FrancophonIA/ELRC3.0 huggingface dataset:
English: TRYPHAENA is a multicentre, randomised phase II clinical trial conducted in 225 adult female patients with HER2-positive locally advanced, operable, or inflammatory breast cancer (T2-4d; primary tumour > 2cm in diameter) who had not received prior trastuzumab, chemotherapy or radiotherapy.
Danish: TRYPHAENA er et randomiseret klinisk fase II multicenterstudie udført hos 225 voksne kvinder med HER2-positiv, lokalt avanceret, operabel eller inflammatorisk brystkræft (T2-4d; primær tumor > 2 cm i diameter), som ikke tidligere havde fået trastuzumab, kemoterapi eller strålebehandling.
English: Perjeta and trastuzumab should be withheld for at least 3 weeks for:
Danish: Behandling med Perjeta og trastuzumab skal afbrydes i mindst tre uger, hvis:
English: Cardiac risk should be carefully considered and balanced against the medical need of the individual patient before use of Perjeta with an anthracycline.
Danish: Før samtidig anvendelse af Perjeta og et antracyklin skal kardielle risikofaktorer nøje overvejes og afbalanceres mod den medicinske nødvendighed hos den enkelte patient.
English: The highest incidence of diarrhoea (all Grades) was reported during the targeted therapy+taxane chemotherapy period (61.4% of patients in the Perjeta arm vs. 33.8% of patients in the placebo arm).The incidence of diarrhoea was much lower after chemotherapy cessation, affecting
Danish: Den højeste forekomst af diarré (alle grader) blev rapporteret i behandlingsperioden med forsøgsbehandling + taxan-kemoterapi (61,4% af patienterne i Perjetaarmen vs. 33,8% af patienterne i placebo-armen).
English: What Perjeta is and what it is used for What you need to know before you are given Perjeta How you are given Perjeta Possible side effects
Danish: Oversigt over indlægssedlen Virkning og anvendelse Det skal du vide, før du begynder at få Perjeta Sådan får du Perjeta
English: One 14 ml vial of concentrate contains 420 mg of pertuzumab at a concentration of 30 mg/ml.
Danish: Et 14 ml hætteglas med koncentrat indeholder 420 mg pertuzumab i en koncentration på 30 mg/ml.
English: Tell a doctor or nurse straight away, if you notice any of the following side effects: Very severe or persistent diarrhoea (7 or more stools per day).
Danish: • Meget svær eller vedvarende diarré (7 eller flere afføringer om dagen).
English: of Perjeta-treated patients and 57.1% of placebo-treated patients had recovered (defined as 2
Danish: Af de patienter, der oplevede symptomatisk hjerteinsufficiens, var 46,7% af de Perjeta-behandlede patienter og 57,1% af de placebo-behandlede patienter restitueret (defineret som to på hinanden følgende LVEF-målinger over 50%) ved data cutoff.
English: † ADRs reported in the post marketing setting
Danish: † Bivirkninger indberettet efter markedsføring.
English: Perjeta has been associated with infusion reactions, including events with a fatal outcome (see section 4.8).
Danish: Der er observeret infusionsreaktioner i forbindelse med brug af Perjeta, inklusive tilfælde med dødeligt udfald (se pkt.
English: Pertuzumab and trastuzumab were administered intravenously (see section 4.2) every 3 weeks starting on Day 1 of the first taxane-containing cycle, for a total of 52 weeks (up to 18 cycles) or until recurrence, withdrawal of consent or unmanageable toxicity.
Danish: 4.2) hver 3. uge med start på dag 1 i den første taxan-holdige serie, i alt 52 uger (op til 18 serier) eller indtil recidiv, tilbagetrækning af informeret samtykke eller uacceptabel toksicitet.
English: How Perjeta works
Danish: Hvordan virker Perjeta?
