natgillin/translations-raw huggingface dataset:
(≥ 1/100 to &lt; 1/10); uncommon (≥ 1/1,000 to &lt; 1/100); rare (≥ 1/10,000 to &lt; 1/1,000); very rare ( &lt; 1/10,000); not known (cannot be estimated from the available data).
Pogostnosti so določene kot: zelo pogosti (≥1/10) ; pogosti (≥ 1/100 do &lt; 1/10); občasni (≥ 1/1.000 do &lt; 1/100); redki (≥ 1/10.000 do &lt; 1/1.000); zelo redki ( &lt; 1/10.000); neznana (ni mogoče oceniti iz razpoložljivih podatkov).
(≥ 1/1000 to &lt; 1/100)
(≥ 1/1000 do &lt; 1/100)
(≥1/1,000 to &lt; 1/100)
(≥ 1/1.000 do &lt; 1/100)
(≥1/1,000 to &lt; 1/100)
(≥1/1.000 do ≤1/100)
(≥1/100 to &lt; 1/10)
(≥1/100 do
+ frequency of acquired resistance &gt; 50 % in some Member States
+ pogostnost pridobljene odpornosti &gt; 50 % v nekaterih državah članicah
+ species with &gt; 50% acquired resistance in one or more Member State
+ z &gt; 50 % pridobljeno odpornostjo v eni ali več državah članicah
, G2-, G3- and G4-serotype RVG cases (any severity) was 61.5 % [95 % CI: 14.2; 84.2] among infants who were &gt; 26 to ≤32 weeks of age at dose 3.
[95-odstotni IZ: 14,2; 84,2] pri dojenčkih, ki so bili ob prejemu 3. odmerka stari &gt; 26 do ≤ 32 tednov.
/mL):
&lt; 100,000
0% ( &lt; 2.0 mEq/l)
0% ( &lt; 2,0 mmol/l)
0- &lt; 6 years N=24
0- &lt; 6 let
0- &lt; 6 years N=24
0- &lt; 6 ára N=24
0.000
P &lt; 0,0001
0.08 ± 0.03 ; 0.01 to 0.15; &lt; 0.0001
0,08 ± 0,03; 0,01 do 0,15; &lt; 0,0001
0.1% of patients receiving Taltz developed a neutrophil count &lt; 1000 cells/mm3.
0,1 % bolnikov, ki so prejemali zdravilo Taltz, je imelo število nevtrofilcev &lt; 1000 celic/mm3.
0.25-0.49; p &lt; 0.00001), moreover, pre-planned subgroup analysis by BRCA-mutation status identified patients with BRCA-mutated ovarian cancer (n=136, 51.3%) as the subgroup that derived the greatest clinical benefit from olaparib maintenance monotherapy.
Poleg tega je vnaprej načrtovana analiza podskupin po mutacijskem stanju gena BRCA pokazala, da so bolnice z rakom jajčnikov in mutacijo gena BRCA (n = 136, 51,3 %) tista podskupina, ki ji je vzdrževalna monoterapija z olaparibom klinično najbolj koristila.
0.3% of patients receiving co-administration had clinically relevant increases in creatinine to values &gt; 200 µmol/L.
Klinično pomembno zvišanje ravni kreatinina nad &gt; 200 μmol/l je imelo 0,3 % bolnikov, ki so sočasno prejemali obe zdravili.
0.3% of patients receiving co-administration had clinically relevant increases in creatinine to values &gt; 200 µmol/l.
Klinično pomembno zvišanje ravni kreatinina nad &gt; 200 µmol/l je imelo 0,3 % bolnikov, ki so sočasno prejemali obe zdravili.
0.63); p &lt; 0.0001], and other types of bleeding (Table 6).
(95 % CI): 0,47 (0,34, 0,63); p &lt; 0,0001] in drugih vrstah krvavitev (preglednica 6).
0.66 [0.54, 0.81] (p-value5 &lt; 0.0001)
0,66 [0,54, 0,81] (vrednost p5 &lt; 0,0001)
0.68 (0.59, 0.78) (p-value &lt; 0.0001)
0,68 (0,59 ; 0,78) (p-vrednost &lt; 0,0001)
0.89 (0.70, 1.13) p-value &lt; 0.0001 (non-inferiority)
0,89 (0,70, 1,13) vrednost p &lt; 0,0001 (neinferiornost)
0.9 mg/ml emodepside &amp; 18 mg/ml toltrazuril
0,9 mg/ml emodepsida &amp; 18 mg/ml toltrazurila
0− &lt; 6 years
0 − &lt; 6 let
1 Adverse drug reactions spontaneously reported to the safety surveillance database over a period in which an estimated &gt; 70 million patients were treated with celecoxib (various doses, durations, and indications).
