FrancophonIA/ELRC3.0 huggingface dataset:
English: 2) Swirl the vial gently to aid reconstitution.
Danish: 2) Hvirvl forsigtigt indholdet i hætteglasset rundt for at understøtte rekonstitueringen.
English: AC→D = doxorubicin plus cyclophosphamide, followed by docetaxel; DCarbH = docetaxel, carboplatin and trastuzumab; CI = confidence interval
Danish: AC→D = doxorubicin plus cyclophosphamid efterfulgt af docetaxel, DCarbH = docetaxel, carboplatin og trastuzumab, CI = konfidensinterval
English: The hazard ratio translates into an absolute benefit, in terms of 3-year disease-free survival rate estimates of 11.8 percentage points (87.2% versus 75.4%) in favour of the AC→PH (trastuzumab) arm.
Danish: Hazard ratio overføres til en absolut gavnlig virkning udtrykt som estimater for 3 års sygdomsfri overlevelsesrate på 11,8 procentpoint (87,2 % versus 75,4 %) i AC→PH (trastuzumab)-armens favør.
English: Other infusion-related symptoms are: feeling sick (nausea), vomiting, pain, increased muscle tension and shaking, headache, dizziness, breathing difficulties, wheezing, high or low blood pressure, heart rhythm disturbances (palpitations, heart fluttering or irregular heart beat), swelling of the face and lips, rash and feeling tired.
Danish: Andre symptomer i forbindelse med infusionen er: Utilpashedsfølelse (kvalme), opkastning, smerter, forøget muskelspænding og rysten, hovedpine, svimmelhed, vejrtrækningsbesvær, pibende vejrtrækning, forhøjet eller lavt blodtryk, forstyrrelser i hjerterytmen (hjertebanken, hjerteflagren eller uregelmæssig hjerterytme), hævelse af ansigt og læber, udslæt og træthedsfølelse.
English: 1) Using a sterile syringe, slowly inject the appropriate volume (as noted above) of sterile water for injection in the vial containing the lyophilised Ontruzant, directing the stream into the lyophilised cake.
Danish: 1) Anvend en steril sprøjte og injicer langsomt den beregnede mængde (som angivet ovenfor) sterilt vand til injektionsvæsker i hætteglasset, som indeholder det frysetørrede Ontruzant, idet strålen rettes mod det frysetørrede kompakte pulver.
English: Ontruzant treatment should only be initiated by a physician experienced in the administration of cytotoxic chemotherapy (see section 4.4), and should be administered by a healthcare professional only.
Danish: Ontruzant-behandling må kun initieres af en læge med erfaring i administration af cytotoksisk kemoterapi (se pkt.
English: • dyspepsia (heartburn)
Danish: • halsbrand (dyspepsi)
English: Data from study JP16003, a single-arm study of trastuzumab (4 mg/kg loading dose as an intravenous infusion and 2 mg/kg infusion weekly) and docetaxel (60 mg/m2 intravenous infusion) in Japanese women with HER2-positive MBC, suggested that concomitant administration of trastuzumab had no effect on the single dose pharmacokinetics of docetaxel.
Danish: Data fra studie JP16003, et enkeltarmsstudie af trastuzumab (4 mg/kg støddosis som en intravenøs infusion og en infusion af 2 mg/kg ugentligt) og docetaxel (60 mg/m2 intravenøs infusion) hos japanske kvinder med HER2-positiv MBC indikerede, at samtidig administration af trastuzumab ikke havde nogen indvirkning på enkeltdosis-farmakokinetikken af docetaxel.
English: Comparison of trastuzumab PK data from Study M77004 in which women with HER2-positive MBC were treated concomitantly with trastuzumab, paclitaxel and doxorubicin to trastuzumab PK data in studies where trastuzumab was administered as monotherapy (H0649g) or in combination with anthracycline plus cyclophosphamide or paclitaxel (H0648g), suggested no effect of doxorubicin and paclitaxel on the pharmacokinetics of trastuzumab.
Danish: En sammenligning af farmakokinetiske data for trastuzumab fra studie M77004, hvor kvinder med HER2-positiv MBC blev behandlet samtidig med trastuzumab, paclitaxel og doxorubicin, med farmakokinetiske data for trastuzumab i studier, hvor trastuzumab blev administreret som monoterapi (H0649g) eller i kombination med antracyklin plus cyclophosphamid eller paclitaxel (H0648g), indikerede ingen påvirkning af doxorubicin og paclitaxel på farmakokinetikken af trastuzumab.
