FrancophonIA/ELRC3.0 huggingface dataset:
English: A total of 1873 patients were randomised in equal proportions to the following three arms:
Danish: Sammenlagt blev 1.873 patienter randomiseret til tre lige store arme:
English: • Arterial thromboembolism (see section 4.4).
Danish: ● Arteriel tromboemboli (se også pkt.
English: Proteinuriab,d
Danish: Proteinuria,b
English: From a clinical trial in patients with persistent, recurrent, or metastatic cervical cancer (GOG-240), 1.8% of Avastin-treated patients and 1.4% of control patients were reported to have had nongastrointestinal vaginal, vesical, or female genital tract fistulae.
Danish: I et klinisk studie hos patienter med persisterende, recidiverende eller metastatisk cervixcancer (GOG0240) blev det rapporteret, at 1,8 % af de Avastinbehandlede patienter og 1,4 % af patienterne i kontrolgruppen havde haft ikke-gastrointestinale -vaginale, -vesikale eller gynækologiske fistler.
English: A GOG PS of 2 at baseline was reported in 0.9% of patients in the CP arm and in 1.2% of patients in the CPB arm.“ The primary efficacy endpoint was overall survival (OS).
Danish: En GOG PS på 2 ved baseline var rapporteret hos 0,9 % af patienterne i CP-armen og 1,2 % af patienterne i CPB-armen.
English: Patients with a history of hypertension may be at increased risk for the development of proteinuria when treated with Avastin.
Danish: Patienter, som tidligere har haft hypertension, kan have øget risiko for at udvikle proteinuri, når de behandles med Avastin.
English: <2D barcode carrying the unique identifier included.>
Danish: 17 ENTYDIG IDENTIFIKATOR - 2D-STREGKODE <Der er anført en 2D-stregkode, som indeholder en entydig identifikator.>
English: Myocardial infarction was reported in up to 1.4% of patients treated with Avastin in combination with chemotherapy compared to up to 0.7% of patients treated with chemotherapy alone.
Danish: Myokardieinfarkt blev rapporteret hos op til 1,4 % af patienterne, som fik Avastin i kombination med kemoterapi, sammenlignet med op til 0,7 % af patienterne, som fik kemoterapi alene.
English: Hazard ratio (97.5% CI) a
Danish: Hazard ratio (97,5 % konfidensinterval)a
English: Hypertension a,b
Danish: Hypertensiona,b
English: The efficacy results are presented in Table 13.
Danish: Effektresultaterne er præsenteret i tabel 13.
English: ● a hole in your gut wall,
Danish: • hul i tarmvæggen,
English: When used for patients with epithelial ovarian, fallopian tube, or primary peritoneal cancer, it will be administered in combination with carboplatin and paclitaxel.
Danish: Når det anvendes til patienter med kræft i æggestokkene, kræft i æggeledere eller primær bughindekræft, bliver det givet sammen med carboplatin og paclitaxel.
English: Bevacizumab, 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).
Danish: Bevacizumab 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.
English: One hundred and five patients were randomised to 5-FU/FA + placebo arm and 104 patients to 5-FU/FA + Avastin (5 mg/kg every 2 weeks) arm. All treatments were continued until disease progression.
Danish: Der blev randomiseret 105 patienter til 5-FU/FA + placebo-armen og 104 patienter til 5-FU/FA + Avastin-armen (5 mg/kg hver 2. uge).
English: 4 ml solution in a vial (Type I glass) with a stopper (butyl rubber) containing 100 mg of bevacizumab.
Danish: 4 ml opløsning i et hætteglas (type I glas) med butylgummiprop indeholdende 100 mg bevacizumab.
English: Bevacizumab, 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).
Danish: Bevacizumab er, i kombination med erlotinib, indiceret til 1.linjebehandling hos voksne patienter med ikke-operabel fremskreden, metastatisk eller recidiverende ikke-planocellulær, ikke-småcellet lungekræft med Epidermal Growth Factor Receptor (EGFR)-aktiverende mutationer (se pkt.
English: Patients were randomised to platinum-based chemotherapy, cisplatin 80 mg/m2 intravenous infusion on day 1 and gemcitabine 1250 mg/m2 intravenous infusion on days 1 and 8 of every 3-week cycle for up to 6 cycles (CG) with placebo or CG with Avastin at a dose of 7.5 or 15 mg/kg IV infusion day 1 of every 3-week cycle.
