natgillin/translations-raw huggingface dataset:
9 • 255 patients who received docetaxel in combination with capecitabine. • 332 patients who received docetaxel in combination with prednisone or prednisolone (clinically important treatment related adverse events are presented). • 744 patients who received docetaxel in combination with doxorubicin and cyclophosphamide (clinically important treatment related adverse events are presented). • 300 gastric adenocarcinoma patients (221 patients in the phase III part of the study and 79 patients in the phase II part) who received docetaxel in combination with cisplatin and 5-fluorouracil (clinically important treatment related adverse events are presented). • 174 and 251 head and neck cancer patients who received docetaxel in combination with cisplatin and 5-fluorouracil (clinically important treatment related adverse events are presented).
9 • 332 bolnikih, ki so prejemali docetaksel v kombinaciji s prednizonom ali prednizolonom (predstavljeni so klinično pomembni z zdravljenjem povezani neželeni učinki). • 744 bolnikih, ki so prejemali docetaksel v kombinaciji z doksorubicinom in ciklofosfamidom (predstavljeni so klinično pomembni z zdravljenjem povezani neželeni učinki). • 300 bolnikov z adenokarcinomom želodca (221 bolnikov v III. fazi študije in 79 bolnikov v II. fazi študije), ki so prejemali docetaksel v kombinaciji s cisplatinom in 5 - fluorouracilom (navedeni so klinično pomembni, z zdravljenjem povezani, neželeni učinki). • 174 in 251 bolnikov z rakom glave in vratu, ki so prejemali docetaksel v kombinaciji s cisplatinom in 5- fluorouracilom (navedeni so klinično pomembni, z zdravljenjem povezani, neželeni učinki).
These reactions were described using the NCI Common Toxicity Criteria (grade 3 = G3; grade 3-4 = G3/ 4; grade 4 = G4) and the COSTART terms.
Neželeni učinki so bili opisani po merilih NCI Common Toxicity Criteria (3. stopnja = S3, 3. – 4. stopnja = S3/ 4, 4. stopnja = S4) in z izrazi COSTART.
Frequencies are defined as: very common (≥ 1/ 10), common (≥ 1/ 100, < 1/ 10); uncommon (≥ 1/ 1,000, < 1/ 100); rare (≥ 1/ 10,000, < 1/ 1,000); very rare (< 1/ 10,000).
Opredelitev pogostnosti je: zelo pogosto (≥ 1/ 10), pogosto (≥ 1/ 100, < 1/ 10); občasno (≥ 1/ 1. 000, < 1/ 100); redko (≥ 1/ 10. 000, < 1/ 1. 000); zelo redko (< 1/ 10. 000).
The most commonly reported adverse reactions of docetaxel alone are: neutropenia (which was reversible and not cumulative; the median day to nadir was 7 days and the median duration of severe neutropenia (< 500 cells/ mm3) was 7 days), anemia, alopecia, nausea, vomiting, stomatitis, diarrhea and asthenia.
Najpogosteje opisani neželeni učinki na sam docetaksel so: nevtropenija (ki je bila reverzibilna in ni bila kumulativna; srednji čas do najmanjšega števila je bil 7 dni, srednje trajanje hude nevtropenije (< 500 celic/ mm3) pa 7 dni), anemija, alopecija, navzea, bruhanje, stomatitis, driska in astenija.
For combination with trastuzumab, adverse events (all grades) reported in ≥ 10% are displayed.
Pri kombinaciji s trastuzumabom so predstavljeni neželeni učinki (vseh stopenj) poročani v ≥ 10%.
23%) in the trastuzumab combination arm compared to docetaxel monotherapy.
V kombinacijski roki s trastuzumabom je prišlo do povečane incidence resnih neželenih učinkov (40% proti 31%) in neželenih učinkov stopnje 4 (34% proti 23%) v primerjavi z monoterapijo z docetakselom.
For combination with capecitabine, the most frequent treatment-related undesirable effects (≥ 5%) reported in a phase III trial in breast cancer patients failing anthracycline treatment are presented (see capecitabine summary of product characteristics).
Pri kombinaciji s kapecitabinom so predstavljeni najpogostejši z zdravljenjem povezani neželeni učinki (≥ 5%), o katerih so poročali v fazi III kliničnega preizkušanja pri bolnicah z rakom dojke z neuspelim zdravljenjem z antraciklini (prosimo, glejte povzetek glavnih značilnosti kapecitabina).
The development of severe peripheral neurotoxicity requires a reduction of dose (see sections 4.2 and 4.4).
Če se pojavijo hudi periferni nevrotoksični učinki, je treba odmerek zmanjšati (glejte poglavji 4. 2 in 4. 4).
Reactions were characterised by a rash including localised eruptions mainly on the feet and hands (including severe hand and foot syndrome), but also on the arms, face or thorax, and frequently associated with pruritus.
Za te reakcije je bil značilen izpuščaj, vključno z lokaliziranimi erupcijami, predvsem na dlaneh in stopalih (vključno z resnim roka/ noga sindromom), pa tudi na rokah, obrazu in prsnem košu; pogosto jih je spremljalo srbenje.
Less frequently, severe symptoms such as eruptions followed by desquamation which rarely lead to interruption or discontinuation of docetaxel treatment were reported (see sections 4.2 and 4.4).
Redkeje so poročali o hudih simptomih, npr. izpuščajih s poznejšo deskvamacijo, zaradi katerih je bilo treba v redkih primerih zdravljenje z docetakselom prekiniti (glejte poglavji 4. 2 in 4. 4).
Severe nail disorders are characterised by hypo- or hyperpigmentation and sometimes pain and onycholysis.
Za hudo prizadetost nohtov so značilni hipo - ali hiperpigmentacija in včasih bolečine in oniholiza.
The peripheral oedema usually starts at the lower
Zastajanje tekočine je vključevalo pojave, kot so periferni edemi, redkeje plevralni izliv, perikardialni izliv, ascites in povečanje telesne mase.
10 extremities and may become generalised with a weight gain of 3 kg or more.
Periferni edemi se ponavadi začnejo na nogah in lahko postanejo generalizirani; telesna masa se lahko poveča za 3 kg ali več.
Fluid retention is cumulative in incidence and severity (see section 4.4).
Zastajanje tekočine je 10 kumulativno po incidenci in izrazitosti (glejte poglavje 4. 4).
Severe reactions were characterised by hypotension and/ or bronchospasm or generalized rash/ erythema (see section 4.4).
Za hude reakcije so bili značilni hipotenzija in/ ali bronhospazem ali generaliziran izpuščaj/ eritem (glejte poglavje 4. 4).
Docetaxel Winthrop 100 mg/ m² single agent
Docetaxel Winthrop 100 mg/ m2 v monoterapiji
MedDRA System Organ classes Investigations
Organski sistemi po
Very common adverse Common adverse reactions reactions ≥ 10% of patients ≥ 1 to < 10% of patients G3/ 4 Blood bilirubin increased (< 5%); G3/ 4 Blood alkaline phosphatase increased (< 4%); G3/ 4 AST increased (< 3%); G3/ 4 ALT increased (< 2%)
Pogosti neželeni učinki Občasni neželeni ≥ 1 do < 10% bolnikov učinki ≥ 0, 1 do < 1%
Uncommon adverse reactions ≥ 0.1 to < 1% of patients
učinki ≥ 10% bolnikov
Arrhythmia (G3/ 4:
aritmija (S3/ 4:
0.7%)
0, 7%) srčno popuščanje
Neutropenia (G4:
nevtropenija (S4:
76.4%); 0.2%) Anaemia (G3/ 4:
76, 4%), anemija (S3/ 4:
8.9%); Febrile neutropenia
8, 9%), febrilna nevtropenija
Peripheral sensory neuropathy (G3:
periferna senzorična nevropatija (S3:
4.1%); Peripheral motor neuropathy (G3/ 4:
4, 1%), periferna motorična nevropatija (S3/ 4:
4%); Dysgeusia (severe:
4%), disgevzija (huda:
Dyspnoea (severe:
dispneja (huda:
Stomatitis (G3/ 4:
stomatitis (S3/ 4:
Constipation (severe:
5, 3%), driska (S3/ 4:
5.3%); 0.2%); Diarrhoea (G3/ 4:
4%), navzea (S3/ 4:
4%); Abdominal pain Nausea (G3/ 4:
4%), bruhanje (S3/ 4:
1%); Vomiting (G3/ 4:
bolečine v trebuhu (hude:
3%) Gastrointestinal haemorrhage (severe:
1%), gastrointestinalna krvavitev (huda:
Alopecia; Skin reaction (G3/ 4:
alopecija, kožna reakcija (S3/ 4:
5.9%); Nail disorders (severe:
5, 9%), spremembe nohtov (hude:
Musculoskeletal and connective tissue disorders
Bolezni mišično - skeletnega sistema in vezivnega tkiva
Myalgia (severe:
mialgija (huda:
1.4%) Arthralgia
artralgija
11
11 Organski sistemi po
MedDRA System Organ classes nutrition disorders
Zelo pogosti neželeni
Very common adverse reactions ≥ 10% of patients
Pogosti neželeni učinki Občasni neželeni ≥ 1 do < 10% bolnikov učinki ≥ 0, 1 do < 1%
Common adverse reactions ≥ 1 to < 10% of patients
učinki ≥ 10% bolnikov izidom v 1, 7%)
Uncommon adverse reactions ≥ 0.1 to < 1% of patients
bolnikov
Infections and infestations
Žilne bolezni Splošne težave in spremembe na mestu
Infections (G3/ 4:
zastajanje tekočine (hudo:
4.6%) 1.7%)
6, 5%),
Hypotension; Hypertension; Haemorrhage
hipotenzija, hipertenzija, krvavitev reakcija na mestu infundiranja,
General disorders and administration site conditions
aplikacije
Fluid retention (severe:
astenija (huda:
Infusion site reaction; 6.5%); Non-cardiac chest pain Asthenia (severe:
11, 2%), bolečine
(severe:
nekardialne bolečine v prsih (hude:
Hypersensitivity (G3/ 4:
preobčutljivost (S3/ 4:
Blood and lymphatic system disorders Rare: bleeding episodes associated with grade 3/ 4 thrombocytopenia.
Redki: krvavitve povezane s trombocitopenijo stopnje 3/ 4.
Nervous system disorders Reversibility data are available among 35.3% of patients who developed neurotoxicity following docetaxel treatment at 100 mg/ m² as single agent.
Podatki o reverzibilnosti so na voljo za 35, 3% bolnikov, pri katerih so se po zdravljenju z docetakselom kot monoterapijo v odmerku 100 mg/ m2 pojavili nevrotoksični učinki.
Skin and subcutaneous tissue disorders Very rare: one case of alopecia non-reversible at the end of the study.
Zelo redki: en primer alopecije, ki na koncu študije ni bila reverzibilna.
73% of the cutaneous reactions were reversible within 21 days.
73% kožnih reakcij je bilo reverzibilnih v 21 dneh.
General disorders and administration site conditions The median cumulative dose to treatment discontinuation was more than 1,000 mg/ m2 and the median time to fluid retention reversibility was 16.4 weeks (range 0 to 42 weeks).
Mediani kumulativni odmerek do prekinitve zdravljenja je bil več kot 1. 000 mg/ m2 in mediani čas do izginotja zastoja tekočine 16, 4 tedna (razpon od 0 do 42 tednov).
The onset of moderate and severe retention is delayed (median cumulative dose:
Zmeren oz. hud zastoj se kasneje pojavi pri bolnikih, ki dobijo premedikacijo (mediani kumulativni odmerek:
818.9 mg/ m2) in patients with premedication compared with patients without premedication (median cumulative dose:
818, 9 mg/ m2), kot pri tistih, ki je ne (mediani kumulativni odmerek:
489.7 mg/ m2); however, it has been reported in some patients during the early courses of therapy.
489, 7 mg/ m2); vendar je pri nekaterih bolnikih opisan med zgodnjimi ciklusi zdravljenja.
