natgillin/translations-raw huggingface dataset:
Hypertensiv encefalopatia
Hypertensive encephalopathya
Patienterne blev randomiseret til paclitaxel alene (90 mg/m indgivet intravenøst som 1-times infusion en gang ugentligt i tre ud af fire uger) eller i kombination med bevacizumab (10 mg/kg indgivet som intravenøs infusion hver 2. uge).
Patients were randomised to paclitaxel alone (90 mg/m2 / IV over 1-hour once weekly for three out of four weeks) or in combination with bevacizumab (10 mg/kg IV infusion every two weeks).
Aneurismer og arterielle dissektioner (se pkt.
Aneurysms and artery dissections (see section 4.8)
Patienter, behandlet med bevacizumab for persisterende, recidiverende eller metastatisk cervixcancer, har en øget risiko for dannelse af fistler mellem vagina og alle dele af mave-tarmkanalen (gastrointestinalevaginale fistler).
Patients treated for persistent, recurrent, or metastatic cervical cancer with bevacizumab are at increased risk of fistulae between the vagina and any part of the GI tract (Gastrointestinal-vaginal fistulae).
Bevacizumabs sikkerhed og virkning ved behandling af recidiverende epitelial ovariecancer, tubacancer og primær peritonealcancer blev undersøgt i tre fase III-studier (AVF4095g, MO22224 og GOG-0213) hos forskellige patientpopulationer og med forskellige kemoterapiregimer.
The safety and efficacy of bevacizumab in the treatment of recurrent epithelial ovarian, fallopian tube or primary peritoneal cancer was studied in three phase III trials (AVF4095g, MO22224 and GOG-0213) with different patient populations and chemotherapy regimens.
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.
Studie JO25567 var et randomiseret, åbent fase II multicenterstudie, gennemført i Japan, for at vurdere effekten og sikkerheden af bevacizumab, 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 randomised, open-label, multi-centre phase II study conducted in Japan to evaluate the efficacy and safety of bevacizumab used in addition to erlotinib in patients with nonsquamous 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.
I studie AVF3694g var hyppigheden af CHF (alle grader) i antracyklin + bevacizumab-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 + bevacizumab (6.2%) and the anthracycline + placebo arms (6.0%).
• Det er muligt, at MVASI kan forårsage allergiske og/eller infusionsrelaterede reaktioner.
• It is possible that MVASI can cause hypersensitivity and/or infusion reactions (reactions related to your injection of the medicine).
Objektiv responsrate1
Objective response rate1
Hvis du holder op med at få MVASI
If you stop treatment with MVASI
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 tumorer 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 tumour 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.
Både bevacizumabdoser svarende til 5 mg/kg/uge og 2,5 mg/kg/uge viste statistisk signifikant fordel med hensyn til samlet overlevelse (hazard ratio 0,751 i E3200-studiet, hazard ratio 0,81 i ML18147-studiet) og progressionfri overlevelse (hazard ratio 0,518 i E3200-studiet, hazard ratio 0,68 i ML18147-studiet).
Both the 5 mg/kg/week and 2.5 mg/kg/week equivalent doses of bevacizumab provided a statistically significant benefit with regards to OS (HR 0.751 in study E3200; HR 0.81 in study ML18147) and PFS (HR 0.518 in study E3200; HR 0.68 in study ML18147).
Kombination med platin- eller taxanbaserede terapier (se pkt.
Combination with platinum- or taxane-based therapies (see sections 4.4 and 4.8)
Osteonekrose af kæbena,b Ikke-mandibulær osteonekrosea,f
Osteonecrosis of the jawa,b, Nonmandibular osteonecrosisa,
Posteriort reversibelt encefalopati-syndrom (PRES) (sjælden) (se også pkt.
Posterior Reversible Encephalopathy Syndrome (PRES) (rare) (see also section 4.4)
MVASI er, i kombination med paclitaxel, indiceret til 1.-linjebehandling af voksne patienter med metastatisk brystkræft.
MVASI in combination with paclitaxel is indicated for first-line treatment of adult patients with metastatic breast cancer.
MVASI er, i kombination med interferon alfa-2a, indiceret til 1.-linjebehandling af voksne patienter med fremskreden og/eller metastatisk renalcellekarcinom.
MVASI in combination with interferon alfa-2a is indicated for first-line treatment of adult patients with advanced and/or metastatic renal cell cancer.
Alvorlige bivirkninger, som kan være almindelige (kan påvirke op til 1 patient ud af 10), omfatter:
Severe side effects, which may be common (may affect up to 1 in 10 people), include:
Behandling af platinfølsom recidiverende sygdom: MVASI administreres enten sammen med carboplatin og gemcitabin i 6 og op til 10 behandlingsserier eller sammen med carboplatin og paclitaxel i 6 og op til 8 behandlingsserier, efterfulgt af fortsat behandling med MVASI som monoterapi indtil sygdomsprogression.
