Navigation Links
Additional Data from the Qnexa Phase 3 Studies Presented at The Obesity Society 27th Annual Scientific Meeting
Date:10/29/2009

on were pooled by dose across all one-year studies in an effort to provide a more accurate estimation of the incidence of each event. This pooled analysis, presented in September, which is a part of the Integrated Summary of Safety (ISS) in the Qnexa NDA, demonstrates that the discontinuation rates for these various cognitive-related events were low and all occurred at a frequency of less than 1%. Specifically, the discontinuation rates from the ISS due to cognitive events from the year-long Qnexa studies (OB-302, OB-303 and OB-202/DM-230) were:


    MedDRA Preferred Terms             Qnexa    Qnexa    Qnexa    Qnexa All
                            Placebo     Low      Mid      Full     doses
                           (n=1,561)  (n=240)  (n=498) (n=1,580)  (n=2,318)
                            -------    -----    -----   -------    -------
    Disturbance in
     Attention               0.2%       0.0%     0.0%     0.9%       0.6%
    Memory Impairment        0.1%       0.0%     0.0%     0.3%       0.2%
    Amnesia (forgetfulness)  0.1%       0.0%     0.2%     0.4%       0.3%
    Aphasia (word finding
     difficulties)           0.0%       0.0%     0.0%     0.3%       0.2%
    Cognitive Disorder       0.1%       0.0%     0.0%     0.1%       0.1%
    Confusional State        0.1%       0.4%     0.2%     0.1%       0.2%
    Bradyphrenia (slow
     thinking)               0.0%       0.0%     0.0%     0.1%       0.0%
    Disorientation           0.0%       0.0%     0.0%     0.0%       0.0%
    Mental Impairment        0.0%       0.0%     0.0%     0.0%       0.0%

    Events are not additive as some patients have reported more than one
    event leading to study drug discontinuation

Of the events shown in the table above, the most frequent reason for patients discontinuing Qnexa was disturbance in attention. For the 1,580 patients receiving full dose Qnexa, the discontinuation rate for this event was 0.9%. This rate is considerably lower
'/>"/>

SOURCE VIVUS, Inc.
Copyright©2009 PR Newswire.
All rights reserved

Page: 1 2 3 4 5 6 7 8

Related medicine technology :

