FrancophonIA/ELRC3.0 huggingface dataset:
English: In GEICAM 9805 study amenorrhoea that started during the treatment period and persisted into the follow-up period was observed to be ongoing in 18 patients (3.4%) in TAC arm and 5 patients (1.0%)
Danish: I studiet GEICAM9805 blev det observeret, at amenorré, som forekom i løbet af behandlingsperioden og fortsatte ind i opfølgningsperioden fortsat blev observeret hos 18 patienter (3,4%) i TAC-armen og hos 5 patienter (1,0%) i FAC-armen.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/09/611/001
Danish: EU/1/09/611/001
English: The incidence of related fever, diarrhoea, anorexia, and peripheral oedema occurred at rates ≥ 10% higher in patients who were
Danish: Hyppigheden af relateret feber, diarré, anoreksi og perifere ødemer var ≥ 10 % højere hos patienter som var 75 år eller ældre end hos patienter under 65 år.
English: At the median follow-up time of 77 months, overall survival (OS) was longer in the TAC arm with TAC-treated patients having a 24% reduction in the risk of death compared to FAC (hazard ratio = 0.76, 95% CI (0.46-1.26, p = 0.29).
Danish: Ved den mediane followup-periode på 77 måneder var den totale overlevelse (OS) længere i TACarmen, hvor TAC-behandlede patienter havde 24 % lavere risiko for død sammenlignet med FACbehandlede patienter (hazard ratio = 0,76; 95 % CI (0,46-1,26; p=0,29).
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON - 80 mg/2.88 ml
Danish: MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE ÆSKE - 80 mg/2,88 ml
English: Dose adjustments during treatment
Danish: Dosisjustering under behandling Generelt
English: In combination with cisplatin and 5-fluorouracil for the treatment of patients with gastric adenocarcinoma, the pivotal clinical study excluded patients with ALT and/or AST > 1.5 × ULN associated with alkaline phosphatase > 2.5 × ULN, and bilirubin> 1 x ULN; for these patients, no dose-reductions can be recommended and docetaxel should not be used unless strictly indicated.
Danish: I kombinationsbehandling med cisplatin og 5-fluoruracil til behandling af patienter med gastrisk adenocarcinom ekskluderede det kliniske pivotalstudie patienter med ALAT og/eller ASAT > 1,5 gange øvre normalværdi associeret med alkalisk fosfatase > 2,5 gange øvre normalværdi, og bilirubin > 1 gange øvre normalværdi.
English: The Docetaxel Teva infusion solution should be used within 4 hours and should be aseptically administered as a 1-hour infusion under room temperature (below 25°C) and normal lighting conditions.
Danish: Docetaxel Teva-infusionsopløsning skal bruges inden for 4 timer og anvendes under aseptiske forhold som en 1-times infusion ved stuetemperatur (under 25°C) og under normale lysforhold.
English: This medicinal product contains 25.1 % (w/w) ethanol, anhydrous (alcohol), i.e. up to 723 mg ethanol, anhydrous per concentrate vial, equivalent to 18.3 ml beer or 7.6 ml wine.
Danish: Dette lægemiddel indeholder 25,1 % vol. ethanol, vandfri (alkohol) dvs. op til 723 mg ethanol, vandfri pr. hætteglas, svarende til 18,3 ml øl eller 7,6 ml vin.
English: In a phase III study, 1,218 patients with unresectable stage IIIB or IV NSCLC, with KPS of 70% or greater, and who did not receive previous chemotherapy for this condition, were randomised to either docetaxel (T) 75 mg/m2 as a 1 hour infusion immediately followed by cisplatin (Cis) 75 mg/m2 over 30-60 minutes every 3 weeks (TCis), docetaxel 75 mg/m2 as a 1 hour infusion in combination with carboplatin (AUC 6 mg/ml.
