Table 2.
Adverse events in cycle 1.
| Any Grade (% of all events) |
Grade 3 or higher (% of all events) |
|
|---|---|---|
| ALLERGY/IMMUNOLOGY | ||
| Autoimmune reaction-uveitis (anterior) | 1 (1) | 0 |
| AUDITORY/EAR | ||
| Hearing (no baseline audiogram) | 1 (1) | 0 |
| CARDIAC ARRHYTHMIA | ||
| Supraventricular and nodal arrhythmia- Sinus tachycardia | 1 (1) | 0 |
| CARDIAC GENERAL | ||
| Bilateral Pedal Edema | 1 (1) | 0 |
| Hypertension | 1 (1) | 0 |
| Hypotension | 3 (2) | 1 (6) |
| CONSTITUTIONAL | ||
| Rigors/chills | 4 (3) | 0 |
| Fatigue | 12 (9) | 0 |
| DEATH | ||
| Death | 1 (1) | 1 (6) |
| DERMATOLOGY/SKIN | ||
| Alopecia | 1 (1) | 0 |
| Bruising (in absence of thrombocytopenia) | 1 (1) | 0 |
| Hyperpigmentation | 1 (1) | 0 |
| Pruritus | 5 (4) | 0 |
| Rash | 6 (4) | 0 |
| Ulceration | 1 (1) | 0 |
| Urticaria | 1 (1) | 0 |
| ENDOCRINE | ||
| Hypothyroidism | 2 (2) | 0 |
| Other (hypopituitarism) | 1 (1) | 1 (6) |
| GASTROINTESTINAL | ||
| Abdominal cramps | 1 (1) | 0 |
| ALT- elevated | 7 (5) | 2 (13) |
| AST- elevated | 7 (5) | 1 (6) |
| Anorexia | 1 (1) | 0 |
| Constipation | 9 (7) | 0 |
| Dehydration | 1 (1) | 0 |
| Diarrhea | 4 (3) | 3 (19) |
| Dry mouth (xerostomia) | 1 (1) | 0 |
| Mucositis – Oral cavity | 2 (2) | 0 |
| Nausea | 2 (2) | 0 |
| Taste alteration (dysgeusia) | 1 (1) | 0 |
| Vomiting | 2 (2) | 0 |
| Weight loss | 1 (1) | 0 |
| GENITOURINARY | ||
| Other- Shortened menstrual peirod | 1 (1) | 0 |
| HEMORRHAGE/BLEEDING | ||
| Hemorrhage, GI – Colon | 1 (1) | 1 (6) |
| Hemorrhage, GI – Stomach | 1 (1) | 1 (6) |
| INFECTION | ||
| With normal ANC or Gr 1–2 neutrophils- Upper airway NOS |
2 (2) | 0 |
| With normal ANC or Gr 1–2 neutrophils- Bladder | 2 (2) | 0 |
| LYMPHATICS | ||
| Other- Lymphadenopathy | 1 (1) | 0 |
| MUSCULOSKELETAL | ||
| Muscle Weakness – Trunk | 1 (1) | 0 |
| Other- Chondroid lesion, humerus | 1 (1) | 0 |
| NEUROLOGY | ||
| Dizziness (vertigo) | 1 (1) | 0 |
| Insomnia | 1 (1) | 0 |
| Mood alteration- anxiety | 1 (1) | 0 |
| Mood alteration- irritability | 1 (1) | 0 |
| Mood alteration- depression | 1 (1) | 0 |
| Neuropathy- sensory | 1 (1) | 0 |
| Sensitive to light | 1 (1) | 0 |
| Tinnitus | 1 (1) | 0 |
| OCCULAR/VISUAL | ||
| Other- Ptosis, unilateral | 1 (1) | 0 |
| Uveitis | 1 (1) | 0 |
| PAIN | ||
| Back | 2 (2) | 0 |
| Chest | 1 (1) | 0 |
| Headache | 7 (5) | 0 |
| Joints | 1 (1) | 0 |
| Extremity-limb | 1 (1) | 0 |
| Muscle | 1 (1) | 0 |
| Throat | 1 (1) | 0 |
| Tumor | 3 (2) | 0 |
| PULMONARY | ||
| Dyspnea | 1 (1) | 0 |
| Plural effusion | 1 (1) | 0 |
| Sinusitis | 1 (1) | 0 |
| SYNDROMES | ||
| Cytokine release syndrome | 20 (15) | 1 (6) |
| TOTAL | 143 (100) | 12 (100) |