natgillin/translations-raw huggingface dataset:
Respiratory, thoracic and mediastinal disorders
Respiratoorsed rindkere ja mediastiinumi häired
Epistaxis Dyspnoea
Ninaverejooks Düspnoe
28 (6.4%) 16 (3.6%)
28 (6, 4%) 16 (3, 6%)
1 (0.2%) 2 (0.5%)
1 (0, 2%) 2 (0, 5%)
0 (0.0%) 0 (0.0%)
0 (0, 0%) 0 (0, 0%)
18 (4.1%)
18 (4, 1%)
Very common Very common Very common Very common Very common Very common
Väga sage Väga sage Väga sage Väga sage Väga sage Väga sage
Diarrhoea Nausea Vomiting Stomatitis Dyspepsia Abdominal pain C / distension
Kõhulahtisus Iiveldus Oksendamine Stomatiit Düspepsia Kõhuvaluc / kõhu paisumine
187 (42.5%) 161 (36.6%) 98 (22.2%) 90 (20.5%) 80 (18.2%) 77 (17.5%)
187 (42, 5%) 161 (36, 6%) 98 (22, 2%) 90 (20, 5%) 80 (18, 2%) 77 (17, 5%)
24 (5.5%) 15 (3.4%) 7 (1.6%) 7 (1.6%) 4 (0.9%) 15 (3.4%)
24 (5, 5%) 15 (3, 4%) 7 (1, 6%) 7 (1, 6%) 4 (0, 9%) 15 (3, 4%)
0 (0.0%) 0 (0.0%) 0 (0.0%) 0 (0.0%) 0 (0.0%) 2 (0.5%)
0 (0, 0%) 0 (0, 0%) 0 (0, 0%) 0 (0, 0%) 0 (0, 0%) 2 (0, 5%)
Very common Very common Common Common Common Common
Väga sage Väga sage Sage Sage Sage Sage
Flatulence Oral pain Constipation Glossodynia Dry mouth Gastro-oesophageal reflux disease
Kõhupuhitus Suuvalu Kõhukinnisus Keelevalu Suukuivus Gastro- ösofageaalne reflukshaigus
46 (10.5%) 44 (10.0%) 37 (8.4%) 37 (8.4%) 31 (7.0%) 12 (2.7%)
46 (10, 5%) 44 (10, 0%) 37 (8, 4%) 37 (8, 4%) 31 (7, 0%) 12 (2, 7%)
0 (0.0%) 2 (0.5%) 2 (0.5%) 0 (0.0%) 0 (0.0%) 1 (0.2%)
0 (0, 0%) 2 (0, 5%) 2 (0, 5%) 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 (0, 0%) 0 (0, 0%) 0 (0, 0%) 0 (0, 0%) 0 (0, 0%)
Mouth ulceration Oral discomfort
Suu haavandumine Ebamugavustunne suus 9
11 (2.5%) 11 (2.5%)
11 (2, 5%) 11 (2, 5%)
Yellow skin/ Skin discolouration
Kollane nahk / naha värvimuutus
146 (33.2%)
146 (33, 2%)
tissue disorders
kahjustused
Palmar-plantar erythrodysaesthesia syndrome
Peopesade - jalataldade erütrodüsesteesia
106 (24.1%)
106 (24, 1%)
27 (6.1%)
27 (6, 1%)
Very common Very common Common Common Common Common Common Common Common Common Common
Väga sage Väga sage Sage Sage Sage Sage Sage Sage Sage Sage Sage
Hair colour changes Rash Dry skin Alopecia Dermatitis Periorbital oedema Skin Reaction Erythema Eczema Pruritus Skin hyperpigmentation
Juuksevärvi muutus Lööve Kuiv nahk Alopeetsia Dermatiit Silmaümbruse turse Nahareaktsioon Erüteem Ekseem Nahasügelus Naha hüperpigmentatsioon
67 (15.2%) 64 (14.5%) 41 (9.3%) 33 (7.5%) 29 (6.6%) 20 (4.5%) 20 (4.5%) 18 (4.1%) 16 (3.6%) 16 (3.6%) 15 (3.4%)
67 (15, 2%) 64 (14, 5%) 41 (9, 3%) 33 (7, 5%) 29 (6, 6%) 20 (4, 5%) 20 (4, 5%) 18 (4, 1%) 16 (3, 6%) 16 (3, 6%) 15 (3, 4%)
0 (0.0%) 3 (0.7%) 0 (0.0%) 0 (0.0%) 1 (0.2%) 0 (0.0%) 3 (0.7%) 0 (0.0%) 1 (0.2%) 0 (0.0%) 0 (0.0%)
