Table 5B.

Serious adverse events (SAEs)

Patient ID	Dose level	Drug dose (mg/m2/24h)	Age	Gender	MedDRA	Gradea	Onset Cycle Dayb	Duration Daysc	Relation to Therapy	Outcomed
0003	3	150	74	Female	Febrile netropenia	3	Cycle 1 Day 4	12	Possible	1
0013	9	1,050	58	Male	Muscle weakness	3	Cycle 1 Day 6	10	Possible	1
0029	9	1,050	58	Male	Confusional state	3	Cycle 1 Day 3	8	Probable	2
0025	10	1,375	76	Female	Hyponatremia	3	Cycle 1 Day 9	1	Possible	1
					Anemia	3	Cycle 2 Day 8	2	Possible	1
					Leukopenia (neutropenia)	3	Cycle 2 Day 6	7	Probable	1
					Anemia	4	Cycle 2 Day 9	1	Possible	1
					Thrombocytopenia*	2	Cycle 2 Day 8	1	Possible	1
					Hyponatremia	4	Cycle 3 Day 11	16	Probable	1
0026	10	1,375	64	Female	Confusional state	3	Cycle 1 Day 3	17	Possible	1
					Delirium	3	Cycle 1 Day 5	15	Possible	1
					Anemia	4	Cycle 1 Day 6	2	Possible	1
					Leukopenia (neutropenia)	4	Cycle 1 Day 7	8	Probable	1
					Thrombocytopenia	3	Cycle 1 Day 9	11	Probable	1
					Nausea*	2	Cycle 1 Day 3	17	Possible	1
					Vomiting*	2	Cycle 1 Day 2	18	Possible	1
					Headache*	2	Cycle 1 Day 2	9	Possible	1
					Lethargy*	2	Cycle 1 Day 6	4	Possible	1
0021	11	1,700	73	Female	Fatigue	3	Cycle 1 Day 5	4	Possible	1
					Hyponatremia	4	Cycle 1 Day 5	12	Probable	2
					Tremors/shaking	3	Cycle 1 Day 5	1	Possible	1

Patient 0003 had myelodysplastic syndrome with leukemic phase. Her neutropenia was evaluated using IWG response criteria [10].

^aGrade 1=Mild, 2=Moderate, 3=Severe, 4=Life-threatening, 5=Fatal.

^bDay relative to the first dose of study medication.

^cDuration of DLT calculated in days from the onset date to the resolution date.

^dOutcome: 1=Resolved, 2=Resolved with residual effects.

^*As a part of multi-organ toxicities.