FrancophonIA/ELRC3.0 huggingface dataset:
English: Proteinuria (see section 4.8)
Danish: Proteinuri (se pkt.
English: B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE Medicinal product subject to restricted medical prescription (see Annex: Summary of Product Characteristics, section 4.2).
Danish: Lægemidlet må kun udleveres efter ordination på en recept udstedt af en begrænset lægegruppe (se bilag I: Produktresumé; pkt.
English: ● a blood clot in the blood vessels of your lungs,
Danish: • en blodprop i lungerne,
English: Pulmonary embolism, Hypoxia, Dysphoniaa
Danish: Pulmonal blødning/ hæmoptysea,b Lungeemboli Epistaxis Dyspnø Hypoksi
English: Number of patients Overall survival Median (months) Hazard ratio
Danish: Antal patienter Samlet overlevelse Median (måneder) Hazard ratio
English: Avastin (15 mg/kg Day 1) every 3 weeks for 6 and up to 10 cycles followed by Avastin (15 mg/kg every 3 weeks) alone until disease progression or unacceptable toxicity
Danish: samtidig med Avastin (15 mg/kg) hver 3. uge i 6 og op til 8 behandlingsserier, efterfulgt af Avastin (15 mg/kg hver 3. uge) som monoterapi indtil sygdomsprogresssion eller uacceptabel toksicitet.
English: This was a phase III randomised, double-blind, active-controlled clinical trial evaluating Avastin in combination with IFL as first-line treatment for metastatic carcinoma of the colon or rectum.
Danish: Studiet var et randomiseret, dobbeltblindet, aktivt kontrolleret, klinisk fase III-studie, som evaluerede Avastin i kombination med IFL som 1.-linjebehandling af metastatisk kolorektalkræft.
English: In patients who only received bevacizumab in combination with chemotherapy and did not continue to receive bevacizumab alone (CPB15), no clinically meaningful benefit in PFS was observed.
Danish: Ingen klinisk betydningsfuld fordel i PFS blev observeret hos patienter, som kun fik bevacizumab i kombination med kemoterapi og ikke fortsatte med at få bevacizumab-monoterapi (CPB15).
English: p-Value Hazard ratio (95% CI) (registration form)b
Danish: Hazard ratio (95% konfidensinterval) (registrerings-form)b p-værdi
English: Thromboembolism arteriala,b, Haemorrhage a,b
Danish: Trombo emboli (arteriel)a,b
English: Gallbladder perforationa,b
Danish: Galde-blæreperfora tiona,b
English: Gastrointestinal disorders
Danish: Gastrointestinale forstyrrelser Proktalgi
English: • CPB15 arm: Five cycles of Avastin (15 mg/kg q3w started cycle 2) in combination with carboplatin (AUC 6) and paclitaxel (175 mg/m2) for 6 cycles followed by placebo alone, for a total of up to 15 months of therapy
Danish: • CPB15-arm: Fem serier af Avastin (15 mg/kg hver 3. uge startende i serie 2) i kombination med carboplatin (AUC 6) og paclitaxel (175 mg/m2) i 6 serier, efterfulgt af placebo alene, i op til sammenlagt 15 måneders behandling
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each vial contains 100 mg bevacizumab.
Danish: ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER Hvert hætteglas indeholder 100 mg bevacizumab.
English: The results of this study from the final protocol defined analyses for progression free survival and response rates for the independently powered capecitabine cohort of Study AVF3694g are presented in Table 11 Results from an exploratory overall survival analysis which include an additional 7 months of follow-up (approximately 46% of patients had died) are also presented.
Danish: Resultater fra en eksplorativ analyse af samlet overlevelse, som inkluderer yderligere 7 måneders opfølgning (ca. 46 % af patienterne var døde), er også præsenteret.
English: ● Superiority of the Avastin-containing arms versus the chemotherapy alone arms in the overall comparison was demonstrated in terms of progression-free survival in the ITT population (Table 7).
Danish: • Avastin-armene var bedre med hensyn til progressionsfri overlevelse i ITT (intent-to-treat) populationen (tabel 7) i forhold til behandlingsarmene, der kun indeholdt kemoterapi.
English: Number of patients Progression-free survival Median (months) Hazard ratio
Danish: Antal patienter Progressionsfri overlevelse Median (måneder) Hazard ratio
English: (p-value = 0.0036)
Danish: (p-værdi = 0,0036)
English: The safety and efficacy of Avastin in the front-line treatment of patients with epithelial ovarian, fallopian tube or primary peritoneal cancer were studied in two phase III trials (GOG-0218 and BO17707) that evaluated the effect of the addition of Avastin to carboplatin and paclitaxel compared to the chemotherapy regimen alone.