0 (0, 0%) 3 (0, 7%) 0 (0, 0%) 0 (0, 0%) 1 (0, 2%) 0 (0, 0%) 3 (0, 7%) 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 (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%)
Skin exfoliation Blister Skin lesion
Naha eksfoliatsioon Villid Nahakahjustus
12 (2.7%) 10 (2.3%) 10 (2.3%)
12 (2, 7%) 10 (2, 3%) 10 (2, 3%)
0 (0.0%) 1 (0.2%) 1 (0.2%)
0 (0, 0%) 1 (0, 2%) 1 (0, 2%)
0 (0.0%) 0 (0.0%) 0 (0.0%)
0 (0, 0%) 0 (0, 0%) 0 (0, 0%)
Muscoloskeletal, connective tissue
Lihas- skeleti, sidekoe ja
Pain in extremity/ limb Arthralgia
Valu jäsemes/ jäsemetes
54 (12.3%) 39 (8.9%)
54 (12, 3%)
5 (1.1%) 3 (0.7%)
5 (1, 1%)
Grade 4 n (%)
0 (0, 0%)
and bone disorders
luude kahjustused
Common Common Common Common
Sage Sage Sage Sage Sage
Myalgia Muscle spasm Back pain Muscular weakness
Artralgia Müalgia Lihasspasm Seljavalu Lihasnõrkus
29 (6.6%) 21 (4.8%) 11 (2.5%) 10 (2.3%)
39 (8, 9%) 29 (6, 6%) 21 (4, 8%) 11 (2, 5%) 10 (2, 3%)
0 (0.0%) 1 (0.2%) 2 (0.5%) 1 (0.2%)
3 (0, 7%) 0 (0, 0%) 1 (0, 2%) 2 (0, 5%) 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%)
General disorders and administration site conditions Psychiatric disorders
Üldised häired ja manustamisko - ha reaktsioonid Psühhiaatrili - sed häired
Fatigue/ Asthenia Mucosal inflammation Oedema d Pyrexia Insomnia
Väsimus/ asteenia Limaskestade põletik Tursed Püreksia Unetus
287 (65.2%) 70 (15.9%) 59 (13.4%) 26 (5.9%) 14 (3.2%)
287 (65, 2%) 70 (15, 9%) 59 (13, 4%) 26 (5, 9%) 14 (3, 2%)
64 (14.5%) 6 (1.4%) 1 (0.2%) 2 (0.5%) 0 (0.0%)
64 (14, 5%) 6 (1, 4%) 1 (0, 2%) 2 (0, 5%) 0 (0, 0%)
5 (1.1%) 1 (0.2%) 0 (0.0%) 0 (0.0%) 0 (0.0%)
5 (1, 1%) 1 (0, 2%) 0 (0, 0%) 0 (0, 0%) 0 (0, 0%)
Lipase increase White blood cell count decreased e
Lipaasisisalduse suurenemine
35 (8.0%) 33 (7.5%)
35 (8, 0%)
12 (2.7%) 15 (3.4%)
12 (2, 7%)
7 (1.6%) 0 (0.0%)
7 (1, 6%)
Ejection fraction decreased
Vere valgeliblede arvu väheneminee
27 (6.1%)
33 (7, 5%)
5 (1.2%)
15 (3, 4%)
Haemoglobin decreased
Väljutusfraktsiooni vähenemine
6 (1.4%)
5 (1, 2%)
Platelet count decrease
Hemoglobiini vähenemine
25 (5.7%)
27 (6, 1%)
4 (0.9%)
6 (1, 4%)
1 (0.2%)
0 (0, 0%)
Weight decreased Blood creatinine phosphokinase increased
Vereliistakute arvu vähenemine
23 (5.2%) 22 (5.0%)
25 (5, 7%)
1 (0.2%) 1 (0.2%)
4 (0, 9%)
0 (0.0%) 1 (0.2%)
1 (0, 2%)
Amylase increased Aspartate aminotransferase increased
Kehakaalu vähenemine
21 (4.8%) 18 (4.1%)
23 (5, 2%)
8 (1.8%) 2 (0.5%)
1 (0, 2%)
0 (0.0%) 1 (0.2%)
0 (0, 0%)
Alanine aminotransferase increased
Kreatiinfosfokinaasi sisalduse suurenemine veres
12 (2.7%)
22 (5, 0%)
0 (0.0%)
1 (0, 2%)
Any adverse event
Amülaasisisalduse suurenemine
414 (94.1%)
21 (4, 8%)
