natgillin/translations-raw huggingface dataset:
Dehydrering Hyponatriæmi
Dehydration Hyponatraemia
● Overfølsomhed over for præparater fremstillet i ovarieceller (CHO) fra kinesisk hamster eller andre rekombinante eller humaniserede antistoffer.
Hypersensitivity to Chinese Hamster Ovary (CHO) cell products or other recombinant human or humanised antibodies.
Ifølge en uafhængig evalueringskomité var forskellen i objektiv responsrate 18% (konfidensinterval: 0,6 % ; 35,3 %) mellem de to behandlingsarme blandt de få patienter, der havde evaluerbare tumor ved baseline samt en bekræftet respons ved tidligere lokal behandling: 27/75 patienter (36,0 %; 95% konfidensinterval: 25,2 %; 47,9 %) i kemoterapi-armen og 34/63 patienter (54,0 %; 95 % konfidensinterval: 40,9 %; 66,6 %) i kemoterapi+bevacizumab-armen.
The difference in ORR per independent central review was 18% (CI: 0.6%, 35.3%) between the two treatment arms in the few patients who had evaluable tumor at baseline and had a confirmed response prior to receiving any local therapy : 27/75 patients (36.0%, 95% CI: 25.2%, 47.9%) in the Chemo arm and 34/63 patients (54.0%, 95% CI: 40.9%, 66.6%) in the Bv + Chemo arm.
Disse resultater påviser robusthed af PFS-analysen vist i tabel 18.
These results demonstrate robustness of the primary analysis of PFS as shown in Table 18.
Median OS (måneder) Hazard ratio (95 % konfidensinterval) p-værdi Alle analyser i tabellen er stratificerede.
Median OS (months) Hazard Ratio (95% CI) p-value All analyses presented in this table are stratified analyses.
Anden faktor
Comparison Other Factor
Avastin bliver givet sammen med paclitaxel og cisplatin eller med paclitaxel og topotecan til patienter, som ikke kan få platin.
Avastin will be administered in combination with paclitaxel and cisplatin or, alternatively, paclitaxel and topotecan in patients who cannot receive platinum therapy.
Avastin anvendes også hos voksne til behandling af metastatisk brystkræft.
Avastin is also used for the treatment of adult patients with metastatic breast cancer.
• tør hud, afskalning og inflammation (betændelseslignende tilstand) i huden, misfarvning af huden,
• dry skin, flaking and inflammation of the skin, change in skin colour,
Studie JO25567 var et randomiseret, åbent fase II multicenterstudie, gennemført i Japan, for at vurdere effekten og sikkerheden af Avastin, som tillæg til erlotinib,, hos patienter med ikke-planocellulær NSCLC med EGFR-aktiverende mutationer (exon 19-deletion eller exon 21L858R-mutation), som ikke tidligere havde fået systemisk behandling af grad IIIB/IV- eller recidiverende sygdom.
Study JO25567 was a randomized, open-label, multi-center Phase II study conducted in Japan to evaluate the efficacy and safety of Avastin used in addition to erlotinib in patients with non-squamous NSCLC with EGFR activating mutations (exon 19 deletion or exon 21 L858R mutation) who had not received prior systemic therapy for Stage IIIB/IV or recurrent disease.
Hazard ratio for progressionsfri overlevelse var 0,47 (95 % konfidensinterval: 0,35; 0,62) og 0,45 (95 % konfidensinterval: 0,31; 0,67) for henholdsvis undergruppe < 65 år og ≥ 65 år .
The HR for PFS was 0.47 (95% CI: 0.35, 0.62) and 0.45 (95% CI: 0.31, 0.67) for the < 65 and ≥ 65 subgroups, respectively.
Behandling med Avastin 15 mg/kg hver 3. uge i kombination med kemoterapi (carboplatin og paclitaxel) i 6 og op til 8 behandlingsserier, efterfulgt af Avastin monoterapi indtil sygdomsprogression eller uacceptabel toksicitet, resulterede i en klinisk betydningsfuld og statistisk signifikant forbedring i samlet overlevelse sammenlignet med behandling med carboplatin og paclitaxel alene, ved data udledt fra eCRF.
Treatment with Avastin at 15 mg/kg every 3 weeks in combination with chemotherapy (carboplatin and paclitaxel) for 6 and up to 8 cycles, followed by Avastin until disease progression or unacceptable toxicity resulted, when data were derived from eCRF, in a clinically meaningful and statistically significant improvement in OS compared to treatment with carboplatin and paclitaxel alone.