Danish: Effekten og sikkerheden af Avastin i frontlinjebehandling af patienter med epitelial ovariecancer, tubacancer eller primær peritonealcancer blev undersøgt i to fase III-studier (GOG-0218 og BO17707).
English: Cellulitis, Infection, Urinary tract infection
Danish: Sepsis Abscesb,d Cellulitis Infektion Urinvejsinfektion
English: Overall survival - Follow-up analysis2 Hazard Ratio (95% CI)
Danish: Samlet overlevelse -Followupanalyse Hazard ratio (95% konfidensinterval)
English: CT (n=144)
Danish: Kemoterapi (n=144)
English: The results of this study are summarised in Table 20.
Danish: Resultater fra studiet er opsummeret i tabel 20.
English: (p-value = 0.0012)
Danish: (p-værdi = 0,0012)
English: However two of the randomized patients discontinued the study before receiving any study treatment ^ Blinded independent review (protocol-defined primary analysis) * Exploratory analysis: final OS analysis at clinical cut off on 31 October 2017, approx. 59% of patients had died.
Danish: * Eksploratorisk analyse: endelig analyse af samlet overlevelse på klinisk cut-off 31. oktober 2017, hvor ca. 59 % af patienterne var døde.
English: b 10 mg/kg every 2 weeks.
Danish: 10 mg/kg hver 2. uge.
English: Foetal abnormalitiesa,b
Danish: Ovariesvigta,b
English: • constipation,
Danish: • træthed,
English: Oxaliplatin 130 mg/m2 IV 2 h Oxaliplatin on day 1 Capecitabine oral bid for 2 weeks (followed by 1 week off treatment)
Danish: Oral capecitabin to gange daglig i 2 uger (efterfulgt af 1 uge uden behandling)
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each vial contains 400 mg bevacizumab.
Danish: ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER Hvert hætteglas indeholder 400 mg bevacizumab.
English: • heart failure,
Danish: • tarmblokade,
English: Follow-up analysis was performed with a data cut-off date of 07 March 2014; all p-values are displayed for descriptive purpose only
Danish: (12,0 vs 15,0 måneder; p = 0,6267) Primær-analyse blev udført ved data cut-off 12. december 2012 og betragtes som den endelige analyse 2 Followup-analyse blev udført ved data cut-off 7. marts 2014; p-værdier er kun vist for oplysende formål
English: • GOG-0213 evaluated the efficacy and safety of bevacizumab in combination with carboplatin and paclitaxel, followed by bevacizumab as a single agent in patients with platinum-sensitive recurrent epithelial ovarian, fallopian tube or primary peritoneal cancer.
Danish: • GOG-0213 evaluerede bevacizumabs virkning og sikkerhed i kombination med carboplatin og paclitaxel, efterfulgt af bevacizumab som monoterapi, hos patienter med platinfølsom, recidiverende epitelial ovariecancer, tubacancer eller primær peritonealcancer.
English: Hypertensionb,d, Thrombo-embolism (venous)b,d
Danish: Tromboemboli (venøs)b,d
English: Hazard ratio (97.5% CI)
Danish: Hazard ratio (97,5 % konfidensinterval)
English: Thromboembolism (arterial)b,d, Haemorrhageb,d,
Danish: Tromboemboli (arteriel)b,d Blødningb,d Dyb venetrombose
English: Anaemia, Lymphopenia
Danish: Anæmi Lymfopeni
English: Supraventricular tachycardia
Danish: Kongestivt hjertesvigtb,d Supraventrikulær takykardi
English: The recommended dose of Avastin is 7.5 mg/kg or 15 mg/kg of body weight given once every 3 weeks as an intravenous infusion.
Danish: Den anbefalede dosis af Avastin er 7,5 mg/kg eller 15 mg/kg legemsvægt en gang hver 3. uge administreret som intravenøs infusion.
English: • blocking of the veins of the legs by a blood clot,
Danish: • blokering af vener i benene på grund af en blodprop,
English: Median (months) Hazard ratio [95% CI]
Danish: Median (måneder) Hazard ratio [95 % konfidensinterval]
English: 7.5 mg/kg IV 30-90 min
Danish: 7,5 mg/kg i.v.