Danish: 1.218 patienter med inoperabel ikke-småcellet lungekræft stadium IIIB eller IV med KPS på 70 % eller mere og som ikke tidligere havde fået kemoterapi mod denne tilstand, blev i et fase III-studie randomiseret til enten docetaxel (T) 75 mg/m2 administreret som 1-times infusion umiddelbart efterfulgt af cisplatin (Cis) 75 mg/m2 administreret i løbet af 30-60 minutter hver 3. uge (TCis),
English: What Docetaxel Teva concentrate vial contains: - The active substance is docetaxel.
Danish: - Aktivt stof: Docetaxel.
English: 4.1.2 Using a syringe fitted with a needle, aseptically withdraw the entire contents of the solvent for Docetaxel Teva vial by partially inverting the vial.
Danish: 4.1.2 Med en sprøjte med påsat kanyle udtages hele indholdet aseptisk fra hætteglasset med opløsningsmiddel til Docetaxel Teva ved at holde hætteglasset på skrå.
English: Tel: +44 1977 628 500
Danish: Teva UK Limited Tel: +44 1977 628 500
English: Anaemia (G3/4: 9.4%); Febrile neutropenia; Thrombocytopenia (G4: 0.8%)
Danish: Anæmi (G3/4: 9,4 %); Febril neutropeni; Trombocytopeni (G4: 0,8 %)
English: Constipation (G3/4: 1.0 %); Gastrointestinal pain (G3/4:
Danish: Konstipation (G3/4: 1,0 %); Gastrointestinale smerter (G3/4:
English: 2.1 Docetaxel Teva 80 mg/2.88 ml vial:
Danish: 2.1 Docetaxel Teva 80 mg/2,88 ml hætteglas:
English: This medicinal product contains 25.1 % (w/w) ethanol, anhydrous (alcohol), i.e. up to 181 mg ethanol, anhydrous per concentrate vial, equivalent to 4.6 ml beer or 1.9 ml wine.
Danish: Dette lægemiddel indeholder 25,1 % vol. ethanol, vandfri (alkohol) dvs. op til 181 mg ethanol, vandfri pr. hætteglas, svarende til 4,6 ml øl eller 1,9 ml vin.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON - 20 mg/0.72 ml
Danish: MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE ÆSKE - 20 mg/0,72 ml
English: Dysgeusia/Parosmia (G3/4: 0.4%);
Danish: Dysgeusi/parosmi (G3/4: 0,4 %);
English: Each box contains one Docetaxel Teva vial (80 mg/2.88 ml) and one corresponding solvent for Docetaxel Teva vial in a carton.
Danish: Hver karton indeholder et Docetaxel Teva hætteglas (80 mg/2,88 ml) og et tilsvarende hætteglas med solvens til Docetaxel Teva.
English: Patients on the comparator arm received cisplatin (P) 100 mg/m2 followed by 5-fluorouracil (F) 1000 mg/m2 per day for 5 days.
Danish: I sammenligningsarmen af studiet fik patienterne cisplatin (P) 100 mg/m2 efterfulgt af 5-fluoruracil (F) 1000 mg/m2 daglig i 5 dage.
English: Tabulated list of adverse reactions in prostate cancer for Docetaxel 75 mg/m² in combination with prednisone or prednisolone
Danish: Tabel over bivirkninger ved behandling af prostatakræft med Docetaxel 75 mg/m² i kombination med prednison eller prednisolon
English: This volume has been established during the development of docetaxel to compensate for liquid loss during preparation of the premix (see section 4) due to foaming, adhesion to the walls of the vial and "dead-volume".
Danish: Dette volumen er blevet fastlagt under udviklingen af docetaxel for at kompensere for væsketab ved fremstillingen af præmixen(se pkt.
English: Frequencies are defined as:
Danish: Hyppigheden af bivirkninger listet nedenfor er fastlagt under anvendelse af de følgende betegnelser:
English: This fill volume has been established during the development of docetaxel to compensate for liquid loss during preparation of the premix due to foaming, adhesion to the walls of the vial and "dead-volume".