Danish: Patienterne blev randomiseret til platinbaseret kemoterapi, cisplatin 80 mg/m2 som intravenøs infusion på dag 1 og gemcitabin 1.250 mg/m2 som intravenøs infusion på dag 1 og 8 i hver 3-ugers serie i op til 6 serier (CG) med placebo eller til CG i kombination med Avastin i en dosis på 7,5 eller 15 mg/kg som intravenøs infusion på dag 1 i hver 3-ugers serie.
English: In patients with NSCLC excluding predominant squamous histology, all Grade reactions were seen with a frequency of up to 9.3% when treated with Avastin plus chemotherapy compared with up to 5% in the patients treated with chemotherapy alone.
Danish: Hos de patienter med NSCLC, der ikke har dominerende planocellulær histologi, der blev behandlet med Avastin og kemoterapi, blev der set bivirkninger af alle grader med frekvenser på op til 9,3 % sammenlignet med op til 5 % hos de patienter, der kun blev behandlet med kemoterapi.
English: • problems with wound healing after surgery,
Danish: • problemer med sårheling efter operation,
English: An overall survival benefit has been demonstrated in trial E4599 with a 15 mg/kg/q3wk dose of bevacizumab.
Danish: Samlet overlevelse er vist i studie E4599 med en dosering af bevacizumab på 15 mg/kg legemsvægt hver 3. uge.
English: • ML18147: Avastin 5.0 mg/kg of body weight every 2 weeks or Avastin 7.5 mg/kg of body weight every 3 weeks in combination with fluoropyrimidine/irinotecan or fluoropyrimidine/oxaliplatin in patients with disease progression following first-line treatment with bevacizumab.
Danish: ● ML 18147: Avastin 5,0 mg/kg legemsvægt hver 2. uge eller Avastin 7,5 mg/kg legemsvægt hver 3. uge i kombination med fluoropyrimidin/irinotecan eller fluoropyrimidin/oxaliplatin til patienter med sygdomsprogression efter 1.linje-behandling med bevacizumab.
English: In clinical trials across all indications the overall incidence of NCI-CTCAE v.3 Grade 3-5 bleeding reactions ranged from 0.4% to 6.9% in Avastin treated patients, compared with up to 4.5% of patients in the chemotherapy control group.
Danish: I kliniske studier inden for alle indikationer spændte hyppigheden af NCI-CTCAE v.3 grad 3-5 blødning fra 0,4 % til 6,9 % hos Avastinbehandlede patienter versus 4,5 % hos de patienter, der fik kemoterapi alene.
English: 16 ml solution in a vial (Type I glass) with a stopper (butyl rubber) containing 400 mg of bevacizumab.
Danish: 16 ml opløsning i et hætteglas (type I glas) med butylgummiprop indeholdende 400 mg bevacizumab.
English: This was a Phase III randomised, controlled, open-label trial investigating Avastin 5.0 mg/kg every 2 weeks or 7.5 mg/kg every 3 weeks in combination with fluoropyrimidine-based chemotherapy versus fluoropyrimidine-based chemotherapy alone in patients with mCRC who have progressed on a firstline bevacizumab-containing regimen.
Danish: Studiet var et fase III randomiseret, kontrolleret, åbent studie, som undersøgte Avastin 5,0 mg/kg hver 2. uge eller 7,5 mg/kg hver 3. uge i kombination med fluoropyrimidin-baseret kemoterapi versus fluoropyrimidin-baseret kemoterapi alene, til patienter med metastatisk kolorektalkræft, som progredierede på et1.linje bevacizumab-indeholdende regime.
English: The results of this study are summarised in Table 18.
Danish: Resultaterne fra dette studie er sammenfattet i tabel 18.
English: In clinical trials of ovarian cancer, Grade 3-5 wound healing complications were observed in up to 1.8% of patients in the bevacizumab arm versus 0.1% in the control arm (NCI-CTCAE v.3).
Danish: I kliniske studier af ovariecancer blev der observeret sårhelingskomplikationer af grad 3-5 hos op til 1,8 % af patienterne i bevacizumab-armen i forhold til 0,1 % i kontrolarmen (NCI-CTCAE v. 3).
