natgillin/translations-raw huggingface dataset:
Lægemidlet må kun udleveres efter ordination på en recept udstedt af en begrænset lægegruppe (se bilag I: Produktresumé; pkt.
B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE Medicinal product subject to restricted medical prescription (see Annex: Summary of Product Characteristics, section 4.2).
• en blodprop i lungerne,
● a blood clot in the blood vessels of your lungs,
Pulmonal blødning/ hæmoptysea,b Lungeemboli Epistaxis Dyspnø Hypoksi
Pulmonary embolism, Hypoxia, Dysphoniaa
Antal patienter Samlet overlevelse Median (måneder) Hazard ratio
Number of patients Overall survival Median (months) Hazard ratio
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.
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
Studiet var et randomiseret, dobbeltblindet, aktivt kontrolleret, klinisk fase III-studie, som evaluerede Avastin i kombination med IFL som 1.-linjebehandling af metastatisk kolorektalkræft.
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.
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).
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.
Hazard ratio (95% konfidensinterval) (registrerings-form)b p-værdi
p-Value Hazard ratio (95% CI) (registration form)b
Trombo emboli (arteriel)a,b
Thromboembolism arteriala,b, Haemorrhage a,b
Galde-blæreperfora tiona,b
Gallbladder perforationa,b
Gastrointestinale forstyrrelser Proktalgi
Gastrointestinal disorders
• 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
• 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
ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER Hvert hætteglas indeholder 100 mg bevacizumab.
STATEMENT OF ACTIVE SUBSTANCE(S) Each vial contains 100 mg bevacizumab.
Resultater fra en eksplorativ analyse af samlet overlevelse, som inkluderer yderligere 7 måneders opfølgning (ca. 46 % af patienterne var døde), er også præsenteret.
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.
• 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.
● 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).
Antal patienter Progressionsfri overlevelse Median (måneder) Hazard ratio
Number of patients Progression-free survival Median (months) Hazard ratio
(p-værdi = 0,0036)
(p-value = 0.0036)
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).
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.
Sepsis Abscesb,d Cellulitis Infektion Urinvejsinfektion
Cellulitis, Infection, Urinary tract infection
Samlet overlevelse -Followupanalyse Hazard ratio (95% konfidensinterval)
Overall survival - Follow-up analysis2 Hazard Ratio (95% CI)
Kemoterapi (n=144)
CT (n=144)
Resultater fra studiet er opsummeret i tabel 20.
The results of this study are summarised in Table 20.
(p-værdi = 0,0012)
(p-value = 0.0012)
* Eksploratorisk analyse: endelig analyse af samlet overlevelse på klinisk cut-off 31. oktober 2017, hvor ca. 59 % af patienterne var døde.
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.
10 mg/kg hver 2. uge.
b 10 mg/kg every 2 weeks.
Ovariesvigta,b
Foetal abnormalitiesa,b
• træthed,
• constipation,
Oral capecitabin to gange daglig i 2 uger (efterfulgt af 1 uge uden behandling)
Oxaliplatin 130 mg/m2 IV 2 h Oxaliplatin on day 1 Capecitabine oral bid for 2 weeks (followed by 1 week off treatment)
ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER Hvert hætteglas indeholder 400 mg bevacizumab.
STATEMENT OF ACTIVE SUBSTANCE(S) Each vial contains 400 mg bevacizumab.
• tarmblokade,
• heart failure,
(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
Follow-up analysis was performed with a data cut-off date of 07 March 2014; all p-values are displayed for descriptive purpose only
• 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.
• 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.
Tromboemboli (venøs)b,d
Hypertensionb,d, Thrombo-embolism (venous)b,d
Hazard ratio (97,5 % konfidensinterval)
Hazard ratio (97.5% CI)
Tromboemboli (arteriel)b,d Blødningb,d Dyb venetrombose
Thromboembolism (arterial)b,d, Haemorrhageb,d,
Anæmi Lymfopeni
Anaemia, Lymphopenia
Kongestivt hjertesvigtb,d Supraventrikulær takykardi
Supraventricular tachycardia
Den anbefalede dosis af Avastin er 7,5 mg/kg eller 15 mg/kg legemsvægt en gang hver 3. uge administreret som intravenøs infusion.
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.
• blokering af vener i benene på grund af en blodprop,
• blocking of the veins of the legs by a blood clot,
Median (måneder) Hazard ratio [95 % konfidensinterval]
Median (months) Hazard ratio [95% CI]
Dysartri
Lethargy
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.
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.
Studiets primære effektparameter var varighed af samlet overlevelse.
The primary efficacy variable of the trial was overall survival.
• 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.
• 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.
Pulmonal hypertensionc Næseseptumperforationc
Pulmonary hypertensionc, Nasal septum perforationc
Intestinal perforation Ileus Intestinal obstruktion Rektovaginale fistlerc,dGastr ointestinale forstyrrelser Stomatitis Proktalgi
Intestinal perforation, Ileus, Intestinal obstruction, Recto-vaginal fistulaec,d,
Cerebrovaskulære tilfælde Synkope Søvnighed Hovedpine
Cerebrovascular accident, Syncope, Somnolence, Headache
Hazard ratio (95 % konfidensinterval) 2 p-værdi
Hazard Ratio (95% CI) 2 p-value 3
Data for det sekundære endepunkt, den samlede overlevelse, er ikke tilgængelig endnu.