English: In the pivotal trial CLEOPATRA in metastatic breast cancer, diarrhoea occurred in 68.4% of Perjetatreated patients and 48.7% of placebo-treated patients (see section 4.4).
Danish: I det pivotale studie CLEOPATRA med metastatisk brystkræft forekom diarré hos 68,4% i Perjetagruppen og hos 48,7% i placebo-gruppen (se pkt.
English: Left ventricular dys function **
Danish: Dysfunktion af venstre ventrikel **
English: In the APHINITY trial, the incidence of NCI-CTCAE v.4 Grade 3-4 neutropenia was 40.6% in patients treated with Perjeta, trastuzumab and chemotherapy compared with 39.1% in patients treated with placebo, trastuzumab and chemotherapy, including 28.3% and 26.5% Grade 4 neutropenia,
Danish: I APHINITY-studiet var hyppigheden af NCI-CTCAE (version 4) grad 3-4 neutropeni 40,6% hos patienter behandlet med Perjeta, trastuzumab og kemoterapi sammenlignet med 39,1% hos patienter behandlet med placebo, trastuzumab og kemoterapi, inklusive henholdsvis 28,3% og 26,5% grad 4 neutropeni.
English: Compared with published data for similar regimens without pertuzumab, high pCR rates were observed in all 3 treatment arms (see Table 4).
Danish: Der blev observeret høje pCR-rater i alle tre behandlingsarme (se tabel 4) sammenlignet med publicerede data for lignende behandlingsregimer uden pertuzumab.
English: Baseline albumin and lean body weight were the most significant covariates influencing CL. CL decreased in patients with higher baseline albumin concentrations and increased in patients with greater lean body weight.
Danish: Clearance faldt hos patienter med høje albumin-koncentrationer ved baseline og steg hos patienter med høj kropsvægt.
English: Docetaxel was given as an initial dose of 75 mg/m2 as an intravenous infusion every three weeks for at least 6 cycles.
Danish: Docetaxel blev givet som intravenøs infusion med en initialdosis på 75 mg/m2 hver 3. uge i mindst 6 serier.
English: Each vial contains a total of 420 mg pertuzumab at a concentration of 30 mg/ml
Danish: Hvert hætteglas indeholder i alt 420 mg pertuzumab i en koncentration på 30 mg/ml.
English: n (%) [95% CI]
Danish: n (%)
English: Demographics were well balanced between arms (median age was 49-50 years, the majority were
Danish: Demografien var velbalanceret imellem behandlingsarmene (median-alder 49-50 år, størstedelen var kaukasiere (77%)), og alle patienter var kvinder.
English: Fever
Danish: • Feber
English: STATEMENT OF ACTIVE SUBSTANCE(S) One 14 ml vial contains 420 mg of pertuzumab at a concentration of 30 mg/ml.
Danish: ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER Et 14 ml hætteglas indeholder 420 mg pertuzumab i en koncentration på 30 mg/ml.
English: In the APHINITY trial, the adverse event of rash occurred in 25.8% of patients in Perjeta arm vs. 20.3% of patients in placebo arm.
Danish: I APHINITY-studiet oplevede 25,8% af patienterne i Perjeta-armen bivirkninger i form af udslæt vs. 20,3% af patienterne i placebo-armen.
English: • Perjeta plus trastuzumab and docetaxel
Danish: • Perjeta plus trastuzumab og docetaxel
English: • Cohort A - 4 cycles of two weekly dose-dense doxorubicin and cyclophosphamide followed by 4 cycles of Perjeta in combination with trastuzumab and paclitaxel.
Danish: • Gruppe A - 4 serier af to ugentlige doxorubicin og cyclophosphamid (kemoterapi med kortere intervaller (dose-dense)) efterfulgt af 4 serier af Perjeta i kombination med trastuzumab og paclitaxel
English: Perjeta + trastuzumab + Chemotherapy N=2400
Danish: Perjeta + trastuzumab + kemoterapi N=2400
English: Perjeta is given with other cancer treatments (trastuzumab andchemotherapy).
