EVOLVE-MS-2 was a Phase 3, multicenter, double-blind, active-controlled, five-week study designed to evaluate the Gl tolerability
, including duration and severity, of diroximel fumarate 462 mg twice daily compared to dimethyl fumarate 240 mg twice daily in 506 patients with RRMS.
As part of the recommended dose part, the study is comprised of three cohorts and designed to assess the safety, tolerability
and anti-tumour activity of AGI-134 as a monotherapy in a basket cohort of multiple solid tumour types, as well as in two additional cohorts in combination with an immune checkpoint inhibitor - in metastatic colorectal cancer and in head and neck squamous cell carcinoma, concluded the company.
For years, first-generation retinoids, prominently known as isotretinoin, an isomer of cis-retinoic acid, has been used in the treatment of acne, with variable tolerability
profiles.8 The efficacy of isotretinoin is largely result of the effects on sebaceous gland differentiation and proliferation as well as modulation of skin androgen receptors.9 In some studies, significant anti- inflammatory and desquamative effects of isotretinoin have also been observed.10
The highest applied concentration was 45 ml Abnobaviscum[R] Fraxini 20 mg.This concentration showed a good tolerability
in the patients and was therefore chosen as dosage for a confirmatory study in future.
CH-1504, a non-metabolized antifolate, is engineered to provide the same potent efficacy as MTX but without the side effects caused by the metabolic breakdown of MTX into by-products that are believed to play a significant role in the liver and kidney toxicities and tolerability
related side effects associated with chronic therapy.
"We have absolute confidence in both the efficacy and tolerability
profile of CIMZIATM, and in gaining US approval" said Melanie Lee, executive vice president R&D for UCB.
The drug tolerability
proved to be good, and there were no safety problems.
Finally, at least for the moment, we see a clearer distinction emerging among antibiotics as "good, better, and best" for anticipated effectiveness and for tolerability
in the current U.S.
Clinicians should consider effectiveness, tolerability
, and the type of vehicle that would be best for an individual patient in making the choice, Robert Sidbury, M.D., said at a conference sponsored by the North Pacific Pediatric Society.
Phase I trials (300 participants) were performed to establish immunogenicity and tolerability
of a range of doses of monovalent HPV L1 vaccines.
Antiviral activity, safety, and tolerability
of a novel, oral small-molecule HIV-1 attachment inhibitor, BMS-488043, in HIV-1-infected subjects, 11th Conference on Retroviruses and Opportunistic Infections, San Francisco, February 8-11, 2004 [abstract 141]
Long-term ventilation, improved clog resistance, good tissue tolerability
, and high infection resistance are combined in one product.
Important considerations include crossclade reactivity (effectiveness in diverse HIV-infected populations), tolerability
, and durability of response.
, and upper gastrointestinal safety of celecoxib for treatment of osteoarthritis and rheumatoid arthritis: systematic review of randomized controlled trials.