1 Neželeni učinki zdravila, spontano prijavljeni v podatkovno bazo za spremljanje varnosti v obdobju, med katerim je celekoksib po ocenah dobivalo &gt; 70 milijonov bolnikov (različni odmerki, trajanje in indikacije).
1 Adverse events occurring with frequencies &lt; 5 % were medically assessed and it was shown that these cases are consistent with the well-established safety profile of zoledronic acid (see section 4.8)
1 Neželene učinke s pogostnostjo &lt; 5 % so ocenili z medicinskega vidika in pokazalo se je, da se ujemajo z že ugotovljenim varnostnim profilom zoledronske kisline (glejte poglavje 4.8).
1 Adverse events occurring with frequencies &lt; 5% were medically assessed and it was shown that these cases are consistent with the well established safety profile of zoledronic acid (see section 4.8)
1 Neželene učinke s pogostnostjo &lt; 5 % so ocenili z medicinskega vidika in pokazalo se je, da se ujemajo z že ugotovljenim varnostnim profilom zoledronske kisline (glejte poglavje 4.8).
1 Adverse events occurring with frequencies &lt; 5% were medically assessed and it was shown that these cases are consistent with the well established safety profile of zoledronic acid (see section 4.8)
1 Neželene učinke s pogostnostjo &lt; 5% so ocenili z medicinskega vidika in pokazalo se je, da se ujemajo z že ugotovljenim varnostnim profilom zoledronske kisline (glejte poglavje 4.8).
1 Adverse events occurring with frequencies &lt; 5% were medically assessed and it was shown that these cases are consistent with the well established safety profile of zoledronic acid (see section 4.8)
Neželene učinke s pogostnostjo &lt; 5 % so ocenili z medicinskega vidika in pokazalo se je, da se ujemajo z že ugotovljenim varnostnim profilom zoledronske kisline (glejte poglavje 4.8)
1 Adverse events occurring with frequencies &lt; 5% were medically assessed and it was shown that these cases are consistent with the well established safety profile of Zometa (see section 4.8)
1 Neželene učinke s pogostnostjo &lt; 5 % so ocenili z medicinskega vidika in pokazalo se je, da se ujemajo z že ugotovljenim varnostnim profilom zdravila Zometa (glejte poglavje 4.8).
1 Adverse events occurring with frequencies &lt; 5% were medically assessed and it was shown that these cases are consistent with the well-established safety profile of zoledronic acid (see section 4.8)
1 Neželene učinke s pogostnostjo &lt; 5 % so ocenili z medicinskega vidika in pokazalo se je, da se ujemajo z že ugotovljenim varnostnim profilom zoledronske kisline (glejte poglavje 4.8).
1 Cochran-Mantel-Haenszel (CMH) test p-value for response rate (vs. imatinib 400 mg) &lt; 0.0001
1 Cochran-Mantel-Haenszel test, vrednost p za delež bolnikov z odzivom (v primerjavi z imatinibom 400 mg) &lt; 0,0001
1 Difference is “≤5 ng/ml” minus “ &gt; 5 ng/ml”
1 razlika je vrednost kategorije“≤5 ng/ml” minus vrednost kategorije“ &gt; 5 ng/ml”
1 frequencies based on pooled clinical trials (very common ≥1/10, common ≥1/100 to &lt; 1/10, uncommon
1 pogostnost glede na združene podatke iz kliničnih preskušanj (zelo pogosti ≥1/10, pogosti ≥1/100 do
1 Haematological response criteria (all responses to be confirmed after &gt; 4weeks):
1Kriteriji hematološkega odziva (vsi odzivi morajo biti potrjeni po  4 tednih):
1 month to &lt; 12 years (N = 18)
1 mesec do &lt; 12 let (N = 18)
1 p &lt; 0.001.
1 p &lt; 0,001
1 p-values &lt; 0.0001
1 Vrednosti p &lt; 0,0001
1 Patients with ≥ one dose of study drug with evaluable baseline liver biopsies and baseline Knodell Histological Activity Index (HAI) score &gt; 3.
