natgillin/translations-raw huggingface dataset:
Cirkulerende koncentrationer af VEGF-bundet aflibercept øges med afliberceptdosen indtil det meste tilgængelige VEGF er bundet.
Circulating concentrations of VEGF-bound aflibercept increase with the aflibercept dose until most available VEGF is bound.
Leukopeni (2) Neutropeni (2)
Leucopenia (2) Neutropenia (2)
Der skal udvises forsigtighed ved behandling af patienter med klinisk signifikant kardiovaskulær sygdom, såsom koronararteriesygdom eller kongestiv hjerteinsufficiens, i anamnesen.
Caution should be exercised when treating patients with history of clinically significant cardiovascular disease such as coronary artery disease, or congestive heart failure with ZALTRAP.
Patienter, som behandles med ZALTRAP, har en øget risiko for blødninger, inklusive alvorlige og undertiden dødelige blødningshændelser.
Patients treated with ZALTRAP have an increased risk of haemorrhage, including severe and sometimes fatal haemorrhagic events.
• Blødning: Meget almindeligt (kan påvirke mere end 1 ud af 10 personer) - dette omfatter blødning fra næsen, men kan også omfatte alvorlige blødninger i dine tarme og andre dele af kroppen, og de kan være dødelige.
• Bleeding: Very common (may affect more than 1 in 10 people) - this includes bleeding from the nose, but may also include severe bleeding in your gut and other parts of the body, which may lead to death.
Dosisjustering ved anvendelse i kombination med ZALTRAP Svær stomatitis og palmoplantar erytrodysæstesisyndrom
FOLFIRI Dose modification when used in combination with ZALTRAP Severe stomatitis and Palmar-Plantar Erythrodysaesthesia syndrome
sanofi-aventis groupe 54, rue La Boétie 75008 Paris Frankrig
sanofi-aventis groupe 54, rue La Boétie 75008 Paris France
I fuld-tykkelses excisions- og incisions-hudsårsmodeller reducerede aflibercept-administration fibrøs respons, neovaskulisering, epidermal hyperplasi/re-epitelisering og strækstyrke.
In full-thickness excisional and incisional skin wound models, aflibercept administration reduced fibrous response, neovascularisation, epidermal hyperplasia/re-epithelialisation, and tensile strength.
Sytten (17) patienter behandlet med ZALTRAP (1,6 %) og to (2) placebo-behandlede patienter (0,2 %) havde også positiv analyse for neutraliserende antistof.
Seventeen (17) patients treated with ZALTRAP (1.6 %) and two (2) placebo-treated patients (0.2 %) were also positive in the neutralising antibody assay.
Administration af ZALTRAP/FOLFIRI bør udsættes, indtil trombocyttallet er 75 x 10
Administration of the ZALTRAP/FOLFIRI should be delayed until platelet count is 75 x 10
• Smerte i mund, tænder og/eller kæbe, hævelse eller sår der ikke vil hele i mund eller kæbe, udflåd, følelsesløshed eller en følelse af tyngde i kæben, eller løse tænder: Ikke almindelig (kan påvirke op til 1 ud af 100 personer) - Disse symptomer kan være tegn på knogleskade i kæben (osteonekrose).
• Pain in the mouth, teeth and/or jaw, swelling or non-healing sores in the mouth or jaw, discharge, numbness or a feeling of heaviness in the jaw, or loosening of a tooth: Uncommon (may affect up to 1 in 100 people) - These symptoms could be signs of bone damage in the jaw (osteonecrosis).
Komplet blodtælling (CBC) med differentialtælling anbefales ved baseline og før initiering af hver cyklus med aflibercept.
Monitoring of complete blood count (CBC) with differential count is recommended at baseline and prior to initiation of each cycle of aflibercept.
ZALTRAP er et sterilt, konserveringsmiddelfrit og nonpyrogent koncentrat, derfor bør infusionsopløsningen klargøres af sundhedspersonale under anvendelse af sikre håndteringsprocedurer og aseptisk teknik.
ZALTRAP is a sterile, preservative-free and non-pyrogenic concentrate, therefore the solution for infusion should be prepared by a healthcare professional using safe-handling procedures and aseptic technique.
Aflibercept fremstilles ved rekombinant DNA-teknologi i et kinesisk hamsterovarie (CHO) K-1 pattedyrs-ekspressionssystem.