12 Docetaxel Winthrop 75 mg/ m² single agent
12 Docetaxel Winthrop 75 mg/ m2 v monoterapiji
MedDRA System Organ classes
Organski sistemi po MedDRA Preiskave
Common adverse reactions ≥ 1 to < 10% of patients
Zelo pogosti neželeni učinki ≥ 10% bolnikov
G3/ 4 Blood bilirubin increased (< 2%)
Pogosti neželeni učinki ≥1 do < 10% bolnikov zvečanje bilirubina v krvi S3/ 4 (< 2%)
Arrhythmia (no severe)
aritmija (nobene hude) febrilna nevtropenija
54.2%); Anaemia (G3/ 4:
54, 2%), anemija (S3/ 4:
10.8%); Thrombocytopenia (G4:
10, 8%), trombocitopenija (S4:
Peripheral sensory neuropathy (G3/ 4:
periferna senzorična nevropatija (S3/ 4:
Peripheral motor neuropathy (G3/ 4:
periferna motorična nevropatija (S3/ 4:
Nausea (G3/ 4:
navzea (S3/ 4:
3.3%); Stomatitis (G3/ 4:
3, 3%), stomatitis (S3/ 4:
1.7%); Vomiting (G3/ 4:
1, 7%), bruhanje (S3/ 4:
0.8%); Diarrhea (G3/ 4:
0, 8%), driska (S3/ 4:
Constipation
zaprtje
Skin and subcutaneous tissue disorders Musculoskeletal and connective tissue disorders
Bolezni kože in podkožja
0.8%) Myalgia
mialgija
Infections and infestations Vascular disorders General disorders and administration site conditions
Infekcijske in parazitske bolezni
Infections (G3/ 4:
okužbe (S3/ 4:
5%) Asthenia (severe:
5%)
12.4%); Fluid retention (severe:
12, 4%), zastajanje tekočine (hudo:
0.8%); Pain
0, 8%), bolečine
Hypersensitivity (no severe)
preobčutljivost (nobene hude)
13 Docetaxel Winthrop 75 mg/ m² in combination with doxorubicin
13 Docetaxel Winthrop 75 mg/ m2 v kombinaciji z doksorubicinom
Very common adverse Common adverse reactions reactions ≥ 10% of patients ≥ 1 to < 10% of patients
Zelo pogosti neželeni učinki ≥ 10% bolnikov
Uncommon adverse reactions ≥ 0.1 to < 1% of patients
Pogosti neželeni učinki Občasni neželeni ≥1 do < 10% bolnikov učinki ≥ 0, 1 do < 1% bolnikov zvečanje AST S3/ 4
G3/ 4 Blood bilirubin increased (< 2.5%); G3/ 4 Blood alkaline phosphatase increased (< 2.5%)
zvečanje bilirubina v (< 1%), krvi S3/ 4 (< 2, 5%), zvečanje ALT S3/ 4 zvečanje alkalne (< 1%) fosfataze v krvi S3/ 4 (< 2, 5%)
Cardiac failure; Arrhythmia (no severe)
srčno popuščanje, aritmija (nobene hude)
91.7%); Anaemia (G3/ 4:
91, 7%), anemija (S3/ 4:
9.4%); Febrile neutropenia; Thrombocytopenia (G4:
9, 4%), febrilna nevtropenija, trombocitopenija (S4:
Peripheral sensory Peripheral motor neuropathy (G3:
periferna senzorična nevropatija (S3:
5%); Stomatitis (G3/ 4:
5%), stomatitis (S3/ 4:
7.8%); Diarrhoea (G3/ 4:
7, 8%), driska (S3/ 4:
6.2%); Vomiting (G3/ 4:
6, 2%), bruhanje (S3/ 4:
5%); Constipation
5%), zaprtje
Alopecia; Nail disorders (severe:
alopecija, spremembe nohtov (hude:
0.4%); Skin reaction (no severe)
0, 4%), kožna reakcija (nobene hude)
Infection (G3/ 4:
okužba (S3/ 4:
Vascular disorders General disorders and administration site conditions
Splošne težave in spremembe na mestu aplikacije
Asthenia (severe:
astenija (huda:
Infusion site reaction 8.1%); Fluid retention (severe:
8, 1%), zastajanje tekočine (hudo:
1.2%); Pain
1, 2%), bolečine
Hypotension
reakcija na mestu infundiranja