1 bolniki, ki so prejeli vsaj en odmerek študijskega zdravila, z izhodiščno biopsijo jeter, ki je bila primerna za ocenjevanje, in z izhodiščnim indeksom histološke aktivnosti po Knodellu &gt; 3 (Knodell Histological Activity Index - HAI)
1 Progression of disability was defined as at least a 1.0 point increase on the EDSS from a baseline EDSS &gt; =1.0 sustained for 12 or 24 weeks or at least a 1.5 point increase on the EDSS from a baseline EDSS =0 sustained for 12 or 24 weeks.
1Napredovanje prizadetosti je bilo definirano s povečanjem na EDSS za vsaj 1,0 točke, od izhodiščne EDSS &gt; =1,0, v trajanju vsaj 12 ali 24 tednov, ali s povečanjem na EDSS za vsaj 1,5 točke, od izhodiščne EDSS =0, v trajanju vsaj 12 ali 24 tednov.
1 rue de la Vierge, Ambarès &amp; Lagrave, F-33565 Carbon Blanc Cedex - France
1 rue de la Vierge, Ambarès &amp; Lagrave, F-33565 Carbon Blanc Cedex – Francija
1 to &lt; 2 years
1 do &lt; 2 leti
1 to &lt; 6 months
1 do &lt; 6 mesecev
1 to &lt; 6 years (N=12)
1 do &lt; 6 let (N=12)
1 While the exact incidence of eosinophilic pneumonia associated with daptomycin is unknown, to date the reporting rate of spontaneous reports is very low ( &lt; 1/10,000).
1 Natančna incidenca eozinofilne pljučnice zaradi daptomicina sicer ni znana, spontana poročila pa so zaenkrat zelo redka ( &lt; 1/10.000).
1 year to &lt; 5 years
1 leto do &lt; 5 let
1 yr &lt; 5 yrs
1 leto &lt; 5 let
1, rue de la Vierge, Ambarès &amp; Lagrave, F-33565 Carbon Blanc cedex, France
1, Rue de la Vierge, Ambarès &amp; Lagrave, F-33565 Carbon Blanc cedex , Francija
1, rue de la Vierge, Ambarès &amp; Lagrave, F-33565 Carbon Blanc cedex, France
1, Rue de la Vierge, Ambarès &amp; Lagrave, F-33565 Carbon Blanc cedex, Francija
1, rue de la Vierge, Ambarès &amp; Lagrave, F-33565 Carbon Blanc cedex, France and/or
1, Rue de la Vierge, Ambarès &amp; Lagrave, F-33565 Carbon Blanc cedex , Francija in/ali
1, rue de la Vierge, Ambarès &amp; Lagrave, F-33565 Carbon Blanc cedex, France or
1, Rue de la Vierge, Ambarès &amp; Lagrave, F-33565 Carbon Blanc cedex , Francija ali
1,000 mg per day for patients &lt; 75 kg and 1,200 mg for those weighing ≥ 75 kg
1.000 mg na dan pri bolnikih s telesno maso &lt; 75 kg in 1.200 mg pri bolnikih s telesno maso ≥ 75 kg.
1,060 patients were randomized to receive either Docetaxel 75 mg/m2 administered 1-hour after doxorubicin 50 mg/m2 and cyclophosphamide 500 mg/m2 (539 patients in TAC arm), or doxorubicin 50 mg/m2 followed by fluorouracil 500 mg/m2 and cyclosphosphamide 500 mg/m2 (521 patients in AC arm), as adjuvant treatment of operable node-negative breast cancer patients with high risk of relapse according to 1998 St. Gallen criteria (tumour size &gt; 2 cm and/or negative ER and PR and/or high histological/nuclear grade (grade 2 to 3) and /or age &lt; 35 years).
1060 bolnic je bilo naključno razporejenih na prejemanje zdravila Docetaksel Teva 75 mg/m2 1 -uro po doksorubicinu 50 mg/m2 in ciklofosfamidu 500 mg/m2 (539 bolnic v kraku TAC), ali na prejemanje doksorubicina 50 mg/m2, ki sta mu sledila fluorouracil 500 mg/m2 in ciklofosfamid 500 mg/m2 (521 bolnic v kraku FAC) kot adjuvantnega zdravljenja operabilnega raka dojke z negativnimi bezgavkami pri bolnicah z velikim tveganjem recidiva po St.- Gallenskih merilih 1998 (velikost tumorja &gt; 2 cm in/ali negativni ER in PR in/ali visoka histološka/jedrna stopnja (2. do 3. stopnja) in/ali starost &lt; 35 let).