Aflibercept is produced by recombinant DNA technology in a Chinese hamster ovary (CHO) K-1 mammalian expression system.
Aflibercept bør seponeres permanent, hvis hypertensionen ikke kan kontrolleres i tilstrækkelig grad med egnet antihypertensionsbehandling eller reduktion af afliberceptdosis, eller hvis der opstår hypertensiv krise eller hypertensiv encefalopati (se pkt.
Aflibercept should be permanently discontinued if hypertension cannot be adequately managed with appropriate anti-hypertensive therapy or aflibercept dose reduction, or if hypertensive crisis or hypertensive encephalopathy occurs (see section 4.2).
Hos seksuelt modne han-cynomolgusaber observeredes der et fald i spermmotiliteten og en øget forekomst af morfologiske abnormaliteter i spermatozoer.
In sexually mature male cynomolgus monkeys a decrease in sperm motility and an increase in incidence of morphological abnormalities of spermatozoa were observed.
Det europæiske lægemiddelagentur har dispenseret fra kravet om at fremlægge resultaterne af studier med ZALTRAP i alle undergrupper af den pædiatriske population ved adenokarcinom i colon og rektum (se pkt.
The European Medicines Agency has waived the obligation to conduct studies with ZALTRAP in all subsets of the paediatric population in adenocarcinoma of the colon and rectum (see section 4.2 for information on paediatric use).
ZALTRAP kan påvirke både mænds og kvinders frugtbarhed.
ZALTRAP may affect male and female fertility.
Hos disse patienter var ikke-renale bivirkninger generelt sammenlignelige hos patienter med nedsat nyrefunktion og patienter uden nedsat nyrefunktion bortset fra, at der blev set en >10 % højere forekomst af dehydrering (alle grader) (se pkt.
In these patients, non-renal events were generally comparable between patients with renal impairment and those without renal impairment, except a > 10 % higher incidence in dehydration (all grades) was noted (see section 4.4).
Posterior reversibelt encefalopatisyndrom (PRES) PRES blev ikke rapporteret i det pivotale fase III-studie med mCRC-patienter.
Posterior reversible encephalopathy syndrome (PRES) PRES was not reported in the pivotal phase III study of MCRC patients.
Behandling med ZALTRAP er forbundet med risiko for kompromitteret sårheling (sårruptur, anastomotisk lækage).
Treatment with ZALTRAP is associated with potential for compromised wound healing (wound dehiscence, anastomotic leakage).
• du har en sygdom, der involverer betændelse i dine tarme, såsom infektion i en del af tarmvæggen (også kaldet ‘diverticulitis'), mavesår eller colitis.
• you have illnesses where your gut is inflamed, such as an infected section of the bowel wall (also called ‘diverticulitis'), stomach ulcers or colitis.
Hos patienter administreres ZALTRAP i en dosis på 4 mg/kg intravenøst hver anden uge, for hvilken der er overskydende mængde cirkulerende frit aflibercept sammenlignet med VEGF-bundet aflibercept.
In patients, ZALTRAP is administered at the dose of 4 mg/kg intravenously every two weeks for which there is an excess of circulating free aflibercept compared to VEGF-bound aflibercept.
• du har haft abnorme rørlignende forbindelser eller passager i kroppen mellem de indre organer og huden eller andre væv (også kaldet ‘fistler').
• you have had any abnormal tube-like connections or passageways inside the body between internal organs and skin or other tissues (also called ‘fistula').
I det pivotale mCRC-studie var 28,2 % af patienterne i alderen ≥65 og <75, og 5,4 % af patienterne var ≥75.
In the pivotal MCRC study, 28.2 % of patients were aged ≥ 65 and < 75 and 5.4 % of patients were aged ≥ 75.
Patienterne skal monitoreres for tegn og symptomer på GI-blødning og andre svære blødninger.
Patients should be monitored for signs and symptoms of GI bleeding and other severe bleeding.
Patienterne bør monitoreres for tegn og symptomer på GI-perforation.
Patients should be monitored for signs and symptoms of GI perforation.
Hos nogle få patienter med svært nedsat nyrefunktion svarede lægemiddeleksponeringen til det, der observeredes hos patienter med normal nyrefunktion.
In the few patients with severe renal impairment, drug exposure was similar to that observed in patients with normal renal function.
Aflibercept bør seponeres i mindst 4 uger forud for elektiv kirurgi.
Aflibercept should be suspended for at least 4 weeks prior to elective surgery.
