natgillin/translations-raw huggingface dataset:
Effektresultater fra studie AVF4095g Progressionsfri overlevelse 
Efficacy results from study AVF4095g
Anoreksi Hypomagnesiæmi Hyponatriæmi 
Anorexia Hypomagnesae mia
Resultater vises i tabel 22. 
Results are presented in table 22.
MVASI er, i kombination med paclitaxel, topotecan eller pegyleret liposomal doxorubicin, indiceret til behandling af voksne patienter med platin-resistent recidiverende epitelial ovariecancer, tubacancer eller primær peritonealcancer, som ikke har gennemgået mere end to kemoterapiregimer, og som ikke tidligere har fået behandling med bevacizumab, andre VEGF-hæmmere eller med VEGF-receptor-målrettede lægemidler (se pkt. 
MVASI in combination with paclitaxel, topotecan, or pegylated liposomal doxorubicin is indicated for the treatment of adult patients with platinum-resistant recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who received no more than two prior chemotherapy regimens and who have not received prior therapy with bevacizumab or other VEGF inhibitors or VEGF receptor-targeted agents (see section 5.1).
Der blev randomiseret 105 patienter til 5-FU/FA + placebo-armen og 104 patienter til 5FU/FA + bevacizumab-armen (5 mg/kg hver 2. uge). 
One hundred and five patients were randomised to 5-FU/FA + placebo arm and 104 patients to 5-FU/FA + bevacizumab (5 mg/kg every 2 weeks) arm. All treatments were continued until disease progression.
Kun patienter, som havde histologisk dokumenteret ovariecancer, primært peritonealcancer eller tubacancer, som havde recidiv ˃ 6 måneder efter platinbaseret kemoterapi, som ikke havde fået kemoterapi for recidiverende sygdom, og som ikke tidligere havde fået bevacizumab eller behandling med andre VEGF-hæmmere eller VEGF-receptor-målrettede lægemidler, blev inkluderet i studiet. 
Only patients with histologically documented ovarian, primary peritoneal, or fallopian tube carcinoma that had recurred > 6 months after platinum-based chemotherapy and who had not received chemotherapy in the recurrent setting and who have not received prior therapy with bevacizumab or other VEGF inhibitors or VEGF receptor-targeted agents were included in the study.
Et stort fase III-studie blev designet for at undersøge behandlingseffekten af bevacizumab i kombination med paclitaxel, målt ved det primære endepunkt progressionsfri overlevelse (PFS). 
A large phase III trial was designed to investigate the treatment effect of bevacizumab in combination with paclitaxel, as measured by the primary endpoint of PFS. A clinically meaningful and statistically significant improvement in PFS was observed.
2 timer 1.000 mg/m2 oral to gange daglig 
1,000 mg/m2 oral bid
Strålebehandling 
Radiotherapy
Proteinuri er blevet rapporteret hos mellem 0,7 % og 54,7 % af patienterne, som fik bevacizumab i kliniske studier. 
In clinical trials, proteinuria has been reported within the range of 0.7% to 54.7% of patients receiving bevacizumab.
• CPB7,5+-arm: Carboplatin (AUC 6) og paclitaxel (175 mg/m bevacizumab (7,5 mg/kg hver 3. uge) i op til 12 måneder (bevacizumab blev startet i anden kemoterapiserie, hvis behandling blev initieret inden for 4 uger efter operation, og i første serie, hvis behandling blev initieret mere end 4 uger efter operation). 
• CPB7.5+ arm: Carboplatin (AUC 6) and paclitaxel (175 mg/m2) for 6 cycles of 3 weeks plus bevacizumab (7.5 mg/kg q3w) for up to 12 months (bevacizumab was started at cycle 2 of chemotherapy if treatment was initiated within 4 weeks of surgery or at cycle 1 if treatment was initiated more than 4 weeks after surgery).
Intestinal obstruktion Rektovaginale fistlerc,d Gastrointestinale forstyrrelser Stomatitis 
Intestinal obstruction, Recto-vaginal fistulaec,d, Gastrointestinal disorder, Stomatitis, Proctalgia
Samlet overlevelse (OS) 
Primary endpoint Overall survival (OS)
• NO16966: bevacizumab 7,5 mg/kg legemsvægt hver 3. uge i kombination med oral capecitabin og intravenøs oxaliplatin (XELOX) eller bevacizumab 5 mg/kg hver 2. uge i kombination med leucovorin plus 5-fluoruracil bolus efterfulgt af 5-fluoruracil infusion og intravenøs oxaliplatin (FOLFOX-4). 
