FrancophonIA/ELRC3.0 huggingface dataset:
English: In cynomolgus monkeys, weekly intravenous administration of pertuzumab at doses up to 150 mg/kg/dose was generally well tolerated.
Danish: Ugentlig intravenøs administration af pertuzumab i doser på op til 150 mg/kg var generelt veltolereret hos cynomolgus-aber.
English: In addition, ADRs reported in the post-marketing setting are included in Table 2.
Danish: I tabel 2 inkluderes desuden bivirkninger indberettet efter markedsføring.
English: In repeated dose toxicity studies in cynomolgus monkeys, no definitive conclusions could be drawn on the adverse effect on male reproductive organs.
Danish: Fra toksicitetsstudier i cynomolgus aber med gentagen dosering, kan der ikke drages nogle endelige konklusioner om bivirkninger på hanners reproduktionssystem.
English: In the pivotal trial CLEOPATRA, the initial dose of Perjeta was given the day before trastuzumab and docetaxel to allow for the examination of Perjetaassociated reactions.
Danish: I samme studie blev initialdosis af Perjeta givet dagen før trastuzumab og docetaxel, så patienten kunne vurderes for Perjeta-relaterede reaktioner.
English: Docetaxel was given intravenously at an initial dose of 75 mg/ m2 followed by 75 mg/ m2 or 100 mg/ m2 (if tolerated) every 3 weeks.
Danish: Docetaxel blev givet intravenøst med en initialdosis på 75 mg/m2 efterfulgt af 75 mg/m2 eller 100 mg/m2 (hvis tolereret) hver 3. uge.
English: Close observation of the patient during and for 60 minutes after the first infusion and during and for 30-60 minutes after subsequent infusions of Perjeta is recommended.
Danish: Det anbefales derfor, at patienten observeres omhyggeligt under den første infusion med Perjeta, og 60 minutter efter infusionen er afsluttet, samt under efterfølgende infusioner, og 30-60 minutter efter infusionen er afsluttet.
English: Nervous system disorders Neuropathy peripheral Headache
Danish: Perifer neuropati Hovedpine Smagsforstyrrelser Perifer sensorisk neuropati Svimmelhed Paræstesier
English: Following surgery all patients received 3 cycles of 5fluorouracil (600 mg/m2), epirubicin (90 mg/m2), cyclophosphamide (600 mg/m2) (FEC) given intravenously every three weeks, and trastuzumab administered intravenously every three weeks to complete one year of therapy.
Danish: Efter operation fik alle patienterne 3 serier bestående af 5fluoruracil (600 mg/m2), epirubicin (90 mg/m2) og cyclophosphamid (600 mg/m2) intravenøst med 3 uger intervaller samt trastuzumab intravenøst hver 3. uge for at fuldføre 1 års behandling.
English: The most common ADRs (≥30%) from this pooled data were diarrhoea, alopecia, nausea, fatigue,
Danish: De mest almindelige bivirkninger (≥ 30%) i disse poolede data var diarré, alopeci, kvalme, træthed, neutropeni og opkastning.
English: Vacaville, CA 95688-9431
Danish: 1000 New Horizons Way Vacaville, CA 95688-9431 USA
English: Paronychia Upper respiratory tract infection
Danish: Paronykie Øvre luftvejsinfektion
English: The most common infusion reactions (≥ 1.0%) in the Perjeta-treated group were pyrexia, chills, fatigue, headache, asthenia, hypersensitivity and vomiting.
Danish: De hyppigste infusionsreaktioner (≥ 1,0%) i Perjetagruppen var pyreksi, kulderystelser, træthed, hovedpine, asteni, overfølsomhed og opkastning.
English: The other ingredients are glacial acetic acid, L-histidine, sucrose, polysorbate 20 and water for injections
Danish: • Øvrige indholdsstoffer: iseddikesyre, L-histidin, saccharose, polysorbat 20 og vand til injektionsvæsker.
English: An infusion reaction was defined in the pivotal trials as any event reported as hypersensitivity, anaphylactic reaction, acute infusion reaction or cytokine release syndrome occurring during an infusion or on the same day as the infusion.
Danish: I de pivotale studier defineredes en infusionsreaktion som enhver bivirkning, der forekom under infusionen eller på infusionsdagen, og som blev rapporteret som overfølsomhed, anafylaktisk reaktion, akut infusionsreaktion eller cytokinfrigivelsessyndrom.
