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pivotale studier af virkningen:
pivotal efficacy studies:

data fra pivotale kliniske forsøg
pivotal clinical trial data

resultater fra pivotale placebokontrollerede undersøgelser
results from pivotal placebo-controlled studies

pivotale studier ms-f203 og ms-f204
pivotal studies ms-f203 and ms-f204

patientpopulationen svarede til den fra det pivotale studie.
the patient population was comparable to the pivotal study.

reaktioner ved injektionsstedet i de pivotale kontrollerede forsøg
chest pain, oedema, influenza like illness

histopatologi resultater fra det pivotale studie blev anvendt.
histopathology from the pivotal study was used.

tabel 4: effektparametre i pivotale fase iii-forsøg
table 4: efficacy results from pivotal phase iii studies

de pivotale fase iii- undersøgelsers design var ellers ens.
the pivotal phase iii studies were otherwise identical in design.

de pivotale kliniske forsøg omfattede ikke børn under 3 år.
the pivotal clinical studies did not include children below 3 years old.

cav kvartilanalyser af pivotale patientstudier med posaconazol tablet og oral suspension
cav quartile analyses of pivotal patient studies with posaconazole tablet and oral suspension

bivirkninger i disse to pivotale undersøgelser, er opstillet i tabel 2.
adverse reactions in these two pivotal studies are summarised in table 2.

i pivotale forsøg sås den største forbedring inden for de første fire uger.
during pivotal trials the greatest improvement was observed within the first 4 weeks.

34 % af kvinderne inkluderet i det pivotale studie) fuldførte forlængelsesstudiet.
34% of the women included in the pivotal study) completed the extension study.

bivirkninger observeret i pivotale og understøttende kliniske forsøg (med 642 patienter)
reactions observed in pivotal and supportive clinical trials (in 642 patients)

alle inkluderede termer er baseret på den højeste procent set i de pivotale kliniske studier.
all the terms included are based on the highest percentage seen in pivotal clinical trials.

de tre pivotale dobbeltblinde placebokontrollerede fase 3-studier inkluderede 143 unge fra 12 til 18 år.
the three pivotal double-blind placebo-controlled phase 3 studies included 143 adolescents between the ages of 12 and 18.

laboratoriefund i det pivotale 3-års studie med oral bondenza 2, 5 mg daglig (mf
29bone painasthenia injection site reactions phlebitis/thrombophlebitis

det pivotale studie med 295 patienter involverede uinstrumenteret posterolateral lumbar spinalfusion hos 208 patienter behandlet med opgenra.
the pivotal study with 295 patients involved un-instrumented postero-lateral lumbar spine fusion in 208 patients treated with opgenra.

i de pivotale forsøg blev der identificeret anti-adalimumab-antistoffer hos 58/1. 053 ge
in the pivotal trials, anti-adalimumab antibodies were identified in 58/1053 (5.5%) patients treated with adalimumab, compared to 2/370 (0.5%) on placebo.in patients not given