English: Lethargy
Danish: Dysartri
English: The recommended dose of Avastin is 10 mg/kg of body weight given once every 2 weeks or 15 mg/kg of body weight given once every 3 weeks as an intravenous infusion.
Danish: Den anbefalede dosis af Avastin er 10 mg/kg legemsvægt en gang hver 2. uge eller 15 mg/kg legemsvægt en gang hver 3. uge administreret som intravenøs infusion.
English: The primary efficacy variable of the trial was overall survival.
Danish: Studiets primære effektparameter var varighed af samlet overlevelse.
English: • CPB15+ arm: Five cycles of Avastin (15 mg/kg q3w started cycle 2) in combination with carboplatin (AUC 6) and paclitaxel (175 mg/m2) for 6 cycles followed by continued use of Avastin (15 mg/kg q3w) as single agent for a total of up to 15 months of therapy.
Danish: • CBP15+-arm: Fem serier af Avastin (15 mg/kg hver 3. uge startende i serie 2) i kombination med carboplatin (AUC 6) og paclitaxel (175 mg/m2) i 6 serier, efterfulgt af fortsat behandling med Avastin (15 mg/kg hver 3. uge) som monoterapi, i op til sammenlagt 15 måneders behandling.
English: Pulmonary hypertensionc, Nasal septum perforationc
Danish: Pulmonal hypertensionc Næseseptumperforationc
English: Intestinal perforation, Ileus, Intestinal obstruction, Recto-vaginal fistulaec,d,
Danish: Intestinal perforation Ileus Intestinal obstruktion Rektovaginale fistlerc,dGastr ointestinale forstyrrelser Stomatitis Proktalgi
English: Cerebrovascular accident, Syncope, Somnolence, Headache
Danish: Cerebrovaskulære tilfælde Synkope Søvnighed Hovedpine
English: Hazard Ratio (95% CI) 2 p-value 3
Danish: Hazard ratio (95 % konfidensinterval) 2 p-værdi
English: The secondary endpoint of Overall Survival (OS) was not mature .
Danish: Data for det sekundære endepunkt, den samlede overlevelse, er ikke tilgængelig endnu.
English: • an open sore or hole in the lining of the stomach or small intestine (the signs may include abdominal pain, feeling bloated, black tarry stools or blood in your stools (faeces) or blood in your vomit),
Danish: • åbent sår eller hul i slimhinderne i maven eller tyndtarmen (symptomer kan være mavesmerter,
English: Compared to patients treated with chemotherapy (carboplatin and paclitaxel) alone in the front-line setting, patients who received bevacizumab at a dose of 15 mg/kg q3w in combination with chemotherapy and continued to receive bevacizumab alone (CPB15+), had a clinically meaningful and statistically significant improvement in PFS.
Danish: Patienter, som fik bevacizumab i en dosis på 15 mg/kg hver 3. uge i kombination med kemoterapi (carboplatin og paclitaxel) og fortsatte med at få bevacizumab-monoterapi (CPB15+), havde en klinisk betydningsfuld og statistisk signifikant forbedring af PFS sammenlignet med patienter, som blev behandlet med kemoterapi alene i frontlinjebehandlingsregimet.
English: The efficacy and safety of Avastin in combination with chemotherapy (paclitaxel and cisplatin or paclitaxel and topotecan) in the treatment for patients with persistent, recurrent or metastatic carcinoma of the cervix was evaluated in study GOG-0240, a randomised, four-arm, open label, multicentre phase III trial.
Danish: Median PFS (måneder) Hazard ratio (95 % konfidensinterval) Median OS (måneder) Hazard ratio (95 % konfidensinterval) Cervixcancer GOG-0240 Effekten og sikkerheden af Avastin i kombination med kemoterapi (paclitaxel og cisplatin eller paclitaxel og topotecan) i behandlingen af patienter med persisterende, recidiverende eller metastatisk cervixkarcinom blev evalueret i studiet GOG-0240, et randomiseret, 4-armet, åbent fase III multicenterstudie.
English: 95% CI (0.69; 0.93)
Danish: 0,80 (p = 0,003) 95 % konfidensinterval (0,69-0,93)
English: Prior radiation is a risk factor for GI perforation in patients treated for persistent, recurrent or metastatic cervical cancer with Avastin and all patients with GI perforation had a history of prior radiation.
