FrancophonIA/ELRC3.0 huggingface dataset:
English: Malignant neoplasm progression Not known Neoplasm progression
Croatian: progresija zloćudnih neoplazmi nepoznato progresija neoplazme nepoznato
English: Trastuzumab has been investigated in one randomised, open-label phase III trial ToGA (BO18255) in combination with chemotherapy versus chemotherapy alone.
Croatian: Trastuzumab je, u randomiziranom, otvorenom ispitivanju faze III ToGA (BO18255), u kombinaciji s kemoterapijom uspoređivan sa samom kemoterapijom.
English: In rare cases, a reduction in the amount of (amniotic) fluid that surrounds the developing baby within the womb has been observed in pregnant women receiving trastuzumab.
Croatian: U rijetkim je slučajevima u trudnica koje primaju trastuzumab primijećeno smanjenje količine (amnijske) tekućine koja okružuje bebu u razvoju unutar maternice.
English: DCarbH (vs. AC→D) (BCIRG 006)
Croatian: DCarbH (naspram AC→D) (BCIRG 006)
English: In addition, caution should be exercised in treating patients with increased cardiac risk, e.g. hypertension, documented coronary artery disease, CHF, LVEF of < 55%, older age.
Croatian: Osim toga, neophodan je oprez pri liječenju bolesnika u kojih postoji povećan srčani rizik, npr. hipertenzija, dokumentirana bolest koronarnih arterija, kongestivno zatajenje srca, ejekcijska frakcija lijeve klijetke (LVEF) < 55%, starija dob.
English: Disease-free survival No. patients with event (%)
Croatian: Preživljenje bez bolesti: broj bolesnica s događajem (%)
English: If you develop a reaction, they will slow down or stop the infusion and may give you treatment to counteract the side effects.
Croatian: Ako razvijete reakciju, infuziju će usporiti ili prekinuti te ćete možda primiti terapiju za suzbijanje nuspojava.
English: Some of the side effects you experience may be due to your underlying cancer.
Croatian: Neke nuspojave koje primijetite mogu biti posljedica samog raka.
English: In the pivotal metastatic trials of intravenous trastuzumab, the incidence of cardiac dysfunction varied between 9% and 12% when it was combined with paclitaxel compared with 1%-4% for paclitaxel alone.
Croatian: U pivotalnim ispitivanjima intravenske formulacije trastuzumaba u metastatskoj bolesti, incidencija srčane disfunkcije kretala se između 9% i 12% kod primjene u kombinaciji s paklitakselom, u usporedbi s 1% - 4% kod primjene samo paklitaksela.
English: Regimen Primary tumour type
Croatian: Režim Vrsta primarnog tumora
English: After aseptic reconstitution with sterile water for injections, chemical and physical stability of the reconstituted solution has been demonstrated for 48 hours at 2°C - 8°C.
Croatian: Nakon aseptičke rekonstitucije sa sterilnom vodom za injekcije, kemijska i fizička stabilnost rekonstituirane otopine dokazana je tijekom 48 sati na temperaturi 2°C - 8°C.
English: Study JP19959 was a substudy of BO18255 (ToGA) performed in male and female Japanese patients with advanced gastric cancer to study the pharmacokinetics of capecitabine and cisplatin when used with or without trastuzumab.
Croatian: Ispitivanje JP19959 bilo je podispitivanje ispitivanja BO18255 (ToGA), provedenoga u muškaraca i žena japanskog podrijetla s uznapredovalim rakom želuca u kojemu se ispitivala farmakokinetika kapecitabina i cisplatina primijenjenih u kombinaciji s trastuzumabom ili bez njega.
English: These may be moderate to severe and have been associated with death (see section 4.8).
Croatian: Navedeni događaji mogu biti umjereni do teški i u nekim slučajevima povezani sa smrtnim ishodom (vidjeti dio 4.8).
English: Polysorbate 20
Croatian: Polisorbat 20
English: Circulating shed HER2-ECD
Croatian: Odcijepljeni HER2-ECD u cirkulaciji
English: 1Blood pressure increased
Croatian: 1povišeni krvni tlak vrlo često
English: In this trial, 87% of patients entered had disease that was IHC3+, and 95% of patients entered had disease that was IHC3+ and/or FISH-positive.
Croatian: U tom je ispitivanju 87% bolesnica bilo IHC3+, a 95% njih je bilo IHC3+ i/ili FISH pozitivno.