Danish: • Perjeta gives sammen med anden kræftmedicin (trastuzumab og kemoterapi).
English: The results for investigator-assessed PFS were similar to those observed for IRF-assessed PFS.
Danish: Resultaterne for progressionsfri overlevelse vurderet af investigator svarede til dem, der blev vist for den uafhængigt vurderede progressionsfrie overlevelse.
English: In the hormone receptor-positive subgroup estimates of IDFS rates were 94.8% versus 94.4% at 3 years and 93.0% versus 91.6% at 4 years in Perjeta-treated patients versus placebo-treated patients, respectively.
Danish: I subgruppen med hormonreceptor-positiv sygdom, var invasiv sygdomsfri overlevelses-raten 94,8% vs. 94,4% efter 3 år og 93,0% vs. 91,6% efter 4 år hos henholdsvis Perjeta-behandlede patienter og placebo-behandlede patienter.
English: A post hoc exploratory analysis revealed that for patients who had received prior trastuzumab (n = 88), the hazard ratio for IRF-assessed PFS was 0.62 (95% CI 0.35, 1.07), compared with 0.60 (95% CI 0.43, 0.83) for patients who had received prior therapy which did not include trastuzumab (n = 288).
Danish: En post-hoc eksplorativ analyse viste, at for patienter, der tidligere havde fået trastuzumab (n = 88), var hazard ratio for den uafhængigt vurderede progressionsfrie overlevelse 0,62 (95% konfidensinterval 0,35-1,07) sammenlignet med
English: Patients were randomised to receive one of the following neoadjuvant regimens for 4 cycles prior to surgery:
Danish: Patienterne blev randomiseret til at få 4 serier af ét af følgende neoadjuverende behandlingsregimer inden operation:
English: [95% CI]
Danish: [95% KI] ypT0 N0
English: Estimates of IDFS rates in the lymph node- positive subgroup were 92.0% versus 90.2% at 3 years and 89.9% vs. 86.7% at 4 years in Perjeta-treated patients versus placebo-treated patients, respectively.
Danish: Den estimerede invasiv sygdomsfri overlevelses-rate i subgruppen med lymfeknude-positiv sygdom var 92,0% vs. 90,2% efter 3 år og 89,9% vs. 86,7% efter 4 år hos henholdsvis Perjeta-behandlede patienter og placebo-behandlede patienter.
English: Perjeta+ Trastuzuma b N=107
Danish: Perjeta + trastuzumab N=107
English: You will also be given trastuzumab and chemotherapyl.
Danish: Udover Perjeta vil du også få trastuzumab og kemoterapi.
English: IDFS= invasive disease free survival; CI= confidence interval; Pla= placebo; Ptz= pertuzumab (Perjeta); T= trastuzumab.
Danish: Pla= placebo; Ptz= pertuzumab (Perjeta); T= trastuzumab.
English: Before starting treatment, you must tell your doctor or nurse if you are pregnant or breast-feeding, or if you think you may be pregnant or are planning to have a baby.
Danish: Hvis du er gravid eller ammer, har mistanke om, at du er gravid, eller planlægger at blive gravid, skal du spørge din læge eller sundhedspersonalet til råds, før du begynder behandlingen med Perjeta.
English: (71.2%) compared to the placebo arm (45.2%).
Danish: I APHINITY-studiet blev der indberettet en højere forekomst af diarré i Perjeta-armen (71,2%) sammenlignet med placebo-armen (45,2%).
English: Vial (Type I glass) with a stopper (butyl rubber) containing 14 ml of solution.
Danish: 14 ml opløsning i et hætteglas (Type I glas) med prop (butylgummi).
English: decline of at least 10% points from baseline and to <50% was <1% (0.6% of Perjeta-treated patients vs 0.3% of placebo-treated patients).
