natgillin/translations-raw huggingface dataset:
Reversibilitetsdata tilgængelige hos 35,3 % af de patienter, som udviklede neurotoksicitet efter docetaxelbehandling med 100 mg/m2 som enkelt stof. 
Reversibility data are available among 35.3% of patients who developed neurotoxicity following docetaxel treatment at 100 mg/m² as single agent.
Disse reaktioner blev beskrevet under brug af NCI Common Toxicity Criteria (grad 3 = G3; grad 3-4 = G3/4; grad 4 = G4) og COSTART-termerne og MEdDRA-termerne. 
These reactions were described using the NCI Common Toxicity Criteria (grade 3 = G3; grade 3-4 = G3/4; grade 4 = G4), the COSTART and the MedDRA terms.
Brug ikke dette lægemiddel efter den udløbsdato, der står på pakningen og hætteglassene efter ”EXP”. 
This medicine should not be used after the expiry date which is stated on the carton and vials after “EXP”.
Derimod induceredes ingen mutationer i Ames test eller i en CHO/HGPRT genmutationsassay. 
However, it did not induce mutagenicity in the Ames test or the CHO/HGPRT gene mutation assay.
Det er vigtigt at læse hele indholdet af denne vejledning inden fremstilling af enten Docetaxel Teva præmix-opløsningen eller Docetaxel Teva infusionsvæske. 
It is important that you read the entire contents of this guide prior to the preparation of either the Docetaxel Teva premix solution or the Docetaxel Teva infusion solution
Patienter bør monitoreres for symptomer på kongestivt hjertesvigt under behandlingen og under opfølgningsperioden. 
Patients should be monitored for symptoms of congestive heart failure during therapy and during the follow up period.
Tør hud; 
Dry skin;
Post-menopausal * Hazard ratio (TAC/FAC) på mindre end 1 indikerer, at der er en sammenhæng mellem TAC og en længere sygdomsfri overlevelse, sammenlignet med FAC. 
Post-Menopausal *a hazard ratio (TAC/FAC) of less than 1 indicates that TAC is associated with a longer disease free survival compared to FAC.
De mest almindeligt rapporterede bivirkninger med docetaxel var: Neutropeni (som var reversibel og ikke kumulativ, median-dagen til nadir var 7 dage og median-varigheden af alvorlig neutropeni (< 500 celler/mm3) var 7 dage), anæmi, alopeci, kvalme, opkastning, stomatitis, diarré og asteni. 
The most commonly reported adverse reactions of docetaxel alone are: neutropenia (which was reversible and not cumulative; the median day to nadir was 7 days and the median duration of severe neutropenia (<500 cells/mm3) was 7 days), anaemia, alopecia, nausea, vomiting, stomatitis, diarrhoea and asthenia.
fluoruracil (klinisk vigtige behandlingsrelaterede bivirkninger er nævnt). 
5-fluorouracil (clinically important treatment related adverse events are presented).
• Et hætteglas med solvens 
• One vial of solvent
Væskeretention (alvorlig/livstruende: 1 %). 
Fluid retention (severe/life threatening: 1%)
I dette studie blev 501 patienter med lokalt fremskredent SCCHN og en WHO-funktionsstatus på 0 eller 1, randomiseret i en af to arme. 
In this study, 501 patients, with locally advanced SCCHN, and a WHO performance status of 0 or 1, were randomised to one of two arms.
Efter induktionskemoterapi skulle patienter i begge behandlingsarme modtage 7 ugers CRT med et minimumsinterval på 3 uger, og ikke senere end 8 uger efter påbegyndelse af sidste cyklus (dag 22 til dag 56 af sidste cyklus). 
Patients in both treatment arms were to receive 7 weeks of CRT following induction chemotherapy with a minimum interval of 3 weeks and no later than 8 weeks after start of the last cycle (day 22 to day 56 of last cycle).
Docetaxel Teva må IKKE anvendes, hvis du er gravid, medmindre det klart er anvist af din læge. 
Docetaxel Teva must NOT be administered if you are pregnant unless clearly indicated by your doctor.
Alderskategori 1 <50 år 
Overall Age category 1 <50 years
Docetaxel Teva må ikke anvendes efter udløbsdatoen, som er anført på karton og hætteglas. 
Docetaxel Teva should not be used after the expiry date shown on the carton and vials.
