FrancophonIA/ELRC3.0 huggingface dataset:
English: One vial contains 420 mg trastuzumab.
Danish: Et hætteglas indeholder 420 mg trastuzumab.
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: Detektion af HER2-overekspression eller amplifikation af HER2-genet i brystkræft Trastuzumab bør kun anvendes til patienter med tumorer, som har overekspression af HER2 eller amplifikation af HER2-genet, som bestemt ved en præcis og valideret analyse.
English: By comparison of simulated serum trastuzumab concentrations after trastuzumab monotherapy (4 mg/kg loading/2 mg/kg q1w intravenous) 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 trastuzumab-serumkoncentrationer efter trastuzumab-monoterapi (4 mg/kg intravenøs støddosis/2 mg/kg ugentlig) og observerede serumkoncentrationer hos japanske kvinder med HER2-positiv metastatisk brystkræft (studie JP16003) blev der ikke fundet evidens for, at samtidig administration af docetaxel påvirkede trastuzumabs farmakokinetik.
English: 4mg/kg + 2mg/kg qw
Danish: 4 mg/kg + 2 mg/kg ugentlig doseringsregime
English: Acute respiratory distress syndrome
Danish: Akut respiratorisk distress syndrom Ikke kendt Bronkospasmer
English: Each 150 mg vial of Trazimera is reconstituted with 7.2 mL of sterile water for injections (not supplied).
Danish: Indholdet af hvert 150 mg Trazimera hætteglas rekonstitueres med 7,2 ml sterilt vand til injektionsvæsker (følger ikke med).
English: Unopened vials of Trazimera may be stored up to 30°C for a single period of up to 3 months.
Danish: Uåbnede hætteglas med Trazimera kan opbevares ved temperaturer på op til 30 °C i en enkelt periode på op til 3 måneder.
English: A weak to moderate complete membrane staining is detected in >10% of the tumour cells.
Danish: En svag til moderat fuldstændig membranfarvning detekteres i > 10 % af tumorcellerne.
English: AC→D = doxorubicin plus cyclophosphamide, followed by docetaxel; AC→DH = doxorubicin plus cyclophosphamide, followed by docetaxel plus trastuzumab; CI = confidence interval
Danish: AC→D = doxorubicin og cyclophosphamid efterfulgt af docetaxel; AC→DH = doxorubicin og cyclophosphamid efterfulgt af docetaxel og trastuzumab
English: The powder is a white cake.
Danish: Pulveret består af et hvidt kompakt pulver.
English: How to store Trazimera
Danish: Sådan får du Trazimera
English: Response rate (95% CI) Median duration of response (months) (range) Median TTP (months) (95% CI)
Danish: Median responsvarighed (måneder) (95 % konfidensinterval) Median TTP (måneder) (95 % konfidensinterval) (2,6-3,5)
English: An updated RMP should be submitted: • At the request of the European Medicines Agency.
Danish: En opdateret RMP skal fremsendes:
English: Strong complete, basolateral or lateral membranous reactivity in ≥10% of tumour cells
Danish: Stærk komplet, basolateral eller lateral membranøs reaktivitet i ≥ 10 % af tumorcellerne
English: • based on a loading dose of 8 mg trastuzumab/kg body weight, or a subsequent 3-weekly dose of 6 mg trastuzumab/kg body weight:
Danish: baseret på en støddosis på 8 mg trastuzumab/kg legemsvægt eller en efterfølgende 3-ugers dosis på 6 mg trastuzumab/kg legemsvægt:
English: Table 10 Overview of Efficacy Analyses BCIRG 006 AC→D versus DCarbH Parameter
Danish: Oversigt over effektanalyserne af AC→D versus DCarbH fra BCIRG 006-studiet Parameter
English: 150 mg vial
Danish: 150 mg hætteglas
English: Glomerulonephropathy
Danish: Glomerulonefropati
English: Common: may affect up to 1 in 10 people
Danish: Almindelige:kan forekomme hos op til 1 ud af 10 patienter allergiske reaktioner
English: Patients experiencing infusion-related symptoms (see section 4.4) should be advised not to drive and use machines until symptoms abate.
Danish: 4.4), skal dog rådes til ikke at køre bil og betjene maskiner, før symptomerne er aftaget.