English: • followed by adequate storage of the prepared solution for intravenous infusion to ensure maintenance of the aseptic conditions.
Croatian: • Pripremljena otopina za intravensku infuziju mora se čuvati na odgovarajući način, kako bi se osiguralo održavanje aseptičkih uvjeta.
English: In general, FISH is considered positive if the ratio of the HER2 gene copy number per tumour cell to the chromosome 17 copy number is greater than or equal to 2, or if there are more than 4 copies of the HER2 gene per tumour cell if no chromosome 17 control is used.
Croatian: Općenito, FISH se smatra pozitivnim ako je omjer broja genskih kopija HER2 po tumorskoj stanici i broja kopija kromosoma 17 veći ili jednak 2 ili ako postoje više od 4 kopije HER2 gena po tumorskoj stanici ako se ne koristi kromosomom 17 kao kontrola.
English: Dry eye
Croatian: • suzne oči
English: Instructions for aseptic reconstitution
Croatian: Upute za aseptičku rekonstituciju
English: It is not known whether trastuzumab is secreted in human milk.
Croatian: Nije poznato izlučuje li se trastuzumab u majčino mlijeko u ljudi.
English: In 3 pivotal clinical trials of adjuvant trastuzumab given in combination with chemotherapy, the incidence of grade 3/4 cardiac dysfunction (specifically symptomatic congestive heart failure) was similar in patients who were administered chemotherapy alone (i.e. did not receive trastuzumab) and in patients who were administered trastuzumab sequentially to a taxane (0.3-0.4%).
Croatian: U 3 pivotalna klinička ispitivanja adjuvantne primjene trastuzumaba u kombinaciji s kemoterapijom, incidencija disfunkcije srca stupnja 3/4 (osobito simptomatsko kongestivno zatajenje srca) je bila slična u bolesnika koji su primili samo kemoterapiju (dakle, nisu primili trastuzumab) i u bolesnika koji su primili trastuzumab nakon taksana (0,3-0,4%).
English: Febrile neutropenia, leukopenia, anaemia, thrombocytopenia and neutropenia occurred very commonly.
Croatian: Febrilna neutropenija, leukopenija, anemija, trombocitopenija i neutropenija su vrlo česte.
English: METHOD AND ROUTE(S) OF ADMINISTRATION For intravenous use after reconstitution and dilution.
Croatian: NAČIN I PUT(EVI) PRIMJENE LIJEKA Za intravensku primjenu nakon rekonstitucije i razrjeđivanja.
English: In rare cases, these reactions are associated with a clinical course culminating in a fatal outcome.
Croatian: U rijetkim slučajevima klinički tijek tih reakcija doveo je do smrtnog ishoda.
English: The rate of infusion-related reactions of all grades varied between studies depending on the indication, the data collection methodology, and whether trastuzumab was given concurrently with chemotherapy or as monotherapy.
Croatian: Stopa reakcija svih stupnjeva povezanih s infuzijom lijeka varirala je od ispitivanja do ispitivanja ovisno o indikaciji, metodologiji prikupljanja podataka te o tome je li se trastuzumab primjenjivao u kombinaciji s kemoterapijom ili kao monoterapija.
English: • swelling of the face, lips and throat
Croatian: • oticanje lica, usana i grla
English: Trehalose dihydrate
Croatian: Trehaloza dihidrat
English: Negative
Croatian: Negativna
English: • abnormal or impaired blood clotting
Croatian: • abnormalno ili poremećeno zgrušavanje krvi
English: If you stop using KANJINTI
Croatian: Ako prestanete primati KANJINTI
English: Trastuzumab 1 Year N = 1,693
Croatian: Trastuzumab tijekom 1 godine N = 1693
English: When trastuzumab was administered after completion of adjuvant chemotherapy NYHA class III-IV heart failure was observed in 0.6% of patients in the one-year arm after a median follow-up of 12 months.
Croatian: Kada se trastuzumab primjenjivao nakon završetka adjuvantne kemoterapije, zatajenje srca NYHA klase III-IV primijećeno je u 0,6% bolesnika iz skupine liječene godinu dana nakon medijana od 12 mjeseci praćenja.
English: Determine the volume of the solution required:
Croatian: Odredite potrebni volumen otopine:
English: In order to improve the traceability of biological medicinal products, the trade name and the batch number of the administered product should be clearly recorded.
