natgillin/translations-raw huggingface dataset:
Of patients receiving sunitinib malate for cytokine-
Şapte (1, 9%) pacienţi care au primit malat de sunitinib versus 0% dintre pacienţii care au primit IFN- α au avut evenimente hemoragice de Gradul 3 sau mai mare legate de tratament.
20 refractory MRCC, 26% experienced bleeding.
26% dintre pacienţii care au primit SUTENT pentru MRCC refractar la citokine au avut hemoragii.
Some of these events were severe, but very rarely fatal.
Unele dintre aceste evenimente adverse au fost severe dar rar au fost letale.
Gastro-intestinal tract Serious, sometimes fatal gastrointestinal complications including gastrointestinal perforation have occurred rarely in patients with intra-abdominal malignancies treated with SUTENT.
Tractul gastro- intestinal Rareori, la pacienţii cu tumori maligne intraabdominale trataţi cu SUTENT au apărut complicaţii gastro- intestinalegrave, uneori letale, inclusiv perforaţie gastro- intestinală.
Treatment-related fatal gastrointestinal bleeding occurred in 0.5% of patients receiving placebo in the GIST Phase 3 study.
0, 5% dintre pacienţii care au primit placebo în studiul GIST de fază 3 au avut hemoragii letale gastrointestinale legate de tratament.
Treatment-related hypertension was reported in approximately 24% of patients receiving sunitinib malate for treatment-naïve MRCC compared to 1% of patients receiving IFN-α.
Hipertensiunea legată de tratament a apărut la aproximativ 24% dintre pacienţii netrataţi anterior care au primit malat de sunitinib pentru MRCC comparativ cu 1% dintre pacienţii care au primit IFN- α.
Severe hypertension occurred in 5% of treatment-naïve patients on sunitinib malate and 1% of patients on IFN-α.
Hipertensiunea severă a apărut la 5% dintre pacienţii netrataţi anterior şi care au primit malat de sunitinib şi la 1% dintre pacienţii care au primit IFN- α.
Haematological Decreased absolute neutrophil counts of grade 3 and 4 severity were reported in 10% and 1.7% of patients on the phase 3 GIST study, respectively and in 16% and 1.6% of patients on the phase 3 MRCC study, respectively.
Hematologie Scăderi absolute ale numărului de neutrofile cu grade de severitate 3 şi 4 s- au raportat la 10% şi respectiv 1, 7% dintre pacienţii aflaţi în studiul GIST de fază 3 şi, respectiv, la 16% şi 1, 6% din pacienţii aflaţi în studiul CRM fază 3.
Decreased platelet counts of grade 3 and 4 severity were reported in 3.7% and 0.4% of patients on the phase 3 GIST study, respectively, and in 8.2% and 1.1% of patients on the phase 3 MRCC study, respectively.
Scăderi ale numărului de trombocite cu grade de severitate 3 şi 4 s- au raportat la 3, 7% şi respectiv 0, 4% dintre pacienţii aflaţi în studiul GIST de fază 3 şi, respectiv, la 8, 2% şi 1, 1% din pacienţii aflaţi în studiul CRM fază 3.
None of these events in the phase 3 studies were fatal, but rare fatal haematological events have been reported through post-marketing experience.
Niciunul dintre aceste evenimente din studiile de fază 3 nu a fost letal; cu toate acestea, după punerea pe piaţă au raportate rare evenimente hematologice letale.
In the treatment-naïve MRCC study, 21% patients on SUTENT and 12% of patients on interferon-α (IFN-α), had an LVEF value below the lower limit of normal.
În studiul MRCC la pacienţi naivi la tratament, 21% dintre pacienţii care au primit SUTENT şi 12% dintre pacientii care au primit interferon α (IFN- α) au avut o valoare a FEVS sub limita inferioară a
One (< 1%) patient who received SUTENT was diagnosed with congestive heart failure (CHF).
Un (< 1%) pacient care a primit SUTENT a fost diagnosticat cu insuficienţă cardiacă congestivă (ICC).
Treatment-related adverse events of ‘ cardiac failure’, ‘ cardiac failure congestive’ or ‘ left ventricular failure’ were reported in 0.7% of patients with solid tumours and 1% of patients treated with placebo.
