Examples of using Clinical development programme in English and their translations into Slovak
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Programming
Details of the clinical development programme will be posted to www. clinicaltrials. gov.
The adverse drug reactionswere determined based on data from the apremilast clinical development programme.
The Brimica Genuair clinical development programme was conducted in patients with moderate or severe COPD.
Sudden death attributable to underlying cardiovascular disease observed during the clinical development programme****.
GSK's clinical development programme for the vaccine includes trials in Europe, as well as Africa, Asia and Latin America.
The safety profile presented in Table 1 is based on the gefitinib clinical development programme and postmarketed experience.
During the clinical development programme the occurrence of cases of melanoma prompted the consideration of a possible association with rasagiline.
Three Grade≥3 events, including one fatal,have been reported across the clinical development programme of olaratumab(see section 4.4).
In the clinical development programme, 1,085 patients with a baseline eGFR 30 mL/min/1.73 m2 to< 60 mL/min/1.73 m2 were evaluated.
No cases of Stevens-Johnson Syndrome orToxic Epidermal Necrolysis have been reported in the clinical development programme of APTIVUS.
These were reported during the Phase 3 clinical development programme, which included a total of 1,030 chronic angina patients treated with Ranexa.
No cases of Stevens-Johnson Syndrome orToxic Epidermal Necrolysis have been reported in the clinical development programme of tipranavir.
In the COPD clinical development programme a total of 6,237 subjects were included in an integrated assessment of adverse reactions.
The CHMP noted that bleomycin is in clinical use since the 1960ies,thereby explaining the lack of a clinical development programme.
These were reported during the Phase 3 clinical development programme, which included a total of 1,030 chronic angina patients treated with Ranexa.
Severe and life-threatening skin reactions, including Stevens-Johnson syndrome,were reported in less than 1% of patients included in the clinical development programme.
The Oslif Breezhaler Phase III clinical development programme involved patients with a clinical diagnosis of moderate to severe COPD.
Patients taking methadone for treatment ofopioid addiction were not included in the clinical development programme and use of naloxegol in these patients should be approached with caution.
In studies across the clinical development programme for lapatinib, cardiac events including LVEF decreases were reported in approximately 1% of patients.
The clinical development programme included one 12-week, two six-month(one of which was extended to one year to evaluate safety and tolerability) and one one-year randomised controlled studies in patients with a clinical diagnosis of COPD.
All the final data on the clinical development programme will be submitted to the regulators as soon as they are available and will be posted on GSK's Clinical Study Register.
The TOBI Podhaler Phase III clinical development programme consisted of two studies and 612 treated patients with a clinical diagnosis of CF, confirmed by quantitative pilocarpine iontophoresis sweat chloride test or well-characterised disease causing mutations in each cystic fibrosis transmembrane regulator(CFTR) gene, or abnormal nasal transepithelial potential difference characteristic of CF.