@entity136 is a novel @entity2353 analog with demonstrated efficacy across a range of solid @entity5 . This paper reviews the single-agent safety profiles of 979 @entity1 in 22 completed clinical studies using a day 1, 8, 15 q 28 day, 800-1250 mg/m2 dose schedule. @entity1503 was mild with WHO grade 3 and 4 @entity137 recorded for hemoglobin (6.8 and 1.3% of @entity1 ), leukocytes (8.6 and 0.7%), neutrophils (19.3 and 6.0%) and platelets (4.1 and 1.1%). Myelosuppression was short lived and rarely of clinical significance. @entity33 and @entity1665 were rare, and @entity390 and @entity391 mild. Transient rises in transaminases, mild @entity644 and @entity811 were common, but rarely clinically significant. @entity177 of uncertain etiology was reported in seven instances. Some @entity1 (18.9%) experienced transient @entity1109 and mild @entity221 was reported in 37.3% of flu @entity1 . Peripheral @entity4 was reported in 20.3% of @entity1 in the absence of cardiac, hepatic or @entity177 . Thus, @entity136 is well tolerated and has a mild @entity137 profile. Of nearly 11,000 protocol-defined injections, 94% were administered and only 14% were reduced. Grade 3 or 4 @entity137 with a frequency of more than 1% were only seen for @entity281 (1.2%), @entity390 and @entity391 (18.4%), and @entity358 (1.4%).

XXXX --a safety review.

@entity1 :: ('9606', 'Species') :: ['patients'] @entity1665 :: ('MESH:D000505', 'Disease') :: ['alopecia'] @entity644 :: ('MESH:D011507', 'Disease') :: ['proteinuria'] @entity2353 :: ('CHEBI:33838', 'Chemical') :: ['nucleoside'] @entity137 :: ('MESH:D064420', 'Disease') :: ['non-laboratory toxicities', 'toxicities', 'toxicity'] @entity390 :: ('MESH:D009325', 'Disease') :: ['nausea'] @entity5 :: ('MESH:D009369', 'Disease') :: ['tumors'] @entity221 :: ('MESH:D005334', 'Disease') :: ['fever'] @entity4 :: ('MESH:D004487', 'Disease') :: ['edema'] @entity33 :: ('MESH:D052016', 'Disease') :: ['Mucositis'] @entity391 :: ('MESH:D014839', 'Disease') :: ['vomiting'] @entity1109 :: ('MESH:D012678', 'Disease') :: ['flu-like symptoms'] @entity1503 :: ('MESH:D006402', 'Disease') :: ['Hematological toxicity'] @entity177 :: ('MESH:D051437', 'Disease') :: ['renal failure', 'Renal failure'] @entity281 :: ('MESH:D007239', 'Disease') :: ['infection'] @entity358 :: ('MESH:D008171', 'Disease') :: ['pulmonary toxicity'] @entity811 :: ('MESH:D006417', 'Disease') :: ['hematuria'] @entity136 :: ('MESH:C056507', 'Chemical') :: ['Gemcitabine', 'gemcitabine']
@entity136 :: (MESH:C056507,Chemical) :: ['Gemcitabine']
