Table 4.
Distribution of Patients by Highest Grade Adverse Event By System Organ Class For All Reported Adverse Events without Regard to Attribution
| Cabozantinib (n=13) | |||||
|---|---|---|---|---|---|
| No. and (%) of Patients by Grade | |||||
| 1 | 2 | 3 | 4 | 5 | |
| System Organ Class | |||||
| Overall Highest Grade | 1 (7.7) |
3 (23.1) |
7 (53.8) |
1 (7.7) |
1 (7.7) |
| Blood and Lymphatic System Disorders | 5 (38.5) |
0 (0.0) |
0 (0.0) |
0 (0.0) |
0 (0.0) |
| Cardiac Disorders | 1 (7.7) |
1 (7.7) |
0 (0.0) |
0 (0.0) |
0 (0.0) |
| Ear and Labyrinth Disorders | 2 (15.4) |
0 (0.0) |
0 (0.0) |
0 (0.0) |
0 (0.0) |
| Endocrine Disorders | 1 (7.7) |
2 (15.4) |
0 (0.0) |
0 (0.0) |
0 (0.0) |
| Eye Disorders | 1 (7.7) |
0 (0.0) |
0 (0.0) |
0 (0.0) |
0 (0.0) |
| Gastrointestinal Disorders | 3 (23.1) |
5 (38.5) |
4 (30.8) |
0 (0.0) |
0 (0.0) |
| General Disorders and Administration Site Conditions | 5 (38.5) |
4 (30.8) |
3 (23.1) |
0 (0.0) |
0 (0.0) |
| Infections and Infestations | 0 (0.0) |
2 (15.4) |
0 (0.0) |
0 (0.0) |
0 (0.0) |
| Injury, Poisoning and Procedural Complications | 1 (7.7) |
0 (0.0) |
0 (0.0) |
0 (0.0) |
0 (0.0) |
| Investigations | 6 (46.2) |
3 (23.1) |
2 (15.4) |
0 (0.0) |
0 (0.0) |
| Metabolism and Nutrition Disorders | 3 (23.1) |
6 (46.2) |
2 (15.4) |
1 (7.7) |
0 (0.0) |
| Musculoskeletal and Connective Tissue Disorders | 5 (38.5) |
2 (15.4) |
1 (7.7) |
0 (0.0) |
0 (0.0) |
| Nervous System Disorders | 3 (23.1) |
7 (53.8) |
1 (7.7) |
0 (0.0) |
0 (0.0) |
| Psychiatric Disorders | 1 (7.7) |
1 (7.7) |
0 (0.0) |
0 (0.0) |
0 (0.0) |
| Renal and Urinary Disorders | 0 (0.0) |
1 (7.7) |
0 (0.0) |
0 (0.0) |
0 (0.0) |
| Respiratory, Thoracic and Mediastinal Disorders | 4 (30.8) |
2 (15.4) |
2 (15.4) |
0 (0.0) |
0 (0.0) |
| Skin and Subcutaneous Tissue Disorders | 5 (38.5) |
1 (7.7) |
0 (0.0) |
0 (0.0) |
0 (0.0) |
| Vascular Disorders | 1 (7.7) |
5 (38.5) |
3 (23.1) |
0 (0.0) |
1 (7.7) |
Adverse events were graded with CTCAE version 4