Avastin bruges også hos voksne til behandling af fremskreden ikke-småcellet lungekræft.
Avastin is also used for the treatment of adult patients with advanced non-small cell lung cancer.
Fortyndet lægemiddel
Diluted medicinal product
● Graviditet (se pkt.
Pregnancy (see section 4.6).
Bevacizumab er, i kombination med carboplatin og paclitaxel, indiceret til frontlinjebehandling af voksne patienter med fremskreden (International Federation of Gynecology and Obstetrics (FIGO) stadie III B, III C og IV) epitelial ovariecancer, tubacancer eller primær peritonealcancer (se pkt.
Bevacizumab, in combination with carboplatin and paclitaxel is indicated for the front-line treatment of adult patients with advanced (International Federation of Gynecology and Obstetrics (FIGO) stages III B, III C and IV) epithelial ovarian, fallopian tube, or primary peritoneal cancer.
• symptomer, som tyder på ændringer i den normale hjernefunktion (hovedpine, synsforstyrrelser,
• symptoms that suggest changes in normal brain function (headaches, vision changes, confusion, or seizures), and high blood pressure,
(p-værdi = 0,3113)
(p-value = 0.3113)
Du kan også opleve hudrødme eller blussende hud, udslæt, kuldegysninger og rysten eller kvalme og opkastning.
You could also experience redness or flushing of the skin or a rash, chills and shivering, feeling sick (nausea) or being sick (vomiting).
Hvis den første infusion tolereres godt, kan den næste infusion gives over 60 minutter.
If the first infusion is well tolerated, the second infusion may be administered over 60 minutes.
I studie AVF3694g var hyppigheden af CHF (alle grader) i antracyklin + Avastin-armen (6,2 %) endvidere sammenlignelig med hyppigheden i antracyklin + placebo-armen (6,0 %).
In addition, in study AVF3694g the incidences of all Grade CHF were similar between the anthracycline + Avastin (6.2%) and the anthracycline + placebo arms (6.0%).
Studie E2100 var et åbent, randomiseret, aktivt kontrolleret, multicenter klinisk studie til evaluering af Avastin i kombination med paclitaxel til lokalt recidiverende eller metastatisk brystkræft hos patienter, som ikke tidligere havde fået kemoterapi for lokalt recidiverende og metastatisk sygdom.
Trial E2100 was an open-label, randomised, active controlled, multicentre clinical trial evaluating Avastin in combination with paclitaxel for locally recurrent or metastatic breast cancer in patients who had not previously received chemotherapy for locally recurrent and metastatic disease.
I to kliniske studier omhandlende metastatisk renalcellekarcinom, blev mikroangiopatisk hæmolytisk anæmi (MAHA) rapporteret hos 7 ud af 19 patienter behandlet med bevacizumab (10 mg/kg hver 2. uge) og sunitinibmaleat (50 mg daglig) i kombination.
Combination of bevacizumab and sunitinib malate In two clinical trials of metastatic renal cell carcinoma, microangiopathic haemolytic anaemia (MAHA) was reported in 7 of 19 patients treated with bevacizumab (10 mg/kg every two weeks) and sunitinib malate (50 mg daily) combination.
Hvert hætteglas indeholder 100 mg bevacizumab i 4 ml opløsning eller 400 mg bevacizumab i 16 ml opløsning.
Each vial contains 100 mg bevacizumab in 4 ml of solution or 400 mg bevacizumab in 16 ml of solution.
EGFR-monoklonale antistoffer bør ikke anvendes til behandling af metastatisk kolorektalkræft i kombination med kemoterapi, som indeholder bevacizumab.
EGFR monoclonal antibodies should not be administered for the treatment of mCRC in combination with bevacizumab-containing chemotherapy.
LÆGEMIDDELFORM OG INDHOLD (PAKNINGSSTØRRELSE) Koncentrat til infusionsvæske, opløsning 1 hætteglas á 4 ml
PHARMACEUTICAL FORM AND CONTENTS Concentrate for solution for infusion 1 vial of 4 ml
Medfødte, familiære og genetiske sygdomme
Congenital, familial, and genetic disorder
Avastin bør seponeres permanent hos patienter, som får grad 3 eller 4 blødninger (NCI-CTCAE v. 3) under behandlingen med Avastin (se pkt.
