Examples of using Pooled phase in English and their translations into Hungarian
{-}
-
Medicine
-
Colloquial
-
Official
-
Ecclesiastic
-
Financial
-
Programming
-
Official/political
-
Computer
Pooled phase 3 studies.
Adverse reactions observed in pooled Phase 2 and 3 studies.
Pooled Phase III studies.
Table 1 lists common adverse reactions from the pooled phase III trials.
Table 10: Treatment-emergent amino-acid substitutions in pooled phase 2 and phase 3 studies: patients who did not achieve SVR with 150 mg simeprevir in combination with peginterferon alfa and ribavirin.
The safety of sugammadex hasbeen evaluated in 3,519 unique subjects across a pooled phase I-III safety database.
Adverse drug reactions for SIRTURO were identified from pooled Phase IIb clinical trial data(both controlled and uncontrolled) containing 335 patients who received SIRTURO in combination with a background regimen of tuberculosis medicinal products.
In 2% and 0.3% of the simeprevir-treated patients grade 3 or 4‘bloodbilirubin increased' was reported, respectively(pooled phase 3 studies).
Immune system disorders: Angioedema and allergic oedema(In the pooled phase III trials, these events were uncommon(≥ 1/1,000 to< 1/100)).
In patients aged> 45 years, dyspnoea was reported in 16.4% of simeprevir-treated patientscompared to 9.1% in placebo-treated patients(all grades; pooled phase 3).
Blood and lymphatic system disorders: Thrombocytopenia(In the pooled phase III trials, these events were uncommon(≥ 1/1,000 to< 1/100)).
In a phase 3 study conducted in China and South-Korea, the mean plasma exposure of simeprevir in Asian HCV infected patients was 2.1-fold highercompared to non-Asian HCV infected patients in a pooled phase 3 population from global studies.
The safety profile ofZinforo was similar to that observed in previous pooled Phase III studies with the exception of both a greater incidence of rash in Asian patients(see below) and a greater incidence of DAGT seroconversion(see section 4.4).
Simeprevir in combination with peginterferon alfa and ribavirin: During the first 12 weeks treatment with simeprevir, dyspnoea was reported in 11.8% of simeprevir-treated patients,compared to 7.6% in placebo-treated patients(all grades; pooled phase 3).
Hepatobiliary disorders: Cholestasis, Hepatitis(incl. hepatocellular injury)(In the pooled phase III trials, these events were rare(≥ 1/10,000 to< 1/1,000)).
Simeprevir in combination with peginterferon alfa and ribavirin: During the 12 weeks treatment with simeprevir, photosensitivity reactions were reported in 4.7% of simeprevir-treated patientscompared to 0.8% in placebo-treated patients(all grades; pooled phase 3).
In analyses of pooled phase 3 studies that allowed up-titration, among the subgroup of patients up-titrated, an increase from 75 mg Q2W to 150 mg Q2W alirocumab at week 12 resulted in an additional 14% mean reduction in LDL-C in patients on a background statin.
Table 7: Treatment-emergent laboratory abnormalities observed at a higher incidence in patients receiving simeprevir in combination with peginterferon alfa andribavirin(pooled phase 3 studies C208, C216 and HPC3007; first 12 weeks of treatments).
From pooled phase III data, Crestor has been shown to be effective at treating the majority of patients with type IIa and IIb hypercholesterolaemia(mean baseline LDL-C about 4.8 mmol/ l) to recognised European Atherosclerosis Society(EAS; 1998) guideline targets; about 80% of patients treated with 10 mg reached the EAS targets for LDL-C levels(< 3 mmol/ l).
Simeprevir in combination with peginterferon alfa and ribavirin: During the 12 weeks treatment with simeprevir,‘blood bilirubin increased' was reported in 7.4% of simeprevir-treated patients,compared to 2.8% in placebo-treated patients(all grades; pooled phase 3).
The safety profile of OLYSIO 150 mg in combination with peginterferon alfa and ribavirin in a phase 3 study conducted in Asian patients in China andSouth-Korea is comparable to non-Asian patients from a pooled phase 3 population from global studies, except for higher frequencies for‘blood bilirubin increased' events(see table 8).
Simeprevir in combination with peginterferon alfa and ribavirin: During the 12 weeks treatment with simeprevir, rash and pruritus were reported in 21.8% and 21.9% of simeprevir-treated patients, compared to 16.6% and 14.6% in placebo-treated patients,respectively(all grades; pooled phase 3).
Table 5 lists the adverse reactions(events occurring in≥1% of patients in any treatment group and≥2% more frequently in any omalizumab treatment group than with placebo(after medical review))reported with 300 mg in the three pooled phase III studies.
A study in Asia of 381 adult patients with CAP treated with Zinforo(600 mg administered over 60 minutes every 12 hours) demonstrated that the safety profile ofZinforo in these patients was similar to that observed in the pooled Phase 3 cSSTI and CAP studies.
Rugby World Cup 2011 will challenge players to pick from the 20 World Cup 2011 participating countries,and attempt to lead their team through the pool phase progress to the Final and the opportunity to lift the prestigious Webb Ellis Cup.
Table 5: Efficacy and safety results from pooled analysis of phase III Einstein DVT and Einstein PE.
Adverse reactions reported during the first six months of two pooled pivotal Phase III trials of 6 and 12 months duration are listed by MedDRA system organ class(Table 1).
Non-melanoma skin cancers were reported more frequently in patientstreated with IMBRUVICA than in patients treated with comparators in pooled comparative randomised phase 3 studies.
Table 1 shows the adverse reactions reported at a frequency of≥2% in 623 patients receivingEsbriet at the recommended dose of 2,403 mg/day in three pooled pivotal Phase 3 studies.