natgillin/translations-raw huggingface dataset:
4 Breast-feeding must be discontinued during pemetrexed therapy (see section 4.6).
Alăptarea trebuie întreruptă în cursul terapiei cu pemetrexed (vezi pct. 4. 6).
Concomitant yellow fever vaccine (see section 4.5).
4. 5).
Pemetrexed can suppress bone marrow function as manifested by neutropenia, thrombocytopenia and anaemia (or pancytopenia) (see section 4.8).
4. 8).
Patients should be monitored for myelosuppression during therapy and pemetrexed should not be given to patients until absolute neutrophil count (ANC) returns to ≥ 1500 cells/ mm3 and platelet count returns to ≥ 100,000 cells/ mm3.
Pacienţii trebuie monitorizaţi pentru mielosupresie în cursul terapiei, iar pemetrexed nu trebuie administrat pacienţilor până când numărul absolut de neutrofile (NAN) nu a revenit la ≥ 1500 celule/ mm3, iar numărul de trombocite nu a revenit la ≥ 100000 celule/ mm3.
Dose reductions for subsequent cycles are based on nadir ANC, platelet count and maximum non-haematologic toxicity seen from the previous cycle (see section 4.2).
4. 2).
Less toxicity and reduction in Grade 3/ 4 haematologic and non-haematologic toxicities such as neutropenia, febrile neutropenia and infection with Grade 3/ 4 neutropenia were reported when pre-treatment with folic acid and vitamin B12 was administered.
Atunci când a fost administrat pretratament cu acid folic şi vitamină B12 s- au raportat toxicitate mai scăzută şi reducerea toxicităţii hematologice şi non- hematologice de grad 3/ 4 cum ar fi neutropenia, neutropenia febrilă şi infecţia cu neutropenie de grad 3/ 4.
Therefore, all patients treated with pemetrexed must be instructed to take folic acid and vitamin B12 as a prophylactic measure to reduce treatment-related toxicity (see section 4.2).
4. 2).
Skin reactions have been reported in patients not pre-treated with a corticosteroid.
La pacienţii care nu au fost pretrataţi cu un glucocorticoid, s- au raportat reacţii cutanate.
Pre-treatment with dexamethasone (or equivalent) can reduce the incidence and severity of skin reactions (see section 4.2).
4. 2).
An insufficient number of patients has been studied with creatinine clearance of below 45 ml/ min.
A fost studiat un număr insuficient de pacienţi cu clearance al creatininei mai mic de 45 ml/ min.
Therefore, the use of pemetrexed in patients with creatinine clearance of < 45 ml/ min is not recommended (see section 4.2).
4. 2).
Patients with mild to moderate renal insufficiency (creatinine clearance from 45 to 79 ml/ min) should avoid taking non-steroidal anti-inflammatory drugs (NSAIDs) as ibuprofen, and aspirin (> 1.3 g daily) for 2 days before, on the day of, and 2 days following pemetrexed administration (see section 4.5).
4. 5).
All patients eligible for pemetrexed therapy should avoid taking NSAIDs with long elimination half- lives for at least 5 days prior to, on the day of, and at least 2 days following pemetrexed administration (see section 4.5).
4. 5).
Many of the patients in whom these occurred had underlying risk factors for the development of renal events including dehydration or pre-existing hypertension or diabetes.
Mulţi dintre pacienţii la care au apărut aceste evenimente aveau factori de risc preexistenţi pentru dezvoltarea evenimentelor renale incluzând deshidratare sau hipertensiune arterială sau diabet preexistente.
The effect of third space fluid, such as pleural effusion or ascites, on pemetrexed is unknown.
Efectul asupra pemetrexed al fluidelor din spaţiul al treilea, cum ar fi revărsatele pleurale sau ascita, este necunoscut.
In patients with clinically significant third space fluid, consideration should be given to draining the effusion prior to pemetrexed administration.