14 Docetaxel Winthrop 75 mg/ m² in combination with cisplatin
14 Docetaxel Winthrop 75 mg/ m2 v kombinaciji s cisplatinom
G3/ 4 AST increased (0.5%); G3/ 4 Blood alkaline phosphatase increased (0.3%)
Pogosti neželeni učinki Občasni neželeni ≥ 1 do < 10% bolnikov učinki ≥ 0, 1 do < 1% bolnikov zvečanje bilirubina v zvečanje AST S3/ 4 krvi S3/ 4 (2, 1%), (0, 5%), zvečanje ALT S3/ 4 zvečanje alkalne (1, 3%) fosfataze v krvi S3/ 4 (0, 3%)
0.7%)
0, 7%) srčno popuščanje febrilna nevtropenija
Anaemia (G3/ 4:
51, 5%), anemija (S3/ 4:
6.9%); Thrombocytopenia (G4:
6, 9%), trombocitopenija (S4:
0.5%) Nervous system disorders
Bolezni živčevja
3.7%); Peripheral motor neuropathy (G3/ 4:
3, 7%), periferna motorična nevropatija (S3/ 4:
Gastrointestinal disorders
zaprtje Bolezni prebavil
9.6%); Vomiting (G3/ 4:
9, 6%), bruhanje (S3/ 4:
7.6%); Diarrhoea (G3/ 4:
7, 6%), driska (S3/ 4:
6.4%); Stomatitis (G3/ 4:
6, 4%), stomatitis (S3/ 4:
0.7%); Skin reaction (G3/ 4:
0, 7%), kožna reakcija (S3/ 4:
Infection (G3/ 4:
Presnovne in prehranske anoreksija motnje Infekcijske in parazitske okužba (S3/ 4:
5.7%)
5, 7%) bolezni
Hypotension (G3/ 4:
hipotenzija (S3/ 4:
Fluid retention (severe:
9, 9%), zastajanje tekočine (hudo:
0.7%); Fever (G3/ 4:
0, 7%), zvišana telesna temperatura (S3/ 4:
15 Docetaxel Winthrop 100 mg/ m² in combination with trastuzumab
15 Docetaxel Winthrop 100 mg/ m2 v kombinaciji s trastuzumabom
MedDRA System Organ classes
Organski sistemi po MedDRA Preiskave Srčne bolezni
Very common adverse reactions ≥ 10% of patients
Zelo pogosti neželeni učinki ≥ 10% bolnikov povečanje telesne mase
Common adverse reactions ≥ 1 to < 10% of patients
Pogosti neželeni učinki ≥ 1 do < 10% bolnikov srčno popuščanje
Investigations Cardiac disorders Blood and lymphatic system disorders
Bolezni krvi in limfatičnega sistema
Weight increased Neutropenia (G3/ 4:
nevtropenija (S3/ 4:
32%); Febrile neutropenia (includes neutropenia associated with fever and antibiotic use) or neutropenic sepsis
32%), febrilna nevtropenija (vključuje nevtropenijo, povezano z zvišano telesno temperaturo in uporabo antibiotika) ali nevtropenična sepsa
Epistaxis; Pharyngolaryngeal pain; Nasopharyngitis; Dyspnoea; Cough; Rhinorrhoea
epistaksa, faringo- laringealna bolečina, nazofaringitis, dispneja, kašelj, rinoreja
Nausea; Diarrhoea; Vomiting; Constipation; Stomatitis; Dyspepsia; Abdominal pain
navzea, driska, bruhanje, zaprtje, stomatitis, dispepsija, bolečine v trebuhu
Skin and subcutaneous tissue disorders Musculoskeletal and connective tissue disorders Metabolism and nutrition disorders
Bolezni kože in podkožja
Alopecia; Erythema; Rash; Nail disorders Myalgia; Arthralgia; Pain in extremity; Bone pain; Back pain Anorexia
alopecija, eritem, izpuščaj, spremembe nohtov
Vascular disorders
Presnovne in prehranske motnje Žilne bolezni
Lymphoedema
anoreksija limfedem
Symptomatic cardiac failure was reported in 2.2% of the patients who received docetaxel plus trastuzumab compared to 0% of patients given docetaxel alone.