• NO16966: bevacizumab 7.5 mg/kg of body weight every 3 weeks in combination with oral capecitabine and intravenous oxaliplatin (XELOX) or bevacizumab 5 mg/kg every 2 weeks in combination with leucovorin plus 5-fluorouracil bolus, followed by 5-fluorouracil infusion, with intravenous oxaliplatin (FOLFOX-4).
I kliniske studier af ovariecancer blev der observeret sårhelingskomplikationer af grad 3-5 hos op til 1,8 % af patienterne i bevacizumab-armen i forhold til 0,1 % i kontrolarmen (NCI-CTCAE v. 3). 
In clinical trials of ovarian cancer, grade 3-5 wound healing complications were observed in up to 1.8% of patients in the bevacizumab arm versus 0.1% in the control arm (NCI-CTCAE v.3).
Hazard ratio (95 % konfidensinterval) (registrerings-form)b p-værdi 
Hazard ratio (95% CI) (registration form)b
Pulmonal hypertensionc Næseseptum perforationc 
Pulmonary hypertensionc, Nasal septum perforationc
Information om føtale misdannelser observeret efter markedsføring er angivet i pkt. 
Information on foetal malformations observed in the post-marketing setting are provided in sections 4.6 and 4.8.
Febril neutropeni Leukopeni Neutropenib Trombocytopeni 
Febrile neutropenia, Leucopenia, Neutropeniab Thrombocytope nia
MVASI vil blive givet sammen med kemoterapibehandling, der indeholder platin. 
MVASI will be administered together with a chemotherapy regimen containing platinum.
Der har været sjældne rapporter om symptomer, der stemmer overens med PRES, en sjælden neurologisk forstyrrelse, hos bevacizumab-behandlede patienter. 
There have been rare reports of bevacizumab-treated patients developing signs and symptoms that are consistent with PRES, a rare neurological disorder.
Ovariesvigtb,c,d 
Ovarian failureb,c,d
Cisplatin/Gemcitabin + bevacizumab 15 mg/kg hver 3. uge 
Cisplatin/Gemcitabine + bevacizumab 15 mg/kg q 3 weeks
Posteriort reversibelt encefalopati-syndrom (PRES) (se pkt. 
Posterior Reversible Encephalopathy Syndrome (PRES) (see section 4.8)
Det primære endepunkt var progressionsfri overlevelse; de sekundære endepunkter omfattede objektiv responsrate og samlet overlevelse. 
The primary endpoint was progression-free survival, with secondary endpoints including objective response rate and overall survival.
• Kemoterapi + bevacizumab-armen: 
• CT + BV arm (chemotherapy plus bevacizumab):
Topotecan + paclitaxel vs cisplatino + paclitaxel 
Topotecan + Paclitaxel vs. Cisplatin + Paclitaxel
Mindre slimhindeblødninger lokaliseret andre steder, som f.eks. gingival eller vaginal blødning, har også været rapporteret som mindre almindelige bivirkninger. 
There have also been less common reactions of minor mucocutaneous haemorrhage in other locations, such as gingival bleeding or vaginal bleeding.
Den primære analyse af investigatorvurderet PFS med cut-off den 28. februar 2010 viser en ustratificeret hazard ratio på 0,79 (95 % konfidensinterval: 0,68-0,91, tosidig log-rank p-værdi 0,0010) med en median PFS på 16,0 måneder i CP-armen og 18,3 måneder i CPB7,5+-armen. 
The primary analysis of investigator assessed PFS with a data cut-off date of 28 February 2010 shows an unstratified hazard ratio of 0.79 (95% CI: 0.68-0.91, 2-sided log-rank p-value 0.0010) with a median PFS of 16.0 months in the CP arm and 18.3 months in the CPB7.5+ arm.
• Hvert 4 ml hætteglas indeholder 100 mg bevacizumab svarende til 1,4 mg/ml efter foreskreven fortynding. 
• Each 4 mL vial contains 100 mg of bevacizumab, corresponding to 1.4 mg/mL when diluted as recommended.
Studiet var et åbent, randomiseret, aktivt kontrolleret, klinisk fase II-studie, som undersøgte bevacizumab i kombination med 5-FU/FA som 1.-linjebehandling af metastatisk kolorektalkræft. 
This was a phase II randomised, active-controlled, open-labelled clinical trial investigating bevacizumab in combination with 5-FU/FA as first-line treatment of metastatic colorectal cancer.