Evenimentele adverse legate de tratament de tip „ insuficienţă cardiacă ”, „ insuficienţă cardiacă congestivă ” sau „ insuficienţă ventriculară stângă ” s- au raportat la 0, 7% dintre pacienţii cu tumori solide şi la 1% dintre pacienţii cărora li s- a administrat placebo.
All patients had GIST.
Toţi pacienţii aveau GIST.
SUTENT and placebo arms).
În studiul GIST de fază 3 (n=312), evenimentele cardiace letale legate de tratament au apărut la 1% dintre pacienţi, în fiecare braţ al studiului (de exemplu braţele cu SUTENT şi placebo).
In a phase 2 study in cytokine-refractory MRCC patients, 0.9% of patients experienced treatment-related fatal myocardial infarction and in the phase 3 study in treatment-naïve MRCC patients, 0.6% of patients on the IFN-α arm and 0 patients on the
Într- un studiu de fază 2 la pacienţi cu MRCC refractar la citokine, 0, 9% dintre pacienţi au avut infarct miocardic letal legat de tratament, iar în studiul de fază 3 la pacienţi cu MRCC netrataţi anterior, 0, 6% dintre pacienţii din braţul cu IFN- α şi 0 pacienţi cu SUTENT au avut evenimente cardiace letale.
Close monitoring for clinical signs and symptoms of CHF should be performed, especially in patients with cardiac risk factors and/ or history of coronary artery disease.
Trebuie efectuată monitorizarea atentă a semnelor şi simptomelor clinice de ICC, în special la pacienţii cu factori de risc cardiac şi/ sau antecedente de boală arterială coronariană
QT Interval prolongationData from non-clinical (in vitro and in vivo) studies, at doses higher than the recommended human dose, indicate that sunitinib has the potential to inhibit the cardiac action potential repolarization process (e. g. prolongation of QT interval).
Alungirea intervalului QT Date din studiile non- clinice (in vitro and in vivo), la doze mai mari decât cele recomandate la om, au indicat că sunitinib are potenţialul de a inhiba procesul de repolarizare a potenţialului de acţiune cardiac (de exemplu prelungirea intervalului QT).
Increases in the QTc interval to over 500 msec occurred in 0.5% and changes from baseline in excess of 60 msec occurred in 1.1% of the 450 solid tumours patients; both these parameters are recognized as potentially significant changes.
Creşteri ale intervalului QTc la peste 500 msec au apărut la 0., 5% din cazuri şi modificări faţă de valorile iniţiale mai mari de 60 msec au apărut la 1,. 1% dintre cei 450 de pacienţi cu tumori solide.; ambii parametri sunt recunoscuţi ca modificări potenţial semnificative.
No patients had a QTc value > 500 msec.
Nici un pacient nu a avut o valoare a QTc > 500 msec.
At therapeutic plasma concentrations, the maximum QTcF (Frederica’ s correction) mean change from baseline was 9.6 msec (90% CI 15.1msec).
La concentraţii plasmatice terapeutice, modificarea medie maximă a QTcF (corecţia Frederica) faţă de valorile iniţiale a fost de 9., 6 msec (IÎ 90% 15, 1 msec).
At approximately twice therapeutic concentrations, the maximum QTcF change from baseline was 15.4 msec (90% CI 22.4 msec).
La concentraţii de aproximativ două ori mai mari decât cele terapeutice, modificarea maximă a QTcF faţă de valorile iniţiale a fost de 15., 4 msec (IÎ 90% 22, 4 msec).
No subjects experienced an effect on the QTc inteval greater than Grade 2 (CTCAE version 3.0).
Nici un subiect nu a avut un efect asupra intervalului QTc mai mare de gradul 2 (CTCAE versiunea 3., 0).
No patient presented with a cardiac arrhythmia.
Nici un pacient nu a avut aritmie cardiacă.
Concomitant treatment with potent CYP3A4 inhibitors, which may increase sunitinib plasma concentrations, should be used with caution and the dose of SUTENT reduced (see Section 4.2 and 4.5).
Tratamentul concomitent cu inhibitori potenţi de CYP3A4 care pot creşte concentraţiile plasmatice de sunitinib, trebuie administrat cu precauţie, iar doza de SUTENT trebuie redusă (vezi pct. 4. 2 şi 4. 5).
Venous Thromboembolic Events Treatment-related venous thromboembolic events were reported in approximately 1.0% of patients with solid tumours who received SUTENT on clinical trials, including GIST and MRCC.
