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A group of 25 to 100 patients with the same type of cancer get the new treatment in a phase II study. They’re treated using the dose and method found to be the safest and most effective in phase I studies.
Phase II studies are sometimes divided into Phase IIa and Phase IIb. There is no formal definition for these two sub-categories, but generally: Phase IIa studies are usually pilot studies designed to find an optimal dose and assess safety ('dose finding' studies).
Phase II trials are designed to determine if the new treatment has sufficiently promising efficacy to warrant further investigation in a large-scale randomized phase III trial, as well as to further assess safety. These studies usually involve a few hundred patients.
Instead, Phase 2 studies provide researchers with additional safety data. Researchers use these data to refine research questions, develop research methods, and design new Phase 3...
Our trial showed that among adults with overweight or obesity (without diabetes), once-weekly subcutaneous semaglutide plus lifestyle intervention was associated with substantial, sustained ...
A phase II study may examine surrogate endpoints for disease, but longer term outcomes and toxicities are usually the focus of most phase III studies. Phase III studies are performed in a less homogeneous patient population than phase II trials, to better reflect real-world results.
Phase 2 trials are designed to determine whether the new treatment has sufficiently promising efficacy to warrant further investigation in a large-scale randomized phase 3 trial, as well as to further assess safety. These studies usually involve a few hundred patients.
This phase 2 study aimed to show that orforglipron is superior in terms of the change in HbA 1c from baseline compared with placebo by evaluating the efficacy, safety, and tolerability of orforglipron in participants with type 2 diabetes compared with placebo and 1·5 mg dulaglutide.
In this double-blind, randomized, phase 2 trial, we assigned patients with relapsing multiple sclerosis to one of five groups: placebo, evobrutinib (at a dose of 25 mg once daily, 75 mg once...
In a phase 2 trial, first-line treatment with axicabtagene ciloleucel, an autologous CD19-targeting CAR T-cell therapy, exhibited a high complete response rate and a manageable safety profile...