English: pCR rate in the breast (ypT0/is)
Danish: pCR-rate i brystet (ypT0/is)
English: However, in the group treated with Perjeta in combination with TCH, docetaxel was given intravenously at 75 mg/m2 (no escalation was permitted) and carboplatin (AUC 6) was given intravenously every three weeks.
Danish: Dog blev der i gruppen behandlet med Perjeta i kombination med docetaxel, carboplatin og trastuzumab givet 75 mg/m2 intravenøs docetaxel (optrapning ikke tilladt) og intravenøs carboplatin (AUC 6) hver 3. uge.
English: Secondary efficacy endpoints were IDFS including second primary non-breast cancer, overall survival (OS), disease-free survival (DFS), recurrence-free interval (RFI) and distant recurrence-free interval (DRFI).
Danish: Sekundære effektendepunkter var invasiv sygdomsfri overlevelse inklusive anden primær kræft (ikke bryst), samlet overlevelse, sygdomsfri overlevelse, recidiv-frit interval samt fjernrecidiv-frit interval.
English: Perjeta must be permanently discontinued in case of NCI-CTCAE Grade 4 hypersensitivity reactions (anaphylaxis), bronchospasm or acute respiratory distress syndrome (see section 4.2).
Danish: Perjeta skal seponeres permanent i tilfælde af NCI-CTCAE grad 4 overfølsomhedsreaktioner (anafylaksi), bronkospasmer eller akut lungesvigt (se pkt.
English: Approximately half the patients in each treatment group had ER-positive and/or PgR-positive disease.
Danish: Ca. halvdelen af patienterne i hver behandlingsgruppe havde østrogenreceptor-positiv og/eller progesteronreceptorpositiv sygdom.
English: Glacial acetic acid, L-histidine, sucrose and polysorbate 20.
Danish: LISTE OVER HJÆLPESTOFFER Iseddikesyre, L-histidin, saccharose og polysorbat 20.
English: PHARMACEUTICAL FORM AND CONTENTS Concentrate for solution for infusion 420 mg/14 ml
Danish: LÆGEMIDDELFORM OG INDHOLD (PAKNINGSSTØRRELSE) Koncentrat til infusionsvæske, opløsning 420 mg/14 ml
English: Chest symptoms such as a dry cough or breathlessness (possible signs of interstitial lung disease, a condition of damage to the tissues around the air sacs in the lungs) Fluid around the lungs causing difficulty in breathing
Danish: • Symptomer fra brystet, såsom tør hoste eller åndenød (kan være et tegn på interstitiel lungesygdom, der er en sygdom, hvor vævet omkring luftsækkende i lungerne er beskadiget)
English: Patients with early breast cancer
Danish: Patienter med tidlig brystkræft
English: FEC (5-fluorouracil [500 mg/m2], epirubicin [100 mg/m2], cyclophosphamide [600 mg/m2]) were given intravenously every three weeks for 3 cycles.
Danish: 5-fluoruracil (500 mg/m2), epirubicin (100 mg/m2) og cyclophosphamid (600 mg/m2) blev givet intravenøst hver 3. uge i 3 serier.
English: It is a clear to slightly pearly (opalescent), colourless to pale yellow liquid.
Danish: Det er en klar til let opaliserende, farveløs til svagt gul væske.
English: Dose reductions are not recommended for Perjeta or trastuzumab.
Danish: Dosisreduktion af Perjeta og trastuzumab frarådes.
English: pCR rate in the breast and lymph node (ypT0/is N0)
Danish: pCR-rate i brystet og lymfeknude (ypT0/is N0)
English: Do not use this medicine after the expiry date which is stated on the outer carton after EXP.
Danish: • Brug ikke Perjeta efter den udløbsdato, der står på pakningen efter Exp. Udløbsdatoen er den sidste dag i den nævnte måned.
English: • the neoadjuvant treatment of adult patients with HER2-positive, locally advanced, inflammatory, or early stage breast cancer at high risk of recurrence (see section 5.1)
Danish: • Neoadjuverende behandling af voksne patienter med HER2-positiv, lokalt avanceret eller inflammatorisk brystkræft eller tidlig brystkræft med høj risiko for tilbagefald (se pkt.