En bivirkning kaldet osteonekrose (knogleskade i kæben) er rapporteret hos kræftpatienter behandlet med ZALTRAP.
A side effect called osteonecrosis (bone damage in the jaw) has been reported in cancer patients treated with ZALTRAP.
Højtiter antistofrespons på aflibercept blev ikke detekteret hos nogen patienter.
High-titre antibody responses to aflibercept were not detected in any patients.
Dehydrering (1)
Dehydration (1)
• En bivirkning, der påvirker dit nervesystem (kaldet ‘posterior reversibelt encefalopatisyndrom' eller PRES): Ikke almindeligt (kan påvirke op til 1 ud af 100 personer)symptomerne kan omfatte hovedpine, synsforandringer, en følelse af forvirring eller anfald med eller uden forhøjet blodtryk.
• A side effect which affects your nervous system (called ‘posterior reversible encephalopathy syndrome' or PRES): Uncommon (may affect up to 1 in 100 people) - signs may include headache, sight changes, feeling confused or fits with or without high blood pressure.
Infektion (1)
Infection (1)
ZALTRAP bør seponeres hos patienter med livstruende (grad 4) tromboemboli (inklusive lungeemboli) (se pkt.
ZALTRAP should be discontinued in patients with life-threatening (Grade 4) thromboembolic events (including pulmonary embolism) (see section 4.2).
• Der bør anvendes infusionsposer af PVC indeholdende DEHP eller polyolefin infusionsposer.
• PVC containing DEHP infusion bags or polyolefin infusion bags should be used.
11,1 (8,5 til 13,8)
11.1 (8.5 to 13.8)
Bortskaffelse Ikke anvendt lægemiddel samt affald heraf skal bortskaffes i henhold til lokale retningslinjer.
Disposal Any unused medicine or waste material should be disposed of in accordance with local requirements.
I en populationsfarmakokinetisk analyse med data fra 1507 patienter med forskellige typer fremskredene maligniteter, som modtog ZALTRAP med eller uden kemoterapi, blev 63 patienter med mildt nedsat leverfunktion (totalt bilirubin >1,0 x - 1,5 x ULN og evt. ASAT) og 5 patienter med moderat nedsat leverfunktion (totalt bilirubin >1,5 x - 3 x ULN og evt. ASAT) blev behandlet med ZALTRAP.
In a population pharmacokinetic analysis with data from 1,507 patients with various types of advanced malignancies receiving ZALTRAP with or without chemotherapy, 63 patients with mild hepatic impairment (total bilirubin > 1.0 x - 1.5 x ULN and any AST) and 5 patients with moderate hepatic impairment (total bilirubin > 1.5 x - 3 x ULN and any AST) were treated with ZALTRAP.
Det kan også vise sig som en pludselig følelsesløshed eller svaghedsfølelse i ansigt, arme eller ben.
It may also present itself as a sudden numb or weak feeling in the face, arms, or legs.
Tilfælde af ONJ er rapporteret hos cancerpatienter behandlet med ZALTRAP, hvoraf flere havde fået tidligere eller samtidig behandling med intravenøse bisfosfonater, for hvilke ONJ er en kendt risiko.
Osteonecrosis of the jaw (ONJ) Cases of ONJ have been reported in cancer patients treated with Zaltrap, several of whom had received prior or concomitant treatment with intravenous bisphosphonates, for which ONJ is an identified risk.
Fortæl det straks til din læge og tandlæge hvis du oplever disse symptomer, mens du behandles med ZALTRAP, eller efter behandlingen er ophørt.
Tell your doctor and dentist immediately if you experience such symptoms while being treated with ZALTRAP or after stopping treatment.
Bivirkninger i Tabel 1 er defineret som enten en klinisk bivirkning eller laboratorieabnormitet med ≥2 % højere incidens (alle grader) i aflibercept-armen i forhold til placeboarmen i mCRC-studiet, inklusive dem, der ikke nåede denne grænse, men stemte overens med anti-VEGF-klassen og blev observeret i et studie med aflibercept.
Adverse reactions in Table 1 are defined as either any adverse clinical reaction or laboratory abnormality having ≥ 2 % greater incidence (all grades) in the aflibercept treatment group in comparison to the placebo treatment group in the MCRC study including those that do not meet this threshold but were consistent with the anti-VEGF class and were seen in any study with aflibercept.
