natgillin/translations-raw huggingface dataset:
In a randomised, comparative Phase III study conducted by the Gynecologic Oncology Group (GOG 0179), topotecan plus cisplatin (n = 147) was compared with cisplatin alone (n = 146) for the treatment of histologically confirmed persistent, recurrent or Stage IVB carcinoma of the cervix where curative treatment with surgery and/or radiation was not considered appropriate.
V randomizirani primerjalni študiji faze III, ki jo je izvedla ginekološka onkološka skupina (študija GOG 0179), so primerjali topotekan in cisplatin (n = 147) s cisplatinom samim (n = 146) pri zdravljenju histološko potrjenega persistentnega rekurentnega karcinoma materničnega vratu ali karcinoma materničnega vratu v stadiju IVB, kjer kurativno zdravljenje s kirurškim posegom in/ali obsevanjem ni bilo primerno.
Age/weight
Starost/telesna masa
In course 1 the incidence was 20%, by course 4 the incidence was 8%.
V 1. ciklusu je bila incidenca 20 %, do 4. ciklusa pa se je zmanjšala na 8 %.
Pharmacotherapeutic group: antineoplastic agents, other antineoplastic agents: ATC code: L01XX17.
Farmakoterapevtska skupina: zdravila z delovanjem na novotvorbe (citostatiki), druga zdravila z delovanjem na novotvorbe (citostatiki), oznaka ATC: L01XX17
Topotecan-induced neutropenia can cause neutropenic colitis.
S topotekanom povzročena nevtropenija lahko povzroči nevtropenični kolitis.
Resulting from its mechanism of action, topotecan is genotoxic to mammalian cells (mouse lymphoma cells and human lymphocytes) in vitro and mouse bone marrow cells in vivo.
Topotekan je zaradi svojega mehanizma delovanja genotoksičen za celice sesalcev (celice limfoma pri miših in človeške limfocite) in vitro in za celice kostnega mozga pri miših in vivo.
Do not take Hycamtin:
Ne jemljite zdravila Hycamtin:
The most frequently reported non-haematological effects were nausea (37%), diarrhoea (29%), fatigue (26%), vomiting (24%), alopecia (21%) and anorexia (18%).
Najpogosteje opisani nehematološki učinki so bili: navzea (37 %), driska (29 %), utrujenost (26 %), bruhanje (24 %), alopecija (21 %) in anoreksija (18 %).
Plasma clearance of total topotecan (active and inactive form) in patients with hepatic impairment only decreased by about 10% compared with the control group of patients.
Plazemski očistek celotnega topotekana (aktivne in neaktivne oblike) se je pri teh bolnikih v primerjavi s kontrolno skupino zmanjšal le za približno 10 %.
The signs and symptoms observed following overdose were consistent with the known undesirable events associated with topotecan (see section 4.8).
Znaki in simptomi, ki so jih opažali po prevelikem odmerjanju, so bili v skladu z znanimi neželenimi učinki topotekana (glejte poglavje 4.8).
Your doctor will determine the correct dose of cisplatin.
Ustrezni odmerek cisplatina vam bo predpisal zdravnik.
You should not receive Hycamtin:
Zdravila Hycamtin ne smete prejeti:
Death due to sepsis occurred in 1% of patients.
Do smrti zaradi sepse je prišlo pri 1 % bolnikov.
HYCAMTIN capsules are indicated as monotherapy for the treatment of adult patients with relapsed small cell lung cancer (SCLC) for whom re-treatment with the first-line regimen is not considered appropriate (see section 5.1).
Kapsule HYCAMTIN so indicirane kot monoterapija za zdravljenje odraslih bolnikov s ponovitvijo drobnoceličnega pljučnega raka, pri katerih ponovno zdravljenje s terapijo prve linije ni primerno (glejte poglavje 5.1).
Doses should be similarly reduced if the platelet count falls below 25 x 10
Podobno je treba zmanjšati odmerke, če se število trombocitov zniža pod 25 x 10
For patients who experience Grade 3 or 4 diarrhoea, the dose should be reduced by 0.4 mg/m2/day for subsequent courses (see section 4.4).
Pri bolnikih z drisko stopnje 3 ali 4 je potrebno odmerek zmanjšati za 0,4 mg/m2/dan pri naslednjih ciklusih (glejte poglavje 4.4).
In reproductive toxicity studies with topotecan in rats there was no effect on male or female fertility; however, in females super-ovulation and slightly increased pre-implantation loss were observed.
