Table 2.
Incidences of AEs in patients participating in the OLE according to treatment sequence
| LAN–LAN group (n = 42) |
PBO–LAN group (n = 47) |
||||
|---|---|---|---|---|---|
| Core study | OLE | Core study and OLE (pooled) | Core study | OLE | |
| Any patients with an AE | 39 (92.9) | 34 (81.0) | 40 (95.2) | 44 (93.6) | 42 (89.4) |
| Treatment-related | 23 (54.8) | 17 (40.5) | 27 (64.3) | 12 (25.5) | 22 (46.8) |
| Severe | 10 (23.8) | 12 (28.6) | 18 (42.9) | 11 (23.4) | 13 (27.7) |
| Moderate | 19 (45.2) | 16 (38.1) | 17 (40.5) | 25 (53.2) | 22 (46.8) |
| Mild | 9 (21.4) | 6 (14.3) | 4 (9.5) | 8 (17.0) | 7 (14.9) |
| Missing | 1 (2.4) | 0 | 1 (2.4) | 0 | 0 |
| Any patients with serious AEs | 9 (21.4) | 11 (26.2) | 17 (40.5) | 12 (25.5) | 14 (29.8) |
| Treatment-related | 1 (2.4) | 2 (4.8)a | 3 (7.1) | 1 (2.1) | 2 (4.3)a |
| Withdrawals due to AEs | N/Ab | 2 (4.8)c | 2 (4.8) | N/Ab | 3 (6.4)c |
| Treatment-related | N/Ab | 0 | 0 | N/Ab | 1 (2.1) |
| Most common individual AEsd | |||||
| Gastrointestinal disorders | |||||
| Diarrhoea | 16 (38.1) | 8 (19.0) | 17 (40.5) | 15 (31.9) | 15 (31.9) |
| Abdominal pain | 12 (28.6) | 7 (16.7) | 16 (38.1) | 7 (14.9) | 10 (21.3) |
| Nausea | 7 (16.7) | 7 (16.7) | 9 (21.4) | 5 (10.6) | 6 (12.8) |
| Constipation | 7 (16.7) | 5 (11.9) | 11 (26.2) | 5 (10.6) | 4 (8.5) |
| Vomiting | 6 (14.3) | 7 (16.7) | 12 (28.6) | 4 (8.5) | 5 (10.6) |
| Flatulence | 5 (11.9) | 2 (4.8) | 6 (14.3) | 5 (10.6) | 1 (2.1) |
| Abdominal distension | 3 (7.1) | 3 (7.1) | 6 (14.3) | 5 (10.6) | 4 (8.5) |
| Dyspepsia | 2 (4.8) | 5 (11.9) | 6 (14.3) | 3 (6.4) | 2 (4.3) |
| Upper abdominal pain | 2 (4.8) | 3 (7.1) | 5 (11.9) | 4 (8.5) | 10 (21.3) |
| Steatorrhoea | 2 (4.8) | 2 (4.8) | 3 (7.1) | 0 | 5 (10.6) |
| Musculoskeletal and connective tissue disorders | |||||
| Arthralgia | 4 (9.5) | 4 (9.5) | 6 (14.3) | 4 (8.5) | 6 (12.8) |
| Back pain | 3 (7.1) | 3 (7.1) | 5 (11.9) | 7 (14.9) | 7 (14.9) |
| Musculoskeletal pain | 3 (7.1) | 2 (4.8) | 5 (11.9) | 1 (2.1) | 2 (4.3) |
| Infections and infestations | |||||
| Nasopharyngitis | 5 (11.9) | 1 (2.4) | 6 (14.3) | 9 (19.1) | 4 (8.5) |
| Urinary tract infection | 3 (7.1) | 2 (4.8) | 4 (9.5) | 2 (4.3) | 5 (10.6) |
| Bronchitis | 2 (4.8) | 3 (7.1) | 5 (11.9) | 1 (2.1) | 7 (14.9) |
| Upper respiratory tract infection | 2 (4.8) | 4 (9.5) | 5 (11.9) | 3 (6.4) | 1 (2.1) |
| Nervous system disorders | |||||
| Dizziness | 7 (16.7) | 4 (9.5) | 9 (21.4) | 1 (2.1) | 2 (4.3) |
| Headache | 7 (16.7) | 2 (4.8) | 9 (21.4) | 6 (12.8) | 4 (8.5) |
| General disorders and administration site conditions | |||||
| Fatigue | 4 (9.5) | 5 (11.9) | 8 (19.0) | 6 (12.8) | 4 (8.5) |
| Asthenia | 7 (16.7) | 0 | 7 (16.7) | 5 (10.6) | 4 (8.5) |
| Metabolism and nutrition disorders | |||||
| Decreased appetite | 5 (11.9) | 4 (9.5) | 6 (14.3) | 3 (6.4) | 5 (10.6) |
| Hyperglycaemia | 3 (7.1) | 3 (7.1) | 6 (14.3) | 0 | 1 (2.1) |
| Skin and subcutaneous tissue disorders | |||||
| Rash | 4 (9.5) | 5 (11.9) | 6 (14.3) | 2 (4.3) | 2 (4.3) |
| Psychiatric disorders | |||||
| Insomnia | 2 (4.8) | 4 (9.5) | 6 (14.3) | 1 (2.1) | 0 |
| Vascular disorders | |||||
| Hypertension | 6 (14.3) | 5 (11.9) | 10 (23.8) | 3 (6.4) | 5 (10.6) |
| Respiratory, thoracic and mediastinal disorders | |||||
| Oropharyngeal pain | 3 (7.1) | 3 (7.1) | 5 (11.9) | 0 | 2 (4.3) |
| Hepatobiliary disorders | |||||
| Cholelithiasis | 6 (14.3) | 9 (21.4) | 14 (33.3) | 4 (8.5) | 7 (14.9) |
Data are number (%) of patients with an AE, while receiving lanreotide autogel/depot 120 mg or placebo and are from the Safety population. AEs were defined according to the MedDRA version 18.1
AE adverse event, OLE open-label extension, LAN–LAN group patients receiving lanreotide autogel/depot in core study as well as the OLE study, PBO–LAN group patients receiving placebo in the core study before crossing over to lanreotide in the OLE study, N/A not applicable, MedDRA Medical Dictionary for Regulatory Activities
aLAN–LAN group: two patients experienced cholelithiasis; PBO–LAN group: one patient experienced tumour necrosis and one experienced pancreatitis
bN/A not applicable (patients who were withdrawn from the core study because of AEs were not eligible for inclusion in the OLE)
cLAN–LAN group: 1 patient with ileus and 1 with evolving stroke (fatal); PBO–LAN group: 1 patient with sudden death, 1 with a fall (fatal), and 1 with tumour necrosis (also reported as a serious AE) and tumour haemorrhage (tumour necrosis and haemorrhage were reported to be treatment related)
dBased on MedDRA version 18.1 preferred terms; AEs occurring in ≥10% of patients in any group