Evenimente tromboembolice venoase
22 Seven patients (3%) on SUTENT and none on placebo in a phase 3 GIST study experienced venous thromboembolic events; five of the seven were Grade 3 deep venous thrombosis (DVT) and two were Grade 1 or 2.
În studiul GIST de fază 3, 7 pacienţi (3%) care au luat SUTENT şi nici unul dintre cei care au luat placebo au avut evenimente tromboembolice venoase.
Respiratory Events Patients who presented with pulmonary embolism within the previous 12 months were excluded from SUTENT clinical studies.
Evenimente respiratorii Pacienţii care au prezentat embolie pulmonară în ultimele 12 luni au fost excluşi din studiile clinice SUTENT.
In patients who received SUTENT in Phase 3 registrational studies, treatment- related pulmonary events (i. e. dyspnoea, pleural effusion, pulmonary embolism or pulmonary oedema) were reported in approximately 5% of patients with GIST and in approximately 14% of patients with MRCC.
Au fost raportate cazuri rare cu evoluţie letală.
Rare cases with fatal outcome were reported Approximately 8% of patients with solid tumours, including GIST and MRCC, who received Sutent in clinical trials experienced treatment-related pulmonary events.
Aproximativ 8% din pacienţii cu tumori solide, inclusiv GIST şi CRM, care au primit SUTENT în studiile clinice, au avut evenimente pulmonare legate de tratament.
Thyroid Dysfunction Baseline laboratory measurement of thyroid function is recommended, and patients with hypothyroidism or hyperthyroidism should be treated as per standard medical practice prior to the start of sunitinib treatment.
Disfuncţie tiroidiană Se recomandă în prealabil investigaţii de laborator ale funcţiei tiroidiene iar pacienţii cu hipotiroidism sau hipertiroidism trebuie trataţi conform practicii medicale standard înainte de începerea tratamentului cu sunitinib.
All patients should be observed closely for signs and symptoms of thyroid dysfunction on sunitinib treatment.
La toţi pacienţii trebuie urmărită îndeaproape apariţia semnelor şi simptomelor de disfuncţie tiroidiană în timpul tratamentului cu sunitinib.
Patients with signs and/ or symptoms suggestive of thyroid dysfunction should have laboratory monitoring of thyroid function performed and be treated as per standard medical practice.
Hipotiroidismul s- a raportat ca
Hypothyroidism was reported as an adverse event in 7 patients (4%) across the two cytokine-refractory MRCC studies; in nine patients (2%) on SUTENT and one patient (< 1%) in the IFN-α arm in the treatment- naïve MRCC study.
25 eveniment advers la 7 pacienţi (4%) din cele două studii MRCC la pacienţi refractari la tratamentul cu citokine; la nouă pacienţi (2%) care au luat SUTENT şi la un pacient (< 1%) în braţul cu IFN- α în studiul MRCC la pacienţi naivi la tratament..
Rare cases of hyperthyroidism, some followed by hypothyroidism, have been reported in clinical trials and through post-marketing experience.
În cadrul studiilor clinice şi al experienţei după punerea pe piaţă au fost observate cazuri rare de hipertiroidism, unele urmate de hipotiroidism
If symptoms of pancreatitis are present, patients should have SUTENT discontinued and be provided with appropriate supportive care.
Dacă sunt prezente simptome de pancreatita, tratamentul cu SUTENT va fi întrerupt la aceşti pacienţi şi va fi asigurat tratament de susţinere.
23 Renal function The safety of continued SUTENT treatment in patients with moderate to severe proteinuria has not been systematically evaluated.
Funcţia renală Siguranţa continuării tratamentului cu SUTENT la pacienţii cu proteinurie moderată până la severă nu a fost evaluată sistematic.
Seizures In clinical studies of SUTENT and from post-marketing experience, seizures have been observed in subjects with or without radiological evidence of brain metastases.
Convulsii În studiile clinice şi în cadrul experienţei după punerea pe piaţă, cu SUTENT, s- au observat convulsii la subiecţii cu sau fără metastaze cerebrale documentate radiologic.
Drugs that may increase sunitinib plasma concentrations:.
Medicamente care pot creşte concentraţiile plasmatice de sunitinib.
Administration of SUTENT with potent inhibitors of the CYP3A4 family (e. g. ritonavir, itraconazole, erythromycin, clarithromycin, grapefruit juice) may increase sunitinib concentrations Combination with inhibitors should therefore be avoided, or the selection of an alternate concomitant medication with no, or minimal potential to inhibit CYP3A4 should be considered.
Administrarea de SUTENT concomitent cu inhibitori potenţi ai enzimelor CYP3A4 (de exemplu, ritonavir, itraconazol, eritromicină, claritromicină, suc de grapefruit) poate determina creşterea concentraţiei de sunitinib.
24 Women of childbearing potential should be advised to avoid becoming pregnant while receiving treatment with SUTENT.
Femeile de vârstă fertilă trebuie sfătuite să evite o sarcină pe parcursul tratamentului cu SUTENT.
The most common treatment-related adverse events (experienced by at least 20% of the patients) of any grade included: fatigue; gastrointestinal disorders, such as diarrhoea, nausea, stomatitis, dyspepsia and vomiting; skin discolouration; dysgeusia and anorexia.
Oboseala, hipertensiunea şi
Fatigue, hypertension and neutropoenia were the most common treatment-related adverse events of Grade 3 maximum severity and increased lipase was the most frequently occurring treatment-related adverse event of Grade 4 maximum severity in patients with solid tumours.
27 neutropenia au fost cele mai frecvente evenimente adverse legate de tratament având gradul de severitate maxim 3, iar creşterea lipazei a fost cel mai frecvent eveniment advers cu grad de severitate maxim 4, legat de tratament, la pacienţii cu tumori solide.
Hepatitis and hepatic failure occurred in < 1% of patients and prolonged QT interval in < 0.1% (see section 4.4).
4).
Fatal events other than those listed in section 4.4 above or section 4.8 below that were considered possibly related to SUTENT drug included multi-system organ failure, disseminated intravascular coagulation, peritoneal haemorrhage, rhabdomyolysis, cerebrovascular accident, dehydration, adrenal insufficiency, renal failure, respiratory failure, pleural effusion, pneumothorax, shock, and sudden death.
4. 8 mai jos şi care au fost considerate ca fiind posibil legate de administrarea SUTENT au inclus insuficienţa multiplă sistemică de organ, coagularea intravasculară diseminată, hemoragia peritoneală, rabdomioliza, accidentul cerebrovascular, deshidratarea, insuficienţa suprarenaliană, insuficienţa renală, insuficienţa respiratorie, efuziunea pleurală, pneumotoraxul, şocul şi moartea subită.
Very common (≥ 1/ 10); common (≥ 1/ 100 to < 1/ 10); uncommon (≥ 1/ 1,000 to < 1/ 100); rare (≥ 1/ 10,000 to < 1/ 1,000); very rare (< 1/ 10,000).
Foarte frecvente (> 1/ 10), frecvente (> 1/ 100 şi < 1/ 10), mai puţin frecvente (> 1/ 1000 şi < 1/ 100), rare (> 1/ 10 000 şi > 1/ 1000), foarte rare (< 1/ 10000)
Treatment-Related Adverse Reactions reported in GIST studies
Reacţii adverse legate de tratament raportate în studiile GIST
Adverse Reactions
Tulburări ale
All Grades n (%)
Foarte frecvente
Nervous system disorders
Tulburări ale gustuluib