204 (46.4%)
8 (1, 8%)
53 (12.0%)
0 (0, 0%)
System Organ Class
10 Organsüsteemi klass
Very common Very common
Sage
Neutropoenia Thrombocytopoenia
Aspartaadi aminotransferaasi sisalduse suurenemine
89 (16.4%) 86 (15.8%)
18 (4, 1%)
46 (8.5%) 37 (6.8%)
2 (0, 5%)
5 (0.9%) 5 (0.9%)
1 (0, 2%)
Very common Common Common
Sage
Anaemia Leukopoenia Lymphopenia
Alaniini aminotransferaasi sisalduse suurenemine
20 (3.7%) 16 (2.9%) 12 (2.2%)
12 (2, 7%)
3 (0.6%) 0 (0%) 1 (0.2%)
1 (0, 2%)
Endocrine
0 (0, 0%)
Very common
Muud kõrvaltoimed
Hypothyroidism
414 (94, 1%)
67 (12.3%)
204 (46, 4%)
7 (1.3%)
53 (12, 0%)
0 (0%)
Järgnevad terminid on ühendatud: a – anoreksia ja söögiisu vähenemine; b – düsgeuusia, asgeuusia ja maitsetundlikkuse häire; c – kõhuvalu ja valu ülakõhus; d – turse, perifeerne turse ja näopiirkonna turse; e – vere valgeliblede, neutrofiilide ja leukotsüütide arvu vähenemine.
10
Varem mitteravitud MRCC ja tsütokiin- refraktoorse MRCC uuringutes esinenud raviga seotud kõrvaltoimed
System Organ Class disorders
Organsüsteem
All Grades n (%)
Kõik raskusastme d n (%)
Common
Väga sage Väga sage Väga sage Sage Sage
Lacrimation increased
Neutropeenia Trombotsütopeenia Aneemia Leukopeenia Lümfopeenia
39 (7.2%)
89 (16, 4%) 86 (15, 8%) 67 (12, 3%) 45 (8, 3%) 21 (3, 9%)
0 (0%)
46 (8, 5%) 37 (6, 8%) 20 (3, 7%) 16 (2, 9%) 12 (2, 2%)
0 (0%)
5 (0, 9%) 5 (0, 9%) 3 (0, 6%) 0 (0%) 1 (0, 2%)
Common
Endokriinsüs - teemi häired
Eyelid oedema
Väga sage
a
Hüpotüreoos
12 (2.2%)
67 (12, 3%)
0 (0%)
7 (1, 3%)
Metabolism and nutrition disorders
Silma kahjustused Metabolismi - ja toitumishäired Närvisüsteemi häired
Very Common Common
Sage Sage Väga Sage Sage Väga sage
Decreased appetite Dehydration
Suurenenud pisaravool Silmalau turse Söögiisu langusa Dehüdratsioon Maitsetundlikkuse häireb
205 (37.7%) 33 (6.1%)
39 (7, 2%) 12 (2, 2%) 205 (37, 7%) 33 (6, 1%) 250 (46, 0%)
9 (1.7%) 7 (1.3%)
0 (0%) 0 (0%) 9 (1, 7%) 7 (1, 3%) 1 (0, 2%)
0 (0%) 1 (0.2%)
0 (0%) 0 (0%) 0 (0%) 1 (0, 2%) 0 (0%)
Very common Very common Common Common Common
Väga sage Sage Sage Sage Sage Sage
Taste disturbance b Headache Dizziness Paraesthesia Neuropathy peripheral
Peavalu Pearinglus Paresteesia Perifeerne neuropaatia Hüpesteesia Hüperesteesia
250 (46.0%) 82 (15.1%) 38 (7.0%) 36 (5.9%) 33 (6.1%)
82 (15, 1%) 38 (7, 0%) 36 (5, 9%) 33 (6, 1%) 20 (3, 7%) 17 (3, 1%)
1 (0.2%) 3 (0.6%) 2 (0.4%) 0 (0%) 1 (0.2%)
3 (0, 6%) 2 (0, 4%) 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%) 0 (0%) 0 (0%)
Common Common
Väga sage Sage Sage
Hypoaesthesia Hyperaesthesia
Hüpertensioon Nahaõhetus Kuumahood
20 (3.7%) 17 (3.1%)
143 (26, 3%) 17 (3, 1%) 12 (2, 2%)
0 (0%) 0 (0%)
55 (10, 1%) 0 (0%) 0 (0%)
Vascular disorders
