Over total study period Initial visit 1 week 3 months 1 year
Patients attending visit N=415 n=415 n=397 n=356 n=277
Subjects with any AE 271 (65.3) 215 (51.8) 117 (29.5) 53 (15.0) 16 (5.8)
Subjects with any moderate or severe AE 96 (23.1) 42 (10.1) 37 (9.3) 22 (6.2) 6 (2.2)
AEs per patient§ 3 (2;5) 2 (1;3) 2 (1;3) 2 (1;2) 1 (1;1,25)
Subjects per specific category of AEs Subjects per specific category of AEs Subjects per specific category of AEs Subjects per specific category of AEs Subjects per specific category of AEs Subjects per specific category of AEs
Oral allergy reactions 243 (58.6) 203 (48.9) 85 (21.4) 32 (9.1) 10 (3.6)
Gastrointestinal reactions 39 (9.4) 12 (2.9) 23 (5.8) 6 (1.7) 1 (0.4)
Airway reactions 51 (12.3) 27 (6.5) 20 (5.0) 7 (2.0) 3 (1.1)
-Lower airway reactions 26 (6.3) 14 (3.4) 8 (2.0) 4 (1.1) 0 (0.0)
-Upper airway reactions 35 (8.4) 13 (3.1) 15 (3.8) 3 (0.8) 3 (1.1)
Skin reactions 20 (4.8) 6 (1.4) 9 (2.3) 7 (2.0) 0 (0.0)
General reactions 28 (6.7) 12 (2.9) 10 (2.5) 8 (2.3) 1 (0.4)
Other 59 (14.2) 18 (4.3) 14 (3.5) 14 (4.0) 4 (1.4)