English: Death (OS event): No. patients with event p=0.014**
Danish: Dødsfald (OS-hændelse): Antal patienter med hændelse p = 0,014**
English: DFS analysis was also performed at the final analysis of OS from the joint analysis of studies NSABP B-31 and NCCTG N9831.
Danish: Der blev også udført en DFS-analyse ved den endelige analyse af OS fra den samlede analyse af studierne NSABP B-31 og NCCTG N9831.
English: The population predicted PK exposure values (median with 5th-95th Percentiles) and PK parameter values at clinically relevant concentrations (Cmax and Cmin) for MBC, EBC and AGC patients treated with the approved q1w and q3w dosing regimens are shown in Table 14 (Cycle 1), Table 15 (steady-state), and Table 16 (PK parameters).
Danish: De populationsforudsagte farmakokinetiske eksponeringsværdier (median med 5-95 percentiler) og farmakokinetiske parameterværdier ved klinisk relevante koncentrationer (Cmax og Cmin) hos patienter med MBC, EBC og fremskreden ventrikelkræft behandlet med de godkendte regimer med dosering ugentligt og hver 3. uge er vist i tabel 14 (cyklus 1), tabel 15 (steadystate) og tabel 16 (farmakokinetiske parametre).
English: 8mg/kg + 6mg/kg q3w
Danish: 8 mg/kg + 6 mg/kg hver
English: The recommended initial loading dose of Ontruzant is 4 mg/kg body weight.
Danish: Den anbefalede initiale støddosis af Ontruzant er 4 mg/kg legemsvægt.
English: L-histidine hydrochloride monohydrate L-histidine α,α-trehalose dihydrate polysorbate 20
Danish: L-histidinhydrochloridmonohydrat L-histidin α,α-trehalosedihydrat polysorbat 20
English: For full instructions on assay performance and interpretation please refer to the package inserts of validated FISH and CISH assays.
Danish: analysens ydeevne og tolkning henvises til indlægssedlerne i validerede FISH- og CISH-analyser.
English: 1) Using a sterile syringe, slowly inject the appropriate volume (as noted above) of water for injections in the vial containing the lyophilised Ontruzant, directing the stream into the lyophilised cake.
Danish: 1) Anvend en steril sprøjte og injicer langsomt den beregnede mængde (som angivet ovenfor) vand til injektionsvæsker i hætteglasset, som indeholder det frysetørrede Ontruzant, idet strålen rettes mod det frysetørrede kompakte pulver.
English: The appropriate amount of solution should be withdrawn from the vial and added to an infusion bag containing 250 mL of 0.9% sodium chloride solution.
Danish: Træk den beregnede volumenmængde af opløsningen op af hætteglasset og tilsæt den til en infusionspose indeholdende 250 ml 0,9 % natriumchloridopløsning.
English: In an exploratory subgroup analysis performed in the TOGA (BO18255) trial there was no apparent benefit on overall survival with the addition of trastuzumab in patients with ECOG PS 2 at baseline [HR 0.96 (95% CI 0.51-1.79)], non-measurable [HR 1.78 (95% CI 0.87-3.66)] and locally advanced disease [HR 1.20 (95% CI 0.29-4.97)].
Danish: En eksploratorisk subgruppeanalyse udført i ToGA (BO18255) studiet viste, at der ikke var tydelig fordel for den samlede overlevelse ved at tilføje af trastuzumab hos patienter med ECOG PS 2 ved baseline [hazard ratio 0,96 (95 % konfidensinterval 0,51-1,79)], med ikke målbar sygdom [hazard ratio 1,78 (95 % konfidensinterval 0,87-3,66)] eller lokalt fremskreden sygdom [hazard ratio 1,20 (95 % konfidensinterval 0,29-4,97)].
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Ontruzant 150 mg powder for concentrate trastuzumab
Danish: LÆGEMIDLETS NAVN, STYRKE OG/ELLER ADMINISTRATIONSVEJ(E) Ontruzant 150 mg pulver til koncentrat trastuzumab
English: Trastuzumab and anthracyclines should not be given concurrently in combination in the MBC setting.
Danish: Trastuzumab og antracykliner bør ikke anvendes i kombination hos patienter med MBC.
English: Any remaining reconstituted solution should be discarded.
Danish: Eventuelt overskydende rekonstitueret opløsning skal smides væk.
