natgillin/translations-raw huggingface dataset:
• 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. 
• 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.
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. 
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.
• 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. 
• 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
Træthed Pyreksi Smerte Slimhindeinflammation 
Lethargy, Mucosal inflammation
Arm 2 Carboplatin/ Paclitaxel + bevacizumab 15 mg/kg hver 3. uge 
Carboplatin/ Paclitaxel + bevacizumab 15 mg/kg q 3 weeks
Den anbefalede dosis af MVASI, når det anvendes sammen med erlotinib, er 15 mg/kg legemsvægt en gang hver 3. uge som intravenøs infusion. 
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.
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. 
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.
• tilstand i hjernen (posteriort reversibelt encefalopati syndrom) med symptomer såsom kramper, hovedpine, forvirring og synsforstyrrelser, 
• a brain condition with symptoms including seizures (fits), headache, confusion, and changes in vision (Posterior Reversible Encephalopathy Syndrome or PRES),
• en blodprop i lungerne, 
• a blood clot in the blood vessels of your lungs,
Studiet var et randomiseret, dobbeltblindet, aktivt kontrolleret, klinisk fase III-studie, som evaluerede bevacizumab i kombination med IFL som 1.-linjebehandling af metastatisk kolorektalkræft. 
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.
Effektresultater for studiet er vist i tabel 13. 
The efficacy results of the study are presented in table 13.
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. 
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.
95 % konfidensinterval for responsrate3 
Difference in response rates 95% CI for difference in response rates4
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. 
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.
Febril neutropeni Leukopeni Neutropenia Trombocytopeni 
Febrile neutropenia, Leucopenia, Neutropeniaa, Thrombocytope nia
Kemoterapi (n = 144) 
CT (n = 144)
(17,5 vs 15,0 måneder: p = 
(17.5 vs.15.0 months; p = 0.0584)
Perifer sensorisk neuropatib Dysartri 
Peripheral sensory neuropathyb, Dysarthria, Headache, Dysguesia
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. 
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)
MVASI administreres sammen med platinbaseret kemoterapi i op til 6 behandlingsserier, efterfulgt af behandling med MVASI som monoterapi indtil sygdomsprogression. 
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.
Ovariesvigta,b 
Ovarian failurea,b
Asteni Træthed 
Asthenia, Fatigue
MVASI bruges også hos voksne til behandling af fremskreden kræft i æggestokkene, kræft i æggeledere eller primær bughindekræft. 
MVASI is also used for the treatment of adult patients with advanced epithelial ovarian, fallopian tube, or primary peritoneal cancer.
* primær analyse 
Primary analysis Overall survival
Antallet af infusioner, som du skal have, afhænger af, hvordan du reagerer på behandlingen. 
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.
Hætteglas (uåbnet) 
Gall bladder perforation (not known)
• 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. 
• 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.
Resultaterne af dette studie vises i tabel 10. 
The results of this trial are presented in table 10.
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. 
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.
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). 
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.
Antal patienter Samlet overlevelse Median (måneder) Hazard ratio (95 % konfidensinterval) 
Number of patients Overall survival Median (months) Hazard ratio (95% confidence interval)
Median PFS (måneder)2 Hazard ratio [95 % konfidensinterval]2 
Median PFS (months)2 Hazard ratio [95% CI]2
Hypertensiv encefalopati (meget sjælden) (se også pkt. 
Nervous system disorders Hypertensive encephalopathy (very rare) (see also section 4.4 and Hypertension in section 4.8)
• 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. 
• 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
Median PFS (måneder) Hazard ratio (95 % konfidensinterval) Median OS (måneder) Hazard ratio (95 % konfidensinterval) 
Median PFS (months) Hazard ratio (95% CI) Median OS (months) Hazard ratio (95% CI)
Den anbefalede dosis af MVASI er 7,5 mg/kg eller 15 mg/kg legemsvægt en gang hver 3. uge administreret som intravenøs infusion. 
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.
(14,9 vs 17,5 måneder; p = 
(14.9 vs. 17.5 months; p = 0.4146)
Det primære endepunkt var progressionsfri overlevelse baseret på vurdering af en ufhængig evalueringskomité. 
The primary endpoint was progression-free survival (PFS) based on independent review assessment.
Resultater fra studiet er opsummeret i tabel 19. 
The results of this study are summarised in table 19.
Median OS (måneder) Hazard ratio (95 % konfidensinterval) Topotecan n = 120 
Median PFS (months) Hazard ratio (95% CI) Median OS (months) Hazard ratio (95% CI) Topotecan n = 120
Samlet overlevelse Median (måneder) Hazard ratio 95 % konfidensinterval 
Overall survival Median (months) Hazard ratio 95% CI
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. 
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.
Leucovorin på dag 1 og 2 5-fluoruracil i.v. 
Leucovorin on day 1 and 2
Osteonekrose af kæbenb,c 
Osteonecrosis of the jawb,c
over 24 timer på dag 1 og cisplatin 50 mg/m i.v på dag 2, hver 3. uge; 
• 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
• næseblod. 
• nose bleeds.
200 mg/m2 i.v. 