English: Table 10 Trial E2100 efficacy results
Danish: Tabel 10. Effektresultater fra studie E2100
English: • CP arm: Carboplatin (AUC 6) and paclitaxel (175 mg/m2) for 6 cycles of 3 weeks duration
Danish: • CP-arm: Carboplatin (AUC 6) og paclitaxel (175 mg/m2) i 6 serier af 3 ugers varighed
English: The primary analysis of investigator-assessed PFS with a data cut-off date of 28 February 2010 shows an unstratified hazard ratio of 0.79 (95% CI: 0.68-0.91, 2-sided log-rank p-value 0.0010) with a median PFS of 16.0 months in the CP arm and 18.3 months in the CPB7.5+ arm.
Danish: Den primære analyse af investigatorvurderet PFS med cut-off den 28. februar 2010 viser en ustratificeret hazard ratio på 0,79 (95 % konfidensinterval: 0,68-0,91, tosidig log-rank p-værdi 0,0010) med en median PFS på 16,0 måneder i CP-armen og 18,3 måneder i CPB7,5+-armen.
English: Each ml of concentrate contains 25 mg of bevacizumab*.
Danish: KVALITATIV OG KVANTITATIV SAMMENSÆTNING 1 ml koncentrat indeholder 25 mg bevacizumab*.
English: Capecitabine 1000 mg/m2 oral bid Placebo or
Danish: Capecitabin 1.000 mg/m2 oral to gange daglig
English: In patients with measurable disease at baseline.
Danish: Patienter med målbar sygdom ved baseline.
English: Post-marketing experience Table 3 Adverse reactions reported in post-marketing setting System organ class (SOC)
Danish: Bivirkninger rapporteret post-marketing Systemorganklasse
English: • CPB7.5+ arm: Carboplatin (AUC 6) and paclitaxel (175 mg/m2) for 6 cycles of 3 weeks plus Avastin (7.5 mg/kg q3w) for up to 12 months (Avastin was started at cycle 2 of chemotherapy if treatment was initiated within 4 weeks of surgery or at cycle 1 if treatment was initiated more than 4 weeks after surgery).
Danish: • CPB7,5+-arm: Carboplatin (AUC 6) og paclitaxel (175 mg/m2) i 6 serier af 3 ugers varighed plus Avastin (7,5 mg/kg hver 3. uge) i op til 12 måneder (Avastin blev startet i anden kemoterapiserie, hvis behandling blev initieret inden for 4 uger efter operation, og i første serie, hvis behandling blev initieret mere end 4 uger efter operation).
English: Pulmonary haemorrhage/haemoptysis
Danish: Pulmonal blødning/hæmoptyse
English: • NO16966: Avastin 7.5 mg/kg of body weight every 3 weeks in combination with oral capecitabine and intravenous oxaliplatin (XELOX) or Avastin 5 mg/kg every 2 weeks in combination with leucovorin plus 5-fluorouracil bolus, followed by 5-fluorouracil infusion, with intravenous oxaliplatin (FOLFOX-4).
Danish: ● NO16966: Avastin 7,5 mg/kg legemsvægt hver 3. uge i kombination med oral capecitabin og intravenøs oxaliplatin (XELOX) eller Avastin 5 mg/kg hver 2. uge i kombination med leucovorin plus 5-fluoruracil bolus efterfulgt af 5-fluoruracil infusion og intravenøs oxaliplatin (FOLFOX-4).
English: Each 16 ml vial contains 400 mg of bevacizumab.
Danish: Hvert 16 ml hætteglas indeholder 400 mg bevacizumab.
English: Seventy-one patients were randomised to receive bolus 5-FU/FA or 5-FU/FA + Avastin (5 mg/kg every 2 weeks).
Danish: Der blev randomiseret 71 patienter til bolus 5-FU/FA eller 5-FU/FA + Avastin (5 mg/kg hver 2. uge).
English: ● 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.
Danish: • 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.
English: (16.2 vs 17.5 months; p = 0.3769)
Danish: (16,2 vs 17,5 måneder; p = 0,3769)
English: Avastin may adversely affect the wound healing process.
Danish: Avastin kan påvirke sårhelingen negativt.
