Table 5.

Nonhematologic adverse events

System organ class: MedDRA Preferred Term	Patients (n [%])a
	Grade 1 AE	Grade 2 AE	Grade 3 AE	Grade 4 AE
Gastrointestinal disorders
Abdominal pain	1 [17]	1 [17]	0	0
Constipation	1 [17]	3 [50]	0	0
Diarrhea	1 [17]	0	1 [17]	0
Dry mouth	2 [33]	0	0	0
Nausea	3 [50]	1 [17]	0	0
Vomiting	1 [17]	2 [33]	0	0
Salivary hypersecretion	1 [17]	0	0	0
General disorders and administration site conditions
Chills	2 [33]	0	0	0
Fatigue	1 [17]	2 [33]	2 [33]	0
Pyrexia	3 [50]	1 [17]	0	0
Asthenia	1 [17]	0	0	0
Chest pain	1 [17]	0	0	0
Localized edema	1 [17]	0	0	0
Peripheral edema	1 [17]	0	0	0
Peripheral coldness	1 [17]	0	0	0
Investigations
Weight decreased	1 [17]	0	0	0
Metabolism and nutrition disorders
Anorexia	2 [33]	0	0	0
Musculoskeletal and connective tissue disorders
Back pain	1 [17]	1 [17]	0	0
Flank pain	1 [17]	0	0	0
Musculoskeletal pain	1 [17]	0	0	0
Neoplasms
Metastases to skin	0	1 [17]	0	0
Nervous system disorders
Dizziness	3 [50]	0	0	0
Headache	2 [33]	0	0	0
Dysgeusia	1 [17]	0	0	0
Migraine	1 [17]	0	0	0
Peripheral sensory neuropathy	0	1 [17]	0	0
Psychiatric disorders
Insomnia	1 [17]	0	0	0
Renal and urinary disorders
Renal pain	0	0	1 [17]	0
Respiratory, thoracic, and mediastinal disorders
Dyspnea	1 [17]	1 [17]	0	0
Cough	1 [17]	0	0	0
Skin and subcutaneous tissue disorders
Dry skin	1 [17]	0	0	0
Hyperhidrosis	1 [17]	0	0	0

If a patient reported an AE more than once, the highest grade was presented for that AE. Patients were counted only once in each preferred term category and only once in each system organ class category, at the highest grade for each

AE adverse event, MedDRA Medical Dictionary for Regulatory Activities

^aPatients (n = 6) may have reported more than one AE