V študijah vpliva na sposobnost razmnoževanja pri podganah topotekan ni vplival na plodnost samcev ali samic, so pa pri samicah opazili superovulacijo in rahel porast predimplantacijskih izgub.
The product should be used immediately after it is prepared for infusion.
Zdravilo morate uporabiti takoj, ko ga pripravite za infundiranje.
If either cisplatin or carboplatin is given on day 1 of the topotecan dosing, a lower dose of each agent must be given to improve tolerability compared to the dose of each agent which can be given if the platinum agent is given on day 5 of the topotecan dosing.
Če prejme cisplatin ali karboplatin na 1. dan dajanja topotekana, je potrebno zaradi boljšega prenašanja zmanjšati odmerek vsakega od teh zdravil v primerjavi z odmerki, ki jih je mogoče dajati, kadar bolnik prejme zdravilo s platino na 5. dan uporabe topotekana.
• The other ingredients are: hydrogenated vegetable oil, glyceryl monostearate, gelatin, titanium dioxide (E171), and for 1 mg capsules only, red iron oxide (E172).
• Druge sestavine zdravila so: hidrogenirano rastlinsko olje, glicerilmonostearat, želatina, titanov dioksid (E171), samo v 1-miligramskih kapsulah tudi rdeči železov oksid (E172).
• Cervical cancer: 0.75 mg per square metre of body surface area per day.
• rak materničnega vratu: 0,75 mg na kvadratni meter telesne površine na dan.
Overall recovery of topotecan-related material following five daily doses of topotecan was 49 to 72% (mean 57%) of the administered oral dose.
Celokupno izločanje s topotekanom povezanih snovi po uporabi petih dnevnih odmerkov topotekana je znašalo od 49 do 72 % (povprečje 57 %) uporabljenega peroralnega odmerka.
Ovarian and small cell lung carcinoma Initial dose
Karcinom jajčnika in drobnocelični pljučni karcinom Začetni odmerek
The median time to onset of Grade 2 or worse diarrhoea was 9 days.
Mediani čas do pojava driske 2. ali hujše stopnje je bil 9 dni.
The response rate in the whole ovarian carcinoma programme (n = 392, all previously treated with cisplatin or cisplatin and paclitaxel) was 16%.
Stopnja odziva na zdravilo za celoten program študij raka na jajčnikih (n = 392, pri bolnicah, ki so se pred tem zdravile s cisplatinom ali cisplatinom in paklitakselom) je bila 16 %.
The capsules are printed with black ink that contains black iron oxide (E172), shellac, anhydrous ethanol, propylene glycol, isopropyl alcohol, butanol, concentrated ammonia solution and potassium hydroxide.
Kapsule so označene s črnim barvilom, ki vsebuje črni železov oksid (E172), šelak, brezvodni etanol, propilenglikol, izopropilalkohol, butanol, koncentrirano raztopino amoniaka in kalijev hidroksid.
Handling and disposal
Ravnanje z zdravilom in odstranjevanje
The extent of exposure was similar following a high-fat meal and in the fasted state, while tmax was delayed from 1.5 to 3 hours (topotecan lactone) and from 3 to 4 hours (total topotecan).
Izpostavljenost učinkovini je bila po mastnem obroku in na tešče podobna, tmax pa se je podaljšal z 1,5 na 3 ure (topotekanov lakton) oz. s 3 na 4 ure (celotni topotekan).
Table 1 Summary of survival, response rate, and time to progression in SCLC patients treated with oral or intravenous topotecan
Povzetek preživetja, deleža odziva in časa do napredovanja pri bolnikih z drobnoceličnim pljučnim rakom, zdravljenih s peroralnim oziroma intravenskim topotekanom
• All items for administration or cleaning, including gloves, should be placed in high-risk, waste disposal bags for high-temperature incineration.
• Vse pripomočke, ki jih potrebujete pri dajanju zdravila ali čiščenju, tudi rokavice, morate odvreči v vreče za shranjevanje nevarnih odpadkov, ki so namenjene sežigu pri visokih temperaturah.
Limited data indicate that the dose should be reduced in patients with moderate renal impairment.
Majhno število podatkov, ki so na voljo, kaže, da je treba pri zdravljenju bolnikov z zmerno ledvično okvaro odmerek zmanjšati.
If you are being treated for cervical cancer, you may get side effects from the other medicine (cisplatin) that you will be given along with Hycamtin.
