Exact(6)
It continues to gather safety and immune response data.
The aim of this study is to gather safety data on cumulative sessions of tDCS in acute subacute phases of stroke, obtain information about effects of this intervention on important physiologic and clinically relevant swallowing parameters, and examine possible dose effects.
The FDA held three public workshops this year to gather safety information on e-cigarettes, but has not yet announced any proposed regulations.
In addition, these assays could be also used to gather safety information on other Cry proteins beyond those obtained in the current safety assessment approach.
It is necessary to establish adequate measures to manage the adverse events in advance and carefully gather safety information as it is expected that there is a correlation between clinical efficacy and the occurrence of immune‐related adverse events.
The objectives for this trial of oral dexamethasone for amelioration of HMB, are to: (1) identify the efficacy of oral dexamethasone, and optimal dose to use; (2) gather safety data; (3) gather methodological and mechanistic insight to allow further development of this or similar treatment option.
Similar(52)
A follow on Phase III study COG-ANBL0931 opened Jan 2010 to accrue 105 patients to gather further safety and efficacy data for FDA approval.
The objective of phase II was to carry out a preliminary assessment of the efficacy of the combination and to gather further safety and toxicity data.
Predominantly non-interventional (however, a PASS may be a clinical trial), their main objective is to gather additional safety monitoring information or to assess a pattern of drug utilization (Fig. 1).
Patients were seen for follow-up at clinic visits every 6 months during treatment to gather general safety data, to document predefined toxicity data, and to receive a new supply of study medications.
Such studies should not only align with risk management objectives to gather additional safety monitoring information or assess a pattern of drug utilization, but also satisfy key regulatory requirements for risk management planning and execution needs.
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