natgillin/translations-raw huggingface dataset:
However, these Member States were not able to reach an agreement and the Dutch medicines regulatory agency referred the matter to the CHMP for arbitration on 31 July 2008. 
Vendar se države članice niso uspele dogovoriti in nizozemska regulativna agencija za zdravila je dne 31. julija 2008 zadevo napotila na CHMP v arbitražo.
Two medicines are bioequivalent when they produce the same levels of the active substance in the body. 
Dve zdravili sta biološko enakovredni, ko v telesu ustvarita enako raven zdravilne učinkovine.
When the receptors are blocked, histamine cannot have its effect, which leads to a decrease in the symptoms of allergy. 
Ko so receptorji blokirani, histamin ne more učinkovati, zaradi česar se simptomi alergije zmanjšajo.
The grounds for the referral were a disagreement from the Czech Republic and Poland, which were of the opinion that ‘bioequivalence' with the reference medicine had not been shown. 
Podlaga za napotitveni postopek je bilo nestrinjanje Češke republike in Poljske, ki sta menili, da „biološka enakovrednost“ z referenčnim zdravilom ni bila dokazana.
The CHMP recommended that the authorisations in these countries should also be suspended. 
CHMP je priporočil, da se dovoljenja za promet z zdravilom tudi v teh državah prekličejo.
Loratadine Sandoz 10 is used to relieve the symptoms of allergic rhinitis (inflammation of the nasal passages caused by an allergy such as hay fever or allergy to dust mites) and long-term idiopathic urticaria (itching and patches on the skin). 
Zdravilo Loratadine Sandoz 10 se uporablja za lajšanje simptomov alergijskega rinitisa (vnetja nosnih prehodov zaradi alergije, kot je seneni nahod ali alergija na pršice) in dolgotrajne idiopatske urtikarije (srbečice in izpuščajev na koži).
Questions and answers on the referral for Loratadine Sandoz 10 loratadine 10 mg tablets 
Vprašanja in odgovori v zvezi z napotitvenim postopkom za zdravilo Loratadine Sandoz 10 loratadin 10 mg tablete
The European Medicines Agency has completed an arbitration procedure following a disagreement among Member States of the European Union (EU) regarding the authorisation of the medicine Loratadine Sandoz 10. 
Evropska agencija za zdravila je zaključila arbitražni postopek, ki je stekel zaradi nestrinjanja držav članic Evropske unije (EU) glede odobritve zdravila Loratadine Sandoz 10.
It works by blocking the receptors that histamine, a substance in the body that causes allergic symptoms, normally attaches to. 
Deluje z blokiranjem receptorjev, na katere se običajno veže histamin, snov v telesu, ki povzroča alergijske simptome.
Until the results of these studies are assessed, the marketing authorisation for Loratadine Sandoz 10 in the Netherlands should be suspended. 
Do ovrednotenja rezultatov teh študij je treba dovoljenje za promet z zdravilom Loratadine Sandoz 10 na Nizozemskem preklicati.
Based on evaluation of the currently available data and the scientific discussion within the Committee, the CHMP was of the opinion that bioequivalence between Loratadine Sandoz 10 and the reference medicine had not been sufficiently demonstrated. 
CHMP je po vrednotenju trenutno razpoložljivih podatkov in znanstvene razprave v Odboru menil, da biološka enakovrednost med zdravilom Loratadine Sandoz 10 in referenčnim zdravilom ni zadostno dokazana.
Why was Loratadine Sandoz 10 reviewed? 
Zakaj je bilo zdravilo Loratadine Sandoz 10 ponovno pregledano?
Loratadine Sandoz 10 is a ‘generic medicine'. 
Zdravilo Loratadine Sandoz 10 je „generično zdravilo“.
The Agency's Committee for Medicinal Products for Human Use (CHMP) has concluded that the benefits of Loratadine Sandoz 10 do not outweigh its risks, and the marketing authorisation granted in the Netherlands cannot be recognised in other Member States of the EU. 
Odbor za zdravila za uporabo v humani medicini (CHMP) pri agenciji EMEA je zaključil, da koristi zdravila Loratadine Sandoz 10 ne odtehtajo z njim povezanih tveganj, zato dovoljenja za promet z zdravilom, odobrenega na Nizozemskem, ni mogoče priznati v ostalih državah članicah EU.