• smertende sår i munden
• painful sores in the mouth
Tilsvarende data hos patienter med RAS-muterede tumorer viste HR for OS på 0,9 (0,7-1,2) med en median på henholdsvis 12,6 og 11,2 måneder for aflibercept og placebo.
Corresponding data in patients with RAS mutant type tumours showed a HR for OS of 0.9 (0.7-1.2) with median 12.6 and 11.2 months for aflibercept and placebo, respectively.
Neutropenisk infektion/sepsis (1) Urinvejsinfektion Nasofaryngitis
Neutropenic infection/sepsis (1) Urinary tract infection Nasopharyngitis
Det anbefales, at afliberceptbehandling ikke initieres i mindst 4 uger efter større indgreb, og ikke før operationssåret er fuldt ophelet.
It is recommended that aflibercept not be initiated for at least 4 weeks following major surgery and not until the surgical wound is fully healed.
ZALTRAP gives som et drop (infusion) i en af dine blodårer (‘intravenøst') for at behandle kræft i tyktarm eller endetarm.
ZALTRAP is given by a drip (infusion) into one of your veins (‘intra-venous') to treat advanced cancers of the colon or rectum.
En populationsfarmakokinetisk analyse blev gennemført med data fra 1507 patienter med forskellige typer fremskredne maligniteter, som modtog ZALTRAP med eller uden kemoterapi.
A population pharmacokinetic analysis was conducted with data from 1,507 patients with various types of advanced malignancies receiving ZALTRAP with or without chemotherapy.
Hvis dette skulle ske for dig, vil lægen stoppe behandlingen med ZALTRAP.
If this should happen to you, your doctor will stop your treatment with ZALTRAP.
Ud af de 611 patienter, som blev behandlet med ZALTRAP/FOLFIRI-regimet i det pivotale studie med mCRC-patienter, var 172 (28,2 %) i alderen ≥65 og <75, og 33 (5,4 %) var ≥75.
Of the 611 patients treated with the ZALTRAP/FOLFIRI regimen in the pivotal study of MCRC patients, 172 (28.2 %) were aged ≥ 65 and < 75 and 33 (5.4 %) were age ≥ 75.
Ved mindre indgreb som anlæggelse af centralt venekateter, biopsi og tandudtrækning kan aflibercept initieres/genstartes, når operationssåret er fuldt ophelet.
For minor surgery such as central venous access port placement, biopsy, and tooth extraction, aflibercept may be initiated/restarted once the surgical wound is fully healed.
PRES kan præsentere sig med ændret mental status, kramper, kvalme, opkastning, hovedpine eller synsforstyrrelser.
PRES may present with altered mental status, seizure, nausea, vomiting, headache, or visual disturbances.
Der var ingen aldersindvirkning på frit aflibercepts farmakokinetik.
There was no effect of age on the pharmacokinetics of free aflibercept.
Trombotiske og emboliske hændelser
Thrombotic and embolic events
Meget almindeligt (kan påvirke mere end 1 ud af 10 personer)
Very common (may affect more than 1 in 10 people)
Bivirkninger og unormale laboratorieværdier rapporteret hos patienter behandlet med ZALTRAP/FOLFIRI-regimet sammenlignet med patienter behandlet med placebo/FOLFIRI-regimet er angivet i Tabel 1 i henhold til MedDRA systemorganklasse og frekvenskategorier.
Adverse reactions and laboratory abnormalities reported in patients treated with the ZALTRAP/FOLFIRI regimen compared to patients treated with the placebo/FOLFIRI regimen are listed in Table 1 according to MedDRA system organ class and frequency categories.
Andre subgruppeanalyser for samlet overlevelse og progressionsfri overlevelse i henhold til alder (<65; ≥65), køn, forudgående brug af bevacizumab, ECOG performance status 0 og 1, tilstedeværelse af metastaser begrænset til leveren, hypertension i anamnesen og antal involverede organer viste en behandlingseffekt til fordel for ZALTRAP/FOLFIRI-regimet i forhold til placebo/FOLFIRI-regimet.
Other subgroup analyses for overall survival and progression free survival according to age (< 65; ≥ 65), gender, presence of liver metastasis only, history of prior hypertension, and number of organs involved, showed a treatment effect favouring the ZALTRAP/FOLFIRI regimen over the placebo/FOLFIRI regimen.
• Fisteldannelse
• Fistula formation
• du oplever anfald (kramper).
• you experience fits (seizures).