English: Trazimera and anthracyclines should not be given concurrently in combination in the adjuvant treatment setting.
Danish: Trazimera og antracykliner bør ikke anvendes i kombination hos patienter, som får adjuverende behandling.
English: Trazimera 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: Trazimera bør kun bruges til patienter med metastatisk eller tidlig brystkræft, som enten har tumorer med overekspression af HER2 eller amplifikation af HER2-genet, bestemt ved en præcis og valideret analyse (se pkt.
English: One vial contains 150 mg trastuzumab.
Danish: Et hætteglas indeholder 150 mg trastuzumab.
English: What you need to know before you are given Trazimera
Danish: Det skal du vide, før du begynder fårTrazimera
English: 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: Den mediane varighed af længerevarende opfølgning i for BCIRG 006-studiet var 10,3 år i både AC→D-armen (interval: 0,0-12,6) og DCarbH-armen (interval: 0,0-13,1), og 10,4 år (interval: 0,0-12,7) i AC→DH-armen.
English: AC→D = doxorubicin plus cyclophosphamide, followed by docetaxel; DCarbH = docetaxel, carboplatin and trastuzumab; CI = confidence interval
Danish: AC→D = doxorubicin og cyclophosphamid efterfulgt af docetaxel; DCarbH = docetaxel, carboplatin og trastuzumab
English: Strong complete membrane staining is detected in >10% of the tumour cells.
Danish: Stærk, fuldstændig membranfarvning detekteres i > 10 % af tumorcellerne.
English: Unopened vial can be stored up to 30ºC for a single period of up to 3 months.
Danish: Et uåbnet hætteglas kan opbevares ved op til 30 °C i en enkeltperiode på højst 3 måneder.
English: • feeling weak and unwell
Danish: •svagheds-og utilpashedsfølelse helvedesild
English: N Cmin (µg/mL) Cmax (µg/mL)
Danish: N Cmin (mikrogram/ml)
English: Trastuzumab 1 Year N=1702***
Danish: N=1.702***
English: Respiratory distress
Danish: Åndedrætsbesvær
English: or - intravenous paclitaxel - 175 mg/m2 as a continuous intravenous infusion, given every 3 weeks for 4 cycles (day 1 of each cycle).
Danish: - intravenøs paclitaxel - 175 mg/m 2 som kontinuerlig intravenøs-infusion, administreret hver 3. uge i 4 serier (dag 1 i hver serie).
English: 420 mg vial
Danish: 420 mg hætteglas
English: Long term follow-up efficacy analysis DFS Hazard rations (95% CI) p-value p<0.0001
Danish: Effektanalyse af længerevarende opfølgning Sygdomsfri overlevelse hazard ratio 95 % konfidensinterval p-værdi p<0,0001
English: Table 9 Overview of Efficacy Analyses BCIRG 006 AC→D versus AC→DH Parameter
Danish: Oversigt over effektanalyserne af AC→D versus AC→DH fra BCIRG 006-studiet Parameter
English: The recommended maintenance dose of Trazimera at three-weekly intervals is 6 mg/kg body weight, beginning three weeks after the loading dose.
Danish: Den anbefalede vedligeholdelsesdosis af Trazimera ved 3-ugers intervaller er 6 mg/kg legemsvægt og den påbegyndes 3 uger efter støddosis.
English: or - intravenous docetaxel - 75 mg/m 2 as an intravenous infusion over 1 hour, given every 3 weeks for 6 cycles (day 2 of cycle 1, then day 1 of each subsequent cycle)
Danish: - intravenøs docetaxel - 75 mg/m 2 som intravenøs-infusion over 1 time, administreret hver 3. uge i 6 serier (dag 2 i serie 1, derefter dag 1 i hver af de efterfølgende serier)
English: Weak to moderate complete, basolateral or lateral membranous reactivity in ≥10% of tumour cells
Danish: En svag til moderat komplet, basolateral eller lateral membranøs reaktivitet i ≥ 10 % af tumorcellerne
English: Data from study JP16003, a single-arm study of trastuzumab (4 mg/kg intravenous loading dose and 2 mg/kg intravenous dose weekly) and docetaxel (60 mg/m2 intravenous dose) 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 enkelt-arm-studie med trastuzumab (4 mg/kg intravenøs støddosis og 2 mg/kg intravenøs dosis ugentligt) og docetaxel (60 mg/m2 intravenøst) hos japanske kvinder med
English: • bladder and skin infections
Danish: •sveden infektion i blæren og huden
English: Death (OS event) No. patients with event p=0.0182
Danish: Død (OS hændelse) - Antal patienter med en hændelse p = 0,0182
English: which was followed by: - carboplatin - at target AUC=6 mg/mL/min administered by intravenous infusion over
Danish: som blev efterfulgt af: - carboplatin - ved tilsigtet AUC=6 mg/ml/min administreret som intravenøs-infusion over 30-60 minutter gentaget hver 3. uge i samlet 6 serier.