O simptomatskem srčnem popuščanju so poročali pri 2, 2% bolnikov, ki so dobivali docetaksel in trastuzumab, in pri 0% bolnikov, ki so dobivali samo docetaksel.
In the docetaxel plus trastuzumab arm, 64% had received a prior anthracycline as adjuvant therapy compared with 55% in the docetaxel arm alone.
V kraku z docetakselom in trastuzumabom je 64% bolnikov predhodno dobivalo antracikline kot adjuvantno terapijo; v kraku, v katerem so bolniki dobivali samo docetaksel, je bil ta delež 55%.
Blood and lymphatic system disorders Very common:
Zelo pogosti:
Haematological toxicity was increased in patients receiving trastuzumab and docetaxel, compared with docetaxel alone (32% grade 3/ 4 neutropenia versus 22%, using NCI-CTC criteria).
Hematoloških toksičnih učinkov je bilo več pri bolnikih, ki so dobivali trastuzumab in docetaksel kot pri tistih, ki so dobivali samo docetaksel (32% nevtropenije stopnje 3/ 4 v primerjavi z 22% po merilih NCI- CTC).
Note that this is likely to be an underestimate since docetaxel alone at a dose of 100 mg/ m2 is known to result in neutropenia in 97% of patients, 76% grade 4, based on nadir blood counts.
Zavedati se je treba, da je to verjetno podcenjen delež, kajti znano je, da docetaksel sam v odmerku 100 mg/ m2 povzroči nevtropenijo pri 97% bolnikov, 76% stopnje 4, na podlagi najnižjega števila celic v krvi.
The incidence of febrile neutropenia/ neutropenic sepsis was also increased in patients treated with Herceptin plus docetaxel (23% versus 17% for patients treated with docetaxel alone).
Pri bolnikih, zdravljenih s Herceptinom in docetakselom, je bila večja tudi incidenca febrilne nevtropenije/ nevtropenične sepse (23% v primerjavi s 17% pri bolnikih, ki so dobivali samo docetaksel).
16 Docetaxel Winthrop 75 mg/ m² in combination with capecitabine
16 Docetaxel Winthrop 75 mg/ m2 v kombinaciji s kapecitabinom
Weight decreased; G3/ 4 Blood bilirubin increased (9%)
Pogosti neželeni učinki ≥ 1 do < 10% bolnikov zmanjšanje telesne mase, zvečanje bilirubina v krvi S3/ 4 (9%)
Neutropenia (G3/ 4:
nevtropenija (S3/ 4:
63%); Anaemia (G3/ 4:
63%), anemija (S3/ 4:
Thrombocytopenia (G3/ 4:
trombocitopenija (S3/ 4:
Dysgeusia (G3/ 4: < 1%); Paraesthesia (G3/ 4: < 1%)
disgevzija (S3/ 4: < 1%), parestezije (S3/ 4: < 1%)
Dizziness; Headache (G3/ 4: < 1%); Neuropathy peripheral
omotica, glavobol (S3/ 4: < 1%), periferna nevropatija
Pharyngolaryngeal pain (G3/ 4:
faringo- laringealna bolečina (S3/ 4:
Dyspnoea (G3/ 4:
dispneja (S3/ 4:
1%); Cough (G3/ 4: < 1%); Epistaxis (G3/ 4: < 1%)
1%), kašelj (S3/ 4: < 1%), epistaksa (S3/ 4: < 1%) bolečine v zgornjem delu
18%); Diarrhoea (G3/ 4:
18%), driska (S3/ 4:
14%); Nausea (G3/ 4:
14%), navzea (S3/ 4:
