Table 2 |.

TEAEs per NCI CTCAE version 5.0

Adverse Events	Grade 1	Grade 2	Grade 3	Grade 4	Grade 5	Total
Any adverse event	2 (9.5)	7 (33.3)	10 (47.6)	1 (4.8)	1a (4.8)	21 (100)
General disorders and administration site conditions	15 (71.4)					15 (71.4)
Urinary tract infection		10 (47.6)	4 (19.0)			14 (66.7)
Fatigue	12 (57.1)					12 (57.1)
Bladder spasm	6 (28.6)	4 (19.0)				10 (47.6)
Back pain	8 (38.1)	1 (4.8)				9 (42.9)
Abdominal pain	8 (38.1)					8 (38.1)
Constipation	8 (38.1)					8 (38.1)
Hypokalemia	4 (19.0)	2 (9.5)	2 (9.5)			8 (38.1)
Nausea	6 (28.6)		1 (4.8)			7 (33.3)
Vomiting	6 (28.6)		1 (4.8)			7 (33.3)
Chills	5 (23.8)	1 (4.8)				6 (28.6)
Flank pain	6 (28.6)					6 (28.6)
Hematuria	3 (14.3)	2 (9.5)	1 (4.8)			6 (28.6)
Hypomagnesemia	6 (28.6)					6 (28.6)
Hypophosphatemia	1 (4.8)	5 (23.8)				6 (28.6)
Leukocytosis			6 (28.6)			6 (28.6)
Rash maculo-papular	5 (23.8)	1 (4.8)				6 (28.6)
Renal and urinary disorders	5 (23.8)	1 (4.8)				6 (28.6)
Acute kidney injury			3 (14.3)	2 (9.5)		5 (23.8)
Dysuria	5 (23.8)					5 (23.8)
Fever	4 (19.0)	1 (4.8)				5 (23.8)
Insomnia	5 (23.8)					5 (23.8)
Investigations	1 (4.8)	2 (9.5)	2 (9.5)			5 (23.8)
Urinary incontinence	5 (23.8)					5 (23.8)
Anemia			4 (19.0)			4 (19.0)
Diarrhea	4 (19.0)					4 (19.0)
Hypotension	3 (14.3)		1 (4.8)			4 (19.0)
Infusion-related reaction	1 (4.8)	3 (14.3)				4 (19.0)
Pruritus	3 (14.3)	1 (4.8)				4 (19.0)
Urinary frequency	4 (19.0)					4 (19.0)
Wound complication	4 (19.0)					4 (19.0)
Anorexia	3 (14.3)					3 (14.3)
Dehydration		1 (4.8)	2 (9.5)			3 (14.3)
Edema limbs	2 (9.5)	1 (4.8)				3 (14.3)
Gastrointestinal disorders	2 (9.5)	1 (4.8)				3 (14.3)
Hypertension		1 (4.8)	2 (9.5)			3 (14.3)
Infections and infestations	1 (4.8)	1 (4.8)	1 (4.8)			3 (14.3)
Non-cardiac chest pain	3 (14.3)					3 (14.3)
Pain	3 (14.3)					3 (14.3)
Sinus tachycardia	3 (14.3)					3 (14.3)
Weight loss	2 (9.5)	1 (4.8)				3 (14.3)
Alkaline phosphatase increased	1 (4.8)	1 (4.8)				2 (9.5)
Anxiety	2 (9.5)					2 (9.5)
Arthralgia	2 (9.5)					2 (9.5)
Atelectasis	2 (9.5)					2 (9.5)
Atrial fibrillation		1 (4.8)	1 (4.8)			2 (9.5)
Chest pain (cardiac)	1 (4.8)	1 (4.8)				2 (9.5)
Creatinine increased	2 (9.5)					2 (9.5)
Dizziness	2 (9.5)					2 (9.5)
Dry mouth	2 (9.5)					2 (9.5)
Dyspnea	2 (9.5)					2 (9.5)
Erectile dysfunction	1 (4.8)	1 (4.8)				2 (9.5)
Fall	2 (9.5)					2 (9.5)
Flatulence	2 (9.5)					2 (9.5)
Generalized muscle weakness	2 (9.5)					2 (9.5)
Genital edema	2 (9.5)					2 (9.5)
Hyperhidrosis	2 (9.5)					2 (9.5)
Hyperkalemia	1 (4.8)	1 (4.8)				2 (9.5)
Kidney infection		1 (4.8)	1 (4.8)			2 (9.5)
Muscle cramp	2 (9.5)					2 (9.5)
