| All Subjects (n = 204) | Telmisartan40/S-Amlodipine2.5 (n = 102) | Telmisartan80 (n = 102) | P-value |
---|---|---|---|---|
Overall AE, n (%) [no. of cases] | 13 (6.37) [15] | 7 (6.86) [7] | 6 (5.88) [8] | 0.774a) |
ADR | 5 (2.45) [5] | 3 (2.94) [3] | 2 (1.96) [2] | 1.000b) |
SAE | – | – | – |  |
Infections and infestations | 3 (1.47) [3] | 1 (0.98) [1] | 2 (1.96) [2] | 1.000b) |
Herpes zoster | 1 (0.49) [1] | 1 (0.98%) [1] | – | 1.000b) |
Nasopharyngitis | 1 (0.49) [1] | – | 1 (0.98) [1] | 1.000b) |
Otitis media chronic | 1 (0.49) [1] | – | 1 (0.98) [1] | 1.000b) |
Skin and subcutaneous tissue disorders | 3 (1.47) [3] | 2 (1.96) [2] | 1 (0.98) [1] | 1.000b) |
Photosensitivity reaction | 1 (0.49) [1] | 1 (0.98) [1] | – | 1.000b) |
Pruritus generalised | 1 (0.49) [1] | – | 1 (0.98) [1] | 1.000b) |
Urticaria | 1 (0.49) [1] | 1 (0.98) [1] | – | 1.000b) |
Investigations | 2 (0.98) [2] | 1 (0.98) [1] | 1 (0.98) [1] | 1.000b) |
Blood glucose increased | 1 (0.49) [1] | – | 1 (0.98) [1] | 1.000b) |
Low density lipoprotein increased | 1 (0.49) [1] | 1 (0.98) [1] | – | 1.000b) |
Nervous system disorders | 2 (0.98) [2] | – | 2 (1.96) [2] | 0.498b) |
Headache | 1 (0.49) [1] | – | 1 (0.98) [1] | 1.000b) |
Migraine without aura | 1 (0.49) [1] | – | 1 (0.98) [1] | 1.000b) |
Cardiac disorders | 1 (0.49) [1] | – | 1 (0.98) [1] | 1.000b) |
Palpitations | 1 (0.49) [1] | – | 1 (0.98) [1] | 1.000b) |
Eye disorders | 1 (0.49) [1] | – | 1 (0.98) [1] | 1.000b) |
Dry eye | 1 (0.49) [1] | – | 1 (0.98) [1] | 1.000b) |
General disorders and administration site conditions | 1 (0.49) [1] | 1 (0.98) [1] | – | 1.000b) |
Oedema peripheral | 1 (0.49) [1] | 1 (0.98) [1] | – | 1.000b) |
Psychiatric disorders | 1 (0.49) [1] | 1 (0.98) [1] | – | 1.000b) |
Insomnia | 1 (0.49) [1] | 1 (0.98) [1] | – | 1.000b) |
Vascular disorders | 1 (0.49) [1] | 1 (0.98) [1] | – | 1.000b) |
Hypotension | 1 (0.49) [1] | 1 (0.98) [1] | – | 1.000b) |