Quality of Life in Patients With Inoperable Malignant Bowel Obstruction

A Phase II, Multicentre, Randomized Controlled Study Evaluating The Quality Of Life In Patients With Inoperable Malignant Bowel Obstruction Treated With Lanreotide Autogel 120 mg in Combination With Standard Care vs. Standard Care Alone (QOL IN IMBO STUDY)

Status

Terminated

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02365584

Acronym

QoL in IMBO

Enrollment

Registered

2015-02-19

Start date

2015-01-31

Completion date

2018-01-16

Last updated

2019-11-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Intestinal Obstruction

Brief summary

The primary objective of the study is to evaluate the impact on quality of life of Lanreotide Autogel 120 mg in combination with standard care, in comparison to the standard care alone, in subjects affected by inoperable malignant bowel obstruction.

Interventions

DRUGlanreotide (Autogel formulation)

Lanreotide Autogel 120 mg by deep subcutaneous route, at the maximal scheduled standard dose of 120 mg/28 days, just for 1 administration.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

SUPPORTIVE_CARE

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Subjects must demonstrate willingness to participate in the study and to be compliant with any protocol procedure. * Provision of written informed consent prior to any study related procedure. * Diagnosis of an inoperable malignant bowel obstruction, confirmed by appropriate imaging report. * In case of peritoneal carcinomatosis, diagnostic confirmation by CT or MRI scan. * Confirmed as inoperable after medical advice. * Patient with a nasogastric tube or presenting with 3 or more episodes of vomiting every day in the last consecutive 48 hours. * Patient life expectancy must be more than 14 days.

Exclusion criteria

* Has operable obstruction or any sub-obstruction. * Has bowel obstruction due to a non-malignant cause; (hypokaliaemia, drug side-effects, renal insufficiency, etc). * Has signs of bowel perforation. * Has prior treatment with somatostatin or any analogue within the previous 60 days. * Has a known hypersensitivity to any of the study treatments or related compounds. * Is likely to require treatment during the study with somatostatin or any analogue other than the study treatment. * Is at risk of pregnancy or lactation, or is likely to father a child during the study. Females of childbearing potential must provide a negative pregnancy test at start of study and must be using oral or double barrier contraception. Non childbearing potential is defined as post-menopause for at least 1 year, surgical sterilisation or hysterectomy at least three months before the start of the study. * Has any mental condition rendering the subject unable to understand the nature, scope and possible consequences of the study, and/or evidence of an uncooperative attitude. * Has abnormal baseline findings, any other medical condition(s) or laboratory findings that, in the opinion of the Investigator, might jeopardise the subject's safety or decrease the chance of obtaining satisfactory data needed to achieve the objective(s) of the study.

Design outcomes

Primary

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

Secondary

Measure	Time frame	Description
Mean Change From Baseline in ESAS Total Score; ITT Population	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 ITT population; a positive change indicates a worsening condition.
Mean Change From Baseline in Single ESAS Items Symptom Scores; ITT Population	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). 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. Mean change from baseline of each individual ESAS item score at Days 7, 14 and 28 is presented; a positive change indicates a worsening condition.
Mean Change From Baseline in Performing General Activity (Karnofsky Performance Status [KPS]); ITT Population	Baseline (Day 1, before randomisation) and Days 7, 14 and 28.	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.
Mean Change From Baseline in Daily Intensity of Abdominal Pain Score (Visual Analogue Scale [VAS]); ITT Population	Baseline (Day 1, before randomisation) and Days 7, 14 and 28.	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.
Mean Change From Baseline in ESAS Total Score; FAS	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.
Mean Daily NGT Secretion Volume, in Patients With a NGT	Baseline (Day 1, before randomisation) and Days 7, 14 and 28.	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.
Mean Change From Baseline in Number of Daily Vomiting Episodes; ITT Population	Baseline (Day 1, before randomisation) and Days 7, 14 and 28.	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.
Assessment of Passage of Stools; ITT Population	From Baseline (Day 1, before randomisation) to Day 28.	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.
Number of Patients Experiencing ≤ 2 Vomiting Episodes/Day During at Least 3 Consecutive Days, in Patients Without NGT	From Baseline (Day 1, before randomisation) to Days 7, 14 and 28.	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.

Countries

Italy

Participant flow

Recruitment details

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.