La pacienţii care prezintă lichid în spaţiul al treilea în cantitate semnificativă clinic trebuie luată în considerare drenarea colecţiilor înainte de administrarea pemetrexed.
Due to the gastrointestinal toxicity of pemetrexed given in combination with cisplatin, severe dehydration has been observed.
Datorită toxicităţii gastro- intestinale a pemetrexed administrat în asociere cu cisplatină a fost observată deshidratare severă.
Therefore, patients should receive adequate antiemetic treatment and appropriate hydration prior to and/ or after receiving treatment.
În consecinţă, pacienţilor trebuie să li se administreze tratament antiemetic adecvat şi hidratare corespunzătoare înainte de şi/ sau după administrarea tratamentului.
Serious cardiovascular events, including myocardial infarction and cerebrovascular events have been uncommonly reported during clinical studies with pemetrexed, usually when given in combination with another cytotoxic agent.
În cursul studiilor clinice cu pemetrexed evenimentele cardio- vasculare grave, incluzând infarctul miocardic şi evenimentele cerebro- vasculare au fost raportate mai puţin frecvent şi s- au produs de obicei atunci când pemetrexed a fost administrat în asociere cu alt medicament citotoxic.
Most of the patients in whom these events have been observed had pre- existing cardiovascular risk factors (see section 4.8).
4. 8).
As a result, concomitant use of live attenuated vaccines (except yellow fever which is contraindicated) is not recommended (see section 4.3 and 4.5).
4. 3 şi 4. 5).
5 Pemetrexed can have genetically damaging effects.
5 Pemetrexed poate avea efecte genetice dăunătoare.
Women of childbearing potential must use effective contraception during treatment with pemetrexed (see section 4.6).
4. 6).
Cases of radiation recall have been reported in patients who received radiotherapy weeks or years previously.
La pacienţii care au efectuat radioterapie cu câteva săptămâni sau ani înainte de tratamentul cu pemetrexed, au fost raportate cazuri de reapariţie a leziunilor post- iradiere.
Concomitant administration of nephrotoxic drugs (e. g. aminoglycoside, loop diuretics, platinum compounds, cyclosporin) could potentially result in delayed clearance of pemetrexed.
Administrarea concomitentă a unor medicamente nefrotoxice (de exemplu, aminoglicozide, diuretice de ansă, compuşi cu platină, ciclosporină) pot determina întârzierea clearance- ului pemetrexed.
Concomitant administration of substances that are also tubularly secreted (e. g. probenecid, penicillin) could potentially result in delayed clearance of pemetrexed.
Administrarea concomitentă a altor substanţe secretate tubular (de exemplu, probenecid, penicilină) poate determina întârzierea clearance- ului pemetrexed.
In patients with normal renal function (creatinine clearance > 80 ml/ min), high doses of non-steroidal anti-inflammatory drugs (NSAIDs, such as ibuprofen > 1600 mg/ day) and aspirin at higher dosage (> 1.3 g daily) may decrease pemetrexed elimination and, consequently, increase the occurrence of pemetrexed adverse events.
La pacienţii cu funcţie renală normală (clearance al creatininei ≥ 80 ml/ min), dozele mari de medicamente antiinflamatoare nesteroidiene (AINS, cum ar fi ibuprofenul > 1600 mg/ zi) şi acidul acetilsalicilic în doze mai mari (≥ 1, 3 g zilnic) pot să scadă eliminarea pemetrexed şi, în consecinţă, să crească frecvenţa evenimentelor adverse ale pemetrexed.
Therefore, caution should be made when administering higher doses of NSAIDs or aspirin at higher dosage, concurrently with pemetrexed to patients with normal function (creatinine clearance > 80 ml/ min).
Ca atare, la pacienţii cu funcţie renală normală (clearance al creatininei ≥ 80 ml/ min), este necesară prudenţă atunci când se administrează doze mari de AINS sau acid acetilsalicilic în doze mai mari, în asociere cu pemetrexed.