English: • bladder and skin infections
Danish: • infektioner i blæren og huden
English: What you need to know before you are given Ontruzant Do not use Ontruzant if:
Danish: Det skal du vide, før du får Ontruzant
English: In the BCIRG 006 study for the primary endpoint, DFS, the hazard ratio translates into an absolute benefit, in terms of 3-year disease-free survival rate estimates of 5.8 percentage points (86.7% versus 80.9%) in favour of the AC→DH (trastuzumab) arm and 4.6 percentage points (85.5% versus 80.9% ) in favour of the DCarbH (trastuzumab) arm compared to AC→D.
Danish: I BCIRG 006-studiet med det primære endepunkt, sygdomsfri overlevelse, kan hazard ratio'en overføres til en absolut gavnlig virkning udtrykt som estimater for 3 års sygdomsfri overlevelsesrate på 5,8 procentpoint (86,7 % versus 80,9 %) til fordel for AC→DH (trastuzumab)-armen og 4,6 procentpoint (85,5 % versus 80,9 % ) til fordel for DCarbH (trastuzumab)-armen sammenlignet med
English: One 15 mL clear glass type I vial with butyl rubber stopper laminated with a fluoro-resin film containing 150 mg of trastuzumab
Danish: Et 15 ml klart type I hætteglas af glas med butylgummiprop lamineret med en fluorresinfilm, som indeholder 150 mg trastuzumab.
English: • The other ingredient(s) are L-histidine hydrochloride monohydrate, L-histidine, α,α-trehalose dihydrate, polysorbate 20.
Danish: • Øvrige indholdsstoffer: L-histidinhydrochloridmonohydrat, L-histidin, α,α-trehalosedihydrat, polysorbat 20.
English: Effect of antineoplastic agents on trastuzumab pharmacokinetics
Danish: Virkning af antineoplastiske midler på farmakokinetikken af trastuzumab
English: In addition, cases of interstitial lung disease including lung infiltrates, acute respiratory distress syndrome, pneumonia, pneumonitis, pleural effusion, respiratory distress, acute pulmonary oedema and respiratory insufficiency have been reported.
Danish: Endvidere er der rapporteret tilfælde af interstitiel lungesygdom herunder lungeinfiltrater, akut respiratorisk distresssyndrom, pneumoni, pneumonitis, pleuraeffusion, respiratorisk distress, akut lungeødem og respirationsinsufficiens.
English: The final OS results from the joint analysis of studies NSABP B-31 and NCCTG N9831 are summarized in Table 8 below:
Danish: De endelige OS-resultater fra den samlede analyse af studierne NSABP B-31 og NCCTG N9831 er sammenfattet i tabel 8 nedenfor:
English: 1Blood pressure decreased
Danish: 1Nedsat blodtryk
English: 4mg/kg + 2mg/kg qw
Danish: 4 mg/kg + 2 mg/kg hver uge
English: L-histidine hydrochloride monohydrate, L-histidine, α,α-trehalose dihydrate, polysorbate 20.
Danish: L-histidinhydrochloridmonohydrat, L-histidin, α,α-trehalosedihydrat, polysorbat 20.
English: Detection of HER2 overexpression or HER2 gene amplification in breast cancer Trastuzumab should only be used in patients whose tumours have HER2 overexpression or HER2 gene amplification as determined by an accurate and validated assay.
Danish: Påvisning af HER2-overekspression eller HER2-genamplifikation ved brystkræft Trastuzumab bør kun anvendes til patienter, hvis tumorer har HER2-overekspression eller HER2genamplifikation bestemt ved hjælp af en præcis og valideret analyse.
English: +Oxygen saturation decreased
Danish: +Reduceret oxygenmætning
English: For the primary endpoint, DFS, the addition of trastuzumab to paclitaxel chemotherapy resulted in a 52% decrease in the risk of disease recurrence.
Danish: For det primære endepunkt, sygdomsfri overlevelse, resulterede tilføjelsen af trastuzumab til paclitaxel-kemoterapi i et 52 % fald i risikoen for sygdomsrecidiv.
English: 1Swelling face
Danish: 1Hævelse i ansigtet
English: Weekly schedule
Danish: Plan for ugentlig administration
English: An absolute benefit of 13 percentage points in favour of the trastuzumab arm was estimated in terms of 3-year event-free survival rate (65% versus 52%).
Danish: * defineret som fravær af invasiv kræft i både brystet og de aksillære lymfeknuder En absolut gavnlig virkning på 13 procentpoint i trastuzumab-armens favør blev estimeret udtrykt som 3 års hændelsefri overlevelsesrate (65 % versus 52 %).