Treatment of platinum-sensitive recurrent disease: MVASI is administered in combination with either carboplatin and gemcitabine for 6 cycles and up to 10 cycles or in combination with carboplatin and paclitaxel for 6 cycles and up to 8 cycles, followed by continued use of MVASI as single agent until disease progression.
• Arteriel tromboemboli (se pkt.
• Arterial thromboembolism (see section 4.4).
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.
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.
score på 0 ved baseline, 43 % en GOG PS-score på 1 og 7 % en GOG PS score på 2.
Overall approximately 50% of patients had a GOG PS of 0 at baseline, 43% a GOG PS score of 1, and 7% a GOG PS score of 2.
Sekundære PFS analyser, baseret på responsvurderinger fra ”on-treatment”populationen, bekræftede den signifikante, superiore, kliniske effekt for patienter, behandlet med bevacizumab (analyser vist i tabel 7).
Secondary PFS analyses, based on ‘on-treatment'-based response assessments, confirmed the significantly superior clinical benefit for patients treated with bevacizumab (analyses shown in table 7), consistent with the statistically significant benefit observed in the pooled analysis.
MVASI bruges også hos voksne til behandling af fremskreden ikke-småcellet lungekræft.
MVASI is also used for the treatment of adult patients with advanced non-small cell lung cancer.
EGFR-mutationsstatus blev bestemt for hver patient før patientscreening, og 154 patienter blev randomiseret til at få enten erlotinib + bevacizumab (oralt erlotinib 150 mg dagligt + bevacizumab [i.v.
EGFR mutation status was determined for each patient prior to patient screening and 154 patients were randomised to receive either erlotinib + bevacizumab (erlotinib 150 mg oral daily + bevacizumab [15 mg/kg IV every 3 weeks]) or erlotinib monotherapy (150 mg oral daily) until disease progression (PD) or unacceptable toxicity.
af de inkluderede patienter.
Patients included in analysis
Studiet sammenlignede effekten af at tilføje bevacizumab til carboplatin plus gemcitabin-kemoterapi og fortsætte med bevacizumab i monoterapi til progression, med behandling med carboplatin plus gemcitabin alene.
The study compared the effect of adding bevacizumab to carboplatin and gemcitabine chemotherapy and continuing bevacizumab as a single agent to progression, to carboplatin and gemcitabine alone.
30-90 min Dag 1, før XELOX, hver 3. uge
7.5 mg/kg IV 30-90 min Day 1, prior to XELOX, q 3 weeks
MVASI bliver givet sammen med paclitaxel og cisplatin eller med paclitaxel og topotecan til patienter, som ikke kan få platin.
MVASI will be administered in combination with paclitaxel and cisplatin or, alternatively, paclitaxel and topotecan in patients who cannot receive platinum therapy.
(p-værdi = 0,8910)
(p-value = 0.8910)
Alvorlige bivirkninger, som kan være meget almindelige (kan påvirke flere end 1 patient ud af 10), omfatter:
Severe side effects, which may be very common (may affect more than 1 in 10 people), include:
Det anbefales at teste for proteinuri før start på behandling med MVASI.
Testing for proteinuria is recommended prior to start of MVASI therapy.
Meget almindelige bivirkninger (kan påvirke flere end 1 patient ud af 10), som ikke var alvorlige, omfatter:
Very common (may affect more than 1 in 10 people) side effects, which were not severe, include:
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, randomised, two-arm phase III evaluation of bevacizumab plus chemotherapy (CT + BV) versus chemotherapy alone (CT).
Behandling med bevacizumab 15 mg/kg hver 3. uge i kombination med kemoterapi (carboplatin og paclitaxel) i 6 og op til 8 behandlingsserier, efterfulgt af bevacizumab 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 bevacizumab at 15 mg/kg every 3 weeks in combination with chemotherapy (carboplatin and paclitaxel) for 6 and up to 8 cycles, followed by bevacizumab 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.
MVASI er, i kombination med erlotinib, indiceret til 1.linjebehandling hos voksne patienter med ikkeoperabel fremskreden, metastatisk eller recidiverende ikke-planocellulær, ikke-småcellet lungekræft med Epidermal Growth Factor Receptor (EGFR)-aktiverende mutationer (se pkt.
MVASI, in combination with erlotinib, is indicated for first-line treatment of adult patients with unresectable advanced, metastatic or recurrent non-squamous non-small cell lung cancer with Epidermal Growth Factor Receptor (EGFR) activating mutations (see section 5.1).