1,060 patients were randomized to receive either Docetaxel 75 mg/m2 administered 1-hour after doxorubicin 50 mg/m2 and cyclophosphamide 500 mg/m2 (539 patients in TAC arm), or doxorubicin 50 mg/m2 followed by fluorouracil 500 mg/m2 and cyclosphosphamide 500 mg/m2 (521 patients in 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 &gt; 2 cm and/or negative ER and PR and/or high histological/nuclear grade (grade 2 to 3) and /or age &lt; 35 years).
1060 bolnic je bilo naključno razporejenih na prejemanje zdravila Docetaksel Teva 75 mg/m2 1 -uro po doksorubicinu 50 mg/m2 in ciklofosfamidu 500 mg/m2 (539 bolnic v kraku TAC), ali na prejemanje doksorubicina 50 mg/m2, ki sta mu sledila fluorouracil 500 mg/m2 in ciklofosfamid 500 mg/m2 (521 bolnic v kraku FAC) kot adjuvantnega zdravljenja operabilnega raka dojke z negativnimi bezgavkami pri bolnicah z velikim tveganjem recidiva po St.- Gallenskih merilih 1998 (velikost tumorja &gt; 2 cm in/ali negativni ER in PR in/ali visoka histološka/jedrna stopnja (2. do 3. stopnja) in/ali starost &lt; 35 let).
1,216 antiretroviral-therapy naïve patients with plasma HIV-1 RNA &gt; 5,000 copies/ml at baseline were assigned to nevirapine 400 mg once daily, nevirapine 200 mg twice daily, efavirenz 600 mg once daily, or nevirapine (400 mg) and efavirenz (800 mg) once daily, plus stavudine and lamivudine for 48 weeks.
1216 bolnikov, ki se še niso zdravili s protiretrovirusnimi zdravili in so imeli izhodiščno plazemsko koncentracijo HIV-1 RNA &gt; 5000 kopij/ml so razvrstili v skupine zdravljenje z nevirapinom po 400 mg enkrat na dan ali po 200 mg dvakrat na dan, efavirenzem po 600 mg enkrat na dan ali nevirapinom (400 mg) in efavirenzem (800 mg) enkrat na dan, skupaj s stavudinom in lamivudinom, ki je trajalo 48 tednov.
1,216 antiretroviral-therapy naïve patients with plasma HIV-1 RNA &gt; 5,000 copies/ml at baseline were assigned to Viramune 400 mg once daily, Viramune 200 mg twice daily, efavirenz 600 mg once daily, or Viramune (400 mg) and efavirenz (800 mg) once daily, plus stavudine and lamivudine for 48 weeks.
1216 bolnikov, ki se še niso zdravili s protiretrovirusnimi zdravili in so imeli izhodiščno plazemsko koncentracijo HIV-1 RNA &gt; 5000 kopij/ml so razvrstili v skupine zdravljenje z zdravilom Viramune po 400 mg enkrat na dan ali po 200 mg dvakrat na dan, efavirenzem po 600 mg enkrat na dan ali zdravilom Viramune (400 mg) in efavirenzem (800 mg) enkrat na dan, skupaj s stavudinom in lamivudinom, ki je trajalo 48 tednov.
1,239 paediatric patients up to 18 years and 566 adult patients &gt; 18 years treated with Eurartesim.
1.239 pediatričnih bolnikov, starih do 18 let, in 566 odraslih bolnikov, starih več kot 18 let, zdravljenih z zdravilom Eurartesim.
1.02)]; CrCL ≥ 80 mL/min [HR (95% CI): 1.15 (0.95, 1.40)].
&lt; 80 ml/min [HR (95 % CI): 0,87 (0,75; 1,02)]; CrCL ≥ 80 ml/min [HR (95 % CI): 1,15 (0,95; 1,40)].
