FrancophonIA/ELRC3.0 huggingface dataset:
English: (14.9 vs. 11.9 months; p = 0.1061)
Danish: (14,9 vs 11,9 måneder; p =
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: Overall survival - Follow-up analysis2 Hazard ratio (95% CI)
Danish: Samlet overlevelse -Followupanalyse2 Hazard ratio (95 % konfidensinterval)
English: • Superiority of the bevacizumab-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: • Bevacizumab-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: • The chosen chemotherapy was combined with bevacizumab 10 mg/kg IV every 2 weeks (or bevacizumab 15 mg/kg every 3 weeks if used in combination with topotecan 1.25 mg/m2 on days 1-5 every 3 weeks).
Danish: hver 2. uge (eller bevacizumab 15 mg/kg hver 3. uge, hvis det anvendes i kombination med topotecan 1,25 mg/m2 på dag 1-5 hver 3. uge).
English: The addition of bevacizumab 5 mg/kg every two weeks to 5-FU/FA resulted in higher objective response rates, significantly longer progression-free survival, and a trend in longer survival as compared to 5-FU/FA chemotherapy alone.
Danish: Sammenlignet med 5-FU/FA-kemoterapi alene medførte tillæg af bevacizumab 5 mg/kg hver 2. uge til 5-FU/FV en højere, objektiv responsrate, signifikant længere progressionsfri overlevelse og en tendens til længere overlevelse.
English: Hypersensitivity reactions/infusion reactions (see section 4.4 and Post-marketing experience below)
Danish: 4.4 og Post-marketing erfaring nedenfor)
English: The majority of patients included in the study were white (87% in all three arms); the median age was 60 years in CPP and CPB15 arms and 59 years in CPB15+ arm; and 29% of patients in CPP or CPB15 and 26% in CPB15+ were over 65 years of age.
Danish: 29 % af patienterne i CPP- og CPB15-armene og 26 % i CPB15+-armen var over 65 år.
English: Metastatic carcinoma of the colon or rectum (mCRC) The recommended dose of MVASI, 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 MVASI 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: Median PFS (months) Hazard ratio (95% CI)4 Randomised patients with stage III suboptimally debulked disease3 CP (n = 154)
Danish: Median PFS (måneder) Hazard ratio (95 % konfidensinterval)4 Randomiserede patienter med stadie III sub-optimalt tumorreduceret sygdom CP (n = 154)
English: MVASI, in addition to platinum-based chemotherapy, is indicated for first-line treatment of adult patients with unresectable advanced, metastatic or recurrent non-small cell lung cancer other than predominantly squamous cell histology.
Danish: MVASI er, i kombination med platinbaseret kemoterapi, indiceret til 1.-linjebehandling af voksne patienter med ikke-operabel fremskreden, metastatisk eller recidiverende, ikke-småcellet lungekræft.
English: Median PFS (months) Hazard ratio (95% CI)4 Randomised patients with stage III suboptimally debulked disease3 CPP (n = 253)
Danish: Median PFS (måneder) Hazard ratio (95 % konfidensinterval)4 Randomiserede patienter med stadie III sub-optimalt tumorreduceret sygdom CPP (n = 253)
English: For further information on proteinuria see section 4.4 and Proteinuria in section 4.8
Danish: 4.4 og Proteinuri i pkt.
English: Results are presented in table 21.
Danish: Resultater vises i tabel 21.
English: • Paclitaxel 80 mg/m2 as a 1-hour IV infusion on days 1, 8, 15, and 22 every 4 weeks
Danish: • Kemoterapi-arm (kemoterapi alene): • Paclitaxel 80 mg/m som 1-times i.v.-infusion på dag 1, 8, 15 og 22 hver 4. uge.
English: In patients with measurable disease at baseline.
Danish: Hos patienter med målbar sygdom ved baseline.
English: P-value
Danish: a p-værdi
English: Gastrointestinal (GI) perforations and Fistulae (see section 4.4)
Danish: Gastrointestinale perforationer og fistler (se pkt.
English: In study BO25041 of bevacizumab added to post-operative radiation therapy (RT) with concomitant and adjuvant temozolomide in paediatric patients with newly diagnosed supratentorial, infratentorial, cerebellar, or peduncular high-grade glioma, the safety profile was comparable with that observed in other tumour types in adults treated with bevacizumab.