In patients with mild to moderate renal insufficiency (creatinine clearance from 45 to 79 ml/ min), the concomitant administration of pemetrexed with NSAIDs (e. g. ibuprofen) or aspirin at higher dosage should be avoided for 2 days before, on the day of, and 2 days following pemetrexed administration (see section 4.4).
4. 4).
In the absence of data regarding potential interaction with NSAIDs having longer half-lives as piroxicam or rofecoxib, the concomitant administration with pemetrexed should be avoided for at least 5 days prior to, on the day of, and at least 2 days following pemetrexed administration (see section 4.4).
4. 4).
Results from in vitro studies with human liver microsomes indicated that pemetrexed would not be predicted to cause clinically significant inhibition of the metabolic clearance of drugs metabolised by CYP3A, CYP2D6, CYP2C9, and CYP1A2.
Rezultatele studiilor in vitro cu microzomi hepatici umani arată că nu se prevede determinarea de către pemetrexed a unei inhibiţii semnificative clinic a clearance- ului metabolic al medicamentelor metabolizate de CYP3A, CYP2D6, CYP2C9 şi CYP1A2.
The high intra-individual variability of the coagulation status during diseases and the possibility of interaction between oral anticoagulants and anticancer chemotherapy require increased frequency of INR (International Normalised Ratio) monitoring, if it is decided to treat the patient with oral anticoagulants.
Variabilitatea intra- individuală mare a statusului coagulării în cursul bolilor şi posibilitatea interacţiunilor dintre anticoagulantele orale şi chimioterapia anticanceroasă necesită o intensificare a monitorizării INR (International Normalised Ratio), dacă se decide tratarea pacientului cu anticoagulante orale.
Concomitant use contraindicated:
4. 3).
Yellow fever vaccine: risk of fatal generalised vaccinale disease (see section 4.3).
6 Utilizare concomitentă nerecomandată: vaccinuri vii atenuate (cu excepţia celui împotriva febrei galbene, la care este contraindicată utilizarea concomitentă): risc de boală sistemică, posibil letală.
Concomitant use not recommended:
Riscul este crescut la persoanele care au deja imunosupresie prin boala lor de bază.
Live attenuated vaccines (except yellow fever, for which concomitant use is contraindicated): risk of systemic, possibly fatal, disease.
Se va utiliza un vaccin inactivat, dacă este disponibil (poliomielită) (vezi pct.
The risk is increased in
4. 4).
6 subjects who are already immunosuppressed by their underlying disease.
4. 6 Sarcina şi alăptarea
Pemetrexed should not be used during pregnancy unless clearly necessary, after a careful consideration of the needs of the mother and the risk for the foetus (see section 4.4).
4. 4).
Women of childbearing potential must use effective contraception during treatment with pemetrexed.
Femeile aflate în perioada fertilă trebuie să utilizeze contracepţie eficientă în timpul tratamentului cu pemetrexed.
Contraceptive measures or abstinence are recommended.
Sunt recomandate măsuri contraceptive sau abstinenţa.
Breast-feeding must be discontinued during pemetrexed therapy (see section 4.3).
4. 3).
However, it has been reported that pemetrexed may cause fatigue.
Totuşi, s- a raportat că pemetrexed poate să determine oboseală.
The table below provides the frequency and severity of undesirable effects that have been reported in > 5% of 168 patients with mesothelioma who were randomised to receive cisplatin and pemetrexed and 163 patients with mesothelioma randomised to receive single agent cisplatin.
Tabelul de mai jos prezintă frecvenţa şi severitatea reacţiilor adverse raportate la > 5% din 168 pacienţi cu mezoteliom care au fost randomizaţi pentru a li se administra cisplatină şi pemetrexed precum şi la 163 pacienţi cu mezoteliom randomizaţi pentru a li se administra cisplatină în monoterapie.
In both treatment arms, these chemonaive patients were fully supplemented with folic acid and vitamin B12.
În ambele braţe de tratament, pacienţilor cărora nu li s- a administrat chimioterapie anterioară, li s- a administrat suplimentare completă cu acid folic şi vitamina B12.
