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Once a drug is approved, "the F.D.A. has a very crude system for monitoring adverse effects, and the adverse effects of statins are very subtle," she said.
Were the methods used for monitoring adverse effects reported?
Different methods of monitoring adverse effects yield different results, which may make comparisons between studies, let alone a formal meta-analysis, meaningless.
In addition, differences in the methods used for monitoring adverse effects may explain the risk differences found in the sensitivity analyses.
Prior to, and during, this period there had been increasing public concern about the safety of medicines, the process for evaluating and monitoring adverse effects and the measures available to protect the public health.
To minimise the risk of bias according to adverse effect detection and reporting, we recorded the methods used for monitoring adverse effects and how the adverse effect was defined in the primary studies.
Similar(54)
Knowledge of their physiological functions can help to monitor adverse effects caused by Bace1 inhibition in patients.
The DSMB will monitor adverse effects and respond to variations in the data, and is responsible for recommending whether the study should continue, whether the protocol should be modified, or whether there should be early termination.
The life cycles of many human pathogens, including foodborne pathogens, comprise stages in the environment outside the eukaryotic host, for which data are sometimes limited but are required to monitor adverse effects on human health [ 1– 3].
A phase I/II clinical study assessing combined treatment with enzalutamide and RU-486 is currently ongoing (NCT02012296) to identify the recommended dose of RU-486 and to monitor adverse effects and antitumor activity of this drug combination.
Both community health workers, who assisted with medication delivery, translation, and assessment of compliance, and public health nurses, who monitored adverse effects and conducted active tracking of noncompliant patients, performed house calls.
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