I kliniske studier omhandlende lokalt recidiverende eller metastatisk brystkræft blev der observeret sårhelingskomplikationer af grad 3-5 hos op til 1,1 % af patienterne, som fik bevacizumab, og hos op til 0,9 % af patienterne i kontrolarmene (NCI-CTCAE v. 3). 
In locally recurrent and metastatic breast cancer trials, grade 3-5 wound healing complications were observed in up to 1.1% of patients receiving bevacizumab compared with up to 0.9% of patients in the control arms (NCI-CTCAE v.3).
* Eksploratorisk analyse, opdateret analyse af samlet overlevelse på klinisk cut-off 28. oktober 2015, hvor ca. 
Exploratory analysis; OS updated analysis at clinical cut-off on 28 October 2015, approx. 45% patient had died and OS is therefore considered immature.
Gastrointestinal perforationa,b 
Gallbladder perforationa,b
(16,2 vs 12,0 måneder: p = 
(16.2 vs. 12.0 months; p = 0.1342)
(12,0 vs 15,0 måneder; p = 
(12.0 vs. 15.0 months;
Der blev randomiseret 71 patienter til bolus 5-FU/FA eller 5-FU/FA + bevacizumab (5 mg/kg hver 2. uge). 
Seventy-one patients were randomised to receive bolus 5-FU/FA or 5-FU/FA + bevacizumab (5 mg/kg every 2 weeks).
Procentdelen af patienter med ECOG-performancestatus 1 eller ≥ 2 var henholdsvis 38,7 % og 5,0 % i kemoterapi-armen og 29,8 % og 9,0 % i kemoterapi + bevacizumabarmen. 
The percentage of patients with an ECOG PS of 1 or ≥ 2 was 38.7% and 5.0% in the CT arm, and 29.8% and 9.0% in the CT + BV arm. Information on race exists for 29.3% of patients and nearly all patients were white.
Medianalder var 46,0 år (spændvidde: 20-83) i kemoterapigruppen og 48,0 år (spændvidde: 22-85) i kemoterapi + bevacizumab-gruppen. 
The median age was 46.0 years (range: 20-83) in the chemo alone group and 48.0 years (range: 22-85) in the chemo + bevacizumab group; with 9.3% of patients in the chemo alone group and 7.5% of patients in the chemo + bevacizumab group over the age of 65 years.
Effektresultaterne er præsenteret i tabel 12. 
The efficacy results are presented in table 12.
I et klinisk studie BO20924 gav tilføjelse af bevacizumab til standardbehandlingen ingen kliniske fordele hos 71 evaluérbare børn (fra 6 måneder til under 18 år) med metastatisk rabdomyosarkom og ikkerabdomyosarkom bløddelssarkom. 
Addition of bevacizumab to standard of care did not demonstrate clinical benefit in clinical trial BO20924, in 71 evaluable children (from age 6 months to less than 18 years old) patients with metastatic rhabdomyosarcoma and non-rhabdomyosarcoma soft tissue sarcoma (see section 4.2 for information on paediatric use).
Patienter i behandling med bevacizumab kan have risiko for at udvikle venøse tromboemboliske bivirkninger, herunder lungeemboli. 
Patients may be at risk of developing venous thromboembolic reactions, including pulmonary embolism under bevacizumab treatment.
Hvert hætteglas med 16 ml koncentrat indeholder 400 mg bevacizumab. 
Each vial of 16 mL of concentrate contains 400 mg of bevacizumab.
Når lægemidlet anvendes til voksne patienter med fremskreden kræft i æggestokkene, kræft i æggelederne eller primær bughindekræft, hvor sygdommen er kommet igen mere end 6 måneder efter sidste kemoterapi, som indeholdt platin, vil MVASI blive givet sammen med carboplatin og gemcitabin eller sammen med carboplatin og paclitaxel. 
When used for those adult patients with advanced epithelial ovarian, fallopian tube, or primary peritoneal cancer whose disease has come back at least 6 months after the last time they were treated with a chemotherapy regimen containing a platinum agent, MVASI will be administered in combination with carboplatin and gemcitabine or with carboplatin and paclitaxel.
• Carboplatin (AUC 4, dag 1) og gemcitabin (1.000 mg/m2 på dag 1 og 8) samtidig med bevacizumab (15 mg/kg, dag 1) hver 3. uge i 6 og op til 10 behandlingsserier, efterfulgt af bevacizumab (15 mg/kg hver 3. uge) som monoterapi indtil sygdomsprogresssion eller uacceptabel toksicitet. 
• Carboplatin (AUC 4, day 1) and gemcitabine (1,000 mg/m2 on days 1 and 8) and concurrent bevacizumab (15 mg/kg day 1) every 3 weeks for 6 and up to 10 cycles followed by bevacizumab (15 mg/kg every 3 weeks) alone until disease progression or unacceptable toxicity.