The Czech Republic and Poland argued that the original study presented by the company was not in line with current guidance, and did not show bioequivalence of Loratadine Sandoz 10 and Clarityne. 
Češka republika in Poljska sta dokazovali, da izvirna študija, ki jo je predložila družba, ni v skladu s trenutnimi priporočili in dabiološka enakovrednost zdravil Loratadine Sandoz 10 in Clarityne ni dokazana.
Sandoz B.V. submitted Loratadine Sandoz 10 for mutual recognition on the basis of the initial authorisation granted in the Netherlands on 22 July 2001. 
je predložila vlogo za medsebojno priznavanje zdravila Loratadine Sandoz 10 na podlagi prvotne odobritve na Nizozemskem 22. julija 2001.
25 September 2008 
23. marec 2009
What is Loratadine Sandoz 10? 
Kaj je zdravilo Loratadine Sandoz 10?
The marketing authorisation in the Netherlands should also be suspended. 
Preklicati pa ga je treba tudi na Nizozemskem.
The CHMP therefore concluded that Loratadine Sandoz 10 could not be considered a generic medicine of Clarityne, and therefore that the marketing 
CHMP je zato zaključil, da zdravila Loratadine Sandoz 10 ni mogoče šteti za generika zdravila Clarityne in posledično v zadevnih državah članicah dovoljenja za promet z zdravilom ni mogoče odobriti.
In addition, the Committee also required that the company carried out additional studies to show bioequivalence of Loratadine Sandoz 10 and Clarityne in accordance with the current guidelines. 
biološko enakovrednost zdravil Loratadine Sandoz 10 in Clarityne v skladu s trenutnimi smernicami.
Company responses provided on: 23 March 2009 Opinion date: 
Datum začetka napotitvenega postopka: 25. september 2008 Odgovori družbe, poslani dne:
Defined as confirmed complete + partial response. 
Opredeljeno kot potrjeno popolni odziv + delni odziv.
Conditions you may need to look out for 
Stanja, na katera morate morda biti pozorni
No clinical data are available. 
Kliničnih podatkov ni na voljo.
This will increase the chance of remembering to take the capsules. 
Tako boste povečali možnost, da se boste spomnili vzeti kapsule.
You may also have blood tests. 
Morda boste opravili tudi preiskave krvi.
Your doctor needs to know if you: 
Vaš zdravnik mora vedeti:
Then carry on taking your capsules at regular times as usual. 
Nato nadaljujte jemanje kapsul ob rednem času, kot po navadi.
Most cases were asymptomatic and reversible. 
Večina primerov je bila asimptomatskih in reverzibilnih.
Descriptions of these effects can be found in sections 2 and 4. 
Opise teh učinkov najdete v 2. in 4. poglavju.
Fertility - both men and women 
Plodnost - moški in ženske
The effects of Tafinlar in people younger than 18 years old are not known. 
Učinki zdravila Tafinlar pri osebah, mlajših od 18 let, niso znani.
The safety profile observed in these patients appears to be consistent with the integrated safety profile of the combination. 
Varnostni profil, ki je bil opažen pri teh bolnikih, je skladen s celostnim varnostnim profilom kombinacije.
Patients were not censored at the time of cross-over 
Bolniki niso bili cenzurirani ob času prehoda.
A total of 125 patients were enrolled into four cohorts: 
Skupno 125 bolnikov so vključili v štiri kohorte:
It is more likely to affect people who have an existing heart problem. 
Verjetneje je, da se to zgodi pri osebah, ki že imajo kakšno težavo s srcem.
This includes medicines obtained without a prescription. 
To velja tudi za zdravila, ki ste jih dobili brez recepta.
Inhibitory concentration 50 (nM) 
Inhibicijska koncentracija 50 (nM)
June 25, 2012 
25. junij 2012
Women of childbearing potential/Contraception in females 
Ženske v rodni dobi/kontracepcija pri ženskah
Date of first authorisation: 26 August 2013 Date of latest renewal: 08 May 2018 
Datum prve odobritve: 26. avgust 2013 Datum zadnjega podaljšanja: 08. maj 2018
• Lack of energy 
• pomanjkanje energije
Study BRF113928 
Študija BRF113928
Do not take Tafinlar: 
Ne jemljite zdravila Tafinlar:
• Red, painful hands and feet 
• rdeče in boleče dlani in stopala
Because many medicinal products are excreted in human milk, a risk to the breast-feeding child cannot be excluded. 