Very common (≥ 1/ 10), Common (≥ 1/ 100 and < 1/ 10), Uncommon (≥ 1/ 1000 and < 1/ 100), Rare (≥ 1/ 10,000 and < 1/ 1000), Very Rare (<  1/ 10,000) and Not known (cannot be estimated from available data-spontaneous reports)
Reacţii adverse Estimarea frecvenţei: foarte frecvente (≥1/ 10), frecvente (≥1/ 100, < 1/ 10), mai puţin frecvente (≥1/ 1000, < 1/ 100), rare (≥1/ 10000, < 1/ 1000), foarte rare (< 1/ 10000), frecvenţă necunoscută (nu poate fi estimată din datele disponibile din rapoarte spontane).
7 System Organ
Clasificare
Event*
Evenimentul *
Pemetrexed/ cisplatin (N = 168)
Pemetrexed/ cisplatină (N= 168)
Cisplatin (N = 163)
Cisplatină (N= 163)
Class
Toxicitate Toxicitate toate grad gradele 3– 4 (%) (%)
All
Toxicitate Toxicitate toate grad gradele 3– 4 (%) (%)
Grade All
Tulburări
All Grade All
Foarte
Grade
Nr. scăzut de
Grades
56, 0 23, 2
3-4
13, 5 3, 1
Grades 3-4 Grades
hematologice şi limfatice
3-4
frecvente
Toxicity Toxicity (%) (%)
neutrofile/ gran ulocite
Toxicity Toxicity (%) (%)
Nr. scăzut de leucocite
Blood and Lymphatic System
14, 9
Very Common
16, 6
Neutrophils/ Granulocytes decreased
Hemoglobină scăzută
56.0 23.2
26, 2
13.5 3.1
4, 2
Disorders
10, 4
Leukocytes decreased
Nr. scăzut de trombocite
53.0 14.9
23, 2
16.6 0.6
8, 6
Haemoglobin decreased
Tulburări oculare
26.2 4.2
Frecvente
10.4 0.0
0, 0
23.2 5.4
0, 6
Eye Disorders
Tulburări
Conjunctivitis
Diaree
5.4 0.0
8, 0
Gastrointestinal Disorders
gastro - intestinale
Very Common
frecvente
Diarrhoea Vomiting Stomatitis/ Pharyngitis
Vărsături Stomatită / Faringită
16.7 3.6 56.5 10.7 23.2 3.0
56, 5 23, 2
8.0 0.0 49.7 4.3 6.1 0.0
10, 7 3, 0
Nausea Anorexia Constipation
Greaţă Anorexie Constipaţie
76.7 5.5 14.1 0.6 7.4 0.6
0, 6
General Disorders
Tulburări generale
Nervous System Disorders
Tulburări ale sistemului
Neuropathy- Sensory
Neuropatie senzorială
Common
nervos
Taste disturbance
0, 0 ***
7.7
0, 0 ***
0.0***
Frecvente
6.1
7, 7
0.0***
6, 1
Creatinine clearance decreased**
Clearance al creatininei scăzut **
Skin and Subcutaneous
Afecţiuni
Very Common
Foarte
Tissue Disorders
ţesutului subcutanat
0.0***
0, 0 **
*Refer to National Cancer Institute CTC version 2 for each grade of toxicity except the term “ creatinine clearance decreased” ** which is derived from the term “ renal/ genitourinary other”. *** According to National Cancer Institute CTC (v2.0; NCI 1998), taste disturbance and alopecia should only be reported as Grade 1 or 2.
* A se vedea CTC versiunea 2 ale Institutului Naţional al Cancerului (NCI) pentru fiecare grad de toxicitate cu excepţia termenului „ clearance al creatininei scăzut ” ** care este derivat din termenul „ alte tulburări renale/ genito- urinare ”. *** Conform CTC al Institutului Naţional al Cancerului (v2. 0, NCI 1998), tulburările gustului şi alopecia trebuie raportate ca fiind numai de gradul 1 sau 2.