English: • increased muscle tone or tension
Danish: • astma øget muskeltonus eller muskelspænding • lungeinfektion (hypertoni)
English: Distant Recurrence No. patients with event p<0.0001
Danish: Distant tilbagefald - Antal patienter med en hændelse p < 0,0001
English: - The other ingredient(s) are L-histidine hydrochloride monohydrate, L-histidine, sucrose, polysorbate 20.
Danish: Øvrige indholdsstoffer: L-histidinhydrochloridmonohydrat, L-histidin, saccharose og polysorbat
English: Ear and labyrinth disorders Deafness
Danish: Øre og labyrint
English: Trazimera 150 mg powder for concentrate trastuzumab
Danish: Trazimera 150 mg pulver til koncentrat trastuzumab
English: Table 4 Efficacy Results from the Monotherapy and Combination Therapy Studies Parameter Monotherapy
Danish: Effektresultater fra studier med monoterapi og kombinationsterapi Parameter
English: Primary efficacy analysis DFS Hazard ratios (95% CI) p-value p<0.0001
Danish: Primær effektanalyse Sygdomsfri overlevelse hazard ratio 95 % konfidensinterval p-værdi p < 0,0001
English: - intravenous push doxorubicin, at 60 mg/m 2, given every 3 weeks for 4 cycles.
Danish: - intravenøs bolus doxorubicin på 60 mg/m 2, administreret hver 3. uge i 4 serier.
English: Table 5 Efficacy Results from the Non-Comparative Monotherapy and Combination Therapy Studies
Danish: Effektresultater fra ikke-komparative studier med monoterapi og kombinationsterapi Parameter
English: MBC and EBC patients had similar PK parameters (e.g.
Danish: Patienter med metastatisk brystkræft og tidlig brystkræft havde sammenlignelige farmakokinetiske parametre (f.eks.
English: A faint/barely perceptible membrane staining is detected in >10% of the tumour cells.
Danish: Svag/lige akkurat synlig membranfarvning detekteres i > 10 % af tumorcellerne.
English: Death (OS event) No. patients with event p=0.0024
Danish: Død (OS hændelse) - Antal patienter med en hændelse p = 0,0024
English: Respiratory failure
Danish: Respirationsinsufficiens
English: Median duration of follow up was 1.8 years in the AC→P arm and 2.0 years in the AC→PH arm
Danish: Median opfølgningstid var 1,8 år i AC→Parmen og 2,0 år i AC→PH-armen.
English: Combination Therapy
Danish: Kombinationsterapi
English: Median Survival (months) (95% CI)
Danish: Median overlevelse (måneder) (95 % konfidensinterval)
English: A: doxorubicin; C: cyclophosphamide; P: paclitaxel; D: docetaxel; Carb: carboplatin; H: trastuzumab CI = confidence interval
Danish: A: doxorubicin; C: cyclophosphamid; P: paclitaxel; D: docetaxel; Carb: carboplatin; H: trastuzumab * På tidspunktet for den endelige analyse af sygdomsfri overlevelse.
English: Response rate (95% CI)
Danish: Responsrate (95 % konfidensinterval)
English: This yields a 20.6 mL solution for single-dose use, containing approximately 21 mg/mL trastuzumab.
Danish: Resultatet er en 20,6 ml opløsning til enkeltdosisbrug, som indeholder ca. 21 mg/ml trastuzumab.
English: Record the “discard by” date in the date field provided on the carton.
Danish: Notér udløbsdatoen i datofeltet på yderpakningen.