Kongestivt hjertesvigta,b Supraventrikulær takykardi
Congestive heart failurea,b, Supraventricular tachycardia
MVASI indeholder:
What MVASI contains
Palmo-plantar erytrodysæstesisyndrom
Palmar-plantar erythrodysaesthesi a syndrome
De eksploratoriske PFS- og OSanalyser af kemoterapi-kohorten (paclitaxel, topotecan og pegyleret liposomal doxorubicin) vises i tabel
The exploratory PFS and OS analyses by chemotherapy cohort (paclitaxel, topotecan and PLD) are summarised in table 23.
• hul i galdeblæren (symptomer kan være mavesmerter, feber og kvalme/opkastning),
• hole in the gall bladder (symptoms and signs may include abdominal pain, fever, and nausea/vomiting),
Bevacizumab kan påvirke sårhelingen negativt.
Bevacizumab may adversely affect the wound healing process.
Cerebrovaskulære tilfælde (inklusiv transitorisk iskæmisk attak) blev rapporteret hos op til 2,7 % af patienterne, som fik bevacizumab 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 bevacizumab in combination with chemotherapy compared to up to 0.5% of patients treated with chemotherapy alone.
• Carboplatin (AUC 4, dag 1) og gemcitabin (1.000 mg/m2 på dag 1 og 8) samtidig med placebo hver 3. uge i 6 og op til 10 behandlingsserier, efterfulgt af placebo (hver 3. uge) som monoterapi indtil sygdomsprogresssion eller uacceptabel toksicitet.
• Carboplatin (AUC 4, day 1) and gemcitabine (1,000 mg/m2 on days 1 and 8) and concurrent placebo every 3 weeks for 6 and up to 10 cycles followed by placebo (every 3 weeks) alone until disease progression or unacceptable toxicity.
I kliniske studier, inden for alle indikationer, var hyppigheden af venøse tromboemboliske bivirkninger 2,8-17,3 % hos de bevacizumab-behandlede 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 bevacizumab-treated patients compared with 3.2% to 15.6% in the control arms.
Bevacizumabs sikkerhed og virkning ved behandling af platinfølsom, recidiverende epitelial ovariecancer, tubacancer eller primær peritonealcancer hos patienter, som ikke tidligere havde fået kemoterapi for recidiverende sygdom eller bevacizumab-behandling, blev undersøgt i et fase III, randomiseret, dobbeltblindet, placebokontrolleret studie (AVF4095g).
The safety and efficacy of bevacizumab 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 or prior bevacizumab treatment, was studied in a phase III randomised, double-blind, placebo-controlled trial (AVF4095g).
En tredje gruppe på 33 patienter fik bolus 5-FU/FA + bevacizumab (10 mg/kg hver 2. uge).
A third group of 33 patients received bolus 5-FU/FA + bevacizumab (10 mg/kg every 2 weeks).
Resultaterne fra dette studie er sammenfattet i tabel 17.
The results of this study are summarised in table 17.
GOG-0213, et fase III randomiseret, kontrolleret og åbent studie, undersøgte sikkerheden og virkningen af bevacizumab 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 randomised controlled open label trial, studied the safety and efficacy of bevacizumab 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.
I et randomiseret fase II-studie (BO20924) blev ialt 154 patienter i alderen ≥ 6 måneder til < 18 år med nylig diagnosticeret metastatisk rabdomyosarkom og ikke-rabdomyosarkom bløddelssarkom 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 randomised 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.
Der er rapporteret tilfælde af dødt knoglevæv (nekrose) i andre knogler end i kæben hos patienter under 18 år, som blev behandlet med bevacizumab.
Death of bone tissue (osteonecrosis) in bones other than the jaw have been reported in patients under 18 years old when treated with bevacizumab.
MVASI kan nedsætte kvinders frugtbarhed.
MVASI may impair female fertility.
(p-værdi5 = 0,0132)
(p-value5 = 0.0132)
Intestinal obstruktion Rektovaginale fistlerd,e Gastrointestinale forstyrrelser Proktalgi
Intestinal obstruction, Recto-vaginal fistulaed,e, Gastrointestinal disorder, Proctalgia
Den totale hyppighed af NCI-CTC grad 3 og 4 hypertension blev set hos mellem 0,4 % og 17,9 % af patienterne, som fik bevacizumab.
The overall incidence of NCI-CTC grade 3 and 4 hypertension in patients receiving bevacizumab ranged from 0.4% to 17.9%.
Effektresultater fra studie GOG-0240 for behandling med bevacizumab
Efficacy results from study GOG-0240 by bevacizumab treatment
Venøs tromboemboli: Hyppigheden af venøse tromboemboliske bivirkninger i kliniske studier var den samme for patienter, som fik bevacizumab 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 bevacizumab in combination with chemotherapy compared to those receiving the control chemotherapy alone.