Danish: Hos patienter, behandlet med Avastin for persisterende, recidiverende eller metastatisk cervixcancer, er tidligere strålebehandling en risikofaktor for gastrointestinal perforation og alle patienter, som fik gastrointestinal perforation, havde tidligere fået strålebehandling,
English: Censored for NPT Median PFS (months) Hazard ratio (95% CI) p -value
Danish: Censureret for NPT Median PFS (måneder) Hazard ratio konfidensinterval) p-værdi
English: The trial met its primary objective of OS improvement.
Danish: Studiet opfyldte det primære mål, som var forbedret samlet overlevelse.
English: If you have conditions causing inflammation inside the abdomen (e.g. diverticulitis, stomach ulcers, colitis associated with chemotherapy), please discuss this with your doctor.
Danish: Tal med din læge, hvis du har tilstande, som forårsager betændelse i maveregionen (f.eks. diverticulitis, mavesår, tyktarmsbetændelse forbundet med kemoterapi).
English: Nasal septum perforation (not known) Pulmonary hypertension (not known) Dysphonia (common)
Danish: Nasal septumperforation (ikke kendt) Pulmonal hypertension (ikke kendt) Dysfoni (almindelig) Mave-tarmkanalen Gastrointestinalt ulcus (ikke kendt) Lever og galdeveje Galdeblæreperforation (ikke kendt) Knogler, led, muskler og bindevæv
English: These clinically significant adverse reactions were reported in clinical trials but the grade 3-5 reactions did not meet the threshold of at least a 2% difference compared to the control arm. Table 2 also includes clinically significant adverse reactions that were observed only in the postmarketing setting, therefore, the frequency and NCI-CTCAE grade is not known.These clinically significant reactions have therefore been included in Table 2 within the column entitled “Frequency Not Known.”
Danish: Tabel 2 indeholder også klinisk signifikante bivirkninger, som kun blev set post-marketing, og derfor kendes hverken frekvensen eller NCI-CTCAE-graden.
English: • headache,
Danish: • hovedpine,
English: Ovarian failure/fertility (see sections 4.4 and 4.6)
Danish: Ovariesvigt/fertilitet (se pkt.
English: • fatigue,
Danish: • forstoppelse,
English: • CPB arm: Carboplatin (AUC5) and paclitaxel (175 mg/m2 IV) and concurrent Avastin (15 mg/kg) every 3 weeks for 6 and up to 8 cycles, followed by Avastin (15 mg/kg every 3 weeks) alone until disease progression or unacceptable toxicity.
Danish: • Carboplatin (AUC4, dag 1) og gemcitabin (1.000 mg/m2 på dag 1 og 8) samtidig med Avastin (15 mg/kg, dag 1) hver 3. uge i 6 og op til 10 behandlingsserier, efterfulgt af Avastin (15 mg/kg hver 3. uge) som monoterapi indtil sygdomsprogresssion eller uacceptabel toksicitet.
English: Number of patients Overall survival Median time (months) 95% CI Hazard ratiob
Danish: Antal patienter Samlet overlevelse Median tid (måneder) 95 % konfidensinterval Hazard ratiob
English: (p-value5 <0.0001)
Danish: (p5<0,0001)
English: Metastatic carcinoma of the colon or rectum (mCRC)
Danish: Metastatisk kolorektalkræft (mCRC)
English: Diarrhoea, Nausea, Vomiting, Abdominal pain
Danish: Diarré Kvalme Opkastning Abdominalsmerter
English: Oxaliplatin 85 mg/m2 IV 2 h Oxaliplatin on day 1 Leucovorin on day 1 and 2
Danish: Oxaliplatin 85 mg/m2 i.v.
English: difference compared to the control arm for NCI-CTCAE Grade 1-5 reactions or at least a 2%
Danish: ● komparativ incidens, som er konstateret mellem behandlingsarme i kliniske studier (med mindst 10 % forskel i forhold til kontrolarmen for NCI-CTCAE grad 1-5 bivirkninger eller med mindst 2 % forskel i forhold til kontrolarmen for NCI-CTCAE grad 3-5 bivirkninger),
English: Investigations Weight decreased
Danish: Nedsat leverfunktion
English: Median PFS (months) Hazard ratio [95% CI] 2
Danish: Median PFS (måneder) 2 Hazard ratio [95 % konfidensinterval] 2
English: 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;
Danish: 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 ML18147studiet) og progressionfri overlevelse (hazard ratio 0,518 i E3200-studiet, hazard ratio 0,68 i ML18147-studiet).
English: Wound healing complications (see section 4.8)
Danish: Sårhelingskomplikationer (se pkt.