Danish: I APHINITY-studiet var forekomsten af symptomatisk hjerteinsufficiens (NYHA klasse III eller IV) med et fald i LVEF på mindst 10% fra baseline og indtil < 50%, på < 1% (0,6% af de Perjetabehandlede patienter vs. 0,3% af de placebo-behandlede patienter).
English: NEOSPHERE is a phase II, multicentre, multinational randomised controlled trial with Perjeta and was conducted in 417 adult female patients with newly diagnosed, early, inflammatory or locally advanced HER2-positive breast cancer (T2-4d; primary tumour > 2cm in diameter) who had not received prior trastuzumab, chemotherapy or radiotherapy.
Danish: NEOSPHERE er et multinationalt, randomiseret, kontrolleret fase II-multicenterstudie med Perjeta, der blev gennemført med 417 voksne kvinder r med nyligt diagnosticeret tidlig inflammatorisk eller lokalt avanceret HER2-positiv brystkræft (T2-d4; primær tumor > 2 cm i diameter), der ikke tidligere havde fået trastuzumab, kemoterapi eller strålebehandling.
English: Objective Response Rate (ORR)^ - secondary endpoint no. of patients with measurable disease
Danish: Antal patienter med en hændelse Median antal måneder Objektiv responsrate^sekundært endepunkt Antal patienter med målbar sygdom
English: Тел: +359 2 818 44 44
Danish: Рош България ЕООД Тел: +359 2 818 44 44
English: 0.81; 95% CI 0.66, 1.00 p-value 0.0446) reduction in risk of recurrence or death in patients randomised to receive Perjeta compared with patients randomised to receive placebo.
Danish: Efter en median-opfølgning på 45,4 måneder, viste data fra APHINITY-studiet et fald på 19% (hazard ratio [HR] = 0,81; 95% konfidensinterval 0,66-1,00 p-værdi 0,0446) i risiko for recidiv eller død hos patienter randomiseret til at få Perjeta sammenlignet med patienter randomiseret til at få placebo.
English: In the NEOSPHERE trial, diarrhoea occurred in 45.8% of patients treated with neoadjuvant Perjeta, trastuzumab and docetaxel compared with 33.6% of patients treated with trastuzumab and docetaxel.
Danish: I NEOSPHERE-studiet forekom diarré hos 45,8% af patienterne behandlet med neoadjuverende Perjeta, trastuzumab og docetaxel sammenlignet med 33,6% af patienterne behandlet med trastuzumab og docetaxel.
English: In addition, in the population PK analysis, no evidence of a drug-drug interaction has been shown between pertuzumab and trastuzumab or between pertuzumab and docetaxel.
Danish: Derudover er der ikke set lægemiddelinteraktion mellem pertuzumab og trastuzumab eller mellem pertuzumab og docetaxel i den populationsfarmakokinetiske analyse.
English: In NEOSPHERE, 8.3% of Asian patients treated with neoadjuvant Perjeta, trastuzumab and docetaxel experienced febrile neutropenia compared with 4.0% of Asian patients treated with neoadjuvant trastuzumab and docetaxel.
Danish: I NEOSPHERE oplevede 8,3% af de asiatiske patienter behandlet med neoadjuverende Perjeta, trastuzumab og docetaxel febril neutropeni sammenlignet med 4,0% af asiatiske patienter behandlet med neoadjuverende trastuzumab og docetaxel.
English: Name and address of the manufacturer responsible for batch release Roche Pharma AG
Danish: Navn og adresse på den fremstiller, der er ansvarlig for batchfrigivelse
English: Perjeta and trastuzumab may be resumed if the LVEF has recovered to ≥50% or to a difference of
Danish: Behandling med Perjeta og trastuzumab kan genoptages hvis LVEF forbedres til ≥ 50% eller til en forskel på <10% point i forhold til værdierne inden behandling.