Danish: Dette volumen er blevet fastlagt under udviklingen af docetaxel for at kompensere for væsketab ved fremstillingen af præmixen (se pkt.
English: Peripheral motor neuropathy (G3/4:
Danish: Perifer motorisk neuropati (G3/4:
English: Each box contains one Docetaxel Teva vial (20 mg/0.72 ml) and one corresponding solvent for Docetaxel Teva vial in a carton.
Danish: Hver karton indeholder et Docetaxel Teva hætteglas (20 mg/0,72 ml) og et tilsvarende hætteglas med solvens til Docetaxel Teva.
English: The pharmacokinetics of docetaxel, doxorubicin and cyclophosphamide were not influenced by their coadministration.
Danish: Den samtidige administration af docetaxel, doxorubicin og cyclofosfamid påvirkede ikke deres farmakokinetik.
English: Fatigue (G3/4: 3.9%); Fluid retention (severe: 0.6%)
Danish: Træthed (G3/4: 3,9 %); Væskeretention (alvorlig 0,6 %)
English: Number of patients Pain response rate (%) 95% CI p-value*
Danish: Smerte-responsrate (%) 95 % CI p-værdi*
English: Anaemia (G3/4: 3%); Neutropenia (G3/4:
Danish: Anæmi (G3/4: 3 %); Neutropeni (G3/4:
English: For cisplatin and 5-fluorouracil dose modifications, see the corresponding summary of product characteristics.
Danish: For modifikationer af doser af cisplatin og 5-fluoruracil: Se tilsvarende produktresumé.
English: Neutropenia (G3/4:
Danish: Neutropeni (G3/4:
English: Patients on the docetaxel arm received docetaxel (T) 75 mg/m2 followed by cisplatin (P) 75 mg/m2 followed by 5-fluorouracil (F) 750 mg/m2 per day as a continuous infusion for 5 days.
Danish: Patienter i docetaxel-armen modtog docetaxel (T) 75 mg/m2 efterfulgt af cisplatin (P) 75 mg/m2 efterfulgt af 5-fluoruracil (F) 750 mg/m2
English: Docetaxel Teva in combination with cisplatin is indicated for the treatment of patients with unresectable, locally advanced or metastatic non-small cell lung cancer, in patients who have not previously received chemotherapy for this condition.
Danish: Docetaxel Teva i kombination med cisplatin er indiceret til behandling af patienter med inoperabel lokalt fremskreden eller metastatisk ikke-småcellet lungekræft hos patienter, der ikke tidligere har fået kemoterapi mod denne tilstand.
English: Some cases of anaphylactic shock, sometimes fatal, have been reported.
Danish: Immunsystemet Der er rapporter om anafylaktisk shock, i nogle tilfælde fatale.
English: in TAC arm. No cases were reported in patients in FAC arm. No patient was diagnosed with myelodysplastic syndrome in either treatment groups.
Danish: Myelodysplastisk syndrom blev ikke diagnosticeret i nogen af behandlingsgrupperne.
English: - For the treatment of head and neck cancer, Docetaxel Teva is administered in combination with cisplatin and 5-fluorouracil.
Danish: - Til behandling af hoved- og halskræft indgives Docetaxel Teva i kombination med cisplatin og 5-fluoruracil.
English: At the end of the follow-up period (actual median follow-up time of 8 years), peripheral oedema was ongoing in 19 TAC patients (2.6%) and 4 FAC patients (0.5%).
Danish: Ved afslutningen af opfølgningsperioden (faktisk median opfølgningstid på 8 år) fortsatte perifert ødem hos 19 TAC patienter (2,6 %) og hos 4 FAC patienter (0,5 %).
English: Solvent vial 15 ml clear glass Type I vial with a bromobutyl rubber stopper and a flip-off cap.
Danish: Hætteglas med solvens 15 ml klart Type I-hætteglas med brombutyl-gummiprop og en afrivningshætte.
English: Using a syringe fitted with a needle, aseptically withdraw the entire contents of the solvent for Docetaxel Teva vial by partially inverting the vial.
Danish: Med en sprøjte udtages hele indholdet aseptisk fra hætteglasset med opløsningsmiddel til Docetaxel Teva ved at holde hætteglasset på skrå.
English: This regimen is administered every
Danish: Dette regime blev administreret hver 3.
English: • Induction chemotherapy followed by chemoradiotherapy (TAX 324) For the induction treatment of patients with locally advanced (technically unresectable, low probability of surgical cure, and aiming at organ preservation) squamous cell carcinoma of the head and neck (SCCHN), the recommended dose of docetaxel is 75 mg/m2 as a 1 hour intravenous infusion on day 1, followed by cisplatin 100 mg/m2 administered as a 30-minute to
Danish: • Induktionskemoterapi efterfulgt af kemo-stråleterapi (TAX 324) Til induktionsbehandling af patienter med lokalt fremskreden pladecellecarcinom i hoved og hals (SCCHN) (teknisk ikke muligt at resektere, lav sandsynlighed for kirurgisk helbredelse samt med bevarelse af organer som mål), er den anbefalede dosis docetaxel 75 mg/m som en 1times intravenøs infusion på dag 1, efterfulgt af cisplatin 100 mg/m2 administreret som en 30 minutter til 3 timers infusion, efterfulgt af 5-fluoruracil 1000 mg/m2 pr. dag som en kontinuerlig infusion fra dag 1 til dag 4.
English: Very common adverse reactions Common adverse reactions
Danish: Meget almindelige bivirkninger Almindelige bivirkninger
English: In the adjuvant treatment of operable node-positive and node-negative breast cancer, the recommended dose of docetaxel is 75 mg/m2 administered 1-hour after doxorubicin 50 mg/m2 and cyclophosphamide 500 mg/m2 every 3 weeks for 6 cycles (TAC regimen) (see also Dose adjustments during treatment).
Danish: Den anbefalede doxetaxel-dosis til adjuverende behandling af operabel lymfeknude-positiv brystkræft og lymfeknude-negativ brystkræft er 75 mg/m2 hver 3. uge i 6 perioder, administreret 1 time efter doxorubicin 50 mg/m2 og cyclofosfamid 500 mg/m2 (TAC-regime) (se også: Dosisjustering under behandling).
English: Solvent vial 6 ml clear glass Type I vial with a bromobutyl rubber stopper and a flip-off cap.
Danish: Hætteglas med solvens 6 ml klart Type I-hætteglas med brombutylgummiprop og en afrivningshætte.
English: • Premix solution: Chemical and physical in-use stability has been demonstrated for 8 hours when stored either between 2°C and 8°C or at room temperature (below 25°C).
Danish: • Præmix-opløsning: Kemisk og fysisk stabilitet under brug er påvist i 8 timer ved opbevaring enten mellem 2 °C og 8 °C eller ved stuetemperatur (under 25 °C).
English: Fatigue/ weakness (G3/4: 5%); Oedema peripheral (G3/4: 1%)
Danish: Træthed/svaghed (G3/4: 5 %); Perifert ødem (G3/4: 1 %);
English: Both regimens were administered every 3 weeks.
Danish: Begge regimer blev administreret en gang hver 3.
English: • The Docetaxel Teva 80 mg/2.88 ml vial contains a solution of docetaxel in polysorbate 80 at a concentration of 27.73 mg/ml.
Danish: • Docetaxel Teva 80 mg/2,88 ml hætteglas indeholder en opløsning af docetaxel i polysorbat 80 med en koncentration på 27,73 mg/ml.
English: Median progression free survival (months) (95%CI)
Danish: Median progressionsfri overlevelse (måneder) (95 %CI)
English: Docetaxel Teva in combination with capecitabine is indicated for the treatment of patients with locally advanced or metastatic breast cancer after failure of cytotoxic chemotherapy.