Very common Common Common Common
Foarte frecvente Frecvente Frecvente Frecvente Frecvente
Headache Paraesthesia Dizziness Neuropathy peripheral
Cefalee Parestezii Ameţeli Neuropatie periferică Hipoestezie
76 (17.3%) 27 (6.1%) 18 (4.1%) 11 (2.5%)
76 (17, 3%) 27 (6, 1%) 18 (4, 1%) 11 (2, 5%) 10 (2, 3%)
5 (1.1%) 1 (0.2%) 1 (0.2%) 0 (0.0%)
5 (1, 1%) 1 (0, 2%) 1 (0, 2%) 0 (0, 0%) 0 (0, 0%)
Hypoaesthesia
Tulburări vasculare
Respiratory, thoracic and mediastinal disorders
Tulburări respiratorii, toracice şi mediastinale,
Epistaxis Dyspnoea
Epistaxis Dispnee
161 (36.6%)
161 (36, 6%)
15 (3.4%)
15 (3, 4%)
Very common Very common Very common Very common
Foarte frecvente Foarte frecvente
Vomiting Stomatitis Dyspepsia Abdominal pain C / distension
Dispepsie Dureri/ distensie abdominalec
98 (22.2%) 90 (20.5%) 80 (18.2%) 77 (17.5%)
80 (18, 2%) 77 (17, 5%)
7 (1.6%) 7 (1.6%) 4 (0.9%) 15 (3.4%)
4 (0, 9%) 15 (3, 4%)
0 (0.0%) 0 (0.0%) 0 (0.0%) 2 (0.5%)
0 (0, 0%) 2 (0, 5%)
tissue disorders
Foarte frecvente
Very common
106 (24, 1%)
Palmar-plantar erythrodysaesthesia syndrome
Modificări de culoare ale părului
106 (24.1%)
67 (15, 2%)
Pain in extremity/ limb
Dureri la nivelul extremităţilor/ membr elor
and bone disorders
ţesutului conjunctiv osoase
Arthralgia Myalgia Muscle spasm Back pain Muscular weakness
Artralgii Mialgii Spasme musculare Durere de spate Slăbiciune musculară
Fatigue/ Asthenia
Oboseală/ Astenie
287 (65.2%)
287 (65, 2%)
64 (14.5%)
64 (14, 5%)
administration site conditions
nivelul locului
Mucosal Inflammation
Inflamaţia mucoasei Edemd
Oedema d Pyrexia
Pirexie
59 (13.4%) 26 (5.9%)
59 (13, 4%) 26 (5, 9%)
Psychiatric disorders
Tulburări psihice Investigaţii diagnostice
Common
Frecvente Frecvente Frecvente
Insomnia
Insomnie Creşterea lipazei Scăderea numărului de celule albe
14 (3.2%)
14 (3, 2%) 35 (8, 0%) 33 (7, 5%)
0 (0.0%)
0 (0, 0%) 12 (2, 7%) 15 (3, 4%)
0 (0.0%)
0 (0, 0%) 7 (1, 6%) 0 (0, 0%)
Common Common
Frecvenţă
Lipase increase White blood cell count decreased e
Reacţii adverse
35 (8.0%) 33 (7.5%)
severitate n (%)
12 (2.7%) 15 (3.4%)
severitate n (%)
7 (1.6%) 0 (0.0%)
severitate n (%)
Ejection fraction decrease
Scăderea fracţiei de ejecţie
Weight decreased Blood creatinine phosphokinase increase
Scăderea greutăţii Creşterea creatinfosfokinazei sanguine
The following terms have been combined: a Anorexia and decreased appetite b Dysgeusia, ageusia and taste disturbance c Abdominal pain and abdominal pain upper d Oedema, oedema peripheral and oedema face e White blood cell count decreased, neutrophil count decreased, and leukocyte count decreased
Următorii termeni au fost combinaţi: a Anorexia şi scăderea apetitului b Disgeuzia, ageuzia şi tulburările gustului c Durere abdominală şi durere abdominală superioară d Edem, edem periferic şi edem facial e Scăderea numărului celulelor sanguine albe, scăderea numărului de neutrofile şi scăderea numărului de leucocite
Treatment-Related Adverse Reactions reported in cytokine-refractory and treatment-naïve MRCC studies
Reacţii adverse legate de tratament raportate în studiile MRCC la pacienţi netrataţi anterior şi refractari la citokine
