Continued Overall Survival Advantage Reported From Pivotal Trial of VELCADE(R) (Bortezomib) for Injection Based Therapy in Patients With Previously Untreated Multip...(uropathy NEC (including peripheral senso...),Health

Date:12/8/2008

uropathy NEC (including peripheral sensory neuropathy and peripheral neuropathy aggravated) (39%), thrombocytopenia and appetite decreased (including anorexia) (each 36%), pyrexia (34%), vomiting (33%), anemia (29%), edema (23%), headache, paresthesia and dysesthesia and headache (each 22%), dyspnea (21%), cough and insomnia (each 20%), rash (18%), arthralgia (17%), neutropenia and dizziness (excluding vertigo) (each 17%), pain in limb and abdominal pain (each 15%), bone pain (14%), back pain and hypotension (each 13%), herpes zoster, nasopharyngitis, upper respiratory tract infection, myalgia and pneumonia (each 12%), muscle cramps (11%), and dehydration and anxiety (each 10%). Twenty percent (20%) of patients experienced at least 1 episode of >/=Grade 4 toxicity, most commonly thrombocytopenia (5%) and neutropenia (3%). A total of 50% of patients experienced serious adverse events (SAEs) during the studies. The most commonly reported SAEs included pneumonia (7%), pyrexia (6%), diarrhea (5%), vomiting (4%), and nausea, dehydration, dyspnea and thrombocytopenia (each 3%).

In the Phase III VELCADE + melphalan and prednisone study, the safety profile of VELCADE in combination with melphalan/prednisone is consistent with the known safety profiles of both VELCADE and melphalan/prednisone. The most commonly reported adverse events for VELCADE in combination with MP vs MP, respectively, were thrombocytopenia (52% vs 47%), neutropenia (49% vs 46%), nausea (48% vs 28%), peripheral neuropathy (47% vs 5%), diarrhea (46% vs 17%), anemia (43% vs 55%), constipation (37% vs 16%), neuralgia (36% vs 1%), leukopenia (33% vs 30%), vomiting (33% vs 16%), pyrexia (29% vs 19%), fatigue (29% vs 26%), lymphopenia (24% vs 17%), anorexia (23% vs 10%), asthenia (21% vs 18%), cough (21% vs 13%), insomnia (20% vs 13%), edema peripheral (20% vs 10%), rash (19% vs 7%), back pain (17% vs 18%), pneumonia (16% vs 11%), dizziness (16% vs 11%), dyspnea (15% vs 13%), headache
'/>"/>

SOURCE Millennium: The Takeda Oncology Company Copyright©2008 PR Newswire. All rights reserved

0 GOOD

Page: 1 2 3 4 5 6
Related medicine technology :

1. Nabi Biopharmaceuticals Announces Continued Positive NicVAX Phase 2b Data at Nine Months
2. FDA Advisory Committees Recommend Continued U.S. Marketing Authorization for Trasylol(R)
3. Facet Solutions Enjoys Continued Clinical Success With the Anatomic Facet Replacement System (AFRS(TM))
4. Abbotts XIENCE(TM) V Everolimus Eluting Coronary Stent Shows Continued Superiority to TAXUS Stent in Reducing Major Adverse Cardiac Events in SPIRIT III Clinical Trial
5. Raven Announces Continued Enrollment of Phase 1/2a Clinical Trial of RAV12 Therapeutic Antibody for Treatment of Adenocarcinomas
6. New Trial Presented at AAAAI Reports that the Growth of Children 2-5 Years Old with Year-Round Allergic Rhinitis Continued According to Normal Age-Adjusted Distribution Over a 6-Month Treatment with Nasacort AQ
7. Continued Funding to Help Advance Exciting Moment in Diabetes Research
8. Vical Receives $6.3 Million Payment for Continued Funding of Allovectin-7(R) Phase 3 Trial
9. ADVENTRX Announces Preliminary Response Rate Data From Discontinued Phase 3 Trial of CoFactor(R)
10. Vidaza Significantly Extends Overall Survival by 74% in Phase 3 Trial in Myelodysplastic Syndromes (MDS)
11. Nexavar Significantly Improved Overall Survival in Phase 3 Asia-Pacific Liver Cancer Trial