Danish: I studie BO25041 blev bevacizumab føjet til post-operativ strålebehandling med samtidig adjuverende temozolomidbehandling hos pædiatriske patienter med nyligt diagnosticeret supratentorielt, infratentorielt, cerebellært eller pedunkulært høj-grads-gliom.
English: Secondary endpoints Median PFS (on treatment)** Hazard ratio (97.5% CI) Overall response rate (invest.
Danish: Median PFS (i behandling)** Hazard ratio (97,5 % konfidensinterval) Samlet responsrate (Investigators vurdering)**
English: Pulmonary haemorrhage/ Haemoptysisa,b, Pulmonary embolism, Epistaxis, Dyspnoea, Hypoxia
Danish: Pulmonal blødning/ hæmoptysea,b Lungeemboli Epistaxis
English: Other reactions with a higher frequency seen in patients over 65 were grade 3-4 leucopenia and thrombocytopenia (NCI-CTCAE v.3); and all grade neutropenia, diarrhoea, nausea, headache and fatigue as compared to those aged ≤ 65 years when treated with bevacizumab (see sections 4.4 and 4.8 under Thromboembolism).
Danish: Andre bivirkninger ved behandling med bevacizumab, der blev set med en højere frekvens hos patienter over 65 år versus patienter ≤ 65 år, var grad 3-4 leukopeni og trombocytopeni (NCI-CTCAE v. 3) samt neutropeni (alle grader), diarré, kvalme, hovedpine og træthed (se pkt.
English: Progression-free survival Median (months) Hazard ratio (95% confidence interval)
Danish: Progressionfri overlevelse Median (måneder) Hazard ratio (95 % konfidensinterval)
English: • The protocol-specified analysis of investigator assessed PFS (without censoring for CA-125 progression or non-protocol therapy [NPT]) shows a stratified hazard ratio of 0.71 (95% CI: 0.61-0.83, 1-sided log-rank p-value < 0.0001) when CPB15+ is compared with CPP, with a median PFS of 10.4 months in the CPP arm and 14.1 months in the CPB15+ arm.
Danish: • Den protokolspecificerede analyse af investigatorvurderet PFS (uden censurering for CA-125 progressioner eller non-protokolleret terapi (NPT)) viser en stratificeret hazard ratio på 0,71 (95 % konfidensinterval: 0,61-0,83, ensidig log-rank p-værdi < 0,0001), når CPB15+ sammenlignes med CPP, med en median PFS på 10,4 måneder i CPP-armen og 14,1 måned i CPB15+-armen.
English: • AVF4095g evaluated the efficacy and safety of bevacizumab in combination with carboplatin and gemcitabine followed by bevacizumab as a single agent in patients with platinum-sensitive recurrent epithelial ovarian, fallopian tube or primary peritoneal cancer.
Danish: • AVF4095g evaluerede bevacizumabs virkning og sikkerhed i kombination med carboplatin og gemcitabin, efterfulgt af bevacizumab som monoterapi, hos patienter med platinfølsom, recidiverende epitelial ovariecancer, tubacancer eller primær peritonealcancer.
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 post-marketing setting, therefore, the frequency and NCI-CTCAE grade is not known.
Danish: Disse klinisk signifikante bivirkninger blev rapporteret i kliniske studier, men grad 3-5 bivirkningerne opfyldte ikke grænsen på mindst 2 % forskel i forhold til kontrolarmen.
English: • CPP arm: Five cycles of placebo (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: • CPP-arm: Fem serier af placebo (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: Lethargy, Mucosal inflammation
Danish: Træthed Pyreksi Smerte Slimhindeinflammation
English: Carboplatin/ Paclitaxel + bevacizumab 15 mg/kg q 3 weeks
Danish: Arm 2 Carboplatin/ Paclitaxel + bevacizumab 15 mg/kg hver 3. uge
English: The recommended dose of MVASI when used in addition to erlotinib is 15 mg/kg of body weight given once every 3 weeks as an intravenous infusion.
Danish: Den anbefalede dosis af MVASI, når det anvendes sammen med erlotinib, er 15 mg/kg legemsvægt en gang hver 3. uge som intravenøs infusion.
English: From a clinical trial in patients with persistent, recurrent, or metastatic cervical cancer (study GOG-0240), grade 3-5 infections have been reported in up to 24% of patients treated with bevacizumab in combination with paclitaxel and topotecan compared with up to 13% of patients treated with paclitaxel and topotecan.