Avastin should be discontinued permanently in patients who experience Grade 3 or 4 bleeding during Avastin therapy (NCI-CTCAE v.3) (see section 4.8).
Effektresultater fra studie AVF4095
Table 20 Efficacy results from study AVF4095g
Disse bivirkninger inkluderede infektiøs endophthalmitis, intraokulær inflammation såsom steril endophthalmitis, uveitis og vitritis, nethindeløsning, rift i pigmentepitelcellelaget i nethinden, forhøjet intraokulært tryk, intraokulær blødning såsom corpus vitreum blødning eller nethindeblødning og konjunktival blødning.
These reactions included infectious endophthalmitis, intraocular inflammation such as sterile endophthalmitis, uveitis and vitritis, retinal detachment, retinal pigment epithelial tear, intraocular pressure increased, intraocular haemorrhage such as vitreous haemorrhage or retinal haemorrhage and conjunctival haemorrhage.
Gastrointestinale blødninger, inklusive rektale blødninger og melæna er blevet rapporteret hos patienter med kolorektalkræft.
Gastrointestinal haemorrhages, including rectal bleeding and melaena have been reported in colorectal cancer patients, and have been assessed as tumour-associated haemorrhages.
Venøs tromboemboli: Hyppigheden af venøse tromboemboliske bivirkninger i kliniske studier var den samme for patienter, som fik Avastin i kombination med kemoterapi, sammenlignet med dem, som fik kemoterapi alene.
Venous thromboembolism: The incidence of venous thromboembolic reactions in clinical trials was similar in patients receiving Avastin in combination with chemotherapy compared to those receiving the control chemotherapy alone.
Generelt er lav albumin og høj tumorbyrde indikativ for sygdommens sværhedsgrad.Clearance af bevacizumab var ca. 30 % hurtigere hos patienter med lave niveauer af serumalbumin og 7 % hurtigere hos patienter med høj tumorbyrde i forhold til en typisk patient med mediane niveauer af serumalbumin og tumorbyrde.
Bevacizumab clearance was approximately 30% faster in patients with low levels of serum albumin and 7% faster in subjects with higher tumour burden when compared with a typical patient with median values of albumin and tumour burden.
Bivirkningerne blev rapporteret ved forskellige tidspunkter i behandlingen fra en uge efter behandlingsstart med Avastin til mere end et år efter.
Reactions were reported at various time points during treatment ranging from one week to greater than 1 year from initiation of Avastin, with most reactions occurring within the first 6 months of therapy.
Studiet var designet som en åben, randomiseret, 2-armet fase III-evaluering af bevacizumab plus kemoterapi versus kemoterapi alene.
This study was designed as an open-label, randomized, two-arm Phase III evaluation of bevacizumab plus chemotherapy (CT+BV) versus chemotherapy alone (CT).
I kliniske studer er der rapporteret 8 tilfælde af PRES. To af de otte tilfælde var ikke radiologisk bekræftet med MR-skanning.
Two of the eight cases did not have radiological confirmation via MRI.
Det anbefales at teste for proteinuri med en urinstix før og under behandlingen.
Monitoring of proteinuria by dipstick urinalysis is recommended prior to starting and during therapy.
Samlet responsrate Rate (procent) 95 % konfidensinterval p-værdi
Overall response rate Rate (percent) 95% CI p-value
I kliniske studier, inden for alle indikationer, var hyppigheden af venøse tromboemboliske bivirkninger 2,8-17,3 % hos de Avastinbehandlede patienter i forhold til 3,2-15,6 % i kontrolgrupperne.
In clinical trials across indications, the overall incidence of venous thromboembolic reactions ranged from 2.8% to 17.3% of Avastin-treated patients compared with 3.2% to 15.6% in the control arms.
Der er rapporteret tilfælde af dødt knoglevæv (nekrose) i andre knogler end i kæben hos patienter under 18 år, som blev behandlet med Avastin.
Death of bone tissue (osteonecrosis) in bones other than the jaw have been reported in patients under 18 years old when treated with Avastin.
Et samlet antal på 116 patienter blev randomiseret til at få bevacizumab 3 mg/kg hver 2. uge (n=39); 10 mg/kg hver 2. uge (n=37) eller placebo (n=40).
weeks (n=39), 10 mg/kg every 2 weeks; (n=37), or placebo (n=40).