200 mg/m2 IV 2 h
HOLLAND 
NETHERLANDS
Hazard ratio (95 % konfidensinterval) p-værdi 
Hazard ratio (95% CI) p-value
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). 
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).
Tromboemboli (venøs)a,b 
Haemorrhagea,b, Thromboembolis m (venous)a,b,
Galdeblæreperfora tionb,c 
Gallbladder perforationb,c
Fistlera,b Myalgi 
Arthralgia, Myalgia
• 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. 
• 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.
Tabel 10. Effektresultater fra studie E2100 
Trial E2100 efficacy results
Pulmonal blødning/ Hæmoptyseb,d Lungeemboli Hypoksi 
Pulmonary haemorrhage/ Haemoptysisb,d,
PFS1-resultater efter sygdomsstadie og tumorreduktionsstatus fra studie BO17707 (ICON7) 
PFS1 results by disease stage and debulking status from study BO17707 (ICON7) Randomised patients stage III optimally debulked disease2,3 CP (n = 368)
Median PFS** Hazard ratio (97,5 % konfidensinterval)a Sekundære endepunkter 
Primary endpoint Median PFS** Hazard ratio (97.5% CI)a
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 ECOG PS of 2.
Det skal du vide, før du begynder at bruge MVASI Sådan skal du bruge MVASI Bivirkninger 
What you need to know before you use MVASI 3.
Kemoterapi + bevacizumab (n = 227) 
Chemotherapy + bevacizumab (n = 227)
Den anbefalede dosis af MVASI er 15 mg/kg kropsvægt en gang hver 3. uge som intravenøs infusion. 
The recommended dose of MVASI is 15 mg/kg of body weight given once every 3 weeks as an intravenous infusion.
1,4 % af patienterne, som fik bevacizumab i kombination med kemoterapi, sammenlignet med op til 0,7 % af patienterne, som fik kemoterapi alene. 
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.
MVASI bruges også hos voksne til behandling af fremskreden nyrekræft. 
MVASI is also used for treatment of adult patients with advanced kidney cancer.
• 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%
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 bevacizumab.
Den anbefalede MVASI-dosis er 10 mg/kg kropsvægt en gang hver 2. uge som intravenøs infusion. 
The recommended dose of MVASI is 10 mg/kg of body weight given once every 2 weeks as an intravenous infusion.
Samlet responsrate 
Response rate
Hazard ratio (95 % konfidensinterval) 
Hazard ratio [95% CI]
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 bevacizumab, the majority of whom had received prior or concomitant treatment with intravenous bisphosphonates, for which ONJ is an identified risk.
Frekvenser for bivirkninger 
Adverse reactions by frequency
ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER Hvert engangshætteglas indeholder 100 mg bevacizumab i 4 ml koncentrat. 
Each single use vial contains 100 mg of bevacizumab in 4 mL of concentrate.
(17,5 vs 14,3 måneder; p = 
(17.5 vs.14.3 months; p = 0.0609)
Søvnighed Hovedpine 
Hepatic impairment
Den progressionsfrie overlevelse og den objektive tumorresponsrate forøgedes signifikant ved tillæg af bevacizumab til IFN alfa-2a behandlingen. 
The addition of bevacizumab to IFN alfa-2a significantly increased PFS and objective tumour response rate.
Sårhelingskomplikationerb,d Eksfoliativ dermatitis Tør hud 
Exfoliative dermatitis, Dry skin, Skin discolouration
# I alt blev 154 patienter (ECOG-performancestatus 0 eller 1) randomiseret. 
p-value Overall response rate Rate (n) p-value Overall survival* (months) Median HR (95% CI) p-value A total of 154 patients (ECOG Performance Status 0 or 1) were randomised.
Dette var et fase III, randomiseret, aktivt kontrolleret, ublindet studie, som undersøgte bevacizumab 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 bevacizumab 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.
Median OS (måneder) Hazard ratio (95 % konfidensinterval) p-værdi 
Median OS (months) Hazard ratio (95% CI) p-value
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)
ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER Hvert engangshætteglas indeholder 400 mg bevacizumab i 16 ml koncentrat. 
Each single use vial contains 400 mg of bevacizumab in 16 mL of concentrate.
over 3 timer på dag 1 og cisplatin 50 mg/m 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)
Median PFS (måneder) Hazard ratio (95 % konfidensinterval)4 
Median PFS (months) Hazard ratio (95% CI)4
(16,2 vs 17,5 måneder; p = 
(16.2 vs. 17.5 months; p = 0.3769)
Arteriel tromboemboli: En forøget forekomst af arterielle tromboemboliske bivirkninger blev observeret hos patienter, som blev behandlet med bevacizumab, uanset indikation. 
Arterial thromboembolism: An increased incidence of arterial thromboembolic reactions was observed in patients treated with bevacizumab across indications, including cerebrovascular accidents, myocardial infarction, transient ischaemic attacks, and other arterial thromboembolic reactions.
Hos patienter, behandlet med MVASI 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, Behandlingen skal seponeres permanent hos patienter, som udvikler gastrointestinal perforation. 