Croatian: Kako bi se poboljšala sljedivost bioloških lijekova, naziv i broj serije primijenjenog lijeka potrebno je jasno evidentirati.
English: In a method comparison study (study D008548) a high degree of concordance (> 95%) was observed for SISH and FISH techniques for the detection of HER2 gene amplification in gastric cancer patients.
Croatian: U ispitivanju uspoređivanja metoda (ispitivanje D008548) u bolesnika s rakom želuca ustanovljen je visok stupanj podudarnosti (> 95%) za SISH i FISH metode utvrđivanja genske amplifikacije HER2.
English: Reversibility of mild symptomatic and asymptomatic left ventricular dysfunction was demonstrated for 79.5% of patients.
Croatian: Reverzibilnost blage simptomatske i asimptomatske disfunkcije lijeve klijetke dokazana je u 79,5% bolesnika liječenih trastuzumabom.
English: Detection of HER2 overexpression or HER2 gene amplification
Croatian: Određivanje povećane ekspresije HER2 ili genske amplifikacije HER2
English: These are very common (may affect more than 1 in 10 people).
Croatian: Oni su vrlo česti (mogu se javiti u više od 1 na 10 osoba).
English: If you receive KANJINTI with any other medicine to treat cancer, such as paclitaxel, docetaxel, an aromatase inhibitor, capecitabine, 5-fluorouracil, or cisplatin you should also read the patient information leaflets for these products.
Croatian: Ako primate KANJINTI u kombinaciji s nekim drugim lijekom za liječenje raka, poput paklitaksela, docetaksela, inhibitora aromataze, kapecitabina, 5-fluorouracila ili cisplatina, pročitajte uputu o lijeku i za te lijekove.
English: The frequency of occurrence of hypoprothrombinaemia is not known.
Croatian: Učestalost hipoprotrombinemije nije poznata.
English: Studies of HER2-positivity rates in gastric cancer (GC) using immunohistochemistry (IHC) and fluorescence in situ hybridisation (FISH) or chromogenic in situ hybridisation (CISH) have shown that there is a broad variation of HER2-positivity ranging from 6.8% to 34.0% for IHC and 7.1% to 42.6% for FISH.
Croatian: Ispitivanja stupnja ekspresije HER2 u bolesnika s rakom želuca uporabom imunohistokemije (IHC) i fluorescentne in-situ hibridizacije (FISH) ili kromogene in-situ hibridizacije (CISH) pokazala su veliku varijabilnost ekspresije HER2 u rasponu od 6,8% do 34,0% kod IHC-a i od 7,1% do 42,6% kod FISH-a.
English: • Severe dyspnoea at rest due to complications of advanced malignancy or requiring supplementary oxygen therapy.
Croatian: • Teška dispneja u mirovanju zbog komplikacija uznapredovale zloćudne bolesti ili potreba za dodatnom terapijom kisikom.
English: KANJINTI is for single-use only, as the product contains no preservatives.
Croatian: KANJINTI je namijenjen samo za jednokratnu primjenu jer ne sadrži konzervanse.
English: Prior chemotherapy must have included at least an anthracycline and a taxane unless patients are unsuitable for these treatments.
Croatian: Prethodna kemoterapija morala je uključivati barem jedan antraciklin i jedan taksan, osim u bolesnika koji nisu bili pogodni za liječenje navedenim lijekovima.
English: Most patients who developed CHF or asymptomatic cardiac dysfunction in pivotal trials improved with standard CHF treatment consisting of an angiotensin-converting enzyme (ACE) inhibitor or angiotensin receptor blocker (ARB) and a beta-blocker.
Croatian: U većine bolesnika u pivotalnim kliničkim ispitivanjima u kojih se razvio CHF ili asimptomatska disfunkcija srca, stanje se poboljšalo primjenom standardnog liječenja CHF-a inhibitorom angiotenzin konvertirajućeg enzima (ACE inhibitorom) ili blokatorom angiotenzinskih receptora i beta-blokatorom.
English: • infections
Croatian: • infekcije
English: Currently no data from clinical trials are available on re-treatment of patients with previous exposure to trastuzumab in the adjuvant setting.
Croatian: Trenutno nema dostupnih podataka dobivenih kliničkim ispitivanjima o ponovnom liječenju bolesnika koji su prethodno adjuvantno liječeni trastuzumabom.