Če se zdravite zaradi raka materničnega vratu, se lahko pojavijo neželeni učinki drugega zdravila (cisplatina), ki ga boste prejeli skupaj z zdravilom Hycamtin.
Similar results were obtained if glomerular filtration rate (ml/min) was estimated using the MDRD formula corrected for body weight.
Rezultati so bili podobni tudi v primerih, ko so hitrost glomerulne filtracije (ml/min) izračunali na osnovi enačbe MDRD s prilagoditvijo na telesno maso bolnika.
In a population of patients with refractory SCLC (those not responding to first-line therapy), the response rate to topotecan was 4.0%.
V skupini bolnikov z neodzivnim drobnoceličnim pljučnim rakom (pri katerih ni prišlo do odziva na zdravljenje prve linije) je bil odziv na topotekan 4,0-odstoten.
• ovarian cancer or small cell lung cancer that has come back after chemotherapy.
• raka na jajčniku ali drobnoceličnega pljučnega raka, ki se je ponovil po kemoterapiji.
• Allergic or hypersensitivity reactions (including rash).
• alergijske ali preobčutljivostne reakcije (vključno s pojavom izpuščaja);
Intravenous topotecan should be considered in the following clinical situations: uncontrolled emesis, swallowing disorders, uncontrolled diarrhoea, clinical conditions and medication that may alter gastrointestinal motility and drug absorption.
Uporaba intravenskega topotekana pride v poštev v naslednjih kliničnih okoliščinah: pri neobvladanem bruhanju, motnjah požiranja, neobvladani driski ter v kliničnih stanjih ali med uporabo zdravil, ki lahko vplivajo na gibljivost prebavil in absorpcijo zdravil.
Personnel handling this medicinal product during reconstitution should wear protective clothing including mask, goggles and gloves.
- Osebje, ki pripravlja zdravilo, mora med rekonstitucijo nositi zaščitna oblačila, masko, zaščitna očala in rokavice.
The response rate to topotecan in the combined small cell lung cancer programme (n = 480) for patients with relapsed disease sensitive to first-line therapy was 20.2%.
Odstotek odziva na topotekan po združenih podatkih programa zdravljenja drobnoceličnega pljučnega raka (n = 480) pri bolnikih s ponovitvijo bolezni, ki je bila dovzetna za zdravljenje prve linije, je bil 20,2 %.
If you get the capsule contents in your eyes, wash them immediately with gently flowing water for at least 15 minutes.
Če zdravilo pride v oči, morate oči takoj vsaj 15 minut izpirati z vodo, ki ne teče premočno.
The hazard ratio for survival with IV topotecan relative to CAV was 1.04 (95% CI: 0.78, 1.40).
Razmerje ogroženosti za preživetje z intravenskim topotekanom relativno glede na kombinacijo CAV je bilo 1,04 (95-odstotni IZ: 0,78, 1,40).
As with other cytotoxic medicinal products, topotecan may cause foetal harm and therefore women of childbearing potential should be advised to avoid becoming pregnant during therapy with topotecan.
Tako kot druga citotoksična zdravila lahko tudi topotekan škoduje plodu, zato je ženske v rodni dobi potrebno opozoriti, da med zdravljenjem s topotekanom ne smejo zanositi.
Therefore, use of the normal starting dose in patients with a mild decrease in renal function is considered established (see section 4.2).
Zato velja, da je uporaba normalnega začetnega odmerka pri bolnikih z blago ledvično okvaro ustrezno utemeljena (glejte poglavje 4.2).
If, during topotecan/cisplatin combination therapy, serum creatinine exceeds 1.5 mg/dl, it is recommended that the full prescribing information be consulted for any advice on cisplatin dose reduction/continuation.
Če med zdravljenjem s kombinacijo topotekan/cisplatin vrednost kreatinina v serumu preseže 1,5 mg/dl, je priporočljivo pregledati navodila za predpisovanje cisplatina glede kakršnegakoli navodila glede zmanjšanja odmerka cisplatina ali nadaljevanja zdravljenja.
The dose of Hycamtin you are given will be worked out by your doctor, based on:
Odmerek zdravila Hycamtin, ki ga boste prejeli, bo zdravnik določil glede na:
However, when combining with platinum agents, there is a distinct sequence-dependent interaction depending on whether the platinum agent is given on day 1 or 5 of the topotecan dosing.