Muscle weakness lower limb	1 (4.8)	1 (4.8)				2 (9.5)
Neoplasms benign, malignant and unspecified (incl. cysts and polyps)	2 (9.5)					2 (9.5)
Paresthesia	2 (9.5)					2 (9.5)
Penile pain	2 (9.5)					2 (9.5)
Productive cough	2 (9.5)					2 (9.5)
Rectal pain	2 (9.5)					2 (9.5)
Sepsis			1 (4.8)	1 (4.8)		2 (9.5)
Sinus bradycardia	2 (9.5)					2 (9.5)
Stomach pain	2 (9.5)					2 (9.5)
Surgical and medical procedures			2 (9.5)			2 (9.5)
Urinary retention	2 (9.5)					2 (9.5)
Urinary tract pain		2 (9.5)				2 (9.5)
Urinary urgency	2 (9.5)					2 (9.5)
Abdominal distention	1 (4.8)					1 (4.8)
Acidosis	1 (4.8)					1 (4.8)
Alanine aminotransferase increased			1 (4.8)			1 (4.8)
Aspartate aminotransferase increased			1 (4.8)			1 (4.8)
Atrioventricular block first degree	1 (4.8)					1 (4.8)
Belching	1 (4.8)					1 (4.8)
Blurred vision	1 (4.8)					1 (4.8)
Cardiac disorders			1 (4.8)			1 (4.8)
Confusion	1 (4.8)					1 (4.8)
Cough	1 (4.8)					1 (4.8)
Delirium	1 (4.8)					1 (4.8)
Duodenal ulcer				1 (4.8)		1 (4.8)
Dysarthria	1 (4.8)					1 (4.8)
Dysgeusia	1 (4.8)					1 (4.8)
Flu-like symptoms	1 (4.8)					1 (4.8)
Flushing		1 (4.8)				1 (4.8)
Gastroesophageal reflux disease		1 (4.8)				1 (4.8)
Headache	1 (4.8)					1 (4.8)
Hearing impaired	1 (4.8)					1 (4.8)
Heart failure			1 (4.8)			1 (4.8)
Hiccups	1 (4.8)					1 (4.8)
Hypermagnesemia	1 (4.8)					1 (4.8)
Hypertriglyceridemia	1 (4.8)					1 (4.8)
Hypoalbuminemia			1 (4.8)			1 (4.8)
Hypocalcemia		1 (4.8)				1 (4.8)
Hyponatremia	1 (4.8)					1 (4.8)
Hypothyroidism		1 (4.8)				1 (4.8)
Injury, poisoning and procedural complications			1 (4.8)			1 (4.8)
Intra-abdominal hemorrhage				1 (4.8)		1 (4.8)
Irritability	1 (4.8)					1 (4.8)
Lung infection					1 (4.8)	1 (4.8)
Lymph leakage	1 (4.8)					1 (4.8)
Malaise	1 (4.8)					1 (4.8)
Memory impairment	1 (4.8)					1 (4.8)
Metabolism and nutrition disorders	1 (4.8)					1 (4.8)
Musculoskeletal and connective tissue disorder	1 (4.8)					1 (4.8)
Myalgia	1 (4.8)					1 (4.8)
Nail infection	1 (4.8)					1 (4.8)
Neck pain	1 (4.8)					1 (4.8)
Pharyngitis		1 (4.8)				1 (4.8)
Pleural effusion	1 (4.8)					1 (4.8)
Psychiatric disorders	1 (4.8)					1 (4.8)
Reproductive system and breast disorders	1 (4.8)					1 (4.8)
Respiratory failure				1 (4.8)		1 (4.8)
Respiratory, thoracic and mediastinal disorders	1 (4.8)					1 (4.8)
Scrotal pain	1 (4.8)					1 (4.8)
Testicular pain	1 (4.8)					1 (4.8)
Thromboembolic event		1 (4.8)				1 (4.8)
Toothache	1 (4.8)					1 (4.8)
Urine discoloration	1 (4.8)					1 (4.8)
Urostomy leak	1 (4.8)					1 (4.8)
Vaginal discharge	1 (4.8)					1 (4.8)
Vascular disorders		1 (4.8)				1 (4.8)

^aGrade 5 SAE not attributed to treatment.