Table 7.
Study Drug-Related Adverse Events in the Safety Population
| System Organ Class Preferred Term | OLIVE | SOYBEAN | ||
|---|---|---|---|---|
| Frequencya | n (%)b | Frequencya | n (%)b | |
| General disorders and administration site conditions | 164 | 85 (38.3) | 157 | 89 (38.5) |
| Swelling | 60 | 19 (8.6) | 50 | 17 (7.4) |
| Pyrexia | 38 | 33 (14.9) | 40 | 35 (15.2) |
| Infusion site swelling | 20 | 16 (7.2) | 26 | 24 (10.4) |
| Gastrointestinal disorders | 65 | 43 (19.4) | 72 | 50 (21.6) |
| Nausea | 22 | 17 (7.7) | 19 | 17 (7.4) |
| Vascular disorders | 47 | 33 (14.9) | 65 | 41 (17.7) |
| Phlebitis | 24 | 12 (5.4) | 31 | 12 (5.2) |
| Peripheral vascular disorder | 14 | 13 (5.9) | 23 | 22 (9.5) |
| Metabolism and nutrition disorders | 35 | 28 (12.6) | 60 | 42 (18.2) |
| Hypokalemia | 3 | 3 (1.4) | 18 | 18 (7.8) |
| Investigations | 41 | 27 (12.2) | 38 | 26 (11.3) |
| Gamma-glutamyltransferase increased | 11 | 11 (5.0) | 7 | 7 (3.0) |
| Injury, poisoning and procedural complications | 44 | 27 (12.2) | 30 | 25 (10.8) |
| Procedural pain | 21 | 12 (5.4) | 9 | 7 (3.0) |
| Incision site pain | 16 | 12 (5.4) | 12 | 10 (4.3) |
| Respiratory, thoracic and mediastinal disorders | 31 | 23 (10.4) | 26 | 20 (8.7) |
| Productive cough | 14 | 14 (6.3) | 11 | 11 (4.8) |
| Cough | 11 | 11 (5.0) | 11 | 11 (4.8) |
| Infections and infestations | 8 | 8 (3.6) | 26 | 24 (10.4) |
| Hepatobiliary disorder | 13 | 13 (5.9) | 7 | 7 (3.0) |
aNumber of events
bNumber and percentage of patients with at least one event