Pri sočasni uporabi s platinovimi spojinami pride do izrazite interakcije, ki je odvisna od zaporedja dajanja zdravil, in sicer od tega, ali bolnik prejme zdravilo s platino na 1. ali 5. dan dajanja topotekana.
Moderate to severe anaemia (Grade 3 and 4 - Hb 8.0 g/dl) occurred in 25% of patients (12% of courses).
Zmerna do huda anemija (3. in 4. stopnje - Hb 8,0 g/dl) se je pojavila pri 25 % bolnikov (v 12 % ciklusov).
If well tolerated, the dose may be increased to 2.3 mg/m 2/day in subsequent cycles (see section 5.2).
Če zdravilo bolnik dobro prenaša, je mogoče v naslednjih ciklusih odmerek povečati na 2,3 mg/m telesne površine na dan (glejte poglavje 5.2).
In clinical studies, rash was reported in 4% of patients and pruritus in 1.5% of patients.
V kliničnih študijah so o izpuščaju poročali pri 4 % bolnikov, o srbenju pa pri 1,5 % bolnikov.
Complete alopecia related/possibly related to topotecan administration was observed in 9% of patients and partial alopecia related/possibly related to topotecan administration in 11% of patients.
Popolno alopecijo, povezano ali morda povezano z uporabo topotekana, so zabeležili pri 9 % bolnikov, delno alopecijo, povezano ali morda povezano z uporabo topotekana, pa pri 11 %.
Topotecan monotherapy is indicated for the treatment of:
Samostojno zdravljenje s topotekanom je indicirano pri:
• Weight loss and loss of appetite (anorexia); tiredness; weakness.
• hujšanje in neješčnost (anoreksija), utrujenost, šibkost;
Hycamtin is used to treat:
Zdravilo Hycamtin uporabljamo za zdravljenje:
• Pregnant staff should be excluded from working with this medicinal product.
• Nosečnice ne smejo rokovati z zdravilom.
Infections and infestations Very common Infection Common
Infekcijske in parazitske bolezni zelo pogosti okužba pogosti sepsa
Other severe events that were recorded as related or possibly related to topotecan treatment were anorexia (12%), malaise (3%) and hyperbilirubinaemia (1%).
Drugi močno izraženi neželeni dogodki, ki so jih ocenili kot posledico ali možno posledico zdravljenja s topotekanom, so bili anoreksija (12 %), splošno slabo počutje (3 %) in hiperbilirubinemija (1 %).
In vitro, topotecan did not inhibit human P450 enzymes CYP1A2, CYP2A6, CYP2C8/9, CYP2C19, CYP2D6, CYP2E, CYP3A or CYP4A, nor did it inhibit the human cytosolic enzymes dihydropyrimidine or xanthine oxidase.
Topotekan in vitro pri človeku ni zaviral delovanja encimov P450 (CYP1A2, CYP2A6, CYP2C8/9, CYP2C19, CYP2D6, CYP2E, CYP3A ali CYP4A).
Overall recovery of topotecan-related material following five daily doses of topotecan was 71 to 76% of the administered IV dose.
Celokupno izločanje s topotekanom povezanih snovi po petih dnevnih odmerkih topotekana je bilo od 71 do 76 % intravensko prejetega odmerka.
In clinical studies with topotecan in combination with cisplatin for the treatment of cervical cancer, therapy was only initiated in patients with serum creatinine less than or equal to 1.5 mg/dl.
Med kliničnimi študijami zdravljenja raka materničnega vratu je bilo zdravljenje s topotekanom v kombinaciji s cisplatinom uvedeno le pri bolnicah, ki so imele vrednost kreatinina v serumu manjšo ali enako 1,5 mg/dl.
• patients with relapsed small cell lung cancer (SCLC) for whom re-treatment with the first-line regimen is not considered appropriate (see section 5.1).
• bolnikih s ponovitvijo drobnoceličnega pljučnega raka, pri katerih ponovno zdravljenje s terapijo prve linije ni primerno (glejte poglavje 5.1).
Hycamtin is used to treat small cell lung cancer that has come back after chemotherapy.
Zdravilo Hycamtin uporabljamo za zdravljenje drobnoceličnega pljučnega raka, ki se je ponovil po kemoterapiji.
Pancytopenia has been reported.
Poročali so o pancitopeniji.
Preclinical studies indicate plasma protein binding of topotecan is low (35%) and distribution between blood cells and plasma was fairly homogeneous.
Predklinične študije kažejo, da se topotekan le malo veže na beljakovine v plazmi (35 %), precej enakomerno pa se razporedi med krvnimi celicami in plazmo.
