Table 2.

Safety

Serious Adverse Events
Cohort	1A	2A	3A	4A	1B	2B	3B	All treatment groups
N	3	3	8	3	3	4	3	27
No (%) of patients with SAE	1 (33.3)	1 (33.3)	4 (50.0)	2 (66.7)	0	4 (100.0)	0	12 (44.4)
No of Treatment emergent SAEs	1	3	6	4	0	7	0
SAEs	Syncope	Abdominal Pain, Pyrexia, Metastatic Pain	Disease Progression, UTI, Failure to thrive, Hypoglycemia, Cerebral Hemorrhage, Mental Status Change	Melena, Mouth hemorrhage, hematuria, urinary bladder hemorrhage		Subdural hematoma, Hypophosphatemia, Metastases to CNS, Dyspnea, Hypoxia, Pleural effusion, DVT
TEAE occurring in more than one patient per cohort
Cohort	1A	2A	3A	4A	1B	2B	3B
N	3	3	8b	3	3	4	3
Event/n (%)	NA	night sweats / 2 (66.7)	Constipation / 4 (50.0), Fatigue / 4 (50.0), Arthralgia / 2 (25.0), Musculoskele tal pain / 2 (25.0), Cough / 2 (25.0)	Diarrhea / 2 (66.7), Dry mouth / 2 (66.7), Hyponatremia / 2 (66.7)	NA	Hypophosphatem ia / 2 (50.0)	Fatigue / 2 (66.7), Arthralgia / 2 (66.7)
TEAE Occurring in More than one patient per study
No. of patients (%)	TEAE
9 (33.3)	fatigue
8 (29.6)	constipation
5 (18.5)	hypophosphatemia, arthralgia
4 (14.8)	headache, cough, diarrhea, decreased appetite,
3 (11.1)	abdominal pain, hyponatremia, night sweats
2 (7.4)	dry mouth, chills, upper respiratory tract infection, dehydration, back pain, muscle spasms, musculoskeletal pain, nodule on extremity, peripheral neuropathy, insomnia, dyspnea, pleural effusion, postnasal drip, hyperhidrosis, pruritis, deep vein thrombosis