Somatuline Autogel Preference and Health Economy Study

Subject Preference for Self or Partner Administration

Time frame · Between week 30 to 34

A global question was asked: 'If you could choose, which administration method would you like to use on a regular basis?' A) Healthcare professional provided injection B) Self/ partner administered injection

Number of Patients Stating at Least One Injection Interfered With Daily Activities

Time frame · Between baseline to week 32, after each injection (8-9 injections)

The subject was asked: 'Does the treatment administration used today interfere with your daily activities?'

Number of Patients Stating at Least One Injection Negatively Interfered With Psychological Wellbeing

Time frame · Between baseline to week 32, after each injection (8-9 injections)

The subject was asked: 'Does the treatment administration used today negatively interfere with your psychological wellbeing?'

Days Sick Leave

Time frame · Group 1 - between week 8 to 20 (self or partner administration), between week 20 to 32 (HCP administration). Group 2 - between week 20 to 32 (self or partner administration), between week 0 to week 12 (HCP administration)

Health care and patient costs associated with the treatment of carcinoid symptoms in subjects treated with lanreotide Autogel were assessed through recording loss of production for subject through total number of days sick leave of the employed patients (n=6).

Total Number of Visits to HCP Due to Carcinoid Symptoms

Time frame · Group 1 - between week 8 to 20 (self or partner administration), between week 20 to 32 (HCP administration). Group 2 - between week 20 to 32 (self or partner administration), between week 0 to week 12 (HCP administration)

Health care and patient costs associated with the treatment of carcinoid symptoms in subjects treated with lanreotide Autogel were assessed by recording the total number of visits made by participants (n=12) to HCP due to carcinoid symptoms.

Perceived Symptom Control Evaluation in Respect to Episodes of Flushing

Time frame · Group 1 - baseline, week 16 to 20 (self or partner administration) and week 30 to 34 (HCP administration). Group 2 - baseline, week 12 (HCP administration) and week 30 (self or partner administration).

Participants were asked how they perceived the symptoms in respect to episodes of flushing since the last injection. Participants included in the study were previously treated with lanreotide Autogel and therefore the assessment at baseline was made in comparison to their previous injection outside of the study protocol.

Perceived Symptom Control Evaluation in Respect to Episodes of Diarrhoea

Time frame · Group 1 - baseline, week 16 to 20 (self or partner administration) and week 30 to 34 (HCP administration). Group 2 - baseline, week 12 to 16 (HCP administration) and week 30 to 34 (self or partner administration).

Participants were asked how they perceived the symptoms in respect to episodes of diarrhoea since the last injection. Participants included in the study were previously treated with lanreotide autogel and therefore the assessment at baseline was made in comparison to previous injection outside of the study protocol.

Chromogranin A Levels

Time frame · Group 1 - Baseline, week 16 to 20 and 30 to 34. Group 2 - Baseline, week 12 and 30 to 34.

Biochemical control was assessed by analysing chromogranin A levels at each site visit, which was mandatory for all subjects. 'Before self or partner administration' was assessed at baseline for group 1 and at week 12 for group 2. 'After self or partner administration' was assessed at week 16 to 20 for group 1 and at week 12 for group 2. 'Before HCP administration' was assessed at week 16 to 20 for group 1 and at baseline for group 2. 'After HCP administration' was assessed at week 30 to 34 for group 1 and week 12 for group 2.

5-hydroxyindoleacetic Acid (5-HIAA) Levels

Time frame · Group 1 - Baseline, week 16 to 20 and 30 to 34. Group 2 - Baseline, week 12 and 30 to 34.

Biochemical control was assessed by analysing 5-HIAA levels at each site visit, which was judged as necessary by the investigator at each site. 'Before self or partner administration' was assessed at baseline for group 1 and at week 12 for group 2. 'After self or partner administration' was assessed at week 16 to 20 for group 1 and at week 12 for group 2. 'Before HCP administration' was assessed at week 16 to 20 for group 1 and at baseline for group 2. 'After HCP administration' was assessed at week 30 to 34 for group 1 and week 12 for group 2.

Healthcare Professionals With Positive Response to Specified Questions on Self or Partner Administration Method

Time frame · Between week 30 to 34

Assessed by the number of HCP with a positive response 'yes' to two questions: 1. Based on your experience during this trial, did you feel confident in the safety of your patients? 2. Based on your experience during this trial, would you recommend suitable patients to try self or partner administration?