Studiet sammenlignede effekten af at tilføje Avastin til carboplatin plus gemcitabin-kemoterapi og fortsætte med Avastin i monoterapi til progression, med behandling med carboplatin plus gemcitabin alene.
The study compared the effect of adding Avastin to carboplatin and gemcitabine chemotherapy and continuing Avastin as a single agent to progression, to carboplatin and gemcitabine alone.
Samlet overlevelse (primær analyse)6 Median (måneder)1
Overall Survival - Primary analysis Median (months)1
I et randomiseret fase II-studie (BO20924) blandt ialt 154 patienter i alderen ≥ 6 måneder til <18 år med nylig diagnosticeret metastatisk rabdomyosarkom og ikke-rabdomyosarkom bløddelssarkom, blev behandlet med standardbehandling (induktion IVADO/IVA+/- lokal behandling efterfulgt af vedligeholdelsebehandling med vinorelbin og cyclophosphamid) med eller uden bevacizumab (2,5 mg/kg/uge) med en samlet behandlingsvarighed på ca. 18 måneder.
In a randomized phase II study (BO20924) a total of 154 patients aged ≥ 6 months to <18 years with newly diagnosed metastatic rhabdomyosarcoma and non-rhabdomyosarcoma soft tissue sarcoma were treated with standard of care (Induction IVADO/IVA+/- local therapy followed by Maintenance Vinorelbine and cyclophosphamide) with or without bevacizumab (2.5 mg/kg/week) for a total duration of treatment of approximately 18 months.
Bevacizumab er, i kombination med paclitaxel, indiceret til 1.-linjebehandling af voksne patienter med metastatisk brystkræft.
Bevacizumab in combination with paclitaxel is indicated for first-line treatment of adult patients with metastatic breast cancer.
Avastin 25 mg/ml koncentrat til infusionsvæske, opløsning Bevacizumab
Avastin 25 mg/ml concentrate for solution for infusion Bevacizumab
Systemiske bivirkninger efter intravitreal anvendelse Der er påvist nedsat koncentration af cirkulerende vaskulær endotelial vækstfaktor (VEGF) efter intravitreal anti-VEGF-behandling.
A reduction of circulating VEGF concentration has been demonstrated following intravitreal antiVEGF therapy.
EGFR-mutationsstatus blev bestemt for hver patient før patientscreening og 154 patienter blev randomiseret til at få enten erlotinib + Avastin (oralt erlotinib 150 mg dagligt + Avastin [i.v.
EGFR mutation status was determined for each patient prior to patient screening and 154 patients were randomised to receive either erlotinib + Avastin (erlotinib 150 mg oral daily + Avastin [15 mg/kg IV every 3 weeks]) or erlotinib monotherapy (150 mg oral daily) until disease progression (PD) or unacceptable toxicity.
Klinisk effekt hos patienter med NSCLC er vist ved dosering af både 7,5 mg/kg og 15 mg/kg.
Clinical benefit in NSCLC patients has been demonstrated with both 7.5 mg/kg and 15 mg/kg doses (see section 5.1).
5,0 mg/kg hver 2.uge eller 7,5 mg/kg hver 3.uge.
5.0 mg/kg every 2 weeks or 7.5 mg/kg every 3 weeks
Hvis muligt bør invasive tandprocedurer undgås hos patienter, som tidligere er blevet eller bliver behandlet med intravenøse bisfosfonater.
In patients who have previously received or are receiving intravenous bisphosphonates invasive dental procedures should be avoided, if possible.
DATO FOR FØRSTE MARKEDSFØRINGSTILLADELSE/FORNYELSE AF TILLADELSEN
DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 12 January 2005
Bevacizumab er, i kombination med interferon alfa-2a, indiceret til 1.-linjebehandling af voksne patienter med fremskreden og/eller metastatisk renalcellekarcinom.
Bevacizumab in combination with interferon alfa-2a is indicated for first line treatment of adult patients with advanced and/or metastatic renal cell cancer.
PFS-undergruppeanalyse af sygdomsstadie og tumoreduktionsstatus er sammenfattet i tabel 19.
PFS subgroup analyses by disease stage and debulking status are summarised in Table 19.
I kliniske studier var forekomsten af arterielle tromboemboliske bivirkninger, inklusive cerebrovaskulære tilfælde, transitorisk iskæmisk attak og myokardieinfarkter højere hos patienter, som fik Avastin i kombination med kemoterapi sammenlignet med patienter, som fik kemoterapi alene.