1. Callisto Pharmaceuticals Opens Additional Sites for Phase II Clinical Trial of Atiprimod in Advanced Carcinoid Cancer Patients
2. Par Pharmaceutical Begins Shipment of Additional Dosage Strength of Generic TOPROL-XL(R)
3. First Osteoporosis Study in Hip Fracture Patients Finds Once-Yearly Reclast(R) Prevents Additional Fractures and Improves Survival
4. PTC Therapeutics Announces Additional Results from Phase 2 Study of PTC124 in Duchenne Muscular Dystrophy
5. Bayer Issues Additional Guidance to Physicians on Trasylol(R)
6. Coley Pharmaceutical Group and Pfizer Nominate Additional Anti-Cancer Compound for Clinical Development
7. Progen Presents Additional Analysis of Data from PI-88 Phase 2 Liver Cancer Study at American Association for the Study of Liver Diseases
8. Pharmacopeia Announces Additional Positive Findings from Phase 1 Multiple Ascending Dose Study of PS433540 (DARA)
9. Sulodexide Data Safety Monitoring Committee Completes Additional Review of Phase 3 Study Data
10. Indevus Reports Additional Positive Phase III Trial Data for NEBIDO(R)
11. Paul Capital Healthcare Purchases Additional Royalty Interest in GlaxoSmithKlines Rotarix(R)
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:10/20/2014)... Norgine B.V. today announced that the Phase ... NER1006, presented at the 79 th Annual Scientific ... Philadelphia, PA , has met its primary ... of cleansing success. The study demonstrated high quality bowel ... screening colonoscopy patients. [1] (Logo: http://photos.prnewswire.com/prnh/20130829/633895-a) ...
(Date:10/19/2014)... Wash. , Oct. 20, 2014 CTI ... that it will report its third quarter 2014 financial ... of the U.S. financial markets. Following the announcement, members ... call to discuss the results and provide a general ... Access to the event can be obtained as follows: ...
(Date:10/18/2014)... , Oct. 18, 2014  In a ... Rights Campaign (HRC), the nation,s largest lesbian, gay, ... endorsed the use of Truvada for Pre-Exposure Prophylaxis ... tool used to prevent the spread of a ... the only brand name anti-HIV drug combination currently ...
Breaking Medicine Technology:Positive Results from Phase II Data Show NER1006 Achieves High Quality Bowel Cleansing Efficacy 2CTI BioPharma to Report Third Quarter 2014 Financial Results on October 29, 2014 2HRC Endorses PrEP, Calls for Bold Action to Expand Access to Anti-HIV Drug 2HRC Endorses PrEP, Calls for Bold Action to Expand Access to Anti-HIV Drug 3
... Milestone Scientific Inc. (OTCQB: MLSS), the recognized leader ... filed its 2010 year-end results for the 12 months ... Exchange Commission on Wednesday, March 30, 2011. ... April 4, 2011 beginning at 4:15 PM Eastern Daylight ...
... UBM Canon and IVD Technology ... The Fundamentals of In Vitro Diagnostics. This one-hour event will ... and will offer an in-depth analysis and discussion from ... With the advent of the sequencing of ...
Cached Medicine Technology:Milestone Scientific Will Host Its 2011 Conference Call on Monday, April 4, 2011 2"IVD Technology" Announces Upcoming Webcast: Omics and the Development of IVDs 2"IVD Technology" Announces Upcoming Webcast: Omics and the Development of IVDs 3
(Date:10/20/2014)... 20, 2014 Punzoné , the first ... U.S., has a lot to celebrate this month. October marks ... the achievements and contributions of Americans of Italian heritage and ... and today it shares its favorite Italian cocktails and encourages ... Italy - even if it is only in a glass. ...
(Date:10/20/2014)... 2014 Do you ever feel difficulty ... a wonderful app Metassessor for teachers, specialists and parents. ... helped its client “Intervention Development LLC” to launch Metassessor ... designed for iOS 4.3 or later and is Compatible ... optimized for iPhone 5. It is now available on ...
(Date:10/19/2014)... The leading review website, Top10BestSEOHosting.com, has ... GreenGeeks are the best Dedicated Server Hosting suppliers. ... want to buy high quality hosting and save ... manager of Top10BestSEOHosting.com says, “We believe that iPage ... everyone. A lot of the global clients enjoy ...
(Date:10/19/2014)... York (PRWEB) October 19, 2014 Dr. ... Population Fund, welcomes news of a ceasefire agreement that ... more than 200 girls who were kidnapped from the ... have languished in captivity long enough, and it is ... and communities," stated Dr. Osotimehin. , "We owe it ...
(Date:10/19/2014)... working in the garment industry for decades, LunaDress’ dress specialists ... one of the company’s top designers, many ladies like prom ... add beauty to them. Chiffon floor length outfits are also ... selection of 2014 long prom dresses. , As a ... in over 20 popular designs. The company intends to meet ...
Breaking Medicine News(10 mins):Health News:Celebrate Italian Heritage Month With Authentic Cocktails from Punzoné: The Only Ultra Premium Line of Organic Imported Italian Vodka 2Health News:Celebrate Italian Heritage Month With Authentic Cocktails from Punzoné: The Only Ultra Premium Line of Organic Imported Italian Vodka 3Health News:Celebrate Italian Heritage Month With Authentic Cocktails from Punzoné: The Only Ultra Premium Line of Organic Imported Italian Vodka 4Health News:Metassessor App Launched: an RTI tool for Teachers & Parents 2Health News:Metassessor App Launched: an RTI tool for Teachers & Parents 3Health News:Top10BestSEOHosting.com Considers iPage And GreenGeeks As The Best Dedicated Server Hosting Suppliers 2Health News:2014 Long Prom Dresses From LunaDress Now Available In Over 20 Popular Designs 2
... , THURSDAY, Oct. 13 (HealthDay News) --,Smoking ... are genetically susceptible to the mental health disorder, according ... population have the variant of the serotonin gene (5-HTT) ... Radboud University Nijmegen in the Netherlands. They analyzed ...
... CHINA (October 13, 2011) Autism Speaks, the world,s ... largest genomic organization in the world and a global ... to create the world,s largest library of sequenced genomes ... Autism Speaks Autism Genetic Resource Exchange (AGRE), this collaboration ...
... will benefit from a new, pan-Canadian Terry Fox Research ... in which ovarian cancer is diagnosed and managed. ... a total of $5-million in funding for a five-year, ... will identify new biomarkers to predict and treat this ...
... disparities between Latinos and non-Latino whites, mostly from a policy ... perspective of the patient, in terms of access, use and ... how do the physicians feel about the quality of care ... patients, compared with physicians whose patients are primarily white and ...
... Maureen Salamon HealthDay Reporter , WEDNESDAY, Oct. ... esophageal cancer for patients with a condition known as ... once reported, a large new Danish study suggests. ... people, researchers determined that those with Barrett,s esophagus -- ...
... , WEDNESDAY, Oct. 12 (HealthDay News) -- Black Americans ... cancer have worse overall and recurrence-free survival rates than whites, ... nearly 15,000 black and white colorectal cancer surgery patients who ... between 1977 and 2002. All the patients received the same ...
Cached Medicine News:Health News:Autism Speaks and BGI to complete whole genome sequencing on 10,000 with autism 2Health News:Terry Fox Research Institute aims to change diagnosis and management of ovarian cancer worldwide 2Health News:Terry Fox Research Institute aims to change diagnosis and management of ovarian cancer worldwide 3Health News:Physicians treating Latinos have high hurdles to jump, study shows 2Health News:Esophageal Cancer Risk Less Dire for Certain Patients: Study 2Health News:Esophageal Cancer Risk Less Dire for Certain Patients: Study 3Health News:Blacks Fare Worse Than Whites After Colon Cancer Surgery 2
... Topcon combines the best 32-bit software package ... hardware offerings to bring you a fast ... high-resolution package takes advantage of the Compaq ... latest graphics capture technology and a formidable ...
... The new TM-1 is a ... that provides precise measurement of ... transmission for all types of ... to easily connect with a ...
Inquire...
... This power table has everything that ... instrumentation. The new AIT-15 offers 20 mm ... convenience outlets, and locking castors to secure ... work perfectly for most any application. Use ...
Medicine Products: