natgillin/translations-raw huggingface dataset:
Median overall survival (months) (95% CI) Hazard ratio:
(95% IZ) Razmerje ogroženosti:
70.6 (49.0-NA)
(49, 0– NP)
30.1 (20.9-51.5)
(20, 9– 51, 5)
(95% CI) *p-value
(95% IZ) * Vrednost p
(0.54-0.90) 0.0058
(0, 54– 0, 90) 0, 0058
Median PFS (months)
Mediano PBN (meseci)
(95% CI) Hazard ratio:
(95% IZ) Razmerje ogroženosti:
(19.3-NA)
(19, 3– NP)
(10.6 - 20.2)
(10, 6– 20, 2)
(95% CI) **p-value
(0, 56– 0, 90) (95% IZ) 0, 004 ** Vrednost p
Best overall response (CR + PR) to
Najboljši celotni odziv (CR + PR) na
chemotherapy (%) (95% CI)
kemoterapijo (%) (95% IZ)
(65.8-77.2)
(65, 8– 77, 2)
(57.9-70.2)
(57, 9– 70, 2)
***p-value
0, 070
0.070
71, 5
Best overall response (CR + PR) to study treatment [chemotherapy +/ - chemoradiotherapy] (%) (95%CI)
raziskovano terapijo [kemoterapija + / - kemoradioterapija] (%) (95% IZ)
76.5 (70.8-81.5)
(70, 8– 81, 5)
71.5 (65.5-77.1)
(65, 5– 77, 1)
***p-value
*** Vrednost p
A Hazard ratio of less than 1 favors 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
Razmerje ogroženosti manj kot 1 pomeni prednost kombinacije docetaksel + cisplatin + fluorouracil * Nekorigirani log- rang test ** Nekorigirani log- rang test, nekorigiran za multiple primerjave *** Test hi- kvadrat, nekorigiran za multiple primerjave NP – ni podatka
The pharmacokinetics of docetaxel have been evaluated in cancer patients after administration of 20-115 mg/ m2 in phase I studies.
Farmakokinetiko docetaksela so ocenili pri onkoloških bolnikih po uporabi 20– 115 mg/ m2 v študijah I. faze.
The kinetic profile of docetaxel is dose independent and consistent with a three-compartment pharmacokinetic model with half lives for the α, β and γ phases of 4 min, 36 min and 11.1 h, respectively.
Kinetični profil docetaksela ni odvisen od odmerka in se sklada s trirazdelčnim farmakokinetičnim modelom, pri čemer je razpolovni čas faze α 4 minute, β 36 minut in γ 11, 1 ure.
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.
Po aplikaciji odmerka 100 mg/ m2 v enourni infuziji je bila povprečna največja koncentracija v plazmi 3, 7 µg/ ml, ustrezna AUC pa 4, 6 h. µg/ ml.
Mean values for total body clearance and steady-state volume of distribution were 21 l/ h/ m2 and 113 l, respectively.
Povprečni celotni telesni očistek je bil 21 l/ h/ m2, volumen porazdelitve v stanju dinamičnega ravnovesja pa 113 l.
Inter individual variation in total body clearance was approximately 50%.
Interindividualno variiranje celotnega telesnega očistka je bilo približno 50%.
Docetaxel is more than 95% bound to plasma proteins.
Docetaksel je v več kot 95% vezan na plazemske beljakovine.
A study of 14C-docetaxel has been conducted in three cancer patients.
Pri treh onkoloških bolnikih so opravili študijo s 14C- docetakselom.
Docetaxel was eliminated in both the urine and faeces following cytochrome P450-mediated oxidative metabolism of the tert-butyl ester group, within seven days, the urinary and faecal excretion accounted for about 6% and 75% of the administered radioactivity, respectively.
Na račun urinskega izločanja je šlo približno 6%, na račun fekalnega pa 75% aplicirane radioaktivnosti.
About 80% of the radioactivity recovered in faeces is excreted during the first 48 hours as one major inactive metabolite and 3 minor inactive metabolites and very low amounts of unchanged medicinal product.
Približno 80% radioaktivnosti v blatu se izloči v prvih 48 urah v obliki enega pomembnega in treh manj pomembnih neaktivnih presnovkov; zelo malo zdravila se izloči nespremenjenega.
The pharmacokinetics of docetaxel were not altered by the age or sex of the patient.
Pri majhnem številu bolnikov (n = 23) z
Docetaxel clearance was not
34 biokemičnimi izvidi, ki so nakazovali blago do zmerno okvaro jetrne funkcije (ALT, AST ≥ 1, 5- kratna ULN hkrati z alkalno fosfatazo ≥ 2, 5- kratno ULN), se je celotni očistek v povprečju zmanjšal za 27% (glejte poglavje 4. 2).
33 modified in patients with mild to moderate fluid retention and there are no data available in patients with severe fluid retention.
Pri bolnikih z blagim do zmernim zastajanjem tekočine se očistek docetaksela ni spremenil; za bolnike s hudim zastajenjem tekočine podatkov ni.
Phase I study evaluating the effect of capecitabine on the pharmacokinetics of docetaxel and vice versa showed no effect by capecitabine on the pharmacokinetics of docetaxel (Cmax and AUC) and no effect by docetaxel on the pharmacokinetics of a relevant capecitabine metabolite 5’ -DFUR.
Študija I. faze za oceno učinka kapecitabina na farmakokinetiko docetaksela in obratno ni odkrila, da bi kapecitabin vplival na farmakokinetiko docetaksela (Cmax in AUC), ali da bi docetaksel vplival na farmakokinetiko 5 '- DFUR, pomembnega presnovka kapecitabina.
The combined administration of docetaxel, cisplatin and 5-fluorouracil in 12 patients with solid tumors had no influence on the pharmacokinetics of each individual medicinal product.
Kombinacija docetaksela, cisplatina in 5- fluorouracila pri 12 bolnikih s čvrstimi tumorji ni vplivala na farmakokinetiko vsakega posameznega zdravila.
Docetaxel has been shown to be mutagenic in the in vitro micronucleus and chromosome aberration test in CHO-K1 cells and in the in vivo micronucleus test in the mouse.
Dokazano je, da je docetaksel mutagen v mikronukleusnem in kromosomskem aberacijskem testu na celicah CHO- K1 in vitro ter v mikronukleusnem testu pri miših in vivo.
However, it did not induce mutagenicity in the Ames test or the CHO/ HGPRT gene mutation assay.
Ni pa izzval mutagenosti v Amesovem testu ali preskusu genske mutacije CHO/ HGPRT.
Concentrate vial: polysorbate 80.
Viala koncentrata: polisorbat 80.
Solvent vial: ethanol 95% water for injections.
95% etanol voda za injekcije.
34 6.3 Shelf-life
35 6. 3 Rok uporabnosti
• 2 years. • Premix solution:
2 leti. • Osnovna raztopina:
The premix solution contains 10 mg/ ml docetaxel and should be used immediately after preparation.
Osnovna raztopina vsebuje 10 mg docetaksela/ ml in jo je treba uporabiti takoj po pripravi.
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). • Infusion solution: the infusion solution should be used within 4 hours at room temperature (below 25 °C).
Vendar je dokazano, da je osnovna raztopina kemično in fizikalno stabilna 8 ur, če je shranjena pri temperaturi med 2 °C in 8 °C ali pri sobni temperaturi (do 25 °C). • Raztopina za infundiranje: raztopino za infundiranje je pri sobni temperaturi (do 25 °C) treba uporabiti v 4 urah.
Do not store above 25 °C or below 2 °C.
Ne shranjujte pri temperaturi nad 25 °C ali pod 2 °C.
For storage conditions of the diluted medicinal product, see section 6.3.
Za pogoje shranjevanje raztopljenega zdravila glejte poglavje 6. 3.
Each blister pack contains: • one single-dose vial of concentrate and, • one single-dose vial of solvent.
Enpretisni omot vsebuje: • eno vialo z enim odmerkom koncentrata in • eno vialo z enim odmerkom vehikla.
Docetaxel Winthrop 20 mg concentrate for solution for infusion vial
Viala Docetaxel Winthrop 20 mg koncentrat za raztopino za infundiranje:
7 ml clear glass Type I vial with a green flip-off cap.
7- ml viala iz prozornega stekla tipa I z zeleno dvižno zaporko.
This vial contains 0.5 ml of a 40 mg/ ml solution of docetaxel in polysorbate 80 (fill volume:
Viala vsebuje 0, 5 ml raztopine docetaksela (v koncentraciji 40 mg/ ml) v polisorbatu 80 (polnilni volumen:
This fill volume has been established during the development of Docetaxel Winthrop to compensate for liquid loss during preparation of the premix due to foaming, adhesion to the walls of the vial and "dead-volume".
Ta polnilni volumen je bil določen med razvojem zdravila Docetaxel Winthrop za nadomestitev izgube tekočine, do katere pride med pripravo osnovne mešanice zaradi penjenja, adhezije na stene viale in "mrtvega volumna".
This overfill ensures that after dilution with the entire contents of the accompanying solvent for Docetaxel Winthrop 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 per vial.
Po razredčenju s celotno vsebino spremljajoče viale z vehiklom za Docetaxel Winthrop to prepolnjenje zagotavlja, da je mogoče izvleči najmanj 2 ml osnovne raztopine z 10 mg/ ml docetaksela, kar ustreza označeni količini 20 mg na vialo.
7 ml clear glass Type I vial with a transparent colourless flip-off cap.
7- ml viala iz prozornega stekla tip I s prosojno, brezbarvno dvižno zaporko.
Solvent vial contains 1.5 ml of a 13% w/ w solution of ethanol 95% in water for injections (fill volume:
Viala z vehiklom vsebuje 1, 5 ml 13% (m/ m) raztopine 95% etanola v vodi za injekcije (polnilni volumen:
The addition of the entire contents of the solvent vial to the contents of the Docetaxel Winthrop 20 mg concentrate for solution for infusion vial ensures a premix concentration of 10 mg/ ml docetaxel.
Dodatek celotne vsebine viale z vehiklom vsebini viale Docetaxel Winthrop 20 mg koncentrat za raztopino za infundiranje zagotavlja koncentracijo docetaksela v osnovni raztopini 10 mg/ ml.
If Docetaxel Winthrop concentrate, premix solution or infusion solution should come into contact with skin, wash immediately and thoroughly with soap and water.
Če pride koncentrat, osnovna raztopina ali raztopina za infundiranje Docetaxel Winthrop v stik s kožo, jo je treba takoj in temeljito umiti z milom in vodo.
If Docetaxel Winthrop concentrate, premix solution or infusion solution should come into contact with mucous membranes, wash immediately and thoroughly with water.
Če pride koncentrat, osnovna raztopina ali raztopina za infundiranje Docetaxel Winthrop v stik s sluznicami, jih je treba takoj in temeljito umiti z vodo.
35 Preparation for the intravenous administration
36 Priprava za intravensko aplikacijo
a) Preparation of the Docetaxel Winthrop premix solution (10 mg docetaxel/ ml)
a) Priprava osnovne raztopine zdravila Docetaxel Winthrop (10 mg docetaksela/ ml)
If the vials are stored under refrigeration, allow the required number of Docetaxel Winthrop boxes to stand at room temperature (below 25 °C) for 5 minutes.
Če so viale shranjene v hladilniku, pustite potrebno število škatel zdravila Docetaxel Winthrop 5 minut stati na sobni temperaturi (do 25 °C).
Using a syringe fitted with a needle, aseptically withdraw the entire contents of the solvent for Docetaxel Winthrop vial by partially inverting the vial.
Uporabite injekcijsko brizgo z nameščeno iglo in aseptično izvlecite celotno količino vehikla za Docetaxel Winthrop iz viale tako, da vialo delno obrnete.
Inject the entire contents of the syringe into the corresponding Docetaxel Winthrop vial.
Vbrizgajte celotno vsebino injekcijske brizge v ustrezno vialo zdravila Docetaxel Winthrop.
Allow the premix vial to stand for 5 minutes at room temperature (below 25 °C) and then check that the solution is homogenous and clear (foaming is normal even after 5 minutes due to the presence of polysorbate 80 in the formulation).