Docetaxel Teva hætteglas må ikke opbevares ved temperaturer over 25 ºC) og skal beskyttes mod lys. 
Docetaxel Teva vials should not be stored above 25°C and should be protected from light.
Du må ikke amme, mens du behandles med Docetaxel Teva. 
You must not breast-feed while you are treated with Docetaxel Teva.
• Nedsat indhold af natrium, kalium, magnesium og/eller calcium i blodet(forstyrrelse i elektrolytbalancen). 
• decrease of the sodium, potassium, magnesium, and/or calcium in your blood (electrolyte balance disorders)
I nogle tilfælde (frekvens ikke kendt) er permanent hårtab blevet observeret 
In some cases (frequency not known) permanent hair loss has been observed
Almene symptomer og reaktioner på administrationsstedet Den mediane kumulative dosis til behandlingsophør var mere end 1000 mg/m2 og mediantiden til reversibilitet af væskeretention var 16,4 uger (interval 0 til 42 uger). 
General disorders and administration site conditions The median cumulative dose to treatment discontinuation was more than 1,000 mg/m2 and the median time to fluid retention reversibility was 16.4 weeks (range 0 to 42 weeks).
Du må ikke blive gravid under behandling med denne medicin og skal bruge effektiv prævention under behandlingen fordi Docetaxel Teva kan skade det ufødte barn. 
You must not become pregnant during treatment with this medicine and must use an effective method of contraception during therapy because Docetaxel Teva may be harmful for the unborn baby.
- Øvrige indholdsstoffer: Polysorbat 80 og 25,1 % (w/w) vandfri ethanol (se punkt 2). 
- The other ingredients are polysorbate 80 and 25.1% (w/w) anhydrous ethanol (see section 2).
Mængden af alkohol i dette lægemiddel kan forringe din evne til at køre bil eller betjene maskiner. 
The amount of alcohol in this medicinal product may impair your ability to drive or use machines.
Docetaxel Teva indeholder alkohol. 
Docetaxel Teva contains alcohol.
Overlevelse i alt var også signifikant længere (p = 0,0201) til fordel for TCF-armen med en nedsættelse af risikoen for død på 22,7 %. 
Overall survival was also significantly longer (p=0.0201) in favour of the TCF arm with a risk reduction of mortality of 22.7%.
Der er rapporteret om meget sjældne tilfælde af hepatitis, nogle gange fatale, hovedsageligt hos patienter med præ-eksisterende leversygdomme. 
Very rare cases of hepatitis, sometimes fatal primarily in patients with pre-existing liver disorders, have been reported.
Ud af 333 patienter behandlet med docetaxel hver tredje uge i et prostatakræftstudie, var 209 patienter 65 år eller derover og 68 patienter var ældre end 75 år. 
Of the 333 patients treated with docetaxel every three weeks in a prostate cancer study, 209 patients were 65 years of age or greater and 68 patients were older than 75 years.
< 1/100); sjælden (≥ 1/10.000 til < 1/1000); meget sjælden (< 1/10.000); hyppighed ikke kendt (kan ikke estimeres ud fra forhåndenværende data). 
to < 1/1,000); very rare (< 1/10,000); not known (cannot be estimated from the available data).
De patienter, der blev behandlet i TCF-armen, havde længere tid til 5 % definitiv forværring af den globale sundhedsstatus på QLQ-C30-spørgeskemaet (p = 0,0121) og en længere tid til definitiv forværring af Karnofsky performance status (p = 0,0088) sammenlignet med patienterne, som fik behandling med CF. 
Patients treated with TCF had a longer time to 5% definitive deterioration of global health status on the QLQ-C30 questionnaire (p=0.0121) and a longer time to definitive worsening of Karnofsky performance status (p=0.0088) compared to patients treated with CF.
Overordnet demonstrerer resultaterne fra studierne en positiv benefit/risiko-fodeling for TAC sammenlignet med FAC. 
Overall, the study results demonstrate a positive benefit risk ratio for TAC compared to FAC.
Stråling blev udført med megavolt-udstyr, med en daglig fraktionering (2 Gy pr. dag, 5 dage om ugen i 7 uger, dosis i alt 70-72 Gy). 
Radiation was delivered with megavoltage equipment using once daily fractionation (2 Gy per day, 5 days per week for 7 weeks, for a total dose of 70-72 Gy).
Docetaxel Teva gives som infusion i en vene (intravenøs anvendelse). 