8 Very common - ≥ 10%; Common is normally defined as - ≥ 1% and < 10%.
Foarte frecvent: ≥ 10%; frecvent se defineşte în mod normal ca ≥ 1% şi < 10%.
For the purpose of this table a cut off of 5% was used for inclusion of all events where the reporter considered a possible relationship to pemetrexed and cisplatin.
Pentru tabelul de mai sus, s- a folosit un prag de 5% pentru includerea tuturor evenimentelor despre care raportorul a considerat posibilă relaţia cu pemetrexed şi cisplatină.
Clinically relevant CTC toxicities that were reported in - ≥ 1% and < 5% (common) of the patients that were randomly assigned to receive cisplatin and pemetrexed include: renal failure, infection, pyrexia, febrile neutropenia, increased AST, ALT, and GGT, urticaria and chest pain.
Toxicitatea relevantă clinic conform CTC şi care a fost raportată la ≥ 1% şi ≤ 5% (frecvent) din pacienţii care au fost randomizaţi să li se administreze cisplatină şi pemetrexed include: insuficienţă renală, infecţie, febră, neutropenie febrilă, ASAT, ALAT şi GGT crescute, urticarie şi dureri toracice.
Clinically relevant CTC toxicities that were reported in < 1% (uncommon) of the patients that were randomly assigned to receive cisplatin and pemetrexed include arrhythmia and motor neuropathy.
Toxicitatea relevantă clinic conform CTC care a fost raportată la < 1% (mai puţin frecvent) din pacienţii care au fost randomizaţi să li se administreze cisplatină şi pemetrexed include aritmie şi neuropatie motorie.
The table below provides the frequency and severity of undesirable effects that have been reported in > 5% of 265 patients randomly assigned to receive single agent pemetrexed with folic acid and vitamin B12 supplementation and 276 patients randomly assigned to receive single agent docetaxel.
Tabelul de mai jos prezintă frecvenţa şi severitatea reacţiilor adverse care au fost raportate la > 5% din 265 pacienţi randomizaţi să li se administreze pemetrexed în monoterapie cu suplimentare de acid folic şi vitamină B12 şi din 276 pacienţi randomizaţi să li se administreze docetaxel în monoterapie.
All patients were diagnosed with locally advanced or metastatic non-small cell lung cancer and received prior chemotherapy.
Toţi pacienţii au avut diagnosticul de cancer pulmonar altul decât cel cu celule mici, local avansat sau metastazat şi li s- a administrat chimioterapie anterioară.
System Organ Class
8 Clasificare pe
All Grades Grade 3 – Toxicity 4 Toxicity (%) (%)
Toxicitate Toxicitate Toxicitate toate grad 3 – 4 toate gradele (%) gradele (%) (%)
All Grades Grade 3 – Toxicity 4 Toxicity (%) (%)
Toxicitate grad 3 – 4 (%)
Blood and Lymphatic System
Tulburări hematologice şi limfatice
Neutrophils/ Granulocytes decreased
Nr. scăzut de granulocite / neutrofile
10.9 5.3
10, 9 5, 3 45, 3
45.3 40.2
40, 2
12.1 4.2
12, 1 4, 2 34, 1
19.2 4.2
19, 2 4, 2 22, 1
22.1 4.3
4, 3
8.3 1.9
8, 3 1, 9 1, 1
Gastrointestinal Disorders
Tulburări gastro - intestinale
Diarrhoea Vomiting Stomatitis/ Pharyngitis
Diaree Vărsături Stomatită / Faringită
12.8 0.4 16.2 1.5 14.7 1.1
12, 8 0, 4 24, 3 16, 2 1, 5 12, 0 14, 7 1, 1 17, 4
24.3 2.5 12.0 1.1 17.4 1.1
2, 5 1, 1 1, 1
Nausea Anorexia
Greaţă Anorexie
30.9 2.6 21.9 1.9
30, 9 2, 6 16, 7 21, 9 1, 9 23, 9
16.7 1.8 23.9 2.5
1, 8 2, 5
5.7 0.0
5, 7 0, 0 4, 0
34.0 5.3
34, 0 5, 3 35, 9
35.9 5.4
5, 4
8.3 0.0
8, 3 0, 0 7, 6
Hepatobilliary Disorders
Tulburări hepatobiliare
SGPT (ALT) elevation
Creştere a SGPT (ALT)
7.9 1.9
7, 9 1, 9 1, 4
SGOT (AST) elevation
Creştere a SGOT (AST)
6.8 1.1
6, 8 1, 1 0, 7
Skin and Sub- cutaneous
Afecţiuni
Rash/ desquamation
Erupţie
14.0 0.0
14, 0 0, 0 6, 2
Tissue Disorders Common
cutanate şi ţesutului
Pruritus
subcutanat
*Refer to National Cancer Institute CTC version 2 for each grade of toxicity. **According to National Cancer Institute CTC (v2.0; NCI 1998), alopecia should only be reported as Grade 1 or 2.