Nato preverite, ali je raztopina homogena in bistra (zaradi polisorbata 80, ki je v pripravku, je penjenje tudi še po 5 minutah normalno).
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).
Vendar je dokazano, da je osnovna raztopina kemično in fizikalno stabilna 8 ur, če je shranjena pri temperaturi med 2 °C in 8 °C ali pri sobni temperaturi (do 25 °C).
Based on the required dose for the patient expressed in mg, aseptically withdraw the corresponding premix volume containing 10 mg/ ml docetaxel from the appropriate number of premix vials using graduated syringes fitted with a needle.
Glede na odmerek (izražen v mg), ki ga potrebuje bolnik, aseptično izvlecite ustrezno količino osnovne raztopine, ki vsebuje 10mg docetaksela/ ml, iz ustreznega števila vial z osnovno raztopino; uporabite graduirane injekcijske brizge z iglo.
Inject the required premix volume into a 250 ml infusion bag or bottle containing either 5% glucose solution or 0.9% sodium chloride solution.
Potrebno količino osnovne raztopine vbrizgajte v 250- ml infuzijsko vrečko ali steklenico, v kateri je 5% raztopina glukoze ali 0, 9% raztopina natrijevega klorida.
If a dose greater than 200 mg of docetaxel is required, use a larger volume of the infusion vehicle so that a concentration of 0.74 mg/ ml docetaxel is not exceeded.
Če je potrebni odmerek večji od 200 mg docetaksela, uporabite več infuzijskega vehikla, tako da končna koncentracija v raztopini za infundiranje ne preseže koncetracije docetaksela 0, 74 mg/ ml.
The Docetaxel Winthrop 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.
Aplicirati jo je treba aseptično v 1- urni infuziji, pri sobni temperaturi (do 25 °C) in v pogojih običajne svetlobe.
As with all parenteral products, Docetaxel Winthrop premix solution and infusion solution should be visually inspected prior to use, solutions containing a precipitate should be discarded.
Tako kot vsa zdravila za parenteralno uporabo je treba tudi osnovno raztopino in raztopino za infundiranje Docetaxel Winthrop pred uporabo pregledati; če vsebuje precipitat, jo je treba zavreči.
Aventis Pharma S. A., 20 avenue Raymond Aron, 92165 Antony Cedex, France
A., 20 avenue Raymond Aron, 92165 Antony Cedex, Francija
20 April 2007
20 mesec 2007
Docetaxel Winthrop 80 mg concentrate and solvent for solution for infusion
Docetaxel Winthrop 80 mg koncentrat in vehikel za raztopino za infundiranje
Each single-dose vial of Docetaxel Winthrop 80 mg concentrate contains docetaxel which is a trihydrate corresponding to 80 mg of docetaxel (anhydrous).
Vsaka viala z enim odmerkom zdravila Docetaxel Winthrop 80 mg koncentratvsebuje docetaksel v obliki trihidrata, ki ustreza 80 mg brezvodnega docetaksela.
The concentrate is a clear viscous, yellow to brown-yellow solution.
Koncentratje bistra, viskozna, rumena do rjavo- rumena raztopina.
Docetaxel Winthrop 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.
Docetaxel Winthrop v kombinaciji s cisplatinom je indiciran za zdravljenje neresektabilnega, lokalno napredovalega ali metastatskega nedrobnoceličnega pljučnega raka pri bolnikih, ki zaradi te bolezni še
38 Prostate cancer
Rak prostate
Breast cancer In the adjuvant treatment of operable node-positive 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 (see also Dose adjustments during treatment).
Rak dojke Pri dopolnilnem zdravljenju operabilnega raka dojke s pozitivnimi bezgavkami je priporočeni odmerek docetaksela 75 mg/ m2, apliciran eno uro po doksorubicinu 50 mg/ m2 in ciklofosfamidu 500 mg/ m2 vsake tri tedne v 6 ciklusih (glejte tudi Prilagajanje odmerka med zdravljenjem).
