Table 3. Toxicities experienced by patients in the clinical trial.
| Number of Patients with Adverse Events Possibly, Probably, or Likely Related to study therapy (Maximum AE Grade Per Patient ) |
|||||
|---|---|---|---|---|---|
| CTCAE Group | 1 | 2 | 3 | 4 | 5 |
| Gastrointestinal | 11 | 6 | 2 | 0 | 0 |
| Pain | 7 | 2 | 0 | 0 | 0 |
| Metabolic/Laboratory | 9 | 6 | 3 | 0 | 0 |
| Allergy/Immunology | 4 | 0 | 0 | 0 | 0 |
| Dermatology/Skin | 7 | 6 | 2 | 0 | 0 |
| Constitutional Symptoms | 9 | 12 | 0 | 0 | 0 |
| Pulmonary/Upper Respiratory | 4 | 2 | 2 | 0 | 1* |
| Lymphatics | 1 | 1 | 0 | 0 | 0 |
| Blood/Bone marrow | 7 | 6 | 1 | 0 | 0 |
| Musculoskeletal/Soft Tissue | 1 | 1 | 0 | 0 | 0 |
| Infection | 0 | 2 | 1 | 0 | 0 |
| Ocular/Visual | 3 | 1 | 0 | 0 | 0 |
| Neurology | 3 | 2 | 1 | 0 | 0 |
| Total | 66 | 46 | 12 | 0 | 1 |
*
The single observed Grade 5 pulmonary toxicity was seen in a patient who also had progressive lymphangitic spread of cancer. It was coded “possibly related” to study therapy by the treating investigator.