* A se vedea CTC versiunea 2, ale Institutului Naţional al Cancerului pentru fiecare grad de toxicitate. ** Conform CTC al Institutului Naţional al Cancerului (v2. 0, NCI 1998), alopecia trebuie raportată ca fiind doar de gradul 1 sau 2.
Very common ≥ 10%; Common is normally defined as ≥ 1% and < 10%.
Foarte frecvent: ≥ 10%; frecvent se defineşte în mod normal ca ≥ 1% şi < 10%.
For the purpose of this table a cut off of 5% was used for inclusion of all events where the reporter considered a possible relationship to pemetrexed.
Pentru tabelul de mai sus, s- a folosit un prag de 5% pentru includerea tuturor evenimentelor pe care raportorul le- a considerat în posibilă relaţie cu pemetrexed.
9 Clinically relevant CTC toxicities that were reported in ≥ 1% and < 5% (common) of the patients that were randomly assigned to pemetrexed include: infection without neutropenia, febrile neutropenia, allergic reaction/ hypersensitivity, increased creatinine, motor neuropathy, sensory neuropathy, erythema multiforme, and abdominal pain.
Toxicitatea relevantă clinic conform CTC care a fost raportată la ≥ 1% şi ≤ 5% (frecventă) din pacienţii care au fost randomizaţi să li se administreze pemetrexed include: infecţie fără neutropenie, neutropenie febrilă, reacţie alergică/ hipersensibilitate, creştere a creatininei, neuropatie motorie, neuropatie senzorială, eritem multiform şi durere abdominală.
Clinically relevant CTC toxicities that were reported in < 1% (uncommon) of the patients that were randomly assigned to pemetrexed include supraventricular arrhythmias.
Toxicitatea relevantă clinic conform CTC care a fost raportată la < 1% (mai puţin frecvent) din pacienţii care au fost randomizaţi să li se administreze pemetrexed include aritmii supraventriculare.
Clinically relevant Grade 3 and Grade 4 laboratory toxicities were similar between integrated Phase 2 results from three single agent pemetrexed studies (n = 164) and the Phase 3 single agent pemetrexed study described above, with the exception of neutropenia (12.8% versus 5.3%, respectively) and alanine transaminase elevation (15.2% versus 1.9%, respectively).
Toxicitatea relevantă clinic de grad 3 şi grad 4 exprimată prin modificări ale probelor de laborator a fost similară la rezultatele integrate din trei studii de faza 2 cu pemetrexed în monoterapie (n = 164) şi din studiul de faza 3, descris mai sus, cu pemetrexed în monoterapie, cu excepţia neutropeniei (12, 8% versus, respectiv, 5, 3%) şi creşterea alanin- amino- transferazei (15, 2% versus, respectiv, 1, 9%).