• Hvert 16 ml hætteglas indeholder 400 mg bevacizumab svarende til 16,5 mg/ml efter foreskreven fortynding. 
• Each 16 mL vial contains 400 mg of bevacizumab, corresponding to 16.5 mg/mL when diluted as recommended.
(p-værdi5 < 0,0001) 
(p-value5 < 0.0001)
Data for det sekundære endepunkt, den samlede overlevelse, er ikke tilgængelige endnu. 
The secondary endpoint of overall survival was not mature.
Sammenlignet med 5-FU/FA-kemoterapi alene medførte tillæg af bevacizumab 5 mg/kg hver 2. uge til 5-FU/FA en højere, objektiv responsrate, længere progressionsfri overlevelse og en tendens til længere overlevelse (se tabel 5). 
The addition of bevacizumab 5 mg/kg every two weeks to 5-FU/FA resulted in higher objective response rates, longer progression-free survival, and a trend in longer survival, compared with 5-FU/FA chemotherapy alone (see table 5).
Når lægemidlet anvendes til voksne patienter med fremskreden kræft i æggestokkene, kræft i æggeledere eller primær bughindekræft, hvor sygdommen er kommet igen tidligere end 6 måneder efter sidste kemoterapi, som indeholdt platin, vil MVASI blive givet sammen med paclitaxel eller topotecan eller pegyleret liposomal doxorubicin. 
When used for those adult patients with advanced epithelial ovarian, fallopian tube, or primary peritoneal cancer whose disease has come back before 6 months after the last time they were treated with a chemotherapy regimen containing a platinum agent, MVASI will be administered in combination with paclitaxel, or topotecan, or pegylated liposomal doxorubicin.
I FOLFOX undergruppen var den mediane PFS 8,6 måneder i placebogruppen vs 9,4 måneder for bevacizumab-behandlede patienter, HR = 0,89, 97,5 % konfidensinterval = [0,73-1,08]; p-værdi = 0,1871. 
In the FOLFOX treatment subgroup, the median PFS was 8.6 months in placebo and 9.4 months in bevacizumab-treated patients, HR = 0.89, 97.5% CI = [0.73; 1.08]; p-value = 0.1871, the corresponding results in the XELOX treatment subgroup being 7.4 vs. 9.3 months, HR = 0.77, 97.5% CI = [0.63; 0.94]; p-value = 0.0026.
Sekundært endepunkt Progressionsfri overlevelse 
Secondary endpoint Progression-free survival (PFS)
Hvert hætteglas med 4 ml koncentrat indeholder 100 mg bevacizumab. 
Each vial of 4 mL of concentrate contains 100 mg of bevacizumab.
Kongestivt hjertesvigtb,d Supraventrikulær takykardi 
Congestive heart failureb,d, Supraventricular tachycardia
85 mg/m i.v. 
85 mg/m2 IV 2 h
Nogle af bivirkningerne er almindelige ved behandling med kemoterapi, men bevacizumab kan forværre disse bivirkninger, når det gives i kombination med kemoterapi, f.eks. palmoplantar erytrodysæstesisyndrom med pegyleret liposomal doxorubicin eller capecitabin, perifer sensorisk neuropati med paclitaxel eller oxaliplatin, negleproblemer og alopeci med paclitaxel og paronykie med erlotinib. 
Examples include palmar-plantar erythrodysaesthesia syndrome with pegylated liposomal doxorubicin or capecitabine, peripheral sensory neuropathy with paclitaxel or oxaliplatin, nail disorders or alopecia with paclitaxel and paronychia with erlotinib.
Patienter med ubehandlede CNS-metastaser, verificeret ved billeddiagnostik eller tegn og symptomer, er rutinemæssigt blevet udeladt af kliniske studier med bevacizumab. 
Patients with untreated CNS metastases were routinely excluded from clinical trials with bevacizumab, based on imaging procedures or signs and symptoms.
Fistlerb,d Muskelsvaghed Rygsmerter 
Dyspnoea, Rhinitis, Epistaxis, Cough
I begge behandlingsarme var der ingen bivirkninger som resulterede i dødsfald. 
No adverse events leading to death occurred in either treatment arm; all deaths were attributed to disease progression.
Objektiv responsrate5 
p-value3,4 Objective response rate5
Effektresultater er præsenteret i tabel 14. 
The efficacy results are presented in table 14.