6%); Vomiting (G3/ 4:
6%), bruhanje (S3/ 4:
4%); Constipation (G3/ 4:
4%), zaprtje (S3/ 4:
1%); Abdominal pain (G3/ 4:
1%), bolečine v trebuhu (S3/ 4:
2%); Dyspepsia
2%), dispepsija
Abdominal pain upper; Dry mouth
trebuha, suha usta
Hand-foot syndrome (G3/ 4:
roka/ noga sindrom (S3/ 4:
24%); Alopecia (G3/ 4:
24%) alopecija (S3/ 4:
6%); Nail disorders (G3/ 4:
6%), spremembe nohtov (S3/ 4:
Dermatitis; Rash erythematous (G3/ 4: < 1%); Nail discolouration; Onycholysis (G3/ 4:
dermatitis, eritematozen izpuščaj (S3/ 4: < 1%), obarvanje nohtov, oniholiza (S3/ 4:
Musculoskeletal and connective tissue disorders Metabolism and nutrition disorders Infections and infestations
Bolezni mišično- skeletnega sistema in vezivnega tkiva Presnovne in prehranske motnje
Myalgia (G3/ 4:
mialgija (S3/ 4:
2%); Arthralgia (G3/ 4:
2%), artralgija (S3/ 4:
1%) Anorexia (G3/ 4:
1%) anoreksija (S3/ 4:
1%); Decreased appetite
1%), zmanjšan apetit
Pain in extremity (G3/ 4: < 1%); Back pain (G3/ 4:
bolečine v udih (S3/ 4: < 1%), bolečine v hrbtu (S3/ 4:
1%) Dehydration (G3/ 4:
1%) dehidracija (S3/ 4:
2%) Oral candidiasis (G3/ 4: < 1%)
2%),
General disorders and administration site conditions
Infekcijske in parazitske bolezni
Asthenia (G3/ 4:
Splošne težave in spremembe na astenija (S3/ 4:
3%); Pyrexia (G3/ 4:
pireksija (S3/ 4:
1%); Fatigue/ weakness (G3/ 4:
1%), utrujenost/ šibkost (S3/ 4:
5%); Oedema peripheral (G3/ 4:
5%), periferni edemi (S3/ 4:
17 Docetaxel Winthrop 75 mg/ m² in combination with prednisone or prednisolone
17 Docetaxel Winthrop 75 mg/ m2 v kombinaciji s prednizonom ali prednizolonom
MedDRA System Organ classes
Organski sistemi po MedDRA Srčne bolezni
Cardiac left ventricular function decrease (G3/ 4:
Pogosti neželeni učinki ≥ 1 do < 10% bolnikov zmanjšanje funkcije levega srčnega prekata (S3/ 4:
32%); Anaemia (G3/ 4:
32%), anemija (S3/ 4:
Thrombocytopenia (G3/ 4:
trombocitopenija, (S3/ 4:
0.6%); Febrile neutropenia
0, 6%), febrilna nevtropenija periferna motorična nevropatija
1.2%); Dysgeusia (G3/ 4:
1, 2%), disgevzija (S3/ 4:
Peripheral motor neuropathy (G3/ 4:
(S3/ 4:
Eye disorders
Očesne bolezni Bolezni dihal, prsnega koša in mediastinalnega prostora
Lacrimation increased (G3/ 4:
močnejše solzenje (S3/ 4:
Epistaxis (G3/ 4:
0, 6%) epistaksa (S3/ 4:
0%); Dyspnoea (G3/ 4:
0%), dispneja (S3/ 4:
0.6%); Cough (G3/ 4:
0, 6%), kašelj (S3/ 4:
2.4%); Diarrhoea (G3/ 4:
2, 4%), driska (S3/ 4:
1.2%); Stomatitis/ Pharyngitis (G3/ 4:
1, 2%), stomatitis/ faringitis (S3/ 4:
0.9%); Vomiting (G3/ 4:
0, 9%), bruhanje (S3/ 4:
Skin and subcutaneous tissue disorders Musculoskeletal and connective bone disorders Metabolism and nutrition disorders
Bolezni kože in podkožja