Ker se v materinem mleku pri človeku izločajo številna zdravila, tveganja za dojenega otroka ni mogoče izključiti.
If you notice any of the following: 
Če opazite kaj od naslednjega:
It is not known whether the ingredients of this medicine can pass into breast milk. 
Ni znano, ali lahko sestavine zdravila tega zdravila prehajajo v materino mleko.
• if you are allergic to dabrafenib or any of the other ingredients of this medicine (listed in section 6). 
• če ste alergični na dabrafenib ali katero koli sestavino tega zdravila (navedeno v poglavju 6).
There is also a risk of increased formation of active metabolites of these medicinal products. 
Obstaja tudi tveganje za večje nastajanje aktivnih presnovkov teh zdravil.
The reduction in plasma concentrations can lead to lost or reduced clinical effect of these medicinal products. 
Znižanje plazemske koncentracije lahko povzroči izgubo ali zmanjšanje kliničnega učinka teh zdravil.
28 capsules 120 capsules 
28 kapsul 120 kapsul
Grade 2 (Intolerable) or Grade 3 
2. stopnja (neznosni) ali 3. stopnja
Your doctor will monitor you periodically. 
Zdravnik vas bo občasno pregledoval.
The transport protein Pgp may also be induced as well as other transporters, e.g. MRP-2. 
Induciran je lahko tudi transportni protein Pgp, pa tudi drugi prenašalci, npr. MRP-2.
Your doctor may decide to adjust your dose. 
Zdravnik vam bo morda prilagodil odmerek.
This means that 
To pomeni, da
The majority of these cases were Grade 1 or 2 and did not require any dose interruptions or dose reductions. 
Večina teh primerov je bila 1. ali 2. stopnje in niso zahtevali prekinitve uporabe ali znižanja odmerka.
The safety and efficacy of dabrafenib have not yet been established in children and adolescents (<18 years). 
Varnost in učinkovitost dabrafeniba pri otrocih in mladostnikih (< 18 let) še nista bili dokazani.
This mutation in the gene may have caused the cancer to develop. 
Ta mutacija gena je morda povzročila nastanek raka.
These data show that the efficacy of the combination will be lower in these patients (see section 5.1). 
Ti podatki pa kažejo, da je učinkovitost kombinacije pri teh bolnikih manjša (glejte poglavje 5.1).
Avoid driving or using machines if you have problems with your vision or if you feel tired or weak, or if your energy levels are low. 
Ne upravljajte vozil in strojev, če imate težave z vidom, če se počutite utrujene ali šibke, ali če imate malo energije.
You need to know about important signs and symptoms to look out for while you're taking this medicine. 
Poznati morate pomembne znake in simptome, na katere morate biti pozorni, medtem ko jemljete to zdravilo.
• Papilloma (a type of skin tumour which is usually not harmful) 
• papilom (vrsta kožnega tumorja, ki običajno ni nevaren)
• Increased sweating, night sweats 
• prekomerno znojenje, nočno znojenje
Grade 4 
4. stopnja
Efficacy results are summarised in Table 10. 
Rezultati učinkovitosti so povzeti v preglednici 10.
2 patients had no previous systemic treatment and were included in the analysis for patients enrolled in Cohort C. 
2 bolnika predhodno še nista prejemala sistemskega zdravljenja in sta bila vključena v analizo bolnikov, vključenih v kohorto C.
Extremadura, 3, Pol. Ind. Allendeduero 09400, Aranda de Duero (Burgos) Spain 
Extremadura, 3, Pol. Ind. Allendeduero 09400, Aranda de Duero (Burgos) Španija
Table 11 Efficacy in previously untreated patients (BREAK-3 Study, 25 June 2012) 
Preglednica 11 Učinkovitost pri predhodno nezdravljenih bolnikih (študija BREAK-3, 25. junij 2012)
They will carry out tests to find out if there are other causes for the fever and treat the problem. 
Opravili bodo preiskave, da bodo ugotovili, ali obstajajo drugi vzroki za zvišano telesno temperaturo, in bodo težavo zdravili.
Subjects at Risk: 
Preizkušanci s tveganjem:
Figure 3 Kaplan-Meier curves of overall survival (BREAK-3) (18 December 2012) 
Slika 3 Kaplan-Meierjevi krivulji celokupnega preživetja (BREAK-3) (18. december 2012)
Abnormal findings should be managed according to clinical practices. 