The secondary endpoint of Overall Survival (OS) was not mature .
• åbent sår eller hul i slimhinderne i maven eller tyndtarmen (symptomer kan være mavesmerter,
• 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),
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.
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.
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.
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.
0,80 (p = 0,003) 95 % konfidensinterval (0,69-0,93)
95% CI (0.69; 0.93)
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,
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.
Censureret for NPT Median PFS (måneder) Hazard ratio konfidensinterval) p-værdi
Censored for NPT Median PFS (months) Hazard ratio (95% CI) p -value
Studiet opfyldte det primære mål, som var forbedret samlet overlevelse.
The trial met its primary objective of OS improvement.
Tal med din læge, hvis du har tilstande, som forårsager betændelse i maveregionen (f.eks. diverticulitis, mavesår, tyktarmsbetændelse forbundet med kemoterapi).
If you have conditions causing inflammation inside the abdomen (e.g. diverticulitis, stomach ulcers, colitis associated with chemotherapy), please discuss this with your doctor.
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
Nasal septum perforation (not known) Pulmonary hypertension (not known) Dysphonia (common)
Tabel 2 indeholder også klinisk signifikante bivirkninger, som kun blev set post-marketing, og derfor kendes hverken frekvensen eller NCI-CTCAE-graden.
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.”
• hovedpine,
• headache,
Ovariesvigt/fertilitet (se pkt.
Ovarian failure/fertility (see sections 4.4 and 4.6)
• forstoppelse,
• fatigue,
• 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.
• 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.
Antal patienter Samlet overlevelse Median tid (måneder) 95 % konfidensinterval Hazard ratiob
Number of patients Overall survival Median time (months) 95% CI Hazard ratiob
(p5<0,0001)
(p-value5 <0.0001)
Metastatisk kolorektalkræft (mCRC)
Metastatic carcinoma of the colon or rectum (mCRC)
Diarré Kvalme Opkastning Abdominalsmerter
Diarrhoea, Nausea, Vomiting, Abdominal pain
Oxaliplatin 85 mg/m2 i.v.
Oxaliplatin 85 mg/m2 IV 2 h Oxaliplatin on day 1 Leucovorin on day 1 and 2
● 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),
difference compared to the control arm for NCI-CTCAE Grade 1-5 reactions or at least a 2%
Nedsat leverfunktion
Investigations Weight decreased
Median PFS (måneder) 2 Hazard ratio [95 % konfidensinterval] 2
Median PFS (months) Hazard ratio [95% CI] 2
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).
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;
Sårhelingskomplikationer (se pkt.
Wound healing complications (see section 4.8)
4.8) Patienter kan have en øget risiko for gastrointestinal perforation og galdeblæreperforation, når de behandles med Avastin.
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.
Letargi
Myalgia
Idet maternel IgG udskilles i mælk, og da bevacizumab kan skade barnets vækst og udvikling (se pkt.
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.
Hypertensiv encefalopati (meget sjælden) (se også pkt.
Hypertensive encephalopathy (very rare) (see also section 4.4 and Hypertension in section 4.8)
• blokering af vener på grund af en blodprop,
• blocking of the veins by a blood clot,
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).
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
Median PFS (måneder) Hazard ratio (95 % konfidensinterval) Median OS (måneder) Hazard ratio (95 % konfidensinterval) Topotecan n=120
Median PFS (months) Hazard ratio (95% CI) Median OS (months) Hazard ratio (95% CI)
Den anbefalede Avastindosis er 10 mg/kg kropsvægt en gang hver 2. uge som intravenøs infusion.
The recommended dose of Avastin is 10 mg/kg of body weight given once every 2 weeks as an intravenous infusion.
Den anbefalede dosis af Avastin er 15 mg/kg kropsvægt en gang hver 3. uge som intravenøs infusion.
The recommended dose of Avastin is 15 mg/kg of body weight given once every 3 weeks as an intravenous infusion.
Anoreksi Hypomagnesiæmi Hyponatriæmi
Hypomagnesaemia Hyponatraemia
Median OS (måneder) Hazard ratio (95 % konfidensinterval) p-værdi
Median OS (months) Hazard Ratio (95% CI) p-value
De fleste havde tidligere eller samtidigt fået behandling med intravenøse bisfosfonater, hvor osteonekrose af kæben er en kendt risiko.
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.
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.
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)
over 3 timer på dag 1 og topotecan 0,75 mg/m2 i.v.
• 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)
Progressionsfri overlevelse Median (måneder) Hazard ratio
Progression-free survival Median (months) Hazard ratio
% patienter med objektivt respons p-værdi
% pts with objective response p -value
Samlet overlevelse (followup-analyse)7 Median (måneder)1
Overall Survival - Follow-up analysis Median (months)
Asteni Træthed
Renal impairment
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.