Hingamisteede, rindkere - ja mediastiinumi häired
Very common Common Common
Väga sage Sage Sage Sage Sage Sage
Hypertension Flushing Hot flush
Ninaverejooks Düspnoe Kurgu - ja neeluvalu Köha Düsfoonia Nina kuivus
143 (26.3%) 17 (3.1%) 12 (2.2%)
86 (15, 8%) 45 (8, 3%) 29 (5, 3%) 23 (4, 2%) 16 (2, 9%) 14 (2, 6%)
55 (10.1%) 0 (0%) 0 (0%)
3 (0, 6%) 6 (1, 1%) 2 (0, 4%) 0 (0%) 0 (0%) 0 (0%)
Respiratory, thoracic and
0 (0%) 0 (0%) 0 (0%) 0 (0%) 0 (0%) 0 (0%)
Very common
11 Organsüsteem
3 (0.6%)
Sagedus
mediastinal
Kõrvaltoimed
45 (8.3%)
Kõik raskusastme d n (%)
0 (0%)
3. raskusaste n (%)
0 (0%)
4. raskusaste n (%)
Common Common Common Common Common Common
Sage Sage Sage
Cough Dysphonia Nasal dryness Dyspnoea exertional Nasal congestion Pleural effusion
Pingutusdüspnoe Ninakinnisus Pleuraefusioon
23 (4.2%) 16 (2.9%) 14 (2.6%) 12 (2.2%) 12 (2.2%) 12 (2.2%)
12 (2, 2%) 12 (2, 2%) 12 (2, 2%)
0 (0%) 0 (0%) 0 (0%) 0 (0%) 0 (0%) 3 (0.6%)
0 (0%) 0 (0%) 3 (0, 6%)
0 (0%) 0 (0%) 0 (0%) 0 (0%) 0 (0%) 0 (0%)
0 (0%) 0 (0%) 0 (0%)
Gastrointestinal disorders
Seedetrakti - häired
Diarrhoea Nausea Dyspepsia Stomatitis Vomiting Abdominal pain c / distension
Kõhulahtisus Iiveldus Düspepsia Stomatiit Oksendamine Kõhuvaluc / kõhu paisumine
326 (59.9%) 290 (53.3%) 189 (34.7%) 185 (34.0%) 178 (32.7%) 106 (19.5%)
326 (59, 9%) 290 (53, 3%) 189 (34, 7%) 185 (34, 0%) 178 (32, 7%) 106 (19, 5%)
38 (7.0%) 19 (3.5%) 8 (1.5%) 13 (2.4%) 17 (3.1%) 10 (1.8%)
38 (7, 0%) 19 (3, 5%) 8 (1, 5%) 13 (2, 4%) 17 (3, 1%) 10 (1, 8%)
Very common Very common Very common Very common Very common Common
Väga sage Väga sage Väga sage Väga sage Väga sage Sage
Constipation Glossodynia Flatulence Oral pain Dry mouth Gastroesophageal reflux disease
Kõhukinnisus Keelevalu Kõhupuhitus Suuvalu Suukuivus Gastro- ösofageaalne reflukshaigus
83 (15.3%) 63 (11.6%) 60 (11.0%) 60 (11.0%) 56 (10.3%) 50 (9.2%)
83 (15, 3%) 63 (11, 6%) 60 (11, 0%) 60 (11, 0%) 56 (10, 3%) 50 (9, 2%)
1 (0.2%) 0 (0%) 0 (0%) 2 (0.4%) 0 (0%) 2 (0.4%)
1 (0, 2%) 0 (0%) 0 (0%) 2 (0, 4%) 0 (0%) 2 (0, 4%)
Common Common Common Common Common Common Common Common
Sage Sage Sage Sage Sage Sage Sage
Dysphagia Cheilitis Gingival bleeding Haemorrhoids Proctalgia Mouth ulceration Stomach discomfort Rectal haemorrhage
Düsfaagia Keelepõletik Igemeverejooks Hemorroidid Proktalgia Suuhaavandid Ebamugavustunne maos
20 (3.7%) 19 (3.5%) 18 (3.3%) 18 (3.3%) 17 (3.1%) 16 (2.9%) 15 (2.8%) 13 (2.4%)
20 (3, 7%) 19 (3, 5%) 18 (3, 3%) 18 (3, 3%) 17 (3, 1%) 16 (2, 9%) 15 (2, 8%)
2 (0.4%) 1 (0.2%) 0 (0%) 0 (0%) 1 (0.2%) 0 (0%) 0 (0%) 0 (0%)
2 (0, 4%) 1 (0, 2%) 0 (0%) 0 (0%) 1 (0, 2%) 0 (0%) 0 (0%)
1 (0.2%) 1 (0.2%) 0 (0%) 0 (0%) 0 (0%) 1 (0.2%) 0 (0%) 0 (0%)