Danish: Docetaxel Teva i kombination med capecitabin er indiceret til behandling af patienter med lokal fremskreden eller metastatisk brystkræft efter svigt af cytotoksisk kemoterapi.
English: Solvent vial: water for injections.
Danish: Solvens hætteglas: vand til injektionsvæsker.
English: • Induction chemotherapy followed by radiotherapy (TAX323)
Danish: • Induktionskemoterapi efterfulgt af kemo-stråleterapi (TAX 324)
English: Dysgeusia (G3/4: <1%); Paraesthesia (G3/4: <1%)
Danish: Dysgeusi (G3/4: < 1 %); Paræstesi (G3/4: < 1 %)
English: At the median follow up time of 10 years and 5 months, TAC-treated patients had a 9% reduction in the risk of death compared to FAC-treated patients (hazard ratio = 0.91, 95% CI (0.63-1.32)).
Danish: Ved den mediane followup-periode på 10 år og 5 måneder havde TAC-behandlede patienter en 9 % lavere risiko for død sammenlignet med FAC-behandlede patienter (hazard ratio = 0,91; 95 % CI (0,63-1,32)).
English: Docetaxel Teva 80 mg/2.88 ml concentrate for solution for infusion is a clear viscous, yellow to brown-yellow solution containing 27.73 mg/ml docetaxel in polysorbate 80.
Danish: Docetaxel Teva 80 mg/2,88 ml koncentrat til infusionsvæske, opløsning, er en klar viskøs, gul til gulbrun opløsning, som indeholder 27,73 mg/ml docetaxel i polysorbat 80.
English: Docetaxel Teva 20 mg/0.72 ml concentrate for solution for infusion is a clear viscous, yellow to brown-yellow solution containing 27.73 mg/ml docetaxel in polysorbate 80.
Danish: Docetaxel Teva 20 mg/0,72 ml koncentrat til infusionsvæske, opløsning, er en klar viskøs, gul til gulbrun opløsning, som indeholder 27,73 mg/ml docetaxel i polysorbat 80.
English: Alopecia; Skin reaction (G3/4:
Danish: Alopeci; Hudlidelser (G3/4:
English: TAC-treated patients had a 32% reduction in the risk of relapse compared to those treated with FAC (hazard ratio = 0.68, 95% CI (0.49-0.93), p=0.01).
Danish: TAC-behandlede patienter havde 32 % lavere risiko for tilbagefald sammenlignet med de patienter, der blev behandlet med FAC (hazard-ratio = 0,68; 95 % CI (0,49-0,93); p = 0,01).
English: 2-year estimate (%) Hazard ratio (95% CI) *p-value
Danish: 2-års estimat (%) Hazard ratio (95 % CI) *p-værdi
English: • The Docetaxel Teva 20 mg/0.72 ml vial contains a solution of docetaxel in polysorbate 80 at a concentration of 27.73 mg/ml.
Danish: • Docetaxel Teva 20 mg/0,72 ml hætteglas indeholder en opløsning af docetaxel i polysorbat 80 med en koncentration på 27,73 mg/ml.
English: Description of selected adverse reactions for adjuvant therapy with Docetaxel 75 mg/m2 in combination with doxorubicin and cyclophosphamide in patients with node-positive (TAX 316) and node-negative (GEICAM 9805) breast cancer
Danish: Beskrivelse af udvalgte bivirkninger ved adjuverende behandling med Docetaxel 75 mg/m² i kombination med doxorubicin og cyclophosphamid hos patienter med lymfeknude-positiv (TAX 316) og lymfeknude-negativ (GEICAM 9805) brystkræft:
English: The addition of the entire contents of the solvent vial to the contents of the Docetaxel Teva 20 mg/0.72 ml concentrate for solution for infusion vial ensures a premix concentration of 10 mg/ml docetaxel.