English: Ontruzant 420 mg powder for concentrate for solution for infusion One vial contains 420 mg of trastuzumab, a humanised IgG1 monoclonal antibody produced by mammalian (Chinese hamster ovary) cell suspension culture and purified by several chromatography steps including specific viral inactivation and removal procedures.
Danish: Et hætteglas indeholder 420 mg trastuzumab, et humaniseret IgG1 monoklonalt antistof, fremstillet ved hjælp af en suspensionskultur af mammaliaceller (ovarieceller fra kinesisk hamster) og oprenset ved hjælp af adskillige kromatografitrin, herunder specifikke procedurer til inaktivering og fjernelse af virus.
English: The efficacy results from the joint analysis of the NSABP B-31 and NCCTG 9831 trials at the time of the definitive analysis of DFS* are summarized in Table 7.
Danish: Virkningsresultaterne fra den fælles analyse af NSABP B-31- og NCCTG N9831-studierne på tidspunktet for den endelige analyse af DFS* er sammenfattet i tabel 7.
English: +Respiratory failure
Danish: +Respirationssvigt
English: Table 5 Efficacy results from the non-comparative monotherapy and combination therapy studies Parameter
Danish: Virkningsresultater fra de ikke-komparative studier med monoterapi og kombinationsterapi Parameter
English: No. patients with event p=0.0555
Danish: Antal patienter med hændelse p = 0,0555
English: Body weight (kg) x dose (8 mg/kg for loading or 6 mg/kg for maintenance) 21 (mg/mL, concentration of reconstituted solution)
Danish: Volumen (ml) = Legemsvægt (kg) x dosis (8 mg/kg til støddosis eller 6 mg/kg til vedligeholdelse) 21 (mg/ml, koncentration af rekonstitueret opløsning)
English: One 40 mL clear glass type I vial with butyl rubber stopper laminated with a fluoro-resin film containing 420 mg of trastuzumab
Danish: Et 40 ml klart type I hætteglas af glas med butylgummiprop lamineret med en fluorresinfilm, som indeholder 420 mg trastuzumab.
English: Body weight (kg) x dose (4 mg/kg for loading or 2 mg/kg for maintenance) 21 (mg/mL, concentration of reconstituted solution)
Danish: Volumen (ml) = Legemsvægt (kg) x dosis (4 mg/kg til støddosis eller 2 mg/kg til vedligeholdelse) 21 (mg/ml, koncentration af rekonstitueret opløsning)
English: In the neoadjuvant setting, the experience of concurrent administration of trastuzumab and low-dose anthracycline regimen is limited (see section 4.4).
Danish: Som neoadjuverende behandling er der begrænset erfaring med samtidig administration af trastuzumab og et regime med lavdosisantracyklin (se pkt.
English: Table 9 Overview of efficacy analyses BCIRG 006 AC→D versus AC→DH
Danish: Oversigt over virkningsanalyser af AC→D versus AC→DH fra BCIRG 006-studiet
English: As a three-weekly regimen the recommended initial loading dose of Ontruzant is 8 mg/kg body weight.
Danish: I et regime med administration hver 3. uge er den anbefalede initiale støddosis af Ontruzant 8 mg/kg legemsvægt.
English: Median duration of follow-up was 1.8 years in the AC→P arm and 2.0 years in the AC→PH arm ** Median duration of long term follow-up for the Joint Analysis clinical studies was 8.3 years (range: 0.1 to 12.1) for the AC→PH arm and 7.9 years (range: 0.0 to 12.2) for the AC→P arm; Median duration of long term follow-up for the BCIRG 006 study was 10.3 years in both the AC→D arm (range: 0.0 to 12.6) arm and the DCarbH arm (range: 0.0 to 13.1), and was 10.4 years (range: 0.0 to 12.7) in the AC→DH arm
Danish: Median varighed af opfølgningen var 1,8 år i AC→Parmen og 2,0 år i AC→PH-armen ** Median varighed af langtidsopfølgning for de kliniske studier i den samlede analyse var 8,3 år (interval: 0,1 til 12,1) for AC→PH-armen og 7,9 år (interval: 0,0 til 12,2) for AC→P-armen.
English: These include, but are not limited to, pulmonary infiltrates, acute respiratory distress syndrome, pneumonia, pneumonitis, pleural effusion, respiratory distress, acute pulmonary oedema and respiratory insufficiency (see section 4.4).
