Page 54 - Abbott

Table 11. Non-serious Adverse Device Events Over Part 1 and Part 2
Part 1 Part 2
TREATMENT (270) CONTROL (280) ALL PATIENTS (550)
Subjects Events Subjects Events Subjects Events Subjects Events
Hemoptysis 1 1 1 1 2 2 0 0
Dyspnea 1 1 0 0 1 1 0 0
Cardiac disorders 1 (0.4%) 1 (16.7%) 1 (0.4%) 1 (9.1%) 2 (0.4%) 2 (11.8%) 0 (0%) 0 (0%)
Congestive heart failure 1 1 0 0 1 1 0 0
Ventricular tachycardia 0 0 1 1 1 1 0 0
Nervous system disorders 0 (0.0%) 0 (0.0%) 1 (0.4%) 1 (9.1%) 1 (0.2%) 1 (5.9%) 0 (0%) 0 (0%)
Dizziness 0 0 1 1 1 1 0 0
Vascular disorders 0 (0.0%) 0 (0.0%) 1 (0.4%) 1 (9.1%) 1 (0.2%) 1 (5.9%) 0 (0%) 0 (0%)
Vessel perforation 0 0 1 1 1 1 0 0

Non-Serious Adverse Events not related to the device

Table 12. Non-Serious Adverse Events not related to the device Over Part 1 and Part 2

Part 1 Part 2
Treatment (270) Control (280) All Patients (550) All Patients (347)
Subjects Events Subjects Events Subjects Events Subjects Events
All Patients with an 216 (80.0%) 1229 223 1135 439 2364 219 787
Event (79.6%) (79.8%) (63.1%)
Blood and lymphatic 27 (10.0%) 37 22 (7.9%) 28 49 (8.9%) 65 13 (3.7%) 16
system disorders
Cardiac disorders 81 (30.0%) 140 69 (24.6%) 117 150 257 49 (14.1%) 71
(27.3%)
Congenital, familial 0 (0.0%) 0 0 (0.0%) 0 0 (0.0%) 0 3 (0.9%) 3
and genetic disorders
Ear and labyrinth 6 (2.2%) 6 2 (0.7%) 2 8 (1.5%) 8 2 (0.6%) 2
disorders
Endocrine disorders 4 (1.5%) 4 9 (3.2%) 10 13 (2.4%) 14 7 (2.0%) 7
Eye disorders 12 (4.4%) 12 14 (5.0%) 16 26 (4.7%) 28 7 (2.0%) 8
Gastrointestinal 64 (23.7%) 104 60 (21.4%) 96 124 200 48 (13.8%) 70
disorders (22.5%)
General disorders 64 (23.7%) 102 45 (16.1%) 80 109 182 50 (14.4%) 62
and administration (19.8%)
site conditions
Hepatobiliary 1 (0.4%) 1 7 (2.5%) 10 8 (1.5%) 11 3 (0.9%) 3
disorders
Immune system 4 (1.5%) 4 4 (1.4%) 4 8 (1.5%) 8 4 (1.2%) 4
disorders
Infections and 76 (28.1%) 129 91 (32.5%) 150 167 279 65 (18.7%) 99
infestations (30.4%)
Injury, poisoning and 32 (11.9%) 44 32 (11.4%) 37 64 (11.6%) 81 32 (9.2%) 43
procedural
complications
Investigations 32 (11.9%) 51 26 (9.3%) 40 58 (10.5%) 91 22 (6.3%) 25
Metabolism and 66 (24.4%) 116 52 (18.6%) 88 118 204 37 (10.7%) 53
nutrition disorders (21.5%)
Musculoskeletal and 49 (18.1%) 75 58 (20.7%) 73 107 148 56 (16.1%) 70
connective tissue (19.5%)
disorders
Neoplasms benign, 6 (2.2%) 8 9 (3.2%) 9 15 (2.7%) 17 6 (1.7%) 7
malignant and
unspecified (incl
cysts and polyps)
Nervous system 61 (22.6%) 86 50 (17.9%) 67 111 153 47 (13.5%) 56
disorders (20.2%)

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