English: Number of IDFS events/Total N (%)
Danish: Antallet af invasiv sygdomsfri overlevelsestilfælde/Samlet antal (%)
English: Left ventricular dysfunction
Danish: Dysfunktion af venstre ventrikel
English: Other medicines and Perjeta Tell your doctor or nurse if you are taking, have recently taken or might take any other medicines.
Danish: Fortæl det altid til lægen eller sundhedspersonalet, hvis du bruger anden medicin eller har gjort det for nylig.
English: There was no evidence of any PK interaction between pertuzumab and any of these agents.
Danish: Der sås ingen tegn på farmakokinetisk interaktion mellem pertuzumab og disse lægemidler.
English: How you are given Perjeta
Danish: Sådan får du Perjeta
English: You will also be given trastuzumab and chemotherapy.
Danish: • Vil du også få trastuzumab og kemoterapi
English: Diarrhoea symptoms returned to baseline after HER2 therapy in the Perjetaarm.
Danish: I Perjeta-armen svandt diarrésymptomerne til baseline niveau efter HER2-behandling.
English: In both the TRYPHAENA and APHINITY trials, the overall frequency of hypersensitivity/anaphylaxis was highest in the Perjeta and TCH treated group (13.2% and 7.6%, respectively), of which 2.6% and 1.3% of events, respectively, were NCI-CTCAE Grade 3-4.
Danish: I både TRYPHAENA- og APHINITY-studiet var den samlede frekvens af overfølsomhed/anafylaksi højest i gruppen behandlet med Perjeta og docetaxel, carboplatin og trastuzumab (henholdsvis 13,2% og 7,6%), hvoraf henholdsvis 2,6% og 1,3% af tilfældene var NCI-CTCAE grad 3-4.
English: Approximately half the patients in each treatment group had hormone receptor-positive disease (defined as ER positive and/or PgR positive).
Danish: Ca. halvdelen af patienterne i hver behandlingsgruppe havde hormonreceptor-positiv sygdom (defineret som østrogenreceptor-positiv og/eller progesteronreceptor-positiv).
English: Common (may affect up to 1 in 10 people):
Danish: Almindelige (kan påvirke op til 1 ud af 10 patienter):
English: In the pivotal trial CLEOPATRA, the majority of patients in both treatment groups experienced at least one leucopenic event (63.0% of patients in the Perjeta-treated group and 58.3% of patients in the placebo-treated group), of which the majority were neutropenic events (see section 4.4).
Danish: I det pivotale studie CLEOPATRA oplevede størstedelen af patienterne i begge behandlingsgrupper mindst et tilfælde af leukopeni (63,0% i Perjeta-gruppen og 58,3% i placebo-gruppen), som i de fleste tilfælde var neutropeni (se pkt.
English: In the neoadjuvant and adjuvant trials, hypersensitivity/anaphylaxis events were consistent with those observed in CLEOPATRA.
Danish: Tilfælde af overfølsomhed/anafylaksi var sammenlignelige i de neoadjuverende og adjuverende studier og med dem observeret i CLEOPATRA.
English: Across all clinical studies, the volume of distribution of the central (Vc) and the peripheral (Vp) compartment in the typical patient, was 3.11 litres and 2.46 litres, respectively.
Danish: Distributionsvoluminet af det centrale og det perifere kompartment er i en typisk patient på henholdsvis 3,11 og 2,46 liter i alle kliniske studier.
English: In the pivotal trial CLEOPATRA in metastatic breast cancer, the overall frequency of investigator reported hypersensitivity/anaphylaxis events during the entire treatment period was 9.3% in the placebo-treated group and 11.3% in the Perjeta-treated group, of which 2.5% and 2.0% were NCI-CTCAE Grade 3-4, respectively.
Danish: I det pivotale studie CLEOPATRA med metastatisk brystkræft var den samlede hyppighed af overfølsomhed/anafylaksi rapporteret af investigator under hele behandlingsperioden 9,3% i placebo gruppen og 11,3% i Perjeta-gruppen, hvoraf henholdsvis 2,5% og 2% var af NCI-CTCAE-grad 3-4.
English: Figure 1 IRF-assessed PFS by patient subgroup
Danish: Figur 1 Uafhængigt vurderet progressionsfri overlevelse for hver patient-subgruppe
English: Your doctor or nurse will check for side effects during your infusion and for 30 to 60 minutes afterwards.
Danish: Lægen eller sygeplejersken vil holde øje med, om du får bivirkninger under infusionen og i 30 til 60 minutter efter, infusionen er afsluttet.