Alopecia; Nail disorders (no severe) Anorexia (G3/ 4:
(S3/ 4:
Exfoliative rash (G3/ 4:
anoreksija (S3/ 4:
0.3%) Arthralgia (G3/ 4:
0, 6%) okužba (S3/ 4:
0.3%); Myalgia (G3/ 4:
3, 3%) utrujenost (S3/ 4:
Infection (G3/ 4:
artralgija (S3/ 4:
3.3%) Fatigue (G3/ 4:
0, 3%), mialgija (S3/ 4:
18 Docetaxel Winthrop 75 mg/ m² in combination with doxorubicin and cyclophosphamide
18 Docetaxel Winthrop 75 mg/ m2 v kombinaciji z doksorubicinom in ciklofosfamidom
MedDRA System Organ classes Investigations
Organski sistemi po MedDRA
0.3%)
Zelo pogosti neželeni učinki ≥ 10% bolnikov
Uncommon adverse reactions ≥ 0.1 to < 1% of patients
Pogosti neželeni učinki Občasni neželeni ≥ 1 do < 10% bolnikov učinki ≥ 0, 1 do < 1% bolnikov
0.1%); Congestive heart failure
0, 1%), kongestivno srčno popuščanje
Anaemia (G3/ 4:
anemija (S3/ 4:
4.3%); Neutropenia (G3/ 4:
4, 3%), nevtropenija (S3/ 4:
65.5%); Thrombocytopenia (G3/ 4:
sinkopa (S3/ 4:
2.0%); Febrile neutropenia
0%) periferna motorična
Dysgeusia (G3/ 4:
disgevzija (S3/ 4:
Peripheral motor 0.7%); neuropathy (G3/ 4:
0, 7%), periferna senzorična nevropatija (S3/ 4:
Syncope (G3/ 4:
nevropatija (S3/ 4:
0%)
0%), nevrokortikalni (S3/ 4:
0.1%); Conjunctivitis (G3/ 4:
0, 3%), nevrocerebelarni (S3/ 4:
0.3%)
0, 1%)
Respiratory, thoracic and mediastinal disorders
Očesne bolezni Bolezni dihal, prsnega koša in mediastinalnega prostora
Cough (G3/ 4:
motnja solzenja (S3/ 4:
0%)
0%) bolečine v trebuhu kolitis/ enteritis/ perforac
5.1%); Abdominal pain (G3/ 4:
5, 1%), stomatitis (S3/ 4:
Stomatitis (G3/ 4:
4, 3%), driska (S3/ 4:
0.5%) 7.1%); Vomiting (G3/ 4:
3, 2%), zaprtje (S3/ 4:
3.2%); Constipation (G3/ 4:
(S3/ 4:
0.4%)
0, 5%) ija debelega črevesa
Alopecia; Skin toxicity (G3/ 4:
alopecija, toksični učinki na koži (S3/ 4:
0.7%); Nail disorders (G3/ 4:
0, 7%), spremembe nohtov (S3/ 4:
Anorexia (G3/ 4:
anoreksija (S3/ 4:
Infection (G3/ 4:
Infekcijske in parazitske okužba (S3/ 4:
3.2%); Neutropenic infection.
3, 2%), bolezni
There were no septic deaths.
Smrti zaradi sepse ni bilo.
Vasodilatation (G3/ 4:
vazodilatacija (S3/ 4:
Phlebitis (G3/ 4:
flebitis (S3/ 4:
0%); Lymphoedema (G3/ 4:
0%), limfedem (S3/ 4:
19 MedDRA System Organ classes General disorders and administration site conditions
19 Organski sistemi po MedDRA Splošne težave in spremembe na mestu aplikacije
Very common adverse Common adverse reactions reactions ≥ 10% of patients ≥ 1 to < 10% of patients Asthenia (G3/ 4:
Zelo pogosti neželeni učinki ≥ 10% bolnikov astenija (S3/ 4:
11%); Fever (G3/ 4:
11%), zvišana telesna temperatura (S3/ 4:
Immune system disorders Reproductive system and breast disorders
Bolezni imunskega sistema Motnje reprodukcije in dojk
1.1%) Amenorrhoea
1, 1%) amenoreja