Neutropoenia Thrombocytopoenia Anaemia Leukopoenia Lymphopenia
Neutropenie Trombocitopenie Anemie Leucopenie Limfopenie
Endocrine disorders
Afecţiuni endocrine
Eyelid oedema
Edemul pleoapei Scăderea apetitului a
Metabolism and nutrition
metabolism şi nutriţie
Decreased appetite
Foarte frecvente
disorders Nervous system disorders
Tulburări ale
Dehydration Taste disturbance b
Tulburări ale gustului b
33 (6.1%) 250 (46.0%)
250
Very common Common Common Common
Foarte frecvente Frecvente
Headache Dizziness Paraesthesia Neuropathy peripheral
Cefalee Ameţeli
82 (15.1%) 38 (7.0%) 36 (5.9%) 33 (6.1%)
82 (15, 1%) 38 (7, 0%)
3 (0.6%) 2 (0.4%) 0 (0%) 1 (0.2%)
3 (0, 6%) 2 (0, 4%)
Common Common
Frecvente Frecvente Frecvente Frecvente
Hypoaesthesia Hyperaesthesia
Parestezii Neuropatie periferică Hipoestezie Hiperestezie
20 (3.7%) 17 (3.1%)
36 (5, 9%) 33 (6, 1%) 20 (3, 7%) 17 (3, 1%)
0 (0%) 0 (0%)
0 (0, 0%) 1 (0, 2%) 0 (0, 0%) 0 (0, 0%)
0 (0%) 0 (0%)
0 (0, 0%) 0 (0, 0%) 0 (0, 0%) 0 (0, 0%)
Flushing Hot flush
Eritem facial Bufeuri
Respiratory, thoracic and mediastinal disorders
Tulburări mediastinale, toracice şi respiratorii
Very common
Foarte frecvente Frecvente Frecvente
Epistaxis
Epistaxis Dispnee Durere faringo - laringeală
86 (15.8%)
86 (15, 8% 0 45 (8, 3%) 29 (5, 3%)
3 (0.6%)
3 (0, 6%) 6 (1, 1%) 2 (0, 4%)
Common Common
Frecvente Frecvente Frecvente
Dyspnoea Pharyngolaryngeal pain
Tuse Disfonie Uscăciunea mucoasei nazale
45 (8.3%) 29 (5.3%)
23 (4, 2%) 16 (2, 9%) 14 (2, 6%)
6 (1.1%) 2 (0.4%)
0 (0%) 0 (0%) 0 (0%)
Common Common Common Common Common Common
Frecvente Frecvente Frecvente
Cough Dysphonia Nasal dryness Dyspnoea exertional Nasal congestion Pleural effusion
Dispnee de efort Congestie nazală Efuziune pleurală
Very common
intestinale
17 (3.1%)
17 (13, 1%)
Abdominal pain c / distension 28
Durere/ distensie abdominalăc
System Organ Class
1 (0, 2%) 0 (0%) 0 (0%) 0 (0%)
Frequency
0 (0%) 0 (0%) 0 (0%) 0 (0%)
Adverse Reactions
Foarte frecvente Frecvente
All Grades n (%)
56 (10, 3%) 50 (9, 2%)
Grade 3 n (%)
0 (0%) 2 (0, 4%)
Grade 4 n (%)
0 (0%) 0 (0%)
Very common Very common Very common Very common Very common Common
Frecvente Frecvente Frecvente Frecvente Frecvente Frecvente
Constipation Glossodynia Flatulence Oral pain Dry mouth Gastroesophageal reflux disease
Disfagie Cheilită Sângerări gingivale Hemoroizi Proctalgii Ulceraţii ale cavităţii bucale
83 (15.3%) 63 (11.6%) 60 (11.0%) 60 (11.0%) 56 (10.3%) 50 (9.2%)
20 (3, 7%) 19 (3, 5%) 18 (3, 3%) 18 (3, 3%) 17 (3, 1%) 16 (2, 9%)
1 (0.2%) 0 (0%) 0 (0%) 2 (0.4%) 0 (0%) 2 (0.4%)
2 (0, 4%) 1 (0, 2%) 0 (0, 0%) 0 (0, 0%) 1( 0, 2%) 0 (0, 0%)
0 (0%) 0 (0%) 0 (0%) 0 (0%) 0 (0%) 0 (0%)
1 (0, 2%) 1 (0, 2%) 0 (0, 0%) 0 (0, 0%) 0 (0, 0%) 1 (0, 2%)
Common Common Common Common Common Common Common Common Very common
Frecvente Frecvente
Dysphagia Cheilitis Gingival bleeding Haemorrhoids Proctalgia Mouth ulceration Stomach discomfort Rectal haemorrhage Palmar-plantar erythrodysaesthesia syndrome
Disconfort gastric Hemoragii rectale
20 (3.7%) 19 (3.5%) 18 (3.3%) 18 (3.3%) 17 (3.1%) 16 (2.9%) 15 (2.8%) 13 (2.4%) 144 (26.5%)