English: Respiratory, thoracic and mediastinal disorders
Danish: Luftveje, thorax og mediastinum +1
English: • Paclitaxel 175 mg/m2 administered 3-weekly for 4 cycles,
Danish: som blev efterfulgt af: Paclitaxel 175 mg/m 2, administreret hver 3. uge i 4 serier,
English: Amongst the most serious and/or common adverse reactions reported in trastuzumab usage (intravenous and subcutaneous formulations) to date are cardiac dysfunction, infusion-related reactions, haematotoxicity (in particular neutropenia), infections and pulmonary adverse reactions.
Danish: Kardiel dysfunktion, infusionsrelaterede reaktioner, hæmatotoksicitet (specielt neutropeni), infektioner og pulmonale bivirkninger er til dato blandt de mest alvorlige og/eller almindelige bivirkninger rapporteret ved anvendelse af trastuzumab (intravenøs og subkutan formulering).
English: • haemorrhoids
Danish: •knoglesmerter hæmorider
English: Table 16 Population Predicted PK Parameter Values at Steady State for Trastuzumab Intravenous Dosing Regimens in MBC, EBC and AGC Patients
Danish: Tabel 16: Populationsforudsagte farmakokinetiske parameter værdier ved steady state for trastuzumab intravenøse doseringsregimer hos patienter med metastatisk brystkræft, tidlig brystkræft og fremskreden ventrikelkræft.
English: • based on a loading dose of 4 mg trastuzumab/kg body weight, or a subsequent weekly dose of 2 mg trastuzumab/kg body weight:
Danish: Beregn det nødvendige volumen af opløsningen: baseret på en støddosis på 4 mg trastuzumab/kg legemsvægt eller en efterfølgende ugentlig dosis på 2 mg trastuzumab/kg legemsvægt:
English: Table 11 Post-Hoc Exploratory Analysis Results from the Joint Analysis NSABP B-31/NCCTG N9831* and BCIRG006 Clinical Studies Combining DFS Events and Symptomatic Cardiac Events AC→PH (vs. AC→P) (NSABP B-31 and NCCTG N9831)
Danish: Resultater for post-hoc eksplorativ analyse fra den samlede analyse fra de kliniske studier NSABP B-31/NCCTG N9831 og BCIRG006, hvor sygdomsfri overlevelse og symptomatiske kardielle bivirkninger blev kombineret
English: • 150 mg trastuzumab that has to be dissolved in 7.2 mL of sterile water for injections, or
Danish: • 150 mg trastuzumab, som skal opløses i 7,2 ml sterilt vand til injektionsvæsker, eller • 420 mg trastuzumab, som skal opløses i 20 ml sterilt vand til injektionsvæsker.
English: Hazard Ratio (95% CI)
Danish: Hazard ratio (95 % konfidensinterval)
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: Desuden blev en post-hoc eksplorativ analyse udført på datasættene fra den samlede analyse fra studierne NSABP B-31/NCCTG N9831
English: Death (OS event): No. patients with event p=0.014
Danish: Død (OS hændelse) - Antal patienter med en hændelse p = 0,014
English: Trazimera 150 mg powder for concentrate for solution for infusion Trazimera 420 mg powder for concentrate for solution for infusion trastuzumab
Danish: Trazimera 150 mg pulver til koncentrat til infusionsvæske, opløsning Trazimera 420 mg pulver til koncentrat til infusionsvæske, opløsning trastuzumab
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: I et klinisk studie med patienter der havde metastatisk ventrikelkræft blev en vedligeholdelsesdosis på 10 mg/kg i 3-ugers intervaller efter en støddosis på 8 mg/kg undersøgt.
English: Trazimera 150 mg powder for concentrate for solution for infusion Trazimera 420 mg powder for concentrate for solution for infusion
Danish: Trazimera 150 mg pulver til koncentrat til infusionsvæske, opløsning Trazimera 420 mg pulver til koncentrat til infusionsvæske, opløsning
English: Table 8 Final Overall Survival Analysis from the joint analysis of trials NSABP B-31 and NCCTG N9831
Danish: Endelig analyse af samlet overlevelse (OS) fra den samlede analyse af NSABP B-31- og NCCTG N9831-studierne
English: This yields a 20.6 mL solution for single-dose use, containing approximately 21 mg/mL trastuzumab, at a pH of approximately 6.0.
