System Organ Class Preferred Term | AEs N = 2183 | ADRs N = 2183 |
---|---|---|
Number of Subjects with AEs, n (%) [events] | 151 (6.9) [234] | 39 (1.8) [50] |
Nervous system disorders | 59 (2.7) [67] | 20 (0.9) [21] |
Dizziness | 30 (1.4) [31] | 9 (0.4) [9] |
Headache | 23 (1.1) [23] | 10 (0.5) [10] |
Syncope | 7 (0.3) [7] | 2 (0.1) [2] |
General disorders and administration site conditions | 25 (1.2) [25] | 5 (0.2) [5] |
Chest pain | 8 (0.4) [8] | 1 (0.1) [1] |
Asthenia | 3 (0.1) [3] | 2 (0.1) [2] |
Cardiac disorders | 19 (0.9) [19] | 2 (0.1) [2] |
Palpitations | 17 (0.8) [17] | 2 (0.1) [2] |
Respiratory, thoracic and mediastinal disorders | 14 (0.6) [15] | 3 (0.1) [4] |
Cough | 6 (0.3) [6] | 2 (0.1) [2] |
Investigations | 11 (0.5) [11] | 2 (0.1) [2] |
Blood pressure increased | 9 (0.4) [9] | 2 (0.1) [2] |
Vascular disorders | 10 (0.5) [13] | 7 (0.3) [9] |
Hypotension | 6 (0.3) [7] | 6 (0.3) [7] |