Danish: I et klinisk studie hos patienter med persisterende, recidiverende eller metastatisk cervixcancer (studie GOG-0240) blev infektioner af grad 3-5 rapporteret hos op til 24 % af patienterne, behandlet med bevacizumab i kombination med paclitaxel og topotecan, sammenlignet med hos op til 13 % af patienterne, behandlet med paclitaxel og topotecan.
English: • a brain condition with symptoms including seizures (fits), headache, confusion, and changes in vision (Posterior Reversible Encephalopathy Syndrome or PRES),
Danish: • tilstand i hjernen (posteriort reversibelt encefalopati syndrom) med symptomer såsom kramper, hovedpine, forvirring og synsforstyrrelser,
English: • a blood clot in the blood vessels of your lungs,
Danish: • en blodprop i lungerne,
English: This was a phase III randomised, double-blind, active-controlled clinical trial evaluating bevacizumab 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 bevacizumab i kombination med IFL som 1.-linjebehandling af metastatisk kolorektalkræft.
English: The efficacy results of the study are presented in table 13.
Danish: Effektresultater for studiet er vist i tabel 13.
English: From a clinical trial in patients with persistent, recurrent, or metastatic cervical cancer (study GOG-0240), grade 3-5 bleeding reactions have been reported in up to 8.3% of patients treated with bevacizumab in combination with paclitaxel and topotecan compared with up to 4.6% of patients treated with paclitaxel and topotecan.
Danish: I et klinisk studie hos patienter med persisterende, recidiverende eller metastatisk cervixcancer (studie GOG-0240) blev blødninger af grad 3-5 rapporteret hos op til 8,3 % af patienterne, som blev behandlet med bevacizumab i kombination med paclitaxel og topotecan, sammenlignet med hos op til 4,6 % af patienterne, som blev behandlet med paclitaxel og topotecan.
English: Difference in response rates 95% CI for difference in response rates4
Danish: 95 % konfidensinterval for responsrate3
English: From a clinical trial in patients with persistent, recurrent, or metastatic cervical cancer (study GOG-0240), grade 3-5 venous thromboembolic events have been reported in up to 15.6% of patients treated with bevacizumab in combination with paclitaxel and cisplatin compared with up to 7.0% of patients treated with paclitaxel and cisplatin.
Danish: I et klinisk studie hos patienter med persisterende, recidiverende eller metastatisk cervixcancer (studie GOG-0240) blev venøs tromboemboli af grad 3-5 rapporteret hos op til 15,6 % af patienterne, som blev behandlet med bevacizumab i kombination med paclitaxel og cisplatin, sammenlignet med hos op til 7,0 % af patienterne, som blev behandlet med paclitaxel og cisplatin.
English: Febrile neutropenia, Leucopenia, Neutropeniaa, Thrombocytope nia
Danish: Febril neutropeni Leukopeni Neutropenia Trombocytopeni
English: CT (n = 144)
Danish: Kemoterapi (n = 144)
English: (17.5 vs.15.0 months; p = 0.0584)
Danish: (17,5 vs 15,0 måneder: p =
English: Peripheral sensory neuropathyb, Dysarthria, Headache, Dysguesia
Danish: Perifer sensorisk neuropatib Dysartri
English: MVASI, in combination with carboplatin and paclitaxel is indicated for the front-line treatment of adult patients with advanced (International Federation of Gynecology and Obstetrics (FIGO)
Danish: MVASI er, i kombination med carboplatin og paclitaxel, indiceret til frontlinjebehandling af voksne patienter med fremskreden (International Federation of Gynecology and Obstetrics (FIGO) stadie III B, III C og IV) epitelial ovariecancer, tubacancer eller primær peritonealcancer (se pkt.
English: First-line treatment of non-squamous NSCLC in combination with platinum-based chemotherapy MVASI is administered in addition to platinum-based chemotherapy for up to 6 cycles of treatment followed by MVASI as a single agent until disease progression.
Danish: MVASI administreres sammen med platinbaseret kemoterapi i op til 6 behandlingsserier, efterfulgt af behandling med MVASI som monoterapi indtil sygdomsprogression.
English: Ovarian failurea,b
Danish: Ovariesvigta,b
English: Asthenia, Fatigue
Danish: Asteni Træthed
English: MVASI is also used for the treatment of adult patients with advanced epithelial ovarian, fallopian tube, or primary peritoneal cancer.
Danish: MVASI bruges også hos voksne til behandling af fremskreden kræft i æggestokkene, kræft i æggeledere eller primær bughindekræft.
