ADVENTRX Announces ANX-530 Safety Data From Registrational Bioequivalence Clin...(rs and administration siteconditions is ...),Health

System Organ Class/Preferred Term ANX-530 Navelbine P value

General Disorders and Administration Site

Conditions 5 14 0.014

Infusion Site Phlebitis 1* 7 -

Asthenia 3 3 -

Fatigue 1 1 -

Infusion Site Irritation 0 1 -

Infusion Site Pruritis 0 1 -

Pyrexia 0 1 -

* One event of infusion site phlebitis was excluded based on its proximity

to an additional dose of Navelbine administered during the study's

follow up period.

A summary of post-hoc analyses regarding injection site reactions is set forth in the following table:

ANX-530 Navelbine P value

Injection Site Reactions 1 9 <0.01

Infusion Site Phlebitis 1 7 0.03

Infusion Site Irritation 0 1 -

Infusion Site Pruritis 0 1 -

General disorders and administration site conditions denotes the system/organ/class MedDRA term. Injection site reactions consist of all grades of investigator-reported phlebitis, irritation and pruritus, in each case at the site of injection. Adverse events were graded based on the investigator's assessment of severity.

The bioequivalence study of ANX-530 was a crossover comparison of ANX-530 and Navelbine with a primary objective of demonstrating the pharmacokinetic equivalence of ANX-530 and Navelbine. Determining the safety o
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