Table 4.

Similarity of patient characteristics for trials in cluster P5 (p<0.01)

Trial NCT00824538	Trial NCT00647218
Menopausal status not specified	Menopausal status not specified
ECOG performance status 0–1	ECOG performance status 0–1
WBC count normal (3.4–10 × 10∧9/L)	WBC ≥ 3,000/mm∧3
Platelet count normal (140–450 × 10∧9/L)	Platelet count ≥ 100,000/mm∧3
Serum creatinine ≤ 1.5 times upper limit of normal (ULN)	Creatinine ≤ 1.5 times upper limit of normal (ULN)
Total bilirubin ≤ 1.5 times ULN	Bilirubin ≤ 1.5 times ULN
LVEF > 50%	Left ventricular ejection fraction ≥ 45%
Not pregnant or nursing	Not pregnant or nursing
Negative pregnancy test	Negative pregnancy test
Fertile patients must use effective contraception	Fertile patients must use effective contraception
No other malignancy within the past 5 years except basal cell carcinoma of the skin	No other malignancies within the past 5 years, except curatively treated nonmelanomatous skin cancer
No concurrent severe illness that would likely preclude study compliance	No serious medical illness that, in the judgment of the treating physician, places the patient at risk
Not Aligned (from trial: NCT00824538)
TSH and T4 levels normal
Absolute Neutrophil Count (ANC) normal (1.8–6.8 × 10∧9/L)
Alkaline phosphatase ≤ 1.5 times ULN
Aspartate Aminotransferase (AST) and Alanine Aminotransferase (ALT) ≤ 2.5 times ULN
Hemoglobin > 9.0 g/dL
Systolic blood pressure (BP) < 140 mm Hg
Diastolic BP < 90 mm Hg
No history of HIV infection
Not Aligned (from trial: NCT00647218)
No other malignancies within the past 5 years, except curatively treated carcinoma in situ of the cervix
No history of hypersensitivity reaction to products containing polysorbate 80 (Tween 80)
No peripheral neuropathy ≥ grade 2