Table 2.
Adverse events (all causality) >10% in any treatment group, N = 36
| Adverse event | Patients, n (%) |
|---|---|
| All | 36 (100) |
| Blood and lymphatic disorders | |
| Total | 14 (38.9) |
| Anemia | 5 (13.9) |
| Leukopenia | 6 (16.7) |
| Cardiac disorders | |
| Total | 9 (25) |
| Tachycardia | 6 (16.7) |
| Eye disorders | |
| Total | 4 (11.1) |
| Vision blurred | 4 (11.1) |
| Gastrointestinal disorders | |
| Total | 31 (86.1) |
| Abdominal distention | 4 (11.1) |
| Abdominal pain | 5 (13.9) |
| Constipation | 16 (44.4) |
| Diarrhea | 16 (44.4) |
| Nausea | 20 (55.6) |
| Vomiting | 10 (27.8) |
| General disorders and administration site disorders | |
| Total | 24 (66.7) |
| Chills | 4 (11.1) |
| Fatigue | 10 (27.8) |
| Edema peripheral | 9 (25) |
| Pain | 4 (11.1) |
| Injury, poisoning and procedural complications | |
| Total | 33 (91.7) |
| Incision site pain | 26 (72.2) |
| Procedural pain | 7 (19.4) |
| Investigations | |
| Total | 19 (52.8) |
| Blood creatinine increased | 5 (13.9) |
| Vitamin D decreased | 4 (11.1) |
| Metabolic and nutritional disorders | |
| Total | 28 (77.8) |
| Dehydration | 4 (11.1) |
| Diabetes mellitus | 4 (11.1) |
| Gout | 4 (11.1) |
| Hyperglycemia | 12 (33.3) |
| Hyperkalemia | 5 (13.9) |
| Hyperlipidemia | 5 (13.9) |
| Hypokalemia | 7 (19.4) |
| Hypomagnesemia | 20 (55.5) |
| Hypophosphatemia | 11 (30.6) |
| Musculoskeletal and connective tissue disorders | |
| Total | 12 (33.3) |
| Back pain | 5 (13.9) |
| Nervous system disorders | |
| Total | 23 (63.9) |
| Dizziness | 4 (13.1) |
| Headache | 6 (16.7) |
| Tremor | 14 (38.9) |
| Psychiatric disorders | |
| Total | 8 (22.2) |
| Insomnia | 5 (13.9) |
| Renal and urinary disorders | |
| Total | 12 (33.3) |
| Hematuria | 6 (16.7) |
| Reproductive system | |
| Total | 5 (13.9) |
| Scrotal edema/pain | 4 (11.1) |
| Respiratory, thoracic and mediastinal disorders | |
| Total | 15 (41.7) |
| Cough | 5 (13.9) |
| Dyspnea | 4 (11.1) |
| Oropharyngeal pain | 6 (16.7) |
| Skin and subcutaneous tissue | |
| Total | 23 (63.9) |
| Pruritus | 11 (30.6) |
| Urticaria | 6 (16.7) |
| Surgical and medical procedures | |
| Total | 4 (11.1) |
| Incisional drainage | 4 (11.1) |
| Vascular disorders | |
| Total | 18 (50) |
| Hypertension | 11 (30.6) |
| Hypotension | 7 (19.4) |
Adverse event coding was done using the MedDRA Version 13.1 dictionary (http://www.who.int/medical_devices/innovation/Med-DRAintroguide_version14_0_March2011.pdf). Subjects who have the same event more than once are counted only once for the preferred term. Subjects who have more than one adverse event within a system organ class are counted only once in that system organ class. Date produced: October 18, 2013.