Nenormalne izsledke je treba obravnavati v skladu s klinično prakso.
• Hormonal contraceptives (see section 4.6) 
• hormonski kontraceptivi (glejte poglavje 4.6)
Oncogenic mutations in BRAF lead to constitutive activation of the RAS/RAF/MEK/ERK pathway. 
Onkogene mutacije BRAF povzročijo konstitutivno aktiviranje poti RAS/RAF/MEK/ERK.
• increased sensitivity to light 
• večja občutljivost za svetlobo
Tafinlar is not recommended for children and adolescents. 
Zdravilo Tafinlar ni priporočljivo za otroke in mladostnike.
Signs and symptoms of heart problems include: 
Med znaki in simptomi težav s srcem so:
Patients should be evaluated for signs and symptoms of infection. 
Bolnike je treba oceniti glede znakov in simptomov okužbe.
In vitro evaluation of drug-drug interaction potential 
In vitro ocena potenciala medsebojnega delovanja zdravil
Take Tafinlar twice a day, on an empty stomach. 
Zdravilo Tafinlar jemljite dvakrat na dan na prazen želodec.
Some of these symptoms (bleeding, fever, changes to your skin and eye problems) are briefly mentioned in this section, but more detailed information is found in section 4, “Possible side effects”. 
Nekateri od teh simptomov (krvavitev, zvišana telesna temperatura, spremembe na koži in težave z očmi) so na kratko omenjeni v tem poglavju, podrobnejše informacije pa najdete v 4. poglavju, "Možni neželeni učinki".
Patients should be instructed to immediately inform their physician if new lesions develop. 
Bolnikom je treba naročiti, naj nemudoma obvestijo zdravnika, če se jim pojavi kakšna nova sprememba.
If their therapeutic effect is of large importance to the patient, and dose adjustments are not easily performed based on monitoring of efficacy or plasma concentrations, these medicinal products are to be avoided or used with caution. 
Če je njihov terapevtski učinek za bolnika zelo pomemben in če odmerka ni mogoče zlahka prilagoditi glede na kontrolo učinkovitosti ali koncentracije v plazmi, se je tem zdravilom treba izogniti ali jih je treba uporabljati previdno.
What Tafinlar is and what it is used for 
Kaj je zdravilo Tafinlar in za kaj ga uporabljamo
Even your disease, symptoms and treatment situation may affect your ability to drive or use machines. 
Tudi vaša bolezen, simptomi in okoliščine zdravljenja lahko prizadenejo vašo sposobnost za upravljanje vozil in strojev.
Tell your doctor if you have a heart disorder. 
Zdravniku morate povedati, če imate kakšno srčno bolezen.
Testicular changes in rat and dog were still present following a 4-week recovery period (see section 4.6). 
Testikularne spremembe so bile pri podganah in psih prisotne tudi še po 4-tedenskem obdobju okrevanja (glejte poglavje 4.6).
These pharmacokinetic differences were not considered clinically relevant. 
Teh farmakokinetičnih razlik niso ocenili kot klinično pomembne.
Don't chew or crush the capsules, since they will otherwise lose their effect. 
Kapsul ne grizite in ne drobite, ker bodo izgubile učinek.
You need to use another effective method of birth control so you do not become pregnant while you are taking this medicine. 
Uporabljati morate nek drug učinkovit način kontracepcije, tako da med jemanjem tega zdravila ne boste zanosili.
Estimated Survival Function 
Funkcija ocene preživetja
Due to small sample size reflected by wide 95% CIs, the results in Cohorts B, C, and D should be interpreted with caution. 
Zaradi majhne velikosti vzorca, ki se kaže v širokem 95 % intervalu zaupanja, je treba rezultate iz kohort B, C in D interpretirati s previdnostjo.
Continue treatment and monitor as clinically indicated. 
Nadaljujte zdravljenje in nadzorujte, kot je klinično indicirano.
All Treated Subjects Population BRAF V600E (Primary) 
Populacija vseh zdravljenih preiskovancev BRAF V600E (primarni)
• digoxin, used to treat heart conditions 
• digoksin, uporablja se za zdravljenje srčnih motenj
Prior to starting treatment with Tafinlar, talk to your doctor about options to improve your chances to have children in the future. 