English: Glacial acetic acid L-Histidine Sucrose
Danish: Iseddikesyre L-histidin
English: • 3 or 4 cycles of FEC or 5-fluorouracil, doxorubicin and cyclophosphamide (FAC), followed by 3 or 4 cycles of docetaxel or 12 cycles of weekly paclitaxel
Danish: • 3 eller 4 serier af 5-fluoruracil, epirubicin og cyclophosphamid eller 5-fluorouracil, doxorubicin og cyclophosphamid efterfulgt at 3 eller 4 serier af docetaxel eller 12 serier af ugentlig paclitaxel
English: Mucosal inflammation Oedema peripheral Pyrexia
Danish: Perifert ødem Pyreksi Træthed Asteni
English: Number (%) of patients with event HR [95% CI]
Danish: Antal (%) patienter med hændelse
English: No patients in the group treated with Perjeta plus trastuzumab and FEC followed by Perjeta plus trastuzumab and docetaxel experienced symptomatic LVD.
Danish: Der blev ikke observeret tilfælde af symptomatisk LVD hos patienter i gruppen behandlet med Perjeta plus trastuzumab og 5-fluoruracil, epirubicin og cyclophosphamid efterfulgt af Perjeta plus trastuzumab og docetaxel.
English: Dry, itchy or acne like skin
Danish: • Tør, kløende eller uren hud
English: Interstitial lung disease Pleural effusion
Danish: Inters titiel lungesygdom Pleuraeffusion
English: • 4 cycles of AC or epirubicin and cyclophosphamide (EC), followed by 3 or 4 cycles of docetaxel or 12 cycles of weekly paclitaxel
Danish: • 4 serier af doxorubicin og cyclophosphamid eller epirubicin og cyclophosphamid efterfulgt af 3 eller 4 serier af docetaxel eller 12 serier af ugentlig paclitaxel
English: In the NEOSPHERE trial, 8.4% of patients treated with neoadjuvant Perjeta, trastuzumab and docetaxel experienced febrile neutropenia compared with 7.5% of patients treated with trastuzumab and docetaxel.
Danish: I NEOSPHERE-studiet oplevede 8,4% af patienterne, som blev behandlet med neoadjuverende Perjeta, trastuzumab og docetaxel, febril neutropeni sammenlignet med 7,5% af patienterne behandlet med trastuzumab og docetaxel.
English: Placebo + trastuzumab + Chemotherapy N=2404
Danish: Placebo + trastuzumab + kemoterapi N=2404
English: The 840 mg loading dose of pertuzumab should be re-administered as a 60 minute infusion, followed by a maintenance dose of 420 mg IV administered every 3 weeks thereafter.
Danish: Startdosis på 840 mg pertuzumab genadministreres som 60 minutters infusion, herefter administreres vedligeholdelsesdosis på 420 mg i.v.
English: (median number of cycles of Perjeta was 4, across all treatment arms) and TRYPHAENA (median number of cycles of Perjeta was 3 - 6 across treatment arms) and from the treatment period of APHINITY (median number of cycles of Perjeta was 18).
Danish: ^ Tabel 2 viser de samlede data fra hele behandlingsperioden i CLEOPATRA (dataskæringspunkt 11. februar 2014, det mediane antal Perjeta-serier var 24), og fra den neoadjuverende behandlingsperiode i NEOSPHERE (det mediane antal Perjeta-serier var , på tværs af alle behandlingsarmene) og TRYPHAENA (det mediane antal Perjeta-serier var 3-6, på tværs af behandlingsarmene) og fra behandlingsperioden i APHINITY (det mediane antal Perjeta-s erier var 18).