English: This translates into an absolute benefit in terms of an 8 year disease-free survival rate of 6.4 percentage points in favour of 1 year trastuzumab treatment.
Croatian: To ukazuje na apsolutnu povoljnost u smislu 8-godišnjeg preživljenja bez simptoma bolesti s razlikom od 6,4 postotnih bodova u korist skupine liječene 1 godinu trastuzumabom.
English: Risk factors associated with interstitial lung disease include prior or concomitant therapy with other antineoplastic therapies known to be associated with it such as taxanes, gemcitabine, vinorelbine and radiation therapy.
Croatian: Faktori rizika za intersticijsku bolest pluća uključuju prethodnu ili istodobnu terapiju drugim antineoplastičnim lijekovima koje se povezuje s intersticijskom bolesti pluća, kao što su to taksani, gemcitabin, vinorelbin i terapija zračenjem.
English: If symptomatic cardiac failure develops during KANJINTI therapy, it should be treated with standard medicinal products for CHF.
Croatian: Ako se tijekom liječenja lijekom KANJINTI razvije simptomatsko zatajenje srca, potrebno je primijeniti standardne lijekove koji se propisuju za CHF.
English: Neoadjuvant-adjuvant treatment
Croatian: Neoadjuvantno-adjuvantno liječenje
English: A vial of KANJINTI aseptically reconstituted with sterile water for injections (not supplied) is chemically and physically stable for 48 hours at 2ºC - 8ºC after reconstitution and must not be frozen.
Croatian: Sadržaj bočice lijeka KANJINTI koji je aseptički rekonstituiran sa sterilnom vodom za injekcije (nije priložena u pakiranju) kemijski je i fizički stabilan tijekom 48 sati na temperaturi 2°C - 8°C nakon rekonstitucije i ne smije se zamrzavati.
English: Faint/barely perceptible membranous reactivity in ≥ 10% of tumour cells; cells are reactive only in part of their membrane
Croatian: Vrlo slaba/jedva primjetna membranska reaktivnost u ≥ 10% tumorskih stanica; stanice su reaktivne samo u dijelu membrane
English: A minority of patients was tested using fluorescence in-situ hybridisation (FISH).
Croatian: Kod manjeg broja bolesnica korištena je metoda fluorescentne in situ hibridizacije (FISH).
English: KANJINTI may be prescribed in combination with the chemotherapy medicine paclitaxel or docetaxel as first treatment for metastatic breast cancer or it may be prescribed alone if other treatments have proved unsuccessful.
Croatian: KANJINTI može biti propisan u kombinaciji s kemoterapijskim lijekovima paklitakselom ili docetakselom u prvoj liniji liječenja metastatskog raka dojke ili može biti propisan sam ako su se drugi oblici liječenja pokazali neuspješnima.
English: In study BCIRG 006, 213/1075 patients in the DCarbH (TCH) arm, 221/1074 patients in the AC→DH (AC→TH) arm, and 217/1073 in the AC→D (AC→T) arm had a Karnofsky performance status ≤ 90 (either 80 or 90).
Croatian: U ispitivanju BCIRG 006 je 213/1075 bolesnica u skupini DCarbH (TCH), 221/1074 bolesnica u skupini AC→DH (AC→TH) i 217/1073 bolesnica u skupini AC→D (AC→T) imalo Karnofsky status ≤ 90 (bilo 80 ili 90).
English: KANJINTI intravenous infusion should be administered by a healthcare provider prepared to manage anaphylaxis and an emergency kit should be available.
Croatian: Intravensku infuziju lijeka KANJINTI treba dati stručni zdravstveni radnik obučen za liječenje anafilaksije, a na raspolaganju treba biti oprema za hitne slučajeve.
English: Patients with history of myocardial infarction (MI), angina pectoris requiring medical treatment, history of or existing CHF (NYHA class II - IV), LVEF of < 55%, other cardiomyopathy, cardiac arrhythmia requiring medical treatment, clinically significant cardiac valvular disease, poorly controlled hypertension (hypertension controlled by standard medical treatment eligible), and haemodynamic effective pericardial effusion were excluded from adjuvant and neoadjuvant EBC pivotal trials with trastuzumab and therefore treatment cannot be recommended in such patients.