Prior radiation is a risk factor for GI perforation in patients treated for persistent, recurrent or metastatic cervical cancer with MVASI and all patients with GI perforation had a history of prior radiation.
MVASI bruges også i behandlingen af voksne patienter med vedvarende livmoderhalskræft, med livmoderhalskræft, som er kommet igen, eller med livmoderhalskræft, der har spredt sig (dannet metastaser). 
MVASI is also used for the treatment of adult patients with persistent, recurrent or metastatic cervical cancer.
over 24 timer på dag 1 og cisplatin 50 mg/m2 i.v på dag 2 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 2 plus bevacizumab 15 mg/kg IV on day 2 (q3w); or
Objektiv responsrate (%) for patienter med målelig sygdom N Responsrate p-værdi < 0,0001) 
Objective response rate (%) in patients with measurable disease
Frekvens af alvorlige bivirkninger 
Severe adverse reactions by frequency
Oxaliplatin Capecitabin 
Capecitabine
(11,9 vs 14,3 måneder; p = 
(11.9 vs.14.3 months; p = 0.4825)
Antal patienter Samlet overlevelse Median tid (måneder) 
a patients with measurable disease at baseline Overall survival Median (months)
Forskel i responsrate 
N Response rate
Cellulitis 
Oxaliplatin
130 mg/m i.v. 
130 mg/m2 IV 2 h
Dette var et fase III, randomiseret, dobbeltblindet (med hensyn til bevacizumab), klinisk studie, hvori bevacizumab 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 bevacizumab 7.5 mg/kg in combination with oral capecitabine and IV oxaliplatin (XELOX), administered on a 3-weekly schedule; or bevacizumab 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.
Hovedpine Dysgeusi 
Hypoxia, Dysphoniaa
Rate (n) p-værdi 
p-value (Chi-squared test)
Responsrate 
AUTHORISATION
Median OS (måneder) Hazard ratio (95 % konfidensinterval) 
Median OS (months) Hazard ratio (95% CI)
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. 
Cases of foetal abnormalities in women treated with bevacizumab alone or in combination with known embryotoxic chemotherapeutics have been observed (see section 4.6) * If specified, the frequency has been derived from clinical trial data.
Dyspnø 
Leucovorin
Det blev udført med patienter med lokalt fremskreden (stadie IIIb med supraklaviculære lymfekirtelmetastaser eller med malignt pleural eller perikardial effusion), metastatisk eller recidiverende ikke-planocellulær NSCLC, som ikke tidligere havde fået kemoterapi. 
Trial BO17704 was a randomised, double-blind phase III trial of bevacizumab in addition to cisplatin and gemcitabine versus placebo, cisplatin and gemcitabine in patients with locally advanced (stage IIIB with supraclavicular lymph node metastases or with malignant pleural or pericardial effusion), metastatic or recurrent non-squamous NSCLC, who had not received prior chemotherapy.
Der er i sjældne tilfælde rapporteret nekrotiserende fasciitis, inklusive dødelige tilfælde, hos patienter behandlet med bevacizumab; dette har som regel været sekundært til sårhelingskomplikationer, gastrointestinal perforation eller fisteldannelse. 
This condition is usually secondary to wound healing complications, gastrointestinal perforation or fistula formation.
Kemoterapi + bevacizumab (n = 179) 
CT + BV (n = 179)
Pulmonal hypertensiona Næseseptumperforationa 
Pulmonary hypertensiona, Nasal septum perforationa
Cisplatin/Gemcitabin + placebo 
Efficacy results for trial BO17704 Cisplatin/Gemcitabine + placebo
Median PFS (måneder) Hazard ratio (95 % konfidensinterval)2 p-værdi3, 4 
Median OS (months) Hazard ratio (95% CI)2 p-value3
Randomiserede patienter med stadie III optimalt tumorreduceret sygdom CPP (n = 219) 
Randomised patients stage III optimally debulked disease2,3
Det sekundære endepunkt var progessionsfri overlevelse. 
The main secondary efficacy endpoint was progression-free survival (PFS).
Tromboemboli (arteriel)a,b 
Hypertensiona,b Thromboembolism arteriala,b,
• vægttab, 
• tiredness,
Synkope 
SN
Dette skal ses i sammenligning med < 1 % af de patienter, der kun fik kemoterapi (NCI-CTCAE v. 3). 
Grade 3-5 reactions have been observed in up to 2.3% of patients treated with bevacizumab plus chemotherapy as compared with < 1% with chemotherapy alone (NCI-CTCAE v.3).
Knogler, led, muskler og bindevæv 
Cerebrovascular accident, Syncope, Somnolence, Headache
Artralgi 
Lethargy
Bevacizumab kan nedsætte fertiliteten hos kvinder (se pkt. 
Bevacizumab may impair female fertility (see sections 4.6 and 4.8).
Followup-analyse blev udført ved data cut-off 7. marts 2014. 
Follow-up analysis was performed with a data cut-off date of 07 March 2014. p-value displayed for descriptive purpose only.
Hazard ratio (95 % konfidenstinterval) (eCRF) 
Median OS (months) Hazard ratio (95% CI) (eCRF)a