Sentence examples for safety cohort from inspiring English sources

Safety assessment was the frequency and severity of AEs (medical occurrences during the study period after the first dose of study drug was administered) in the safety cohort, which included participants who received at least one dose of study drug.

The efficacy follow-up in the safety cohort lasted for 365 days.

A second, smaller group of 201 patients with a less severe coagulation abnormality was subsequently enrolled as a safety cohort.

A causal relationship between gatifloxacin and these ADEs is supported by animal data (8), manufacturer safety cohort studies (5), in vitro assays (9), a large randomized trial (10), and >20 published case reports.

In the 1-year safety cohort, 30% of patients treated with full-dose PHEN/TPM had serum bicarbonate levels < 21 mEq/L sometime after randomization compared to 22% on mid-dose PHEN/TPM, and 6% on placebo; this reduction in serum bicarbonate was also observed in the 2-year safety cohort (OB-305) for 30% of patients on full-dose PHEN/TPM, 23% on mid-dose PHEN/TPM, and 4% on placebo.

In a subsequent analysis [ 27], in which the drug safety cohort represented a third (n = 4,307) of the total sample (n = 13,171), Wolfe et al. reported an adjusted frequency of CHF of 3.9%95%5% CI 3.4 4.3%) in RA patients compared to 2.3%95%5% CI 1.6 3.3%) in controls with knee or hip OA.

Search strategy An updated search of the Cochrane central register of controlled trials (Cochrane Library 2009, issue 2), which contains the Acute Respiratory Infections Group's specialised register, Medline (1950-Aug 2009), Embase (1980-Aug 2009), and post-marketing pharmacovigilance data and comparative safety cohorts.

Other than patients with GBM, who could enrol in the safety expansion cohort or in the erlotinib combination cohort, patients with central nervous system disease were excluded.

Up to 12 additional patients per arm could subsequently be enrolled to receive ficlatuzumab at the RP2D in the safety expansion cohort (patients with solid tumours) or the multiple myeloma cohort (n=4, methods described in Supplementary Appendix Tables A2 and A3).

The planned enrollment for phase 1 was up to 36 evaluable patients, including up to 27 evaluable patients in three dose cohorts during dose escalation and approximately 9 evaluable patients in a safety expansion cohort at the MTD/RP2D.

With respect to safety, a cohort study with 1020 ginger-exposed pregnancies (466 in the first trimester) found no increased risk of malformations, stillbirth/perinatal death, low birth weight, preterm birth, or low Apgar score [ 16].