Assessment of Passage of Stools; ITT Population Day 20 · No	9 Participants	8 Participants
Assessment of Passage of Stools; ITT Population Day 21 · Yes	2 Participants	2 Participants
Assessment of Passage of Stools; ITT Population Day 21 · No	9 Participants	7 Participants
Assessment of Passage of Stools; ITT Population Day 22 · Yes	2 Participants	2 Participants
Assessment of Passage of Stools; ITT Population Day 22 · No	9 Participants	6 Participants
Assessment of Passage of Stools; ITT Population Day 23 · Yes	3 Participants	2 Participants
Assessment of Passage of Stools; ITT Population Day 23 · No	7 Participants	5 Participants
Assessment of Passage of Stools; ITT Population Day 24 · Yes	3 Participants	2 Participants
Assessment of Passage of Stools; ITT Population Day 24 · No	7 Participants	6 Participants
Assessment of Passage of Stools; ITT Population Day 25 · Yes	2 Participants	2 Participants
Assessment of Passage of Stools; ITT Population Day 25 · No	7 Participants	5 Participants
Assessment of Passage of Stools; ITT Population Day 26 · Yes	2 Participants	2 Participants
Assessment of Passage of Stools; ITT Population Day 26 · No	6 Participants	6 Participants
Assessment of Passage of Stools; ITT Population Day 27 · Yes	1 Participants	2 Participants
Assessment of Passage of Stools; ITT Population Day 27 · No	7 Participants	4 Participants
Assessment of Passage of Stools; ITT Population Day 28 · Yes	3 Participants	2 Participants
Assessment of Passage of Stools; ITT Population Day 28 · No	4 Participants	5 Participants

Adverse Events

Standard Care

Serious events: 2 serious events

Other events: 5 other events

Deaths: 2 deaths

Standard Care + Lanreotide Autogel

Serious events: 2 serious events

Other events: 5 other events

Deaths: 2 deaths

Serious adverse events

Serious adverse events
Measure	Standard Care n=21 participants at risk Patients received standard care only according to site clinical practice.	Standard Care + Lanreotide Autogel n=22 participants at risk Patients received standard care according to site clinical practice and a single administration of Lanreotide Autogel 120 mg by deep subcutaneous injection on Day 1.
Gastrointestinal disorders Gastrointestinal haemorrhage	9.5% 2/21 • Number of events 2 • From baseline (Day 1) until end of study (Day 28). Treatment emergent adverse events are reported for the safety population which included all patients who received at least one dose of study therapy.	0.00% 0/22 • From baseline (Day 1) until end of study (Day 28). Treatment emergent adverse events are reported for the safety population which included all patients who received at least one dose of study therapy.
Cardiac disorders Cardiac failure	0.00% 0/21 • From baseline (Day 1) until end of study (Day 28). Treatment emergent adverse events are reported for the safety population which included all patients who received at least one dose of study therapy.	4.5% 1/22 • Number of events 1 • From baseline (Day 1) until end of study (Day 28). Treatment emergent adverse events are reported for the safety population which included all patients who received at least one dose of study therapy.
Cardiac disorders Myocardial infarction	0.00% 0/21 • From baseline (Day 1) until end of study (Day 28). Treatment emergent adverse events are reported for the safety population which included all patients who received at least one dose of study therapy.	4.5% 1/22 • Number of events 1 • From baseline (Day 1) until end of study (Day 28). Treatment emergent adverse events are reported for the safety population which included all patients who received at least one dose of study therapy.

Other adverse events

Other adverse events
Measure	Standard Care n=21 participants at risk Patients received standard care only according to site clinical practice.	Standard Care + Lanreotide Autogel n=22 participants at risk Patients received standard care according to site clinical practice and a single administration of Lanreotide Autogel 120 mg by deep subcutaneous injection on Day 1.
General disorders Pyrexia	9.5% 2/21 • Number of events 2 • From baseline (Day 1) until end of study (Day 28). Treatment emergent adverse events are reported for the safety population which included all patients who received at least one dose of study therapy.	4.5% 1/22 • Number of events 1 • From baseline (Day 1) until end of study (Day 28). Treatment emergent adverse events are reported for the safety population which included all patients who received at least one dose of study therapy.
Infections and infestations Pharyngitis	0.00% 0/21 • From baseline (Day 1) until end of study (Day 28). Treatment emergent adverse events are reported for the safety population which included all patients who received at least one dose of study therapy.	9.1% 2/22 • Number of events 2 • From baseline (Day 1) until end of study (Day 28). Treatment emergent adverse events are reported for the safety population which included all patients who received at least one dose of study therapy.
Metabolism and nutrition disorders Hypokalaemia	14.3% 3/21 • Number of events 3 • From baseline (Day 1) until end of study (Day 28). Treatment emergent adverse events are reported for the safety population which included all patients who received at least one dose of study therapy.	0.00% 0/22 • From baseline (Day 1) until end of study (Day 28). Treatment emergent adverse events are reported for the safety population which included all patients who received at least one dose of study therapy.
Vascular disorders Hypotension	0.00% 0/21 • From baseline (Day 1) until end of study (Day 28). Treatment emergent adverse events are reported for the safety population which included all patients who received at least one dose of study therapy.	9.1% 2/22 • Number of events 2 • From baseline (Day 1) until end of study (Day 28). Treatment emergent adverse events are reported for the safety population which included all patients who received at least one dose of study therapy.

Additional Information

Medical Director

Ipsen SpA

Phone: see email

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee Results are owned by the Sponsor and data communication collected in a center by the investigator is allowed only after publication of aggregate results of the study by the Sponsor. If an investigator intends to communicate data, the Sponsor must be informed and should review the manuscript/publication before its submission. The investigator should accept any Sponsor comments provided they are not in contrast to the reliability of data, with rights, with the safety and well-being of patients.
Publication restrictions are in place

Restriction type: OTHER