These differences were likely due to differences in the patient population, since the Phase 2 studies included both chemonaive and heavily pre-treated breast cancer patients with pre-existing liver metastases and/ or abnormal baseline liver function tests.
9 faza 2 au inclus atât pacienţi fără chimioterapie anterioară precum şi paciente cu cancer mamar, cu tratament anterior intensiv, cu metastaze hepatice preexistente şi/ sau cu teste ale funcţiei hepatice anormale iniţial.
The table below provides the frequency and severity of undesirable effects considered possibly related to study drug that have been reported in > 5% of 839 patients with NSCLC who were randomized to receive cisplatin and pemetrexed and 830 patients with NSCLC who were randomized to receive cisplatin and gemcitabine.
Tabelul de mai jos prezintă frecvenţa şi severitatea reacţiilor adverse considerate ca având o posibilă legătură cu medicaţia de studiu şi care au fost raportate la > 5% din 839 pacienţi cu NSCLC randomizaţi să li se administreze cisplatină şi pemetrexed şi din 830 pacienţi cu NSCLC randomizaţi să li se administreze cisplatină şi gemcitabină.
All patients received study therapy as initial treatment for locally advanced or metastatic NSCLC and patients in both treatment groups were fully supplemented with folic acid and vitamin B12.
Tuturor pacienţilor li s- a administrat medicaţia de studiu ca tratament iniţial al NSCLC local avansat sau metastazat şi la ambele grupuri de tratament s- a administrat suplimentar acid folic şi vitamina B12.
Frequency
Clasificare pe Frecvenţa aparate,
Event**
Evenimentul **
Pemetrexed/ cisplatin (N = 839)
Pemetrexed/ cisplatină (N=839)
Gemcitabine/ cisplatin (N = 830)
Gemcitabină/ cisplatină (N=830)
All Grade All
sisteme şi organe
Grades 3-4 Grades
Toxicitate Toxicitate Toxicitate toate grad 3 – 4 toate gradele (%) gradele (%) (%)
Toxicity Toxicity (%) (%)
Toxicitate grad 3 – 4 (%)
Toxicity Toxicity (%) (%)
Tulburări hematologice şi limfatice
Neutrophils/ Granulocytes decreased
Scăderea hemoglobinemie i Scăderea numărului de neutrofile / granulocite
29.0* 15.1*
33, 0 * 5, 6 * 45, 7 * 29, 0 * 15, 1 * 38, 4 *
38.4* 26.7*
9, 9 * 26, 7 *
17.8 4.8*
17, 8 4, 8 * 20, 6
10.1* 4.1*
10, 1 * 4, 1 * 26, 6 *
Nausea Vomiting Anorexia Constipation Stomatitis/ pharyngitis
Greaţă Vărsături Anorexie Constipaţie Stomatită / Faringită
56.1 39.7 26.6 21.0 13.5
56, 1 7, 2 * 53, 4 39, 7 6, 1 35, 5 26, 6 2, 4 * 24, 2 21, 0 0, 8 19, 5 13, 5 0, 8 12, 4
7.2* 6.1 2.4* 0.8 0.8
3, 9 * 6, 1 0, 7 * 0, 4 0, 1
53.4 35.5 24.2 19.5 12.4
Diaree fără colostomie
12.8
12, 4 1, 3 12, 8
Dyspepsia/ heartburn
Dispepsie / pirozis
5.9
5, 2 0, 1 5, 9
Very Common
Foarte frecvente Frecvente
44.9
42, 7 6, 7 44, 9
Nervous System
Tulburări ale sistemului
8.5*
8, 5 * 0, 0 * 12, 4 *
0.0*
0, 6 *
12.4*
nervos
Disorders
Tulburări ale gustului
Taste disturbance
8, 1 0, 0 *** 8, 9
10.1*
10, 1 * 0, 8 6, 9 *
Skin and Subcutaneous
Afecţiuni cutanate şi ale
21.4*
11, 9 * 0 *** 21, 4 *
Tissue Disorders
10 ţesutului subcutanat