COMMON TERMINOLOGY in English translation

Gradering op basis van de National Cancer Institute(NCI) Common Terminology Criteria for Adverse Events(CTCAE) v3.0.

Grading based on National Cancer Institute(NCI) Common Terminology Criteria for Adverse Events(CTCAE) v3.0.

NB: toxiciteitsgraden zijn overeenkomstig de National Cancer Institute Common Terminology Criteria for Adverse Events Version 4 NCI-CTCAE v.4.

Note: toxicity grades are in accordance with National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0 NCI-CTCAE v.4.

Opmerking: Graden van toxiciteit zijn in overeenstemming met National Cancer Institute Common Terminology Criteria for Adverse Events versie 4 NCI-CTCAE v4.

Note: Toxicity grades are in accordance with National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0 NCI-CTCAE v4.

Als een patiënt een onverdraagbare of ernstige huidreactie(≥ graad 3; Common Terminology Criteria for Adverse Events, CTCAE) ervaart, moet de behandeling met cetuximab onderbroken worden.

If a patient experiences an intolerable or severe skin reaction( grade 3; Common Terminology Criteria for Adverse Events, CTCAE), cetuximab therapy must be interrupted.

De dosis dient aangepast te worden als patiënten de volgende bijwerkingen vertonen de graden verwijzen naar de CTCAE(Common Terminology Criteria for Adverse Events) versie 4.

Dose modifications should be made if patients experience the following adverse reactions Grades refer to Common Terminology Criteria for Adverse Events CTCAE 4.0.

Iclusig wordt in verband gebracht met ernstige(graad 3 of 4 volgens de Common Terminology Criteria for Adverse Events van het National Cancer Institute)

Iclusig is associated with severe(National Cancer Institute Common Terminology Criteria for Adverse Events grade 3 or 4)

A Opmerking: Classificatie van de ernst van de bijwerkingen op basis van de National Cancer Institute(NCI) Common Terminology Criteria for Adverse Events(CTCAE), versie 4.

A Note: The intensity of clinical adverse events graded by the National Cancer Institute(NCI) Common Terminology Criteria for Adverse Events(CTCAE) version 4.0.

Alle rapportage is gebaseerd op bijwerkingen van alle gradaties aan de hand van de National Cancer Institute- Common Terminology Criteria for Adverse Events v 3.0, tenzij anders aangegeven.

All reporting is based on ADRs of all grades using National Cancer Institute- Common Terminology Criteria for Adverse Events v 3.0 except where noted.

De toediening van nelarabine moet worden gestaakt bij de eerste tekenen van een neurologische afwijking vermeld in de Common Terminology Criteria Adverse Event(NCI CTCAE)

Nelarabine must be discontinued at the first sign of neurological events of National Cancer Institute Common Terminology Criteria Adverse Event(NCI CTCAE)

de patiënt een toxiciteit ontwikkelt, die volgens de bijwerkingencriteria(Common Terminology Criteria for Adverse Events, CTCAE) van het NCI gelijk of ernstiger is dan graad 2.

equal to grade 2 on the National Cancer Institute Common Terminology Criteria for Adverse Events NCI CTCAE.

Let op: De gradering van de toxiciteit is in overeenstemming met de terminologiecriteria van het National Cancer Institute Common Terminology Criteria for Adverse Events Version 4(NCI-CTCAE v4). a Aanbevelingen voor het gebruik van hormonale substitutietherapie zijn beschreven in rubriek 4.4.

Note: Toxicity grades are in accordance with National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0(NCI-CTCAE v4). a Recommendation for the use of hormone replacement therapy is provided in section 4.4.

Ernstige bijwerkingen(zoals gedefinieerd door het National Cancer Institute Common Terminology Criteria for Adverse Events(NCI CTCAE graad ≥ 3)

Severe adverse events(defined according to National Cancer Institute Common Terminology Criteria for Adverse Events(NCI CTCAE grade≥3) version 3.0) were equally distributed

de meest voorkomende graad ≥ 3 bijwerkingen volgens de Common Terminology Criteria for Adverse Events van het National Cancer Institute(NCI-CTCAE)(>

of Grade 1 or 2 severity. the most common National Cancer Institute- Common Terminology Criteria for Adverse Events(NCI-CTCAE) Grade≥ 3 ADRs(> 2%) were thrombocytopenia,

hoger volgens het National Cancer Institute Common Terminology Criteria for Adverse Events(NCI CTCAE)

that are National Cancer Institute Common Terminology Criteria for Adverse Events(NCI CTCAE)

Wanneer een geval van CTCAE graad 3(Common Terminology Criteria for Adverse Events schaal)

In the event of common terminology criteria for adverse events(CTCAE) grade 3

Stop de behandeling met olaratumab onmiddellijk en permanent(zie rubriek 4.4). a Gradering van bijwerkingen volgens de Amerikaanse indeling van het National Cancer Institute(National Cancer Institute Common Terminology Criteria for Adverse Events,

Immediately and permanently discontinue treatment with olaratumab(see section 4.4). a Grade per National Cancer Institute Common Terminology Criteria for Adverse Events(NCI CTCAE), Version 4.03 b

Common terminology used in professional service organizations,

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