Table 2 TEAEs
Lanreotide autogel (n = 64)a | Lanreotide 40 mg PR (n = 64) | |
|---|---|---|
Any TEAE | 60 (93.8) | 63 (98.4) |
Related to study treatment | 58 (90.6) | 58 (90.6) |
Mild | 25 (39.1) | 28 (43.8) |
Moderate | 33 (51.6) | 27 (42.2) |
Severe | 2 (3.1) | 8 (12.5) |
Any serious TEAE | 1 (1.6) | 2 (3.1) |
Related to study treatment | 0 | 1 (1.6) |
Any TEAE leading to withdrawal | 1 (1.6) | 2 (3.1) |
Related to study treatment | 0 | 1 (1.6) |
TEAEs in > 10% of patients by preferred term | ||
Diarrhea | 51 (79.7) | 46 (71.9) |
Cholelithiasis | 23 (35.9) | 18 (28.1) |
Abdominal distension | 22 (34.4) | 27 (42.2) |
Upper respiratory tract infection | 21 (32.8) | 18 (28.1) |
Abdominal pain | 18 (28.1) | 20 (31.3) |
Upper abdominal pain | 13 (20.3) | 16 (25.0) |
Hyperglycaemia | 12 (18.8) | 12 (18.8) |
Headacheb | 10 (15.6) | 17 (26.6) |
Decreased appetitec | 10 (15.6) | 0 |
Sinus bradycardia | 9 (14.1) | 12 (18.8) |
Weight decreased | 8 (12.5) | 4 (6.3) |
Nauseab | 7 (10.9) | 16 (25.0) |
Constipation | 7 (10.9) | 10 (15.6) |
Nasopharyngitis | 7 (10.9) | 10 (15.6) |
Blood glucose increased | 7 (10.9) | 6 (9.4) |
Flatulence | 7 (10.9) | 3 (4.7) |
Injection-site indurationb | 6 (9.4) | 14 (21.9) |
Dizziness | 6 (9.4) | 10 (15.6) |
Alopecia | 5 (7.8) | 9 (14.1) |
Thyroid nodule | 4 (6.3) | 7 (10.9) |
Abnormal gastrointestinal sounds | 3 (4.7) | 9 (14.1) |
Injection-site painb | 2 (3.1) | 9 (14.1) |
Rectal tenesmusb | 1 (1.6) | 9 (14.1) |
Vomiting | 1 (1.6) | 7 (10.9) |