Pre-assignment details

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

Participants by arm

Arm	Count
Standard Care Patients received standard care only according to site clinical practice.	21
Standard Care + Lanreotide Autogel 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.	22
Total Title	43
Total	86

Withdrawals & dropouts

Period	Reason	FG000	FG001
Overall Study	Adverse Event	2	2
Overall Study	Disease Progression	9	12
Overall Study	Withdrawal by Subject	1	0

Baseline characteristics

Characteristic	Standard Care	Standard Care + Lanreotide Autogel	Total Title
Age, Continuous	61.8 Years STANDARD_DEVIATION 9.6	62.8 Years STANDARD_DEVIATION 12.3	62.3 Years STANDARD_DEVIATION 10.9
Race/Ethnicity, Customized Caucasian / White	21 Participants	22 Participants	43 Participants
Sex: Female, Male Female	14 Participants	19 Participants	33 Participants
Sex: Female, Male Male	7 Participants	3 Participants	10 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk
deaths Total, all-cause mortality	2 / 21	2 / 22
other Total, other adverse events	5 / 21	5 / 22
serious Total, serious adverse events	2 / 21	2 / 22

Outcome results

Primary

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)

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.

Time frame: 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.

Arm	Measure	Value (LEAST_SQUARES_MEAN)	Dispersion
Standard Care	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
Standard Care + Lanreotide Autogel	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)	190 Scores on a scale x time (day)	Standard Error 12.4

Comparison: Analysis of covariance (ANCOVA), where the AUC was the dependent and the independent was the baseline ESAS total score.p-value: =0.539695% CI: [-47, 25]ANCOVA

Secondary

Assessment of Passage of Stools; ITT Population

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.

Time frame: 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.