1.3–2.5 kg
&gt; 2,5–5 kg
1.62 (1.32, 1.99) , P &lt; 0.0001
nepsihiatrična kohorta psihiatrična kohorta
1.96 (1.51, 2.54), P &lt; 0.0001
189/1.032 (18,3 %)
1/10,000 to &lt; 1/1,000), very rare ( &lt; 1/10,000) and not known (cannot be estimated from the available data).
&lt; 1/1.000), zelo redki ( &lt; 1/10.000) in neznana pogostnost (ni mogoče oceniti iz razpoložljivih podatkov).
10 mg benazepril hydrochloride &amp; 80 mg spironolactone
10 mg benazeprilijev hidroklorid &amp; 80 mg spironolakton
10 years to &lt; 18 years
10 let do &lt; 18 let
10 yrs &lt; 18 yrs
10 let &lt; 18 let
100 to &lt; 200 cells/mm3
100 do &lt; 200 celic/mm3
1060 patients were randomized to receive either docetaxel 75 mg/m2 administered 1-hour after doxorubicin 50 mg/m2 and cyclophosphamide 500 mg/m2 (539 patients in TAC arm), or doxorubicin 50 mg/m2 followed by fluorouracil 500 mg/m2 and cyclosphosphamide 500 mg/m2 (521 patients in 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 &gt; 2 cm and/or negative ER and PR and/or high histological/nuclear grade (grade 2 to 3) and /or age &lt; 35 years).
1060 bolnic je bilo naključno razporejenih na prejemanje zdravila Docetaksel 75 mg/m2 1 -uro po doksorubicinu 50 mg/m2 in ciklofosfamidu 500 mg/m2 (539 bolnic v kraku TAC), ali na prejemanje doksorubicina 50 mg/m2, ki sta mu sledila fluorouracil 500 mg/m2 in ciklofosfamid 500 mg/m2 (521 bolnic v kraku FAC) kot adjuvantnega zdravljenja operabilnega raka dojke z negativnimi bezgavkami pri bolnicah z velikim tveganjem recidiva po St.- Gallenskih merilih 1998 (velikost tumorja &gt; 2 cm in/ali negativni ER in PR in/ali visoka histološka/jedrna stopnja (2. do 3. stopnja) in/ali starost &lt; 35 let).
1060 patients were randomized to receive either docetaxel 75 mg/m2 administered 1-hour after doxorubicin 50 mg/m2 and cyclophosphamide 500 mg/m2 (539 patients in TAC arm), or doxorubicin 50 mg/m2 followed by fluorouracil 500 mg/m2 and cyclosphosphamide 500 mg/m2 (521 patients in 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 &gt; 2 cm and/or negative ER and PR and/or high histological/nuclear grade (grade 2 to 3) and /or age &lt; 35 years).
500 mg/m² (539 bolnic v kraku TAC), ali na prejemanje doksorubicina 50 mg/m², ki sta mu sledila fluorouracil 500 mg/m² in ciklofosfamid 500 mg/m² (521 bolnic v kraku FAC) kot adjuvantnega zdravljenja operabilnega raka dojke z negativnimi bezgavkami pri bolnicah z velikim tveganjem recidiva po St.-Gallenskih merilih 1998 (velikost tumorja &gt; 2 cm in/ali negativni ER in PR in/ali visoka histološka/jedrna stopnja (2. do 3. stopnja) in/ali starost &lt; 35 let).
1060 patients were randomized to receive either docetaxel 75 mg/m2 administered 1-hour after doxorubicin 50 mg/m2 and cyclophosphamide 500 mg/m2 (539 patients in TAC arm), or doxorubicin 50 mg/m2 followed by fluorouracil 500 mg/m2 and cyclosphosphamide 500 mg/m2 (521 patients in 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 &gt; 2 cm and/or negative ER and PR and/or high histological/nuclear grade (grade 2 to 3) and /or age &lt; 35 years).
Po stratifikaciji glede na število pozitivnih bezgavk (1-3, 4 ali več) je bilo 1.491 bolnic randomiziranih na prejemanje docetaksela 75 mg/m2, apliciranega 1 uro po doksorubicinu 50 mg/m2 in ciklofosfamidu 500 mg/m2 (krak TAC), ali na prejemanje doksorubicina 50 mg/m2, ki sta mu sledila fluorouracil 500 mg/m2 in ciklofosfamid 500 mg/m2 (krak FAC).
