Table 3 ∣.
Adverse events/toxicities new or worsening relative to enrollment, at least possibly related to treatment
| Toxicity grade CTCAE v4.0 | |||||
|---|---|---|---|---|---|
| 01-Mild | 02-Moderate | 03-Severe | 04-Life threatening | ||
| Toxicity category CTCAE v4.0 | Toxicity description CTCAE v4.0 | N | N | N | N |
| Blood and lymphatic system disorders | Anemia | 2 | 2 | – | – |
| Elevated white blood cells | – | 1 | – | – | |
| Hepatotoxicity | – | 1 | – | – | |
| Cardiac disorders | Ventricular tachycardia | 1 | – | – | – |
| Ear and labyrinth disorders | Vertigo | 1 | – | – | – |
| Endocrine disorders | Adrenal insufficiency | 1 | 1 | 1 | – |
| Hyperthyroidism | 1 | – | – | – | |
| Hypophysitis | – | – | 1 | – | |
| Hypothyroidism | 2 | 1 | – | – | |
| Eye disorders | Blurred vision | 1 | – | – | – |
| Conjunctivitis | 1 | 1 | – | – | |
| Double vision | 1 | – | – | – | |
| Dry eye | 1 | – | – | – | |
| Itchiness, right eye | 1 | – | – | – | |
| Visual changes | – | 1 | – | – | |
| Watering eyes | 1 | – | – | – | |
| Gastrointestinal disorders | Abdominal distension | – | – | 1 | – |
| Abdominal pain | 2 | – | 1 | – | |
| Colitis | 1 | 1 | – | – | |
| Constipation | 4 | – | – | – | |
| Diarrhea | 4 | 1 | 1 | – | |
| Duodenal hemorrhage | 1 | – | – | – | |
| Dyspepsia | 1 | – | – | – | |
| Gastroesophageal reflux disease | 1 | – | 1 | – | |
| Mouth sore | 1 | – | – | – | |
| Nausea | 8 | 6 | 1 | – | |
| Vomiting | 4 | 6 | – | – | |
| General disorders and admin site conditions | Chills | 4 | – | – | – |
| Edema, limbs | 1 | 1 | – | – | |
| Facial numbness with lip tingling | 1 | – | – | – | |
| Fatigue | 14 | 9 | 1 | – | |
| Fever | 2 | 1 | – | – | |
| Gait disturbance | 2 | 2 | – | – | |
| Localized edema | 1 | – | – | – | |
| Malaise | 4 | 1 | – | – | |
| Night sweats | 1 | – | – | – | |
| Infections and infestations | Infection, other; influenza B | – | 1 | – | – |
| Oral Thrush | – | 1 | – | – | |
| Sinusitis | – | 1 | – | – | |
| Upper respiratory infection | – | 1 | – | – | |
| Investigations | Alanine aminotransferase increased | 6 | 1 | 1 | – |
| Alkaline phosphatase increased | – | 1 | 1 | – | |
| Aspartate aminotransferase increased | 6 | 1 | 3 | – | |
| Blood bilirubin increased | 1 | – | – | – | |
| Elevated thyroid-stimulating hormone | 1 | – | – | – | |
| Lymphocyte count decreased | 1 | – | 1 | – | |
| Platelet count decreased | 1 | 2 | – | – | |
| Weight gain | 1 | – | – | – | |
| Weight loss | 1 | – | – | – | |
| Decreased white blood cells | 1 | 1 | – | – | |
| Metabolism and nutrition disorders | Anorexia | 7 | 2 | – | – |
| Hyperglycemia | 3 | – | – | – | |
| Hypokalemia | – | – | 2 | – | |
| Hypomagnesemia | 1 | – | – | – | |
| Hyponatremia | 4 | – | 1 | – | |
| Hypophosphatemia | – | 2 | – | – | |
| Transaminitis | 1 | – | – | – | |
| Musculoskeletal and connective tissue disorders | Arthralgia | 3 | – | – | – |
| Back pain | – | 2 | – | – | |
| Body aches | 1 | – | – | – | |
| Bone pain | 1 | – | – | – | |
| Generalized muscle weakness | 3 | 1 | 2 | – | |
| Muscle cramps, back and legs | 1 | – | – | – | |
| Muscle weakness, left-sided | 1 | – | – | – | |
| Muscle weakness, lower limb | 1 | – | – | – | |
| Muscle weakness, right-sided | – | 1 | – | – | |
| Myalgia | 5 | – | – | – | |
| Myositis | – | 1 | – | – | |
| Neck pain | 2 | – | – | – | |
| Pain in extremity | 1 | – | – | – | |
| Nervous system disorders | Cerebral edema | – | 1 | 1 | 2 |
| Dizziness | 4 | 1 | – | – | |
| Dysarthria | – | 1 | – | – | |
| Dysgeusia | 4 | 1 | – | – | |
| Expressive aphasia | – | 1 | – | – | |
| Facial muscle weakness | 1 | – | – | – | |
| Headache | 6 | 4 | 2 | – | |
| Memory impairment | 1 | – | – | – | |
| Seizure | 4 | – | – | – | |
| Somnolence | – | 1 | – | – | |
| Syncope | – | – | 1 | – | |
| Psychiatric disorders | Anxiety | 1 | – | – | – |
| Confusion | 2 | – | 4 | – | |
| Delirium | – | – | 1 | – | |
| Depression | 1 | – | – | – | |
| Insomnia | 5 | – | – | – | |
| Respiratory, thoracic and mediastinal disorders | Cough | 3 | 1 | – | – |
| Dyspnea | 3 | – | – | – | |
| Pneumonitis | 1 | – | – | – | |
| Skin and subcutaneous tissue disorders | Alopecia | 1 | – | – | – |
| Dry skin | 1 | – | – | – | |
| Itchy skin | – | 1 | – | – | |
| Pruritus | 3 | – | – | – | |
| Rash, acneiform | 2 | – | – | – | |
| Rash, maculopapular | 2 | – | – | – | |
| Vascular disorders | Hypertension | – | 1 | – | – |
| Hypotension | – | 1 | – | – | |
CTCAE, Common Terminology Criteria for Adverse Events.