Pred začetkom zdravljenja z zdravilom Tafinlar se z zdravnikom posvetujte o možnostih za povečanje verjetnosti, da bi imeli otroke v prihodnje.
Pregnancy, breast-feeding and fertility Tafinlar is not recommended during pregnancy. 
Nosečnost, dojenje in plodnost Zdravilo Tafinlar ni priporočljivo med nosečnostjo.
BRAF mutations have been identified at a high frequency in specific cancers, including approximately 50% of melanoma. 
Mutacije BRAF so z veliko pogostnostjo odkrili pri specifičnih vrstah raka, med drugim pri približno 50 % melanomov.
Efficacy results from the primary analysis and a post-hoc analysis with 6-months additional follow up are summarised in Table 11. 
Rezultati učinkovitosti iz primarne analize in post hoc analize po dodatnem 6-mesečnem spremljanju so povzeti v preglednici 11.
Taking Tafinlar may cause fever in more than 1 in 10 people. 
Jemanje zdravila Tafinlar lahko povzroči zvišano telesno temperaturo pri več kot 1 od 10 bolnikov.
The capsules are to be swallowed whole with water. 
Kapsule je treba zaužiti cele z vodo.
Dabrafenib binds to human plasma protein and is 99.7% bound. 
Dabrafenib se veže na beljakovine v človeški plazmi in delež vezave je 99,7 %.
Treatment should continue until the patient no longer derives benefit or the development of unacceptable toxicity (see Table 2). 
Zdravljenje se mora nadaljevati, dokler bolniku ne koristi več oziroma do pojava nesprejemljivih toksičnih učinkov (glejte preglednico 2).
No overall differences in efficacy were observed between these subjects and younger subjects. 
V celoti se učinkovitost med temi bolniki in mlajšimi bolniki ni razlikovala.
• have or have ever had any kidney problems. 
• če imate ali ste kdaj imeli kakšne težave z ledvicami.
Baseline characteristics were balanced between treatment groups. 
Izhodiščne značilnosti so bile med terapevtskima skupinama uravnotežene.
• Appearance of new skin cancer (melanoma) 
• pojav novega kožnega raka (melanoma)
If overdose occurs, the patient should be treated supportively with appropriate monitoring as necessary. 
V primeru prevelikega odmerjanja je treba bolnika zdraviti podporno in ga ustrezno nadzirati, kot je potrebno.
Table 12 Survival data from the primary analysis and post-hoc analyses 
Preglednica 12: Podatki o preživetju iz primarne analize in post hoc analiz.
In the adjuvant melanoma setting, patients should be treated for a period of 12 months unless there is disease recurrence or unacceptable toxicity. 
Pri adjuvantnem zdravljenju melanoma je treba bolnike zdraviti 12 mesecev, razen če pride do ponovitve bolezni ali nesprejemljivih toksičnih učinkov.
Tafinlar is not recommended during pregnancy, since it may potentially harm an unborn baby. 
Zdravilo Tafinlar ni priporočljivo med nosečnostjo, ker morda lahko škoduje nerojenemu otroku.
Dose modification exceptions (where only one of the two therapies is dose reduced) for selected adverse reactions 
Izjeme pri prilagajanju odmerka (pri katerih je treba odmerek prilagoditi samo pri enem od obeh zdravil) za izbrane neželene učinke
The number of affected medicinal products is expected to be large; although the magnitude of the interaction will vary. 
Pričakovati je, da to zadeva številna zdravila, a velikost medsebojnega delovanja se razlikuje.
A decrease in exposure was observed with repeat dosing, likely due to induction of its own metabolism. 
Med ponavljajočim se odmerjanjem so opažali zmanjšanje izpostavljenosti, verjetno zaradi indukcije lastne presnove.
Other medicines and Tafinlar 
Druga zdravila in zdravilo Tafinlar
Your doctor may decide that you should take a lower dose if you get side effects. 
Zdravnik se lahko odloči, da boste jemali nižji odmerek, če se vam pojavijo neželeni učinki.