English: Randomisation was stratified by breast cancer type (operable, locally advanced, or inflammatory) and ER and /or PgR positivity.
Danish: Randomisering var stratificeret efter typen af brystkræft (operabel, lokalt avanceret eller inflammatorisk) og østrogenreceptor-positivitet og/eller progesteronreceptor-positivitet.
English: Pertuzumab was given intravenously at an initial dose of 840 mg, followed by 420 mg every three weeks.
Danish: Pertuzumab blev givet intravenøst med en initialdosis på 840 mg efterfulgt af 420 mg hver 3. uge.
English: • a drop in LVEF to less than 40% • a LVEF of 40%-45% associated with a fall of ≥ 10% points below pre-treatment value.
Danish: • Et LVEF på 40-45% i forbindelse med et fald på ≥ 10% point i forhold til værdien inden behandling.
English: Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
Danish: Overfølsomhed over for det aktive stof eller et eller flere af hjælpestofferne anført i pkt.
English: Once the infusion is prepared it should be administered immediately (see section 6.3).
Danish: Infusionsvæsken bør administreres straks efter tilberedning (se pkt.
English: declines in LVEF of at least 10% points from baseline and to <50% were reported in 2.7% of Perjetatreated patients and 2.8% of placebo-treated patients, of whom 79.7% of Perjeta-treated patients and
Danish: Asymptomatiske eller lette symptomatiske (NYHA klasse II) fald i LVEF på mindst 10% fra baseline og indtil < 50% blev indberettet hos 2,7% af de Perjeta-behandlede patienter og 2,8% af de placebo-behandlede patienter, hvoraf 79,7% af de Perjeta-behandlede patienter og 80,6% af de placebo-behandlede patienter var restitueret ved data cutoff.
English: If you have ever had a chemotherapy medicine from the class called anthracyclines, e.g. doxorubicin or epirubicin - these medicines can damage heart muscle and increase the risk of heart problems with Perjeta.
Danish: For eksempel doxorubicin eller epirubicin - denne type medicin kan skade hjertet og øge risikoen for, at du får hjerteproblemer med Perjeta.
English: Common (≥ 1/100 to < 1/10) Uncommon( ≥ 1/1,000 to < 1/100) Rare (≥ 1/10,000 to < 1/1,000) Very rare (< 1/10,000)
Danish: Sjælden (≥1/10.000 til <1/1.000)
English: APHINITY is a multicentre, randomised, double-blind, placebo-controlled Phase III trial conducted in 4804 patients with HER2-positive early breast cancer who had their primary tumour excised prior to randomisation.
Danish: APHINITY er et randomiseret, dobbelt-blindet, placebo-kontrolleret, fase III-multicenterstudie udført hos 4804 patienter med HER2-positiv tidlig brystkræft, som havde fået fjernet primærtumor inden randomisering.
English: In the TRYPHAENA study, Perjeta was given concurrently with epirubicin, as part of the FEC (5-fluorouracil, epirubicin, cyclophosphamide) regimen (see sections 4.8 and 5.1).
Danish: I TRYPHAENA-studiet blev Perjeta administreret samtidigt med epirubicin, som en del af 5-fluorouracil, epirubicin, cyclophosphamid-regimet (se pkt.
English: The cancer has not spread to other parts of the body and treatment is going to be given before surgery takes place (treatment before surgery is called neoadjuvant therapy) The cancer has not spread to other parts of the body and treatment is going to be given after surgery (treatment after surgery is called adjuvant therapy)
Danish: • Kræften ikke har spredt sig til andre dele af kroppen, og behandlingen vil blive givet før operation (behandling før operation kaldes neoadjuverende behandling)
English: Randomisation was stratified by breast cancer type (operable, locally advanced, or inflammatory) and ER or PgR positivity.
Danish: Randomisering var stratificeret efter typen af brystkræft (operabel, lokalt avanceret eller inflammatorisk) og østrogenreceptor-positivitet eller progesteronreceptor-positivitet.
English: The mean decrease from baseline at that time for physical function was -10.7 (95% CI-11.4, -10.0) in the Perjeta arm and -10.6 (95% CI -11.4, -9.9) in the placebo arm; global health status was -11.2 (95% CI -12.2, -10.2) in the Perjeta arm and -10.2
Danish: På det tidspunkt var det gennemsnitlige fald fra baseline i fysisk funktionsniveau -10,7 (95% konfidensinterval -11,4; -10,0) i Perjeta-armen og -10,6 (95% konfidensinterval -11,4; -9,9) i placebo-armen.