English: Gastrointestinal (GI) perforations and Fistulae (see section 4.8) Patients may be at an increased risk for the development of gastrointestinal perforation and gall bladder perforation when treated with Avastin.
Danish: 4.8) Patienter kan have en øget risiko for gastrointestinal perforation og galdeblæreperforation, når de behandles med Avastin.
English: Myalgia
Danish: Letargi
English: As maternal IgG is excreted in milk and bevacizumab could harm infant growth and development (see section 5.3), women must discontinue breast-feeding during therapy and not breast-feed for at least six months following the last dose of Avastin.
Danish: Idet maternel IgG udskilles i mælk, og da bevacizumab kan skade barnets vækst og udvikling (se pkt.
English: Hypertensive encephalopathy (very rare) (see also section 4.4 and Hypertension in section 4.8)
Danish: Hypertensiv encefalopati (meget sjælden) (se også pkt.
English: • blocking of the veins by a blood clot,
Danish: • blokering af vener på grund af en blodprop,
English: BO17707 was a Phase III, two arm, multicentre, randomised, controlled, open-label study comparing the effect of adding Avastin to carboplatin plus paclitaxel in patients with FIGO stage I or IIA (Grade
Danish: BO17707 var et fase III, to-armet, multicenter, randomiseret, kontrolleret, åbent studie, som sammenlignede effekten af tillæg af Avastin til carboplatin plus paclitaxel hos patienter med FIGOstadie I eller IIA (grad 3 eller clear cell histologi alene, n = 142) eller FIGO-stadie IIB-IV (alle grader og alle histologiske typer, n =1.386) epitelial ovariecancer, tubacancer eller primær peritonealcancer efter operation (NCI-CTCAE v. 3).
English: Median PFS (months) Hazard ratio (95% CI) Median OS (months) Hazard ratio (95% CI)
Danish: Median PFS (måneder) Hazard ratio (95 % konfidensinterval) Median OS (måneder) Hazard ratio (95 % konfidensinterval) Topotecan n=120
English: The recommended dose of Avastin is 10 mg/kg of body weight given once every 2 weeks as an intravenous infusion.
Danish: Den anbefalede Avastindosis er 10 mg/kg kropsvægt en gang hver 2. uge som intravenøs infusion.
English: The recommended dose of Avastin is 15 mg/kg of body weight given once every 3 weeks as an intravenous infusion.
Danish: Den anbefalede dosis af Avastin er 15 mg/kg kropsvægt en gang hver 3. uge som intravenøs infusion.
English: Hypomagnesaemia Hyponatraemia
Danish: Anoreksi Hypomagnesiæmi Hyponatriæmi
English: Median OS (months) Hazard Ratio (95% CI) p-value
Danish: Median OS (måneder) Hazard ratio (95 % konfidensinterval) p-værdi
English: Cases of ONJ have been reported in cancer patients treated with Avastin, the majority of whom had received prior or concomitant treatment with intravenous bisphosphonates, for which ONJ is an identified risk.
Danish: De fleste havde tidligere eller samtidigt fået behandling med intravenøse bisfosfonater, hvor osteonekrose af kæben er en kendt risiko.
English: Paclitaxel 175 mg/m2 IV over 3 hours on Day 1 and cisplatin 50 mg/m2 IV on Day 2 (q3w); or Paclitaxel 175 mg/m2 IV over 3 hours on Day 1 and cisplatin 50 mg/m2 IV on Day 1 (q3w)
Danish: over 24 timer på dag 1 og cisplatin 50 mg/m2 i.v på dag 2, hver 3. uge; eller Paclitaxel 175 mg/m2 i.v.
English: • Paclitaxel 175 mg/m2 IV over 3 hours on Day 1 and topotecan 0.75 mg/m2 IV over 30 minutes on days 1-3 (q3w)
Danish: over 3 timer på dag 1 og topotecan 0,75 mg/m2 i.v.
English: Progression-free survival Median (months) Hazard ratio
Danish: Progressionsfri overlevelse Median (måneder) Hazard ratio
English: % pts with objective response p -value
Danish: % patienter med objektivt respons p-værdi
English: Overall Survival - Follow-up analysis Median (months)
Danish: Samlet overlevelse (followup-analyse)7 Median (måneder)1
English: Renal impairment
Danish: Asteni Træthed
English: Compared to patients treated with chemotherapy (carboplatin and paclitaxel) alone in the front-line setting, patients who received bevacizumab at a dose of 7.5 mg/kg q3w in combination with chemotherapy and continued to receive bevacizumab for up to 18 cycles had a statistically significant improvement in PFS.