Docetaxel Teva will be given by infusion into one of your veins (intravenous use).
Der blev udført eksplorativ undergruppeanalyse af sygdomsfri overlevelse for patienter, der opfylder kriterierne for kemoterapi ifølge 2009 St. Gallen-kriterierne - (ITT population). 
Exploratory subgroup analyses for disease-free survival for patients who meet the 2009 St. Gallen chemotherapy criteria - (ITT population) were performed and presented here below:
Med en hazard ratio under 1 kan docetaxel + cisplatin+fluoruracil anvendes med fordel * Ujusteret log-rank test ** Ujusteret log-rank test, ikke justeret efter multipel sammenligning *** Chi-square-test, ikke justeret for multipel sammenligning NA: Ikke relevant (Not Applicable) 
A hazard ratio of less than 1 favours docetaxel + cisplatin + fluorouracil * Un-adjusted log-rank test ** Un-adjusted log-rank test, not adjusted for multiple comparisons *** Chi-square test, not adjusted for multiple comparisons NA-not applicable
uger for TCF-armen og 4 uger for CF-armen. 
The length of a treatment cycle was 3 weeks for the TCF arm and 4 weeks for the CF arm.
• 1.312 og 121 patienter, som fik henholdsvis 100 mg/m2 og 75 mg/m2 docetaxel som enkeltstof. 
• 1,312 and 121 patients who received 100 mg/m² and 75 mg/m² of docetaxel as a single agent respectively.
Dato for første markedsføringstilladelse: 26. januar 2010 Dato for seneste fornyelse: 14 juli 2014 
DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 26 January 2010
Der er rapporter om dissemineret intravaskulær koagulation (DIC), ofte i forbindelse med sepsis eller multiorgansvigt. 
Disseminated intravascular coagulation (DIC), often in association with sepsis or multi-organ failure, has been reported.
Mængden af alkohol i dette lægemiddel kan ændre virkningen af anden medicin. 
The amount of alcohol in this medicinal product may alter the effects of other medicines.
I docetaxel - plus trastuzumabarmen, havde 64 % modtaget en tidligere behandling med antracyklin som adjuverende behandling sammenlignet med 55 % i docetaxel-armen alene. 
In the docetaxel plus trastuzumab arm, 64% had received a prior anthracycline as adjuvant therapy compared with 55% in the docetaxel arm alone.
Ved kombination med docetaxel, var carboplatins clearance af carboplatin ca. 50 % højere end de værdier, der tidligere er rapporteret for carboplatinmonoterapi. 
When combined to docetaxel, the clearance of carboplatin was about 50% higher than values previously reported for carboplatin monotherapy.
Koncentrat i hætteglas Polysorbat 80 
Polysorbate 80
Tumor-responsrate (%) 95 % CI p-værdi* †Stratificeret log rank test *Tærskel for statistisk signifikans =0,0175 **PSA: Prostata-Specific Antigen 
Tumour response rate (%) 95% CI p-value* †Stratified log rank test *Threshold for statistical significance=0.0175 **PSA: Prostate-Specific Antigen
Patienter, som får Grad 3- eller 4-stomatitis, bør have deres dosis reduceret til 60 mg/m2. 
Patients who experience Grade 3 or 4 stomatitis should have their dose decreased to 60 mg/m².
Docetaxel Teva er ordineret af din læge til behandling af brystkræft, specielle former for lungekræft (ikke-småcellet lungekræft), prostatakræft, gastrisk kræft eller hoved- og halskræft: - Ved behandling af fremskreden brystkræft kan Docetaxel Teva enten indgives alene eller i kombination med doxorubicin, eller trastuzumab eller capecitabin. 
Docetaxel Teva has been prescribed by your doctor for the treatment of breast cancer, special forms of lung cancer (non-small cell lung cancer), prostate cancer, gastric cancer or head and neck cancer: - For the treatment of advanced breast cancer, Docetaxel Teva could be administered either alone or in combination with doxorubicin, or trastuzumab, or capecitabine.
Skønt mulige in vivo-interaktioner mellem docetaxel og andre samtidigt administrerede lægemidler ikke er undersøgt formelt, har in vitrointeraktioner med kraftigt proteinbundne stoffer såsom erythromycin, diphenhydramin, propranolol, propafenon, phenytoin, salicylat, sulfamethoxazol og natriumvalproat, ikke påvirket docetaxels proteinbinding. 