Sammenlignet med patienter behandlet med kemoterapi (paclitaxel, topotecan eller pegyleret liposomal doxorubicin) alene ved recidiverende platinresistent 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.
MVASI anvendes også hos voksne til behandling af metastatisk brystkræft.
MVASI is also used for the treatment of adult patients with metastatic breast cancer.
Dødelig udgang blev rapporteret hos 0,8 % af patienterne, som fik bevacizumab, sammenholdt med 0,5 % hos patienter, som fik kemoterapi alene.
Fatal outcome was reported in 0.8% of patients receiving bevacizumab compared to 0.5% in patients receiving chemotherapy alone.
Dehydrering Hyponatriæmi
Dehydration, Hyponatraemia
Gastrointestinalt ulcusa
Gastrointestin al ulcera
Natriumphosphat
Sodium phosphate
Kemoterapi (n = 225)
Chemotherapy (n = 225)
Resultater for effekt i studie AVF2107g
Efficacy results for trial AVF2107g
• Studie E2100 (paclitaxel) • Median PFS-øgning på 5,6 måneder, hazard ratio 0,421 (p < 0,0001, 95 % konfidensinterval
• Study E2100 (paclitaxel) Median PFS increase 5.6 months, HR 0.421 (p < 0.0001, 95% CI 0.343; 0.516)
Studiet var et randomiseret, dobbeltblindet, aktivt kontrolleret, klinisk fase II-studie, som undersøgte effekt og sikkerhed af bevacizumab 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 bevacizumab 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.
Median PFS (måneder) Hazard ratio (95 % konfidensinterval) p-værdi Responsrater (for patienter med målbar sygdom) Investigators vurdering
Median PFS (months) HR (95% CI) p-value Response rates (for patients with measurable disease) Investigator assessment
MVASI er, i kombination med paclitaxel og cisplatin eller alternativt med paclitaxel og topotecan, hos patienter, som ikke kan behandles med platin, indiceret til behandling af voksne patienter med persisterende, recidiverende eller metastatisk cervixcancer (se pkt.
MVASI, in combination with paclitaxel and cisplatin or, alternatively, paclitaxel and topotecan in patients who cannot receive platinum therapy, is indicated for the treatment of adult patients with persistent, recurrent, or metastatic carcinoma of the cervix (see section 5.1).
Bivirkningerne blev rapporteret ved forskellige tidspunkter i behandlingen fra en uge efter behandlingsstart med bevacizumab 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 bevacizumab, with most reactions occurring within the first 6 months of therapy.
MVASI 25 mg/ml koncentrat til infusionsvæske, opløsning bevacizumab
MVASI 25 mg/mL concentrate for solution for infusion bevacizumab
Abscesb,d Cellulitis Infektion Urinvejsinfektion
Sepsis, Abscessb,d, Cellulitis, Infection, Urinary tract infection
GOG-0218 var et fase III, multicenter, randomiseret, dobbeltblindet, placebokontrolleret, tre-armet studie, som evaluerede effekten af tillæg af bevacizumab 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 bevacizumab 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 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 postoperativ strålebehandling (RT) og adjuverende temozolomid (T) med og uden bevacizumab: 10 mg/kg i.v.
In a randomised 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.
I kliniske studier var forekomsten af arterielle tromboemboliske bivirkninger, inklusive cerebrovaskulære tilfælde, transitorisk iskæmisk attak og myokardieinfarkter højere hos patienter, som fik bevacizumab 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 bevacizumab in combination with chemotherapy compared to those who received chemotherapy alone.
Kvalme Opkastning Abdominalsmerter
Vomiting, Abdominal pain
MVASI bør seponeres permanent hos patienter, som får grad 3 eller 4 blødninger (NCI-CTCAE v. 3) under behandlingen med bevacizumab (se pkt.
MVASI should be discontinued permanently in patients who experience grade 3 or 4 bleeding during bevacizumab therapy (NCI-CTCAE v.3) (see section 4.8).
• XELOX-armene var non-inferior med hensyn til progressionsfri overlevelse og samlet overlevelse i den egnede ”per protocol” patientpopulation i forhold til FOLFOX-4-armene.
• Non-inferiority of the XELOX-containing arms compared with the FOLFOX-4-containing arms in the overall comparison was demonstrated in terms of progression-free survival and overall survival in the eligible per-protocol population.
LÆGEMIDLETS NAVN MVASI 25 mg/ml koncentrat til infusionsvæske, opløsning.
NAME OF THE MEDICINAL PRODUCT MVASI 25 mg/mL concentrate for solution for infusion.