English: The dose of docetaxel could be escalated to 100 mg/m2 at the investigator's discretion if the initial dose was well tolerated.
Danish: Dosis af docetaxel kunne efter investigators skøn titreres op til 100 mg/m2, såfremt initialdosis var veltolereret.
English: Trastuzumab was given intravenously at an initial dose of 8 mg/kg, followed by 6 mg/kg every three weeks.
Danish: Trastuzumab blev givet intravenøst med en initialdosis på 8 mg/kg efterfulgt af 6 mg/kg hver 3. uge.
English: Your doctor or nurse will check for side effects during your infusion and for 60 minutes afterwards.
Danish: Lægen eller sundhedspersonalet vil holde øje med, om du får bivirkninger under infusionen og i 60 minutter efter, infusionen er afsluttet
English: You should use effective contraception during treatment with Perjeta and for 6 months after stopping treatment.
Danish: Du skal bruge sikker prævention, mens du er i behandling med Perjeta og i 6 måneder efter, behandlingen er stoppet.
English: In this study, cardiac safety was similar to that observed in patients given the same regimen but with Perjeta administered sequentially (following FEC chemotherapy).
Danish: I dette studie svarede den kardielle sikkerhed til den observeret hos patienter i samme regime, men med Perjeta administreret sekventielt (efter 5-fluorouracil, epirubicin, cyclophosphamidkemoterapi).
English: Placebo + trastuzumab + chemotherapy
Danish: Placebo + trastuzumab + kemoterapi
English: In NEOSPHERE, two patients in the Perjeta and docetaxel-treated group experienced anaphylaxis.
Danish: I NEOSPHERE oplevede 2 patienter i gruppen behandlet med Perjeta og docetaxel anafylaksi.
English: In the pivotal trial CLEOPATRA in metastatic breast cancer, rash occurred in 51.7% of Perjeta-treated patients, compared with 38.9% of placebo-treated patients.
Danish: I det pivotale studie CLEOPATRA med metastatisk brystkræft forekom udslæt hos 51,7% i Perjetagruppen sammenlignet med 38,9% i placebo-gruppen.
English: Docetaxel was given as an initial dose of 75 mg/m2 IV infusion every three weeks with the option to escalate to 100 mg/m2 at the investigator's discretion if the initial dose was well tolerated.
Danish: Docetaxel blev givet med en initialdosis på 75 mg/m2 som intravenøs infusion hver 3. uge med mulighed for at optrappe til 100 mg/m2 efter investigators skøn, hvis initialdosis var veltolereret.
English: The incidence of rash was higher in patients who received six cycles of Perjeta compared with patients who received three cycles of Perjeta, independent of the chemotherapy given.
Danish: Hyppigheden af udslæt var højere hos patienter, der fik 6 serier Perjeta sammenlignet med patienter, der fik 3 serier Perjeta, uafhængig af hvilken kemoterapi, der var givet.
English: Perjeta 420 mg concentrate for solution for infusion pertuzumab
Danish: Perjeta 420 mg koncentrat til infusionsvæske, opløsning pertuzumab
English: Early Breast Cancer
Danish: Tidlig brystkræft
English: Early breast cancer Perjeta is indicated for use in combination with trastuzumab and chemotherapy in:
Danish: Perjeta er i kombination med trastuzumab og kemoterapi indiceret til:
English: Severe hypersensitivity, including anaphylaxis and events with a fatal outcome, has been observed with Perjeta (see section 4.8).
Danish: Der er observeret svære overfølsomhedsreaktioner, herunder anafylaksi og tilfælde med dødeligt udfald,med Perjeta (se pkt.
English: Uncommon (may affect up to 1 in 100 people):
Danish: Sjældne (kan påvirke op til 1 ud af 100 patienter):
English: The estimate of IDFS at 4-years was 92.3% in the Perjeta-treated group versus 90.6% in the placebo treated group.
Danish: Estimat af invasiv sygdomsfri overlevelse efter 4 år var 92,3% i den Perjeta-behandlede gruppe vs. 90,6% i den placebo-behandlede gruppe.
English: The incidence of NCI-CTCAE Grade 3-4 diarrhoea was 9.3% in Perjeta-treated patients vs 5.1% in placebo-treated patients.