Danish: Patienter, som fik bevacizumab i en dosis på 7,5 mg/kg hver 3. uge i kombination med kemoterapi (carboplatin og paclitaxel) og fortsatte med at få bevacizumab i op til 18 serier, havde en statistisk signifikant forbedring af PFS sammenlignet med patienter, som blev behandlet med kemoterapi alene i frontlinjebehandlingsregimet.
English: Pulmonary haemorrhage/ Haemoptysisb,d,
Danish: Pulmonal blødning/ Hæmoptyseb,d Lungeemboli Hypoksi Dysfonia
English: Table 19 PFS1 results by disease stage and debulking status from study BO17707 (ICON7) Randomised patients stage III optimally debulked disease 2,3 CP (n = 368)
Danish: PFS1-resultater efter sygdomsstadie og tumorreduktionsstatus fra studie BO17707 (ICON7)
English: Median (months) Hazard ratio (95% CI) p-value
Danish: Median (måneder) Hazard ratio (95 % konfidensinterval) p-værdi
English: Renal thrombotic microangiopathy b,c
Danish: Renal trombotisk mikroangiopatib,c Aneurismer og arterielle dissektioner
English: Renal thrombotic microangiopathya,b,
Danish: Renal trombotisk mikroangiopatia,b Aneurismer og arterielle dissektioner
English: Avastin is also used for treatment of adult patients with advanced kidney cancer.
Danish: Avastin bruges også hos voksne til behandling af fremskreden nyrekræft.
English: Hazard ratio (95% CI)4
Danish: Hazard ratio (95 % konfidensinterval)4
English: Thromboembolism (see section 4.4)
Danish: Tromboemboli (se pkt.
English: Progression-free survival Median time (months) Hazard ratio
Danish: Progressionsfri overlevelse Median tid (måneder) Hazard ratio
English: Asthenia, Fatigue, Pyrexia, Pain, Mucosal inflammation
Danish: Asteni Træthed Pyreksi Smerte Slimhindeinflammation
English: Paclitaxel 175 mg/m2 IV over 3 hours on Day 1 and cisplatin 50 mg/m2 IV on Day 1 plus bevacizumab 15 mg/kg IV on Day 1 (q3w)
Danish: over 3 timer på dag 1 og cisplatin 50 mg/m2 i.v på dag 1 plus bevacizumab 15 mg/kg i.v.
English: Tell your doctor, pharmacist or nurse if you are taking, have recently taken or might take any other medicines.
Danish: Brug af anden medicin sammen med Avastin Fortæl altid lægen eller apotekspersonalet, hvis du bruger anden medicin eller har gjort det for nylig.
English: 2 Investigator assessed PFS analysis with data cut-off date of 30 November 2010.
Danish: Median PFS (måneder) Hazard ratio (95 % konfidensinterval)4 Investigatorvurderet PFS-analyse med data cut-off den 30. november 2010.
English: This was a phase III randomised, active-controlled, open-label trial investigating Avastin 10 mg/kg in combination with leucovorin with 5-fluorouracil bolus and then 5-fluorouracil infusional, with IV oxaliplatin (FOLFOX-4), administered on a 2-weekly schedule in previously-treated patients (second line) with advanced colorectal cancer.
Danish: Dette var et fase III, randomiseret, aktivt kontrolleret, ublindet studie, som undersøgte Avastin 10 mg/kg i kombination med leucovorin og 5-fluoruracil bolus efterfulgt af 5-fluoruracil infusion med i.v.
English: Gastrointestinal ulcer (not known)
Danish: Ikke-gastrointestinale fistler (se pkt.
English: Median PFS (months) Hazard ratio (95% CI)
Danish: Median PFS (måneder) Hazard ratio (95 % konfidensinterval)
English: Radiotherapy
Danish: Proteinurib
English: The addition of Avastin to IFN-alpha-2a significantly increased PFS and objective tumour response rate.
Danish: Den progressionsfrie overlevelse og den objektive tumorresponsrate forøgedes signifikant ved tillæg af Avastin til IFN alfa-2a behandlingen.
English: Avastin may impair female fertility (see sections 4.6 and 4.8).
Danish: Avastin kan nedsætte fertiliteten hos kvinder (se pkt.
English: 5 mg/kg IV 30-90 min
Danish: 30-90 min