Det er nå øyet som ser. Se på den listen her, og ha i mente at du skal behandles 1-2 ganger i uken i 9 måneder. Tror det blir 9 tunge måneder. Og husk at dette er en miks av 5mg, 12mg og 18mg. Nå går de videre med de høyeste doseringene, hvordan blir bivirkningene da?
Og hva skjer når pasienten går av behandling, stopper effekten av behandlingen?
• Majority of adverse events were mild to moderate in severity.
• No DLTs reported to date in patients with B-NHL.
• Fifty-one patients (75.0%) experienced at least one adverse event of
grade 3/4/5 severity.
• No clinically significant neurotoxicity has been observed, including no
seizure and/or encephalopathy.
• Twenty-eight patients (41.2%) experienced at least one nervous system
adverse event of any grade and attribution; those occurring in two or more
patients were headache (19.1%), dizziness (13.2%), paresthesia (4.4%),
neuropathy peripheral (4.4%), and somnolence (2.9%).
- Two patients experienced grade ≥3 nervous system events: one had
depressed level of consciousness that was judged by the investigator
to be unrelated to the study drug and the other patient had transient
(<48 hours) somnolence in the setting of cytokine release syndrome
(CRS) associated with study drug. No neurological event required
termination of the study drug.
• Twenty-eight patients (41.2%) experienced at least one adverse event of
infection and infestations, of which seven patients (10.3%) had at least one
grade 3/4 event.
• Two patients discontinued treatment due to related adverse events:
grade 3 hemolysis and grade 3 fatigue.
• Three patients died due to adverse events during the study. Reasons for
death per investigator and sponsor assessments are as follows:
- A fatal event of multi-organ failure deemed unrelated to REGN1979.
Primary reason of death was due to PD;
- A fatal event of cardiac arrest deemed unrelated to REGN1979;
- A fatal event of gastric perforation attributed to REGN1979. The patient
had demonstrated involvement of the gastric wall with lymphoma
I tillegg defineres CR på en litt an måte, det ser man på tumoreduksjon.
A metabolic response is any reaction by the body to a specific influence or impact. Metabolism is a general term describing the organic process in any cellular structure. A metabolic response can occur with respect to individual cells, a gland, an organ, or a process such as the cardiovascular system. Metabolism is often understood in terms of the metabolic rate, which is the amount of energy expended by the body in a given period. Metabolic response, when stated without reference to a specific action, is a neutral term; metabolic responses occur and may be correspondingly assessed or measured in respect of a wide variety of circumstances.