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Table 4 Drug-related toxicities by dose level for N = 24 Patients

From: Phase I study of oral ridaforolimus in combination with paclitaxel and carboplatin in patients with solid tumor cancers

  Level 1: RIDA 10 mg; P 175 mg/m2; C 5 (n = 4) Level 1A: RIDA 10 mg; P 175 mg/m2; C 5 (n = 6) Level 2A: RIDA 20 mg; P 175 mg/m2; C 5 (n = 4) Level 3A: RIDA 30 mg; P 175 mg/m2; C 5 (n = 3) Level 4A: RIDA 30 mg; P 175 mg/m2; C 6 (n = 7)
Grade Total No. of Patients Grade Total No. of Patients Grade Total No. of Patients Grade Total No. of Patients Grade Total No. of Patients
1 2 3 4 1 2 3 4 1 2 3 4 1 2 3 4 1 2 3 4
Alkaline phosphatase increased 2     2 1     1       1     1 1     1
Alopecia   1    1 1 3    4   3    3 2 2    3 2 2    2
Anemia 2 2 3   4 3 4    4 3 4 2   4 1 2    2 3 4 5   6
Anorexia       1 1    2 1     1   2    2 4     4
Dehydration            1     1 1 3    3 1 2 1   3
Diarrhea   1    1 1 1    2 2 1    3       3 1 1   4
Dysphagia       1     1   1    1       1 1 1   3
Dyspnea 1     1    2   2            2 1    2
Fatigue 2 2    2 1 2    3 1 2    2 2 2    3 3 3 1   5
Fever 2     2       1     1 1     1 3     3
Hyperglycemia   1 1   1 2 2    2 2   1   2   1    1 2 2    3
Hypertriglyceridemia   1 1   1 2     2 2     2       3     3
Hypoalbuminemia 1 1    2 2   1   3                
Hypokalemia       1     1 2 1 1 1 2 1     1 2   2   3
Hypomagnesemia   1    1 2     2 2 1    2 1     1 4 2    4
Mucositis oral 1 1    2       2 2    3 2 1    2 3 3 1   4
Nausea 1     1 1     1 1 2 1   3 2 2    3 5   1   5
Neutrophil count decreased 1 1 2 2 4 4 2   4 5   1 3 1 3   2 1 2 3 2 4 4 3 6
Pain 1     1       2     2       3     3
Peripheral sensory neuropathy 1 1    1 3 1    3   1    1 1     1 2     2
Platelet count decreased 1 4    4 3   1 1 3 4 3 2 1 4 1 1 1 2 3 3 4 4 4 6
Transaminases increased            1     1 3     3 1     1
Urinary tract infection   1 1   2             1    1 1 3 1   4
Vomiting 1     1 2     2    1   1 1     1 1 1 1   3
White blood cell decreased       4 2 4   5 1 2 2 1 3     1 1 1 2 2   3
  1. RIDA Ridaforolimus, P paclitaxel, C carboplatin