Examples of using Pooled data in English and their translations into Croatian
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The safety profile is based on pooled data from 981 patients treated with IMBRUVICA in three phase 2 clinical studies
In patients receiving rilpivirine hydrochloride in combination with FTC/TDF in Phase 3 studies(TMC278-C209 and TMC278-C215 pooled data), most HIV-1 isolates with emergent phenotypic resistance to rilpivirine had cross-resistance to at least one other NNRTI 28/31.
The safety summary is based on pooled data from phase 2 and 3 clinical trials in more than 2,600 subjects who received Viekirax
Table 4: Virologic outcomes of randomised treatment of studies TMC278-C209 and TMC278-C215(pooled data for patients receiving rilpivirine hydrochloride
and dry mouth(4.2%) were reported significantly more often with entacapone than with placebo in pooled data from clinical studies involving 406 patients taking the medicinal product and 296 patients taking placebo.
Table 1: All treatment-emergent adverse drug reactions reported in patients in phase III studies(pooled data of the phase III studies for the indications wet AMD,
The placebo-controlled Phase 2 and Phase 3 Studies(pooled data) included 1,346 HCV-infected patients incidence rates are based on adverse event reporting rates additionally,
The pooled data from the Phase 3 TMC278-C209
and diarrhoea(12%) pooled data from Phase 3 clinical studies GS-US-236-0102 and GS-US-236-0103.
and headache(6%) pooled data from Phase 3 clinical studies GS-US-292-0104 and GS-US-292-0111 in 866 treatment-naïve adult patients receiving Genvoya.
Based on pooled data from 3 clinical trials in which 6,130 infants received RotaTeq
The safety profile is based on pooled data from Phase IIb and Phase III clinical
rash generalised d Frequency based upon number of women from 10 to 55 years of age while on treatment in the pooled data.
probably related to dolutegravir and abacavir/lamivudine[pooled data from 679 anti retroviral naïve subjects receiving this combination in the Phase IIb to IIIb clinical trials,
Summary of the safety profile The overall safety profile of daclatasvir is based on data from 2215 patients with chronic HCV infection who received Daklinza once daily either in combination with sofosbuvir with or without ribavirin(n=679, pooled data) or in combination with peginterferon alfa and ribavirin(n=1536, pooled data) from a total of 14 clinical studies.
The overall safety profile of daclatasvir is based on data from 2215 patients with chronic HCV infection who received Daklinza once daily either in combination with sofosbuvir with or without ribavirin(n=679, pooled data) or in combination with peginterferon alfa and ribavirin(n=1536, pooled data) from a total of 14 clinical studies.
Table 1 shows pooled data from the overall treatment period in CLEOPATRA(data cutoff 11 February 2014; median number of
The overall safety profile of simeprevir is based on data from 580 HCV genotype 1 infected patients who received simeprevir in combination with sofosbuvir with or without ribavirin(pooled data from the clinical phase 2 study HPC2002 and the clinical phase 3 studies HPC3017 and HPC3018) and 1,486 HCV genotype 1 infected patients who received simeprevir(or placebo) in combination with peginterferon alfa and ribavirin pooled data from the clinical phase 2 studies C205
INPULSIS-2, and their pooled data- treated set.
In a population pharmacokinetic analysis of pooled data from 19 Phase 1 studies, the average t1/2 of perampanel was 105 hours.