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Table 2 TEAEs

From: Efficacy and safety of lanreotide autogel compared with lanreotide 40 mg prolonged release in Chinese patients with active acromegaly: results from a phase 3, prospective, randomized, and open-label study (LANTERN)

 Lanreotide autogel
(n = 64)a
Lanreotide 40 mg PR
(n = 64)
Any TEAE60 (93.8)63 (98.4)
 Related to study treatment58 (90.6)58 (90.6)
 Mild25 (39.1)28 (43.8)
 Moderate33 (51.6)27 (42.2)
 Severe2 (3.1)8 (12.5)
Any serious TEAE1 (1.6)2 (3.1)
 Related to study treatment01 (1.6)
Any TEAE leading to withdrawal1 (1.6)2 (3.1)
 Related to study treatment01 (1.6)
TEAEs in > 10% of patients by preferred term
 Diarrhea51 (79.7)46 (71.9)
 Cholelithiasis23 (35.9)18 (28.1)
 Abdominal distension22 (34.4)27 (42.2)
 Upper respiratory tract infection21 (32.8)18 (28.1)
 Abdominal pain18 (28.1)20 (31.3)
 Upper abdominal pain13 (20.3)16 (25.0)
 Hyperglycaemia12 (18.8)12 (18.8)
 Headacheb10 (15.6)17 (26.6)
 Decreased appetitec10 (15.6)0
 Sinus bradycardia9 (14.1)12 (18.8)
 Weight decreased8 (12.5)4 (6.3)
 Nauseab7 (10.9)16 (25.0)
 Constipation7 (10.9)10 (15.6)
 Nasopharyngitis7 (10.9)10 (15.6)
 Blood glucose increased7 (10.9)6 (9.4)
 Flatulence7 (10.9)3 (4.7)
 Injection-site indurationb6 (9.4)14 (21.9)
 Dizziness6 (9.4)10 (15.6)
 Alopecia5 (7.8)9 (14.1)
 Thyroid nodule4 (6.3)7 (10.9)
 Abnormal gastrointestinal sounds3 (4.7)9 (14.1)
 Injection-site painb2 (3.1)9 (14.1)
 Rectal tenesmusb1 (1.6)9 (14.1)
 Vomiting1 (1.6)7 (10.9)
  1. Data are number (%) of patients from the safety population with AE classification from the Medical Dictionary for Regulatory Activities version 19.0. aOne patient randomly allocated to receive lanreotide 40 mg PR group incorrectly received lanreotide autogel at the first administration of study treatment. The patient experienced three AEs (gastrointestinal disorders of mild intensity and neither serious nor treatment-related); these AEs were considered to be prior AEs (i.e. not TEAEs) for lanreotide 40 mg PR and are not included in the above summary table
  2. Between-group differences of > 10% are presented in the lanreotide 40 mg PR group (b) and the lanreotide autogel group (c)
  3. AE adverse event, PR prolonged release, TEAE treatment-emergent AE