1 (0, 2%) 1 (0, 2%) 0 (0%) 0 (0%) 0 (0%) 1 (0, 2%) 0 (0%)
11
Sage
Adverse Reactions
Pärasoole verejooks
All Grades n (%)
13 (2, 4%)
Grade 3 n (%)
0 (0%)
Grade 4 n (%)
0 (0%)
Palmar-plantar erythrodysaesthesia syndrome
Peopesade- jalataldade erütrodüsesteesia
144 (26.5%)
144 (26, 5%)
46 (8.5%)
46 (8, 5%)
Yellow discolouration/ Skin discolouration
Naha kollasus / naha värvimuutus
Very common Very common Very common Very common Common Common Common Common Common Common Common
Väga sage Väga sage Väga sage Väga sage Sage Sage Sage Sage Sage Sage Sage
Rash Dry skin Hair colour changes Alopecia Erythema Skin exfoliation Pruritus Periorbital oedema Dermatitis Skin lesion Nail disorder/ discolouration
Lööve Kuiv nahk Juuste värvi muutus Alopeetsia Erüteem Naha eksfoliatsioon Nahasügelus Silmaümbruse turse Dermatiit Nahakahjustus Küünte kahjustus / värvimuutus
121 (22.2%) 108 (19.9%) 103 (18.9%) 64 (11.8%) 51 (9.4%) 47 (8.6%) 40 (7.4%) 31 (5.7%) 27 (5.0%) 26 (4.8%) 25 (4.6%)
121 (22, 2%) 108 (19, 9%) 103 (18, 9%) 64 (11, 8%) 51 (9, 4%) 47 (8, 6%) 40 (7, 4%) 31 (5, 7%) 27 (5, 0%) 26 (4, 8%) 25 (4, 6%)
2 (0.4%) 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%)
2 (0, 4%) 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%)
1 (0.2%) 0 (0%) 0 (0%) 0 (0%) 0 (0%) 0 (0%) 0 (0%) 0 (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%)
Blister Skin reaction Hyperkeratosis Acne
Villid Nahareaktsioon Hüperkeratoos Akne
23 (4.2%) 23 (4.2%) 22 (4.0%) 19 (3.5%)
23 (4, 2%) 23 (4, 2%) 22 (4, 0%) 19 (3, 5%)
1 (0.2%) 6 (1.1%) 4 (0.7%) 0 (0%)
1 (0, 2%) 6 (1, 1%) 4 (0, 7%) 0 (0%)
Musculoskeletal and connective tissue disorders
12 Skeleti - lihassüsteemi ja sidekoe häired
Very common Common Common Common Common
Väga sage Sage Sage Sage Sage
Pain in extremity Arthralgia Myalgia Muscle Spasm Back pain
Valu jäsemetes Artralgia Müalgia Lihasspasm Seljavalu
96 (17.6%) 49 (9.0%) 48 (8.8%) 26 (4.8%) 17 (3.1%)
96 (17, 6%) 49 (9, 0%) 48 (8, 8%) 26 (4, 8%) 17 (3, 1%)
6 (1.1%) 1 (0.2%) 2 (0.4%) 0 (0%) 2 (0.4%)
6 (1, 1%) 1 (0, 2%) 2 (0, 4%) 0 (0%) 2 (0, 4%)
General disorders and administration
Üldised häired ja
Fatigue/ asthenia Mucosal inflammation
Väsimus/ asteenia
397 (73.0%) 127 (23.3%)
397 (73, 0%)
95 (17.5%) 8 (1.5%)
95 (17, 5%)
1 (0.2%) 0 (0%)
1 (0, 2%)
Very common Common Common Common Common
manustamiskoha Väga sage reaktsioonid Väga sage Sage Sage Sage Sage Psühhiaatrilised Sage häired Sage Uuringud Väga sage
Oedema d Pyrexia Chills Pain Chest pain
Limaskesta põletik Tursedd Püreksia Külmavärinad Valu Valu rindkeres Unetus Depressioon Väljutusfraktsiooni vähenemine
99 (18.2%) 37 (6.8%) 35 (6.4%) 20 (3.7%) 13 (2.4%)