Danish: Tilsætning af hele indholdet fra hætteglasset med solvens til indholdet af Docetaxel Teva 20 mg/0,72 mlkoncentrat til infusionsvæske, opløsning, sikrer en præmix-koncentration på 10 mg/ml docetaxel.
English: Gastrointestinal haemorrhage (severe:
Danish: Konstipation (alvorlig Mavesmerter (alvorlig Gastrointestinal Hæmorrhage (alvorlig
English: Between infusions of Docetaxel Teva the following may occur, and the frequency may vary with the combinations of medicines that are received:
Danish: Hyppigheden kan variere alt efter kombinationen af den medicin, du får:
English: In GEICAM 9805 study peripheral sensory neuropathy that started during the treatment period persisted into the follow-up period in 10 patients (1.9%) in TAC arm and 4 patients (0.8%) in FAC arm. At the end of the follow-up period (median follow-up time of 10 years and 5 months), peripheral sensory neuropathy was observed to be ongoing in 3 patients (0.6%) in TAC arm, and in 1 patient (0.2%) in FAC arm.
Danish: I studiet GEICAM 9805 forekom perifer sensorisk neuropati under behandlingen og fortsatte ind i opfølgningsperioden hos 10 patienter (1,9 %) i TAC-armen og hos 4 patienter (0,8 %) i FAC-armen.Ved afslutningen af opfølgningsperioden (median opfølgningstid på 10 år og 5 måneder) blev det observeret, at perifer sensorisk neuropati fortsatte hos 3 patienter (0,6 %) i TAC-armen og hos 1 patient (0,2 %) i FAC-armen.
English: Patients should be retreated with docetaxel when neutrophils recover to a level ≥1,500 cells/mm3 (see section 4.2).
Danish: Behandling med docetaxel bør gentages, når neutrofiltallet igen er ≥ 1.500 celler/mm3 (se pkt.
English: • Induction chemotherapy followed by chemoradiotherapy (TAX324) The safety and efficacy of docetaxel in the induction treatment of patients with locally advanced squamous cell carcinoma of the head and neck (SCCHN) was evaluated in a randomised, multi-centre open-label, phase III study (TAX324).
Danish: • Induktionskemoterapi efterfulgt af kemostråleterapi (TAX324) Sikkerheden og effekten af docetaxel i den indledende behandling af patienter med lokalt fremskredent pladecellecarcinom i hoved og hals (SCCHN) blev evalueret i et randomiseret, multicenter, open-label fase III-studie (TAX 324).
English: However the chemical and physical stability of the premix solution has been demonstrated for 8 hours when stored either between 2°C and 8°C or at room temperature (below 25°C).
Danish: Dog har præmixen vist sig kemisk og fysisk stabil i en 8 timers periode, når den blev opbevaret enten ved temperatur mellem 2 °C og 8 °C eller ved stuetemperatur (under 25 ºC).
English: The addition of the entire contents of the solvent vial to the contents of the Docetaxel Teva 80 mg/2.88 ml concentrate for solution for infusion vial ensures a premix concentration of 10 mg/ml docetaxel.
Danish: Tilsætning af hele indholdet fra hætteglassene med solvens til indholdet af Docetaxel Teva 80 mg/2,88 ml koncentrat til infusionsvæske, opløsning, sikrer en præmix-koncentration på 10 mg/ml docetaxel.
English: This overfill ensures that after dilution with the entire contents of the accompanying solvent for docetaxel vial, there is a minimal extractable premix volume of 2 ml containing 10 mg/ml docetaxel which corresponds to the labelled amount of 20 mg/0.72 ml per vial.
Danish: Dette overskud sikrer, at der efter fortynding med hele indholdet af den medfølgende solvens til docetaxel hætteglas kan udtages et præmix-volumen på mindst 2 ml, som indeholder 10 mg/ml docetaxel, hvilket svarer til den mængde, der er angivet på pakningen på 20 mg/0,72 ml pr. hætteglas.