Under behandling med aflibercept anbefales det at monitorere blodtrykket hver anden uge, inklusive før hver administration, eller når det er klinisk indiceret.
It is recommended to monitor blood pressure every two weeks, including before each administration or as clinically indicated during treatment with aflibercept.
• Grad 4 venøs tromboemboli (inklusive lungeemboli)
• Grade 4 venous thromboembolic events (including pulmonary embolism)
Citronsyremonohydrat
Citric acid monohydrate
• hævelse og følelsesløshed i hænder og fødder i forbindelse med kemoterapi (kaldet
• swelling and numbness of the hands and feet that happens with chemotherapy (called
• En udvidelse og svækkelse af en blodårevæg eller en rift i en blodårevæg (aneurismer og arterielle dissektioner).
• an enlargement and weakening of a blood vessel wall or a tear in a blood vessel wall (aneurysms and artery dissections)
Enkeltdosis-hætteglas.
Single-dose vial.
PRAKTISKE OPLYSNINGER FOR SUNDHEDSPERSONALE VEDRØRENDE KLARGØRING OG HÅNDTERING AF ZALTRAP 25 mg/ml KONCENTRAT TIL INFUSIONSVÆSKE, OPLØSNING
PRACTICAL INFORMATION FOR HEALTHCARE PROFESSIONALS ON PREPARATION AND HANDLING OF ZALTRAP 25 mg / ml CONCENTRATE FOR SOLUTION FOR INFUSION
4,67 (4,21 til 5,36)
4.67 (4.21 to 5.36)
Aflibercept-administration bør suspenderes ved ≥2 gram proteinuri/24 timer og påbegyndes igen, når proteinurien er <2 gram/24 timer.
Aflibercept administration should be suspended for ≥ 2 grams of proteinuria/24 hours and restarted when proteinuria is <2 grams/24 hours.
Det vil blive givet sammen med anden medicin kaldet ‘kemoterapi' herunder ‘5-fluoruracil', ‘folinsyre' og ‘irinotecan'.
It will be given with other medicines called ‘chemotherapy', including ‘5-fluorouracil', ‘folinic acid', and ‘irinotecan'.
På grund af hyperosmolalitet (1000 mOsmol/kg) af ZALTRAP-koncentratet må ufortyndet ZALTRAP ikke administreres som intravenøs indsprøjtning eller bolus.
Due to hyperosmolality (1000 mOsmol / kg) of the ZALTRAP concentrate, undiluted ZALTRAP concentrate must not be administered as an intravenous push or bolus.
For kontraindikationer relateret til FOLFIRI-komponenter (irinotecan, 5-FU og folinsyre ) henvises til de respektive produktresuméer.
For contraindications related to FOLFIRI components (irinotecan, 5-FU, and folinic acid), refer to the current respective summary of product characteristics.
• polyurethan
• polyurethane
På tværs af alle kliniske onkologistudier blev der observeret samme hyppighed af lavtiter antilægemiddel-antistof (ADA) respons (post baseline) i ADA-analysen hos patienter behandlet med placebo og ZALTRAP (henholdsvis 3,3 % og 3,8 %).
Overall across all clinical oncology studies, similar incidence of low titre anti-drug antibody (ADA) responses (post baseline) in the ADA assay were observed in both patients treated with placebo and ZALTRAP (3.3 % and 3.8 %, respectively).
I tilfælde af en let til moderat overfølsomhedsreaktion over for ZALTRAP (inklusive ansigtsrødme, udslæt, urticaria og pruritus) bør aflibercept seponeres midlertidigt, indtil reaktionen er forsvundet.
In the event of a mild to moderate hypersensitivity reaction to ZALTRAP (including flushing, rash, urticaria, and pruritus), aflibercept should be temporarily suspended until the reaction is resolved.
Operative tandindgreb skal, hvis muligt, undgås hos patienter i behandling med ZALTRAP, som tidligere har fået eller som får intravenøse bisfosfonater (se pkt.
Invasive dental procedures should, if possible, be avoided in patients treated with Zaltrap and who have previously received or are receiving intravenous bisphosphonates (see section 4.8).
• Sår der heler langsomt eller ikke vil hele: Ikke almindelig (kan påvirke op til 1 ud af 100 personer) - dette er når et ar har vanskeligt ved at hele eller holdes lukket, eller hvis et ophelet sår åbnes igen.
