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. 2017 Feb 2;10:591–596. doi: 10.2147/OTT.S124097

Table 3.

Safety in the treated population of the Western European cohort

Safety, n (%) nab-P + Gem
(n=39)a
Gem
(n=36)
Patients with ≥1 AE leading to death 2 (5) 2 (6)
Grade ≥3 hematologic AEs in >10% of patients in either armb (n=37)
 Neutropenia 17 (46) 12 (33)
 Leukopenia 13 (35) 7 (19)
 Anemia 8 (22) 0
 Thrombocytopenia 5 (14) 1 (3)
Grade ≥3 nonhematologic AEs in >10% of patients in either armc
 Asthenia 8 (21) 2 (6)
 Peripheral neuropathyd 5 (13) 1 (3)
 Alopecia 4 (10) 0

Notes:

a

One patient was randomized to the Gem-only arm but received nab-paclitaxel plus gemcitabine;

b

Assessment of the event was made on the basis of laboratory values;

c

Assessment of the event was made on the basis of investigator assessment of treatment-related AEs;

d

Peripheral neuropathy was reported on the basis of groupings of preferred terms, defined by standardized queries in the Medical Dictionary for Regulatory Activities.

Abbreviations: AE, adverse event; Gem, gemcitabine; nab-P, nab-paclitaxel.