English: Hypersensitivity (G3/4: 1.7%)
Danish: Overfølsomhed (G3/4: 1,7 %).
English: This overfill ensures that after dilution with the entire contents of the accompanying solvent for docetaxel vial, there is a minimal extractable premix volume of 8 ml containing 10 mg/ml docetaxel which corresponds to the labelled amount of 80 mg/2.88 ml per vial.
Danish: Dette overskud sikrer, at der efter fortynding med hele indholdet af den medfølgende solvens til docetaxel hætteglas kan udtages et præmix-volumen på mindst 8 ml, som indeholder 10 mg/ml docetaxel, hvilket svarer til den mængde, der er angivet på pakningen på 80 mg/2,88 ml pr. hætteglas.
English: If Docetaxel Teva concentrate, premix solution or infusion solution should come into contact with skin, wash immediately and thoroughly with soap and water.
Danish: Hvis Docetaxel Teva-infusionskoncentrat, præmix-opløsning eller infusionsvæske skulle komme på huden, så vask omgående og grundigt med sæbe og vand.
English: The recommended dose of docetaxel is 75 mg/m2 as a 1 hour infusion, followed by cisplatin 75 mg/m2, as a 1 to 3 hour infusion (both on day 1 only), followed by 5-fluorouracil 750 mg /m2 per day given as a 24-hour continuous infusion for 5 days, starting at the end of the cisplatin infusion.
Danish: Den anbefalede dosis af docetaxel er 75 mg/m2 som en 1-times infusion, efterfulgt af cisplatin 75 mg/m2, som en 1-3-timers infusion (begge kun på dag 1), efterfulgt af 5-fluoruracil 750 mg/m2 pr.
English: Single-use vials.
Danish: Engangshætteglas.
English: At the median follow up time of 10 years and 5 months, TAC-treated patients had a 16.5% reduction in the risk of relapse compared to those treated with FAC (hazard ratio = 0.84, 95% CI (0.65-1.08), p=0.1646).
Danish: Ved den mediane followup-periode på 10 år og 5 måneder havde TAC-behandlede patienter 16,5 % lavere risiko for tilbagefald sammenlignet med de patienter, der blev behandlet med FAC (hazard ratio = 0,84; 95 % CI (0,65-1,08); p = 0,1646).
English: Dyspnoea (G3/4: 1%); Cough (G3/4: <1%); Epistaxis (G3/4: <1%)
Danish: Dyspnø (G3/4: 1 %); Hoste (G3/4: < 1 %); Epistaxis (G3/4:
English: Stomatitis (G3/4: 23.7%); Vomiting (G3/4: 14.3%)
Danish: Stomatitis (G3/4: 23,7 %); Opkastning (G3/4: 14,3 %).
English: Tabulated list of adverse reactions in breast cancer for adjuvant therapy with Docetaxel 75 mg/m² in combination with doxorubicin and cyclophosphamide in patients with node-positive (TAX 316) and node-negative (GEICAM 9805) breast cancer - pooled data
Danish: Tabel over bivirkninger ved behandling af brystkræft med adjuverende behandling med Docetaxel 75 mg/m² i kombination med doxorubicin og cyclofosfamid hos patienter med lymfeknude-positiv (TAX 316) og lymfeknude-negativ (GEICAM 9805) brystkræft - pooled data:
English: At the end of the follow-up period (actual median follow-up time of 8 years), alopecia was observed to be ongoing in 29 TAC patients (3.9%) and 16 FAC patients (2.2%).
Danish: Ved slutningen af opfølgningsperioden (faktisk median opfølgningstid var 8 år) blev alopeci fortsat observeret hos 29 TAC-patienter (3,9 %) og hos 16 FAC-patienter (2,42 %).
English: Best overall response to study treatment [chemotherapy +/- radiotherapy] (%) (95%CI) ***p-value
Danish: Bedste respons i alt til undersøgelsesbehandling [kemoterapi +/- strålebehandling] (%) (95 %CI) ***p-værdi