Table 2.
Distribution of RTOG 0837 patients by highest grade adverse event by system organ class for all reported adverse events without regard to attribution
| Placebo (n = 52) | Cediranib (n = 92) | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| System Organ Class | n and (%) of Patients by Grade | n and (%) of Patients by Grade | ||||||||
| 1 | 2 | 3 | 4 | 5 | 1 | 2 | 3 | 4 | 5 | |
| Overall highest grade | 2 | 12 | 19 | 11 | 5 | 1 | 13 | 44 | 22 | 11 |
| (3.8) | (23.1) | (36.5) | (21.2) | (9.6) | (1.1) | (14.1) | (47.8) | (23.9) | (12.0) | |
| Blood and lymphatic system disorders | 16 | 2 | 5 | 2 | 0 | 19 | 7 | 7 | 3 | 0 |
| (30.8) | (3.8) | (9.6) | (3.8) | (0.0) | (20.7) | (7.6) | (7.6) | (3.3) | (0.0) | |
| Cardiac disorders | 2 | 2 | 0 | 0 | 0 | 7 | 1 | 0 | 1 | 0 |
| (3.8) | (3.8) | (0.0) | (0.0) | (0.0) | (7.6) | (1.1) | (0.0) | (1.1) | (0.0) | |
| Ear and labyrinth disorders | 8 | 2 | 0 | 0 | 0 | 7 | 4 | 0 | 0 | 0 |
| (15.4) | (3.8) | (0.0) | (0.0) | (0.0) | (7.6) | (4.3) | (0.0) | (0.0) | (0.0) | |
| Endocrine disorders | 2 | 1 | 0 | 0 | 0 | 7 | 3 | 1 | 0 | 0 |
| (3.8) | (1.9) | (0.0) | (0.0) | (0.0) | (7.6) | (3.3) | (1.1) | (0.0) | (0.0) | |
| Eye disorders | 6 | 1 | 0 | 0 | 0 | 21 | 1 | 0 | 0 | 0 |
| (11.5) | (1.9) | (0.0) | (0.0) | (0.0) | (22.8) | (1.1) | (0.0) | (0.0) | (0.0) | |
| Gastrointestinal disorders | 17 | 15 | 2 | 0 | 1 | 18 | 49 | 16 | 0 | 0 |
| (32.7) | (28.8) | (3.8) | (0.0) | (1.9) | (19.6) | (53.3) | (17.4) | (0.0) | (0.0) | |
| General disorders and administration site conditions | 13 | 25 | 7 | 0 | 2 | 16 | 47 | 16 | 0 | 2 |
| (25.0) | (48.1) | (13.5) | (0.0) | (3.8) | (17.4) | (51.1) | (17.4) | (0.0) | (2.2) | |
| Hepatobiliary disorders | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 1 | 0 | 0 |
| (0.0) | (0.0) | (0.0) | (0.0) | (0.0) | (1.1) | (0.0) | (1.1) | (0.0) | (0.0) | |
| Immune system disorders | 0 | 1 | 0 | 0 | 0 | 1 | 1 | 0 | 0 | 0 |
| (0.0) | (1.9) | (0.0) | (0.0) | (0.0) | (1.1) | (1.1) | (0.0) | (0.0) | (0.0) | |
| Infections and infestations | 2 | 10 | 6 | 2 | 0 | 3 | 16 | 9 | 0 | 4 |
| (3.8) | (19.2) | (11.5) | (3.8) | (0.0) | (3.3) | (17.4) | (9.8) | (0.0) | (4.3) | |
| Injury, poisoning, and procedural complications | 13 | 2 | 1 | 0 | 0 | 18 | 8 | 1 | 0 | 0 |
| (25.0) | (3.8) | (1.9) | (0.0) | (0.0) | (19.6) | (8.7) | (1.1) | (0.0) | (0.0) | |
| Investigations | 8 | 10 | 10 | 8 | 0 | 24 | 24 | 16 | 21 | 0 |
| (15.4) | (19.2) | (19.2) | (15.4) | (0.0) | (26.1) | (26.1) | (17.4) | (22.8) | (0.0) | |
| Metabolism and nutrition disorders | 15 | 10 | 11 | 2 | 0 | 22 | 28 | 18 | 6 | 0 |
| (28.8) | (19.2) | (21.2) | (3.8) | (0.0) | (23.9) | (30.4) | (19.6) | (6.5) | (0.0) | |
| Musculoskeletal and connective tissue disorders | 7 | 3 | 9 | 0 | 0 | 15 | 21 | 11 | 0 | 0 |
| (13.5) | (5.8) | (17.3) | (0.0) | (0.0) | (16.3) | (22.8) | (12.0) | (0.0) | (0.0) | |
| Neoplasms benign, malignant, and unspecified (incl cysts and polyps) | 0 | 0 | 0 | 0 | 1 | 1 | 0 | 0 | 0 | 2 |
| (0.0) | (0.0) | (0.0) | (0.0) | (1.9) | (1.1) | (0.0) | (0.0) | (0.0) | (2.2) | |
| Nervous system disorders | 14 | 13 | 14 | 1 | 0 | 20 | 29 | 18 | 1 | 3 |
| (26.9) | (25.0) | (26.9) | (1.9) | (0.0) | (21.7) | (31.5) | (19.6) | (1.1) | (3.3) | |
| Psychiatric disorders | 9 | 12 | 2 | 1 | 0 | 17 | 18 | 2 | 0 | 0 |
| (17.3) | (23.1) | (3.8) | (1.9) | (0.0) | (18.5) | (19.6) | (2.2) | (0.0) | (0.0) | |
| Renal and urinary disorders | 5 | 5 | 1 | 0 | 0 | 15 | 6 | 1 | 0 | 0 |
| (9.6) | (9.6) | (1.9) | (0.0) | (0.0) | (16.3) | (6.5) | (1.1) | (0.0) | (0.0) | |
| Reproductive system and breast disorders | 2 | 0 | 0 | 0 | 0 | 2 | 1 | 0 | 0 | 0 |
| (3.8) | (0.0) | (0.0) | (0.0) | (0.0) | (2.2) | (1.1) | (0.0) | (0.0) | (0.0) | |
| Respiratory, thoracic, and mediastinal disorders | 13 | 1 | 0 | 0 | 1 | 24 | 7 | 5 | 2 | 0 |
| (25.0) | (1.9) | (0.0) | (0.0) | (1.9) | (26.1) | (7.6) | (5.4) | (2.2) | (0.0) | |
| Skin and subcutaneous tissue disorders | 19 | 15 | 1 | 0 | 0 | 33 | 27 | 5 | 0 | 0 |
| (36.5) | (28.8) | (1.9) | (0.0) | (0.0) | (35.9) | (29.3) | (5.4) | (0.0) | (0.0) | |
| Social circumstances | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 |
| (0.0) | (0.0) | (0.0) | (0.0) | (0.0) | (1.1) | (0.0) | (0.0) | (0.0) | (0.0) | |
| Surgical and medical procedures | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 1 | 0 | 0 |
| (0.0) | (0.0) | (0.0) | (0.0) | (0.0) | (0.0) | (1.1) | (1.1) | (0.0) | (0.0) | |
| Vascular disorders | 3 | 8 | 6 | 1 | 0 | 5 | 23 | 17 | 2 | 0 |
| (5.8) | (15.4) | (11.5) | (1.9) | (0.0) | (5.4) | (25.0) | (18.5) | (2.2) | (0.0) | |