Severe neutropenia lasted beyond seven days in 11% of courses overall.
Huda nevtropenija je pri 11 % vseh ciklusov zdravljenja trajala več kot sedem dni.
Median time to progression was similar in the two groups (13.3 weeks and 12.3 weeks, respectively).
Mediana časa do napredovanja je bila v obeh skupinah podobna, in sicer pri topotekanu 13,3 tedna, pri kombinaciji CAV pa 12,3 tedna.
When combining topotecan with other chemotherapy agents, reduction of the doses of each medicinal product may be required to improve tolerability.
Pri sočasni uporabi topotekana z drugimi kemoterapevtiki je morda zaradi boljšega prenašanja potrebno zmanjšati odmerek vsakega zdravila.
All items for administration or cleaning, including gloves, should be placed in high-risk, waste disposal bags for high-temperature incineration.
- Vse pripomočke, ki jih potrebujete pri dajanju zdravila ali čiščenju, tudi rokavice, je treba odvreči v vreče za shranjevanje nevarnih odpadkov, ki so namenjene sežigu pri visokih temperaturah.
Any unused product or waste material should be disposed of in accordance with local requirements for cytotoxic material.
Neuporabljeno zdravilo ali odpadni material zavrzite v skladu z lokalnimi predpisi za citotoksične snovi.
In addition, elevated hepatic enzymes have been reported with intravenous topotecan overdose.
Poleg tega so poročali o povišanih vrednostih jetrnih encimov v primeru prevelikega odmerjanja z intravenskim topotekanom.
Topotecan inhibits topoisomerase-I by stabilising the covalent complex of enzyme and strand-cleaved DNA which is an intermediate of the catalytic mechanism.
Topotekan zavira topoizomerazo I tako, da stabilizira kovalentni kompleks tega encima in enojne verige DNA, ki je vmesni produkt katalitičnega mehanizma.
Dosing recommendations for patients receiving oral topotecan with creatinine clearance less than 30 ml/min have not been established.
Priporočila za odmerjanje peroralnega topotekana pri bolnikih z očistkom kreatinina pod 30 ml/min niso določena.
In vitro data using human liver microsomes indicate the formation of small amounts of Ndemethylated topotecan.
V raziskavi in vitro, v kateri so uporabili mikrosome človeških jeter, so opazili nastanek majhne količine N-demetiliranega topotekana.
In an open-label study involving children (n = 108, age range: infant to 16 years) with recurrent or progressive solid tumours, topotecan was administered at a starting dose of 2.0 mg/m given as a
V odprti študiji pri otrocih (n = 108, razpon starosti: od dojenčka do 16 let) z rekurentnim ali progresivnim solidnim tumorjem so otroci topotekan prejemali v začetnem odmerku 2,0 mg/m v obliki 30-minutne infuzije 5 dni.
Inhibitors of ABCB1 and ABCG2 administered with oral topotecan have been shown to increase topotecan exposure.
Sočasna uporaba zaviralcev ABCB1 in ABCG2 ter peroralnega topotekana poveča izpostavljenost topotekanu.
However, as with other cytotoxic medicinal products, topotecan is genotoxic and effects on fertility, including male fertility, cannot be excluded.
Ker pa je topotekan - tako kot druga citotoksična zdravilagenotoksičen, ni mogoče izključiti učinkov na plodnost, vključno z učinki na plodnost samcev.
• Unusual bruising or bleeding, caused by a decrease in the number of clotting cells in the blood.
• neobičajne modrice ali krvavitve, ki so posledica zmanjšanega števila trombocitov, ki zagotavljajo strjevanje krvi.
There is no known antidote for topotecan overdose.
Antidot za preveliko odmerjanje s topotekanom ni znan.
For severe cases (CTC Grade 3/4) reported as related/possibly related to topotecan administration the incidence was diarrhoea 5% (see section 4.4), fatigue 4%, vomiting 3%, nausea 3% and anorexia 2%.
Incidenca hudih primerov (3. in 4. stopnja po CTC), ki so bili opisani kot povezani ali morda povezani z uporabo topotekana, je bila: driska 5 % (glejte poglavje 4.4), utrujenost 4 %, bruhanje 3 %, navzea 3 % in anoreksija 2 %.
Growth factors were administered to 19% of patients in 8% of courses.
Rastne dejavnike so uporabili pri 19 % bolnikov v 8 % ciklusov.