Croatian: Bolesnici koji su imali infarkt miokarda (IM) u anamnezi, anginu pektoris koju treba liječiti, ranije ili postojeće kongestivno zatajenje srca (NYHA klase II-IV), LVEF < 55%, neku drugu kardiomiopatiju, srčanu aritmiju koju treba liječiti, klinički značajnu bolest srčanih zalistaka, loše kontroliranu hipertenziju (hipertenzija kontrolirana standardnim liječenjem nije predstavljala prepreku) i hemodinamički učinkovit perikardijalni izljev bili su isključeni iz pivotalnih ispitivanja adjuvantnog i neoadjuvantnog liječenja ranog raka dojke trastuzumabom, pa se liječenje za te bolesnike ne može preporučiti.
English: Patients with EBC should be treated with KANJINTI for 1 year or until disease recurrence, whichever occurs first; extending treatment in EBC beyond one year is not recommended (see section 5.1).
Croatian: U bolesnika s ranim rakom dojke liječenje lijekom KANJINTI traje godinu dana ili do povrata bolesti, što god nastupi ranije; ne preporučuje se produljiti liječenje ranog raka dojke dulje od jedne godine (vidjeti dio 5.1).
English: For any other method that may be used for the assessment of HER2 protein or gene expression, the analyses should only be performed by laboratories that provide adequate state-of-the-art performance of validated methods.
Croatian: Što se tiče ostalih metoda koje se mogu koristiti za procjenu ekspresije HER2 proteina ili HER2 gena, analize je potrebno provoditi isključivo u laboratorijima koji raspolažu odgovarajućim, suvremenim validiranim metodama.
English: Patients were recruited to the trial who were previously untreated for HER2-positive inoperable locally advanced or recurrent and/or metastatic adenocarcinoma of the stomach or gastro-oesophageal junction not amenable to curative therapy.
Croatian: U ispitivanje su uključeni bolesnici koji prethodno nisu bili liječeni zbog HER2-pozitivnog inoperabilnog lokalno uznapredovalog ili rekurentnog i/ili metastatskog adenokarcinoma želuca ili gastroezofagealnog spoja nepogodnog za kurativno liječenje.
English: Pharmacokinetic data from Study H4613g/GO01305 suggested that carboplatin had no impact on the PK of trastuzumab.
Croatian: Farmakokinetički podaci iz ispitivanja H4613g/GO01305 ukazali su da karboplatin ne utječe na farmakokinetiku trastuzumaba.
English: To ensure validation of testing procedures and the generation of accurate and reproducible results, HER2 testing must be performed in a laboratory staffed by trained personnel.
Croatian: Kako bi se osigurala primjena validiranih postupaka testiranja i dobivanje preciznih i ponovljivih rezultata, ispitivanje HER2 mora provesti laboratorij s primjereno obučenim osobljem.
English: Causing excessive foaming during reconstitution or shaking the reconstituted solution may result in problems with the amount of KANJINTI that can be withdrawn from the vial.
Croatian: Stvaranje prevelike pjene tijekom rekonstitucije ili protresanje rekonstituirane otopine može uzrokovati poteškoće s izvlačenjem odgovarajuće količine lijeka KANJINTI iz bočice.
English: In patients receiving trastuzumab after completion of adjuvant chemotherapy the risk of cardiac dysfunction was associated with a higher cumulative dose of anthracycline given prior to initiation of trastuzumab and a body mass index (BMI) > 25 kg/m2.
Croatian: U bolesnika koji su trastuzumab primali nakon završetka adjuvantne kemoterapije, rizik od disfunkcije srca povezivao se s većom kumulativnom dozom antraciklina primijenjenoga prije početka liječenja trastuzumabom te indeksom tjelesne mase (BMI) većim od 25 kg/m2.
English: In the neoadjuvant-adjuvant EBC study (BO22227), at a median follow-up exceeding 70 months, 10.1% (30/296) of patients treated with trastuzumab intravenous developed antibodies against trastuzumab.
Croatian: U sklopu ispitivanja neoadjuvantnog-adjuvantnog liječenja ranog raka dojke (BO22227), nakon medijana praćenja od više od 70 mjeseci, u 10,1% (30/296) bolesnika liječenih trastuzumabom za intravensku primjenu razvila su se protutijela na trastuzumab.
English: A study of trehalose, a major formulation excipient did not reveal any toxicities.
Croatian: Ispitivanja trehaloze, glavne pomoćne tvari u sastavu lijeka, nisu pokazala toksičan učinak.