Danish: Resultatet er en 20,6 ml opløsning til enkeltdosisbrug, som indeholder ca. 21 mg/ml trastuzumab med en pH på ca. 6,0.
English: • diarrhoea
Danish: Diarré
English: Table 15 Population Predicted Steady State PK Exposure Values (median with 5th - 95th Percentiles) for Trastuzumab Intravenous Dosing Regimens in MBC, EBC and AGC Patients
Danish: Tabel 15: Populationsforudsagte steady-state farmakokinetiske eksponeringsværdier (med 5-95 percentiler) for trastuzumab intravenøse doseringsregimer hos patienter med metastatisk brystkræft, tidlig brystkræft og fremskreden ventrikelkræft.
English: This yields a 7.4 mL solution for single-dose use, containing approximately 21 mg/mL trastuzumab, at a pH of approximately 6.0.
Danish: Resultatet er en 7,4 ml opløsning til enkeltdosisbrug, som indeholder ca. 21 mg/ml trastuzumab med en pH på ca. 6,0.
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
Danish: Effektresultaterne fra den samlede analyse af NSABP B-31- og NCCTG N9831-studierne efter den endelige analyse af sygdomsfri overlevelse
English: Trazimera 420 mg powder for concentrate for solution for infusion trastuzumab
Danish: Trazimera 420 mg pulver til koncentrat til infusionsvæske, opløsning trastuzumab
English: • neck pain
Danish: •acne kløen
English: Ejection fraction decreased
Danish: Nedsat iltmætning
English: which was followed by • CMF on day 1 and 8 every 4 weeks for 3 cycles which was followed after surgery by • additional cycles of adjuvant trastuzumab (to complete 1 year of treatment)
Danish: som efter operation blev efterfulgt af: Yderligere serier af adjuverende trastuzumab (indtil 1 års behandling var fuldført).
English: • abnormal heart rhythm
Danish: • unormal hjerterytme
English: Table 14 Population Predicted Cycle 1 PK Exposure Values (median with 5th - 95th Percentiles) for Trastuzumab Intravenous Dosing Regimens in MBC, EBC and AGC Patients Regimen
Danish: Tabel 14: Populations-forudsagte farmakokinetiske eksponeringsværdier (median med 595 percentiler) i serie 1 for trastuzumab intravenøse doseringsregimer hos patienter med metastatisk brystkræft, tidlig brystkræft og fremskreden ventrikelkræft.
English: Trazimera 420 mg powder for concentrate for solution for infusion
Danish: Trazimera 420 mg pulver til koncentrat til infusionsvæske, opløsning
English: België/Belgique/Belgien Luxembourg/Luxemburg Pfizer NV/SA Tél/Tel: +32 (0)2 554 62 11
Danish: België/Belgique/Belgien Luxembourg/Luxemburg Pfizer NV/SA.
English: - The NSABP B-31 and NCCTG N9831 studies that comprise the joint analysis were designed to investigate the clinical utility of combining trastuzumab treatment with paclitaxel following AC chemotherapy, additionally the NCCTG N9831 study also investigated adding trastuzumab sequentially to AC→P chemotherapy in patients with HER2 positive EBC following surgery.
Danish: NSABP B-31- og NCCTG N9831-studierne, som udgør den samlede analyse, var designet til at undersøge den kliniske anvendelighed af at kombinere trastuzumab-behandling med paclitaxel efter AC-kemoterapi.
English: Trazimera and anthracyclines should not be given concurrently in combination in the MBC setting.
Danish: Trazimera og antracykliner bør ikke anvendes i kombination hos patienter med metastatisk brystkræft.
English: METHOD OF ADMINISTRATION
Danish: ANVENDELSESMÅDE OG ADMINISTRATIONSVEJ
English: Tumour cell cluster with a faint ⁄ barely perceptible membranous reactivity irrespective of percentage of tumour cells stained
Danish: Tumorcellegruppe med en svag/lige akkurat synlig membranøs reaktivitet uden hensyntagen til procentdelen af farvede tumorceller
English: Hazard Ratio versus AC→P (95% CI)
Danish: Hazard ratio versus AC→P (95 % konfidensinterval)
English: In the pivotal trial BO22227, trastuzumab was administered concurrently with neoadjuvant chemotherapy that contained four cycles of epirubicin (cumulative dose 300 mg/m2); at a median follow-up exceeding 70 months, the incidence of cardiac failure/congestive cardiac failure was 0.3% in the trastuzumab intravenous arm.