Arm	Measure	Group	Category	Value (COUNT_OF_PARTICIPANTS)
Standard Care	Assessment of Passage of Stools; ITT Population	Day 20	No	9 Participants
Standard Care	Assessment of Passage of Stools; ITT Population	Day 2	No	13 Participants
Standard Care	Assessment of Passage of Stools; ITT Population	Day 16	Yes	3 Participants
Standard Care	Assessment of Passage of Stools; ITT Population	Day 4	Yes	4 Participants
Standard Care	Assessment of Passage of Stools; ITT Population	Day 21	Yes	2 Participants
Standard Care	Assessment of Passage of Stools; ITT Population	Day 8	No	12 Participants
Standard Care	Assessment of Passage of Stools; ITT Population	Day 4	No	15 Participants
Standard Care	Assessment of Passage of Stools; ITT Population	Day 7	Yes	3 Participants
Standard Care	Assessment of Passage of Stools; ITT Population	Day 5	Yes	6 Participants
Standard Care	Assessment of Passage of Stools; ITT Population	Day 21	No	9 Participants
Standard Care	Assessment of Passage of Stools; ITT Population	Day 5	No	13 Participants
Standard Care	Assessment of Passage of Stools; ITT Population	Day 16	No	11 Participants
Standard Care	Assessment of Passage of Stools; ITT Population	Day 6	Yes	4 Participants
Standard Care	Assessment of Passage of Stools; ITT Population	Day 6	No	15 Participants
Standard Care	Assessment of Passage of Stools; ITT Population	Day 22	Yes	2 Participants
Standard Care	Assessment of Passage of Stools; ITT Population	Day 8	Yes	6 Participants
Standard Care	Assessment of Passage of Stools; ITT Population	Day 14	No	10 Participants
Standard Care	Assessment of Passage of Stools; ITT Population	Day 9	Yes	4 Participants
Standard Care	Assessment of Passage of Stools; ITT Population	Day 9	No	13 Participants
Standard Care	Assessment of Passage of Stools; ITT Population	Day 17	Yes	2 Participants
Standard Care	Assessment of Passage of Stools; ITT Population	Day 10	Yes	3 Participants
Standard Care	Assessment of Passage of Stools; ITT Population	Day 25	No	7 Participants
Standard Care	Assessment of Passage of Stools; ITT Population	Day 10	No	13 Participants
Standard Care	Assessment of Passage of Stools; ITT Population	Day 13	No	12 Participants
Standard Care	Assessment of Passage of Stools; ITT Population	Day 11	Yes	5 Participants
Standard Care	Assessment of Passage of Stools; ITT Population	Day 26	Yes	2 Participants
Standard Care	Assessment of Passage of Stools; ITT Population	Day 11	No	10 Participants
Standard Care	Assessment of Passage of Stools; ITT Population	Day 17	No	12 Participants
Standard Care	Assessment of Passage of Stools; ITT Population	Day 12	Yes	4 Participants
Standard Care	Assessment of Passage of Stools; ITT Population	Day 27	Yes	1 Participants
Standard Care	Assessment of Passage of Stools; ITT Population	Day 12	No	11 Participants
Standard Care	Assessment of Passage of Stools; ITT Population	Day 13	Yes	3 Participants
Standard Care	Assessment of Passage of Stools; ITT Population	Day 15	Yes	2 Participants
Standard Care	Assessment of Passage of Stools; ITT Population	Day 18	No	11 Participants
Standard Care	Assessment of Passage of Stools; ITT Population	Day 27	No	7 Participants
Standard Care	Assessment of Passage of Stools; ITT Population	Day 19	Yes	3 Participants
Standard Care	Assessment of Passage of Stools; ITT Population	Day 18	Yes	3 Participants
Standard Care	Assessment of Passage of Stools; ITT Population	Day 19	No	8 Participants
Standard Care	Assessment of Passage of Stools; ITT Population	Day 3	Yes	4 Participants
Standard Care	Assessment of Passage of Stools; ITT Population	Day 22	No	9 Participants
Standard Care	Assessment of Passage of Stools; ITT Population	Day 7	No	16 Participants
Standard Care	Assessment of Passage of Stools; ITT Population	Day 23	Yes	3 Participants
Standard Care	Assessment of Passage of Stools; ITT Population	Day 23	No	7 Participants
Standard Care	Assessment of Passage of Stools; ITT Population	Day 3	No	15 Participants
Standard Care	Assessment of Passage of Stools; ITT Population	Day 24	Yes	3 Participants
Standard Care	Assessment of Passage of Stools; ITT Population	Day 15	No	12 Participants
Standard Care	Assessment of Passage of Stools; ITT Population	Day 24	No	7 Participants
Standard Care	Assessment of Passage of Stools; ITT Population	Day 1	Yes	2 Participants
Standard Care	Assessment of Passage of Stools; ITT Population	Day 25	Yes	2 Participants
Standard Care	Assessment of Passage of Stools; ITT Population	Day 20	Yes	2 Participants
Standard Care	Assessment of Passage of Stools; ITT Population	Day 26	No	6 Participants
Standard Care	Assessment of Passage of Stools; ITT Population	Day 1	No	19 Participants
Standard Care	Assessment of Passage of Stools; ITT Population	Day 28	Yes	3 Participants
Standard Care	Assessment of Passage of Stools; ITT Population	Day 14	Yes	5 Participants
Standard Care	Assessment of Passage of Stools; ITT Population	Day 28	No	4 Participants
Standard Care	Assessment of Passage of Stools; ITT Population	Day 2	Yes	6 Participants
Standard Care + Lanreotide Autogel	Assessment of Passage of Stools; ITT Population	Day 28	No	5 Participants
Standard Care + Lanreotide Autogel	Assessment of Passage of Stools; ITT Population	Day 7	Yes	3 Participants
Standard Care + Lanreotide Autogel	Assessment of Passage of Stools; ITT Population	Day 7	No	16 Participants
Standard Care + Lanreotide Autogel	Assessment of Passage of Stools; ITT Population	Day 9	Yes	5 Participants
Standard Care + Lanreotide Autogel	Assessment of Passage of Stools; ITT Population	Day 12	No	11 Participants
Standard Care + Lanreotide Autogel	Assessment of Passage of Stools; ITT Population	Day 13	No	13 Participants