Danish: Disse omfatter, men er ikke begrænset til, lungeinfiltrater, akut respiratorisk distresssyndrom, pneumoni, pneumonitis, pleuraeffusion, respiratorisk distress, akut lungeødem og respirationsinsufficiens (se pkt.
English: A faint/barely perceptible membrane staining is detected in >10% of the tumour cells.
Danish: Der påvises en svag/knap synlig membranfarvning i > 10 % af tumorcellerne.
English: Table 4 Efficacy results from the monotherapy and combination therapy studies Parameter
Danish: Virkningsresultater fra studier med monoterapi og kombinationsterapi Parameter
English: Ontruzant should only be used in patients with metastatic or early breast cancer whose tumours have either HER2 overexpression or HER2 gene amplification as determined by an accurate and validated assay (see sections 4.4 and 5.1).
Danish: Ontruzant bør kun anvendes til patienter med metastatisk eller tidlig brystkræft, hvis tumorer enten har HER2-overekspression eller HER2-genamplifikation bestemt ved hjælp af en præcis og valideret analyse (se pkt.
English: Single doses of trastuzumab alone greater than 10 mg/kg have not been administered in the clinical trials; a maintenance dose of 10 mg/kg q3w following a loading dose of 8 mg/kg has been studied in a clinical trial with metastatic gastric cancer patients.
Danish: En vedligeholdelsesdosis på 10 mg/kg hver 3. uge efter en støddosis på 8 mg/kg er blevet undersøgt i et klinisk studie med patienter med metastatisk ventrikelkræft.
English: Primary efficacy analysis DFS hazard ratios (95% CI) p-value p<0.0001
Danish: Primær virkningsanalyse DFS hazard ratio (95 % CI) p-værdi p < 0,0001
English: By comparison of simulated serum trastuzumab concentrations after trastuzumab monotherapy (4 mg/kg loading/2 mg/kg q1w intravenous infusion) and observed serum concentrations in Japanese women with HER2-positive MBC (study JP16003) no evidence of a PK effect of concurrent administration of docetaxel on the pharmacokinetics of trastuzumab was found.
Danish: Ved sammenligning af simulerede serumkoncentrationer af trastuzumab efter trastuzumab-monoterapi (4 mg/kg støddosis/2 mg/kg hver uge intravenøs infusion) og observerede serumkoncentrationer hos japanske kvinder med HER2-positiv MBC (studie JP16003) blev der ikke fundet evidens for, at samtidig administration af docetaxel påvirkede farmakokinetikken af trastuzumab.
English: Weak to moderate complete, basolateral or lateral membranous reactivity in ≥10% of tumour cells
Danish: Svag til moderat komplet, basolateral eller lateral membranøs reaktivitet i ≥ 10 % af tumorcellerne
English: Table 16 Population predicted PK parameter values at steady state for trastuzumab intravenous infusion dosing regimens in MBC, EBC and AGC patients
Danish: Populationsforudsagte farmakokinetiske parameterværdier ved steady-state for trastuzumabdoseringsregimer med intravenøs infusion hos patienter med MBC, EBC og AGC
English: The reconstituted Ontruzant solution contains 21 mg/mL of trastuzumab.
Danish: Den rekonstituerede Ontruzant-opløsning indeholder 21 mg/ml trastuzumab.
English: No. patients with event p=0.0275
Danish: Antal patienter med hændelse p = 0,0275
English: Patients with EBC should be treated with Ontruzant for 1 year or until disease recurrence, whichever occurs first; extending treatment in EBC beyond one year is not recommended (see section 5.1).
Danish: Behandling af EBC bør ikke forlænges ud over ét år (se pkt.
English: Ontruzant 150 mg powder for concentrate for solution for infusion Appropriate aseptic technique should be used.
Danish: Ontruzant 150 mg pulver til koncentrat til infusionsvæske, opløsning Der skal anvendes passende aseptisk teknik.
English: Ontruzant 420 mg powder for concentrate for solution for infusion Appropriate aseptic technique should be used.
Danish: Ontruzant 420 mg pulver til koncentrat til infusionsvæske, opløsning Der skal anvendes passende aseptisk teknik.
English: The appropriate amount of solution should be withdrawn from the vial and added to a polyvinylchloride, polyethylene or polypropylene infusion bag containing 250 mL of 0.9% sodium chloride solution.
