Table 3. Concomitant diagnoses at baseline by system organ class.
|
MedDRA preferred term
| ||
|---|---|---|
| Medical history | Tiotropium | Placebo |
| Number of patients | 238 (100) | 219 (100) |
| Number of patients with ≥1 disease or syndrome | 190 (79.8) | 179 (81.7) |
| Blood and lymphatic system disorders | 0 (0.0) | 2 (0.9) |
| Cardiac disorders | 30 (12.6) | 24 (11.0) |
| Congenital, familial and genetic disorders | 0 (0.0) | 1 (0.5) |
| Ear and labyrinth disorders | 2 (0.8) | 9 (4.1) |
| Endocrine disorders | 16 (6.7) | 13 (5.9) |
| Eye disorders | 12 (5.0) | 12 (5.5) |
| Gastrointestinal disorders | 41 (17.2) | 43 (19.6) |
| General disorders and administration site conditions | 1 (0.4) | 2 (0.9) |
| Hepatobiliary disorders | 5 (2.1) | 1 (0.5) |
| Immune system disorders | 22 (9.2) | 17 (7.8) |
| Infections and infestations | 4 (1.7) | 7 (3.2) |
| Injury poisoning and procedural complications | 1 (0.4) | 4 (1.8) |
| Investigations | 4 (1.7) | 5 (2.3) |
| Metabolism and nutritional disorders | 69 (29.0) | 86 (39.3) |
| Musculoskeletal and connective tissue disorders | 72 (30.3) | 64 (29.2) |
| Neoplasms benign, malignant, unspecified | 0 (0.0) | 0 (0.0) |
| Nervous system disorders | 23 (9.7) | 28 (12.8) |
| Psychiatric disorders | 32 (13.4) | 22 (10.0) |
| Renal and urinary disorders | 6 (2.5) | 10 (4.6) |
| Reproductive system and breast disorders | 18 (7.6) | 20 (9.1) |
| Respiratory, thoracic and mediastinal disorders | 16 (6.7) | 8 (3.7) |
| Skin and subcutaneous tissue disorders | 11 (4.6) | 11 (5.0) |
| Social circumstances | 3 (1.3) | 3 (1.4) |
| Surgical and medical procedures | 6 (2.5) | 3 (1.4) |
| Vascular disorders | 105 (44.1) | 118 (53.9) |
Data shown as number (%) of patients.