Danish: Hyppigheden af NCI-CTCAE grad 3-4 diarré var 9,3% i Perjeta-gruppen imod 5,1% i placebo-gruppen.
English: Treatment including oxygen, beta agonists, antihistamines, rapid i.v.
Danish: Behandling med ilt, beta-agonister, antihistaminer, hurtig intravenøs væskebehandling og antipyretika kan også lindre symptomerne.
English: Heart problems (heart failure) with symptoms that can include cough, shortness of breath, and swelling (fluid retention) in your legs or arms.
Danish: • Hjerteproblemer (hjertesvigt) med symptomer, som kan inkludere hoste, åndenød og hævede ben og arme (væske i kroppen).
English: In the remaining 7 cases the events reported were indeed suggestive of IRR/ hypersensitivity/ anaphylaxis and in 3/7 of them, a causal relationship between the administration of pertuzumab and the fatal event could not be excluded.
Danish: I 3 af disse 7 hændelser kunne en årsagssammenhæng mellem administration af pertuzumab og et dødeligt udfald ikke udelukkes.
English: The recommended initial loading dose of pertuzumab is 840 mg administered as a 60 minute intravenous infusion, followed every 3 weeks thereafter by a maintenance dose of 420 mg administered over a period of 30 to 60 minutes.
Danish: Anbefalet initiale startdosis af pertuzumab er 840 mg administreret som en 60 minutters intravenøs infusion, efterfulgt af en vedligeholdelsesdosis på 420 mg over 30 til 60 minutter hver 3. uge.
English: Perjeta + trastuzumab + chemotherapy
Danish: Perjeta + trastuzumab + kemoterapi
English: Unstratified HR (95% CI)
Danish: Ustratificeret hazard ratio (95% konfidensinterval)
English: In the pivotal trial CLEOPATRA in metastatic breast cancer, the incidence of NCI-CTCAE v.3 Grade 3-4 neutropenia was balanced in the two treatment groups (86.3% of Perjeta-treated patients and 86.6% of placebo-treated patients, including 60.7% and 64.8% Grade 4 neutropenia, respectively).
Danish: I det pivotale studie CLEOPATRA med metastatisk brystkræft var hyppigheden af NCI-CTCAE version 3 grad 3-4 neutropeni ensartet i de to behandlingsgrupper (86,3% i Perjeta-gruppen og 86,6% i placebo-gruppen, inklusive henholdsvis 60,7% og 64,8% grad 4 neutropeni).
English: For instructions on dilution of Perjeta prior to administration, see sections 6.2 and 6.6.
Danish: 6.2 og 6.6. for instruktioner om fortynding af Perjeta før administration.
English: You must not be given Perjeta
Danish: Du må ikke få Perjeta:
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Perjeta 420 mg concentrate for solution for infusion pertuzumab
Danish: LÆGEMIDLETS NAVN, STYRKE OG/ELLER ADMINISTRATIONSVEJ(E) Perjeta 420 mg koncentrat til infusionsvæske, opløsning pertuzumab
English: BERENICE is a non-randomized, open-label, multicentre, multinational, Phase II trial conducted in 401 patients with HER2-positive locally advanced, inflammatory, or early-stage breast cancer (with primary tumours > 2cm in diameter or node-positive disease).
Danish: BERENICE er et ikke-randomiseret, åbent, multicenter, multinationalt fase II-studie udført hos 401 patienter med HER2-positiv lokalt avanceret eller inflammatorisk brystkræft eller tidlig brystkræft (med primær tumorer > 2 cm i diameter eller lymfeknude-positiv).
English: • an IV infusion with an initial loading dose of trastuzumab 8 mg/kg body weight followed every 3 weeks thereafter by a maintenance dose of 6 mg/kg body weight or
Danish: • En intravenøs infusion med en initial startdosis af trastuzumab på 8 mg/kg kropsvægt,
English: The difference in pCR rate is considered likely to translate into a clinically meaningful difference in long term outcomes and is supported by positive trends in PFS (HR 0.69, 95% CI 0.34, 1.40) and DFS (HR 0.60, 95% CI 0.28, 1.27).
Danish: Det anses for sandsynligt, at forskellen i pCR-raten kan overføres til en klinisk betydningsfuld forskel i langsigtede resultater, hvilket understøttes af positive tendenser for progressionsfri overlevelse (hazard ratio 0,69; 95% konfidensinterval 0,34;