Communication with patients prior to drug administration regarding these side effects and proactive management of early and all signs and symptoms of diarrhoea is important.
Pomembno je takojšnje ukrepanje v primeru zgodnjih in vseh znakov in simptomov driske.
• Accidental contact with the skin or eyes should be treated immediately with copious amounts of water.
• Ob naključnem stiku zdravila s kožo ali z očmi jih morate takoj sprati z veliko količino vode.
Signs include: fever serious deterioration of your general condition local symptoms such as sore throat or urinary problems (for example, a burning sensation when urinating, which may be a urinary infection).
Med znaki so: zvišana telesna temperatura, resno poslabšanje splošnega zdravstvenega stanja, lokalni simptomi, npr. vnetje žrela ali težave s sečili (npr. pekoč občutek pri uriniranju, ki je lahko znak okužbe sečil).
The use of topotecan should be confined to units specialised in the administration of cytotoxic chemotherapy.
Topotekan se sme uporabljati le v ustanovah, ki so specializirane za uporabo citotoksičnih kemoterapevtikov.
9/l) in 25% of patients (8% of courses); moderate (platelets between 25.0 and
9/l) se je razvila pri 25 % bolnikov (v 8 % ciklusov zdravljenja), zmerna (število trombocitov med 25,0 in 50,0 x 10
Patients without prior cisplatin chemoradiotherapy Cisplatin Topotecan/Cisplatin
Bolnice brez predhodne kemoterapije s cisplatinom cisplatin topotekan/cisplatin
Hycamtin 0.25 mg and 1 mg capsules are available in packs containing 10 capsules.
0,25-miligramske in 1-miligramske kapsule zdravila Hycamtin so na voljo v pakiranjih, ki vsebujejo po 10 kapsul.
• High body temperature (fever).
• zvišana telesna temperatura;
Therapeutic interventions associated with non-haematological effects included anti-emetic agents, given to 47% of patients in 38% of courses and anti-diarrhoeal agents, given to 15% of patients in 6% of courses.
Med terapevtskimi ukrepi zaradi nehematoloških učinkov je bila uporaba antiemetikov (dobilo jih je 47 % bolnikov v 38 % ciklusov) in antidiaroikov (dobilo jih je 15 % bolnikov v 6 % ciklusov).
Skin and subcutaneous tissue disorders Very common Alopecia Common
Bolezni kože in podkožja zelo pogosti alopecija pogosti srbenje
This can lead to severe bleeding from relatively small injuries such as a small cut.
Že pri relativno blagi poškodbi, npr. manjši vreznini, se lahko pojavi obilna krvavitev.
In 18% of courses with severe thrombocytopenia the duration was >7 days.
V 18 % ciklusov s hudo trombocitopenijo je ta trajala >7 dni.
The adverse events listed above have the potential to occur with a higher frequency in patients who have a poor performance status (see section 4.4).
Zgoraj navedeni neželeni dogodki so lahko pogostejši pri bolnikih s slabšo telesno zmogljivostjo (glejte poglavje 4.4).
In dose-finding studies involving 523 patients with relapsed ovarian cancer and 631 patients with relapsed small cell lung cancer, the dose-limiting toxicity of topotecan monotherapy was found to be haematological.
V študijah za določitev ustreznega odmerka, v katere je bilo vključenih 523 bolnic s ponovitvijo raka na jajčniku in 631 bolnikov s ponovitvijo drobnoceličnega pljučnega raka, so ugotovili, da pri zdravljenju s topotekanom kot samostojnim zdravilom, odmerek omejuje hematološka toksičnost.
WARNING: Cytotoxic agents, special handling instructions (see Package Leaflet).
OPOZORILO: Citotoksično zdravilo, posebna navodila za ravnanje (glejte Navodilo za uporabo).
Median survival (weeks) (95% CI) Hazard ratio (95% CI) Response rate (%) (95% CI) Difference in response rate (95% CI) Median time to progression (weeks) (95% CI) Hazard ratio (95% CI) N = total number of patients treated CI = confidence interval
Mediano preživetje (tedni) (95-odstotni IZ) Razmerje tveganja (95-odstotni IZ) Delež odziva (%) (95-odstotni IZ) Razlika v deležu odziva (95-odstotni IZ) Mediani čas do napredovanja (tedni) (95-odstotni IZ) Razmerje tveganja (95-odstotni IZ) n = celotno število zdravljenih bolnikov IZ = interval zaupanja