English: (p-value = 0.0185)
Danish: (p-værdi = 0,0185)
English: E4599 was an open-label, randomised, active-controlled, multicentre clinical trial evaluating Avastin as first-line treatment of patients with locally advanced (stage IIIb with malignant pleural effusion), metastatic or recurrent NSCLC other than predominantly squamous cell histology.
Danish: Studie E4599 var et åbent, randomiseret, aktivt kontrolleret, multicenter klinisk studie til evaluering af Avastin som 1.-linjebehandling af patienter med lokal fremskreden (stadie IIIb med malignt pleural effusion), metastatisk eller recidiverende NSCLC, der ikke har dominerende planocellulær histologi.
English: Bevacizumab, in combination with carboplatin and gemcitabine or in combination with carboplatin and paclitaxel, is indicated for treatment of adult patients with first recurrence of platinum-sensitive epithelial ovarian, fallopian tube or primary peritoneal cancer who have not received prior therapy with bevacizumab or other VEGF inhibitors or VEGF receptor-targeted agents.
Danish: Bevacizumab er, i kombination med carboplatin og gemcitabin eller i kombination med carboplatin og paclitaxel, indiceret til behandling af voksne patienter med første recidiv af platinsensitiv epitelial ovariecancer, tubacancer eller primær peritonealcancer, som ikke tidligere har fået behandling med bevacizumab eller andre vaskulær endotelial vækstfaktor (VEGF)-hæmmere eller VEGF-receptormålrettede lægemidler.
English: In most clinical trials urine protein levels of ≥ 2g/24 hrs led to the holding of Avastin until recovery to < 2g/24 hrs.
Danish: timer i urinen til seponering af Avastinbehandlingen, indtil der var nået et niveau på < 2 g/24 timer.
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Avastin 25 mg/ml concentrate for solution for infusion Bevacizumab
Danish: LÆGEMIDLETS NAVN, STYRKE OG/ELLER ADMINISTRATIONSVEJ(E) Avastin 25 mg/ml koncentrat til infusionsvæske, opløsning Bevacizumab i.v.
English: • runny nose,
Danish: • løbende næse,
English: Avastin is a medicine used for the treatment of adult patients with advanced cancer in the large bowel, i.e., in the colon or rectum.
Danish: Avastin er medicin som anvendes hos voksne til behandling af fremskreden kræft i tyktarmen eller endetarmen.
English: The overall mean age was 59.4 years; 56.6% of patients had an ECOG
Danish: Den samlede gennemsnitsalder var 59,4 år, 56,6 % af patienterne havde en ECOG-performancestatus på 0, 43 % havde en status på 1 og 0,4 % havde en status på 2.
English: Hypersensitivity reactions/infusion reactions (see section 4.8) Patients may be at risk of developing infusion/hypersensitivity reactions.
Danish: 4.8) Der er risiko for, at patienterne udvikler infusions-/overfølsomhedsreaktioner.
English: Only patients with histologically documented ovarian, primary peritoneal, or fallopian tube carcinoma that had recurred > 6 months after platinum-based chemotherapy and who had not received chemotherapy in the recurrent setting and who have not received prior therapy with bevacizumab or other VEGF inhibitors or VEGF receptor-targeted agents were included in the study.
Danish: Kun patienter, som havde histologisk dokumenteret ovariecancer, primært peritonealcancer eller tubacancer, som havde recidiv ˃6 måneder efter platinbaseret kemoterapi, som ikke havde fået kemoterapi for recidiverende sygdom, og som ikke tidligere havde fået bevacizumab eller behandling med andre VEGF-hæmmere eller VEGF-receptor-målrettede lægemidler, blev inkluderet i studiet.
English: In clinical trials, proteinuria has been reported within the range of 0.7% to 54.7% of patients receiving Avastin.
Danish: Proteinuri er blevet rapporteret hos mellem 0,7 % og 54,7 % af patienterne, som fik Avastin i kliniske studier.
English: Haemorrhage
Danish: Bløddelssarkom
English: After discontinuation of bevacizumab treatment, ovarian function recovered in the majority of patients.
Danish: Ovariefunktionen blev genoprettet hos størstedelen af patienterne efter seponering af bevacizumab.
English: Two large Phase III trials were designed to investigate the treatment effect of Avastin in combination with two individual chemotherapy agents, as measured by the primary endpoint of PFS. A clinically meaningful and statistically significant improvement in PFS was observed in both trials.