English: Weak, numb, tingling or prickling sensations mainly affecting the feet and legs Nose bleeds
Danish: • Svaghedsfølelse, følelsesløshed, prikken og stikken i især ben og fødder
English: In the neoadjuvant period of the BERENICE trial, the incidence of NYHA Class III/IV symptomatic LVD (congestive heart failure according to NCI-CTCAE v.4) was 1.5% in the group treated with dose dense doxorubicin and cyclophosphamide (AC) followed by Perjeta plus trastuzumab and paclitaxel and none of the patients (0%) experienced symptomatic LVD in the group treated with FEC followed by Perjeta in combination with trastuzumab and docetaxel.
Danish: I den neoadjuverende behandlingsperiode af BERENICE-studiet var hyppigheden af NYHA klasse III/IV symptomatisk LVD (kongestiv hjerteinsufficiens ifølge NCI-CTCAE version 4) 1,5% i gruppen behandlet med kemoterapi (doxorubicin og cyclophosphamid) med kortere intervaller (dose-dense) efterfulgt af Perjeta plus trastuzumab og paclitaxel.
English: Prespecified subgroup analyses without adjusting for multiple comparisons, therefore, results are considered descriptive.
Danish: Lymfeknude-status Positiv Negativ Hormonereceptor-status Negativ Positiv Præ-specificerede subgruppe-analyser uden at justere for flere sammenligninger, og derfor betragtes res ultaterne for des kriptive
English: NAME OF THE MEDICINAL PRODUCT Perjeta 420 mg concentrate for solution for infusion
Danish: LÆGEMIDLETS NAVN Perjeta 420 mg koncentrat til infusionsvæske, opløsning.
English: Inflammation of your digestive tract (e.g. sore mouth) Decrease in the number of red blood cells - shown in a blood test Joint or muscle pain, muscle weakness
Danish: • Nedsat antal røde blodlegemer - måles i blodprøve
English: Respiratory, thoracic and medias tinal dis orders
Danish: Vaskulære sygdomme Hedeture Luftveje, thorax og mediastinum
English: Febrile neutropenia occurred in 13.7% of Perjeta-treated patients and 7.6% of placebo-treated patients.
Danish: Febril neutropeni forekom hos 13,7% i Perjeta-gruppen og hos 7,6% i placebo-gruppen.
English: Responders***
Danish: Antal patienter, der responderer***
English: Patients who only received Perjeta plus trastuzumab prior to surgery subsequently received both FEC and docetaxel post surgery.
Danish: Patienter, der kun fik Perjeta plus trastuzumab inden operation fik efter operation både 5-fluoruracil, epirubicin og cyclophosphamid og docetaxel.
English: Immune system disorders Infusion reaction°°, * Hypersensitivity°, *
Danish: Infusionsreaktion ºº, * Overfølsomhedº, * Lægemiddeloverfølsomhedº, *
English: 18.1% of patients in the Perjeta arm vs. 9.2% of patients in the placebo arm in the post-chemotherapy targeted therapy period.
Danish: Forekomsten af diarré var meget lavere efter ophør af kemoterapi, hvilket påvirkede 18,1% af patienterne i Perjeta-armen vs. 9,2% af patienterne i placebo-armen i forsøgsbehandlingsperioden efter kemoterapi.
English: Patient Reported Outcomes (PRO)
Danish: Patient-rapporterede resultater
English: (vs. Trastuzumab +Docetaxel)
Danish: (vs. Perjeta trastuzumab docetaxel)
English: Laboratory abnormalities
Danish: Laboratorieafvigelser
English: The bag should be gently inverted to mix the solution in order to avoid foaming.
Danish: For at undgå skumdannelse skal posen vendes forsigtigt, når infusionsvæsken blandes.
English: Unopened vial
Danish: Uåbnede hætteglas
English: • Cohort B - 4 cycles of FEC followed by 4 cycles of Perjeta in combination with trastuzumab and docetaxel.
Danish: • Gruppe B - 4 serier af 5-fluoruracil, epirubicin og cyclophosphamid efterfulgt af 4 serier af Perjeta i kombination med trastuzumab og docetaxel
English: Name and address of the manufacturer of the biological active substance(s) Genentech, Inc.