• Wounds which heal slowly or not at all: Uncommon (may affect up to 1 in 100 people) - this is when a scar has trouble healing or staying closed, or if a healed wound re-opens.
Kliniske data tyder på, at der ikke kræves ændring af startdosis til patienter med let til moderat nedsat nyrefunktion.
Clinical data suggest that no change in starting dose is required in patients with mild to moderate renal impairment.
Eksisterende hypertension skal være tilstrækkeligt under kontrol, før behandling med aflibercept initieres.
Pre-existing hypertension must be adequately controlled before starting aflibercept.
De bivirkninger, som hyppigst medførte permanent seponering hos ≥1 % af patienterne behandlet med ZALTRAP/FOLFIRI-regimet, var vaskulære hændelser (3,8 %) inklusive hypertension (2,3 %), infektioner (3,4 %), asteni/træthed (1,6 %, 2,1 %), diarré (2,3 %), dehydrering (1 %), stomatitis (1,1 %), neutropeni (1,1 %), proteinuri (1,5 %) og lungeemboli (1,1 %).
The most frequent adverse reactions leading to permanent discontinuation in ≥ 1 % of patients treated with the ZALTRAP/FOLFIRI regimen were vascular disorders (3.8 %) including hypertension (2.3 %), infections (3.4 %), asthenia/fatigue (1.6 %, 2.1 %),diarrhoea (2.3 %), dehydration (1 %), stomatitis (1.1 %), neutropenia (1.1 %), proteinuria (1.5 %), and pulmonary embolism (1.1 %).
Oxaliplatin-baserede regimer blev administreret i kombination med bevacizumab hos 373 patienter
Oxaliplatin-based regimens were administered in combination with bevacizumab in 373 patients (30.4 %).
EXP Holdbarhed efter fortynding: Se indlægssedlen.
EXP Shelf life after dilution: see package leaflet.
Patienterne fik i gennemsnit 9 cykler med ZALTRAP/FOLFIRI-regimet.
Patients received a median number of 9 cycles of the ZALTRAP/FOLFIRI regimen.
Ved recidiv bør 5-FU-bolus og -infusionsdoser desuden reduceres med 20 % i efterfølgende cykler.
If recurrence, 5-FU bolus and infusion doses should additionally be reduced by 20 % in subsequent cycles.
Diagnosen PRES bekræftes med MR-scanning af hjernen.
The diagnosis of PRES is confirmed by brain Magnetic Resonance Imaging (MRI).
Den anbefalede dosis ZALTRAP er 4 mg/kg legemsvægt som intravenøs infusion over 1 time efterfulgt af FOLFIRI-regime.
The recommended dose of ZALTRAP, administered as an intravenous infusion over 1 hour, is 4 mg / kg of body weight, followed by the FOLFIRI regimen.
Forhøjet ASAT (2) Forhøjet ALAT (2)
Increased AST (2) Increased ALT (2)
• Protein i urinen (også kaldet ‘proteinuri'): Meget almindeligt (kan påvirke mere end 1 ud af 10 personer) - dette er meget almindeligt at se i tests.
• Protein in the urine (also called ‘proteinuria'): Very common (may affect more than 1 in 10 people) - this is very commonly seen in tests.
Den hyppigst indberettede form for blødning var mindre (grad 1-2) epistaxis, der forekom hos 27,7 % af patienterne i ZALTRAP-armen.
The most common reported form of bleeding was minor (grade 1-2) epistaxis occurring in 27.7 % of patients treated with the ZALTRAP/FOLFIRI regimen.
Hvert hætteglas med koncentrat til infusionsvæske er udelukkende til engangsbrug (enkeltdosis).
Each vial of concentrate for solution for infusion is for single use (single-dose) only.
Behandlingstildelingen blev stratificeret efter ECOG-performancestatus (0 versus 1 versus 2) og efter tidligere behandling med bevacizumab (ja eller nej).
Treatment assignment was stratified by the ECOG performance status (0 versus 1 versus 2) and according to prior therapy with bevacizumab (yes or no).
5,3 (4,50 til 5,55)
5.3 (4.50 to 5.55)
5,4 (4,53 til 5,68)
5.4 (4.53 to 5.68)
For yderligere toksicitet relateret til irinotecan, 5-FU og folinsyre henvises til de respektive produktresuméer.
For additional toxicities related to irinotecan, 5-FU, or folinic acid, refer to the current respective summary of product characteristics.