Danish: To store fase III-studier blev designet for at undersøge behandlingseffekten af Avastin i kombination med to individuelle kemoterapeutika, målt ved det primære endepunkt progressionsfri overlevelse (PFS).
English: In locally recurrent and metastatic breast cancer trials, Grade 3-5 wound healing complications were observed in up to 1.1% of patients receiving Avastin compared with up to 0.9% of patients in the control arms (NCI-CTCAE v.3).
Danish: I kliniske studier omhandlende lokalt recidiverende eller metastatisk brystkræft blev der observeret sårhelingskomplikationer af grad 3-5 hos op til 1,1 % af patienterne, som fik Avastin, og hos op til 0,9 % af patienterne i kontrolarmene (NCI-CTCAE v. 3).
English: • inflammation of the moist lining of mouth and gut, lungs and air passages, reproductive, and urinary tracts,
Danish: • inflammation (betændelseslignende reaktion) i slimhinder i mund og tarme, lunger og luftveje,
English: (p-value = 0.0188)
Danish: (p-værdi = 0,0188)
English: 5 mg/kg every 2 weeks.
Danish: 5 mg/kg hver 2. uge.
English: (11.9 vs.14.3 months; p = 0.4825)
Danish: (11,9 vs 14,3 måneder; p = 0,4825)
English: Table 4 Efficacy results for trial AVF2107g
Danish: Resultater for effekt i studie AVF2107g
English: The results of this study are summarised in Table 16.
Danish: Resultaterne fra dette studie er sammenfattet i tabel 16.
English: • sickness,
Danish: • kvalme,
English: Bevacizumab in combination with paclitaxel, topotecan, or pegylated liposomal doxorubicin is indicated for the treatment of adult patients with platinum-resistant recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who received no more than two prior chemotherapy regimens and who have not received prior therapy with bevacizumab or other VEGF inhibitors or VEGF receptor-targeted agents (see Section 5.1).
Danish: Bevacizumab er, i kombination med paclitaxel, topotecan eller pegyleret liposomal doxorubicin, indiceret til behandling af voksne patienter med platin-resistent recidiverende epitelial ovariecancer, tubacancer eller primær peritonealcancer, som ikke har gennemgået mere end to kemoterapiregimer, og som ikke tidligere har fået behandling med bevacizumab, andre VEGF-hæmmere eller med VEGFreceptor-målrettede lægemidler (se pkt.
English: (16.2 vs. 12.0 months; p = 0.1342)
Danish: (16,2 vs 12,0 måneder; p = 0,1342)
English: The recommended dose of Avastin, administered as an intravenous infusion, is either 5 mg/kg or 10 mg/kg of body weight given once every 2 weeks or 7.5 mg/kg or 15 mg/kg of body weight given once every 3 weeks.
Danish: Den anbefalede dosis af Avastin administreres som intravenøs infusion og administreres enten som 5 mg/kg eller 10 mg/kg legemsvægt en gang hver 2. uge eller som 7,5 mg/kg eller 15 mg/kg legemsvægt en gang hver 3. uge.
English: NAME OF THE MEDICINAL PRODUCT Avastin 25 mg/ml concentrate for solution for infusion.
Danish: LÆGEMIDLETS NAVN Avastin 25 mg/ml koncentrat til infusionsvæske, opløsning.
English: It is recommended that treatment be continued until progression of the underlying disease or until unacceptable toxicity (see section 5.1).
Danish: Det anbefales, at behandlingen fortsættes indtil progression af den underliggende sygdom eller indtil uacceptabel toksicitet (se pkt.
English: • PLD 40 mg/m2 as a 1 mg/min IV infusion on Day 1 only every 4 weeks.
Danish: • Pegyleret liposomal doxorubicin 40 mg/m2 som 1 mg/min i.v.-infusion, kun på dag 1 hver 4. uge.
English: There have also been less common reactions of minor mucocutaneous haemorrhage in other locations, such as gingival bleeding or vaginal bleeding.
Danish: Mindre slimhindeblødninger lokaliseret andre steder, som f.eks. gingival eller vaginal blødning har også været rapporteret som mindre almindelige bivirkninger.
English: The median age was 46.0 years (range: 20−83) in the Chemo alone group and 48.0 years
Danish: Medianalder var 46,0 år (spændvidde: 20-83) i kemoterapigruppen og 48,0 år (spændvidde: 22-85) i kemoterapi+Avastingruppen.