Standard Care + Lanreotide Autogel	Assessment of Passage of Stools; ITT Population	Day 14	Yes	1 Participants
Standard Care + Lanreotide Autogel	Assessment of Passage of Stools; ITT Population	Day 14	No	14 Participants
Standard Care + Lanreotide Autogel	Assessment of Passage of Stools; ITT Population	Day 15	Yes	2 Participants
Standard Care + Lanreotide Autogel	Assessment of Passage of Stools; ITT Population	Day 15	No	10 Participants
Standard Care + Lanreotide Autogel	Assessment of Passage of Stools; ITT Population	Day 16	Yes	2 Participants
Standard Care + Lanreotide Autogel	Assessment of Passage of Stools; ITT Population	Day 16	No	9 Participants
Standard Care + Lanreotide Autogel	Assessment of Passage of Stools; ITT Population	Day 17	Yes	3 Participants
Standard Care + Lanreotide Autogel	Assessment of Passage of Stools; ITT Population	Day 17	No	9 Participants
Standard Care + Lanreotide Autogel	Assessment of Passage of Stools; ITT Population	Day 18	Yes	2 Participants
Standard Care + Lanreotide Autogel	Assessment of Passage of Stools; ITT Population	Day 19	No	8 Participants
Standard Care + Lanreotide Autogel	Assessment of Passage of Stools; ITT Population	Day 20	Yes	2 Participants
Standard Care + Lanreotide Autogel	Assessment of Passage of Stools; ITT Population	Day 20	No	8 Participants
Standard Care + Lanreotide Autogel	Assessment of Passage of Stools; ITT Population	Day 21	Yes	2 Participants
Standard Care + Lanreotide Autogel	Assessment of Passage of Stools; ITT Population	Day 21	No	7 Participants
Standard Care + Lanreotide Autogel	Assessment of Passage of Stools; ITT Population	Day 23	Yes	2 Participants
Standard Care + Lanreotide Autogel	Assessment of Passage of Stools; ITT Population	Day 25	Yes	2 Participants
Standard Care + Lanreotide Autogel	Assessment of Passage of Stools; ITT Population	Day 25	No	5 Participants
Standard Care + Lanreotide Autogel	Assessment of Passage of Stools; ITT Population	Day 26	No	6 Participants
Standard Care + Lanreotide Autogel	Assessment of Passage of Stools; ITT Population	Day 27	Yes	2 Participants
Standard Care + Lanreotide Autogel	Assessment of Passage of Stools; ITT Population	Day 2	No	16 Participants
Standard Care + Lanreotide Autogel	Assessment of Passage of Stools; ITT Population	Day 3	Yes	3 Participants
Standard Care + Lanreotide Autogel	Assessment of Passage of Stools; ITT Population	Day 8	Yes	3 Participants
Standard Care + Lanreotide Autogel	Assessment of Passage of Stools; ITT Population	Day 1	Yes	2 Participants
Standard Care + Lanreotide Autogel	Assessment of Passage of Stools; ITT Population	Day 1	No	20 Participants
Standard Care + Lanreotide Autogel	Assessment of Passage of Stools; ITT Population	Day 2	Yes	3 Participants
Standard Care + Lanreotide Autogel	Assessment of Passage of Stools; ITT Population	Day 3	No	17 Participants
Standard Care + Lanreotide Autogel	Assessment of Passage of Stools; ITT Population	Day 4	Yes	2 Participants
Standard Care + Lanreotide Autogel	Assessment of Passage of Stools; ITT Population	Day 4	No	18 Participants
Standard Care + Lanreotide Autogel	Assessment of Passage of Stools; ITT Population	Day 5	Yes	3 Participants
Standard Care + Lanreotide Autogel	Assessment of Passage of Stools; ITT Population	Day 5	No	17 Participants
Standard Care + Lanreotide Autogel	Assessment of Passage of Stools; ITT Population	Day 6	No	17 Participants
Standard Care + Lanreotide Autogel	Assessment of Passage of Stools; ITT Population	Day 8	No	17 Participants
Standard Care + Lanreotide Autogel	Assessment of Passage of Stools; ITT Population	Day 9	No	14 Participants
Standard Care + Lanreotide Autogel	Assessment of Passage of Stools; ITT Population	Day 10	Yes	1 Participants
Standard Care + Lanreotide Autogel	Assessment of Passage of Stools; ITT Population	Day 10	No	15 Participants
Standard Care + Lanreotide Autogel	Assessment of Passage of Stools; ITT Population	Day 11	Yes	1 Participants
Standard Care + Lanreotide Autogel	Assessment of Passage of Stools; ITT Population	Day 11	No	14 Participants
Standard Care + Lanreotide Autogel	Assessment of Passage of Stools; ITT Population	Day 12	Yes	1 Participants
Standard Care + Lanreotide Autogel	Assessment of Passage of Stools; ITT Population	Day 13	Yes	1 Participants
Standard Care + Lanreotide Autogel	Assessment of Passage of Stools; ITT Population	Day 18	No	8 Participants
Standard Care + Lanreotide Autogel	Assessment of Passage of Stools; ITT Population	Day 19	Yes	2 Participants
Standard Care + Lanreotide Autogel	Assessment of Passage of Stools; ITT Population	Day 22	Yes	2 Participants
Standard Care + Lanreotide Autogel	Assessment of Passage of Stools; ITT Population	Day 22	No	6 Participants
Standard Care + Lanreotide Autogel	Assessment of Passage of Stools; ITT Population	Day 23	No	5 Participants
Standard Care + Lanreotide Autogel	Assessment of Passage of Stools; ITT Population	Day 24	Yes	2 Participants
Standard Care + Lanreotide Autogel	Assessment of Passage of Stools; ITT Population	Day 24	No	6 Participants
Standard Care + Lanreotide Autogel	Assessment of Passage of Stools; ITT Population	Day 26	Yes	2 Participants
Standard Care + Lanreotide Autogel	Assessment of Passage of Stools; ITT Population	Day 27	No	4 Participants
Standard Care + Lanreotide Autogel	Assessment of Passage of Stools; ITT Population	Day 28	Yes	2 Participants
Standard Care + Lanreotide Autogel	Assessment of Passage of Stools; ITT Population	Day 6	Yes	2 Participants

Secondary

Mean Change From Baseline in Daily Intensity of Abdominal Pain Score (Visual Analogue Scale [VAS]); ITT Population

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.