Den mediane, samlede overlevelse var 20,3 måneder for placebogruppen vs 21,2 måneder for bevacizumab-behandlede patienter i FOLFOX undergruppen, HR = 0,94, 97,5 % konfidensinterval = [0,75-1,16]; p-værdi = 0,4937. 
The median overall survival was 20.3 months in placebo and 21.2 months in bevacizumab-treated patients in the FOLFOX treatment subgroup, HR = 0.94, 97.5% CI = [0.75; 1.16]; p-value = 0.4937, the corresponding results in the XELOX, treatment subgroup being 19.2 vs. 21.4 months, HR = 0.84, 97.5% CI = [0.68; 1.04]; p-value = 0.0698.
Kemoterapi (n = 182) 
CT (n = 182)
• CPB arm: Carboplatin (AUC 5) og paclitaxel (175 mg/m i.v.) 
• CPB arm: Carboplatin (AUC5) and paclitaxel (175 mg/m2 IV) and concurrent bevacizumab
Størstedelen af patienterne i de 2 behandlingsarme (74 % og 71 %) havde lavt differentierede (grad 3) (NCI-CTCAE v. 3) primære tumorer ved baseline. 
The majority of the patients in each treatment arm (74% and 71%) had poorly differentiated (grade 3)
Patienter med målbar sygdom ved baseline. 
Patients with measurable disease at baseline.
MVASI er medicin, som anvendes hos voksne til behandling af fremskreden kræft i tyktarmen eller endetarmen. 
MVASI is a medicine used for the treatment of adult patients with advanced cancer in the large bowel, i.e., in the colon or rectum.
(14,9 vs 11,9 måneder; p = 
(14.9 vs. 11.9 months; p = 0.1061)
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). 
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.
Samlet overlevelse -Followupanalyse2 Hazard ratio (95 % konfidensinterval) 
Overall survival - Follow-up analysis2 Hazard ratio (95% CI)
• 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. 
• 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).
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). 
• 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).
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. 
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.
4.4 og Post-marketing erfaring nedenfor) 
Hypersensitivity reactions/infusion reactions (see section 4.4 and Post-marketing experience below)
29 % af patienterne i CPP- og CPB15-armene og 26 % i CPB15+-armen var over 65 år. 
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.
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. 
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.
Median PFS (måneder) Hazard ratio (95 % konfidensinterval)4 Randomiserede patienter med stadie III sub-optimalt tumorreduceret sygdom CP (n = 154) 
Median PFS (months) Hazard ratio (95% CI)4 Randomised patients with stage III suboptimally debulked disease3 CP (n = 154)
MVASI er, i kombination med platinbaseret kemoterapi, indiceret til 1.-linjebehandling af voksne patienter med ikke-operabel fremskreden, metastatisk eller recidiverende, ikke-småcellet lungekræft. 
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.
Median PFS (måneder) Hazard ratio (95 % konfidensinterval)4 Randomiserede patienter med stadie III sub-optimalt tumorreduceret sygdom CPP (n = 253) 
Median PFS (months) Hazard ratio (95% CI)4 Randomised patients with stage III suboptimally debulked disease3 CPP (n = 253)
4.4 og Proteinuri i pkt. 
For further information on proteinuria see section 4.4 and Proteinuria in section 4.8
Resultater vises i tabel 21. 
Results are presented in table 21.
• Kemoterapi-arm (kemoterapi alene): • Paclitaxel 80 mg/m som 1-times i.v.-infusion på dag 1, 8, 15 og 22 hver 4. uge. 
• Paclitaxel 80 mg/m2 as a 1-hour IV infusion on days 1, 8, 15, and 22 every 4 weeks
Hos patienter med målbar sygdom ved baseline. 
In patients with measurable disease at baseline.
a p-værdi 
P-value
Gastrointestinale perforationer og fistler (se pkt. 
Gastrointestinal (GI) perforations and Fistulae (see section 4.4)
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. 
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.
Median PFS (i behandling)** Hazard ratio (97,5 % konfidensinterval) Samlet responsrate (Investigators vurdering)** 
Secondary endpoints Median PFS (on treatment)** Hazard ratio (97.5% CI) Overall response rate (invest.
Pulmonal blødning/ hæmoptysea,b Lungeemboli Epistaxis 
Pulmonary haemorrhage/ Haemoptysisa,b, Pulmonary embolism, Epistaxis, Dyspnoea, Hypoxia
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. 
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).
Progressionfri overlevelse Median (måneder) Hazard ratio (95 % konfidensinterval) 
Progression-free survival Median (months) Hazard ratio (95% confidence interval)
• 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. 
• 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.