For treatment
40 Nedrobnocelični pljučni rak Pri bolnikih z nedrobnoceličnim pljučnim rakom, ki še niso bili zdravljeni s kemoterapijo, je priporočena shema odmerjanja docetaksel v odmerku 75 mg/ m2, ki mu takoj sledi cisplatin v odmerku 75 mg/ m2, apliciran 30– 60 minut.
39 after failure of prior platinum-based chemotherapy, the recommended dose is 75 mg/ m² as a single agent.
Za zdravljenje po neuspehu predhodne, na platini osnovane kemoterapije, je priporočeni odmerek 75 mg/ m2 v monoterapiji.
• Induction chemotherapy followed by radiotherapy (TAX 323) For the induction treatment of inoperable locally advanced squamous cell carcinoma of the head and neck (SCCHN), the recommended dose of docetaxel is 75 mg/ m2 as a 1 hour infusion followed by cisplatin 75 mg/ m2 over 1 hour, on day one, followed by 5-fluorouracil as a continuous infusion at 750 mg/ m2 per day for five days.
• Indukcijska kemoterapija in nato radioterapija (TAX323) Za indukcijsko zdravljenje inoperabilnega lokalno napredovalega skvamoznoceličnega karcinoma glave in vratu (SCCHN – squamous cell carcinoma of the head and neck), je priporočeni odmerek docetaksela 75 mg/ m2 v obliki enourne infuzije, ki ji sledi cisplatin 75 mg/ m2, infundiran 1 uro dolgo, prvega dne, temu pa sledi 5- fluorouracil v obliki neprekinjene infuzije v odmerku 750 mg/ m2 na dan pet dni.
Adjuvant therapy for breast cancer In the pivotal trial in patients who received adjuvant therapy for breast cancer and who experienced complicated neutropenia (including prolonged neutropenia, febrile neutropenia, or infection), it was recommended to use G-CSF to provide prophylactic coverage (eg, day 4 to 11) in all subsequent cycles.
41 Adjuvantna terapija raka dojke V raziskavi osrednjega pomena pri bolnicah z rakom dojke, pri katerih se je med dopolnilnim zdravljenjem razvila nevtropenija z zapleti (dalj časa trajajoča nevtropenija, febrilna nevtropenija ali okužba), so priporočali profilaktično uporabo G- CSF (npr. od 4. do 11. dne) v vseh naslednjih ciklih zdravljenja.
Patients who continued to experience this reaction should remain on G-CSF and have their docetaxel dose reduced to 60 mg/ m².
Pri bolnicah, pri katerih ta reakcija traja, je treba z dajanjem G- CSF nadaljevati in jim odmerek docetaksela zmanjšati na 60 mg/ m2.
40 However, in clinical practice neutropenia could occur earlier.
V klinični praksi pa se lahko nevtropenija pojavi bolj zgodaj.
Recommended dose modifications for toxicities in patients treated with docetaxel in combination with cisplatin and 5-fluorouracil (5-FU):
Priporočene prilagoditve odmerka v primeru toksičnih učinkov pri bolnikih, ki prejemajo docetaksel v kombinaciji s cisplatinom in 5- fluorouracilom (5- FU):
First episode: reduce docetaxel and 5-FU doses by 20%.
Prvi pojav: zmanjšajte odmerka docetaksela in 5- FU za 20%.
Third episode: reduce docetaxel dose by 20%.
Tretji pojav: zmanjšajte odmerek docetaksela za 20%.
Second episode: reduce docetaxel dose by 20%.
Drugi pojav: zmanjšajte odmerek docetaksela za 20%.
In the pivotal SCCHN trials patients who experienced complicated neutropenia (including prolonged neutropenia, febrile neutropenia, or infection), it was recommended to use G-CSF to provide prophylactic coverage (eg, day 6-15) in all subsequent cycles.
42 V ključnem SCCHN preskušanju pri bolnikih, pri katerih se je pojavila komplicirana nevtropenija (ki vključuje dolgotrajno nevtropenijo, fibrilno nevtropenijo ali okužbo), je bilo priporočeno, naj se v vseh naslednjih ciklih za profilaktično kritje (na primer med 6. in 15. dnem) uporablja G- CSF.