Danish: I det pivotale studie BO22227 blev trastuzumab administreret samtidig med neoadjuverende kemoterapi, der indeholdt 4 serier med epirubicin (kumulativ dosis 300 mg/m2).
English: No staining is observed or membrane staining is observed in <10% of the tumour cells
Danish: Der ses ingen farvning eller membranfarvning ses i < 10 % af tumorcellerne.
English: Disease-free survival No. patients with event p=0.0003
Danish: Sygdomsfri overlevelse p = 0,0003
English: Pleural effusion
Danish: Makulopapuløst udslæt
English: Tell your doctor, pharmacist or nurse if you are taking, have recently taken or may take any other medicines.
Danish: Brug af anden medicin sammen med Trazimera Fortæl det altid til lægen, apotekspersonalet eller sundhedspersonalet, hvis du tager anden medicin eller har gjort det for nylig.
English: [0.54, 0.69]) showed a similar DFS benefit compared to the definitive primary DFS analysis, despite 24.8% patients in the AC→P arm who crossed over to receive trastuzumab.
Danish: Resultatet af den opdaterede analyse af sygdomsfri overlevelse (stratificeret hazard ratio=0,61; 95 % konfidensinterval [0,54- 0,69]) viste lignende gavnlig effekt med hensyn til sygdomsfri overlevelse sammenlignet med den endelige primære analyse af sygdomsfri overlevelse på trods af, at 24,8 % af patienterne i AC→P armen skiftede til at få trastuzumab.
English: Uncommon: may affect up to 1 in 100 people
Danish: Ikke almindelige:kan forekomme hos op til 1 ud af 100 patienter døvhed ujævnt udslæt infektion i blodet
English: Trazimera 150 mg powder for concentrate for solution for infusion trastuzumab
Danish: Trazimera 150 mg pulver til koncentrat til infusionsvæske, opløsning trastuzumab
English: Hazard Ratio vs AC→P (95% CI) p-value
Danish: Hazard ratio versus AC→P (95 % konfidensinterval) p-værdi
English: Table 7 Summary of Efficacy results from the joint analysis of the NSABP B-31 and NCCTG N9831 trials at the time of the definitive DFS analysis
Danish: Resumé af effektresultater fra den samlede analyse af NSABP B-31- og NCCTG N9831studierne efter den endelige analyse af sygdomsfri overlevelse*
English: Trazimera vial
Danish: Trazimera hætteglas
English: Distant disease-free survival - No. patients with event - No. patients without event P-value versus Observation Hazard Ratio versus Observation
Danish: Hazard ratio versus observation Tilbagefaldsfri overlevelse - Antal patienter med en hændelse - Antal patienter uden en hændelse p-værdi versus observation Hazard ratio versus observation Distant sygdomsfri overlevelse - Antal patienter med en hændelse
English: • inflammation of the breast
Danish: •angst betændelse i brystet
English: Distant recurrence No. patients with event p=0.0008
Danish: Antal patienter med en hændelse p=0,0275
English: Overall survival (death) - No. patients with event - No. patients without event P-value versus Observation Hazard Ratio versus Observation
Danish: - Antal patienter uden en hændelse p-værdi versus observation Hazard ratio versus observation Samlet overlevelse (død) - Antal patienter med en hændelse - Antal patienter uden en hændelse p-værdi versus observation Hazard ratio versus observation
English: • numbness or tingling of the fingers and toes
Danish: •kramper i benene mund-og hudtørhed
English: Recurrence-free survival - No. patients with event - No. patients without event P-value versus Observation Hazard Ratio versus Observation
Danish: Sygdomsfri overlevelse - Antal patienter med en hændelse - Antal patienter uden en hændelse p-værdi versus observation
English: Hazard Ratio vs AC→D (95% CI) p-value
Danish: Hazard ratio versus AC→D (95 % konfidensinterval) p-værdi
English: • hair loss
Danish: • hævelse af hjernen
English: • throat infections
Danish: •unormale tanker nyresygdomme