Danish: Navn og adresse på fremstilleren af det biologisk aktive stof
English: was 8.3% in the group treated with Perjeta plus trastuzumab and FEC (5-fluorouracil, epirubicin, cyclophosphamide) followed by Perjeta plus trastuzumab and docetaxel; 9.3% in the group treated with Perjeta plus trastuzumab and docetaxel following FEC; and 6.6% in the group treated with
Danish: epirubicin og cyclophosphamid efterfulgt af Perjeta plus trastuzumab og docetaxel, 9,3% i gruppen behandlet med Perjeta plus trastuzumab og docetaxel efter 5-fluoruracil, epirubicin og cyclophosphamid, og 6,6% i gruppen behandlet med Perjeta i kombination med docetaxel, carboplatin og trastuzumab.
English: In the TRYPHAENA trial, febrile neutropenia occurred in 17.1% of patients treated with neoadjuvant Perjeta + TCH, and 9.3% of patients treated with neoadjuvant Perjeta, trastuzumab and docetaxel following FEC.
Danish: I TRYPHAENA-studiet opstod der febril neutropeni hos 17,1% af patienterne behandlet med neoadjuverende Perjeta plus docetaxel, carboplatin og trastuzumab og hos 9,3% af patienterne behandlet med neoadjuverende Perjeta, trastuzumab og docetaxel efter 5fluoruracil, epirubicin og cyclophosphamid.
English: Five studies evaluated the effects of pertuzumab on the PK of co-administered cytotoxic agents, docetaxel, paclitaxel, gemcitabine, capecitabine, carboplatin and erlotinib.
Danish: Pertuzumabs effekt på farmakokinetikken af de cytotoksiske lægemidler docetaxel, paclitaxel, gemcitabin, capecitabin, carboplatin og erlotinib ved samtidig administration er undersøgt i fem kliniske studier.
English: The loading dose of 8 mg/kg of trastuzumab IV should be readministered over approximately 90 minutes, followed by a maintenance dose of 6 mg/kg IV administered every 3 weeks thereafter.
Danish: genadministreres over ca. 90 minutter, herefter administreres vedligeholdelsesdosis på 6 mg/kg i.v.
English: Gastrointestinal disorders Diarrhoea Vomiting
Danish: Obstipation Dyspepsi Abdominalsmerter
English: In the TRYPHAENA trial, diarrhoea occurred in 72.3% of patients treated with neoadjuvant Perjeta+TCH and 61.4% of patients treated with neoadjuvant Perjeta, trastuzumab and docetaxel following FEC.
Danish: I TRYPHAENA-studiet forekom diarré hos 72,3% af patienterne behandlet med neoadjuverende Perjeta plus docetaxel, carboplatin og trastuzumab og hos 61,4% af patienterne behandlet med neoadjuverende Perjeta, trastuzumab og docetaxel efter 5-fluoruracil, epirubicin og cyclophosphamid.
English: 21.0, 23.6) in the Perjeta arm versus +9.2 (95% CI 8.2, 10.2) in the placebo arm.
Danish: Ændring i diarrésymptomer øgedes til +22,3 (95% konfidensinterval - 21,0; 23,6) i Perjeta-armen vs. +9,2 (95% konfidensinterval - 8,2; 10,2) i placeboarmen.
English: Hair loss
Danish: • Hårtab
English: p-value (with
Danish: p-værdi (med Simes korr.
English: A population pharmacokinetic analysis was performed with data from 481 patients across different clinical trials (phase I, II and III) with various types of advanced malignancies who had received Perjeta as a single agent or in combination at pertuzumab doses ranging from 2 to 25 mg/kg administered every 3 weeks as a 30-60 minutes intravenous infusion.
Danish: En populationsfarmakokinetisk analyse blev udført med data fra 481 patienter med forskellige typer af avanceret malignitet fra forskellige kliniske studier (fase I, II og III).