Although the possible in vivo interaction of docetaxel with concomitantly administered medicinal product has not been investigated formally, in vitro interactions with tightly protein-bound agents such as erythromycin, diphenhydramine, propranolol, propafenone, phenytoin, salicylate, sulfamethoxazole and sodium valproate did not affect protein binding of docetaxel.
TTP-medianen var 37,3 uger (95 % CI: 33,4 - 42,1) i AT-armen og 31,9 uger (95 % CI: 27,4 - 36,0) i AC-armen. 
The median TTP was 37.3 weeks (95% CI:33.4 - 42.1) in AT arm and 31.9 weeks (95% CI: 27.4 - 36.0) in AC arm.
Myalgi (alvorlig 1,4 %) Artralgi 
Myalgia (severe: 1.4%) Arthralgia
I dette studie havde 87 % af patienterne sygdom, som var IHC 3+, og 95 % af de inkluderede patienter havde sygdom, som var IHC3+ og/eller patienterne var FISH-positive. 
In this study, 87% of patients had disease that was IHC 3+, and 95% of patients entered had disease that was IHC 3+ and/or FISH positive.
Medicinen hedder Docetaxel Teva. 
The name of this medicine is Docetaxel Teva.
• 1.276 patienter (744 i TAX 316 og 532 i GEICAM 9805), som fik docetaxel i kombination med doxorubicin og cyclofosfamid (bivirkninger til klinisk vigtig behandling er præsenteret). 
• 1,276 patients (744 and 532 in TAX 316 and GEICAM 9805 respectively) who received docetaxel in combination with doxorubicin and cyclophosphamide (clinically important treatment related adverse events are presented).
lymfeknude-negativ brystkræft med høj risiko for tilbagefald ifølge 1998 St. Gallen-kriterierne (tumorstørrelse > 2 cm og/eller negative østrogenreceptorer (ER) og progesteronreceptorer (PR) og/eller høj histologisk/nukleær grad (grad 2 til 3) og/eller alder < 35 år). 
FAC arm), as adjuvant treatment of operable node-negative breast cancer patients with high risk of relapse according to 1998 St. Gallen criteria (tumour size >2 cm and/or negative ER and PR and/or high histological/nuclear grade (grade 2 to 3) and /or age <35 years).
De bivirkninger, som sandsynligvis er relateret til anvendelsen af docetaxel, er set hos: 
The adverse reactions considered to be possibly or probably related to the administration of docetaxel have been obtained in:
Median-antallet af cyklusser administreret pr. patient var 6 (med et interval på 1-16) for TCF-armen sammenlignet med 4 (med et interval på 1-12) for CF-armen. 
The median number of cycles administered per patient was 6 (with a range of 1-16) for the TCF arm compared to 4 (with a range of 1-12) for the CF arm. Time to progression (TTP) was the primary endpoint.
Tal med din læge, hvis du er afhængig af alkohol, lider af epilesi, eller hvis din leverfunktion er nedsat. 
Discuss with your doctor if you suffer from alcohol dependency, epilepsy or liver impairment.
Neutropeni (G3/4: 32 %); Febril neutropeni (inklusive neutropeni associeret med feber og brug af antibiotika) eller neutropenisk sepsis 
Neutropenia (G3/4: 32%); Febrile neutropenia (includes neutropenia associated with fever and antibiotic use) or neutropenic sepsis
In vitro-studier har vist, at docetaxels metabolisme kan ændres ved samtidig medicinering med stoffer, som inducerer, hæmmer eller metaboliseres (og således hæmmer enzymet kompetitivt) af cytochrom P450 3A, f.eks. ciclosporin, ketokonazol og erythromycin. 
In vitro studies have shown that the metabolism of docetaxel may be modified by the concomitant administration of compounds which induce, inhibit or are metabolised by (and thus may inhibit the enzyme competitively) cytochrome P450-3A such as ciclosporine, ketoconazole and erythromycin.
Efter administration af docetaxel 100 mg/m2 givet som infusion over 1 time, fandtes den gennemsnitlige maksimale plasmakoncentration at være 3,7 mg/ml med et AUC på 4,6 h.μg/ml. 
Following the administration of a 100 mg/m2 dose given as a one hour infusion a mean peak plasma level of 3.7 μg/ml was obtained with a corresponding AUC of 4.6 h.μg/ml.