English: Primary analysis Overall survival
Danish: * primær analyse
English: The number of infusions that you receive will depend on how you are responding to treatment; you should continue to receive this medicine until MVASI fails to stop your tumour growing.
Danish: Antallet af infusioner, som du skal have, afhænger af, hvordan du reagerer på behandlingen.
English: Gall bladder perforation (not known)
Danish: Hætteglas (uåbnet)
English: • The primary analysis of investigator assessed PFS (censoring for CA-125 progressions and NPT) shows a stratified hazard ratio of 0.62 (95% CI: 0.52-0.75, 1-sided log-rank p-value < 0.0001) when CPB15+ is compared with CPP, with a median PFS of 12.0 months in the CPP arm and 18.2 months in the CPB15+ arm.
Danish: • Den primære analyse af investigatorvurderet PFS (censureret for CA-125-progressioner og NPT) viser en stratificeret hazard ratio på 0,62 (95 % konfidensinterval: 0,52-0,75, ensidig log rank pværdi < 0,0001), når CPB15+ sammenlignes med CPP, med en median PFS på 12,0 måneder i CPP-armen og 18,2 måneder i CPB15+-armen.
English: The results of this trial are presented in table 10.
Danish: Resultaterne af dette studie vises i tabel 10.
English: In a trial of patients with persistent, recurrent or metastatic cervical cancer, the incidence of GI-vaginal fistulae was 8.3% in bevacizumab-treated patients and 0.9% in control patients, all of whom had a history of prior pelvic radiation.
Danish: I et studie hos patienter med persisterende, recidiverende eller metastatisk cervixcancer var forekomsten af gastrointestinale-vaginale fistler 8,3 % hos bevacizumab-behandlede patienter og 0,9 % i kontrolgruppen.
English: The safety and efficacy of bevacizumab 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 bevacizumab to carboplatin and paclitaxel compared to the chemotherapy regimen alone.
Danish: Effekten og sikkerheden af bevacizumab i frontlinjebehandling af patienter med epitelial ovariecancer, tubacancer eller primær peritonealcancer blev undersøgt i to fase III-studier (GOG-0218 og BO17707).
English: Number of patients Overall survival Median (months) Hazard ratio (95% confidence interval)
Danish: Antal patienter Samlet overlevelse Median (måneder) Hazard ratio (95 % konfidensinterval)
English: Median PFS (months)2 Hazard ratio [95% CI]2
Danish: Median PFS (måneder)2 Hazard ratio [95 % konfidensinterval]2
English: Nervous system disorders Hypertensive encephalopathy (very rare) (see also section 4.4 and Hypertension in section 4.8)
Danish: Hypertensiv encefalopati (meget sjælden) (se også pkt.
English: • CPB15 arm: Five cycles of bevacizumab (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 bevacizumab (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: 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)
English: The recommended dose of MVASI 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 MVASI er 7,5 mg/kg eller 15 mg/kg legemsvægt en gang hver 3. uge administreret som intravenøs infusion.
English: (14.9 vs. 17.5 months; p = 0.4146)
Danish: (14,9 vs 17,5 måneder; p =
English: The primary endpoint was progression-free survival (PFS) based on independent review assessment.
Danish: Det primære endepunkt var progressionsfri overlevelse baseret på vurdering af en ufhængig evalueringskomité.
English: The results of this study are summarised in table 19.
Danish: Resultater fra studiet er opsummeret i tabel 19.
English: Median PFS (months) Hazard ratio (95% CI) Median OS (months) Hazard ratio (95% CI) Topotecan n = 120
Danish: Median OS (måneder) Hazard ratio (95 % konfidensinterval) Topotecan n = 120
English: Overall survival Median (months) Hazard ratio 95% CI
Danish: Samlet overlevelse Median (måneder) Hazard ratio 95 % konfidensinterval
English: The recommended dose of MVASI 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 MVASI 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: Leucovorin on day 1 and 2
Danish: Leucovorin på dag 1 og 2 5-fluoruracil i.v.
English: Osteonecrosis of the jawb,c
Danish: Osteonekrose af kæbenb,c
English: • Paclitaxel 135 mg/m2 IV over 24 hours on day 1 and cisplatin 50 mg/m2 IV on day 2, every 3 weeks (q3w); or
Danish: over 24 timer på dag 1 og cisplatin 50 mg/m i.v på dag 2, hver 3. uge;
English: • nose bleeds.
