Table 2.
Treatment-related Adverse Events by Dose Level
Adverse events were graded with CTCAE version 4
| Trametinib+GSK (High) (n=14) | Trametinib+GSK (Low) (n=12) | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| No. and (%) of Patients by Grade | No. and (%) of Patients by Grade | |||||||||
| System Organ Class | 1 | 2 | 3 | 4 | 5 | 1 | 2 | 3 | 4 | 5 |
| Overall Highest Grade | 1 (7.1) |
4 (28.6) |
9 (64.3) |
0 (0.0) |
0 (0.0) |
2 (16.7) |
6 (50.0) |
4 (33.3) |
0 (0.0) |
0 (0.0) |
| Blood and Lymphatic System Disorders | 3 (21.4) |
2 (14.3) |
2 (14.3) |
0 (0.0) |
0 (0.0) |
3 (25.0) |
3 (25.0) |
1 (8.3) |
0 (0.0) |
0 (0.0) |
| Cardiac Disorders | 1 (7.1) |
0 (0.0) |
0 (0.0) |
0 (0.0) |
0 (0.0) |
0 (0.0) |
0 (0.0) |
0 (0.0) |
0 (0.0) |
0 (0.0) |
| Eye Disorders | 2 (14.3) |
1 (7.1) |
0 (0.0) |
0 (0.0) |
0 (0.0) |
1 (8.3) |
0 (0.0) |
0 (0.0) |
0 (0.0) |
0 (0.0) |
| Gastrointestinal Disorders | 4 (28.6) |
5 (35.7) |
3 (21.4) |
0 (0.0) |
0 (0.0) |
6 (50.0) |
4 (33.3) |
2 (16.7) |
0 (0.0) |
0 (0.0) |
| General Disorders and Administration Site Conditions | 5 (35.7) |
4 (28.6) |
1 (7.1) |
0 (0.0) |
0 (0.0) |
3 (25.0) |
4 (33.3) |
2 (16.7) |
0 (0.0) |
0 (0.0) |
| Immune System Disorders | 0 (0.0) |
0 (0.0) |
1 (7.1) |
0 (0.0) |
0 (0.0) |
0 (0.0) |
0 (0.0) |
0 (0.0) |
0 (0.0) |
0 (0.0) |
| Infections and Infestations | 0 (0.0) |
1 (7.1) |
0 (0.0) |
0 (0.0) |
0 (0.0) |
0 (0.0) |
0 (0.0) |
0 (0.0) |
0 (0.0) |
0 (0.0) |
| Injury, Poisoning and Procedural Complications | 1 (7.1) |
0 (0.0) |
0 (0.0) |
0 (0.0) |
0 (0.0) |
0 (0.0) |
0 (0.0) |
0 (0.0) |
0 (0.0) |
0 (0.0) |
| Investigations | 7 (50.0) |
3 (21.4) |
0 (0.0) |
0 (0.0) |
0 (0.0) |
4 (33.3) |
4 (33.3) |
0 (0.0) |
0 (0.0) |
0 (0.0) |
| Metabolism and Nutrition Disorders | 0 (0.0) |
6 (42.9) |
3 (21.4) |
0 (0.0) |
0 (0.0) |
4 (33.3) |
5 (41.7) |
0 (0.0) |
0 (0.0) |
0 (0.0) |
| Musculoskeletal and Connective Tissue Disorders | 2 (14.3) |
0 (0.0) |
0 (0.0) |
0 (0.0) |
0 (0.0) |
1 (8.3) |
1 (8.3) |
0 (0.0) |
0 (0.0) |
0 (0.0) |
| Nervous System Disorders | 2 (14.3) |
0 (0.0) |
1 (7.1) |
0 (0.0) |
0 (0.0) |
4 (33.3) |
1 (8.3) |
0 (0.0) |
0 (0.0) |
0 (0.0) |
| Psychiatric Disorders | 0 (0.0) |
1 (7.1) |
0 (0.0) |
0 (0.0) |
0 (0.0) |
0 (0.0) |
0 (0.0) |
0 (0.0) |
0 (0.0) |
0 (0.0) |
| Renal and Urinary Disorders | 2 (14.3) |
0 (0.0) |
1 (7.1) |
0 (0.0) |
0 (0.0) |
2 (16.7) |
1 (8.3) |
0 (0.0) |
0 (0.0) |
0 (0.0) |
| Respiratory, Thoracic and Mediastinal Disorders | 4 (28.6) |
0 (0.0) |
0 (0.0) |
0 (0.0) |
0 (0.0) |
5 (41.7) |
0 (0.0) |
0 (0.0) |
0 (0.0) |
0 (0.0) |
| Skin and Subcutaneous Tissue Disorders | 7 (50.0) |
1 (7.1) |
3 (21.4) |
0 (0.0) |
0 (0.0) |
4 (33.3) |
2 (16.7) |
1 (8.3) |
0 (0.0) |
0 (0.0) |
| Vascular Disorders | 2 (14.3) |
3 (21.4) |
3 (21.4) |
0 (0.0) |
0 (0.0) |
2 (16.7) |
3 (25.0) |
0 (0.0) |
0 (0.0) |
0 (0.0) |