15 (2, 8%) 13 (2, 4%)
2 (0.4%) 1 (0.2%) 0 (0%) 0 (0%) 1 (0.2%) 0 (0%) 0 (0%) 0 (0%) 46 (8.5%)
0 (0, 0%) 0 (0, 0%)
1 (0.2%) 1 (0.2%) 0 (0%) 0 (0%) 0 (0%) 1 (0.2%) 0 (0%) 0 (0%) 0 (0%)
0 (0%)
Skin and subcutaneous
Foarte frecvente
Very common
Erupţie cutanată
Very common
Piele uscată
Hair colour changes
Decolorarea părului
Very common Common Common Common Common Common Common Common
Foarte frecvente Frecvente Frecvente Frecvente Frecvente Frecvente Frecvente Frecvente
Alopecia Erythema Skin exfoliation Pruritus Periorbital oedema Dermatitis Skin lesion Nail disorder/ discolouration
Alopecie Eritem Exfoliere cutanată Prurit Edem periorbital Dermatită Leziuni cutanate Afecţiuni ale unghiilor/ decolorare
0 (0%) 2 (0.4%) 4 (0.7%) 1 (0.2%) 1 (0.2%) 4 (0.7%) 1 (0.2%) 0 (0%)
0 (0%) 2 (0, 4%) 4 (0, 7%) 1 (0, 2%) 1 (0, 2%) 4 (0, 7%) 1 (0, 2%) 0 (0, 0%)
0 (0%) 0 (0%) 0 (0%) 0 (0%) 0 (0%) 0 (0%) 0 (0%) 0 (0%)
0 (0%) 0 (0%) 0 (0%) 0 (0%) 0 (0, 0%) 0 (0, 0%) 0 (0, 0%) 0 (0, 0%)
0 (0%) 0 (0%) 0 (0%) 0 (0%)
0 (0, 0%) 0 (0, 0%) 0 (0, 0%) 0 (0, 0%)
Musculoskeletal and connective tissue disorders
Tulburări musculo -
Very common Common Common Common Common
Foarte frecvente
Pain in extremity Arthralgia Myalgia Muscle Spasm Back pain
Dureri la nivelul extremităţilor
96 (17.6%) 49 (9.0%) 48 (8.8%) 26 (4.8%) 17 (3.1%)
96 (17, 6%)
6 (1.1%) 1 (0.2%) 2 (0.4%) 0 (0%) 2 (0.4%)
6 (1, 1%)
General disorders and
scheletice ale ţesutului conjunctiv şi ale tesutului osos Tulburări generale şi la
Very common
Frecvente Frecvente Frecvente Frecvente Foarte frecvente
Fatigue/ asthenia
Artralgii Mialgii Spasme musculare Dureri lombare Astenie/ Oboseală
397 (73.0%)
49 (9, 0%) 48 (8, 8%) 26 (4, 8%) 17 (3, 1%) 397 (73, 0%)
95 (17.5%)
1 (0, 2%) 2 (0, 4%) 0 (0, 0%) 2 (0, 4%) 95 (17, 5%)
1 (0.2%)
0 (0%) 0 (0%) 0 (0, 0%) 0 (0, 0%) 1 (0, 2%)
administration site conditions
nivelul locului administrare
Very common
Foarte Frecvente
Mucosal inflammation
Inflamaţia mucoasei Edem d
Oedema d Pyrexia Chills
Foarte frecvente
5 (0.9%) 3 (0.6%) 2 (0.4%)
5 (0, 9%)
Pain Chest pain
Pirexie Frisoane Durere Durere toracică
20 (3.7%) 13 (2.4%)
37 (6, 8%) 35 (6, 4%) 20 (3, 7%) 13 (2, 4%)
0 (0%) 2 (0.4%)
3 (0, 6%) 2 (0, 4%) 0 (0%) 2 (0, 4%)
Insomnia Depression Ejection fraction decrease
Insomnie Depresie Scăderea fracţiei de ejecţie
Weight decrease Platelet count decrease
Scădere în greutate Reducerea numărului de trombocite
Lipase increase Haemoglobin decreased
Toate gradele de severitate n (%)
11 (2%) 0 (0%)
0 (0, 0%)
Blood creatine phosphokinase increased
Creşterea fosfatazei alcaline sanguine
Aspartate aminotransferase increased
Creşterea aspartataminotransfe razei
This includes spontaneous case reports as well as serious adverse events from ongoing studies, the expanded access programmes, clinical pharmacology studies and exploratory studies in unapproved indications.
Aceste includ cazuri raportate spontan precum şi reacţii adverse grave din studiile clinice în desfăşurare, programele de acces extins, studiile de farmacologie clinică şi studiile exploratorii în indicaţiile neaprobate.