In clinical trials, the incidence of arterial thromboembolic reactions including cerebrovascular accidents (CVAs), transient ischaemic attacks (TIAs) and myocardial infarctions (MIs) was higher in patients receiving Avastin in combination with chemotherapy compared to those who received chemotherapy alone.
Cerebrovaskulære tilfælde (inklusiv transitorisk iskæmisk attak) blev rapporteret hos op til 2,7 % af patienterne, som fik Avastin i kombination med kemoterapi i forhold til op til 0,5 % af patienterne, som fik kemoterapi alene.
Cerebrovascular accidents (including transient ischaemic attacks) were reported in up to 2.7% of patients treated with Avastin in combination with chemotherapy compared to up to 0.5% of patients treated with chemotherapy alone.
95 % konfidensinterval for responsrate3
Responders (Response rate 95% CI for Response Rates3
• Avastin kan øge risikoen for blødning eller problemer med sårhelingen efter operation.
● This medicine can increase the risk of bleeding or increase the risk of problems with wound healing after surgery.
Klar til let opaliserende, farveløs til lysebrun væske.
Clear to slightly opalescent, colourless to pale brown liquid.
Sekundært endepunkt
Secondary Endpoints
I et randomiseret fase II-studie (BO25041) blev 121 patienter ≥ 3 år til <18 år med nyligt diagnosticeret supratentorielt eller infratentorielt cerebellært eller pedunkulært høj-grads-gliom behandlet med post-operativ strålebehandling (RT) og adjuverende temozolomid (T) med og uden bevacizumab: 10 mg/kg i.v.
In a randomized phase II study (BO25041) a total of 121 patients aged ≥ 3 years to <18 years with newly diagnosed supratentorial or infratentorial cerebellar or peduncular high-grade glioma (HGG) were treated with post operative radiation therapy (RT) and adjuvant temozolomide (T) with and without bevacizumab: 10 mg/kg every 2 weeks IV.
Resultater vises i Tabel 23.
Results are presented in Table 23.
Studie BO17704 har vist, at bevacizumab givet som både 7,5 mg/kg legemsvægt hver 3. uge og 15 mg/kg legemsvægt hver 3. uge øger progressionsfri overlevelse og responsraten.
Trial BO17704 has demonstrated that both 7.5 mg/kg/q3wk and 15 mg/kg/q3wk bevacizumab doses increase progression free survival and response rate.
4.4 og Post-marketing erfaring nedenfor) I nogle kliniske studier har anafylaktiske og anafylaktoide reaktioner været rapporteret oftere hos patienter, som blev behandlet med Avastin i kombination med kemoterapi end med kemoterapi alene.
Hypersensitivity reactions/infusion reactions (see section 4.4 and Post-marketing experience below) In some clinical trials anaphylactic and anaphylactoid-type reactions were reported more frequently in patients receiving Avastin in combination with chemotherapy than with chemotherapy alone.
Sammenlignet med patienter behandlet med kemoterapi (paclitaxel, topotecan eller pegyleret liposomal doxorubicin) alene ved recidiverende platin-resistent sygdom havde patienter behandlet med bevacizumab i en dosis på 10 mg/kg hver 2. uge (eller 15 mg/kg hver 3. uge, hvis anvendt i kombination med 1,25 mg/m2 topotecan på dag 1-5 hver 3. uge) i kombination med kemoterapi, og som fortsatte behandling med bevacizumab indtil sygdomsprogression eller uacceptabel toksicitet, statistisk signifikant forbedring i PFS.
Compared to patients treated with chemotherapy (paclitaxel, topotecan or PLD) alone in the recurrent platinum-resistant setting, patients who received bevacizumab at a dose of 10 mg/kg every 2 weeks (or 15 mg/kg every 3 weeks if used in combination with 1.25 mg/m2 topotecan on Days 1-5 every 3 weeks) in combination with chemotherapy and continued to receive bevacizumab until disease progression or unacceptable toxicity, had a statistically significant improvement in PFS.
Denne gruppe medicinske termer kan involvere samme underliggende patofysiologi (fx arterielle tromboemboliske bivirkninger inklusive cerebrovaskulære tilfælde, myokardieinfarkt, transitorisk iskæmisk attak og andre arterielle tromboemboliske hændelser).