127 (23, 3%) 99 (18, 2%) 37 (6, 8%) 35 (6, 4%) 20 (3, 7%) 13 (2, 4%) 22 (4, 0%) 15 (2, 8%) 84 (15, 4%)
5 (0.9%) 3 (0.6%) 2 (0.4%) 0 (0%) 2 (0.4%)
8 (1, 5%) 5 (0, 9%) 3 (0, 6%) 2 (0, 4%) 0 (0%) 2 (0, 4%) 0 (0, 0%) 1 (0, 2%) 16 (2, 9%)
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%)
Common Common Very common
Väga sage
Insomnia Depression Ejection fraction decreased
Kehakaalu vähenemine
22 (4.0%) 15 (2.8%) 84 (15.4%)
57 (10, 5%)
0 (0%) 1 (0.2%) 16 (2.9%)
1 (0, 2%)
Very common Common
Sage
Weight decreased Platelet count decreased
Trombotsüütide arvu vähenemine
57 (10.5%) 41 (7.5%)
41 (7, 5%)
1 (0.2%) 15 (2.8%)
15 (2, 8%)
0 (0%) 2 (0.4%)
2 (0, 4%)
White blood cell count decreased e
Vere valgeliblede arvu väheneminee
37 (6.8%)
37 (6, 8%)
16 (2.9%)
16 (2, 9%)
Lipase increased Haemoglobin decreased
Lipaasi sisalduse suurenemine
36 (6.6%) 25 (4.6%)
36 (6. 6%)
19 (3.5%) 8 (1.5%)
19 (3. 5%)
11 (2%) 0 (0%)
11 (2%)
Blood creatine phosphokinase increased
Hemoglobiinisisalduse vähenemine
19 (3.5%)
25 (4, 6%)
7 (1.3%)
8 (1, 5%)
2 (0.4%)
0 (0%)
Aspartate aminotransferase
Kreatiniinfosfokinaasi sisalduse suurenemine veres
18 (3.3%)
19 (3, 5%)
7 (1.3%)
7 (1, 3%)
0 (0%)
2 (0, 4%)
12
Sage
Adverse Reactions increased
Aspartaadi aminotransferaasi sisalduse suurenemine
All Grades n (%)
18 (3, 3%)
Grade 3 n (%)
7 (1, 3%)
Blood amylase increased
Vere amülaasisisalduse suurenemine
18 (3.3%)
18 (3, 3%)
11 (2.0%)
11 (2, 0%)
2 (0.4%)
2 (0, 4%)
15 (2.8%)
15 (2, 8%)
Blood pressure increased
Vererõhu tõus Alaniini aminotransferaasi sisalduse suurenemine
15 (2.8%)
15 (2, 8%) 14 (2, 6%)
2 (0.4%)
2 (0, 4%) 7 (1, 3%)
0 (0%)
0 (0%) 2 (0, 4%)
Alanine aminotransferase increased
Järgnevad terminid on ühendatud: a – anoreksia ja söögiisu vähenemine; b
Any adverse event
Kõik kõrvaltoimed
524 (96.3%)
524 (96, 3%)
296 (54.4%)
296 (54, 4%)
57 (10.5%)
57 (10, 5%)
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
– düsgeuusia, asgeuusia ja maitsetundlikkuse häire; c – kõhuvalu ja valu ülakõhus; d – turse, perifeerne turse ja näopiirkonna turse; e – vere valgeliblede, neutrofiilide ja leukotsüütide arvu vähenemine.
Adverse reactions from post-marketing experience
13 Kõrvaltoimed pärast turuletoomist
The following adverse reactions have been identified during post-approval use of SUTENT.
Pärast SUTENTi turustamist on teatatud järgmist tüüpi reaktsioonidest.
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.
Need hõlmavad nii spontaanseid kõrvaltoimeid kui ka tõsiseid kõrvaltoimeid käimasolevatest kliinilistest uuringutest, laiendatud turuletuleku programmidest, kliinilise farmakoloogia uuringutest ja registreerimata näidustustel läbi viidud kliinilistest uuringutest.