Overlevelsesprocenten var 93,7 % i TAC-armen og 91,4 % i FAC-armen ved tidspunktet for 8-års followup, og 91,3 % i TAC-armen og 89 % i FAC-armen ved tidspunktet for 10-års followup. 
The survival rate was 93.7% in the TAC arm and 91.4% in the FAC arm, at the 8-year follow-up time point, and 91.3% in the TAC arm and 89% in the FAC arm, at the 10-year follow-up time point.
Den anden interim-analyse blev udført efter optagelse af i alt 400 sygdoms-fri overlevelser (DFS), hvilket førte til en medianopfølgningstid på 55 måneder. 
The second interim analysis was done after 400 DFS events had been recorded overall, which led to a median follow-up of 55 months.
Tid indtil progressiv sygdom var længere i kombinationsarmen med docetaxel + docetaxel (p < 0,0001). 
Time to progressive disease was superior in the docetaxel + capecitabine combination arm (p<0.0001).
256 patienter blev randomiseret til behandling med docetaxel alene (100 mg/m2 som 1 times intravenøs infusion hver 3. uge). 
256 patients were randomised to treatment with docetaxel alone (100 mg/ m2 as a 1 hour intravenous infusion every 3 weeks).
• Følelsesløshed eller stikkende og prikkende fornemmelse eller smerter i led eller muskler 
• feeling of numbness or pins and needles or pain in the joints or muscles
Hvis du vil have yderligere oplysninger om Docetaxel Teva, skal du henvende dig til den lokale repræsentant for indehaveren af markedsføringstilladelsen: 
For any information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder:
Med en hazard ratio < 1 kan docetaxel + cisplatin+5-FU anvendes med fordel *Cox model (tilpasning til primær tumor, T og N kliniske stadier og PSWHO) **Logrank test *** Chi-square-test 
A hazard ratio of less than 1 favours docetaxel + cisplatin + 5-FU *Cox model (adjustment for Primary tumour site, T and N clinical stages and PSWHO) **Log rank test *** Chi-square test
In vivo er docetaxels aktivitet uafhængig af behandlingsregimet og har eksperimentelt vist et bredt spektrum af antitumoraktivitet over for fremskredne murine og transplanterede humane tumorer. 
In vivo, docetaxel is schedule independent and has a broad spectrum of experimental anti-tumour activity against advanced murine and human grafted tumours.
• operabel lymfeknude-positiv brystkræft • operabel, lymfeknude-negativ brystkræft 
• operable node-positive breast cancer • operable node-negative breast cancer
Docetaxel + trastuzumab var effektivt til patienterne, uanset om de havde fået adjuverende anthracyklin eller ikke. 
Docetaxel plus trastuzumab was efficacious in patients whether or not they had received prior adjuvant anthracyclines.
Docetaxel Teva indeholder ethanol (alkohol) 
Docetaxel Teva contains ethanol (alcohol)
Tilberedning til intravenøs administration a) Tilberedning af Docetaxel Teva præmix (10 mg docetaxel/ml) 
Preparation for the intravenous administration a) Preparation of the Docetaxel Teva premix solution (10 mg docetaxel/ml)
Statusskalaen for hoved- og hals-underskalaer (PSS-HN) var designet til at måle sprogforståelse, evnen til at indtage føde offentligt samt en normal kost. 
The performance status scale, for head and neck (PSS-HN) subscales designed to measure understandability of speech, ability to eat in public, and normalcy of diet, was significantly in favour of TPF as compared to PF.
Hyppigheder defineres som: meget almindelig (≥ 1/10); almindelig (≥ 1/100 til < 1/10); ikke almindelig (≥ 1/1000 til 
very common (≥1/10), common (≥1/100 to < 1/10); uncommon (≥1/1,000 to < 1/100); rare (≥1/10,000
Undergruppeanalyser - adjuverende behandling hos patienter med lymfeknude-negativ brystkræft (intent-to-treat analyse) 
Subset Analyses-Adjuvant Therapy in Patients with Node-negative Breast Cancer Study (Intent-toTreat Analysis)
• 174 og 251 hoved- og halskræftpatienter, som blev behandlet med docetaxel i kombination med cisplatin og 5-fluoruracil (klinisk vigtige behandlingsrelaterede bivirkninger er nævnt). 