This group of medical terms may involve the same underlying pathophysiology (e.g. arterial thromboembolic reactions include cerebrovascular accident, myocardial infarction, transient ischaemic attack and other arterial thromboembolic reactions).
Effektresultater fra studie GOG-0218
Table 16 Efficacy results from study GOG-0218
• mave- og tarmproblemer,
• stomach and intestinal disorder,
Dødelig udgang blev rapporteret hos 0,8 % af patienterne, som fik Avastin, sammenholdt med 0,5 % hos patienter, som fik kemoterapi alene.
Fatal outcome was reported in 0.8% of patients receiving Avastin compared to 0.5% in patients receiving chemotherapy alone.
Hypertension (se pkt.
Hypertension (see section 4.4)
10 mg/kg hver 2. uge b
a 10 mg/kg every 2 weeks b
Investigatorvurderet GOG-protokolspecificeret PFS-analyse (hverken censureret for CA-125-progressioner eller censureret for non-protokolleret terapi (NPT) før sygdomsprogression) med data cut-off den 25. februar
Investigator assessed GOG protocol-specified PFS analysis (neither censored for CA-125 progressions nor censored for NPT prior to disease progression) with data cut-off date of 25 February, 2010.
GOG-0213, et fase III randomiseret, kontrolleret og åbent studie, undersøgte sikkerheden og virkningen af Avastin hos patienter med platinfølsom, recidiverende epitelial ovariecancer, tubacancer eller primær peritonealcancer, som ikke tidligere havde fået kemoterapi for recidiverende sygdom.
GOG-0213, a phase III randomized controlled open label trial, studied the safety and efficacy of Avastin in the treatment of patients with platinum-sensitive, recurrent epithelial ovarian, fallopian tube or primary peritoneal cancer, who have not received prior chemotherapy in the recurrent setting.
Patienter i Avastinbehandling kan have risiko for at udvikle venøse tromboemboliske bivirkninger, herunder lungeemboli.
Patients may be at risk of developing venous thromboembolic reactions, including pulmonary embolism under Avastin treatment.
Hver ml koncentrat indeholder 25 mg bevacizumab svarende til 1,4 til 16,5 mg/ml efter foreskreven fortynding.
Each ml of concentrate contains 25 mg of bevacizumab, corresponding to 1.4 to 16.5 mg/ml when diluted as recommended.
Studiet var et randomiseret, dobbeltblindet, aktivt kontrolleret, klinisk fase II-studie, som undersøgte effekt og sikkerhed af Avastin i kombination med 5-FU/FA som 1.-linjebehandling af metastatisk kolorektalkræft hos patienter, som ikke var optimale kandidater for 1.-linjebehandling med irinotecan.
This was a phase II randomised, double-blind, active-controlled clinical trial evaluating the efficacy and safety of Avastin in combination with 5-FU/FA as first-line treatment for metastatic colorectal cancer in patients who were not optimal candidates for first-line irinotecan treatment.
GOG-0218 var et fase III, multicenter, randomiseret, dobbeltblindet, placebokontrolleret, tre-armet studie, som evaluerede effekten af tillæg af Avastin til et godkendt kemoterapiregime (carboplatin og paclitacxel) hos patienter med fremskreden (Stadie III B, III C og IV ifølge FIGO stadieinddeling version 1988) epitelial ovariecancer, tubacancer eller primær peritonealcancer.
The GOG-0218 study was a phase III multicentre, randomised, double-blind, placebo-controlled, three arm study evaluating the effect of adding Avastin to an approved chemotherapy regimen (carboplatin and paclitaxel) in patients with advanced ( Stages IIIB, IIIC and IV according to FIGO staging version dated 1988) epithelial ovarian, fallopian tube or primary peritoneal cancer.
I kliniske studier var den samlede forekomst af arterielle tromboemboliske bivirkninger op til 3,8 % i Avastin-armen sammenlignet med op til 2,1 % i kontrolgruppen, som fik kemoterapi alene.
In clinical trials, the overall incidence of arterial thromboembolic reactions ranged up to 3.8% in the Avastin containing arms compared with up to 2.1% in the chemotherapy control arms.
% af patienter med objektivt respons p-værdi
% patients with objective response p -value
Kongestiv hjerteinsufficiens (CHF) (se pkt.
Congestive heart failure (CHF) (see section 4.8)