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. Author manuscript; available in PMC: 2013 Oct 1.
Published in final edited form as: Clin Cancer Res. 2012 Jul 26;18(19):5489–5498. doi: 10.1158/1078-0432.CCR-12-0507

Table 4.

Summary of Adverse Events for All Treatment Cycles

100 mg qd1
N=6
120 mg qd
N=3
150 mg qd2
N=11

Grade 1 2 3 4 1 2 3 4 1 2 3 4

Variable

Hematologic

 Anemia 1 (17) 4 (67) 1 (17) - - 2 (67) 1 (33) - 2 (18) 4 (36) 3 (27) 1 (9)

 Neutropenia - - 2 (33) 4 (67) - - 1 (33) 2 (67) - - 1 (9) 9 (82)

 Febrile Neutropenia - - - 1 (17)3 - - - - - - 1 (9) -

 Thrombocytopenia 2 (33) 1 (17) 1 (17) 1 (17) - - 1 (33) - 1 (9) 4 (36) 2 (18) 2 (18)

Allergy - - 1 (17) - - - 1 (33) - 1 (9) 1 (9) - -

Fatigue 2 (33) 1 (17) 2 (33) - 3 (100) - - - 3 (27) 7 (64) - -

Dermatogic

 Flushing 1 (17) - - - 1 (33) - - - 1 (9) - 1 (9) -

 Alopecia - 6 (100) - - 1 (33) 2 (67) - - 2 (18) 8 (73) - -

 Pruritis - 1 (17) - - - - - - 1 (9) - - -

 Rash - - - - - - - - 3 (27) - - -

Gastrointestinal4, 5

 Anorexia 2 (33) 1 (17) - - 3 (100) - - - 5 (45) 3 (27) - -

 Constipation - 2 (33) - - 1 (33) - - - 4 (36) 1 (9) - -

 Diarrhea 4 (67) 2 (33) - - 3 (100) - - - 6 (55) 1 (9) - -

 Mucositis/Stomatitis 2 (33) - - - 1 (33) - - - - - - -

 Nausea 2 (33) 2 (33) - - 3 (100) - - - 4 (36) 5 (45) - -

 Dysgeusia 1 (17) - - - - - - - 1 (9) - - -

 Vomiting 2 (33) 1 (17) - - 2 (67) - - - 4 (36) 3 (27) - -

Metabolic6,7

 Electrolyte 1 (17)6 - - - 2 (67)6 - - - 7 (64)6 5 (45)6 2 (18)6 1 (9)6

 Hyperglycemia - - - - - - - - 1 (9) 2 (18) - -

Neurologic8

 Anxiety - 1 (17) - - - - - - - 1 (9) - -

 Sensory neuropathy 3 (50) 1 (17) - - 2 (67) - - - 5 (45) 1 (9) 1 (9) -

Ocular 1 (17) - - - 1 (33) - - - - - - -

Pain9

 Head 1 (17) - - - - - - - 3 (27) - - -

 Joint - 2 (33) - - - 1 (33) - - - - 1 (9) -

 Muscle - 1 (17) 1 (17)1 - - - - - - - - -

 Other 1 (17) - 1 (17) - - - - - 1 (9) - 1 (9) -

Pulmonary10

 Cough 1 (17) - - - 1 (33) - - - 2 (18) - - -

 Dyspnea - - 1 (17) - 2 (67) 1 (33) - - 3 (27) 1 (9) 1 (9) -
1

Additional toxicities in cohort 1 included musculoskeletal toxicity characterized by grade 1 joint-function toxicity (n=1) and grade 1 muscular complaints (n=1). The grade 3 myalgia is reported under pain.

2

Additional toxicities in cohort 3 included the following: grade 3 hypotension (n=1), grade 1 weight loss (n=2), grade 1 epitaxis (n=1), and grade 1 facial and neck edema (n=1).

3

There was one report of infection associated with febrile neutropenia. Two other infections occurred including 1 urinary tract infection occurred in cohort 1.

4

Gastrointestinal toxicity also included the following: (1) grade 1 dehydration (n=1) in cohort 1; (2) grade 1 distension (n=1), grade 1 xerostomia (n=1), grade 1 gastritis (n=1) in cohort 2; and (3) grade 1 xerostomia (n=1) in cohort 3.

5

Gastrointestinal toxicity included other unspecified etiologies: (1) grade 1 (n=1) and grade 2 (n=1) in cohort 1; (2) grade 1 (n=1) in cohort 2; and (3) grade 1 (n=1) in cohort 3.

6

Electrolyte abnormalities were the following: (1) grade 1 hyponatremia (n=1) in cohort 1; (2) grade 1 hypomagnesemia (n=1) and hypokalemia (n=1) in cohort 2; and (3) grade 3 hypercalcemia (n=1); grade 2 hypocalcemia (n=1); hypomagnesemia (grade 1 (n=2), grade 2 (n=1)); hypophosphatemia (grade 2 (n=2), grade 3 (n=1)); hypokalemia (grade 1 (n=3), grade 4 (n=1)); and grade 1 hyponatremia (n=2) in cohort 3. More than one electrolyte abnormality may have occurred in one patient.

7

Metabolic toxicities also included the following: grade 1 elevated transaminases (n=1), grade 1 elevated alkaline phosphatase (n=1), and proteinuria (grade 1 (n=1), grade 2 (n=1)) in cohort 3.

8

Neurologic toxicity included one case of grade 1 somnolence/depressed level of consciousness in cohort 2.

9

Pain toxicity also included the following: (1) grade 2 neuralgia (n=1), grade 1 sinus pain (n=1), and grade 1 throat pain (n=1) in cohort 1; and (2) grade 1 back pain (n=1) and grade 1 extremity pain (n=1) in cohort 2.

10

Pulmonary toxicity also included the following: (1) grade 1 other unspecified etiology (n=1) in cohort 1; and (2) grade 2 hypoxia (n=1 in cohort 2.