1060 patients were randomized to receive either DOCETAXEL KABI 75 mg/m2 administered 1-hour after doxorubicin 50 mg/m2 and cyclophosphamide 500 mg/m2 (539 patients in TAC arm), or doxorubicin 50 mg/m2 followed by fluorouracil 500 mg/m2 and cyclosphosphamide 500 mg/m2 (521 patients in 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 &gt; 2 cm and/or negative ER and PR and/or high histological/nuclear grade (grade 2 to 3) and /or age &lt; 35 years).).
1060 bolnic je bilo naključno razporejenih na prejemanje zdravila DOCETAKSEL KABI 75 mg/m2 1-uro po doksorubicinu 50 mg/m2 in ciklofosfamidu 500 mg/m2 (539 bolnic v kraku TAC), ali na prejemanje doksorubicina 50 mg/m2, ki sta mu sledila fluorouracil 500 mg/m2 in ciklofosfamid 500 mg/m2 (521 bolnic v kraku FAC) kot adjuvantnega zdravljenja operabilnega raka dojke z negativnimi bezgavkami pri bolnicah z velikim tveganjem recidiva po St.- Gallenskih merilih 1998 (velikost tumorja &gt; 2 cm in/ali negativni ER in PR in/ali visoka histološka/jedrna stopnja (2. do 3. stopnja) in/ali starost &lt; 35 let).
1060 patients were randomized to receive either Docetaxel Winthrop 75 mg/m2 administered 1-hour after doxorubicin 50 mg/m2 and cyclophosphamide 500 mg/m2 (539 patients in TAC arm), or doxorubicin 50 mg/m2 followed by fluorouracil 500 mg/m2 and cyclosphosphamide 500 mg/m2 (521 patients in 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 &gt; 2 cm and/or negative ER and PR and/or high histological/nuclear grade (grade 2 to 3) and /or age &lt; 35 years).
1060 bolnic je bilo naključno razporejenih na prejemanje zdravila Docetaxel Winthrop 75 mg/m2 1 -uro po doksorubicinu 50 mg/m2 in ciklofosfamidu 500 mg/m2 (539 bolnic v kraku TAC), ali na prejemanje doksorubicina 50 mg/m2, ki sta mu sledila fluorouracil 500 mg/m2 in ciklofosfamid 500 mg/m2 (521 bolnic v kraku FAC) kot adjuvantnega zdravljenja operabilnega raka dojke z negativnimi bezgavkami pri bolnicah z velikim tveganjem recidiva po St.-Gallenskih merilih 1998 (velikost tumorja &gt; 2 cm in/ali negativni ER in PR in/ali visoka histološka/jedrna stopnja (2. do 3. stopnja) in/ali starost &lt; 35 let).
1060 patients were randomized to receive either Docetaxel Winthrop 75 mg/m2 administered 1-hour after doxorubicin 50 mg/m2 and cyclophosphamide 500 mg/m2 (539 patients in TAC arm), or doxorubicin 50 mg/m2 followed by fluorouracil 500 mg/m2 and cyclosphosphamide 500 mg/m2 (521 patients in 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 &gt; 2 cm and/or negative ER and PR and/or high histological/nuclear grade (grade 2 to 3) and /or age &lt; 35 years).).
1060 bolnic je bilo naključno razporejenih na prejemanje zdravila Docetaxel Winthrop 75 mg/m2 1 -uro po doksorubicinu 50 mg/m2 in ciklofosfamidu 500 mg/m2 (539 bolnic v kraku TAC), ali na prejemanje doksorubicina 50 mg/m2, ki sta mu sledila fluorouracil 500 mg/m2 in ciklofosfamid 500 mg/m2 (521 bolnic v kraku FAC) kot adjuvantnega zdravljenja operabilnega raka dojke z negativnimi bezgavkami pri bolnicah z velikim tveganjem recidiva po St.-Gallenskih merilih 1998 (velikost tumorja &gt; 2 cm in/ali negativni ER in PR in/ali visoka histološka/jedrna stopnja (2. do 3. stopnja) in/ali starost &lt; 35 let).
1060 patients were randomized to receive either Taxespira 75 mg/m2 administered 1-hour after doxorubicin 50 mg/m2 and cyclophosphamide 500 mg/m2 (539 patients in TAC arm), or doxorubicin 50 mg/m2 followed by fluorouracil 500 mg/m2 and cyclosphosphamide 500 mg/m2 (521 patients in 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 &gt; 2 cm and/or negative ER and PR and/or high histological/nuclear grade (grade 2 to 3) and /or age &lt; 35 years).).