In combination with cisplatin and 5-fluorouracil for the treatment of patients with gastric adenocarcinoma, the pivotal clinical trial 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.
V ključnem kliničnem preskušanju docetaksela v kombinaciji s cisplatinom in 5- fluorouracilom pri bolnikih z adenokarcinomom želodca so izključili bolnike z ALT in/ ali AST > 1, 5 x ULN ter hkrati alkalno fosfatazo > 2. 5 x ULN in bilirubinom > 1 x ULN; pri teh bolnikih ni mogoče priporočiti zmanjšanja odmerka in docetaksela se ne sme uporabljati, če ni strogo indiciran.
In the case of severe neutropenia (< 500 cells/ mm3 for seven days or more) during a course of docetaxel therapy, a reduction in dose for subsequent courses of therapy or the use of appropriate symptomatic measures are recommended (see section 4.2).
43 Če se med zdravljenjem z docetakselom pojavi huda nevtropenija (< 500 celic/ mm3 sedem dni ali več), je med naslednjimi ciklusi priporočljivo zmanjšati odmerek ali uporabiti ustrezne simptomatske ukrepe (glejte poglavje 4. 2).
42 In patients treated with docetaxel in combination with cisplatin and 5-fluorouracil (TCF), febrile neutropenia and neutropenic infection occurred at lower rates when patients received prophylactic G-CSF.
Med bolniki, ki so docetaksel prejemali v kombinaciji s cisplatinom in 5- fluorouracilom (TCF), sta se febrilna nevtropenija in nevtropenična okužba redkeje pojavili pri bolnikih, ki so profilaktično prejemali G- CSF.
43 Cardiac toxicity
44 Kardiotoksičnost
In patients treated with docetaxel every three weeks, the incidence of related nail changes occurred at a rate ≥ 10% higher in patients who were 65 years of age or greater compared to younger patients.
Pri bolnikih zdravljenih z docetaksel vsake tri tedne, ki so bili starejši od 65 let, je bila incidenca pojavljanja z zdravljenjem povezanih sprememb na nohtih ≥ 10% večja v primerjavi z mlajšimi bolniki.
44 4.5 Interaction with other medicinal products and other forms of interaction
4. 5 Medsebojno delovanje z drugimi zdravili in druge oblike interakcij
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, terfenadine, ketoconazole, erythromycin and troleandomycin.
Študije in vitro so pokazale, da lahko presnovo docetaksela spremeni sočasna uporaba zdravil, ki inducirajo ali inhibirajo citokrom P450- 3A ali se z njim presnavljajo (in ga tako lahko kompetitivno 45 inhibirajo), kot so ciklosporin, terfenadin, ketokonazol, eritromicin in troleandomicin.
The adverse reactions considered to be possibly or probably related to the administration of docetaxel have been obtained in: • 1312 and 121 patients who received 100 mg/ m² and 75 mg/ m² of docetaxel as a single agent respectively. • 258 patients who received docetaxel in combination with doxorubicin. • 406 patients who received docetaxel in combination with cisplatin.
Podatki o neželenih učinkih, ki so morda ali verjetno povezani z uporabo docetaxela, so bili zbrani pri: • 1312 bolnikih, ki so v monoterapiji prejemali 100 mg/ m² docetaxela, 121 pa jih je prejemalo 75 mg/ m². • 258 bolnikih, ki so prejemali docetaksel v kombinaciji z doksorubicinom. • 406 bolnikih, ki so prejemali docetaksel v kombinaciji s cisplatinom. • 92 bolnicah, ki so prejemale docetaksel v kombinaciji s trastuzumabom. • 255 bolnikih, ki so prejemali docetaksel v kombinaciji s kapecitabinom. • 332 bolnikih, ki so prejemali docetaksel v kombinaciji s prednizonom ali prednizolonom (predstavljeni so klinično pomembni z zdravljenjem povezani neželeni učinki). • 744 bolnikih, ki so prejemali docetaksel v kombinaciji z doksorubicinom in ciklofosfamidom (predstavljeni so klinično pomembni z zdravljenjem povezani neželeni učinki).