Danish: • næseblod.
English: 200 mg/m2 IV 2 h
Danish: 200 mg/m2 i.v.
English: NETHERLANDS
Danish: HOLLAND
English: Hazard ratio (95% CI) p-value
Danish: Hazard ratio (95 % konfidensinterval) p-værdi
English: BO17707 was a phase III, two-arm, multicentre, randomised, controlled, open-label study comparing the effect of adding bevacizumab to carboplatin plus paclitaxel in patients with FIGO stage I or IIA (grade 3 or clear cell histology only; n = 142), or FIGO stage IIB-IV (all grades and all histological types, n = 1,386) epithelial ovarian, fallopian tube or primary peritoneal cancer following surgery (NCI-CTCAE v.3).
Danish: stadie I eller IIA (grad 3 eller clear cell histologi alene, n = 142) eller FIGO-stadie IIB-IV (alle grader ogalle histologiske typer, n = 1.386) epitelial ovariecancer, tubacancer eller primær peritonealcancer efter operation (NCI-CTCAE v. 3).
English: Haemorrhagea,b, Thromboembolis m (venous)a,b,
Danish: Tromboemboli (venøs)a,b
English: Gallbladder perforationb,c
Danish: Galdeblæreperfora tionb,c
English: Arthralgia, Myalgia
Danish: Fistlera,b Myalgi
English: • CPB15+ arm: Five cycles of bevacizumab (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 bevacizumab (15 mg/kg q3w) as single agent for a total of up to 15 months of therapy.
Danish: • CBP15+-arm: Fem serier af bevacizumab (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 bevacizumab (15 mg/kg hver 3. uge) som monoterapi, i op til sammenlagt 15 måneders behandling.
English: Trial E2100 efficacy results
Danish: Tabel 10. Effektresultater fra studie E2100
English: Pulmonary haemorrhage/ Haemoptysisb,d,
Danish: Pulmonal blødning/ Hæmoptyseb,d Lungeemboli Hypoksi
English: PFS1 results by disease stage and debulking status from study BO17707 (ICON7) Randomised patients stage III optimally debulked disease2,3 CP (n = 368)
Danish: PFS1-resultater efter sygdomsstadie og tumorreduktionsstatus fra studie BO17707 (ICON7)
English: Primary endpoint Median PFS** Hazard ratio (97.5% CI)a
Danish: Median PFS** Hazard ratio (97,5 % konfidensinterval)a Sekundære endepunkter
English: 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 ECOG PS of 2.
Danish: Ca. 50 % af patienterne havde en ECOG PS på 1, og 7 % af patienterne i de 2 behandlingsarme havde en ECOG PS på 2.
English: What you need to know before you use MVASI 3.
Danish: Det skal du vide, før du begynder at bruge MVASI Sådan skal du bruge MVASI Bivirkninger
English: Chemotherapy + bevacizumab (n = 227)
Danish: Kemoterapi + bevacizumab (n = 227)
English: The recommended dose of MVASI is 15 mg/kg of body weight given once every 3 weeks as an intravenous infusion.
Danish: Den anbefalede dosis af MVASI er 15 mg/kg kropsvægt en gang hver 3. uge som intravenøs infusion.
English: Myocardial infarction was reported in up to 1.4% of patients treated with bevacizumab in combination with chemotherapy compared to up to 0.7% of patients treated with chemotherapy alone.
Danish: 1,4 % af patienterne, som fik bevacizumab i kombination med kemoterapi, sammenlignet med op til 0,7 % af patienterne, som fik kemoterapi alene.
English: MVASI is also used for treatment of adult patients with advanced kidney cancer.
Danish: MVASI bruges også hos voksne til behandling af fremskreden nyrekræft.
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: 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 bevacizumab.
Danish: Idet maternel IgG udskilles i mælk, og da bevacizumab kan skade barnets vækst og udvikling (se pkt.
English: The recommended dose of MVASI is 10 mg/kg of body weight given once every 2 weeks as an intravenous infusion.
Danish: Den anbefalede MVASI-dosis er 10 mg/kg kropsvægt en gang hver 2. uge som intravenøs infusion.
English: Response rate
Danish: Samlet responsrate
English: Hazard ratio [95% CI]
Danish: Hazard ratio (95 % konfidensinterval)
English: Cases of ONJ have been reported in cancer patients treated with bevacizumab, 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.