English: Patients with untreated CNS metastases were routinely excluded from clinical trials with Avastin, based on imaging procedures or signs and symptoms.
Danish: Patienter med ubehandlede CNS-metastaser, verificeret ved billeddiagnostik eller tegn og symptomer, er rutinemæssigt blevet udeladt af kliniske studier med Avastin.
English: Hypertensive encephalopathyc
Danish: Hypertensiv encefalopatia
English: Relative to control arm
Danish: I forhold til kontrolarmen
English: • Infection or inflammation of the eye globe,
Danish: • infektion eller vævsirritation (inflammation) i øjeæblet,
English: The primary endpoint was progression-free-survival, with secondary endpoints including objective response rate and overall survival.
Danish: Det primære endepunkt var progressionsfri overlevelse; de sekundære endepunkter omfattede objektiv responsrate og samlet overlevelse.
English: HR (95% CI) p-value
Danish: HR (95% konfidensinterval) p-værdi
English: The addition of Avastin 5 mg/kg every two weeks to 5-FU/FA resulted in higher objective response rates, longer progression-free survival, and a trend in longer survival, compared with 5-FU/FA chemotherapy alone (see Table 5).
Danish: Sammenlignet med 5-FU/FA-kemoterapi alene medførte tillæg af Avastin 5 mg/kg hver 2. uge til 5-FU/FA en højere, objektiv responsrate, længere progressionsfri overlevelse og en tendens til længere overlevelse (se tabel 5).
English: Febrile neutropenia, Leucopenia, Neutropeniab, Thrombo-cytopenia
Danish: Febril neutropeni Leukopeni Neutropenib Trombocytopeni
English: Cases of foetal abnormalities in women treated with bevacizumab alone or in combination with known embryotoxic chemotherapeutics have been observed (see section 4.6 )
Danish: Der er observeret tilfælde af anormaliteter hos fostre, hvor moderen er blevet behandlet med bevacizumab alene eller i kombination med kemoterapeutika med kendt embryotoksicitet (se pkt.
English: Laboratory abnormalities
Danish: Unormale laboratorieprøver
English: Within each frequency category, adverse reactions are presented in the order of decreasing seriousness.
Danish: Inden for hver frekvensgruppe er bivirkningerne anført med de alvorligste først.
English: (17.5 vs.15.0 months; p = 0.0584)
Danish: (17,5 vs 15,0 måneder; p = 0,0584)
English: Rectal haemorrhage
Danish: Recidiverende ovariecancer
English: (p-value < 0.0001)
Danish: (p-værdi < 0,0001)
English: Table 8 Efficacy results for trial E3200
Danish: Effektresultater fra studie E3200
English: This was a phase II randomised, active-controlled, open-labelled clinical trial investigating Avastin in combination with 5-FU/FA as first-line treatment of metastatic colorectal cancer.
Danish: Studiet var et åbent, randomiseret, aktivt kontrolleret, klinisk fase II-studie, som undersøgte Avastin i kombination med 5-FU/FA som 1.-linjebehandling af metastatisk kolorektalkræft.
English: Study MO22224 evaluated the efficacy and safety of bevacizumab in combination with chemotherapy for platinum-resistant recurrent epithelial ovarian, fallopian tube or primary peritoneal cancer.
Danish: Studie MO22224 evaluerede bevacizumabs virkning og sikkerhed i kombination med kemoterapi til platinresistent, recidiverende epitelial ovariecancer, tubacancer og primær peritonealcancer.
English: Dyspnoea, Rhinitis
Danish: Nyrer og urinveje
English: The overall rates of discontinuation due to adverse events were 8.8% in the CT arm and 43.6% in the CT + BV arm (mostly due to Grade 2-3 adverse events) and the median time to discontinuation in the CT + BV arm was 5.2 months compared with 2.4 months in the CT arm.
Danish: Den samlede seponeringsfrekvens på grund af bivirkninger var 8,8 % i kemoterapi-armen og 43,6 % i kemoterapi + bevacizumab-armen (hovedsagelig på grund af bivirkninger af grad 2-3).
English: For further information on proteinuria see section 4.4 and Proteinuria in section 4.8.
Danish: 4.4 og Proteinuri i pkt.