Real-World Study (RWS) of Lanreotide Autogel (LAN) for the Treatment of Patients With Acromegaly in China

Percentage of participants achieving full biochemical control

Time frame · At 12 months

Defined as fasting Growth Hormone (GH) ≤ 2.5 μg/L and Insulin-like Growth Factor-1 (IGF-1) normalization

Percentage of participants achieving fasting GH < 1 μg/L and IGF-1 normalization

Time frame · At 12 months

Percentage of participants achieving fasting GH ≤2.5 μg/L and IGF-1 ≤1.3 Upper Limit of Normal (ULN)

Time frame · At 12 months

Mean change in fasting GH and IGF-1 concentrations.

Time frame · From baseline to 3, 6, and 12 months

Mean change in the proportion of patients experiencing each of the symptoms (headache, excessive sweating, joint pain, fatigue, and soft tissue swelling) as evaluated by physicians.

Time frame · From baseline to 6 and 12 months

Mean change in Quality of Life (QoL) scores

Time frame · From baseline to 6 and 12 months

Assessed by the Acromegaly Quality of Life Questionnaire (AcroQoL).

Treatment utilisation of LAN, evaluated by the total number of injections received

Time frame · From baseline to 12 months

Treatment utilisation of LAN, evaluated by number of participants in Extended Dosing Interval (EDI)

Time frame · From baseline to 12 months

Incidence of all Adverse Events (AEs)

Time frame · From baseline to 3, 6 and 12 months

Including Serious Adverse Events (SAEs) and special situations assessed according to incidence, intensity, causality, outcome, action taken, and seriousness.

Mean change in physical examination results

Time frame · From baseline to 3, 6, and 12 months

Including Body Mass Index (BMI) and weight

Mean change in vital signs blood pressure

Time frame · From baseline to 3, 6, and 12 months