English: The efficacy results from study MO16432 are summarised in Table 12.
Croatian: Podaci o djelotvornosti liječenja iz ispitivanja MO16432 sažeto su prikazani u Tablici 12.
English: For time to response and duration of response no difference could be recorded between the arms.
Croatian: Između ispitivanih skupina nije uočena razlika u vremenu potrebnom za postizanje odgovora ni trajanju odgovora.
English: Trastuzumab binds with high affinity and specificity to sub-domain IV, a juxta-membrane region of HER2's extracellular domain.
Croatian: Trastuzumab se visokim afinitetom i specifičnošću veže za poddomenu IV jukstamembranske regije ekstracelularne domene HER2.
English: For the other parameters the improvements seen for the combination were for overall response (16.5% versus 6.7%); clinical benefit rate (42.7% versus 27.9%); time to progression (4.8 months versus 2.4 months).
Croatian: Od ostalih parametara, pri primjeni kombinirane terapije uočeno je poboljšanje ukupne stope odgovora na liječenje (16,5% naspram 6,7%), stope kliničke koristi (42,7% naspram 27,9%), vremena do progresije bolesti (4,8 mjeseci naspram 2,4 mjeseca).
English: For full instructions on assay performance and interpretation please refer to the package inserts of validated FISH and CISH assays.
Croatian: Detaljne upute o izvođenju testa i tumačenju rezultata analize potražite u pakiranjima validiranih FISH i CISH testova.
English: Each carton contains 1 vial of powder.
Croatian: Jedno pakiranje sadrži 1 bočicu s praškom.
English: It is also used in combination with medicines called aromatase inhibitors with patients with high levels of HER2 and hormone-receptor positive metastatic breast cancer (cancer that is sensitive to the presence of female sex hormones).
Croatian: Također se primjenjuje u kombinaciji s lijekovima koji se zovu inhibitori aromataze u liječenju bolesnika s visokom razinom proteina HER2 i metastatskim rakom dojke pozitivnim na hormonske receptore (rakom dojke kojeg spolni hormoni potiču na rast).
English: • intravenous 5-fluorouracil - 800 mg/m2/day as a continuous intravenous infusion over 5 days,
Croatian: ili - intravenski 5-fluorouracil - 800 mg/m2/dnevno u kontinuiranoj intravenskoj infuziji tijekom
English: Observation N = 1,693
Croatian: Opservacija N = 1693
English: Neutralising anti-trastuzumab antibodies were detected in post-baseline samples in 2 of 30 patients in the trastuzumab intravenous arm.
Croatian: Neutralizirajuća protutijela na trastuzumab pronađena su u uzorcima prikupljenima nakon početka ispitivanja u 2 od 30 bolesnika u skupini liječenoj trastuzumabom za intravensku primjenu.
English: In the final population PK model, in addition to primary tumour type, body weight, serum aspartate aminotransferase and albumin were identified as a statistically significant covariates affecting the exposure of trastuzumab.
Croatian: U konačnom populacijskom farmakokinetičkom modelu, kao statistički značajne kovarijante koje utječu na izloženost trastuzumabu su, uz primarnu vrstu tumora, identificirane i tjelesna težina te razina aspartat aminotransferaze i albumina u serumu.
English: These events have been observed in patients receiving trastuzumab therapy alone or in combination with paclitaxel or docetaxel, particularly following anthracycline (doxorubicin or epirubicin) containing chemotherapy.
Croatian: Ti su događaji primijećeni u bolesnika koji su primali monoterapiju trastuzumabom ili trastuzumab u kombinaciji s paklitakselom ili docetakselom, osobito nakon kemoterapije koja je sadržavala antracikline (doksorubicin ili epirubicin).
English: In study BO16348, after a median follow-up of 8 years the incidence of severe CHF (NYHA class III & IV) in the trastuzumab 1 year treatment arm was 0.8%, and the rate of mild symptomatic and asymptomatic left ventricular dysfunction was 4.6%.
Croatian: U ispitivanju BO16348, nakon medijana praćenja od 8 godina, incidencija teškog kongestivnog zatajenja srca (NYHA klase III i IV) u skupini liječenoj 1 godinu trastuzumabom iznosila je 0,8%, dok je stopa blage simptomatske i asimptomatske disfunkcije lijeve klijetke iznosila