Rare:
Südame häired Aeg- ajalt:
Cardiac failure, cardiac failure congestive, left ventricular failure Prolonged QT interval, Torsade de pointes
Südamepuudulikkus, südame paispuudulikkus, südame vasaku vatsakese puudulikkus
Pancreatitis Gastrointestinal perforation
Pankreatiit Seedetrakti perforatsioon
Hepatobiliary disorders:
Maksa ja sapiteede häired Aeg- ajalt:
Uncommon:
Uuringud
Elevated thyroid stimulating hormone (TSH)
Kilpnääret stimuleeriva hormooni (TSH) sisalduse suurenemine
Infections and Infestations Non known:
Infektsioonid ja infestatsioonid Teadmata sagedus:
Muscoloskeletal and Not known:
Lihas- skeleti ja sidekoe kahjustused Teadmata sagedus:
Pulmonary disorders
Kopsu kahjustused
Infections (with or without neutropoenia) connective tissue disorders Myopathy and/ or rhabdomyolysis
Müopaatia ja/ või rabdomüolüüs
Not known:
Teadmata sagedus:
Not known:
Teadmata sagedus
Pleural effusion Pulmonary embolism and respiratory failure
Pulmonaaremboolia ja hingamispuudulikkus
Thromboembolic events:
Trombemboolilised sündmused:
Cases of pulmonary embolism, in some cases with fatal outcome, have been reported.
On teatatud kopsuarteri trombemboolia juhtudest, mis mõnikord on olnud fataalsed.
Cases of serious infection (with or without neutropoenia), including pneumonia, have been reported.
On teatatud tõsistest infektsiooni juhtudest (neutropeeniaga või ilma), sealhulgas pneumoonia.
Few cases had a fatal outcome.
Mõned neist on olnud fataalsed.
Rare cases of myopathy and/ or rhabdomyolysis, some with acute renal failure, have been reported.
Teatatud on harvadest müopaatia ja/ või rabdomüolüüsi juhtudest, mõnikord on nende esinemisel kaasnenud ka äge neerupuudulikkus.
Patients with signs or symptoms of muscle toxicity should be managed as per standard medical practice.
Lihastoksilisuse nähtude ja sümptomitega patsiente tuleb ravida tavapärasel viisil.
13 Blood and lymphatic system disorders:
Vere ja lümfisüsteemi häired:
Rare cases of thrombotic microangiopathy have been reported.
Harvadel juhtudel on teatatud trombootilisest mikroangiopaatiast.
Temporary suspension of SUTENT is recommended; following resolution, treatment may be resumed at the discretion of the treating physician.
Sellisel juhul on soovitatav SUTENTi manustamine ajutiselt katkestada, pärast seisundi lahenemist võib raviarsti otsusel ravi jätkata.
Endocrine Disorders:
Endokriinsüsteemi häired:
Rare cases of hyperthyroidism, some followed by hypothyroidism, have been reported in clinical trials and through post-marketing experience (See also section 4.4).
Kliinilistes uuringutes ja turustamisjärgselt on harvadel juhtudel teatatud hüpertüreoosist, millele osadel juhtudel on järgnenud hüpotüreoos (vt lõik 4. 4).
Cases of proteinuria and rare cases of nephrotic syndrome have been reported.
Harvadel juhtudel on teatatud proteinuuriat ja nefrootilist sündroomi.
The safety of continued SUTENT treatment in patients with moderate to severe proteinuria has not been systematically evaluated.
SUTENT- ravi jätkamise ohutust mõõduka või raske proteinuuriaga patsientidel ei ole süstemaatiliselt hinnatud.
Discontinue SUTENT in patients with nephrotic syndrome (see also section 4.4).
Nefrootilise sündroomi korral tuleb SUTENTi manustamine lõpetada (vt lõik 4. 4).
4.9 Overdose
14 4. 9 Üleannustamine
There is no experience of acute overdosage with SUTENT.
SUTENTi ägedast üleannustamisest ei ole teatatud.
There is no specific antidote for overdosage with SUTENT and treatment of overdose should consist of general supportive measures.
SUTENTi üleannustamise puhul ei ole spetsiifilist antidooti ja üleannustamise ravi peab hõlmama üldisi toetavaid meetmeid.