• 174 and 251 head and neck cancer patients who received docetaxel in combination with cisplatin and 5-fluorouracil (clinically important treatment related adverse events are presented).
De mest almindelige bivirkninger ved Docetaxel Teva givet alene er: Fald i antallet af røde og hvide blodlegemer, hårtab, kvalme, opkastning, sår i munden, diarré og træthed. 
The most commonly reported adverse reactions of Docetaxel Teva alone are: decrease in the number of red blood cells or white blood cells, alopecia, nausea, vomiting, sores in the mouth, diarrhoea and tiredness.
Data fra et multicenter åbent randomiseret studium støtter anvendelsen af den adjuverende behandling til patienter med operabel lymfeknude-positiv brystkræft og KPS ≥ 80 % i alderen mellem 18 og 70 år. 
Data from a multi-centre open-label randomised study support the use of docetaxel for the adjuvant treatment of patients with operable node-positive breast cancer and KPS ≥ 80%, between 18 and 70 years of age.
Yderligere forsigtighedsregler for anvendelse ved adjuverende behandling af brystkræft Kompliceret neutropeni 
Additional cautions for use in adjuvant treatment of breast cancer
Gennemsnitsværdierne for den totale clearance og steady-state distributionsvolumen var henholdsvis 21 l/h/m2 og 113 l. Den interindividuelle variation i totalclearance var ca. 50 %. 
Mean values for total body clearance and steady-state volume of distribution were 21 l/h/m2 and 113 l, respectively.
Følgende allergiske reaktioner kan forekomme (kan forekomme hos flere end 1 ud af 10 patienter) 
During the infusion at the hospital the following allergic reactions may occur (may affect more than 1 in 10 people):
Se også ” Docetaxel Teva indeholder ethanol (alkohol)” nedenfor. 
See also section ”Docetaxel Teva contains ethanol (alcohol)” below.
Efter endt kemoterapi, med et minimuminterval på 4 uger og et maksimuminterval på 7 uger, blev de patienter, hvis sygdom ikke forværredes, strålebehandlet (RT) i 7 uger i henhold til de fastlagte retningslinjer (PF/RT). 
At the end of chemotherapy, with a minimal interval of 4 weeks and a maximal interval of 7 weeks, patients whose disease did not progress received radiotherapy (RT) according to institutional guidelines for 7 weeks (PF/RT).
Der er ingen relevant anvendelse af Docetacel Teva i den pædiatriske population til indikationerne brystkræft, ikke-småcellet lungekræft, prostatakræft, gastrisk karcinom samt hoved- og halskræft med undtagelse af type II og III lavt differentieret nasofaryngealt karcinom. 
There is no relevant use of Docetaxel Teva in the paediatric population in the indications breast cancer, non-small cell lung cancer, prostate cancer, gastric carcinoma and head and neck cancer, not including type II and III less differentiated nasopharyngeal carcinoma.
Median overlevelse i alt var også signifikant længere til fordel for TPF-armen sammenlignet med PF-armen (median overlevelse i alt: 18,6 vs. 14,5 måneder respektivt) med en 28 % reduktion af risikoen for død, p = 0,0128. 
Median overall survival was also significantly longer in favour of the TPF arm compared to the PF arm (median OS: 18.6 vs. 14.5 months respectively) with a 28% risk reduction of mortality, p = 0.0128.
• Infusionsopløsning: Kemisk og fysisk stabilitet under brug er påvist i 4 timer ved stuetemperatur (under 25 °C). 
• Infusion solution: Chemical and physical in-use stability has been demonstrated for 4 hours at room temperature (below 25°C).
Infektioner (G3/4: inklusive sepsis og pneumoni, fatal hos 
Infections (G3/4: 5.7%; including sepsis and pneumonia, fatal in
• et hætteglas (5,12 ml) med solvens (vand til injektionsvæsker). 
• one vial (5.12 ml) of solvent (water for injections).
Patienter uden forværret sygdom skulle modtage kemostråleterapi (CRT) ifølge protokollen (TPF/CRT). 
All patients who did not have progressive disease were to receive chemoradiotherapy (CRT) as per protocol (TPF/CRT).
Infektioner og parasitære 
Infections and infestations
• Betændelse i tyktarm, tyndtarm, som kan være dødelig (hyppighed ikke kendt); perforering af tarmene. 
• inflammation of the colon, small intestine, which could be fatal (frequency not known);