Danish: Træk den beregnede volumenmængde af opløsningen op af hætteglasset og tilsæt den til en infusionspose af polyvinylchlorid, polyethylen eller polypropylen indeholdende 250 ml 0,9 %
English: Serious IRRs to trastuzumab infusion including dyspnoea, hypotension, wheezing, hypertension, bronchospasm, supraventricular tachyarrhythmia, reduced oxygen saturation, anaphylaxis, respiratory distress, urticaria and angioedema have been reported (see section 4.8).
Danish: Der er rapporteret alvorlige infusionsrelaterede reaktioner på trastuzumab-infusion, herunder dyspnø, hypotension, pibende vejrtrækning, hypertension, bronkospasme, supraventrikulær takyarytmi, reduceret oxygenmætning, anafylaksi, respiratorisk distress, urticaria og angioødem (se pkt.
English: Death (OS event) No. patients with event p=0.0182
Danish: Dødsfald (OS-hændelse) Antal patienter med hændelse p = 0,0182
English: Strong complete, basolateral or lateral membranous reactivity in ≥10% of tumour cells
Danish: Potent komplet, basolateral eller lateral membranøs reaktivitet i ≥ 10 % af tumorcellerne
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Ontruzant 420 mg powder for concentrate for solution for infusion trastuzumab
Danish: LÆGEMIDLETS NAVN, STYRKE OG/ELLER ADMINISTRATIONSVEJ(E) Ontruzant 420 mg pulver til koncentrat til infusionsvæske, opløsning trastuzumab
English: Table 3 Recommended scoring system to evaluate the IHC staining patterns in gastric cancer
Danish: Anbefalet scoringssystem til evaluering af IHC-farvningsmønstrene ved ventrikelkræft Score
English: • abnormal or impaired blood clotting
Danish: • unormal eller reduceret blodstørkning
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Ontruzant 150 mg powder for concentrate for solution for infusion One vial contains 150 mg of trastuzumab, a humanised IgG1 monoclonal antibody produced by mammalian (Chinese hamster ovary) cell suspension culture and purified by several chromatography steps including specific viral inactivation and removal procedures.
Danish: Et hætteglas indeholder 150 mg trastuzumab, et humaniseret IgG1 monoklonalt antistof, fremstillet ved hjælp af en suspensionskultur af mammaliaceller (ovarieceller fra kinesisk hamster) og oprenset ved hjælp af adskillige kromatografitrin, herunder specifikke procedurer til inaktivering og fjernelse af virus.
English: The recommended weekly maintenance dose of Ontruzant is 2 mg/kg body weight, beginning one week after the loading dose.
Danish: Den anbefalede ugentlige vedligelsesdosis af Ontruzant er 2 mg/kg legemsvægt med start én uge efter støddosis.
English: - intravenous paclitaxel - 80 mg/m2 as a continuous intravenous infusion, given every week for 12 weeks.
Danish: Paclitaxel i kombination med trastuzumab blev administreret som følger: - intravenøs paclitaxel - 80 mg/m2 som en kontinuerlig intravenøs infusion administreret hver uge i 12 uger.
English: In addition a post-hoc exploratory analysis was performed on the data sets from the joint analysis (JA) NSABP B-31/NCCTG N9831* and BCIRG006 clinical studies combining DFS events and symptomatic cardiac events and summarised in Table 11:
Danish: Der blev endvidere udført en post-hoc eksplorativ analyse på datasættene fra den samlede analyse af de kliniske studier NSABP B-31/NCCTG N9831* og BCIRG006, som kombinerede DFS og symptomatiske kardielle hændelser.
English: The median overall survival for the high HER2-expressing group was 11.8 months versus 16 months, HR 0.65 (95% CI 0.51-0.83) and the median progression free survival was 5.5 months versus 7.6 months, HR 0.64 (95% CI 0.51-0.79) for FP versus FP + H, respectively.
Danish: Den mediane samlede overlevelse for den høje HER2-ekspressionsgruppe var 11,8 måneder versus 16 måneder, hazard ratio 0,65 (95 % konfidensinterval 0,51-0,83), og den mediane progressionsfri overlevelse var 5,5 måneder versus 7,6 måneder, hazard ratio 0,64 (95 % konfidensinterval 0,51-0,79) for henholdsvis FP og FP + H. For den samlede overlevelse var hazard ratio 0,75 (95 % konfidensinterval 0,51-1,11) i IHC2+/FISH+ gruppen, og 0,58 (95 % konfidensinterval 0,41-0,81) i IHC3+/FISH+ gruppen.