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.
Pulmonal blødning/ Hæmoptyseb,d Lungeemboli Hypoksi Dysfonia
Pulmonary haemorrhage/ Haemoptysisb,d,
PFS1-resultater efter sygdomsstadie og tumorreduktionsstatus fra studie BO17707 (ICON7)
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)
Median (måneder) Hazard ratio (95 % konfidensinterval) p-værdi
Median (months) Hazard ratio (95% CI) p-value
Renal trombotisk mikroangiopatib,c Aneurismer og arterielle dissektioner
Renal thrombotic microangiopathy b,c
Renal trombotisk mikroangiopatia,b Aneurismer og arterielle dissektioner
Renal thrombotic microangiopathya,b,
Avastin bruges også hos voksne til behandling af fremskreden nyrekræft.
Avastin is also used for treatment of adult patients with advanced kidney cancer.
Hazard ratio (95 % konfidensinterval)4
Hazard ratio (95% CI)4
Tromboemboli (se pkt.
Thromboembolism (see section 4.4)
Progressionsfri overlevelse Median tid (måneder) Hazard ratio
Progression-free survival Median time (months) Hazard ratio
Asteni Træthed Pyreksi Smerte Slimhindeinflammation
Asthenia, Fatigue, Pyrexia, Pain, Mucosal inflammation
over 3 timer på dag 1 og cisplatin 50 mg/m2 i.v på dag 1 plus bevacizumab 15 mg/kg i.v.
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)
Brug af anden medicin sammen med Avastin Fortæl altid lægen eller apotekspersonalet, hvis du bruger anden medicin eller har gjort det for nylig.
Tell your doctor, pharmacist or nurse if you are taking, have recently taken or might take any other medicines.
Median PFS (måneder) Hazard ratio (95 % konfidensinterval)4 Investigatorvurderet PFS-analyse med data cut-off den 30. november 2010.
2 Investigator assessed PFS analysis with data cut-off date of 30 November 2010.
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.
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.
Ikke-gastrointestinale fistler (se pkt.
Gastrointestinal ulcer (not known)
Median PFS (måneder) Hazard ratio (95 % konfidensinterval)
Median PFS (months) Hazard ratio (95% CI)
Proteinurib
Radiotherapy
Den progressionsfrie overlevelse og den objektive tumorresponsrate forøgedes signifikant ved tillæg af Avastin til IFN alfa-2a behandlingen.
The addition of Avastin to IFN-alpha-2a significantly increased PFS and objective tumour response rate.
Avastin kan nedsætte fertiliteten hos kvinder (se pkt.
Avastin may impair female fertility (see sections 4.6 and 4.8).
30-90 min
5 mg/kg IV 30-90 min
Dette skal ses i sammenligning med < 1 % af de patienter, der kun fik kemoterapi (NCICTCAE v. 3).
Grade 3-5 reactions have been observed in up to 2.3% of patients treated with Avastin plus chemotherapy as compared with < 1% with chemotherapy alone (NCI-CTCAE v.3).
HR var 0,93 (95% konfidensinterval: 0,61 ; 1,41; p-værdi = 0,72).
arm compared with RT/T alone (HR = 1.44; 95% CI: 0.90, 2.30).
• Spørg lægen, apotekspersonalet eller sundhedspersonalet, hvis der er mere, du vil vide.
● If you have any further questions, ask your doctor, pharmacist or nurse.
1 Kaplan-Meier-estimater
p-value (Chi-squared Test) Kaplan-Meier estimates
Ca. 50 % af patienterne havde en ECOG PS på 1, og 7 % af patienterne i de 2 behandlingsarme havde en ECOG PS på 2.
The majority of patients included in the study were White (96%), the median age was 57 years in both treatment arms, 25% of patients in each treatment arm were 65 years of age or over, and approximately 50% of patients had an ECOG PS of 1; 7% of patients in each treatment arm had an
Fistlerb,d Muskel
Fistulab,d, Muscular weakness, Back pain
Dette var et fase III, randomiseret, dobbeltblindet (med hensyn til bevacizumab), klinisk studie, hvori Avastin 7,5 mg/kg i kombination med oral capecitabin og i.v.
This was a phase III randomised, double-blind (for bevacizumab), clinical trial investigating Avastin 7.5 mg/kg in combination with oral capecitabine and IV oxaliplatin (XELOX), administered on a 3weekly schedule; or Avastin 5 mg/kg in combination with leucovorin with 5-fluorouracil bolus, followed by 5-fluorouracil infusional, with IV oxaliplatin (FOLFOX-4), administered on a 2-weekly schedule.
Arteriel tromboemboli: En forøget forekomst af arterielle tromboemboliske bivirkninger blev observeret hos patienter, som blev behandlet med Avastin, uanset indikation.
Arterial thromboembolism: An increased incidence of arterial thromboembolic reactions was observed in patients treated with Avastin across indications, including cerebrovascular accidents, myocardial infarction, transient ischaemic attacks, and other arterial thromboembolic reactions.