If indicated, elimination of unabsorbed drug may be achieved by emesis or gastric lavage.
Kui näidustatud, võib imendumata ravimi eliminatsiooni esile kutsuda oksendamise või maoloputusega.
Antineoplastic agents - Protein-tyrosine kinase inhibitor, ATC Code:
Antineoplastilised ained- Proteiin- türosiini kinaasi inhibiitor, ATC- kood:
LO1XE04
L01XE04
Sunitinib malate inhibits multiple receptor tyrosine kinases (RTKs) that are implicated in tumour growth, pathologic angiogenesis, and metastatic progression of cancer.
Sunitiniibmalaat inhibeerib paljusid retseptori türosiini kinaase (RTK- d), mis on seotud kasvaja kasvamise, patoloogilise angiogeneesi ja metastaatilise progresseerumisega.
Sunitinib was identified as inhibitor of platelet-derived growth factor receptors (PDGFRα and PDGFRβ), vascular endothelial growth factor receptors (VEGFR1, VEGFR2 and VEGFR3), stem cell factor receptor (KIT), Fms-like tyrosine kinase-3 (FLT3), colony stimulating factor receptor (CSF-1R), and the glial cell-line derived neurotrophic factor receptor (RET).
Sunitiniib identifitseeriti kui vereliistakutest pärit kasvufaktori retseptori (PDGFR- α ja PDGFR- β), veresoonte endoteeli kasvufaktori retseptori (VEGFR1, VEGFR2 ja VEGFR3), tüvirakkude faktori retseptori (KIT), Fms - sarnase türosiini kinaas- 3 (FLT3), kolooniaid stimuleeriva faktori retseptori (CSF- 1R) ja gliiarakkude rakuliinist pärit neurotroofse faktori retseptori (RET) inhibiitor.
CLINICAL STUDIES The clinical safety and efficacy of SUTENT has been studied in the treatment of patients with malignant gastrointestinal stromal tumour (GIST) who were resistant to imatinib (i. e. those who experienced disease progression during or following treatment with imatinib) or intolerant to imatinib (i. e. those who experienced significant toxicity during treatment with imatinib that precluded further treatment) and the treatment of patients with metastatic renal cell carcinoma (MRCC) Efficacy is based on time to tumour progression and an increase in survival in GIST and on progression free survival and objective response rates for treatment-naïve and cytokine-refractory MRCC respectively.
Tõhusus põhineb vastavalt ajal kasvaja progresseerumiseni ja elulemuse suurenemisel GIST- i puhul ning progresseerumisvabal elulemusel ja objektiivsetel vastuse tasemetel varem mitteravitud ja tsütokiin- refraktaarse MRCC puhul.
Gastrointestinal Stromal Tumours An initial open-label, dose-escalation study was conducted in patients with GIST after failure of imatinib (Median maximum daily dose 800 mg) due to resistance or intolerance.
Gastrointestinaalsed stromaaltuumorid GISTiga patsientidel viidi pärast imatiniibravi (mediaanne maksimaalne ööpäevane annus 800 mg) ebaõnnestumist kas resistentsuse või talumatuse tõttu läbi esialgne avatud suureneva annusega uuring.
Ninety-seven patients were enrolled at various doses and schedules; 55 patients received 50 mg at the recommended treatment schedule 4 weeks on / 2 weeks off (“ schedule 4/ 2”).
Erinevate annuserühmade ja manustamisskeemidega uuringusse hõlmati 97 patsienti, 55 patsienti sai 50 mg soovitatud 4- nädalase raviskeemi järgi, seejärel oli 2- nädalane vahe ("skeem 4/ 2").
In this study the median Time To Progression (TTP) was 34.0 weeks (95% CI = 22.0 – 46.0 weeks).
Selles uuringus oli mediaanaeg haiguse progresseerumiseni (time to progression, TTP) 34, 0 nädalat (95% CI=22, 0... 46, 0 nädalat).
A phase 3, randomized, double-blind, placebo-controlled study of SUTENT was conducted in patients with GIST who were intolerant to, or had experienced disease progression during or following treatment with, imatinib (Median maximum daily dose 800 mg).
SUTENTi III faasi randomiseeritud topeltpime platseeboga kontrollitud uuring viidi läbi GISTiga patsientidel, kes ei talunud imatiniibi (mediaanne maksimaalne ööpäevane annus 800 mg) või kelle haigus imatiniibravi ajal või pärast seda progresseerus.