1060 bolnic je bilo naključno razporejenih na prejemanje zdravila Taxespira75 mg/m2 1 -uro po doksorubicinu 50 mg/m2 in ciklofosfamidu 500 mg/m2 (539 bolnic v kraku TAC), ali na prejemanje doksorubicina 50 mg/m2, ki sta mu sledila fluorouracil 500 mg/m2 in ciklofosfamid 500 mg/m2 (521 bolnic v kraku FAC) kot adjuvantnega zdravljenja operabilnega raka dojke z negativnimi bezgavkami pri bolnicah z velikim tveganjem recidiva po St.- Gallenskih merilih 1998 (velikost tumorja &gt; 2 cm in/ali negativni ER in PR in/ali visoka histološka/jedrna stopnja (2. do 3. stopnja) in/ali starost &lt; 35 let).
1060 patients were randomized to receive either TAXOTERE 75 mg/m2 administered 1-hour after doxorubicin 50 mg/m2 and cyclophosphamide 500 mg/m2 (539 patients in TAC arm), or doxorubicin 50 mg/m2 followed by fluorouracil 500 mg/m2 and cyclosphosphamide 500 mg/m2 (521 patients in 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 &gt; 2 cm and/or negative ER and PR and/or high histological/nuclear grade (grade 2 to 3) and /or age &lt; 35 years).
1060 bolnic je bilo naključno razporejenih na prejemanje zdravila TAXOTERE 75 mg/m2 1 -uro po doksorubicinu 50 mg/m2 in ciklofosfamidu 500 mg/m2 (539 bolnic v kraku TAC), ali na prejemanje doksorubicina 50 mg/m2, ki sta mu sledila fluorouracil 500 mg/m2 in ciklofosfamid 500 mg/m2 (521 bolnic v kraku FAC) kot adjuvantnega zdravljenja operabilnega raka dojke z negativnimi bezgavkami pri bolnicah z velikim tveganjem recidiva po St.- Gallenskih merilih 1998 (velikost tumorja &gt; 2 cm in/ali negativni ER in PR in/ali visoka histološka/jedrna stopnja (2. do 3. stopnja) in/ali starost &lt; 35 let).
1060 patients were randomized to receive either TAXOTERE 75 mg/m2 administered 1-hour after doxorubicin 50 mg/m2 and cyclophosphamide 500 mg/m2 (539 patients in TAC arm), or doxorubicin 50 mg/m2 followed by fluorouracil 500 mg/m2 and cyclosphosphamide 500 mg/m2 (521 patients in 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 &gt; 2 cm and/or negative ER and PR and/or high histological/nuclear grade (grade 2 to 3) and /or age &lt; 35 years).).
1060 bolnic je bilo naključno razporejenih na prejemanje zdravila TAXOTERE 75 mg/m2 1 -uro po doksorubicinu 50 mg/m2 in ciklofosfamidu 500 mg/m2 (539 bolnic v kraku TAC), ali na prejemanje doksorubicina 50 mg/m2, ki sta mu sledila fluorouracil 500 mg/m2 in ciklofosfamid 500 mg/m2 (521 bolnic v kraku FAC) kot adjuvantnega zdravljenja operabilnega raka dojke z negativnimi bezgavkami pri bolnicah z velikim tveganjem recidiva po St.- Gallenskih merilih 1998 (velikost tumorja &gt; 2 cm in/ali negativni ER in PR in/ali visoka histološka/jedrna stopnja (2. do 3. stopnja) in/ali starost &lt; 35 let).
12 to &lt; 18 years
12 do &lt; 18 let
12 to &lt; 18 years ETR
12 do &lt; 18 let ETR N=60
12 to &lt; 24 months
12 do &lt; 24 mesecev
12 to &lt; 18 years (12, 17)
12 do &lt; 18 let (12, 17)
12 to &lt; 18 years (N=8)
12 do &lt; 18 let (N=8)
12- &lt; 18 years N=23
12- &lt; 18 let
12- &lt; 18 years N=23
12- &lt; 18 ára N=23
13 (20.0%), p &lt; 0.0001
13 (20,0 %), p &lt; 0,0001