Table 6.
Number of patients with at least 1 SAE by MedDRA system organ class during the PEDAL trial
| Variable | All, n (%) | CON, n (%) | EX, n (%) |
|---|---|---|---|
| Number of randomized patients who attended baseline visit | 335 | 160 | 175 |
| Number of patients with any event | 125 | 56 (35.0) | 69 (39.4) |
| Blood and lymphatic system disorders | 2 (0.6) | 0 (0.0) | 2 (1.1) |
| Cardiac disorders | 15 (4.5) | 6 (3.8) | 9 (5.1) |
| Congenital, familial, and genetic disorders | 1 (0.3) | 1 (0.6) | 0 (0.0) |
| Gastrointestinal disorders | 14 (4.2) | 4 (2.5) | 10 (5.7) |
| General disorders and administration site conditions | 17 (5.1) | 12 (7.5) | 5 (2.9) |
| Hepatobiliary disorders | 3 (0.9) | 1 (0.6) | 2 (1.1) |
| Infections and infestations | 47 (14.0) | 18 (11.2) | 29 (16.6) |
| Injury, poisoning, and procedural complications | 28 (8.4) | 12 (7.5) | 16 (9.1) |
| Investigations | 5 (1.5) | 4 (2.5) | 1 (0.6) |
| Metabolism and nutrition disorders | 17 (5.1) | 4 (2.5) | 13 (7.4) |
| Musculoskeletal and connective tissue disorders | 4 (1.2) | 1 (0.6) | 3 (1.7) |
| Neoplasms benign, malignant and unspecified (including cysts and polyps) | 1 (0.3) | 0 (0.0) | 1 (0.6) |
| Nervous system disorders | 8 (2.4) | 3 (1.9) | 5 (2.9) |
| Psychiatric disorders | 4 (1.2) | 1 (0.6) | 3 (1.7) |
| Renal and urinary disorders | 1 (0.3) | 1 (0.6) | 0 (0.0) |
| Reproductive system and breast disorders | 2 (0.6) | 1 (0.6) | 1 (0.6) |
| Respiratory, thoracic and mediastinal disorders | 13 (3.9) | 3 (1.9) | 10 (5.7) |
| Skin and subcutaneous tissue disorders | 1 (0.3) | 0 (0.0) | 1 (0.6) |
| Social circumstances | 1 (0.3) | 1 (0.6) | 0 (0.0) |
| Surgical and medical procedures | 37 (11.0) | 13 (8.1) | 24 (13.7) |
| Vascular disorders | 10 (3.0) | 6 (3.8) | 4 (2.3) |
CON, control group; EX, exercise intervention group; MedDRA, Medical Dictionary for Regulatory Activities; PEDAL, PrEscription of intraDialytic exercise to improve quAlity of Life; SAE, serious adverse event.
CON—usual care maintenance hemodialysis. EX—intradialytic exercise training plus usual care maintenance hemodialysis.