Extremadura, 3, 09400 Aranda De Duero, Burgos, Spain Novartis Pharmaceuticals UK Limited, Frimley Business Park, Frimley, Camberley, Surrey GU16 7SR, United Kingdom 
Extremadura, 3, 09400 Aranda De Duero, Burgos, Španija Novartis Pharmaceuticals UK Limited, Frimley Business Park, Frimley, Camberley, Surrey GU16 7SR, Velika Britanija
• Heart rate that is lower than the normal range and/or a decrease in heart rate 
• frekvenca srčnega utripa, ki je nižja od normalne vrednosti in/ali znižanje frekvence srčnega utripa
Radiological tumour assessment was conducted every 3 months for the first two years and every 6 months thereafter, until first relapse was observed. 
V prvih dveh letih so radiološko oceno tumorja opravljali vsake 3 mesece, kasneje pa vsakih 6 mesecev, dokler ni prišlo do prve ponovitve bolezni.
Don't take more Tafinlar than your doctor has recommended, since this may increase the risk of side effects. 
Ne vzemite več zdravila Tafinlar, kot vam je naročil zdravnik, saj to lahko poveča tveganje za neželene učinke.
Gemfibrozil had no clinically relevant effect on the systemic exposure to dabrafenib metabolites (≤13%). 
Gemfibrozil ni imel klinično pomembnega vpliva na sistemsko izpostavljenost metabolitom dabrafeniba (≤ 13 %).
In addition, older patients experienced more serious adverse reactions compared to younger patients (41% versus 22%). 
Poleg tega so imeli starejši bolniki več resnih neželenih učinkov kot mlajši (41 % v primerjavi z 22 %).
Do not take Tafinlar after the expiry date (EXP) which is stated on the bottle label and the carton. 
Zdravila Tafinlar ne smete uporabljati po datumu izteka roka uporabnosti (EXP), ki je naveden na nalepki plastenke in škatli.
Interactions with many medicinal products eliminated through metabolism or active transport is expected. 
Pričakovati je mogoče medsebojna delovanja s številnimi zdravili, ki se izločajo s presnavljanjem ali aktivnim transportom.
• Low levels of white blood cells 
• znižano število belih krvnih celic
Although data in moderate renal impairment are limited these data may indicate no clinically relevant effect. 
Čeprav je podatkov o zmerni okvari ledvic malo, ti podatki lahko nakazujejo, da ni pomembnega kliničnega vpliva.
Tafinlar can also affect how some other medicines work. 
Tudi zdravilo Tafinlar lahko vpliva na delovanje nekaterih zdravil.
Any prior systemic anti-cancer treatment, including radiotherapy, was not allowed. 
Predhodno sistemsko protitumorsko zdravljenje, vključno z obsevanjem, ni bilo dovoljeno.
Dabrafenib has minor influence on the ability to drive and use machines. 
Dabrafenib ima blag vpliv na sposobnost vožnje in upravljanja strojev.
Take Tafinlar for as long as your doctor recommends. 
Zdravilo Tafinlar uporabljajte, kolikor dolgo vam svetuje zdravnik.
Table 1 Recommended dose level reductions 
Preglednica 1 Priporočena znižanja odmerka
Your medicine targets proteins made from this mutated gene and slows down or stops the development of your cancer. 
Vaše zdravilo deluje usmerjeno na beljakovine, ki jih ustvarja mutirani gen, in upočasni ali ustavi razvoj raka.
Intracranial response assessed by the investigator in Cohorts B, C and D were secondary endpoints of the study. 
Intrakranialni odziv v kohortah B, C in D po oceni raziskovalcev, je bil sekundarni cilj opazovanja študije.
• Increase in some substances (enzymes) produced by the liver 
• zvišane vrednosti nekaterih snovi (encimov), ki nastajajo v jetrih
• Acne-like problems 
• aknam podobne težave
Animal studies have shown reproductive toxicity and embryo-foetal developmental toxicities, including teratogenic effects (see section 5.3). 
Študije na živalih so pokazale reproduktivno toksičnost in embriofetalno razvojno toksičnost, vključno s teratogenimi učinki (glejte poglavje 5.3).
Patients should be made aware of the potential for fatigue and eye problems to affect these activities. 
Bolnika je treba seznaniti z možnostjo za utrujenost in težave z očmi, ki lahko vplivajo na takšne dejavnosti.
Primary tumour or tumour from a metastatic site was tested with an investigational use only assay (IUO). 
Primarni tumor ali tumor z metastatskega mesta so testirali s testom, ki je bil le za raziskovalno uporabo (IUO - investigational use only).